UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES May 29, 2002 Memorandum SUBJECT: Carbaryl: Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document. PC Code 056801; Submission No. S533427 ;DP Barcode: D281418.

FROM: Jeffrey L. Dawson, Chemist/ Risk Assessor Reregistration Branch 1 Health Effects Division (7509C)

THROUGH: Whang Phang, PhD, Senior Scientist Reregistration Branch 1 Health Effects Division (7509C)

TO: Anthony Britten, Chemical Review Manager Reregistration Branch Special Review and Registration Division Reviewers: Science Advisory Committee on Exposure; Alan Nielsen. Risk Assessment Review Committee (June 6, 2001 Report)

This document presents updated occupational and residential exposures/ risks which have been calculated due to recent changes in the hazard assessment for carbaryl (April 25, 2002 HIARC Meeting) and changes in the FQPA safety factor from 10 to 1 based on recent policy changes (April 3, 2002 FQPA SFC Report). Several modifications to the exposure assessment have also been incorporated due to recent changes in Exposure SAC Policy (e. g., how risks from pet use products are calculated, the use of ARTF data from greenhouses, and mosquito control applications), the submission of a Sevin XLR Label for mosquito control, and changes in the short term/ intermediateterm exposure duration interface from 7 days to 30 days. Also included in this document is a sitespecific assessment of risks associated with a Section 24C (SLN WA 900013) where carbaryl is intended to control Ghost and Mud Shrimp in oyster beds. Table of Contents Executive Summary.............................................................. 4 1.0 Occupational and Residential Exposure/ Risk Assessment ......................... 12 1.1 Purpose .............................................................. 12 1.2 Criteria for Conducting Exposure Assessments .............................. 12 1.3 Summary of Hazard Concerns ......................................... 12 1. 4 Incident Reports.................................................... 14 1. 5 Summary of Use Patterns and Formulations .............................. 14 1.5.1 End Use Products ............................................ 15 1.5.2 Mode of Action and Targets Controlled ........................... 17 1.5.3 Registered Use Categories and Sites ............................. 18 1.5.4 Application Parameters ....................................... 22 2.0 Occupational Exposures and Risks .......................................... 25 2.1 Occupational Handler Exposures and Risks ................................. 25 2.1.1 Handler Exposure Scenarios .................................... 26 2.1.2 Data and Assumptions For Handler Exposure Scenarios .............. 30 2.1.3 Occupational Handler Exposure and Non Cancer Risk Estimates ....... 45 2.1.4 Occupational Handler Exposure and Risk Estimates for Cancer. ........ 56 2.1.5 Summary of Risk Concerns and Data Gaps for Handlers .............. 62 2.1.6 Recommendations For Refining Occupational Handler Risk Assessment . 63 2.2 Occupational Postapplication Exposures and Risks ........................ 63 2.2.1 Occupational Postapplication Exposure Scenarios ................... 63 2.2.2 Data and Assumptions for Occupational Postapplication Exposure Scenarios ........................................................... 69 2.2.3 Occupational Postapplication Exposure and Noncancer Risk Estimates . . 77 2.2.4 Occupational Postapplication Exposure and Risk Estimates for Cancer ........................................................... 86 2.2.5 Summary of Occupational Postapplication Risk Concerns and Data Gaps ........................................................... 92 2.2.6 Recommendations For Refining Occupational Postapplication Risk Assessment.................................................. 93 2. 3 Occupational Risk Characterization .................................... 93 2.3.1 Handler Characterization ....................................... 93 2.3.2 Postapplication Characterization ................................. 95 3.0 Residential and Other Non Occupational Exposures and Risks ..................... 97 3.1 Residential Handler Exposures and Risks ................................ 97 3.1.1 Handler Exposure Scenarios .................................... 98 3.1.2 Data and Assumptions For Handler Exposure Scenarios .............. 99 3.1.3 Residential Handler Exposure and Non Cancer Risk Estimates ........ 108 3.1.4 Residential Handler Exposure and Risk Estimates for Cancer ......... 113 3.1.5 Summary of Risk Concerns and Data Gaps for Handlers ............. 117 3.1.6 Recommendations For Refining Residential Handler Risk Assessment . . 117 3.2 Residential Postapplication Exposures and Risks ......................... 117 3.2.1 Residential Postapplication Exposure Scenarios .................... 118 3.2.2 Data and Assumptions for Residential Postapplication Exposure Scenarios .......................................................... 123 3.2.3 Residential Postapplication Exposure and Noncancer Risk Estimates . . . 129 3.2.4 Residential Postapplication Exposure and Risk Estimates for Cancer . . . 142 3.2.5 Summary of Residential Postapplication Risk Concerns and Data Gaps . 144 3.2.6 Recommendations For Refining Residential Postapplication Risk Assessment .......................................................... 146 3. 3 Residential Risk Characterization ..................................... 146 3.3.1 Handler Characterization ...................................... 146 3.3.2 Postapplication Characterization ................................ 147 Appendix A: Use Information For Carbaryl Appendix B: Carbaryl Occupational Handler Exposure Data Appendix C: Carbaryl Occupational Handler Risk Assessment Appendix D: Carbaryl Residue Dissipation (DFR & TTR) Data Appendix E: Carbaryl Occupational Postapplication Risk Assessment Appendix F: Carbaryl Residential Handler Exposure Data Appendix G: Carbaryl Residential Handler Risk Assessment Appendix H: Carbaryl Residential Postapplication Risk Assessment For Turf Uses Appendix I: Carbaryl Residential Postapplication Risk Assessment For Garden/ Ornamental Uses Appendix J: Carbaryl Residential Postapplication Risk Assessment For Pet Uses Appendix K: Determination of Deposition Factors For Carbaryl Mosquito Control Uses Appendix L: Carbaryl Residential Postapplication Risk Assessment For Mosquito Control Appendix M: Carbaryl Residential Postapplication Risk Assessment For Oyster Bed Uses 4 Executive Summary Carbaryl [1 napthyl methylcarbamate] is one of the most widely used broadspectrum insecticides in agriculture, professional turf management, professional ornamental production, and in the residential pet, lawn and garden markets. Carbaryl formulations include baits, dusts, pet collars, flowable concentrates, emulsifiable concentrates, granulars, soluble concentrates, and wettable powders. Carbaryl is used in agriculture to control pests on terrestrial food crops including fruit and nut trees (e. g., apples, pears, almonds, walnuts, and citrus), many types of fruit and vegetables (e. g., cucumbers, tomatoes, lettuce, blackberries, and grapes), and grain crops (e. g., corn, rice, sorghum, and wheat). Carbaryl is also used for direct animal treatments to control pests on poultry and companion animals such as dogs and cats. There are other uses for ornamentals and turf, including production facilities such as greenhouses, golf courses, and residential sites that can be treated by professional applicators (e. g., annuals, perennials, shrubs). Carbaryl can also be used by homeowners on lawns, for home and garden uses, and on companion animals. There are no labels for indoor uses such as crack and crevice treatments of a residence. In agriculture, groundboom, airblast, and aerial applications are typical. Other applications can also be made using handheld equipment such as low pressure handwand sprayers, backpack sprayers, and turfguns. Homeowners can also use other types of application equipment including trigger sprayers, hose end sprayers, and ready to use dust packaging. Carbaryl also has more specialized uses that can lead to exposures in the general population which were considered in this assessment such as an adulticide for mosquito control and for Ghost and Mud shrimp control in oyster beds in Washington State.

A number of studies were considered in the development of the carbaryl risk assessment that include scenario and/ or chemical specific handler exposure data for occupational uses and also for residential uses. Chemical specific residue dissipation data were also considered for agricultural crops, turf, and the oyster bed uses. The occupational handler exposure studies that were used, quantified: exposure to pet groomers using a carbaryl containing shampoo; exposure during application of a granular with two different backpack devices and spoons; application with a trigger sprayer; and application to turf with high volume/ low pressure handgun for liquid sprays and a granular spreader. There are no data compensation issues associated with any of these data. In all other cases, occupational handler exposure was addressed using PHED (Pesticide Handlers Exposure Database). The occupational postapplication assessment was completed using 5 different residue dissipation studies on 4 crops and turf. The dislodgeable foliar residue (DFR) dissipation studies were all conducted by the Agricultural Reentry Task Force (ARTF) using carbaryl on cabbage, olives, sunflowers, and tobacco. Again, there are no data compensation issues associated with the DFR data because Aventis is a member of the ARTF. The sunflower and tobacco data were used only to assess risks for their specific crop groups because of aerial application with the sunflowers and due to various features of the tobacco crop (e. g., leaf type and shape). The olive and cabbage data were generally used to complete the assessments for all tree crops and all other crops, respectively. The turf transferable residue (TTR) data were generated by the Aventis Corporation at sites in California, Georgia, and Pennsylvania. These chemical specific dissipation data were all used in conjunction with the Agency's revised policy on transfer coefficients to calculate postapplication exposures and risks (August 7, 2000/ Policy 003.1). All of the studies used by the 5 Agency to assess occupational risks were considered to be the best source of data available for the scenario where it was used. These recent studies are all considered high quality based on current Agency guidance. The oyster bed uses were evaluated using sediment and water concentration data generated by the Washington State Department of Ecology or the Shoalwater Creek Indian Tribe.

A number of other studies were submitted by the Aventis Corporation that focused on quantifying exposures during the application of homeowner products. Three studies used carbarylcontaining products to quantify exposures during application of a dust to dogs, application of various products to gardens (i. e., dusts, trigger sprayer, and liquid application with hose end sprayer or low pressure handwand), and application of a liquid to trees and shrubs using a hose end sprayer or low pressure handwand sprayer. In addition to these studies, which were all conducted by the Aventis Corporation, an additional study completed by the ORETF that quantified exposures during granular application to turf with a rotary spreader and during liquid spray application to turf with a hose end sprayer was used. Aventis is a member of the ORETF so there are no data compensation issues associated with the use of this study. For postapplication exposures, Aventis also submitted a study which quantified dermal exposure on turf using oxadiazon (Ronstar formulation). The Agency did not use this study in the risk assessment because of technical issues including levels of transferability compared to the carbaryl TTR data and the dormant timing of the application which is not typical for carbaryl. In cases where chemical or scenario specific data were unavailable, the Agency relied on guidance provided in the SOPs For Residential Exposure Assessment and various supporting documents.

This risk assessment incorporates the recent revisions by the HIARC and reconsideration of the FQPA safety factor based on recently revised policies. Calculations have been completed for short term and intermediate term exposures for all occupational scenarios. Chronic exposures have also been calculated for a limited number of scenarios in the ornamental/ greenhouse industry where such exposure patterns might be expected. Risks for residential handlers are considered to be shortterm in nature only because homeowner uses are expected to be infrequent. Residential postapplication risks have been calculated based on short term and intermediate term exposures because repeated postapplication exposures are likely while they are not for handlers based on use patterns. Cancer risks were calculated for all adults scenarios using a linear, low dose extrapolation approach (LADD or Lifetime Average Daily Dose and Q1*). The short and intermediate term dermal risk assessments for carbaryl were based on a 21 day dermal toxicity study in rats that used technical material where decreases in red blood cell and brain cholinesterase were observed (NOAEL = 20 mg/ kg/ day). The short term inhalation and nondietary ingestion risk assessments for carbaryl were based on a developmental neurotoxicity study in rats where alterations in FOB parameters on the first day of dosing were observed (NOAEL = 1 mg/ kg/ day). The results of this study were applied to short term exposure durations of up to 30 days. The intermediate term inhalation and non dietary ingestion risk assessments for carbaryl are based on a subchronic neurotoxicity study in (NOAEL = 1 mg/ kg/ day). The effects that were observed and selected as the basis for the endpoint used in risk assessment included decreases in plasma, red blood cell, whole blood and brain cholinesterase activity and changes in functional observational battery (FOB) parameters. The results of this study were applied to exposure durations greater than 30 days up to several months. The chronic risk assessments for carbaryl were based on a 1 year dog feeding study 6 (LOAEL = 3.1 mg/ kg/ day). The effects that were observed and selected as the basis for the endpoint used in risk assessment included decreases in plasma, and brain cholinesterase activity. The results of this study were applied to chronic exposure durations and to all routes of exposure (i. e., dermal, inhalation, and non dietary ingestion). Carbaryl was classified as a Class C carcinogen and was assessed for carcinogenic risk from exposure using a linear, low dose extrapolation approach with a Q1* of 8.75 x 10 4 (mg/ kg/ day) 1 . A dermal absorption factor of 12.7 percent was selected from a rat dermal absorption study using radiolabeled 14 C. A 100 percent inhalation absorption factor was used to convert all inhalation exposures to an oral equivalent inhalation dose.

The Agency's level of concern for noncancer risks (i. e., target level for MOEs or Margins of Exposure) is defined by the uncertainty factors that are applied to the assessment. The Agency applies a factor of 100 in cases to account for inter species extrapolation to humans from the animal test species and to account for intra species sensitivity. In cases where a NOAEL was not identified and a LOAEL was used for risk assessments, an additional uncertainty factor of 3 was applied for chronic exposures. Based on the requirements of the 1996 Food Quality Protection Act, the Agency must also consider sensitive populations in its non occupational risk assessments. The Agency reduced the FQPA safety factor to 1x for non occupational exposures to carbaryl because there are no residual concerns regarding pre or post natal toxicity or with the completeness of the toxicity or exposure databases. The total uncertainty factors that have been applied to different noncancer risk assessments include 100 for short term and intermediate term occupational scenarios. Chronic occupational exposures, which are very limited in scope, have an uncertainty factor of 300 because a LOAEL from the chronic dog study has been used for risk assessment purposes. Since the FQPA safety factor is 1x, all residential scenarios have the same factors applied to each duration of exposure as well. Cancer risk levels were evaluated based on 1996 Agency guidance by then office director Dan Barolo that stipulates a risk concern ranging from 1x10 4 to 1x10 6 for occupational settings and 1x10 6 for residential settings.

