Pop. Subgroup** All commodities No Decompositing Eliminating Strawberries Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD General U. S. Population 0.004294 43 0.004291 43 0.003614 36 All Infants (< 1 year old) 0.006747 67 0.006747 67 0.006675 67 Children 1 2 years old 0.009390 94 0.009359 93 0.007110 71 Children 3 5 years old 0.008084 81 0.008075 81 0.006126 61 Children 6 12 years old 0.005434 54 0.005434 54 0.003952 40 Youth 13 19 years old 0.003248 32 0.003243 32 0.002359 24 Adults 20 49 years old 0.002925 29 0.002919 29 0.002368 24 Females 13 49 years old 0.003227 32 0.003219 32 0.002424 24 Adults 50+ years old 0.002971 30 0.002961 30 0.002564 26 ** The values for the highest exposed population are bolded.

When the CMBS data were included in the assessment, the acute risk picture for carbaryl was not impacted ( Table 8). Children ( 1 2 years old) and children ( 3 5 years old) all infants had the highest associated risk levels at 86 percent and 77 percent of the aPAD, respectively. At the present time, information from the industry sponsored Carbamate Market Basket Survey has been approved for use in dietary risk assessments with appropriate characterization of uncertainties associated with the conduct of the study. Hence, the use of these data in this assessment should be considered with associated caveats ( e. g., rubbing fruit).

Table 8. Results of Acute Dietary Exposure Analysis With Market Basket Survey Data Included*

Population Subgroup ** aPAD ( mg/ kg/ day) 95th Percentile 99th Percentile 99.9th Percentile Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD General U. S. Population 0.01 0.000455 5 0.001248 12 0.004003 40 All Infants (< 1 year old) 0.01 0.000688 7 0.002394 24 0.005600 56 Children 1 2 years old 0.01 0.001836 18 0.003371 34 0.008590 86 Children 3 5 years old 0.01 0.001189 12 0.002237 22 0.007732 77 Children 6 12 years old 0.01 0.000725 7 0.001382 14 0.005217 52 Youth 13 19 years old 0.01 0.000360 4 0.000801 8 0.003182 32 Adults 20 49 years old 0.01 0.000289 3 0.000728 7 0.002801 28 Females 13 49 years old 0.01 0.000275 3 0.000705 7 0.003016 30 Table 8. Results of Acute Dietary Exposure Analysis With Market Basket Survey Data Included*

Population Subgroup ** aPAD ( mg/ kg/ day) 95th Percentile 99th Percentile 99.9th Percentile Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % aPAD 42 Adults 50+ years old 0.01 0.000272 3 0.000735 7 0.002691 27 * Market basket survey data included for apple, banana, broccoli, grape, lettuce, orange, peach and tomato.

** The values for the highest exposed population are bolded.

4.2.3 Chronic Dietary Risk Assessment Chronic dietary risks were calculated using the same equations as described above for the acute dietary risk estimates with different inputs appropriate for this exposure duration. Chronic dietary risks are not of concern as risks were < 1 percent of the cPAD for all population subgroups considered ( Table 9). The Carbamate Market Basket Survey ( CMBS) was not used in the calculation of chronic dietary risks because risks were low without considering it and it is not appropriate because it is for single serving data.

Table 9. Results of Chronic Dietary Exposure Analysis Population Subgroup cPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % cPAD General U. S. Population 0.01 0.000024 < 1 All Infants (< 1 year old) 0.01 0.000055 < 1 Children 1 2 years old 0.01 0.000076 < 1 Children 3 5 years old 0.01 0.000054 < 1 Children 6 12 years old 0.01 0.000029 < 1 Youth 13 19 years old 0.01 0.000015 < 1 Adults 20 49 years old 0.01 0.000020 < 1 Females 13 49 years old 0.01 0.000018 < 1 Adults 50+ years old 0.01 0.000021 < 1 4.2.4 Cancer Dietary Risk Assessment The following equations were used to calculate dietary exposure and cancer risk using the Q1* approach for carbaryl ( i. e., linear, low dose extrapolation). Cancer risks were only calculated for the general population.

Dietary exposure ( mg/ kg/ day) = consumption x residue Dietary cancer risk = average food exposure ( mg/ kg/ day) x Q1* ( mg/ kg/ day) 1 Risk estimates above 1 x 10 6 are considered to be of concern. Results indicate a maximum lifetime risk 43 of 2.14x10 8 based on the exposures calculated for the general US population ( Table 9). The Carbamate Market Basket Survey ( CMBS) was not used in the calculation of chronic dietary risks.

4.2.5 Characterization/ Uncertainties of the Dietary Risk Estimates In the course of conducting a Tier 3/ 4 dietary exposure analysis, decisions are made regarding the following: the residue data used in the analysis ( e. g., field trials, monitoring data, etc.), refinements incorporated in DEEM FCID   such as % CT and processing factors, sensitivity analyses, and a variety of other issues which may be chemical or crop specific. Characterization of this assessment and associated uncertainties include:

° The results of the Critical Exposure Contribution analysis showed that strawberries comprised a large percentage of the residues found in the tail end of acute exposure for children. Strawberry residues are from USDA PDP data.

° This assessment is highly refined. Very little field trial data were used and processing, cooking and washing factors were incorporated to the greatest extent possible. Nonetheless, further refinement could be carried out with the submission of additional washing, cooking, canning, and other processing studies and with monitoring data for commodities where field trial data were found to be best source of residue data.

4.3 Estimated Environmental Concentrations In Water The Environmental Fate and Effects Division ( EFED) provided an analysis of the available monitoring data and a screening level assessment using simulation models to estimate the potential Estimated Environmental Concentrations ( EECs) of carbaryl in ground and surface water ( D288455). Section 4.3.1: Environmental Fate Characteristics provides a summary of the fate characteristics of carbaryl. Section 4.3.2: Monitoring Data provides a summary of the monitoring data that were considered in this assessment. Section 4.3.3: Modeling EECs presents the EECs used for comparison to the DWLOCs ( Drinking Water Levels of Concern) calculated for the aggregate risk assessment ( presented in Section 5 below). [ Note: For the acute dietary assessment, DWLOCs were not calculated because a distribution of water concentrations was directly incorporated into DEEM/ FCID. Further explanation is provided below.]

4.3.1 Environmental Fate Characteristics Carbaryl is considered to be mobile and not likely to persist or accumulate in the environment and its degradate, 1 naphthol, appears to be less persistent and mobile than carbaryl itself. Under acidic conditions with limited microbial activity they may persist.

Carbaryl dissipates in the environment by abiotic and microbially mediated degradation. The major degradation products are CO2 and 1 naphthol, which is further degraded to CO2. Carbaryl is stable to hydrolysis in acidic conditions but hydrolyzes in neutral ( t1/ 2 = 12 days) and alkaline environments ( pH= 9, t1/ 2 = 3.2 days). Carbaryl is degraded by photolysis in water ( t1/ 2 = 21 days). Under aerobic conditions, the compound degrades rapidly by microbial metabolism, with half lives of 4 to 5 days in soil 44 and aquatic environments. In anaerobic environments metabolism is much slower with ½ lives on the order of 2 to 3 months. Carbaryl is mobile in the environment ( Kf = 1.7 to 3.5).

The major metabolite of carbaryl degradation by abiotic and microbially mediated processes is 1 naphthol. This degradate represented up to 67 percent of the applied carbaryl in degradation studies. It is also formed in the environment by degradation of napthalene and other polyaromatic hydrocarbons. Only limited information is available for the environmental transport and fate of 1 naphthol. While guideline studies were not specifically submitted for 1 naphthol, open literature data suggest it is less persistent and less mobile than carbaryl.

4.3.2 Monitoring Data Monitoring data for groundwater and surface water are available but are limited in terms of its usefulness for quantitative assessment. As reported in the U. S. E. P. A. Pesticides in Groundwater Database, carbaryl was detected in 0.4% of wells sampled. Carbaryl was detected in California ( 2 out of 1433 wells), Missouri ( 11 out of 325 wells), New York ( 69 out of 21027 wells) Rhode Island ( 13 out of 830 wells) and Virginia ( 11 out of 138 wells) ( Jacoby et al., 1992). The maximum concentration detected was 610 µ g/ L in NY, though typically the measured concentrations were significantly lower.

The EPA STORET database contains 9389 records indicating that analysis was done for carbaryl. Of these, only 4 were reported concentrations above the detection limits. These analyses were all from one well in Cleveland, OK in 1988. The 4 reported concentrations were between 0.8 and 1 ppb.

Carbaryl was detected at greater than the detection limit ( 0.003 : g/ L) in 1.1% of groundwater samples in the USGS NAWQA program. The maximum observed concentration was 0.021 : g/ L. Detections were mainly from three settings: wheat ( 5.8 % of well samples from wheat land use), orchards and vineyards ( 1.7 % of well samples from orchard and vineyard land use), and urban ( 1.8% of urban groundwater samples). A number of field studies have reported detectable carbaryl concentrations in surface waters. Because of limitation in the analytical methods used, there is some question as to the accuracy of carbaryl analysis. Poor analytical methods probably have resulted in lower detection rates and lower concentrations than actually present.

Carbaryl was detected in surface water in 46% of the 36 NAWQA study units between 1991 and 1998. Carbaryl ( along with diazinon) was one of the two most widely detected insecticides. A significant portion of the total carbaryl applied was apparently transported to streams. Out of 5220 surface water samples analyzed, 1082 or about 21 percent were reported as having detections greater than the minimum detection limit ( MDL). The maximum reported concentration was 5.5 ug/ L. For samples with positive detections the mean concentration was 0.11 : g/ L with a standard deviation of 0.43 : g/ L. In areas with high agricultural use, the load measured in surface waters was relatively consistent across the country at about 0.1 percent of the amount used in the basins. Streams draining urban areas showed more frequent detections and higher concentrations than streams draining agricultural or mixed land use areas.

Bayer CropScience submitted results of an on going surface water monitoring study of carbaryl residues in surface water in areas with high agricultural and residential use. In this drinking water study, 45 raw water was collected at 16 sites in agricultural areas and four in areas draining suburban areas. Samples at municipal water treatment facilities were collected for 3 years. When raw water showed positive detections for carbaryl, finished water samples collected at the same time were analyzed. This study provides useful information on measured concentrations of carbaryl in selected surface waters of the United States. Based on our analysis of sites selected, we do not concur, however, that these results can be used directly in the dietary risk assessment to represent exposure to carbaryl in surface water source drinking water. The information from this study does provide good quality data that can be used in association with other monitoring data sets to characterize carbaryl exposure. These data will be used in conjunction with other monitoring data, to evaluate conservatism in surface water modeling estimates of carbaryl exposure from surface water source drinking water. Several major drawbacks to the quantitative use of these data are:

° With only 16 sites to represent vulnerable surface water bodies for selected agricultural uses ( really 15, as the LA site was selected to represent population exposure not because source waters were vulnerable) and four suburban sites, this study is not likely to provide comprehensive coverage of even all high carbaryl usage sites, given the great geographic diversity of carbaryl use areas and carbaryl uses.

° We do not concur that sites sampled represent the " the highest probable risk of human exposure to carbaryl in surface water in each state". Based on our analysis of carbaryl use areas, we would conclude that some of the agricultural sites monitored are not particularly vulnerable.

° The monitoring interval ( one week to two weeks) is unlikely to capture peak concentrations necessary for estimating acute dietary risk, given the variable nature of concentration distributions.

4.3.3 Modeling EECs Because of the relatively limited persistence of the compound in the environment, it is highly unlikely that the non targeted monitoring studies which have been completed detected the maximum concentrations that occur. As a result, the non targeted monitoring data have been determined to be of limited utility in developing estimated environmental concentrations ( EECs) for ecological and human health risk assessment. Therefore, computer modeling was used to estimate surface water and groundwater concentrations that could be expected from normal agricultural use ( Table 10). The results of the modeling are supported by the available monitoring data. These results have been characterized as conservative, though not unreasonable estimates of possible concentrations in drinking water.