For occupational handlers, most scenarios have risks associated with them that meet or exceed the Agency's uncertainty factors for noncancer risk assessments (i. e., 100 for short term and intermediate term and 300 for chronic) and requirements for cancer risk results (i. e., range of 1x10 6 to 1x10 4 as defined by Office Director Barolo in 1996) at some level of personal protection. Current carbaryl labels typically require that handlers wear long pants, long sleeved shirts, and gloves. Respirators are generally not required. For most scenarios, the noncancer risks for this personal protection ensemble do not meet Agency risk requirements and additional levels of personal protection are required to achieve Agency risk targets. In fact, in many cases engineering controls such as closed loading systems or closed cab tractors are needed. The Agency does have risk concerns over the use of carbaryl in some agricultural and other occupational settings (i. e., MOEs at any level of personal protection are <100 or <300, depending on the duration). As would be expected, these scenarios with the highest associated risk also have high daily chemical use based on application rates or high acreages treated or the exposures for the scenarios in question are relatively high. Generally, the areas that appear to be problematic include: large acreage aerial and chemigation applications in agriculture or for wide area treatments such as mosquito control; airblast applications at higher rates; pet grooming; and the use of certain handheld equipment for applications to turf or gardens (e. g., bellygrinder). This general trend was essentially the same for 7 both short term and intermediate term exposures. Risks for corresponding scenarios based on cancer concerns were generally less than noncancer results across all scenarios. In fact, in all but one scenario, cancer risks were <1x10 4 at current carbaryl label requirements of single layer clothing, gloves, and no respirator for both private growers and commercial applicators. Higher levels of personal protection reduce this risk to <1x10 4 for all scenarios in both populations. If a 1x10 6 risk level is specified as a concern, results are similar in that risks for a majority of scenarios are <1x10 6 at current label requirements. In fact, only 8 of the 128 scenarios considered for private applicators have cancer risks >1x10 6 (and less than 1x10 4 ) even when the most protective ensembles of either protective clothing or engineering controls are considered. For commercial applicators, results indicate that risks for about half of the scenarios considered are <1x10 6 at current label requirements and that only 21 of the 128 scenarios considered have cancer risks >1x10 6 (and less than 1x10 4 ) even when the most protective ensembles of either protective clothing or engineering controls are considered. Several data gaps were also identified in many different use areas that include: dust use for animal grooming and in agriculture; various specialized hand equipment application methods (e. g., powered backpack, power hand fogger, and tree injection); and nursery operations such as seedling dips.

Current label requirements specify 12 hour Restricted Entry Intervals (REIs) while PreHarvest Intervals (PHIs) are less than 7 days for most crops with some as long as 28 days. For all but the lowest exposure scenarios in some crops, MOEs do not meet or exceed required uncertainty factors until several days after application. If short term risks are considered, MOEs meet or exceed the Agency uncertainty factor generally in the range of 3 to 5 days after application for lower to medium exposure activities and from 8 to 12 days after application in most higher exposure scenarios. If intermediate term risks are considered, MOEs are not of concern based on a 30 day average exposures except for higher level exposures such as harvesting in some crops. Chronic exposures are of concern for the cut flower industry but not for other general greenhouse and nursery production activities based on the most recent ARTF data. Cancer risks were calculated for private growers and professional farmworkers with the only difference being the annual frequency of exposure days. Cancer risks for private growers and commercial farmworkers are generally in the 10 8 to 10 6 range on the day of application. If a 1x10 4 cancer risk is the target, the current REI would be adequate for all scenarios considered in the assessment. If a 1x10 6 cancer risk is used, then durations longer than the current REI should be considered for some cases which are not considered low to medium exposures. It should be noted that the cancer risk calculations are less restrictive than noncancer risk estimates for the same scenarios in all cases.

Many mechanized or partially mechanized processes are possibly associated with the use of carbaryl that may limit or eliminate exposures (e. g., combines for grain harvest). Mechanized practices can be divided into fully mechanized activities that meet the definition of "No contact" in the Agency's Worker Protection Standard (WPS) and mechanically assisted practices with potential for exposure. In the case of fully mechanized activities, the Agency does not complete a quantitative exposure assessment but applies criteria outlined in the Agency's Worker Protection Standard (WPS). In cases of partially mechanized activities where the potential for exposure exists, the Agency assesses the resulting exposures similarly to those resulting from hand labor activities. The Agency also acknowledges that there is some potential for exposure because individuals 8 engaged in fully mechanized activities have short term excursions from the protected area for various reasons (e. g., unclogging machinery or equipment inspection for breakage). In these cases, the WPS § 170.112( c) Exception for short term activities applies. Several data gaps exist such as an incomplete DFR database and a lack of exposure data on partially mechanized cultural practices where there is a potential for exposure. Additionally, because of the number and breadth of carbaryl uses, there may be many exposure pathways where the transfer coefficient approach is not an appropriate model (e. g., hand transplanting where no foliar contact occurs) that have not been quantitatively addressed due to a lack of data.

For residential handlers, MOEs associated with most scenarios (40 of 52 considered) are generally not of concern because they exceed the Agency's uncertainty factors for noncancer risk assessments (i. e., MOE = 100). The scenarios of concern involve the use of dusts (in gardens and on pets) and for some liquid sprays on gardens. Cancer risks were calculated for a single day of use then the allowable annual number of days exposure was defined based on a cancer risk limit of 1x10 6 . Based on a single day of exposure, cancer risks for most scenarios are in the 10 8 to 10 10 range although there is one scenario where the risks slightly exceed 1x10 6 (dusting dogs  1.09x10 6 ) even for a single day of use. It should be noted that there are 5 scenarios where the allowable days per year of exposure is less than or equal to 5 which should be considered in conjunction with the use/ usage data from Aventis that indicates 5 uses per year is the 84 th percentile. The database for carbaryl is fairly complete compared to many other chemicals. Recent, high quality data generated by the Aventis Corporation and the ORETF, of which Aventis is a member, have been used to address the key residential uses of carbaryl on lawns, flower and vegetable gardens, and pets. Use and usage inputs also appear to be essentially consistent with the information provided by the Aventis Corporation at the 1998 SMART meeting. No key data gaps have been identified by the Agency at this time for residential handlers. However, it is likely that there are scenarios that remain unaddressed by the Agency at this time due to a lack of data or other meta information. The Agency will address other appropriate scenarios as they are identified.

The Agency considered a number of residential postapplication exposure scenarios for different segments of the population including toddlers, youth aged children and adults. Short term and intermediate term noncancer risks were calculated for all scenarios. Additionally, cancer risks were calculated for the exposure scenarios involving adults. In residential settings, the Agency does not use REIs or other mitigation approaches to limit exposures because they are viewed as impractical and not enforceable. As such, risk estimates on the day of application are the key concern. 9 The Agency considered a number of exposure scenarios for products that can be used in the residential environment representing different segments of the population including toddlers, youthaged children and adults. Short term and intermediate term noncancer MOEs were calculated for all scenarios. Chronic exposures from pet collars were also considered. Additionally, cancer risks were calculated for the exposure scenarios involving adults where methods are currently available. Cancer risks were not calculated for children per Agency policy. In residential settings, the Agency does not use REIs or other mitigation approaches to limit exposures because they are viewed as impractical and not enforceable. As such, risk estimates on the day of application are the key concern.

The Agency has short term risk concerns for exposures to adults doing heavy yardwork, for toddlers playing on treated lawns, and for toddlers that have contact with treated pets. Activities associated with home gardening (e. g., harvesting) and golfing for adults, home gardening for youthaged children or any age or activity considered in the adulticide mosquito control or oyster assessment do not have risk concerns even on the day of application (i. e., MOEs $ 100 on the day of application). For adults, the MOEs for heavy yardwork do not meet or exceed risk targets (i. e., MOE = 100) up to 5 days after application. For toddlers, the Agency has concerns for pet treatments and also for lawn uses. In fact, pet uses never reach acceptable levels even 30 days after application and not until 18 days at the maximum application rate considered on turf. Toddler MOEs from pet and turf uses represent total exposures from many pathways. For the pet uses, dermal and hand tomouth exposures essentially both equally contribute to the overall estimate. For the turf uses, dermal and hand to mouth exposures are also the key contributors to the overall estimates.

The Agency does not have intermediate term risk concerns for adults and youth aged children for any of the uses considered including lawncare, home gardens, golfing, and any aspect of adulticide mosquito control. In contrast, the Agency does have intermediate term risk concerns for all toddler exposure scenarios considered (i. e., pet treatments and lawncare uses). As with the short term MOEs, pet and turf uses represent total exposures where the significant contributions to overall exposures are again made equally from the dermal and hand to mouth exposure pathways.

Cancer risks were calculated only for adults and were found to be in the 10 8 to 10 11 range, regardless of the scenarios considered, on the day of application (e. g., lawncare, golfing and gardening). Risks did not exceed 1x10 6 on the day of application for any scenario considered. All postapplication cancer risks were calculated based on an annual frequency of 1 exposure per year. It is likely that additional events could occur but data linking postapplication activities and carbaryl use patterns are not available. To address this issue, the Agency calculated the number of exposures that can occur under a cancer risk ceiling of 1x10 6 and determined that from 20 days per year to exposures every day of the year could occur depending upon the scenario. Results indicate most activities can occur from every day of the year even at residue levels present on the day of application.. 10 Unlike many residential risk assessments, the postapplication residential assessment for carbaryl is based on a number of chemical specific studies that have been used to calculate risks from turf uses (e. g., TTR study) and in gardens (i. e., DFR data). There are no transferable residue data available for pet uses which is a key data gap. Additional data could potentially be used to refine risk estimates for the other settings such as additional DFR data on different crops and TTR data which are more appropriate for hand to mouth and object to mouth exposures.

The Agency combines or aggregates risks resulting from exposures to individual chemicals when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population. For carbaryl, the Agency has combined risk values (i. e., MOEs) for different kinds of exposures associated with the turf (dermal, hand to mouth, object to mouth, and soil ingestion) and pet scenarios (dermal and hand to mouth). These represent the standard set of exposures that are typically added together when chemicals are used on turf or on pets because it is logical they can co occur. Typically, the Agency only adds exposures from different exposure scenarios together (e. g., spraying and gardening) when risks from both are not already a concern. For carbaryl, there are risk concerns for many residential handler scenarios already so the Agency did not add risk values from any postapplication exposure together with applicator risks.

It should also be noted that the Agency considered other sources of information in the development of this assessment. For example, carbaryl residues were identified in the Agency study entitled Pesticide Exposure in Children Living in Agricultural Areas along the United States Mexico Border Yuma County, Arizona. Preliminary results of this study indicate that carbaryl residues were identified in the dust of 20 percent of the 152 houses sampled and in approximately 24 percent of 25 samples collected in 6 schools in the same region. Also, in a 1995 study conducted by the Centers For Disease Control, 1000 adults were monitored via urine collection. One of the analytes measured in that study (1 napthol) is a potential metabolite of carbaryl as well as of napthalene and napropamide. This metabolite was identified in 86 percent of the 1000 adults monitored where the mean value was 17 ppb and the 99 th percentile was 290 ppb. These values were not used quantitatively in the risk assessment for carbaryl because of the uncertainties associated with them such as it cannot be clearly defined if carbaryl or the other chemicals with common metabolites were the key contributors to the measured dose levels. The Agency instead considers them a qualitative indicator that exposures in the general population are likely to occur. Risk estimates using controlled study data are protective when considered in light of the available monitoring data. [Note: The Aventis Corporation is in the process of conducting a biomonitoring study with children who live in households where carbaryl has been used. Preliminary results indicate that levels at the highest percentiles of the distribution are similar to those predicted in the Agency's turf risk assessments for toddlers which are intended to represent the higher percentiles of the exposure distribution. A more detailed analysis will be completed upon submission.]

A total of 16 different studies were used by the Agency to calculate carbaryl risks. Most used carbaryl (some handler studies did not) and were scenario specific. Each study is considered to be the best source of information for the scenario in which it was used. Each of the traditional carbaryl exposure studies are considered to be high quality and essentially the current state of the art. There appear to be some data quality issues associated with the Washington State water and 11 sediment monitoring data. Where data were not available, the Agency used PHED, the most current policy for transfer coefficients, and the most current approaches for calculating residential exposures in the assessment. The Agency also extensively incorporated the use and usage information supplied by the Aventis Corporation at the 1998 SMART meeting. The information provided at that meeting essentially confirm the Agency interpretation of carbaryl use patterns which is a key element in the development of a risk assessment.

This risk assessment applied the latest exposure data, toxicology information, and use data. The overall results indicate that the Agency has risk concerns for essentially every marketplace where carbaryl is used. Occupational handler risks can be mitigated through the use of additional protective measures over and above the current label such as engineering controls (e. g., closed cabs or loading systems). Current label REIs are 12 hours. For almost every crop/ activity combination considered except some low exposure activities, the current REI appears to be inadequate. Residential handler and postapplication risks also are of concern across many areas. 12 1.0 Occupational and Residential Exposure/ Risk Assessment 1.1 Purpose This document is the occupational and residential non dietary exposure and risk assessment for carbaryl which will be used in the reregistration process.

1.2 Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure assessment is required for an active ingredient if (1) certain toxicological criteria are triggered and (2) there is a potential for exposure to handlers (mixers, loaders, applicators) during use or to persons entering treated sites after application is complete. Toxicological endpoints were selected for short, intermediate, and long term exposures (e. g., NOAEL for short and intermediate term dermal exposures is 20.0 mg/ kg/ day based on a 21 day dermal administration toxicity study in rats). Additionally, carbaryl has been classified as a Group C possible human carcinogen (i. e., Q1* = 8.75 x 10 4 (mg/ kg/ day) 1 ). There is a significant potential for exposure in a variety of agricultural, commercial, and residential settings. Therefore, risk assessments are required for occupational and residential handlers and for occupational and residential postapplication exposures that can occur as a result of carbaryl use.

1.3 Summary of Hazard Concerns The toxicological endpoints that were used to complete the occupational and residential risk assessments are summarized below and in Table 1 which has been extracted from the latest HIARC document detailing the April 2002 meeting, the revised Q1* memo of November 8, 2001 (Brunsman, TXR No. 0050265), and the latest FQPA SFC committee report from April 2002. Effects were identified at different durations of exposure ranging from short term (up to 30 days) to chronic durations (every working day). Carbaryl was classified as a Class C carcinogen and is assessed for carcinogenic risk using a linear, low dose extrapolation approach with a Q1* of 8.75 x 10 4 (mg/ kg/ day) 1 .

Carbaryl is a widely used carbamate insecticide where the use patterns can vary widely ranging from shorter term exposures through uses on virtually every working day. As such, when the HIARC recently evaluated the carbaryl hazard database, endpoints were selected to address each duration of exposure. Exposures can occur to occupational users and the general population so both were considered in this assessment.

The short and intermediate term dermal risk assessments for carbaryl are based on NOAEL of 20.0 mg/ kg/ day defined in a dermal toxicity study in rats (MRID 45630601) based on decreases in RBC and brain cholinesterase in males and females. The short term inhalation and nondietary ingestion risk assessments for carbaryl are based on a NOAEL of 1.0 mg/ kg/ day defined in a developmental neurotoxicity study in rats (MRIDs 44393701, 45456701, 45456702, and 45456703) based on decreased body weight gain, alterations in FOB measurements, and cholinesterase inhibition (plasma, whole blood, and brain). The LOAEL for this study was observed at 10 13 mg/ kg/ day. The results of this study were applied to exposure durations of up to 30 days and have been applied only to the inhalation and nondietary ingestion routes of exposure. The intermediateterm inhalation and nondietary risk assessments for carbaryl (i. e., durations that exceed 30 days but are not chronic in nature) are based on a NOAEL of 1.0 mg/ kg/ day that was defined in a subchronic neurotoxicity study in rats (MRID 441226 01). The LOAEL for this study is also 10 mg/ kg/ day. The effects that were observed and selected as the basis for the endpoint used in risk assessment included decreases in plasma, whole blood, red blood cell, and brain cholinesterase activity and FOB changes. The results of this study were also applied only to the inhalation and nondietary ingestion routes of exposure. The chronic risk assessments for carbaryl are based on a 1 year dog feeding study (MRIDs 401667 01 and 420228 01). The effects that were observed and selected as the basis for the endpoint used in risk assessment included decreases in plasma, and brain cholinesterase activity. A NOAEL was not defined in the study so the endpoint that was selected was the LOAEL. The results of this study were applied to chronic exposure durations and have been applied to all routes of exposure (i. e., dermal, inhalation, and non dietary ingestion).

A dermal absorption factor of 12.7 percent was selected from a rat dermal absorption study using radiolabeled 14 C; this value was used to calculate the oral equivalent dermal dose for noncancer chronic duration exposures and for the calculation of cancer risks. No inhalation toxicity studies were selected for risk assessment purposes so a route to route extrapolation was used to address risks from inhalation exposures. No inhalation absorption study was conducted, therefore a 100 percent inhalation absorption factor is used to convert all inhalation exposures to an oral equivalent inhalation dose.

The Agency's level of concern for noncancer risks (i. e., target level for MOEs) is defined by the uncertainty factors that are applied to the assessment. The Agency applies a factor of 100 in cases to account for inter species extrapolation to humans from the animal test species and to account for intra species sensitivity. In cases where a NOAEL is not identified and LOAEL values have to be used for risk assessments, the Agency generally applies an additional factor of 3 as was done with carbaryl for chronic duration exposures. Based on the requirements of the 1996 Food Quality Protection Act, the Agency must also consider sensitive populations in its non occupational risk assessments. The Agency removed the FQPA 1x safety factor for non occupational exposures to carbaryl (April 3, 2002 FQPA SFC report).

Table 1. Endpoints for Assessing Non Dietary Risks for Carbaryl Type of Exposure Study Dose Endpoint UF Short and Intermediateterm Dermal (1 day to several months) 21 Dermal Toxicity Study Using Technical Grade Carbaryl  Rats (MRID 45630601) 20 mg/ kg/ day (NOAEL) Significant decreases in RBC and brain chlolinesterase (ChE) 100 for residential and 100 for occupational Short term Inhalation & Non dietary Ingestion (1 to 30 days) Developmental Neurotoxicity Study  Rats (MRIDs 44393701, 45456701, 45456702, 45456703) & Acute Neurotoxicity Study  Rats (MRIDs 438452 01/ 04) 1 mg/ kg/ day (NOAEL) Decreased body weight gain; FOB changes; and decreases in plasma, RBC, whole blood, and brain cholinesterase (ChE) 100 for residential and 100 for occupational Table 1. Endpoints for Assessing Non Dietary Risks for Carbaryl Type of Exposure Study Dose Endpoint UF 14 Intermediate term Inhalation & Non dietary Ingestion (30 days to several months) Subchronic Neurotoxicity Study  Rats (MRID 441226 01) 1 mg/ kg/ day (NOAEL) Decreases in plasma, RBC and brain cholinesterase (ChE) and FOB changes 100 for residential, and 100 for occupational Chronic Dermal & Inhalation Dog Chronic Toxicity (MRID 401667 01 and 420228 01) 3.1 mg/ kg/ day (LOAEL) Decreases in brain cholinesterase (ChE) in females 300 for residential, and 300 for occupational Dermal Absorption Rat Dermal Absorption Study 12.7 percent Inhalation Absorption 100% inhalation absorption value  no study available Q1* 0. 000875 Based on increased incidence of hemangiomas/ hemangiosarcomas in male mice A series of acute toxicity tests were also conducted using carbaryl (i. e., outside of the rat study which is discussed above). The results indicate that carbaryl is a category III toxicant via the oral and dermal routes and a category IV toxicant via inhalation. It is also a category IV eye and skin irritant. Results were negative for dermal sensitization and delayed acute neurotoxicity in hens.

1.4 Incident Reports An incidence report has been completed by the Agency. It is considered with the information included in this document in the overall human health risk assessment for carbaryl. The identifying information for the incident report (i. e., date and author, etc.) is included in the overall human health risk assessment.

1.5 Summary of Use Patterns and Formulations Carbaryl products are described in this section. Additionally, available information that describes the manner in which registered carbaryl end use products are used is provided in this section (e. g. use categories/ sites, application methods and application rates). For more detailed information, please refer to Appendix A of this document. Appendix A contains the Quantitative Usage Analysis For Carbaryl produced in 1998 by the Biological and Economic Analysis Division and the Use Profile Report For Carbaryl also produced in 1998 by the Biological and Economic Analysis Division. 15 1.5.1 End Use Products Carbaryl (1 naphthyl N methyl carbamate) is a broad spectrum carbamate insecticide marketed in a variety of end use products for both occupational and homeowner use. End use product names include Adios, Bugmaster, Carbamec, Carbamine, Crunch, Denapon, Dicarbam, Hexavin, Karbaspray, Nac, Rayvon, Septene, Sevin, Tercyl, Tornado, Thinsec, and Tricarnam. Use sites include but are not limited to: fruit and nut trees; vegetable crops; field and forage crops; grapes; forestry; lawns and other turf such as golf courses; ornamental trees, shrubbery, annuals, and perennials; wide area treatment targets such as residential mosquito adulticide uses; poultry production facilities; and companion animals (e. g., dogs and cats).

Table 2 summarizes the technical and manufacturing products with their respective EPA registration numbers.

Table 2: Technical and Manufacturing Carbaryl Products Formulation EPA Reg. No. (% active ingredient)

Technical 34704 707 (99%); 264 324 (99%), 325 (97.5%); 19713 75 (99%)

Manufacturing Product 264 328 (80%); 769 971 (80%); 19713 369 (50 %); 4816 270 (97.5%), 407 (1%)

Based on a review (2/ 27/ 01) of the Office of Pesticide Programs – Reference Files System (REFS), there are 307 active product labels. Carbaryl formulations include dusts, emulsifiable concentrates, soluble concentrates; water dispersible granulars; flowable concentrates; wettable powders; granulars; baits; pet dips and pet shampoos; aerosol sprays; ready to use pump sprayers; and pet collars (i. e., treated articles). Table 3 outlines the formulations and EPA registration numbers for labels of carbaryl end use products according to REFs. Many of the products described in Table 3 can be used in a variety of settings ranging from agriculture and commercial facilities to residential areas. Some products are marketed in a single marketplace while others are sold for use in each setting. From sales information provided by the Aventis Corporation at the SMART meeting with EPA on September 24, 1998 approximately 34 percent of carbaryl end use products are used in the homeowner/ residential setting while 59 percent is used in agriculture. The remaining 7 percent is used in nursery, landscape and golf course industries. 16 Table 3: End Use Product Formulations and EPA Reg. Number.

Formulation Type EPA Registration Number (Percent Active Ingredient)

Emulsifiable Concentrates & Flowable Concentrates 7401 83, 210 (25%), 208( 13%); 19713 49( 43.4%), 89 (22.5%), 131( 49%); 51036 66( 43.3%), 123( 22.5%); 10163 60 (43.7% ), 134( 80%); 10107 42 (43.4%), 44 (23.4%); 11715 207, 209, 229 (42.6%); 33955 533 (23.4%); 67517 31( 5%); 9779 260 (43.4%); 8660 133 (11.7%); 264 321 (40%), 333 (44.1%), 334( 22.5%), 335 349 (43%), 422 (48%) ; 2217 366 (50%), 600 (23.4%); 4 59( 0.5%), 122 (0. 3%); 237 (22.5%); 192 174 (21.3%); 239 2628( 21.3%); 270 286 (23%); 407 383 (24%); 5905 251 (40.38%); 5887 102, 162 (0. 3%) 0; 769 493( 42.85%), 573 (23%), 648, 865, 883 (21.3%); 28293 222( 21.3%); 59144 6 (21.3%); 46515 35 (11.7%); 16 76 (21.3%); 34704 447( 43%); 8660 70 (24.4%); 909 103( 21.3%); 46515 36( 21.3%); 7401 38, 62 (5%), 386 (13.5); 802 585 (21.3%); 50383 10 (22.5%); 54705 4 (41.2%); 16 76 SLNs: CO8800 1300, FL8900 3700, HI9700 0300, NC9600 0300, OH9600 0300,OR9500 0600,PA9600 0200, VA9500 0100, WA9700 2200 Wettable Powders & Soluble Granules 33955 450 (50%); 51036 151( 80%); 19713 50 (80%), 52( 50%), 363 (85%), 84 (95%); 10163 133 (80%); 9779 294( 90%); 8660 60 (50%); 5905 517 (80%); 264 314 (50%), 315 (85%), 316 (80%), 427 (39.7%), 526 (80%); 5481 65 (50%), 242 (0. 5%), 271 (50%); 5887 86 (50%); 2217 389 (50%); 4 157 (13.5%), 387 (50%); 769 574 (80%), 868 (50%), 919 (21.3), 920, 834, 972 (50%); 70 285 (50%); 1386 445; 34704 350( 50%), 619 (80%); 1386 455; 16 99( 50%); 407 287( 50%); 228 249( 5%)

SLNs: CA7802 070, CA8100 5900, CA8300 0700, CA8300 0701, CA8300 0702, FL8900 3600, HI9600 0900, NC8200 0700, NC8700 0702, WA9000 1300 Dusts 67517 32 (10%); 9198 141 (2. 37%), 147( 5%), 148( 10%); 4 29 (1. 25%), 143 (5%), 413, 415; 16 12 (2%), 98 (10%), 121( 5%), 127( 2%); 239 1349, 1513 (10%), 2181 (5%); 270 272 (5%); 70 165 (10%), 166( 5%); 16 27 (5%); 67572 16 (5%), 36 (10%); 59144 3 (5%), 5 (10%); 50383 16 (5%); 49585 4, 24 (5%), 26( 10%); 435763 5%); 34911 6 (5%); 28293 6, 10, 301, 302( 5%), 14( 12.5%), 18, 102, 301 (10%), 237( 5%); 19713 53,212 10%), 213( 5%), 244( 80%); 829 128 (5%), 131( 1.75%), 142( 50%), 200( 10%); 2217 383, 572 (5%); 272475 (5%); 2781 25( 5%); 769 559, 611, 613, 642, 647, 906 (5%), 835( 1.75%), 229, 612, 665( 10%), 614 12.5%); 655 788( 5%), 789 (10%); 11715 250( 12.5%), 255, 294( 5%), 292( 10%); 9779 74 (5%); 8660 72,234 5%), 241( 10%); 7401 69, 310( 5%), 291( 1.75), 334( 2%), 81, 166, 154( 10%); 5887 43( 5%); 5481 275,282 321( 2%), 58, 98, 253, 283, 316, 451 (5%), 312, 323( 7.5%), 108, 277, 294( 10%), 190( 46%); 4758 7, 32 34( 5%); 4306 10( 5%); 3342 100( 5%); 5887 77( 0.3%); 2935 193 (5%), 320( 10%); 3342 51( 5%), 53( 2%), 56 1.75%), 69( 10%); 2393 375( 5%); 1386 451, 630( 5%) 633( 10%); 869 118( 5%). 180( 10%); 802 442( 5%); 572 107( 5%); 192 70( 5%); 228 251, 252( 5%); 51036 13( 10%), 48( 5%); 33955 462( 5%); 10163 124( 10%); 10159 2( 5%); 10107 43( 10%), 45( 5%); 9779 81( 10%), 61( 50%); 36272 14( 5%); 37425 13( 12.5%); 497843 12.5%); 71949 11( 10%), 10( 5%)