Surface Water Modeling: Computer modeling with the EPA PRZM3.12 and EXAMS 2.98.04 programs were used to estimate the concentration of carbaryl in surface water. Index reservoir scenarios corrected for Percent Cropped Area ( PCA) for representative crops were used. Three different application rates were used in modeling: the maximum allowed on the label for the specific crop, an " average" rate and the maximum rate reported to actually be used. EECs varied greatly depending on the geographic location, crop and application rate. The maximum calculated acute and chronic EECs ( 316 ppb and 14.2 ppb, respectively) resulted from use on citrus in Florida. Modeling " average" and maximum resulting use rates gave EEC values generally 40 60% lower than maximum. The source of 46 drinking water in relation to the EECs must be carefully considered when using these data. In this case, the results for Florida provided the highest estimates, however; in Florida the majority of drinking water is derived from groundwater (> 90%) so high surface water concentrations do not necessarily indicate high exposure. As a result, both Florida and the results for Pennsylvania apples ( acute EEC = 62.9 ppb) and Ohio sweetcorn ( chronic EEC = 5.5 ppb) have been considered in the aggregate assessment ( see Section 5.0 for more information). The EECs for Pennsylvania apples and Ohio sweetcorn provide the next highest values for the acute and chronic estimates, respectively. For the acute dietary assessment, DWLOCs were not calculated because a distribution of water concentrations generated using PRZM/ EXAMS was directly incorporated into DEEM/ FCID. This means that the acute EECs were not directly used for risk assessment purposes. They have been presented here for comparative purposes and to provide additional characterization.

Ground Water Modeling: SCI GROW 2.2 was used to calculate a groundwater screening exposure value to be used in determining the potential risk to human health. Carbaryl chemical properties are outside the range of values for which SCI GROW was developed ( i. e., aerobic metabolism is faster and its partition coefficient is larger which equates to less leaching than the reference compounds  both factors indicate carbaryl degrades faster). SCI GROW estimates for groundwater EECs may not predict with complete accuracy, maximum levels because the concentrations calculated are 90 day averages. It is possible; therefore, that groundwater concentration peaks could not be identified. Groundwater levels are anticipated, however, to be more stable over time than surface water concentrations.

Table 10: Carbaryl Drinking Water Estimated Environmental Concentrations ( EECs)

Crop Application Rate Descriptor Number of Applications per Year Pounds A. I. per application Water Acute ( ppb) ( 1 in 10 year peak single day concentration) Water Chronic ( ppb) ( 1 in 10 year annual average concentration)

Source: Surface Water ( PRZM/ EXAMs)

Sweet Corn ( OH) ( PCA = 0.46) Maximum1 8 2 57.3 5.53 *

Average2 2 3.4 49.8 2.31 Maximum3 Reported 3 1 25.6 1.26 Source: Surface Water ( PRZM/ EXAMs)

Field Corn ( OH) ( PCA = 0.46) Maximum1 4 2 51.3 2.72 Average2 2 1 14.6 0.68 Maximum3 Reported 2 1.5 21.9 1.02 Source: Surface Water ( PRZM/ EXAMs)

Apples ( PA) ( PCA = 0.87) Maximum1 5 2 62.9 * 2.20 Average2 2 1.2 23.4 0.63 Maximum3 Reported 2 1.6 34.4 1.04 Source: Surface Water ( PRZM/ EXAMs)

Sugar Beats ( MN) ( PCA = 0.87) Maximum1 2 1.5 48.2 2.16 Average2 1 1.5 13.6 0.73 Maximum3 Reported 1 1.2 10.8 0.58 Table 10: Carbaryl Drinking Water Estimated Environmental Concentrations ( EECs)

Crop Application Rate Descriptor Number of Applications per Year Pounds A. I. per application Water Acute ( ppb) ( 1 in 10 year peak single day concentration) Water Chronic ( ppb) ( 1 in 10 year annual average concentration)

47 Source: Surface Water ( PRZM/ EXAMs)

Citrus ( FL) ( PCA = 0.87) Maximum1 4 5 316 * 14.2 *

Average2 2 3.4 203 7.33 Maximum3 Reported 3 4.3 272 10.0 Source: Surface Water ( NAWQA) 5.5 ( Maximum Observed ) NA Source: Surface Water ( Bayer Monitoring Data) 0.18 ( Maximum Observed) NA Source: Groundwater ( SCI GROW) Maximum1 5 4 0.8 0.8 Source: Groundwater ( NAWQA Monitoring Data) 0.02 0.02 1 Maximum application rate on label 2 Average application rate from Quantitative Usage Analysis for Carbaryl, prepared July 21, 1998 by Frank Hernandez, OPP/ BEAD 3 Maximum rate of application reported in DOANES survey data * = Value used for risk assessment. Note acute EECs were not used directly in the risk assessment. A ranking approach was used based on these EECs to determine which water concentration distributions were selected for direct incorporation into DEEM/ FCID for the acute aggregate assessment.

4.4 Residential Risk Assessment The residential risk assessment addresses exposures that individuals receive through their use of consumer products that contain carbaryl and those exposures one could receive from frequenting areas that have been previously treated with carbaryl such as a home lawn, a garden, or public areas such as a golf course. Carbaryl can also be applied in wide area treatments such as on oyster beds or as a mosquito adulticide. These exposures have also been addressed in this assessment. The Occupational and Residential Exposure Assessment ( D287251) was prepared by Jeff Dawson with the exception of the tobacco assessment completed by Dr. Virginia Dobozy. The document D287251 contains detailed descriptions of the data used, methods, and risks calculated for each scenario. Please refer to that document for more specific information.

Section 4.4.1: Home Uses provides more specific information pertaining to how carbaryl consumer products are used which was considered in addition to the information presented above in Section 4.1: Summary of Registered Uses because it applied more directly to the development of the residential risk assessment. Section 4.4.2: Deterministic Residential Handler Risk Assessment describes the data, methods, and risk results ( both cancer and noncancer) associated with the use of consumer products which contain carbaryl. Section 4.4.3: Deterministic Residential Postapplication Risk Assessment describes the data, methods, and risk results associated with exposures to the general population that occur from frequenting treated areas. Section 4.4.4: Risks Based On Suburban Resident 48 Biological Monitoring Study describes the biomonitoring data ( and supporting data), methods, and risk results ( both cancer and noncancer) associated with the monitored individuals. Section 4.4.5: Residential Risk Characterization provides information pertaining to the quality of the assessment including discussions of the data used, uncertainties with the methods, and any other information that might be used to describe the quality of the results. Section 4.4.6: Risks Associated With Use In Tobacco describes how risks were calculated for smokers who may consume carbaryl treated tobacco in their cigarettes. Section 4.4.7: Other Residential Uses characterizes other potential sources of exposure outside of those quantitatively described in this assessment.

For clarity, the term " deterministic" has been used here to generically refer to the assessments based on the standard Agency approach for calculating residential exposure ( i. e., point estimates). The underlying purpose of this description is to differentiate these risks from those associated with the suburban resident biological monitoring study.

4.4.1 Home Uses Carbaryl is a widely used consumer product. Available products include liquids, wettable powders, and dusts for insect control on fruits, vegetables, ornamentals, and lawns. Products for flea control on pets are also available. The equipment used in applications may include dust shaker cans, garden hose end sprayers, trigger sprayers, low pressure handwands, belly grinders, push type spreaders, aerosol cans, and pet collars. In addition to the information presented in Section 4.1: Summary Of Registered Uses, Bayer at the time of the September 24, 1998 SMART Meeting also presented additional information that was key to the residential risk assessment based on the Sevin User Survey. Results from the Residential Exposure Joint Venture survey were also considered although it should be noted that these results do not significantly alter the factors used for the Agency's deterministic assessments ( based on Nako, 2/ 5/ 03, D284657). Carbaryl accounted for approximately 9 percent of the total residential insecticide market and was ranked fourth on the list behind the pyrethroids, chlorpyrifos, and diazinon. In addition, the registrant also presented the following:

° According to the registrant, insect control on vegetables (~ 58% of users), annuals (~ 50% of users), lawns (~ 35% of users), trees/ shrubs (~ 34% of users) account for the majority of homeowner uses for carbaryl. Pet uses also accounted for ~ 13 percent of users.

° The annual frequency of use, for all crops/ targets, was reported to be at the 60th percentile for 1 to 2 times per year and at the 84th percentile for 5 times per year.

° Aphids, ants, fire ants, fleas, and slugs/ snails are predominant pests controlled by residential carbaryl users (~ 30 down to 15% of users, respectively).

° Most ( 75%) of vegetable gardens treated with carbaryl are < 800 ft2 but ~ 8 percent are between 800 and 1500 ft2, ~ 9 percent are between 1500 and 5000 ft2, and ~ 6 percent are greater than 5000 ft2. Tomatoes, peppers, cucumbers, beans, and fruit trees represent the most treated garden plants.

° Most ( 82%) of flower gardens treated with carbaryl are < 500 ft2 but ~ 10 percent are between 500 and 1200 ft2, and ~ 8 percent are greater than 1200 ft2. Roses, shrubs, and certain annuals represent 49 the most treated flowering/ ornamental plants.

° Dusts ( 65%) and liquid concentrates ( 25%) account for most carbaryl sales in the residential annual market of 2 million pounds per year.

° According to the results of the Residential Exposure Joint Venture survey, carbaryl use on lawns is not predominant in the residential market. Uses on vegetables and ornamentals account for the most use in the residential marketplace. Approximately 1.2 percent of the general United States population uses carbaryl on lawns and about ½ of that is for spot treatments which would be considered a negligible exposure scenario by the Agency ( i. e., about 0.5 percent of the population uses carbaryl on lawns in a way that creates a significant exposure source). Approximately 4 to 5 percent of the United States population uses carbaryl on vegetables and ornamentals. Conditional probabilities indicate that if a turf application is made, then at most 18 percent of the time that individual will also treat their vegetables or 44 percent of the time at most that individual will also treat their ornamentals. The survey indicated also that about 67 percent of the general population uses pesticides and about 8.9 percent of all households use products containing carbaryl.

4.4.2 Deterministic Residential Handler Risk Assessment The anticipated use patterns and current labeling indicate 17 major residential exposure scenarios, based on the types of equipment and techniques, in which homeowners can be exposed to carbaryl during the application process. The quantitative exposure/ risk assessment developed for residential handlers is based on these scenarios. For most scenarios, multiple uses and application rates were considered for a total of 54 distinct combinations. The 17 major scenarios include:

( 1) Garden Uses: Ready to use Trigger Sprayer; ( 2) Garden Uses: Ornamental Duster; ( 3) Garden Uses: Hose end Sprayer; ( 4) Garden Uses: Low Pressure Handwand; ( 5) Tree/ ornamental Uses: Low Pressure Handwand; ( 6) Tree/ ornamental Uses: Hose end Sprayer; ( 7) Garden Uses: Backpack Sprayer; ( 8) Lawncare Liquid Uses: Hose end Sprayer; ( 9) Pet ( Dog and Cat) Uses: Dusting; ( 10) Pet ( Dog and Cat) Uses: Liquid Application; ( 11) Lawncare Granular and Bait Uses: Belly Grinder; ( 12) Lawncare Granular and Bait Uses: Push type Spreader; ( 13) Ornamental and Garden Uses: Granulars and Baits By Hand; ( 14) Various Pest Uses: Aerosol Cans; ( 15) Pet ( Dog and Cat) Uses: Collars; ( 16) Garden and Ornamental Uses: Sprinkler Can; and ( 17) Garden and Ornamental Uses: Paint on.

Data and Assumptions A series of assumptions and exposure factors served as the basis for completing the residential handler risk assessments, as described below. 5 PHED is a generic database, which includes the results of over 100 exposure studies, developed by US EPA, Pest Management Regulatory Agency/ Health Canada and the California Department of Pesticide Regulation, in cooperation with the pesticide industry.

50 ° Label maximum use rates and use information specific to residential products served as the basis for the risk calculations. If additional information, such as average or typical rates, were available, these values were 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 Quantitative Usage Analysis ( QUA). These data indicate that in most cases, average application rates differ from maximum application rates by a factor of approximately two. The average application rates identified from the studies conducted by Bayer CropScience were also considered.