Granular 28293 233 (6. 3%); 9198 142 (3. 5%); 5887 94, 170 (5%); 769 728 (5%), 970*( 3.5%), 976( 2%); 59144 26*( 1%), 27* (2%); 34704 289( 10%), 373* (5%); 32802 58( 3.9%), 59* (1. 43); 10404 61*( 6.3%), 62*( 4%); 8378 31*( 4.3%), 36*( 1.43%); 5481 89( 10%), 90, 97*( 5%), 95*( 4%),  100*( 5%); 264 430*( 7%); 90983 5%); 869 228*( 2%); 9779 156*( 5%); 8660 28* (1%); 7401 43( 3.34%), 51( 1.8%); 192 199 (2%); 4142 4.6%); 572 204( 8%); 802 351( 5%); 264 429( 7%); 5905 169( 10%), 180( 180%); 9198 106( 6.2%), 139 4.6%), 143( 4%), 144( 4.55%), 145( 6.3%), 146( 8%); 19713 334( 10%); 51036 225( 5%); 67572 81( 1%)

Bait 67650 2 (2%);; 61282 4, 21( 10.04%), 16, 22 (5%); 42057 39 (4%); 32802 51 (5%); 10370 152 (5%); 8278 3 (5%); 769 729, 730 (5%); 802 493 (5%); 31282 22* (5%); 4 333* (5%); 1386 655*( 5%); 10107 143* (5%); 869 119( 5%); 7401 72*( 4%), 148 (2%), 265( 4%); 8119 5 (5%); 239 2514 (5%); 70 244( 5%); 829182 4.25%), 285 (5%); 961 290( 7.15%), 355( 5.93%); 264 312 (10%), 320( 5%); 2393 209( 5%); 6973 10( 4%); 7729 7( 5%); 8660 111( 5%), 188( 4.55%); 10163 32( 5%); 11656 20( 4%), 21( 5%); 28293 235( 5%); 34704 23,483 5%); 49399 1( 2%), 2( 5%); 51036 61( 5%),, 185, 210( 13%), 204, 227( 1.3%), 286( 10%); 59639 52,60 5%); 2935 366( 5%); 19713 494( 5%); 34911 8( 4%); 67572 56( 4%); 71949 12( 5%)

SLNs: FL9200 0800 Dips, Shampoos 28293 8( 60%); 2097 8 (0. 5%)

Pet collars (treated articles) 2724 272 (8. 5%), 273 (16%) Table 3: End Use Product Formulations and EPA Reg. Number.

Formulation Type EPA Registration Number (Percent Active Ingredient)

17 Ready to Use Pump Sprayers & Aerosol Cans 1910 2 (1%); 67572 75 (0. 126%); 9444 98, 190 (0. 5%); 769 977( 0.126%); 8119 3 (5%); 28293 97 (0. 5%)

1.5.2 Mode of Action and Targets Controlled Carbaryl (1 naphthyl methylcarbamate) belongs to the carbamate class of pesticides. Like the other carbamates, carbaryl antagonizes acetylcholine and competes for binding sites on the enzyme cholinesterase. In agriculture and residential/ recreational areas, carbaryl is used as a contact insecticide recommended for use against pests in a variety of settings. These pests include (i. e., based on information provided on labels and in the Use Profile Report included as Appendix A of this document):

° On Fruit Trees and Nut Trees: apple aphid, apple maggot, apple mealybug, apple rust mite, apple sucker, bagworms, California pearlslug, codling moth, eastern tent caterpillar, European apple sawfly, eyespotted bud moth, fruittree leafroller, green fruitworm, Japanese beetle, lesser appleworm, lygusbugs, orange tortrix, pear leaf blister mite, pear psylla, pear rust mite, periodical cicada, plum curculio, redbanded leafroller, scale insects, tarnished plant bug, tentiform leafminers. White apple leafhopper, wooly apple aphid, navel orangeworm, peach twig borer, san Jose scale, European raspberry aphid, omnivorous leafroller, raspberry sawfly, rose chafer, snowy rose tree cricket, blueberry maggot, sherry fruitworm, cranberry fruitworm, European fruit lecanium, chestnut weevil, avocado leafroller, california orangedog, citrus cutworm citrus root weevil, fullers rose beetle, orange tortrix, western tussock moth, west Indian sugarcane borer, filbert aphid, filbert leafroller, filbertworm, eight spotted forester, grape berry moth, grape leaffolder, grape leafhopper, June beetles, saltmarsh caterpillar, western grapeleaf skeletonizer, western yello striped armyworm, olive scale, apple pendemis, cucumber beetles, European earwig, lesser peach tree borer, oriental fruit moth, peach twig borer, tarnished plant bug, tussock moth, black margined aphid, fall webworm, pecan leaf phylloxera, pecan nut casebearer, pecan spittlebug, pecan stem phylloxera, pecan weevil, twig girdler, walnut caterpillar, calico scale.

° On Terrestrial Food and Feed Crops: blister beetles, Mexican bean beetles alfalfa caterpillar, beanleaf beetle, cucumber beetle, grasshoppers, green cloverworm, japanese beetle, leafhoppers, three cornered alfalfa hopper, thrips, velvetbean caterpillar, alfalfa weevil larvae, armyworm, cloverhead weevil, cotton fleahopper, cotton leafworm, flea beetle, striped blister beetle, boll weevil, bollworms, cotton leafperforator, plant bugs, saltmarsh caterpillar, corn earworm, corn rootworm adults, southwestern corn borer, japanese beetle, European corn borer, cutworms, Egyptian alfalfa weevil larvae, Essex skipper, European alfalfa beetle, fall armyworm, lygus bugs, webworms, yellowstriped armyworm, asparagus beetle, apache cicada, stinkbugs, tarnished plant bug, webworm, cowpea curculio, aster leafhoppers, harlequin bug, imported cabbageworm, melonworm, 18 pickleworm, squash bugs, pink bollworm, range caterpillars, thrips, white grubs, white fringed beetle adult, Colorado potato beetle, pea leaf weevil, tomato fruitworm, tomato hornworm, grape colaspis, sweet potatoweevil;, tortoise beetles, green June beetle grubs, budworms, cereal leaf beetle (except in CA).

° On Ornamentals: blister beetle, flea beetle, boxelder bug, japanese beetle, June beetle, lace bug, leafhopper, leafroller, mealybug, plant bug, psyllids, rose aphid thrips, apple aphid, bagworm, birch leafminer, cankerworm, eastern spruce gall aphid, elm leaf aphid, elm leaf beetle, gypsy moth, mimosa webworm, oak leafminer, orange tortrix, periodical cicada, puss caterpillar, rose aphid, rose slug, sawfly, scale, tent caterpillar, thrips, willow leaf beetle.

° On Lawns/ Turf: ants, bluegrass billbug, chinch bug, cut worm, crane fly, earwig, European chafer, fall armyworm, fleas, green June beetle, leafhopper, millipedes, mosquitoes, sod webworms (lawn moths), ixoides spp.( deer tick, bear tick, black legged tick), amblyomma spp.( lone star tick).

° Poultry: northern fowl mite, chicken mite, lice, fleas, bedbugs, fowl ticks.

° In and Around Buildings: indoors: ants, crickets, firebrats, silverfish, bees, wasps, brown dog ticks, fleas, carpenter ants, scorpions, centipedes, earwigs, millipedes, cockroaches, spiders.

° Outdoors: ants, bees, wasps, brown dog ticks, carpenter ants, centipedes, cockroaches, crickets, earwigs, firebrats, fire ants (mound treatment), silverfish, fleas millipedes, scorpions and spiders.

° Public Health/ Wide Area: mosquitoes.

° Dogs and cats: fleas and ticks, on animal and in bedding/ housing.

1.5.3 Registered Use Categories and Sites An analysis of the current labeling and available use information was completed using the Office of Pesticide Programs– Label Use Information System (LUIS) in addition to REFs. Carbaryl is registered for use in a variety of occupational and homeowner/ residential scenarios. For reasons of clarity in the risk assessment process, the use patterns have been described in a manner that delineates occupational from homeowner/ residential uses.

Occupational Use Sites Occupational populations are potentially exposed while making carbaryl applications to the following targets or after contact with the treated targets after previous carbaryl applications. The following list is a summary of occupational use sites as described in the Carbaryl Use Profile prepared by Don Atwood of the Biological and Economic Analysis Division in November of 1998 19 (see Appendix A). [Note: Modifications to the Use Profile have been made based on label deletions and modifications since November of 1998.]

Terrestrial Food Crop Cucurbits  cucumber, melons, Chinese okra, pumpkin, and squash Flavoring and Spice Crops  dill Fruiting Vegetables  tomato, eggplant and pepper Grain Crops  prosso millet Leafy and Stem Vegetables  beets, broccoli, brussels sprouts, cabbage, chinese cabbage, cauliflower, celery, Swiss chard, collards, dandelion, endive (escarole), hanover salad, kale, kohlrabi, lettuce (head, crisphead types, leaf types), mustard, parsley, rhubarb, and spinach Miscellaneous Fruits  olive Miscellaneous Vegetables  asparagus Nut Crops  almond, chestnut, filbert (hazelnut), pecan, pistachio, and walnut (english/ black) Pome Fruits  crabapple, pear, and quince Root Crop Vegetables  beets, carrot (including tops), horseradish, radish, rutabaga, salsify, and sweet potato Small Fruits  blackberry, blueberry, boysenberry, caneberries, cranberry, dewberry, loganberry, raspberry (black, red), and strawberry Specialized Field Crops  okra Stone Fruits  apricot, cherry, nectarine, peach, plum, and prune Terrestrial Food+ Feed Crop Citrus Fruits grapefruit, lemon, lime, orange, tangerine Crops Grown for Oil  field corn, flax, and sunflower Miscellaneous Fruits  longan and mango Fiber Crops  flax Fruiting Vegetables  tomato Grain Crops  field corn, rice, sorghum and wheat Groups of Agricultural Crops Which Cross Established Crop Groupings  cotton, peanuts, peas, sorghum, soybeans, and vegetables Leafy and Stem Vegetables  mustard and turnip Nut Crops  almond, chesnuts, filberts, pecans, pistachios and walnuts Pome Fruits  apple, pears, loquats, crabapples and oriental pears Root Crop Vegetables  parsnip, white/ irish potato, salsify, and turnip Seed and Pod Vegetables  beans (dried type), succulent beans (lima and snap), cowpea/ blackeyed pea, cowpea/ sitao, lentils, peanuts, peas (dried type), field peas, southern peas, succulent peas, and soybeans (edible) Small Fruits  grapes, caneberries, blueberries, cranberries and strawberries Specialized Field Crops  popcorn, sweet corn, and sunflower Sugar Crops  sugar beet 20 Terrestrial Feed Crop Forage Grasses  corn, grass forage/ fodder/ hay, millet (proso), pastures, rangeland, rice, sorghum, and wheat Forage Legumes and Other Nongrass Forage Crops  alfalfa, clover, cotton, and trefoil Grain Crops  proso millet Groups of Agricultural Crops Which Cross Established Crop Groupings  grasses grown for seed Terrestrial non food crop Agricultural Uncultivated Areas  Agricultural fallow/ idleland and Agricultural rights of way/ fencerows/ hedgerows Commercial/ Industrial/ Institutional Premises and Equipment Commercial/ Institutional/ Industrial premises/ Equipment (Outdoor) Fiber Crops Forest Trees  christmas tree plantations Groups of Agricultural Crops Which Cross Established Crop Groupings  Fruits (unspecified) Nonagricultural Uncultivated Areas  Outdoor buildings/ structures, rights ofway fencerows/ hedgerows, uncultivated areas/ soils, and recreational areas Ornamental Lawns and Turf  commercial/ industrial lawns, golf course turf, Ornamental sod farm (turf), and recreational area lawns Specialized Field Crops  tobacco Wide Area/ General Outdoor Treatments  fencerows/ hedgerows, urban areas, and wide area/ general outdoor treatment (public health use)

Terrestrial non food+ outdoor residential Nonagricultural Uncultivated Areas  rights of way/ fencerows/ hedgerows Ornamental Herbaceous Plants Ornamental Lawns and Turf Ornamental Nonflowering Plants Ornamental Woody Shrubs and Vines Ornamental and/ or Shade Trees Wide Area/ General Outdoor Treatments  fencerows/ hedgerows Terrestrial+ Greenhouse non food crop Ornamental Herbaceous Plants Ornamental Woody Shrubs and Vines Ornamental and/ or Shade Trees Animal Uses Poultry (chickens, ducks, geese, game birds, turkeys) Livestock (cattle, sheep, horses, etc.) 21 Pets (cats and dogs)

Aquatic food crop Aquatic Sites  commercial fishery water systems Grain Crops  rice Small Fruits  cranberry Fish & Shellfish Uses  oyster beds Aquatic non food industrial Aquatic Sites  Drainage systems Forestry Forest Trees  forest plantings (reforestation programs, tree farms, tree plantations, etc), forest trees (all or unspecified), maple (forest), and shelterbelt plantings Homeowner/ Residential Use Sites Residential and non occupational use sites include those labeled for outdoor applications such as on lawns, gardens, and ornamentals as well as for use on companion animals such as dogs or cats. There are no labels that allow indoor premise treatments (e. g., crack and crevice or broadcast). Carbaryl can be purchased and used by homeowners in residential settings. It can also be used by professionals such as LCOs (Lawn Care Operators) in residential settings. Exposures can also occur as a result of uses in other areas frequented by the general population such as parks and recreational areas, treated Christmas tree plantations, and forests. Veterinary clinic uses can also result in exposures due to contact with treated animals. The following is a list of use sites in the residential environment.

° Trees: fruits, nuts, and shade/ ornamental;

° Lawns and Ornamentals: lawns, house perimeter, shrubs and flowers;

° Vegetables: beans, berries, broccoli, brussels sprouts, cabbage, carrots, cauliflower, corn, cowpeas, cucumbers, eggplant, herbs, lettuce, melon, okra, onions, peas, peppers, potatoes, summer squash, tomatoes;

° Pets: dogs, cats, and housing/ bedding; and ° Fire Ant Mounds 22 1.5.4 Application Parameters Application parameters are generally defined by the physical nature of the use site, the physical nature of the formulation (e. g., formula and packaging), by the equipment required to deliver the chemical to the use site, and by the application rate required to achieve an efficacious dose. As such, the application parameters for major crop groups or application targets have been summarized by identifying the maximum application rates for each group and the equipment that can be used to make applications. All of the information presented below are summarized from the Agency's QUA and Use Profile documents included as Appendix A, from the SMART meeting information provided to the Agency on September 24, 1998 by the Aventis Corporation, from current carbaryl labels, and from the use summary used in the dietary exposure aspect of the risk assessment.

Selected crop groupings and application targets along with corresponding typical (if available) and maximum application rates that are used in the risk assessment are presented in Table 4 below. Additionally, the equipment that can be used to make applications are also discussed below for each crop group considered. The Agency could not quantitatively address the use of carbaryl in every specific crop or setting in its risk assessment because of the associated level of complexity that would be added to the risk assessment process. Instead, representative crops or targets were selected that were used as the basis for the assessment. A broad range of rates were used to ensure that use scenarios would be addressed in the range of values selected.

Table 4: Representative Application Rates Considered in Risk Assessment Crop or Target Occupational Products Residential Products lb ai/ 1000 ft 2 (units may vary) lb ai/ A/ acre (units may vary) max. apps/ season lb ai/ season Average Rates Alfalfa, clover, trefoil 1. 5 1/ cutting 1. 5/ cutting 1. 1 Asparagus 2 4  postharvest 3  broadcast 2  postharvest 6  broadcast 10  postharvest 0.9 0. 023 0. 094 Beans (fresh & dried), cowpeas, peas 1.5 4 6 0. 9 0.012 0.047 Beets, carrot, horseradish, radish, parsnip 2  foliar 2.2  soil broadcast 6  foliar 4  soil 6 0. 8 0.012 0.047 Blueberries 2  foliar 0.5 lb/ 1000 ft 2  soil 5 10 1. 7 0.012 0.047 Cole Crops (broccoli, brussel sprouts, cabbage, cauliflower, chinese cabbage, collards, kale, kohlrabi, mustard greens) 2  foliar 2.2  soil broadcast 4 6 0.8 0. 012 0.047 Caneberries 2  foliar 2.2  soil broadcast 5 4 10 Not specified 1.7 0. 012 0.047 Celery, Dandelion 2  foliar 2.2  soil broadcast 4 6 1.0 0. 012 0.047 Citrus 16 (foliar in CA only) 10 (foliar in FL only) 7.5  foliar 1 lb/ 100 gal. 1 Not specified 8 Not specified 20 Not specified 20 Not specified 2.7 to 3.4 (lemons & oranges) 0.023 0.176 Table 4: Representative Application Rates Considered in Risk Assessment Crop or Target Occupational Products Residential Products lb ai/ 1000 ft 2 (units may vary) lb ai/ A/ acre (units may vary) max. apps/ season lb ai/ season Average Rates 23 Corn (field and pop) 2 4 8 1. 0 0.012 0.047 Corn (sweet) 2  foliar 2.2  soil broadcast 8 4 16 Not specified 1.3 0. 012 0.047 Cranberry 2 5 10 2.0 0. 012 0.047 Cucurbits (cucumber, melon, pumpkin, squash) 1 6 6 1. 1 0.012 0.047 Fruiting Vegetable (tomato, eggplant, pepper) 2 7 8 1. 0 0.012 0.047 Grapes 2 5 10 1.4 0. 012 0.047 Grasses Grown For Seed 1.5 2 3 0. 8 (based on hay) Leafy Vegetable (head and leaf lettuce, endive, mustard green) 2  foliar 2.2  soil broadcast 5 4 6 Not specified 1.1 0. 012 0.047 Nuts (almond, chestnut, pecan, pistachio, walnut, etc.), foliar or dormant/ delayed 5 4 15 2.5 (pecans) 0.047 0.12 Nuts (almond, chestnut, pecan, walnut), foliar in CA 1 lb ai/ 100 gal Not specified Not specified Not specified 0.047 0.12 Ornamental 2.2 or 2% solution   1. 5 0.023 Oyster beds (SLN only) 10 Not specified Not specified  Peanut 2 5 8 0. 8 0.012 0.047 Pome fruit 3 8 15 1. 2 (based on apples) 0.012 0.07 Poultry 1/ 1000 ft 2 broiler 0.64 0.76/ 100 layers

Potatoes & Tubers (turnips) 2 6 6 0.8 Rangeland pastures 1 1 1 0. 9 Rice 1.5 2 4 1. 1 Right of Way 1. 5 3 0. 4 Sorghum 2 4 6 1. 1 Stone fruit (apricot, cherry, nectarine, peach, plum/ prune), foliar or dormant/ delayed 3 4  CA only 3 foliar & 1 dormant/ delayed 14 1.1 0. 047 0.12 Stone fruit (apricot, cherry, nectarine, peach, plum/ prune), foliar 1 lb ai/ 100 gal Not specified Not specified Not specified 0.047 0.12 Strawberries 2 5 10 1.4 0. 012 0.047 Sugar beets 1. 5 to 2 2 to 4 4 1.3 0. 012 0.047 Sweet Potatoes 2 foliar 8 lb/ 100 gal drip 8 foliar Not specified 8 foliar 1.2 1.6 foliar Not specified 0.012 0.047 Sunflower 1. 5 2 3 0.7 0. 012 0.047 Tobacco 2 4 8 1. 1

Tree farm 1  2 0. 7

Turf/ golf 8  liquids 9  granulars  0. 8/ 1000sf 2 to 4 0. 047 to 0.25 (lawns) [max levels for different products] Wheat, flax 1.5 2 3 0. 8

Ants 2% sol    2% sol Mosquito Control 2

Outdoor Banding 2% sol    2% sol Table 4: Representative Application Rates Considered in Risk Assessment Crop or Target Occupational Products Residential Products lb ai/ 1000 ft 2 (units may vary) lb ai/ A/ acre (units may vary) max. apps/ season lb ai/ season Average Rates 24 Domestic Animals (e. g., cats/ dogs) Dust 0.2 lb ai/ dog Sha. 0.01 lb ai/ dog    Dust 0.2 lb ai/ dog Sha. 0.01 lb ai/ dog Domestic Animals (e. g., cats/ dogs) 1.3 oz/ dog collar    1.3 oz/ dog collar ° Tree Crops: The application rate for commercial crops is between 2 to 6 lb ai per acre for most crops. Citrus rates are higher at 16 lb ai per acre (CA only). Equipment for commercial use is airblast, aerial and chemigation.

° Grapes: The application rate for commercial crops is 2 lb ai per acre. Equipment for commercial use is airblast, over the row groundboom, power duster, aerial and chemigation.

° Field, forage, fiber, small fruit (i. e., berries) and vegetable crops: The application rate for commercial crops is 1 to 2 lb ai per acre. Equipment for commercial use is groundboom, aerial and chemigation.

° Non crop areas: The application rate for commercial area is 1 lb ai per acre. Equipment is groundboom, aerial and right of way sprayer.

° Ornamentals: The application rate for commercial area is 2.2 lb ai per acre. Equipment for commercial use is low pressure handwand, backpack, high pressure handwand and airblast/ mist blower.

° Lawn Care (professional certified operator (pco)): The application rate for pco applicators is up to 8 lb ai per acre. The application equipment is hand held power sprayers and granular spreaders.

° Evergreens in large stands: the application rate for commercial crops is 1 lb per acre or 1.8 lb ai per 1000 square feet to the seed, mound or trunk. Equipment used for commercial areas is airblast, aerial, and high pressure handwand.

° Poultry: The application rates for commercial poultry production vary from 0.0048 lb ai per bird, to 0.08 lb ai per 1000 square feet and are also reported as 1 lb ai per 3.1 gallons. Application equipment for commercial production includes, compressed air sprayer, fogger, backpack sprayer and mist blower and power sprayers.

° Homeowner fruits and nuts: 0.0039 lb ai per gallon or up to 0.8 lb ai per 5 trees. Application equipment includes, hose end sprayer and hand held pump sprayer. 25 ° Homeowner vegetables: The application rate for homeowner vegetable gardens is 0.0026 lb ai per 20 foot row. The application equipment includes, hose end sprayer, hand held pump sprayer, hand held dusters and shaker cans.

° Homeowner lawn care: Maximum application rates range from 2 lb ai/ acre (0.047 lb ai/ 1000 ft2) up to almost 11 lb ai per acre (0.25 lb ai/ 1000 ft2) depending upon the product/ packaging and the pest. For the vast majority of products (e. g., professional application to residential lawns that could result in postapplication exposures and open packaging for homeowners) the maximum application rates are 8 lb ai/ acre for liquids and 9 lb ai/ acre for granules. Equipment for homeowner use is hose end sprayer, granular spreader, and belly grinder.

° Homeowner ornamentals: The application rate for homeowner ornamentals is 0.02 lb ai per gallon of water or 0.5 lb ai per 50 shrubs. Equipment for homeowner is hose end or hand held pump sprayers.

° Pets: Pet care products are applied via containers (i. e., powders and dusts by shake can, ready to use and pressurized containers) and rubbed in by hand. Application rate is made by the handler. Shampoos also are applied in the same manner. Pet collar application rate is 1 collar per animal and each collar contains 16 percent ai. Application equipment is a pet collar.

° Pet bedding: Applications are made to cover bedding by dusters or spray formulas including pressurized sprays.

2.0 Occupational Exposures and Risks It has been determined there is a potential for exposure in both occupational and residential/ homeowner scenarios from handling carbaryl products during the application process (i. e., mixer/ loaders, applicators, flaggers and mixer/ loader/ applicators) and from entering areas previously treated with carbaryl (e. g., postapplication worker exposure). As a result, risk assessments have been completed for both occupational handler and postapplication scenarios as well as residential handler and postapplication scenarios. This section includes the occupational aspects of the risk assessment. Occupational handler exposures and risks are addressed in Section 2.1: Occupational Handler Exposures and Risks while occupational post application worker risks are presented and summarized in Section 2.2: Occupational Post Application Exposures and Risks. The calculated risks are characterized in Section 2.3: Occupational Risk Characterization.

2.1 Occupational Handler Exposures and Risks The Agency uses the term "Handlers" to describe those individuals who are involved in the pesticide application process. The agency believes that there are distinct job functions or tasks related to applications and that exposures can vary depending on the specifics of each task. Job requirements (e. g., amount of chemical to be used in an application), the kinds of equipment used, 26 the crop or target being treated, and the circumstances of the user (e. g., the level of protection used by an applicator) can cause exposure levels to differ in a manner specific to each application event. The scenarios that serve as the basis for the risk assessment are presented in Section 2.1.1: Handler Exposure Scenarios. The exposure data and assumptions that have been used for the calculations are presented in Section 2.1.2: Data and Assumptions For Handler Exposure Scenarios. The calculations and the algorithms that have been used for the noncancer elements of the risk assessment as well as the risk values are presented in Section 2.1.3: Handler Exposure and NonCancer Risk Estimates while the analogous information using the Q1* for cancer estimates are presented in Section 2.1.4: Handler Exposure and Risk Estimates For Cancer. Section 2.1.5: Summary of Risk Concerns and Data Gaps For Handlers presents the overall risk picture for carbaryl. Finally, recommendations are presented in Section 2.1.6: Recommendations For Refining Occupational Handler Risk Assessment.

2.1.1 Handler Exposure Scenarios Exposure scenarios can be thought of as ways of categorizing the kinds of exposures that occur related to the use of a chemical. The use of scenarios as a basis for exposure assessment is very common as described in the U. S. EPA Guidelines For Exposure Assessment (U. S. EPA; Federal Register Volume 57, Number 104; May 29, 1992). The purpose of this section is to describe the exposure scenarios that were used by the Agency in the assessment for carbaryl handlers and to explain how the scenarios were defined. Information from the current labels; use and usage information; toxicology data; and exposure data were all key components in the developing the exposure scenarios.

The first step in the handler risk assessment process is to identify the kinds of individuals that are likely to be exposed to carbaryl during the application process. In order to do this in a consistent manner, the Agency has developed a series of general descriptions for tasks that are associated with pesticide applications. Common tasks (as an example) can include: preparation of dilute, waterbased spray solutions for application; transferring or loading dilute spray solutions into sprayers for application; and making applications with specific types of equipment such as a groundboom or airblast sprayer. Tasks associated with occupational pesticide use (i. e., for "handlers") can generally be categorized using one of the following terms:

C Occupational Mixer/ loaders: these individuals perform tasks in preparation for an application. For example, they would prepare dilute spray solutions and/ or load/ transfer solid materials (e. g., granulars) or dilute spray solutions into application equipment such as a groundboom tractor or planter prior to application.