° The exposure duration ( i. e., years per lifetime) values in the cancer risk assessment are consistent with those used for other chemicals ( i. e., 50 years with home use chemicals and 70 year lifetime). Cancer risks were calculated assuming one exposure per year. In addition the number of days of exposure per year which could occur under the ceiling established by an acceptable risk level of 1x10 6 were also calculated. These estimates can then be compared to the annual use frequency of 1 2x ( 60th percentile) and 5x ( 84th percentile) presented at the SMART meeting.

° The unit exposure values used in this assessment were based on three carbaryl specific residential handler studies which quantified exposures during pet treatments with a dust; applications to gardens using a ready to use trigger sprayer, a dust, a hose end sprayer, and a low pressure handwand; and during applications to trees using a low pressure handwand and a hose end sprayer. Two other studies completed by the Outdoor Residential Exposure Task Force ( ORETF) and the Pesticide Handlers Exposure Database ( Version 1.1 August 1998) ( PHED) 5 were also used as sources of surrogate information. [ Note to Risk Managers: There is no data compensation issue associated with the use of the ORETF data in the carbaryl risk assessment because Bayer CropScience, the registrant for carbaryl, is a member of the ORETF]. Summaries of the five studies are included in the Occupational and Residential Risk Assessment ( D287251). These studies are all considered to be of high quality. The quality of the data in PHED varies from scenarios that meet study guideline requirements to others where a limited number of poor quality data points are available. However, in all cases, the data used represent the best available for the scenario. The PHED unit exposure values range between geometric mean and median of available exposure data. When data from other studies were used, the appropriate statistical measure of central tendency was used. Central tendency values, coupled with other inputs used by HED, are thought to result in conservative, deterministic estimates of risk. For pet collars only, a scenario from the SOPs For Residential Exposure Assessment not based on monitoring data was used to calculate exposures. The factors derived from the SOPs are generally thought to be conservative.

° Average body weight of adult handlers is assumed to be 70 kg because the toxicology endpoint values used for the risk assessments are appropriate for average adult body weight representing the general population. No specific effects were observed consistently in the toxicology studies to 51 indicate an increased sensitivity of one gender over another.

° Homeowner handler assessments were completed based on individuals wearing shorts and shortsleeved shirts.

° Homeowner handlers are expected to complete all tasks associated with the use of a pesticide product including mixing/ loading, if needed, as well as the application;

° Calculations were based on scenarios in the home that would reasonably be treated in a day ( but would not necessarily take more than an hour or two) such as the size of a lawn, the size of a garden, the amount that can be applied with a piece of equipment, or the number of pets an individual might keep. Based on Agency Exposure SAC Policy 12: Recommended Revisions To The Standard Operating Procedures For Residential Exposure Assessment, the daily volumes handled and area treated, excerpted from the policy, used in each residential scenario include ( along with corresponding inputs defined from carbaryl studies and the SMART meeting for a comparative analysis to allow for a more informed risk management decision):

° 1 container of each ready to use non pet product including garden dusts, trigger sprayers and aerosol cans ( scenarios for 25% and 50% used of the total product volume were also presented for the trigger sprayer and garden dust scenarios to allow for a more informed risk management decision); ° ½ container of each ready to use pet product, including dusts and liquid shampoos; ° 1 pet collar; ° 100 gallons of finished spray output for hose end sprayers; ° 5 gallons when mixing/ loading/ applying liquids with a backpack sprayer or a low pressure handwand sprayer; value was also used for sprinkler can applications; ° 1 gallon of paint on solution for ornamental/ garden uses; ° 20,000 square feet to represent the surface area treated for broadcast applications to lawns; ° 1000 square feet as the treatment area for many spot applications in lawns, gardens, and ornamentals ( this value used as appropriate when application rates were based on a square foot basis for spot type treatments); and ° 5 mounds per day treated for fire ant applications. 52 ° For direct pet treatments, the Residential SOPs were used to define the amount of chemical that can be used to treat single animals, which was then used to calculate total human dose levels. The actual per animal application rates used were ½ of 6 oz. bottle for liquid shampoo ( 0.5%) and ½ of 4 lb. container for powders ( 10%).

° Results from the Residential Exposure Joint Venture pesticide user survey were summarized and evaluated by ( Nako, 2/ 5/ 03, D284657). It is important to note that the results of this survey do not conflict with the input values that were used in the Agency's deterministic risk assessments.

<IP_ADDRESS> Deterministic Residential Handler Noncancer Risks Noncancer risks were calculated using the Margin of Exposure ( MOE) approach, which is a ratio of the body burden to the toxicological endpoint of concern. Short term dermal MOEs were calculated using a NOAEL of 20.0 mg/ kg/ day from the 21 day dermal toxicity study in rats with technical material and short term inhalation MOEs were calculated using a NOAEL of 1 mg/ kg/ day from the oral developmental neurotoxicity study in rats. Body burden values were determined by first calculating daily exposures using application parameters ( i. e., rate and area treated) along with unit exposure levels. Exposures were then normalized by body weight and adjusted for absorption factors ( 100 percent for both dermal and inhalation) as appropriate to calculate average daily dose levels ( i. e., body burdens) as illustrated in equation below.

Daily Exposure ( mg ai/ day) =

Unit Exposure ( mg ai/ lb ai) x Application Rate ( lb ai/ A) x Daily Acres Treated ( A/ day)

Where:

Daily Exposure = Amount deposited on the surface of the skin that is available for dermal absorption or amount that is inhaled, also referred to as potential dose ( mg ai/ day); Unit Exposure = Normalized exposure value derived from August 1998 PHED Surrogate Exposure Table and various referenced exposure studies noted above ( mg ai/ lb ai); Application Rate = Normalized application rate based on a logical unit treatment such as acres or gallons, maximum and typical values are generally used ( lb ai/ A); and Daily Acres Treated = Normalized application area based on a logical unit treatment such as acres ( A/ day) or gallons per day can be substituted ( gal/ day).

The dermal absorption factor of 100 percent based on an absorption study in rats was used for all dermal calculations since no route to route conversion was required. No specific inhalation absorption factor is available for carbaryl. Therefore, a factor of 100 percent was used for route to route calculations as is done with all pesticides. MOEs were calculated using the following formula.

MOE = NOAEL ( mg ai/ kg/ day) Average Daily Dose ( mg ai/ kg/ day) 53 Where:

MOE = Margin of exposure, value used to represent risk or how close a chemical exposure is to being a concern ( unitless); Average Daily Dose = The amount as absorbed dose received from exposure to a pesticide in a given scenario ( mg pesticide active ingredient/ kg body weight/ day); and NOAEL = No observed adverse effect level or dose level in a toxicity study where no observed adverse effects occurred in the study ( mg pesticide active ingredient/ kg body weight/ day).

A combined ( dermal and inhalation) MOE was determined because common toxicity ( cholinesterase inhibition) endpoints were used to calculate dermal and inhalation risks for each exposure duration. The following formula was used to calculate total MOE values by combining the route specific MOEs:

MOE total = 1/(( 1/ MOE a) + ( 1/ MOE b) +.... ( 1/ MOE n))

Where: MOE a, MOE b, and MOE n represent MOEs for each exposure route of concern Short term risks for residential handlers ( intermediate term scenarios are not thought to exist because of the sporadic nature of applications by homeowners) are presented in Table 11. For most scenarios ( 40 out of 52), risks are not of concern because MOEs exceed the required uncertainty factor of 100. As expected, the scenarios for which MOEs do not meet or exceed 100 have a relatively high unit exposure associated with them or the amount of chemical used over a day is relatively high ( based on high application rates and/ or high amounts of area treated). The use of dusts in gardens and for pet grooming along with some liquid sprays on ornamentals appear to be the most problematic scenarios. Unlike the occupational handler scenarios, the use of different levels of personal protective clothing and equipment is not considered for residential handlers because of a lack of availability, training, and maintenance. [ Note: Scenarios where MOEs are of concern ( i. e., < 100) for are highlighted in the table.]

TABLE 11 CARBARYL NONCANCER MOEs ATTRIBUTABLE TO COMBINED SHORT TERM HOMEOWNER HANDLER DERMAL AND INHALATION EXPOSURES SCEN. SCEN. DESCRIPTOR CROP TYPE OR TARGET EXPOSURE FACTORS DERMAL MOEs INHALATION MOEs COMBINED MOEs APPL. RATE ( lb ai/ unit) BASIS FOR RATE ( defines unit treated) TREATED UNITS ACTIVE USED ( lb ai/ event)

1 Garden: Ready to Use Trigger Sprayer ( MRID 444598 01) Vegetables/ Ornamentals 0.003 32 oz bottle 0.126 % ( 769 977) 0.25 0.00075 34567.9 1393034.8 33730.9 Vegetables/ Ornamentals 0.003 32 oz bottle 0.126 % ( 769 977) 0.5 0.0015 17284.0 696517.4 16865.4 Vegetables/ Ornamentals 0.003 32 oz bottle 0.126 % ( 769 977) 1 0.003 8642.0 348258.7 8432.7 Average Study Use Rate 0.012 ( lb ai/ 1000 ft2) 1 0.012 2160.5 87064.7 2108.2 TABLE 11 CARBARYL NONCANCER MOEs ATTRIBUTABLE TO COMBINED SHORT TERM HOMEOWNER HANDLER DERMAL AND INHALATION EXPOSURES SCEN. SCEN. DESCRIPTOR CROP TYPE OR TARGET EXPOSURE FACTORS DERMAL MOEs INHALATION MOEs COMBINED MOEs APPL. RATE ( lb ai/ unit) BASIS FOR RATE ( defines unit treated) TREATED UNITS ACTIVE USED ( lb ai/ event)

54 2 Garden/ Ornamental Dust ( MRID 444598 01) Vegetables/ Ornamentals 0.4 4 lb bottle 10% ( 239 1513) 0.25 0.1 94.6 804.6 84.6 Vegetables/ Ornamentals 0.4 4 lb bottle 10% ( 239 1513) 0.5 0.2 47.3 402.3 42.3 Vegetables/ Ornamentals 0.4 4 lb bottle 10% ( 239 1513) 1 0.4 23.6 201.1 21.2 Average Study Use Rate 0.079 ( lb ai/ 1000 ft2) 1 0.079 119.7 1018.5 107.1 3 Garden: Hose End ( MRID 444598 01) General Use ( 2% soln) 0.02 ( lb ai/ gal spray applied) 100 2 20.6 17500.0 20.6 Perimeter Nuisance Pest 0.19 ( lb ai/ 1000 ft2) 1 0.19 216.7 184210.5 216.5 Vegetables 0.012 ( lb ai/ 1000 ft2) 1 0.012 3431.4 2916666.7 3427.3 Vegetables/ Ornamentals 0.023 ( lb ai/ 1000 ft2) 1 0.023 1790.3 1521739.1 1788.2 Vegetables 0.047 ( lb ai/ 1000 ft2) 1 0.047 876.1 744680.9 875.1 Average Study Use Rate 0.26 ( lb ai/ 1000 ft2) 1 0.26 158.4 134615.4 158.2 Fire Ant 0.0075 ( lb ai/ gal spray) 100 0.75 54.9 46666.7 54.8 4 Garden: Low Pressure Handwand ( MRID 444598 01) General Use ( 2% soln) 0.02 ( lb ai/ gal spray applied) 5 0.1 368.4 77777.8 366.7 Perimeter Nuisance Pest 0.19 ( lb ai/ 1000 ft2) 1 0.19 193.9 40935.7 193.0 Vegetables 0.012 ( lb ai/ 1000 ft2) 1 0.012 3070.2 648148.1 3055.7 Vegetables/ Ornamentals 0.023 ( lb ai/ 1000 ft2) 1 0.023 1601.8 338164.3 1594.3 Vegetables 0.047 ( lb ai/ 1000 ft2) 1 0.047 783.9 165484.6 780.2 Average Study Use Rate 0.083 ( lb ai/ 1000 ft2) 1 0.083 443.9 93708.2 441.8 Fire Ant 0.0075 ( lb ai/ gal spray) 5 0.0375 982.5 207407.4 977.8 5 Trees/ Ornamentals: Low Pressure Handwand ( MRID 445185 01) Ornamental 0.023 ( lb ai/ 1000 ft2) 1 0.176 1087.0 468227.4 1084.4 Pome Fruit 0.07 ( lb ai/ 1000 ft2) 1 0.07 357.1 153846.2 356.3 Nuts/ Stone Fruit 0.12 ( lb ai/ 1000 ft2) 1 0.12 208.3 89743.6 207.9 Citrus 0.176 ( lb ai/ 1000 ft2) 1 0.023 142.0 61188.8 141.7 Average Study Use Rate 0.0047 ( lb ai/ gal, 17g ai/ 4 min at 2GPM) 5 0.024 1063.8 458265.1 1061.4 6 Trees/ Ornamentals: Hose End Sprayer ( MRID 445185 01) Ornamental 0.023 ( lb ai/ 1000 ft2) 1 0.176 1560.8 1217391.3 1558.8 Pome Fruit 0.07 ( lb ai/ 1000 ft2) 1 0.07 512.8 400000.0 512.2 Nuts/ Stone Fruit 0.12 ( lb ai/ 1000 ft2) 1 0.12 299.1 233333.3 298.8 Citrus 0.176 ( lb ai/ 1000 ft2) 1 0.023 204.0 159090.9 203.7 Average Study Use Rate 0.005 ( lb ai/ gal spray) 100 0.5 71.8 56000.0 71.7 TABLE 11 CARBARYL NONCANCER MOEs ATTRIBUTABLE TO COMBINED SHORT TERM HOMEOWNER HANDLER DERMAL AND INHALATION EXPOSURES SCEN. SCEN. DESCRIPTOR CROP TYPE OR TARGET EXPOSURE FACTORS DERMAL MOEs INHALATION MOEs COMBINED MOEs APPL. RATE ( lb ai/ unit) BASIS FOR RATE ( defines unit treated) TREATED UNITS ACTIVE USED ( lb ai/ event)