C Occupational Applicators: these individuals operate application equipment during the release of a pesticide product into the environment. These individuals can make applications using equipment such as groundboom sprayers or tractor drawn spreaders for granular materials. C Occupational Mixer/ loader/ applicators: these individuals are involved in the entire pesticide application process (i. e., they do all job functions related to a pesticide application 27 event). These individuals would prepare a dilute spray solution and then also apply the solution. The Agency always considers some exposures to be mixer/ loader/ applicator exposures because of the equipment used and the logistics associated with such applications. For example, if one uses a small handheld device such as a 1 gallon low pressure handwand sprayer it is anticipated that one individual will mix a spray solution and then apply the solution because of labor and logistical considerations.

C Occupational Flaggers: these individuals guide aerial applicators during the release of a pesticide product onto an intended target.

Next, assessors must understand how exposures to carbaryl occur (i. e., frequency and duration) and how the patterns of these occurrences can cause the effects of the chemical to differ (referred to as dose response). Wherever possible, use and usage data determine the appropriateness of certain types of risk assessments (e. g., a chronic risk assessment is not warranted for a vast majority of carbaryl uses because chronic duration exposure patterns do not occur). Other parameters are also defined from use and usage data such as application rates and application frequency. The Agency always completes risk assessments using maximum application rates for each scenario because what is possible under the label (the legal means of controlling pesticide use) must be evaluated, for complete stewardship, in order to ensure there are no concerns for each specific use. Additionally, whenever the Agency has additional information such as typical application rates for some crops, as in this case, it uses the information to further evaluate the overall risks associated with the use of the chemical in order to allow for a more informed risk management decision. In this case, average application rates (considered to be the same as typical rates for the purposes of this assessment) defined in the recent Quantitative Usage Analysis were available for some crops and integrated into the assessment.

A chemical can produce different effects based on how long a person is exposed, how frequently exposures occur, and the level of exposure. It is likely that carbaryl exposures can occur in a variety of patterns. The Agency believes that occupational carbaryl exposures can occur over a single day or up to weeks at a time even though each crop or application target is generally treated only a few times per season. Intermittent exposures over several weeks are also anticipated. Some applicators may apply carbaryl over a period of weeks because they need to cover large acreages, they may be custom or professional applicators that are completing a number of applications within a region, or they may be applying carbaryl over a period of several days (e. g., a veterinary assistant who dips dogs periodically over a period of several weeks). The Agency classifies exposures up to 30 days as short term and exposures greater than 30 days up to several months as intermediate term. The Agency completes both short and intermediate term assessments for occupational scenarios in essentially all cases because these kinds of exposures are likely and acceptable use and usage data are not available to justify deleting intermediate term scenarios. For carbaryl, the agency has completed both short term assessment and intermediate term assessments because of likely extended periods of exposure in segments of the user population. [Note: The dermal toxicity study NOAEL has been applied to both durations and the NOAELs from the studies used to evaluate inhalation exposures are the same number so the results for both short term and intermediate term risks are numerically identical.] Long term or chronic exposures (essentially every working day over a year) 28 can also occur for some chemicals including an anticipated small number of carbaryl users, particularly in the greenhouse and floriculture industry. These have been addressed as appropriate. Finally, cancer risks have also been calculated using a amortized lifetime dose (LADD) and linear, low dose extrapolation (i. e., the Q1*).

The toxicity of chemicals can also vary based on the route of exposure or how a chemical enters the body. For example, exposures to the skin can result in a different toxic effect and/ or severity of reaction than exposures via inhalation. The effects of a chemical can also vary for different durations of exposure. The toxicology database for carbaryl indicates that the Agency consider exposures to the skin combined with exposures via inhalation because the effects and the dose levels at which effects occur are the same regardless of whether it is deposited on the skin or it is inhaled (e. g., cholinesterase inhibition was the effect noted for the inhalation endpoint defined in the acute neurotoxicity study and for the dermal endpoint defined in the 21 day dermal toxicity study used for the short term risk assessment). This is also true for all different durations of exposure as similar effects were observed in all toxicity studies selected as the source of the endpoints used for risk assessment purposes. [Note: For further information regarding the toxicity endpoints, see Section 1.3: Summary of Toxicity Concerns Relating To Occupational/ Residential Exposures.]

Occupational handler exposure assessments are completed by the Agency using different levels of personal protection. The Agency typically evaluates all exposures with a tiered approach. The lowest tier is represented by the baseline exposure scenario followed by increasing the levels of personal protection represented by personal protective equipment or PPE (e. g., gloves, extra clothing, and respirators) and engineering controls (e. g., closed cabs and closed loading systems). This approach is always used by the Agency in order to be able to define label language using a riskbased approach and not based on generic requirements for label language. [Note: Current labels mostly require single layer clothing, chemical resistant gloves, and no respirator.] In addition, the minimal level of adequate protection for a chemical is generally considered by the Agency to be the most practical option for risk reduction (i. e., over burdensome risk mitigation measures are not considered a practical alternative). The levels of protection that formed the basis for the calculations in this assessment include (which were combined to obtain 8 different scenarios):

C Baseline: Represents typical work clothing or a long sleeved shirt and long pants with no respiratory protection. No chemical resistant gloves are included in this scenario.

C Minimum Personal Protective Equipment (PPE): Represents the baseline scenario with the use of chemical resistant gloves and a dust/ mist respirator with a protection factor of 5.

C Maximum Personal Protective Equipment (PPE): Represents the baseline scenario with the use of an additional layer of clothing (e. g., a pair of coveralls), chemical resistant gloves, and an air purifying respirator with a protection factor of 10. C Engineering Controls: Represents the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods which have no known devices that can be used to routinely lower the exposures for these methods. 29 It has been determined that exposure to pesticide handlers is likely during the occupational use of carbaryl in a variety of environments including agriculture, commercial/ industrial premises, and in residential environments. The anticipated use patterns and current labeling indicate 28 major occupational exposure scenarios based on the types of equipment and techniques that can potentially be used to make carbaryl applications. The quantitative exposure/ risk assessment developed for occupational handlers is based on these scenarios. [Note: The scenario numbers correspond to the tables of risk calculations included in the occupational risk calculation aspects of the appendices.]

Mixing/ Loading (1a) Dry Flowable for Aerial/ Chemigation in Agriculture; (1b) Dry Flowable for Airblast; (1c) Dry Flowable for Groundboom; (1d) Dry Flowable for High Pressure Handwand and Right of Way Sprayers; (1e) Dry Flowable for LCO Applications; (1f) Dry Flowable for Aerial Wide Area Uses; (2a) Granular for Aerial; (2b) Granular for Broadcast Spreader; (3a) Liquids for Aerial/ Chemigation; (3b) Liquids for Airblast; (3c) Liquids for Groundboom; (3d) Liquids for High Pressure Handwand and Right of Way Sprayers; (3e) Liquids for LCO Applications; (3f) Liquids for Aerial Wide Area Uses; (3g) Liquids for Ground Wide Area Uses; (4a) Wettable Powder for Aerial/ Chemigation; (4b) Wettable Powder for Airblast; (4c) Wettable Powder for Groundboom; (4d) Wettable Powder for High Pressure Handwand and Right of Way Sprayers; (4e) Wettable Powder for LCO Applications; (4f) Wettable Powder for Aerial Wide Area Uses;

Applicator: (5a) Aerial/ Liquid Application; (5b) Aerial/ Liquid Wide Area Application; (5c) Aerial/ Granular Application; (6a) Airblast Application; (6b) Wide Area Ground Fogger (Airblast as surrogate); (7) Groundboom Application; (8) Solid Broadcast Spreader Application; (9) Aerosol Can Application; (10) Trigger Sprayer (RTU) Application; (11) Right of Way Sprayer Application; (12) High Pressure Handwand Application; 30 (13) Veterinary Technician/ Animal Groomer Liquid Application; (14) Veterinary Technician/ Animal Groomer Dust Application; (15) Granulars/ Bait and Pellets Dispersed by Hand; (16) Granulars/ Bait and Pellets Dispersed with Spoon;

Mixer/ Loader/ Applicator: (17) Low Pressure/ High Volume Turfgun Application; (18a) Wettable powder, Low pressure handwand; (18b) Liquid: Low Pressure Handwand; (19) Backpack; (20) Granular Belly Grinder; (21) Push type Granular Spreader; (22) Handheld Fogger; (23) Powered Backpack; (24) Granular Backpack; (25) Tree Injection; (26) Drenching/ Dipping Seedlings For Propagation; (27) Sprinkler Can;

Flaggers: (28a) Flagging For Liquid Sprays; and (28b) Flagging For Granular Applications.

2.1.2 Data and Assumptions For Handler Exposure Scenarios A series of assumptions and exposure factors served as the basis for completing the occupational handler risk assessments. Each assumption and factor is detailed below on an individual basis. In addition to these values, exposure values were used to calculate risk estimates. Mostly, these values were taken from the Pesticide Handlers Exposure Database (PHED). In other cases, chemical specific data were submitted to support the reregistration of carbaryl. Both PHED and the individual studies are presented below. 31 The assumptions and factors used in the risk calculations include:

C Carbaryl is one of the most widely used pesticide chemicals. It has an extraordinary number of use patterns that are impossible to completely capture in this document. As such, the Agency has patterned this risk assessment on a series of likely representative scenarios that are believed by the Agency to represent the vast majority of carbaryl uses. Refinements to the assessment will be made as more detailed information about carbaryl use patterns become available.

C The carbaryl 80 S label EPA Reg 264 316 has a 24( c) label (SLN WA 900013) that allows application to oyster beds to control ghost and mud shrimp. The application rate is 8 lb ai/ acre based on information from Bob Merkel of the Washington State Department of Agriculture (WSDA) [contained in email from CRM Anthony Britten of 1/ 3/ 02]. WSDA information also indicates that applications are completed with helicopters over a 3 day period in July and that approximately 800 acres are treated usually with 3 aircraft. Beds are treated with 10 gallons of spray solution per acre at a concentration of 0.8 lb ai/ gallon. With this information, the Agency calculated that approximately 89 acres would be treated per day by each helicopter and that 711 lb ai would also be used. The Agency did not calculate risks specifically for this scenario. However, the Agency considered a wide range of aerial application scenarios in this assessment. For all formulations and for pilots, the vegetable scenario based on 2 lb ai/ acre and 350 acres treated per day (i. e., 700 lb ai applied per day) yields essentially the same risk numbers that would be associated with treating oyster beds. As a result, please refer to the aerial vegetable scenarios to obtain risk estimates for treating oyster beds.

C Average body weight of an adult handler is 70 kg because the toxicity endpoint values used for the assessments are appropriate for average adult body weight representing the general population. This is the case because none of the effects identified in the selected toxicity studies were sex specific (i. e., NOAELs selected by HIARC were the same for males and females).

C All analyses were completed using chemical specific exposure data or data that were deemed to be a source of acceptable surrogate exposure data for the scenario in question. Several handler assessments were completed using "low quality" PHED data due to the lack of a more acceptable dataset. Additionally, in some cases, no empirical data were available for the scenario but an exposure assessment approach was developed based on an approach outlined in the SOPs For Residential Exposure Assessment. In these cases, the assumptions and approached included in the SOPs served as the basis for the assessment (e. g., some pet uses). The PHED unit exposure values range between the geometric mean and the median of the available exposure data. Factors derived from the SOPs For Residential Exposure Assessment are generally considered to be conservative. When data from other studies were used, the appropriate statistical measure of central tendency was used (see each study summary below for data descriptor). 32 C Several generic protection factors were used to calculate handler exposures. The protection factors used for clothing layers (i. e., 50%) and gloves (90%) have not been completely evaluated by the Agency. Additionally, the Agency uses a 98% reduction factor to estimate exposures that involve the use of engineering controls. There is an ongoing project through NAFTA to address the issue of protection factors (a draft document assessing protection factors using PHED has been completed). The results of this effort show that the protection factors being currently used by the Agency are within those predicted in the analysis. The values used for respiratory protection (i. e., PF 5 or PF 10) are based on the NIOSH Respirator Decision Logic.

C Exposure factors used to calculate daily exposures to handlers are based on applicable data if available. For lack of appropriate data, values from a scenario deemed similar enough by the assessor might be used. As a example, mixer/ loader/ applicator data for hose end sprayers were used to assess sprinkler can applications. The nature of these application methods are believed to be similar enough to bridge the data. There are other instances where the Agency has bridged specific data to represent other scenarios.

C Separate short term, intermediate term, and chronic risk assessments were completed for the noncancer endpoints based on the toxicity endpoints that were identified. The Agency believes that there are exposure scenarios that fit each of these categories. All noncancer scenarios are expected to be short or intermediate term in nature. The Agency only anticipates a limited number of scenarios that are chronic in nature which are included in the greenhouse and ornamental industry. The Agency also calculated cancer risks for private growers (i. e., those growers who would treat their own fields) and for more frequent carbaryl users such as a commercial applicator. The range in the cancer risk assessments is intended to address the large population of growers who likely complete their own applications but also to address likely smaller, more highly exposed commercial applications. The Agency has used a value of 30 application events per year for all commercial applicator scenarios and 10 days per year to account for private growers (i. e., 1/ 3rd of the analogous professional job function, this is also used for the postapplication risk assessment). These values are supported by the data included in the University of California studies of seasonal labor in California and the recent Department of Labor National Agricultural Worker Survey (NAWS).

C The exposure duration (i. e., years per lifetime) values used by the Agency in the cancer risk assessment are consistent with those used for other chemicals (i. e., 35 working years and 70 year lifetime). 33 C In many scenarios it is likely that a grower would mix, load, and apply chemicals all in one day because of limited labor, efficiency, or many other reasons. In most cases, however, the Agency considers mixing/ loading, and application as separate job functions. This is done primarily due to a lack of data that allows additivity between tasks to be appropriately assessed. Also, this approach allows for more flexibility in the risk management process. For example, if a closed loading system might be required for mixer/ loaders but engineering controls might not be required to reduce applicator exposures. If combined exposure estimates were considered, engineering controls might have been required for both tasks.