55 7 Garden: Backpack Sprayer ( PHED) General Use ( 2% soln) 0.02 ( lb ai/ gal spray applied) 5 0.1 2745.1 23333.3 2456.1 Perimeter Nuisance Pest 0.19 ( lb ai/ 1000 ft2) 1 0.19 1444.8 12280.7 1292.7 Vegetables 0.012 ( lb ai/ 1000 ft2) 1 0.012 22875.8 194444.4 20467.8 Vegetables/ Ornamentals 0.023 ( lb ai/ 1000 ft2) 1 0.023 11935.2 101449.3 10678.9 Vegetables 0.047 ( lb ai/ 1000 ft2) 1 0.047 5840.6 49645.4 5225.8 Average Study Use Rate 0.083 ( lb ai/ 1000 ft2) 1 0.083 3307.3 28112.5 2959.2 Fire Ant 0.0075 ( lb ai/ gal spray) 5 0.0375 7320.3 62222.2 6549.7 8 Lawn Care: Hose End Sprayer ( MRID 449722 01/ ORETF OMA 004) Lawn ( broadcast) 0.25 ( lb ai/ 1000 ft2) 20 5 25.5 875.0 24.7 Lawn ( spot) 0.25 ( lb ai/ 1000 ft2) 1 0.25 509.1 17500.0 494.7 9 Dusting Dog ( MRID 444399 01) Average Study Use Rate 0.0026 ( lb ai/ dog) 1 0.0026 163.2 1076.9 141.7 Dog ( 10% & ½ of 2 lb) 0.1 ( lb ai/ dog) 1 0.1 4.2 28.0 3.7 Dog ( 5% & ½ of 2 lb) 0.05 ( lb ai/ dog) 1 0.05 8.5 56.0 7.4 10 Dogs: Liquid Application Dog ( 0.5% & ½ of 6 oz) 0.001 ( lb ai/ dog) 1 0.001 14000000.0 No Data No Data 11 Granular & Baits Lawn Care: Belly Grinder Lawn ( spot) 0.21 ( lb ai/ 1000 ft2) 1 0.21 60.6 5376.3 59.9 Lawn ( spot) 0.1 ( lb ai/ 1000 ft2) 1 0.1 127.3 11290.3 125.9 12 Granular & Baits Lawn Care: Push Type Spreader ( MRID 449722 01/ ORETF OMA 003) Lawn ( broadcast) 0.21 ( lb ai/ 1000 ft2) 20 4.2 490.2 18315.0 477.4 Lawn ( broadcast) 0.1 ( lb ai/ 1000 ft2) 20 2 1029.4 38461.5 1002.6 13 Granulars & Baits By Hand Ornamentals and Gardens 0.21 ( lb ai/ 1000 ft2) 1 0.21 15.5 713.8 15.2 14 Aerosol Various 0.005 ( 0.5 % ai in soln./ 1 pt can) 16 0.08 79.5 364.6 65.3 15 Collar Dog 0.013 ( 16 % ai per 1.3 oz collar) 1 0.013 10769230.8 No Data No Data 16 Sprinkler Can ( Source: Scenario 6) Ornamentals ( 2% Soln) 0.02 ( 2% soln used ad libitum) 5 0.1 359.0 280000.0 358.5 17 Ornamental Paint On Ornamentals ( 2% Soln) 0.02 ( 2% soln used ad libitum) 1 0.02 304.3 12323.9 297.0 56 <IP_ADDRESS> Residential Handler Cancer Risks Cancer risks were calculated by comparing the Lifetime Average Daily Dose ( LADD) to the Q1* ( 8.75 x 10 4 ( mg/ kg/ day) 1). The LADD was calculated using the equation below.

LADD = ADD xTreatment frequency x Working duration 365 days/ year Lifetime Where:

LADD = Lifetime Average Daily Dose or the amount as absorbed dose received from exposure to a pesticide in a given scenario amortized over a lifetime ( mg pesticide active ingredient/ kg body weight/ day); ADD = Average Daily Dose or the amount as absorbed dose received from exposure to a pesticide in a given scenario on a daily basis ( mg pesticide active ingredient/ kg body weight/ day) [ Note: Represents inhalation and dermal exposure contributions, dermal component has been calculated with a 12.7 % absorption factor defined in a rat study.]; Treatment Frequency = The annual frequency of an application by an individual ( days/ year); Working Duration = The amount of a lifetime that an individual spends engaged in a career involving pesticide exposure ( years); Lifetime = The average life expectancy of an individual ( years).

Cancer risk was then calculated using the following equation:

Risk = LADD x Q1*

Where:

Risk = Probability of excess cancer cases over a lifetime ( unitless); Lifetime Average Daily Dose = The amount as absorbed dose received from exposure to a pesticide in a given scenario over a lifetime ( mg pesticide active ingredient/ kg body weight/ day, also referred to as LADD); and Q1* = Quantitative dose response factor used for linear, low dose response cancer risk calculations ( mg/ kg/ day) 1.

Table 12 presents the quantitative risks associated with each scenario considered in the assessment. For all but one scenario, cancer risks are less than 1x10 6 when a single application per year is evaluated. Risks for most are in the 10 8 or 10 10 range. However, when treating dogs with ½ bottle of 10 percent dust the risk is 1.09x10 6. [ Note: The scenario where risks are still of concern ( i. e., > 1x10 6) is highlighted in the table.] The risk associated with dusting a dog should also be taken in context of the uncertainties associated with cancer risk assessment. In effect, this value is 1x10 6. This table also includes the allowable number of days exposure per year. There are 5 scenarios where 5 days or less of exposure per year is allowable. These results should be considered in conjunction with the use and usage 57 information supplied by the Bayer that indicates the 60th percentile annual frequency of use is between 1 and 2 uses per year and that 5 uses per year is at the 84th percentile. As with the noncancer risks, the use of dusts in gardens and for pet grooming along with some liquid sprays on ornamentals appear to be the most problematic scenarios. Cancer risks appear to be less of concern compared to noncancer risks for all corresponding scenarios.

TABLE 12: CARBARYL CANCER RISKS ATTRIBUTABLE TO COMBINED HOMEOWNER HANDLER DERMAL AND INHALATION EXPOSURES SCEN. SCEN. DESCRIPTOR CROP TYPE OR TARGET EXPOSURE FACTORS CANCER RISK ALLOWED DAYS/ YR APPL. RATE ( lb ai/ unit) BASIS FOR RATE ( defines unit treated) TREATED UNITS ACTIVE USED ( lb ai/ event) 1 Garden: Ready to Use Trigger Sprayer ( MRID 444598 01) Vegetables/ Ornamentals 0.003 32 oz bottle 0.126 % ( 769 977) 0.25 0.00075 1.27e 10 > 365 Vegetables/ Ornamentals 0.003 32 oz bottle 0.126 % ( 769 977) 0.5 0.0015 2.54e 10 > 365 Vegetables/ Ornamentals 0.003 32 oz bottle 0.126 % ( 769 977) 1 0.003 5.08e 10 > 365 Average Study Use Rate 0.012 ( lb ai/ 1000 ft2) 1 0.012 2.03e 09 > 365 2 Garden/ Ornamental Dust ( MRID 444598 01) Vegetables/ Ornamentals 0.4 4 lb bottle 10% ( 239 1513) 0.25 0.1 4.81e 08 21 Vegetables/ Ornamentals 0.4 4 lb bottle 10% ( 239 1513) 0.5 0.2 9.62e 08 10 Vegetables/ Ornamentals 0.4 4 lb bottle 10% ( 239 1513) 1 0.4 1.92e 07 5 Average Study Use Rate 0.079 ( lb ai/ 1000 ft2) 1 0.079 3.80e 08 26 3 Garden: Hose End ( MRID 444598 01) General Use ( 2% soln) 0.02 ( lb ai/ gal spray applied) 100 2 2.11e 07 5 Perimeter Nuisance Pest 0.19 ( lb ai/ 1000 ft2) 1 0.19 2.01e 08 50 Vegetables 0.012 ( lb ai/ 1000 ft2) 1 0.012 1.27e 09 > 365 Vegetables/ Ornamentals 0.023 ( lb ai/ 1000 ft2) 1 0.023 2.43e 09 > 365 Vegetables 0.047 ( lb ai/ 1000 ft2) 1 0.047 4.97e 09 201 Average Study Use Rate 0.26 ( lb ai/ 1000 ft2) 1 0.26 2.75e 08 36 Fire Ant 0.0075 ( lb ai/ gal spray) 100 0.75 7.93e 08 13 4 Garden: Low Pressure Handwand ( MRID 444598 01) General Use ( 2% soln) 0.02 ( lb ai/ gal spray applied) 5 0.1 1.18e 08 85 Perimeter Nuisance Pest 0.19 ( lb ai/ 1000 ft2) 1 0.19 2.25e 08 45 Vegetables 0.012 ( lb ai/ 1000 ft2) 1 0.012 1.42e 09 > 365 Vegetables/ Ornamentals 0.023 ( lb ai/ 1000 ft2) 1 0.023 2.72e 09 > 365 Vegetables 0.047 ( lb ai/ 1000 ft2) 1 0.047 5.56e 09 180 Average Study Use Rate 0.083 ( lb ai/ 1000 ft2) 1 0.083 9.82e 09 102 Fire Ant 0.0075 ( lb ai/ gal spray) 5 0.0375 4.44e 09 225 5 Trees/ Ornamentals: Low Pressure Handwand ( MRID 445185 01) Ornamental 0.023 ( lb ai/ 1000 ft2) 1 0.176 4.01e 09 250 Pome Fruit 0.07 ( lb ai/ 1000 ft2) 1 0.07 1.22e 08 82 Nuts/ Stone Fruit 0.12 ( lb ai/ 1000 ft2) 1 0.12 2.09e 08 48 Citrus 0.176 ( lb ai/ 1000 ft2) 1 0.023 3.06e 08 33 Average Study Use Rate 0.0047 ( lb ai/ gal, 17g ai/ 4 min at 2GPM) 5 0.47 4.09e 09 244 6 Trees/ Ornamentals: Hose End Sprayer ( MRID 445185 01) Ornamental 0.023 ( lb ai/ 1000 ft2) 1 0.176 2.79e 09 359 Pome Fruit 0.07 ( lb ai/ 1000 ft2) 1 0.07 8.49e 09 118 Nuts/ Stone Fruit 0.12 ( lb ai/ 1000 ft2) 1 0.12 1.45e 08 69 Citrus 0.176 ( lb ai/ 1000 ft2) 1 0.023 2.13e 08 47 Average Study Use Rate 0.005 ( lb ai/ gal spray) 100 0.025 6.06e 08 16 TABLE 12: CARBARYL CANCER RISKS ATTRIBUTABLE TO COMBINED HOMEOWNER HANDLER DERMAL AND INHALATION EXPOSURES SCEN. SCEN. DESCRIPTOR CROP TYPE OR TARGET EXPOSURE FACTORS CANCER RISK ALLOWED DAYS/ YR APPL. RATE ( lb ai/ unit) BASIS FOR RATE ( defines unit treated) TREATED UNITS ACTIVE USED ( lb ai/ event)

58 7 Garden: Backpack Sprayer ( PHED) General Use ( 2% soln) 0.02 ( lb ai/ gal spray applied) 5 0.1 1.66e 09 > 365 Perimeter Nuisance Pest 0.19 ( lb ai/ 1000 ft2) 1 0.19 3.15e 09 317 Vegetables 0.012 ( lb ai/ 1000 ft2) 1 0.012 1.99e 10 > 365 Vegetables/ Ornamentals 0.023 ( lb ai/ 1000 ft2) 1 0.023 3.81e 10 > 365 Vegetables 0.047 ( lb ai/ 1000 ft2) 1 0.047 7.79e 10 > 365 Average Study Use Rate 0.083 ( lb ai/ 1000 ft2) 1 0.083 1.38e 09 > 365 Fire Ant 0.0075 ( lb ai/ gal spray) 5 0.0375 6.22e 10 > 365 8 Lawn Care: Hose End Sprayer ( MRID 449722 01/ ORETF OMA 004) Lawn ( broadcast) 0.25 ( lb ai/ 1000 ft2) 20 5 1.73e 07 6 Lawn ( spot) 0.25 ( lb ai/ 1000 ft2) 1 0.25 8.64e 09 116 9 Dusting Dog ( MRID 444399 01) Average Study Use Rate 0.0026 ( lb ai/ dog) 1 0.0026 2.82e 08 35 Dog ( 10% & ½ of 2 lb) 0.1 ( lb ai/ dog) 1 0.1 1.09e 06 1 Dog ( 5% & ½ of 2 lb) 0.05 ( lb ai/ dog) 1 0.05 5.43e 07 2 10 Dogs: Liquid Application Dog ( 0.5% & ½ of 6 oz) 0.001 ( lb ai/ dog) 1 0.001 3.11e 13 > 365 11 Granular & Baits Lawn Care: Belly Grinder Lawn ( spot) 0.21 ( lb ai/ 1000 ft2) 1 0.21 7.21e 08 14 Lawn ( spot) 0.1 ( lb ai/ 1000 ft2) 1 0.1 3.43e 08 29 12 Granular & Baits Lawn Care: Push Type Spreader ( MRID 449722 01/ ORETF OMA 003) Lawn ( broadcast) 0.21 ( lb ai/ 1000 ft2) 20 4.2 8.97e 09 112 Lawn ( broadcast) 0.1 ( lb ai/ 1000 ft2) 20 2 4.27e 09 234 13 Granulars & Baits By Hand Ornamentals and Gardens 0.21 ( lb ai/ 1000 ft2) 1 0.21 2.83e 07 4 14 Aerosol Various 0.005 ( 0.5 % ai in soln./ 1 pt can) 16 0.08 5.94e 08 17 15 Collar Dog 0.013 ( 16 % ai per 1.3 oz collar) 1 0.013 4.04e 13 > 365 16 Sprinkler Can ( Source: Scenario 6) Ornamentals ( 2% Soln) 0.02 ( 2% soln used ad libitum) 5 0.1 1.21e 08 82 17 Ornamental Paint On Ornamentals ( 2% Soln) 0.02 ( 2% soln used ad libitum) 1 0.02 1.44e 08 69 4.4.3 Deterministic Residential Postapplication Risk Assessment Carbaryl uses are extremely varied and include home gardens, ornamentals, turf ( golf courses and lawns) and companion animals ( e. g., on dogs and cats). Carbaryl also has more limited uses that were considered including as a mosquito adulticide in residential areas and for Ghost/ Mud shrimp control in Washington. As a result, a wide array of individuals of varying ages can potentially be exposed when they do activities in areas that have been previously treated or have contact with treated companion animals. The residential postapplication risk assessment addresses these types of exposures. 59 The risks from postapplication exposure to carbaryl residues were determined for the following populations:

1) Residential ( homeowner) Adults: The following postapplication scenarios were assessed: residential turf ( lawncare and after mosquito control), swimming/ beach activity ( oyster bed treatments), golfing ( turfcare and after mosquito control), home garden exposure to deciduous trees and home garden exposure to fruiting vegetables. Within each scenario, ranges of exposure were evaluated for different application rates, duration of exposure, and postapplication activities ( e. g., weeding, harvesting).

2) Toddlers ( 3 year olds): Toddlers were selected as a representative population for turf and companion animal assessments. Exposures from turf were evaluated separately for lawncare uses and after mosquito control. Beach activity ( oyster bed treatments) was also evaluated. Separate risk assessments were considered individually and as a total exposure for turf  dermal exposure and hand to mouth, object to mouth and soil ingestion. For pet uses and the beach play assessments, dermal and hand to mouth exposures were considered individually and as a total exposure. A separate assessment was also done for toddlers who could potentially ingest carbaryl granules in an episodic fashion. [ Note: Values for this population were used in the aggregate risk calculations for children ( 1 to 6 years old).]

3) Youth aged children ( ages 10 to 12): children of this age could help with garden maintenance ( deciduous trees and fruiting vegetables) and therefore were considered for activities related to fruiting vegetables and fruit trees.

Data and Assumptions A series of data, assumptions, and exposure factors served as the basis for completing the residential handler risk assessments, as described below. The assumptions and factors used in the risk calculations are consistent with current Agency policy for completing residential exposure assessments ( i. e., SOPs For Residential Exposure Assessment and related documents).

° Several carbaryl specific studies were used in the development of this assessment including a turf transferable residue ( TTR) study conducted in California, Georgia, and Pennsylvania at 8.17 lb ai/ acre ( MRID 451143 01). This study was conducted using the standard ORETF protocol. The Georgia data were used for the assessment ( all were similar). Residue transferability observed in this data was 1.20 percent. The Agricultural Reentry Task Force ( ARTF) conducted several dislodgeable foliar residue ( DFR) studies with carbaryl. The olive pruning ( MRID 451751 02) and cabbage weeding ( MRID 451917 01) studies were used in the home garden risk assessments. Bayer is a member of the ARTF so there are no data compensation issues associated with the use of these data. All of these carbaryl specific studies should be considered high quality for risk assessment purposes. A study was also submitted by Wellmark ( MRID 45792201) which quantified transferable residues from dogs wearing carbaryl containing collars which were used for the pet risk assessment. This study was of marginal quality but it did provide product specific information and was used in conjunction with standard Agency approaches for comparative purposes. 60 ° Two other studies completed by the Washington State Department of Ecology were used for completing the risk assessment for the oyster bed use. These studies provided water and sediment concentration data in Willapa Bay where these applications occur.

° Exposure frequency values used in cancer risk assessments for adults are the same as those used for residential handlers ( 1 time per year). However, the Agency does believe that there are higher frequency golfers ( i. e., average golfers over all ages play 18 rounds year) based on a 1992 report ( Golf Course Operations, Cost of Doing Business/ Profitability by the Center For Golf Course Management). The number of exposure days per year has also been calculated for all postapplication exposure scenarios.

° Several models and published data sources were also used to develop the risk assessment. These include papers related to: deposition from mosquito control by Dukes et al from Florida A& M University and transference of residues from treated pets by Boone et al from Mississippi State University. The Agency's Standard Operating Procedures For Residential Exposure Assessment were the primary guidance used for this assessment. Several other models and guidance documents were also used including the Agency's SWIMODEL ( for swimmers in Willapa Bay after oyster bed treatments); AgDrift V2.0 ( for risks from mosquito control), and the Risk Assessment Guidance For Superfund or RAGS ( for dermal exposures during beach play and oyster harvest). Specific information from the mosquito control label and historical information for oyster bed applications were also used to complete the assessments ( e. g., droplet spectra requirements to predict deposition from aerial treatments during mosquito control).

° The Agency calculates total exposures to individual chemicals when it is likely that behaviors could occur simultaneously that would lead to the overall dose for the exposed population of concern. The Agency has added together risk values ( i. e., MOEs) for different kinds of exposures within 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.

° Exposures to children playing on treated turf as well as adults on turf ( lawncare and golfing) have been addressed using the latest Agency approaches for this scenario including: ° 5 percent of the application rate has been used to calculate the 0 day residue levels used for defining risks from hand to mouth behaviors, measured TTR values are not used because of differences in transferability versus what would be expected during hand tomouth behaviors; ° 20 percent of the application rate has been used to calculate the 0 day residue levels used for defining risks from object to mouth behaviors, measured TTR values are not used because of differences in transferability versus what would be expected during hand tomouth behaviors, a higher percent transfer has been used for object to mouth behaviors because it involves a teething action believed to be more analogous to DFR/ leaf wash sample collection where 20 percent is also used; 61 ° the measured TTR levels quantified in MRID 451143 01 have been used to complete the dermal exposure calculations as the 0 day transferability was > 1 percent of the application rate for the short and intermediate term data sources, studies where transferability is less than 1 percent are not used for risk assessment purposes because the transfer coefficients used by the Agency for defining exposures are based on Jazzercize studies in which TTR values were measured by techniques where transferability is generally in the 1 to 5 percent range other than the ORETF roller method where transferability tends to be lower; ° short and intermediate term exposures have been calculated because play and mouthing behaviors are assumed to routinely occur daily and for extended periods such as over 30 days, carbaryl residues are also expected to be present based on residue dissipation data ( i. e., slow dissipation rate); ° in cases where 0 day residues have been calculated based on application rates ( i. e., hand / object to mouth residues and for soil dissipation), dissipation over time measured in the TTR study ( i. e., slope of decay curve) has been used to predict TTR and soil levels over time, carbaryl residues were detectable even at 14 days after application ( i. e., final sampling interval) at all sites in the TTR studies used in this assessment, at 14 days average residues at the Georgia and Pennsylvania study sites were still orders of magnitude above the quantitation limit, this indicates that predicted residue levels for extended durations should be considered appropriate based on the empirical data ( e. g., critical for consideration of intermediate term exposures); ° the transfer coefficients used, except golfing, are those presented at the 1999 Agency presentation before the FIFRA Science Advisory Panel that have been adopted in routine practice by the Agency; ° transfer coefficients have been adjusted for differences between short and intermediateterm exposures; ° adult golfers have been assessed using a transfer coefficient of 500 cm2/ hour [ Note: The Agency is currently developing a policy on golfer exposures and has used this value in other assessments]; ° 3 year old toddlers are expected to weigh 15 kg; ° hand to mouth exposures are based on a frequency of 20 events/ hour and a surface area per event of 20 cm2 representing the palmar surfaces of three fingers; ° saliva extraction efficiency is 50 percent meaning that every time the hand goes in the mouth approximately ½ of the residues on the hand are removed; ° object to mouth exposures are based on a 25 cm2 surface area; ° exposure durations are expected to be 2 hours based on information in the Agency's Exposure Factors Handbook except for golfers where the exposure duration for an 18 hole round of golf is 4 hours based on a 1992 report ( Golf Course Operations, Cost of Doing Business/ Profitability by the Center For Golf Course Management); ° soil residues are contained in the top centimeter and soil density is 0.67 mL/ gram; ° dermal, hand and object to mouth, and soil ingestion are added together to represent an overall risk from exposure to turf while granular ingestion is considered to be a much more episodic behavior and is considered separately by the Agency; 62 ° children of various ages down to the very young ( e. g., 4 or 5 years old) are currently playing golf, the Agency recognizes that age may impact exposures because of changes in behavior and skin surface area to body weight ratios but has not yet developed a quantitative approach for calculating their risks; and ° comments were received on the previous version of the assessment ( D281418, 5/ 29/ 02) that indicated a concern because the Agency did not consider " feral" food intake, the Agency position is that the hand to mouth and object to mouth assessments included for children playing on turf would address this issue particularly since the object to mouth scenario is based on a child mouthing treated turf.