C The Agency has evaluated scenarios that may be limited in nature such as flagging during aerial applications because engineering controls (i. e., Global Positioning Satellite technology) are now predominantly used as indicated by the 1998 National Agricultural Aviation Association (NAAA) survey of their membership. It appears, however, flaggers are still used in approximately 10 to 15 percent of aerial application operations. In cases like these, the Agency strongly encourages the use of the engineering control system but will continue to evaluate risks for flaggers and any other population where a clear exposure pathway exists until the potential for exposure is eliminated.

C The Agency always considers the maximum application rates allowed by labels in its risk assessments in order to be able to consider what is legally possible based on the label. If additional information such as average or typical rates are available, these values are used as well in order to allow risk managers to make a more informed risk management decision. Average application rates were available from the SMART meeting and BEAD's QUA. These data indicate that in most cases, average application rates differ from maximum application rates on average by a factor of two. For example, when interpreting the results of the cancer assessment, the small differences generally seen in the available rates should be considered along with the overall magnitude of the cancer risk results. However, it should be noted that because there appears to be little difference between the typical and maximum application rates, overall risk results are not expected to be sensitive to changes in this parameter.

C The average occupational workday is assumed to be 8 hours. The daily areas to be treated were defined for each handler scenario (in appropriate units) by determining the amount that can be reasonably treated in a single day (e. g. acres, animals). The factors used for the carbaryl assessment are the same as those detailed in the Health Effects Division Science Advisory Committee on Exposure Policy 9: Standard Values for Daily Acres Treated in Agriculture which was completed on July 5, 2000. The following daily volumes handled and acres, excerpted from the policy, to be treated in each occupational scenario include:

C Aerial applications: 1200 acres for large field crops and forest treatments, 350 acres for other field crops, and 7500 acres for mosquito control adulticide applications; C Groundboom: 200 acres for large field crops (e. g., wheat and corn), 80 acres treated for other field crop groundboom applications, and 40 acres on golf course turf; C Airblast: 40 acres treated for agricultural applications; 34 C Ground fogger: 3000 acres for mosquito control (airblast as surrogate); C 8 pet animals treated per day for veterinary and professional groomer uses; C 1000 gallons of spray solution prepared when mixing/ loading liquids for high pressure handwand application or making the application; C 40 gallons when mixing/ loading/ applying liquids with a backpack sprayer or a low pressure handwand sprayer; C 10 mounds per day treated for fire ant applications. [Note: The veterinary and fireant treatments are not included in the policy but represent values that have been used by the Agency in previous assessments. Some carbaryl use patterns may not be summarized above, refer to Policy 9 for further information.]

C For direct pet animal treatments, Agency policy outlined in the Residential SOPs, was used to define the amount of chemical applied in animal treatments. For pet treatments, the SOPs prescribe that ½ of a container is used to treat each animal. Dusts and liquid shampoos for carbaryl are available in a 6 ounce bottle (0.5% solution) and a 4 lb container (10% dust).

C Currently the Agency has no exposure monitoring data on dust applications to crops in agriculture. There are other data gaps that have been identified for carbaryl applications. Each is identified in the calculation tables and is also noted in the summary of risk calculations.

C Ultra low volume applications for uses such as mosquito control adulticides were considered using a large acreage estimate to aerial applicators. The mosquito adulticide uses that were evaluated in the same manner as other chemicals used for that purpose (e. g., the same acreage estimates were used as for other chemicals like fenthion and naled).

C The impact of using large area (i. e., acreage) estimates should be considered when interpreting the results such as with the scenarios intended to address wide area treatments. For wide area treatments, the Agency considered large acreage aerial applications but did not quantitatively consider ground/ truck fogging which is another likely application method. In the past, the Agency has used airblast application exposure data to address this scenario. However, already given the complexity of the handler risk assessment and the rangefinder nature of using airblast data, the Agency has not completed these calculations. A qualitative estimate of risks can be made by considering the airblast results for agriculture and adjusting the risk values as appropriate for acres treated (3000 acres/ day for ground foggers) and application rate.

The Agency uses a concept known as unit exposure as the basis for the scenarios used to assess handler exposures to pesticides. Unit exposures numerically represent the exposures one would receive related to an application. They are generally presented as (mg active ingredient exposure/ pounds of active ingredient handled). The Agency has developed a series of unit exposures that are unique for each scenario typically considered in our assessments (i. e., there are different unit exposures for different types of application equipment; job functions; and levels of protection). The unit exposure concept has been established in the scientific literature and also 35 through various exposure monitoring guidelines published by the U. S. EPA and international organizations such as Health Canada and OECD (Organization For Economic Cooperation and Development). The concept of unit exposures can be illustrated by the following example. If an individual makes an application using a groundboom sprayer with either 10 pounds of chemical A or 10 pounds of chemical B using the same application equipment and protective measures, the exposures to chemicals A and B would be similar. The unit exposure in both cases would be 1/ 10th of the total exposure (measured in milligrams) received during the application of either chemical A or chemical B (i. e., milligrams on the skin after applying 10 pounds of active ingredient divided by 10 pounds of active ingredient applied).

The unit exposure values that were used in this assessment were based on one carbarylspecific occupational handler exposure monitoring study during professional dog grooming, three other studies which were used as sources of surrogate exposure information that are not currently included in the Pesticide Handler Exposure Database (PHED) Version 1.1 August 1998, and PHED itself. A brief summary of these studies is provided below in this section. Along with these data, unit exposures from PHED were used to complete remaining aspects of this risk assessment. Each is discussed and summarized below.

Occupational Handler Exposure Studies: A total of five studies are described in this section. One study monitored carbaryl use during professional dog grooming activities. The other studies were not completed with carbaryl but were completed with other active ingredients and used as a source of surrogate exposure information for various carbaryl use patterns. Each study can be identified with the following information. A summary of each is also provided below.

°" Dermal Exposure and Inhalation Exposure to Carbaryl by Commercial Pet Groomers During Applications of Adams ™ Carbaryl Shampoo." EPA MRID 446584 01, September 1998 Report dated August 10, 1998; Author; Thomas C. Mester, Ph. D. Sponsor: Pfizer Animal Health.

°" Worker Exposure Study During Application In Banana Plantation With Temik 10G, RP Study SA 98337, EPA MRID 451672 01, Vol. 3 of 4" EPA MRID 451672 01; November 1999 Report; Author: Michel Urtizberea; Sponsor: Aventis Crop Protection; EPA DER Completed on 10/ 17/ 00 (DP Barcode D267546).

°" Worker Exposure Study During Application Of Regent 20GR In Banana Plantation, (RP Study 94/ 136  Amended, EPA MRID 452507 01, Vol. 4 of 4, Analytical Lab. CP/ Man/ ENH/ 338/ 95/ 0072)" EPA MRID 452507 02; June 1996 Report; Author: P. G. Pontal; Sponsor: Aventis Crop Protection; EPA DER Completed on 1/ 05/ 01 (DP Barcode 270065). 36 °" Exposure of Applicators to Propoxur During Trigger Pump Spray Applications of a Liquid Product " EPA MRID 410547 01; November 1, 1988; Author: R. D. Knarr, Ph. D., CIH; Sponsor: Bayer Corporation; EPA review (9/ 29/ 89) by Versar, Inc. for PHED purposes under Contract 68 02 4254, Task 220.

°" Integrated Report For Evaluation of Potential Exposures To Homeowners and Professional Lawncare Operators Mixing, Loading, and Applying Granular And Liquid Pesticides To Residential Lawns " EPA MRID 449722 01; October 10, 1999; Author: Dennis R. Klonne, Ph. D.; Sponsor: Outdoor Residential Exposure Task Force; EPA Review by Gary Bangs (April 30, 2001).

[Note to Chemical Review Manager: There are no data compensation issues associated with the use of non ORETF data included in MRIDs 451672 01 and 452507 01 as these studies were sponsored and submitted by the Aventis Corporation and the propoxur trigger sprayer study has a signed PHED data waiver but just has not been included into PHED at this time. Appendix B contains the data excerpted from MRID 446585 01 in various tables which is a carbaryl specific study recently completed by the Aventis Corporation. Data from the other referenced studies are not included in Appendix B because separate reviews exist for each which can be independently referenced. Some of the handler exposure data used in this assessment are from the Outdoor Residential Exposure Task Force (ORETF). There is also no data compensation issue associated with the use of the ORETF data in the carbaryl risk assessment because the Aventis Corporation, the registrant for carbaryl, is a member of the ORETF. The task force recently submitted proprietary data to the Agency on hose end sprayers, push type granular spreaders, and handgun sprayers (MRID # 44972201). The ORETF data were used in this assessment in place of PHED data. The ORETF data were designed to replace the present PHED data with higher confidence, higher quality data that contains more replicates than the PHED data for those scenarios. Finally, the Agency identified several occupational exposure studies from the literature by investigators such as Popendorf and Wolfe. These data have not been used by the Agency quantitatively in this assessment because of several issues but were qualitatively considered and also used to confirm the currently used exposure data.]

MRID 446584 01 (carbaryl specific dog groomer data): The data collected reflect the dermal and respiratory exposure of commercial pet groomers applying the end use product, Adams® Carbaryl Flea and Tick Shampoo containing 0.50 percent carbaryl. These data meet most of the criteria specified in Series 875 Occupational and Residential Exposure Test Guidelines. The data are of sufficient scientific quality to be used in the reregistration of carbaryl. The protocol was reviewed by the then Occupational and Residential Exposure Branch of the Health Effects Division. The protocol was accepted as written with the stipulation that protective latex gloves not be worn by groomers because "this protocol was required as a worst case estimate of exposure. Therefore, the use of gloves in this study needs to be deleted" (From George Tompkins to Michael Metzger, dated November 26, 1996). In this study, applications of Adams® Carbaryl Flea and Tick Shampoo were made by professional pet groomers to 8 dogs at 2 sites in Georgia. A total of 16 replicates were monitored for dermal and inhalation exposure. Eight dogs of various sizes and hair lengths were shampooed during each replicate. Dermal exposure was monitored with face and neck swabs, 100 37 percent cotton union suit dosimeter worn underneath a short sleeved t shirt, long pants and a 65/ 35 polyester cotton long sleeved smock (i. e., represents a short sleeved shirt under a long sleeved coat/ smock). Hand exposure was quantified using handwash rinses (no protective gloves were worn). Inhalation exposure was monitored using personal air pumps with XAD2 resin tubes.

Between 373.3 to 3719.95 mg carbaryl (average use was 1360 mg ai) was used to shampoo 8 dogs. According to label directions, the application rate is a subjective determination by the individual groomers based on amount needed to create the desired lather. The dogs were wetted, shampooed to a lather (lather remained on dogs for 5 minutes) and rinsed. It is not clear how many or which of the dogs got further post shampoo attention such as grooming or drying.

After completing 8 dog shampoos the dosimeters were collected. Face/ neck swabs and 2 hand rinses were performed along with collection of the 100 percent cotton union suit. Only wholebody dosimeter values were adjusted for field recovery (87 percent). No other samples were corrected for recovery as the field and laboratory recoveries generally were >90 percent. Dermal exposures ranged between 0.88 mg and 17 mg ai and inhalation exposures range between 0.05 µg (non detect) and 1.96 µg ai. The limit of detection (LOD) was 0.010 µg/ ml. The limit of quantitation (LOQ) was 1 µg per whole body dosimeter, 0.10 µg/ ml for 50 ml hand wash aliquot, 0.10 µg per facial wipe, 0.10 µg per resin tube, and 0.10 µg for glass fiber filter/ support pad. Table 5 contains the results which have been normalized based on each of the following factors:

° mg ai exposed per lb ai handled; ° ai exposed per hour, and ° mg ai per lb dog shampooed. ° The geometric mean of the normalized numbers was used in reregistration calculations because it is a measure of central tendency.

Even though the study protocol was approved prior to completion of the field work, the following factors should be considered when interpreting these results. In this task, direct contact of the dipping solution with the hands represents a major potential source of exposure. Therefore, obtaining accurate hand exposure estimates is critical in defining the risks for this use. The study measured the amount of carbaryl left on the hands after 8 shampoos and rinses using an aqueous handwash method. Shampoo was applied, a lather was created and rinsed off with a large degree of hand contact with the shampoo and water stream. Carbaryl repeatedly contacted the hand for the duration of the grooming and some was removed during the rinsing of each dog. Because of this potential flux of residues off and on the groomer's hands and the presence of surfactants which may impact dermal absorption levels, the handwash method may underestimate exposures. This study should not be used for residential exposure assessments because protective clothing (i. e., smock and long pants) were worn over the whole body dosimeters and adjusting the data using negative protection factors which is generally not considered appropriate. 38 Table 5: Unit Exposure Values Obtained From Professional Dog Groomer Study (MRID 446584 01)

Dermal Inhalation Unit Arithmetic Mean Geometric Mean Median Unit Arithmetic Mean Geometric Mean Median mg ai / lb ai handled 1900 1800 1800 µg ai / lb ai handled 24 12 19 mg ai / hour application 1.6 1. 1 1.1 µg ai / hour application 0.20 0.96 0.21 mg ai / lb of dog treated 0.18 0.13 0.14 µg ai / lb of dog treated 0.020 0.011 0.020 Appendix B contains the data excerpted from MRID 446585 01. Data from none of the other studies are included in Appendix B because separate reviews exist for each of the other studies which can be independently referenced.