° Exposures to children and adults working in home gardens have been addressed using the latest Agency approaches for this scenario including: ° youth aged children are considered along with adults; ° 12 year old youth are expected to weigh 39.1 kg; ° exposure durations are expected to be 40 minutes; ° Pre Harvest Intervals ( PHIs) are less than 7 days for most crops with some as long as 28 days; ° transfer coefficients for youth were calculated by adjusting the appropriate adult transfer coefficients by a 50% factor as has been done by the Agency since the inception of the SOPs For Residential Exposure Assessment; ° the updated transfer coefficients specified in Agency policy 003 described above in the occupational risk assessment for fruit tree thinners and harvesters have been used rather than those currently specified in the SOPs because they represent more refined estimates of exposure for the fruiting vegetable and deciduous tree crop groups, these crop groups have been used in the SOPs to represent home garden exposures; ° the combination of adjusting transfer coefficients for youth aged children and using appropriate body weights for the age group results in dose levels that are slightly lower than that of adults in the same activity ( the TC reduction and body weight reduction is essentially a 1: 1 ratio); and ° the DFR data used for the assessments are the same as those used in the occupational risk assessment for the selected crop groups.

C Exposures to children after contact with treated pets have been addressed using the latest Agency approaches for this scenario including: ° only toddlers are considered because their exposures are thought to be highest exposed population ( i. e., they are considered the sentinel population by the Agency); ° a equilibrium approach based on a single child " hug" of the treated animal is used to assess dermal exposure as described in the 1999 Agency SAP Overview document ( i. e., the skin loads after a single contact with the treated animal and additional contacts don't proportionally add exposures), the surface area of the dermal hug is based on a toddler skin surface area and typical clothing; ° residue dissipation is 5 percent per day for the shampoo and dust products ( based on data from J. Chambers at Mississippi State University on other pet use products); 63 ° the Agency default for transferability of residues from fur is 20 percent, however, a pet collar transferable residue study ( MRID 45792201) was submitted and used in the assessment for comparative purposes with the Agency's standard approach, the data from this study were used to develop an alternative transferability factor of 2.6 percent for dusts and liquid applications ( even though the physical forms are very different which should be considered); ° the active lifetime of a collar is expected to be 120 days based on label statements which was used by the Agency, a daily emission term from the collar of 0.000290 mg/ cm2/ gram ai/ day is also based on measured data from Mississippi State University for a pet collar, additionally data from a pet collar transferable residue study ( MRID 45792201) was submitted and used in the assessment for comparative purposes with the Agency's standard approach the data from this study were used to complete risk calculations using direct measurements of transferable residue concentration on dogs; ° risks are based on an even loading of residues across the entire surface of a 30 lb dog which has been chosen as a representative animal, the animal surface area was calculated using ( 12.3 * Body Weight ( g) 0.65) from the Agency's 1993 Wildlife Exposure Factors Handbook ( i. e., dog surface area of 5986 cm2); ° the approach used to address the hand to mouth exposure pathway has been modified since the previous risk assessment, in previous assessment contact with dogs was based on 40 events per day, in each event, the palmar surface of the hands ( i. e., 20cm2/ event) is placed in the mouth of the child contributing to nondietary ingestion exposure, in the revised approach the frequency term has been modified to an equilibrium approach analogous to the dermal " hug" exposure component ( i. e., the frequency = 1) because the data on which the transferable residue concentrations are based rely on a 5 minute heavy rubbing/ petting technique that would lead to concentrations on the hands that would be expected to be significantly higher than would result from a single contact.

<IP_ADDRESS> Deterministic Residential Postapplication Exposure and Noncancer Risks Two different types of noncancer risk calculations were required based on expected exposure durations, i. e., short term (# 30 days) and intermediate term ( 30 days up to several months). Intermediate term risks were calculated in a postapplication situation, when they were not for residential handlers, because residue dissipation data demonstrated that carbaryl residues persist over that time and it is clear that the behaviors considered as the basis for this assessment can occur routinely over extended periods of time thus creating a potential window for those exposures ( e. g., children playing outside on the grass is expected to be a routine activity). Noncancer risks were calculated using the MOE approach, as described under Section 4.4.2. The toxicological endpoint of concern and target MOE for short term and intermediate term dermal exposures is the same as that used for the short term dermal exposure for residential handlers ( i. e., NOAEL of 20 mg/ kg from the 21 day dermal toxicity study in the rat and a target MOE of 100). The endpoints of concern and target MOE for short term and intermediate term nondietary ingestion exposure were defined in the rat developmental neurotoxicity study and subchronic neurotoxicity studies, respectively ( i. e., NOAEL of 1 mg/ kg/ day defined in both studies with a target MOE of 100). 64 Several different types of calculations were used in this assessment to reflect the varying age groups, behaviors, data, and activities that were considered. In essence, all can be summarized by saying that a source of some sort ( e. g., DFR on leaves) comes in contact with a person as they are doing an activity ( e. g., harvesting garden plants). Exposures were then calculated by multiplying the source concentration by some factor ( e. g., transfer coefficient for fruit harvesting) and the duration. All of the calculations are explained in detail in the Occupational and Residential Exposure Chapter ( D287251). Two of the key algorithms are presented below for informational purposes. These represent the predominant types of exposures considered in the postapplication assessment ( i. e., dermal and hand tomouth

Dermal exposures were calculated by considering the potential sources of exposure in the environment, which represent the DFRs on garden plants, TTRs on lawns, and transferable residues on treated pets using the following equation. It should also be noted that there are distinct transfer coefficients for different activities ( e. g., fruit harvest versus lawncare).

DE( t) ( mg/ day) = ( TR( t) ( µ g/ cm2) x TC ( cm2/ hr) x Hr/ Day)/ 1000 ( µ g/ mg)

Where:

DE( t) = Daily exposure or amount deposited on the surface of the skin at time ( t) attributable for activity in a previously treated area, also referred to as potential dose ( mg ai/ day); TR( t) = Transferable residues that can either be dislodgeable foliar or turf/ pet transferable residues at time ( t) where the longest duration is dictated by the decay time observed in the studies ( µ g/ cm2); TC = Transfer Coefficient ( cm2/ hour); and Hr/ day = Exposure duration meant to represent a typical workday ( hours).

[ Note: For pets, the TC and Hr/ day terms are replaced with a onetime " hug" scenario.]

Likewise, nondietary ingestion from hand to mouth behaviors also consider the environmental concentrations and the mouthing behaviors of children. The following equation describes how these exposures have been calculated.

Where: D = dose from hand to mouth activity ( mg/ day); TR = Transferable residues that can either be dislodgeable foliar or turf/ pet transferable residues at time ( t) where the longest duration is dictated by the decay time observed in the studies ( µ g/ cm2); SE = saliva extraction factor (%); 6 Maximum rates of 4 to 8 lb ai/ acre are specified for different pests. There is one carbaryl label with a turf application rate of 11 lb ai/ acre; however, based on the information from the registrant at the SMART meeting and the TTR study ( MRID 45334301), the maximum rate is more likely to be 8 lb ai/ acre. In addition, risks exceed HED's level of concern at 8 lbs ai/ acre.

65 SA = surface area of the hands ( cm2); Freq = frequency of hand to mouth events ( events/ hour); and Hr = exposure duration ( hours).

[ Note: For pets, the SA and frequency terms are replaced with a onetime " hug" scenario.]

The ( TR( t)) input may represent levels on a single day after application in the case of short term risk calculations. For intermediate term calculations, 30 day average concentrations were calculated based on the applicability of the toxicology data ( i. e., intermediate term endpoint is applied to exposures > 30 days). For the mosquito control scenarios the method used in the calculation was similar to that used in the turf assessment except that an additional factor was incorporated to account for the amount that deposits on grass in treated areas. The oyster bed analyses were completed using RAGS where dose is based on skin loading which is then absorbed. Exposures for swimmers were calculated using the Agency's SWIMODEL.

Adult Short term MOEs only for lawncare ( i. e., heavy yardwork) exceed the Agency's level of concern on the day of application ( i. e., 43 to 88). For this activity, it takes 1 and 5 days, respectively at the 4 and 8 lb ai/ acre application rates, 6 for residues to dissipate to a point where short term MOEs are $ 100. In all other scenarios considered, short term MOEs are $ 100 on the day of application. These other scenarios include vegetable gardening, golfing, tending fruit trees, and more localized exposures that occur after mosquito control or oyster bed treatments. Intermediate term MOEs were calculated using 30 day average exposures and the dissipation rate for carbaryl. In all cases, intermediate term MOEs are $ 100. Table 13 presents the postapplication MOE values calculated for adults after lawn and home garden applications of carbaryl.

Table 13: Summary of Carbaryl Noncancer Postapplication Residential MOEs For Adults Scenario Descriptor Results Short term MOE on Day 0 Days Short term MOE$ UF Intermediate term MOE Residential Turf ( Lawncare) Max Rate at 4 lb ai/ A 88 1 842 Max Rate at 8 lb ai/ A 43 5 412 Aerial  Mosquito Adulticide 0.016 to 1.0 lb ai/ A 3700 231268 ( 1738 w/ inhalation at 1 lb ai/ acre) 0 35463 2216454 Ground  Mosquito Adulticide 0.016 to 1.0 lb ai/ A 7031 439409 0 67380 4211262 Golfing Max Rate at 4 lb ai/ A 1274 0 12297 Table 13: Summary of Carbaryl Noncancer Postapplication Residential MOEs For Adults Scenario Descriptor Results Short term MOE on Day 0 Days Short term MOE$ UF Intermediate term MOE 66 Max Rate at 8 lb ai/ A 624 0 6021 Aerial  Mosquito Adulticide 0.016 to 1.0 lb ai/ A 53654 3353387 0 517764 32360224 Ground  Mosquito Adulticide 0.016 to 1.0 lb ai/ A 101943 6371435 0 983751 61484426 Home Garden ( Deciduous Tree) Very Low Exposure ( propping) 17373 0 53139 Low Exposure ( irrigation, scout, weed) 1737 0 5314 High Exposure ( harvest, prune, train, tie) 1158 0 3543 Very High Exposure ( thin) 579 0 1771 Home Garden ( Fruiting Vegetable) Low Exposure ( irrigation, scout, thin, weed) 1758 0 9468 Medium Exposure ( irrigation, scout) 1256 0 6763 High Exposure ( harvest, prune, stake, tie) 879 0 4734 Oyster Beds Oyster Harvest 967137 0 2680745 Swimming 293651 0 No Data Inhalation MOE for adult mosquito control calculated using a ground concentration of 40 ng/ L calculated with AgDrift, a respiration rate for light activity, and a 20 minute duration to allow for dissipation of the spray. The MOE for inhalation is 3279.

Youth aged children ( 10 to 12 years old) were only considered in the home garden scenarios per Agency guidance. Short term MOEs for these children were similar to those calculated for adults in that they were $ 100 for all of the gardening scenarios considered on the day of application. Intermediate term MOEs were calculated using 30 day average exposures and the dissipation rate for carbaryl. In all cases, intermediate term MOEs are $ 100. Table 14 below summarizes the postapplication MOE values calculated for youth home garden applications of carbaryl. 67 Table 14: Summary of Carbaryl Noncancer Postapplication Residential MOEs For Youth Aged Children Scenario Descriptor Results Short term MOE on Day 0 Days Short term MOE$ UF Intermediate term MOE Home Garden ( Deciduous Tree) Very Low Exposure ( propping) 19408 0 59364 Low Exposure ( irrigation, scout, weed) 1941 0 5936 High Exposure ( harvest, prune, train, tie) 1294 0 3958 Very High Exposure ( thin) 647 0 1979 Home Garden ( Fruiting Vegetable) Low Exposure ( irrigation, scout, thin, weed) 1964 0 10577 Medium Exposure ( irrigation, scout) 1403 0 7555 High Exposure ( harvest, prune, stake, tie) 982 0 5289 Toddler ( 3 year old) exposures were considered for a variety of scenarios as described above including play on treated turf, play with treated pets, after mosquito control, and after oyster bed treatments. Ingestion of granules, which is considered a highly episodic event by the Agency is also described below. The results from all scenarios considered are presented below in Table 15.