EPA MRID 45167201 (Temik granular backpack study): A total of 12 mixer/ loader/ applicator events during granular backpack (i. e., a specialized device manufactured by Swissmex Rapid) application to bananas were monitored during August of 1998 on the island of Martinique which is in the French West Indies. Weather was typical of the application season in that it was hot, humid, and rainy at points. Monitoring was completed using whole body dosimeters, handwashes, facial wipes, and personal sampling pumps equipped with XAD resin/ filter combination samplers. Temik 10G was supplied in 22 pound boxes which was loaded directly into the backpack devices (i. e., 4 to 8 boxes were used per replicate). The application rate for aldicarb used in this study is 20 grams of Temik 10G (i. e., 2 grams ai/ plant) which is equivalent to about 3.56 lb ai/ acre at approximately 2000 plants per acre. The numbers of acres treated ranged from approximately 2.5 to 5 acres. The pounds of active ingredient handled ranged from 8.8 up to 17.6 per replicate. Each applicator wore the whole body dosimeters covered by a cotton coverall, Tyvek gloves supplied with the Temik 10G formulation, and an apron on their backs between their backs and the backpack applicator. The Tyvek gloves were changed with each box of Temik 10G used. In many instances, the gloves were compromised because they were ripped. In one case, the gloves filled with rainwater. In many other cases, when the whole body dosimeters were removed, they were found to be wet and muddy.

Analysis of aldicarb and its sulfoxide and sulfone degradates was completed. The residue levels were added together to obtain total exposure levels. The limits of quantification (LOQ) were 1.0 µg per sample for the whole body dosimeters and handwashes (600 mL volume). The LOQ for the facial wipes was 0.10 µg per sample and 0.050 0.10 µg per sample for the air filters.

Field and laboratory recovery data were generated for all media for all residues measured (i. e., parent and metabolites). Field recovery data were generated in a manner that addressed field sampling, field storage, transport, laboratory storage, and analysis. Residues were corrected for the overall average field recovery for each residue/ matrix combination. Generally, recovery was adequate for all media/ residue combinations. If the PHED grading criteria are applied, all residue/ matrix combinations (except facial wipes with sulfone residues) have at least grade "B" data and in many cases the data meet the grade "A" criteria. The grade "B" criteria require laboratory recovery data with an average of at least 80 percent and a coefficient of variation of 25 or less 39 accompanied with field recoveries that are at least 50 percent but not exceeding 120 percent. The grade "A" criteria require laboratory recovery data with an average of at least 90 percent and a coefficient of variation of 15 or less accompanied with field recoveries that are at least 70 percent but not exceeding 120 percent.

Unit exposure values were calculated using the data from the study and a commercial spreadsheet program (Table 6). The exposures that were calculated were normalized by the amount of chemical used, the duration of the application interval, and by the body weight of the individual applicators. For each calculation, the arithmetic mean, geometric mean, and various percentiles were calculated. No analyses were completed with these data to ascertain the exact type of distribution. The Agency typically uses the best fit values from the Pesticide Handlers Exposure Database which are representations of the central tendency. Considering the standard practice, the Agency will use the geometric mean for risk assessment purposes. The other values are presented for comparative purposes.

Table 6: Unit Exposure Values Obtained From Granular Backpack Application Study (MRID 451672 01)

Type (mg exp./ lb ai handled) (mg exp./ hour) (mg exp./ kg body weight/ day) Dermal Inhalation Dermal Inhalation Dermal Inhalation Arith. Mean 0.1391 0.0046 0.5473 0.0179 0.0585 0.0018 Geo. Mean 0.0995 0.0042 0.3979 0.0169 0.0409 0.0017 25th %tile 0.0474 0.0031 0.2511 0.0134 0.0220 0.0015 75th %tile 0.1691 0.0062 0.7436 0.0229 0.0765 0.0023 90th %tile 0.2217 0.0068 0.8489 0.0264 0.0947 0.0027 95th %tile 0.3510 0.0076 1.2119 0.0282 0.1390 0.0028 99th %tile 0.4722 0.0083 1.5594 0.0298 0.1805 0.0030 EPA MRID 452507 01 (Fipronil Spoon Application Study): A total of 18 mixer/ loader/ applicator events during granular backpack (i. e., a specialized device manufactured by Horstine Farmery) or spoon application to bananas were monitored during applications on three different days in June, 1994 on the same banana plantation in Cameroon. [Note: Only the spoon application data included in this study are used in the carbaryl risk assessment as backpack granular applications have been assessed using the data presented above.] The 18 replicates were distributed over the 3 sampling days as follows: 6 spoon/ hand applications on day 1; 4 spoon/ hand applications on day 2; and 8 backpack events on day 3. Weather was typical of the application season in that it was hot and humid. Monitoring was completed using whole body dosimeters, cotton gloves, cotton caps, and personal sampling pumps equipped with filters. Regent 20GR was supplied in 22 pound boxes which was loaded directly into the backpack devices or buckets for the spoon applicators. The application rate for fipronil used in this study is 7.5 grams of Regent 20GR (i. e., 0.15 grams ai/ plant) which is equivalent to about 0.26 lb ai/ acre (0.00033 lb ai/ plant) at approximately 800 plants per acre. The numbers of acres treated ranged from approximately 0.75 to 1 acre. The pounds of active ingredient handled ranged from about a quarter to half a pound per replicate. Each 40 applicator wore whole body dosimeters that also served as the normal work clothing. PVC gloves were also worn over cotton gloves which served as the dosimeters. A protection factor of 50 percent was used by the Agency to calculate exposure levels under a layer of normal work clothing. Dosimeter samples were segmented into arms, legs, and torso for analysis.

Analysis of fipronil residues was completed with gas chromatography and electron capture detection. The limits of quantification (LOQ) were 9.7 µg per sample for all media used. The limit of detection (LOD) varied for each media. The LOD for the cotton gloves was 0.5 µg per sample, 0.10 µg per sample for the air filters, and 2.0 to 4.0 µg per sample for the whole body dosimeters depending upon the sample analyzed. Field and laboratory recovery data were generated for all media. Field recovery data were generated in a manner that addressed field sampling, field storage, transport, laboratory storage, and analysis. However, the laboratory recovery data were indeterminate because the sample media could not be identified for each reported result. The overall recovery values do appear to be quantitative. Residues were corrected for the overall average field recovery for each residue/ matrix combination. Generally, recovery was adequate for all media/ residue combinations (i. e., all correction factors were greater than 85 percent). If the PHED grading criteria are applied and the overall laboratory recovery averages are used all residue/ matrix combinations are considered grade "A" data. The grade "A" criteria require laboratory recovery data with an average of at least 90 percent and a coefficient of variation of 15 or less accompanied with field recoveries that are at least 70 percent but not exceeding 120 percent.

Unit exposure values were calculated using the data from the study and a commercial spreadsheet program. The exposures that were calculated were normalized by the amount of chemical used, the duration of the application interval, and by the body weight of the individual applicators (see table below). The values are based on a 50 percent clothing penetration factor and are separated for each equipment type monitored in this study. For each normalization factor, the arithmetic mean, geometric mean, and various percentiles were calculated. No analyses were completed with these data to ascertain the exact type of distribution. The Agency typically uses the best fit values from the Pesticide Handlers Exposure Database which are representations of the central tendency. Considering the standard practice, the Agency will use the geometric mean for risk assessment purposes. The other values are presented for comparative purposes.

Table 7: Unit Exposure Values Obtained From Granular Spoon Application Study (MRID 452507 01) Type (mg exp./ lb ai handled) (mg exp./ hour) (mg exp./ kg body weight/ day) Dermal Inhalation Dermal Inhalation Dermal Inhalation Applications with a Spoon Arith. Mean 2.875 0.106 0.433 0.016 0.025 0.001 Geo. Mean 1.978 0.045 0.246 0.006 0.014 0.0003 Median 1.889 0.039 0.221 0.005 0.011 0.0003 25th %tile 0.990 0.024 0.104 0.003 0.006 0.0001 75th %tile 4.140 0.066 0.677 0.007 0.035 0.0004 90th %tile 6.113 0.316 0.999 0.052 0.059 0.003 95th %tile 7.276 0.402 1.190 0.066 0.072 0.004 99th %tile 8.207 0.471 1.342 0.077 0.082 0.005 41 EPA MRID 410547 01 (Propoxur trigger sprayer study): A total of 15 applicator events during residential applications using a hand operated trigger pump sprayer, attached with an 18 inch hose to half gallon cans containing 0.95 percent propoxur, were completed in this study. The study was completed between October 26 and November 1, 1988 in the Kansas City Missouri metro area. Each person monitored in the study was a Bayer (the sponsor corporation) employee. Three employees were used to complete all replicates. In each replicate, "each applicator used a separate one half gallon can of Raid for each house. The cap was removed from the top of the can and the hose sprayer was attached by inserting the dip tube into the can and tightening the screw cap. The sprayer was primed by pumping the trigger. The applicator treated the outside of the home in areas where pests were likely to be found, such as screens, door and window frames, foundation walls, patios, porches, stoops, and decks. When the application was completed, the hose sprayer was secured under the handle of the can." The data included in the study indicate that exposure durations ranged from 9 to 21 minutes per replicate and the amount of active ingredient handled ranged from 0.16 to 0.4 oz (i. e., 0.01 to 0.025 lb ai). Dermal (nonhand) exposure monitoring during each replicate was completed using gauze sponges held in "aluminized paper holders" with an open sampling surface area of 24.6 cm 2 while hand exposures were quantified with the handwash technique (2  200 mL aliquots of ethanol per hand for a total volume of 800 mL per person). Inhalation exposures were monitored using standard personal sampling pumps operating a 1 liter per minute with quartz microfiber filters. Samples were collected in this study to represent exposures when a person was wearing normal work clothing (i. e., long pants and long sleeved shirts) and chemical resistant gloves.

Analysis of propoxur residues was completed with high performance liquid chromatography, post column derivatization, and fluorescence detection. The limits of quantification (LOQ) were 10 µg per sample for the handwash solutions, 0.1 µg/ sample for the inhalation filters, and 0.03 µg/ cm 2 for the dermal patch samples. Field and laboratory recovery data were generated for all media. This study was reviewed in September 1989 under EPA contract 68 02 4254 by Versar. The values used for regulatory purposes have been excerpted from that review (including recovery results). Average laboratory recovery for all media ranged from 99.2 to 109 percent while the coefficients of variation for each media were generally less than 5 (i. e., for the patches, the CV = 16.5). Patches and filters were fortified at 1 µg/ sample while hand rinses were fortified at either 200 or 1000 µg/ sample. Average field recovery results ranged from 90.3 to 102.2 percent while coefficients of variation also were generally less than 5 (i. e., inside patch CV= 6.9). Patches were fortified at levels from 1 to 50 µg/ sample, hand rinses were fortified at 200 µg/ sample, and filters were fortified at 0.2 µg/ sample.

Unit exposure values were calculated using the data from the study and a commercial spreadsheet program. The exposures that were calculated were normalized by the amount of chemical used by individual applicators (Table 8). 42 Table 8: Unit Exposure Values Obtained From Propoxur Trigger Pump Sprayer Study (MRID 410547 01) Type (mg exp./ lb ai handled) Dermal Inhalation Geometric Mean 13.5 0. 123 Unit exposure values excerpted from Versar PHED Data review under Contract 68 02 4254 (9/ 29/ 89).

EPA MRID 449722 01 (ORETF Handler Studies): A report was submitted by the ORETF (Outdoor Residential Exposure Task Force) that presented data in which the application of various products used on turf by homeowners and lawncare operators (LCOs) was monitored. All of the data submitted in this report were completed in a series of studies. The two studies that monitored LCO exposure scenarios used a granular spreader (ORETF Study OMA001) and a low pressure, high volume turf handgun (ORETF Study OMA002) are summarized below.

OMA001: A loader/ applicator study was performed by the Outdoor Residential Exposure Task Force (ORETF) using Dacthal (active ingredient DCPA, dimethyl tetrachloroterephthalate) as a surrogate compound to determine "generic" exposures of lawn care operators (LCOs) applying a granular pesticide formulation to residential lawns. Surrogate chemicals were chosen by the Task Force for their representativeness based on physical chemical properties and other factors. Dacthal, which was the surrogate chemical used for the granular spreader and low pressure hand gun sprayer studies, has a molecular weight of 331.97 and a vapor pressure of 1.6 x 10 6 , and is believed to be an appropriate surrogate for many relatively nonvolatile pesticides. The study was designed to simulate a typical work day for a LCO applying granular pesticide formulation to home lawns. Each LCO replicate involved loading and applying approximately 3.3 lb ai (360 lb formulated product) over a period of about 4 hours to 15 simulated residential lawns (6480 ft 2 each) with a rotary type spreader. The average industry application rate of 2 lb ai/ acre was simulated (actual rate achieved was about 1.9 lb ai/ acre). The monitoring period included driving, placing the spreader onto and off of the truck, carrying and loading the formulation in the spreader, and the actual application. Incidental activities such as repairs, cleaning up spills, and disposing of empty bags were monitored. A total of 40 replicates (individual application events) were monitored using passive dosimetry (inner and outer whole body dosimeters, hand washes, face/ neck wipes, and personal inhalation monitors with OVS tubes). The inner samples represent a single layer of clothing. Inhalation exposure was calculated using an assumed respiratory rate of 17 Lpm for light work (NAFTA, 1999), the actual sampling time for each individual, and the pump flow rate. In 20 of the replicates, the subjects wore chemical resistant gloves while in the remaining replicates, no gloves were worn. No gloves were worn in any replicate while driving. All results were normalized for the amount of active ingredient handled. Nearly all samples (for every body part and for inhalation) were above the level of quantitation (LOQ) for dacthal. Where results were less 43 than the reported LOQ, ½ LOQ value was used for calculations, and no recovery corrections were applied. The overall laboratory recoveries (83 101%) and field recoveries (73 98%). The unit exposure values are presented in Table 9 below. [Note the inhalation exposure value is a median because the data were found to be neither normally nor lognormally distributed. All dermal values are geometric means as the data were lognormally distributed.]