Short term MOEs from exposure to treated turf ( in products labeled for direct application to turf) were < 100 on the day of application for both rates considered ( i. e., 4 and 8 lb ai/ acre). In fact, short term MOEs from individual pathways were not $ 100 for any turf scenario considered on the day of application except for the soil ingestion component of the turf assessment which is a very minor contributor to overall exposures. As a reminder, dermal, hand to mouth, and object to mouth exposures pathways were considered along with soil ingestion. Total short term MOEs ( all pathways) were $ 100 at the lower 4 lb ai/ acre application rate 14 days after application and 18 days at the higher 8 lb ai/ acre application rate. Dermal and hand to mouth exposures were the key contributors while soil ingestion was a minor contributor to the total MOE estimates. Intermediate term MOEs were calculated using 30 day average exposures and the dissipation rate for carbaryl. For both rates, intermediate term MOEs were < 100. Exposures to toddlers were also considered after application of carbaryl as a mosquito adulticide. The risks are presented along with the turf use risks because the methods are similar except that mosquito control calculations also account for deposition from aerial and ground foggers. Regardless of how applications are made ( i. e., by ground or air), both short term MOEs on the day of application and intermediate term MOEs were $ 100. An inhalation component was also included for mosquito control on the day of application ( MOE was well above 100). 68 The assessments for pet uses considered dermal and nondietary ingestion exposures and also calculated total MOEs. Short term MOEs for pet uses using the Agency's current approach were < 100 even 30 days after application regardless of whether the formulation used was a dust, liquid or collar. Hand to mouth and dermal exposures are approximately equal contributors to the overall estimates for each product type. The results are similar for the intermediate term MOEs for each scenario. There is one pet use which is also considered to be a chronic exposure by the Agency. Pet collars are assumed to be worn all of the time so chronic exposure can potentially occur. The chronic MOE for pet collars mirrors the short and intermediate term results. The Agency also utilized the results of the submitted study for comparative rangefinder purposes that quantified transferable residues from carbaryl collars. [ Note: The Agency anticipates because of the slow collar release that corresponding transferable residues for collars would be lower than for other products.] The Agency has concerns over the lack of quality control data in this study but opted to provide risk estimates based on it for comparison because it is chemical specific. A transferability factor of 2.6 percent, instead of the Agency's standard 20 percent, was developed from this study then used to complete assessments for dusts and liquid products Even using the 2.6 percent factor, MOEs for dusts and liquid products were well < 100 on the day of application. However, the intermediate term MOE for liquids was > 100 using this factor. Direct transferable residue concentrations from the study were also used to calculate risks for collars. Using these concentrations, MOEs exceeded Agency targets by a small margin. The Agency has concerns for the use of dust and liquid products on pets given that the risks associated with dusts and liquids, regardless of whether or not the collar study data were used in the assessment, did not exceed Agency targets ( i. e., MOEs< 100). The Agency believes that the use of the transferable residue concentrations from the collar study is reasonable to use for the collar assessment. However, because of the marginal quality of the study the Agency believes confirmatory data are needed because MOEs using these data are marginally above 100. The study cannot also be considered for use in any chronic assessment since it measured residue concentrations only out to 7 days after placement of the collars.

The assessments for beach play for toddlers after oyster bed treatment considered dermal and nondietary ingestion exposures and also calculated total MOEs. Short term MOEs were > 100 even if the highest monitored sediment concentration value from any study available to the Agency was used as the basis for the calculations. The intermediate term results were similar. 69 Table 15: Summary of Carbaryl Noncancer Postapplication Residential Aggregate MOEs For Toddlers Scenario Descriptor Results Short term MOE on Day 0 Days For Short term MOE$ UF Intermediateterm MOE Chronic MOE Pet Treatments Liquids ( Agency approach) 9.5 + 30 18.6 NA Dusts ( Agency approach) 0.10 + 30 0.19 NA Collars ( Agency approach) 84.5 + 30 84.5 110 ( need 300)

Liquids ( 2.6% transferability based on collars) 73.2 7 143 NA Dusts ( 2.6% transferability based on collars) 0.73 + 30 1.43 NA Collars ( measured transferable residues over whole dog ) 346 364 at 1 week NA ( only 7 day monitoring) NA ( only 7 day monitoring)

Residential Turf Max Rate at 4 lb ai/ A 11 14 91 NA Max Rate at 8 lb ai/ A 5 18 45 NA Aerial  Mosquito Adulticide 0.016 to 1.0 lb ai/ A 448 27983 ( 350 w/ inhalation at 1 lb ai/ acre) 0 3826 239095 NA Ground  Mosquito Adulticide 0.016 to 1.0 lb ai/ A 851 53167 0 7269 454280 NA Oyster Beds Beach Play 29532 0 81859 NA Inhalation MOE for children mosquito control calculated using a ground concentration of 40 ng/ L calculated with AgDrift, a respiration rate for light activity, and a 20 minute duration to allow for dissipation of the spray. The MOE for inhalation is 1609.

Ingestion of carbaryl granules is also a potential source of exposure because children can eat them if they are found in treated lawns or gardens. This scenario is considered to be an episodic in nature. Therefore, acute dietary endpoints are always used. The concentration of carbaryl in granular products ranges generally from 2 to 10 percent. If this information is coupled with the body weight of a toddler ( 15 kg), the NOAEL of 1 mg/ kg/ day for short term assessments ( which is also the same value used for the aPAD), and the uncertainty factor of 100 the amount of formulation that can be consumed at the uncertainty factor MOE level can be calculated. The Agency generally presents these results based on the number of carbaryl granules that can be ingested. However, the number of homeowner formulations is extensive and impossible to characterize in that much detail so a general weight estimate is presented. If a 2 percent formulation is ingested, 7.5 mg represents exposure at an MOE of 100 ( i. e., 1.6 x 10 5 lb). If a 10 percent formulation is ingested, 1.5 mg represents exposure at an MOE of 100 ( i. e., 3.3 x 10 6 lb). 70 For illustrative purposes, if one considers a 2 percent formulation and the density of soil ( 0.67 mL/ gram, many granulars are clay based), only 0.005 mL of formulation would need to be ingested to have a risk concern ( i. e., 7.5 mg * 1g/ 1000mg * 0.67 mL/ gram). Note that this volume is orders of magnitude less than a teaspoon of granular formulation ( i. e., 0.1% of a teaspoon where a tsp. = 5 mL).

<IP_ADDRESS> Deterministic Residential Postapplication Exposure and Risks For Cancer Postapplication cancer risks were calculated for adults only considering the same scenarios. Risks were calculated using a frequency of one exposure per year for 50 years. Cancer risks were calculated using a linear low dose extrapolation approach in which a LADD is calculated and then compared with a Q1* ( 8.75 x 10 4 ( mg/ kg/ day) 1), as described in Section <IP_ADDRESS>. The number of days of exposure per year under a ceiling limit of cancer risks equal to 1x10 6 was also calculated.

For all scenarios on turf, cancer risks are in the 10 8 range or less on the day of application when a single reentry event per year during lawncare activities is evaluated. For home gardening, golfing or from mosquito control, risks are slightly lower in the 10 9 to 10 12 range when a single reentry event per year is evaluated on the day of application. Table 16 below summarizes the postapplication risk values calculated for adults after applications of carbaryl. Risk managers should consider these values represent a single reentry day into a treated area over each year of a 50 year lifetime on the day of application and that the Agency lacks data to link the annual frequency of reentry activity to residential applications. As with the residential handler risks above, the Agency calculated the number of exposure days needed to reach a risk level of 1x10 6 for each scenario on the day of application, values range from 20 to over 365 days per year while most exceed 365 days per year.

Table 16: Summary of Carbaryl Postapplication Residential Cancer Risks For Adults Scenario Descriptor Results Risk on Day 0 Allowed Days/ Year Residential Turf ( Lawncare) Max Rate at 4 lb ai/ A 2.5 x 10 8 40 Max Rate at 8 lb ai/ A 5.1 x 10 8 20 Aerial  Mosquito Adulticide 0.016 to 1.0 lb ai/ A 9.5 x 10 12 to 5.9 x 10 10 > 365 Ground  Mosquito Adulticide 0.016 to 1.0 lb ai/ A 5.0 x 10 12 to 3.1 x 10 10 > 365 Table 16: Summary of Carbaryl Postapplication Residential Cancer Risks For Adults Scenario Descriptor Results Risk on Day 0 Allowed Days/ Year 71 Golfing Max Rate at 4 lb ai/ A 1.7 x 10 9 > 365 Max Rate at 8 lb ai/ A 3.5 x 10 9 287 Aerial  Mosquito Adulticide 0.016 to 1.0 lb ai/ A 6.5 x 10 13 to 4.1 x 10 11 > 365 Ground  Mosquito Adulticide 0.016 to 1.0 lb ai/ A 3.4 x 10 13 to 2.1 x 10 11 > 365 Home Garden ( Deciduous Tree) Very Low Exposure ( propping) 2.5 x 10 10 > 365 Low Exposure ( irrigation, scout, weed) 2.5 x 10 9 > 365 High Exposure ( harvest, prune, train, tie) 3.8 x 10 9 266 Very High Exposure ( thin) 7.5 x 10 9 133 Home Garden ( Fruiting Vegetable) Low Exposure ( irrigation, scout, thin, weed) 2.5 x 10 9 > 365 Medium Exposure ( irrigation, scout) 3.5 x 10 9 289 High Exposure ( harvest, prune, stake, tie) 4.9 x 10 9 202 Oyster Beds Oyster Harvest 4.5 x 10 12 > 365 Swimming 6.1 x 10 12 > 365 4.4.4 Risks Based On Carbaryl Suburban Resident Biomonitoring Study This study quantified exposures in August 2001 to carbaryl via biological monitoring of inhabitants in 23 suburban residences after application of Sevin GardenTech Ready to Spray formulation ( 22.5 % ai w/ w). This formulation of carbaryl is labeled for use on lawns, gardens, and ornamentals for insect control. Ten families were monitored in Missouri and 13 families were monitored in California. Six total urine samples ( 24 hour composites) were collected from each resident, 4 years old and above, beginning 2 days prior to application and ending 3 days after application ( i. e., samples collected  2,  1, 0, 1, 2, 3 days after application). A metabolite of carbaryl ( 1 naphthol) was measured and those levels were used to calculate absorbed dose estimates for carbaryl. The LOQ or Limit of Quantitation was 10ppb or 0.01ppm. All totaled, 106 people were monitored including 23 applicators, 28 non applicator adults, and 55 children ages 4 to 17. The number of children, segmented by different age groups, were as follows: 4 to 5 years ( 13); 6 to 10 years ( 19); 11 to 15 years ( 20); and 16 to 17 years ( 3). The monitored families 72 were from central Missouri near Columbia and southern California about 50 miles east of Los Angeles in Riverside. The objective of this study was to monitor people in residences while they were engaged in normal activities. No directives as to the use of personal protective equipment or hygiene issues related to pesticide exposure were provided by the investigators. Along with 1 naphthol results, the data provided for each person in the study included personal information ( age, weight, sex, height); the time they spent outdoors and the nature of their activites ( i. e., in a recall survey, they were asked if they performed certain activities that could lead to exposure such as yardwork or play); and information pertaining to the exposures received ( e. g., daily creatinine output and urine volumes).

Ready to Use hose end sprayer packages, which eliminate the need for mixing a solution from concentrated formulations, were used to make all applications. Applications were made to " lawn and/ or garden or ornamental" areas. The protocol for this study required that each family treat their lawn ( i. e., a broadcast style application) and garden or ornamental area ( i. e., at all sites, lawn areas were treated). Uses like these represent a small percentage of the overall United States general population ( i. e., 18 % of those who treat lawns also treat their vegetables and 44 % of those who treat lawns also treat their ornamentals, 0.5% of the general population broadcast treats their lawn which could lead to significant exposure). However, the Agency believes that the use pattern monitored in the study can also be used to represent treatments only to lawns because it believes that most exposure in this study either came from time spent on lawns by children or it occurred during the application process.

The first step in the analysis of the biological monitoring data was to evaluate the sample collection process. A review of the field sample collection procedures was completed and all processes appear appropriate. Daily urine volumes and creatinine outputs were examined to establish the level of variability within individuals. Extremely variable results would be an indication of suspect sampling events. Along with the intrapersonal comparisons described above, comparisons using the daily output of creatinine of those monitored to clinically accepted values were made to ensure complete collection compared to recognized values. Overall, the data appear to be of sufficient quality for use in risk assessment as the intra individual variability are what would be expected and the results indicate that most samples compare well with established clinical reference values indicating complete sample collection in this study.

The investigators corrected results for 1 naphthol in individual samples if creatinine levels, urine volumes, or other parameters were aberrant based on the use of statistical tests to define outlier results. After the 1 naphthol concentrations were defined, carbaryl absorbed dose estimates were calculated using factors determined in an analysis of pertinent pharmacokinetic data ( including human studies) conducted by Bayer. Bayer indicated " the recommended stoichiometric conversion factor to represent recent ( within 96 hours post exposure) 1 naphthol measurements in human urine samples as estimates of carbaryl absorbed dose is 3.5 [ i. e., 1 naphthol normalized concentration ( per L) or dose ( per kg body weight), corrected for analytical method recovery efficiency, x 3.5 = carbaryl concentration or dose.]" The 3.5 factor was derived by multiplying a stoichiometric conversion factor based on molecular weight differences between carbaryl and 1 naphthol ( i. e., 1.4 = MW carbaryl 201.2/ MW 1 naphthol 144.2) by the partition coefficient of 2.5 developed based on the 3 human oral studies that indicate 40 percent of the administered dose is eliminated in the urine ( i. e., 1.4 x 2.5 = 3.5). The other key piece of information is the time it takes for a single dose to be eliminated in humans. The excretion profile indicates that it takes 73 96 hours for a single dose to be eliminated and that approximately 50 percent is eliminated throughout the first 24 hours after an exposure event then the rest in a steadily declining mode out to total elimination at 96 hours.

The pharmacokinetic factors and correction factors for defining 1 naphthol concentrations apply to each exposure event that could occur. With this study, there are additional considerations because of the non controlled nature of the activities of those monitored ( i. e., many exposure events could occur per person). As a result, there are several possible approaches for calculating dose levels that would be used for risk assessment purposes because of the duration it takes to eliminate carbaryl residues from the body and the associated excretion profile ( i. e., 50 % in 24 hours, total in 96 hours). In order to complete a comprehensive analysis, the Agency has considered the data in several ways including:

° Post Application Total Dose: All post application dose values were added together over the sample collection timeframe of 96 hours. The justification for this approach is that it takes 96 hours for carbaryl residues to be eliminated from the body ( i. e., the length of post application monitoring in the study). There are considerations because it can overestimate dose if there are multiple exposures on separate days but it could also underestimate dose if significant contributing events to the overall dose occurred at a later point in the monitoring thus leading to an incomplete sample collection.

° Individual Daily Dose: Dose estimates were calculated based on results for each individual person day monitored in the study. This approach was used by Bayer in their analysis of the data. There are considerations because it assumes what could be called a " quasi steady state approach" but it does not account for mass balance over the 96 hours needed to eliminate residues which could severely underestimate exposures. Based on the pharmacokinetic information, only 50 percent of carbaryl residues are eliminated on the first day after exposure.

° Individual Daily Dose Corrected For Mass Balance: The individual person day dose estimates were used but they were corrected for mass balance observed in the pharmacokinetic analysis which indicated only 50 percent of carbaryl residues are eliminated on the first day after exposure.

[ Note: The Agency evaluated the data in the manner described above to examine the differences in each approach and the impacts upon the ultimate risk calculations. The differences which were identified are described below and a recommendation to use the Post Application Total Dose for regulatory use is provided. The other estimates are provided only for comparative purposes.]

The next step was to group data for individuals based on factors that included location, age, gender, and applicator status to statistically summarize the data and to examine if there were relationships between factors such as application rate or time spent outside and dose. The summarized data for 4 to 5 year olds ( N= 13) is presented in Table 17 as an example of the statistics that were calculated for each population of interest. 74 Table 17: Summary Statistics For Children ( 4 to 5 years) Who Reside In Houses Where Lawns And/ Or Gardens Were Treated Statistic Age ( Yrs) Applied ( lb ai) Area Treated ( ft2) Appl. Rate ( lbai/ 1000 ft2) Total Time Outdoors ( Min.) Post Application Total Dose ( µ g/ kg/ day) Individual Daily Dose ( µ g/ kg/ day) Corrected Individual Daily Dose ( µ g/ kg/ day)

Avg. 4.4 0.813 5961 0.327 256 44.6 11.2 22.3 Minimum 4 0.562 400 0.047 0 0.6 0 0 Maximum 5 1.350 12000 1.404 1200 219.9 126.0 252.0 Median 4 0.901 6707 0.144 60 21.9 4.5 9.0 25th % tile 4 0.562 1400 0.104 45 12.3 1.6 3.2 75th % tile 5 0.901 9404 0.401 240 39.2 10.0 19.9 95th % tile 5 1.350 11565 0.983 966 164.9 57.4 114.8 99th % tile 5 1.350 11913 1.320 1153 208.9 97.7 195.4 The Total Time Outdoors represents the total amount of time spent outdoors by the subjects on the day of application and all monitored days thereafter. The Post Application Total Dose represents carbaryl equivalent dose residues in urine added together from the day of application through the last day of monitoring as the excretion profile of carbaryl/ 1 naphthol indicates a 96 hour clearance interval. Individual Daily Dose estimates represent 24 hour person day samples not corrected for mass balance or adjusted with any other pharmacokinetic factor. Corrected Individual Daily Dose estimates represent 24 hour person day samples which have been corrected for 50 percent mass balance/ elimination on each day sampled. [ Note: The Agency recommends Post Application Total Dose values for regulatory action because they account for mass balance and are conservative in nature compared with the other approaches.]

In order to develop a better understanding of the exposures that occurred in this study, the Agency completed a series of regression analyses that compared exposures for different groups ( e. g., applicators and non applicator adults) against several elements of the supporting data. For applicators, exposures were compared against factors that included: the amount of active ingredient applied; the application rate; and the time spent outdoors on the day of application. [ Note: In one case, no duration was reported so the Agency used a value of 1 minute for calculation purposes.] Similar analyses were completed for non applicator adults and children. Analyses also were completed using an approach that considered whether location, age, or gender played roles in exposure trends. The Agency also completed regressions for each non applicator individual to define if the time spent outdoors on a daily basis correlated with their daily exposures. This showed no clear cut trend between daily dose and daily time spent outdoors. [ Note: This analysis was not completed for applicators since it is clear in their case that the amount ai handled per day is critical to their exposure.] The results of the analyses based on total exposure for each group are presented in Table 18. 75 Table 18: Total Exposure Regression Analysis Results For Carbaryl Suburban Resident Biomonitoring Study Population Subset Correlation Coefficients Total Exp vs. AI Applied Total Exp vs. Appl. Rate Total Exp vs. Duration Applicators MO 0.257 0.122 0.205 CA NA all ai same 0.077 0.750 All 0.535 0.235 0.437 Non applicator Adult MO 0.436 0.075 0.140 CA NA all ai same 0.034 0.572 All 0.028 0.007 0.371 Children  All Ages MO 0.018 0.257 0.414 CA NA all ai same 0.066 0.164 All 0.215 0.069 0.095 Children  All Locations 4 to 5 yrs 0.404 0.228 0.677 6 to 10 yrs 0.328 0.268 0.039 11 to 15 yrs 0.449 0.001 0.192 16 to 17 yrs 0.888 0.780 0.972 Results were similar for all locations and age groups when children were further subdivided by gender and a regression analysis completed. A rank order analysis also shows that 5 of the 10 children with the highest total dose in the entire monitored children's population were in the 11 to 15 year old age group.

The results of the regression analysis for all groups was in many ways inconclusive because there appeared to be little association between total exposures and any single exposure parameter that was examined. Some of the parameters, however, did appear to be more highly associated with exposures in certain cases compared to others. Results for the 16 to 17 year old children should also be considered circumspect because the size of the population for this analysis was only 3 individuals. For applicators, it does appear that the amount of active ingredient handled might be the best indicator of exposure although it is confounded by the lack of a result for California because all applicators there used identical amounts of chemical making the analysis impossible. When the entire group was considered though, this parameter appears to have the highest association ( i. e., the correlation coefficient is 0.535). Proximity to the source of exposure ( i. e., time spent outdoors) appears to be the most associated parameter to overall exposure for those who were not involved in the application process regardless of whether or not they were adults or children. In fact, this parameter had the largest correlation coefficient ( i. e., highest association) for a majority of the scenarios considered ( i. e., 6 of 10). Further delineation of the population based on gender or location had no discernible effect. The results of this analysis were not unexpected to the Agency because of the complex nature of the residential environments that were evaluated in this study. None of the parameters which were possibly key indicators of exposure were 76 controlled. As such, the Agency has treated the data from this study as a representative population for situations where there have been applications to lawns and gardens or ornamentals with carbaryl. Finally, it should also be noted that application rate in most cases has the weakest correlation in all populations when it is compared to dose.

Bayer also completed an analysis of the biomonitoring data. The following list of " key findings" were excerpted directly from their analysis:

° " The exposure to applicators applying carbaryl by hose end spray applicator were comparable to the ORETF hose end sprayer exposure study. ° Pre application 1 naphthol urine levels were comparable to 1 naphthol levels reported from the NHEXAS surveys. ° The 4 to 12 year age group had the highest overall exposure of all cohort groups in the study. ° Yard activity was the primary determinant for post application exposure potential. ° Application rate played less significant role in post application exposure and the required postapplication activity with treated areas to affect the exposure potential. ° Secondary routes of exposure such as vapor intrusion, track in, or dust levels appear to be insignificant sources of exposure. ° Results from this study indicates that the Agency assessment of residential exposure overestimates actual monitored exposures because it overestimates the actual amount of active ingredient handled and the standardized activity pattern routines greatly overestimates the actual contact with treated turf. ° All cohorts had daily mean margins of exposure that exceeded 100."

The Agency concurs with all of these conclusions except the last two. The Agency completed an analysis that compared the Agency's approach against the approach used by Bayer which indicates that the Bayer approach consistently provides lower exposure estimates than believed appropriate by the Agency ( Table 19). Additionally, the Agency's analysis of the Residential Exposure Joint Venture's use information for carbaryl does not preclude the use of the exposure factors ( e. g., use rate or amount applied) contained in the previous assessment. It should also be noted that risk estimates were calculated using geometric mean individual daily dose values which were not corrected for mass balance as defined by Bayer's own pharmacokinetic analysis. 77 Table 19: Dose Levels Calculated By Bayer Based On Suburban Resident Biomonitoring Study Population Location Carbaryl Geometric Mean Dose Values Calculated By Bayer ( µ g/ kg/ day) Agency Arith. Mean Dose ( µ g/ kg/ day)

Individual Daily Dose Day 0 Individual Daily Dose Day 1 Individual Daily Dose Day 2 Individual Daily Dose Day 3 Post Application Total Dose ( Agency Approach) Individual Daily Dose All Days Post Application Total Dose Applicators MO 8.3 6.1 2.6 1.9 18.9 NA NA CA 1.7 1.6 1.1 1.8 6.2 NA NA All NA NA NA NA NA 4.8 19.1 Bayer MOE on Day 0 in MO = 120. MOEs for total dose estimates based on geometric means are 53 in MO and 161 in CA.

Non Applicator Adults MO 0.57 0.77 0.92 1.85 4.1 NA NA CA spouse 0.54 0.96 0.83 0.42 2.8 NA NA CA resident 2.27 1.32 0.92 2.89 7.4 NA NA All NA NA NA NA NA 2.0 8.1 Bayer MOE on Day 3 in CA resident = 346. MOEs for their total dose estimates based on geometric means are 243 in MO and 135 in CA residents.

Children Ages 13  17 MO 1.46 2.17 0.89 1.49 6.01 NA NA CA 0.49 2.20 5.85 5.60 14.14 NA NA All NA NA NA NA NA 7.88 31.5 Bayer MOE on Day 2 in CA = 171. MOEs for their total dose estimates based on geometric means are 166 in MO and 70.7 in CA. [ Note: Agency values based on 11 to 15 year olds.]

Children Ages 4 12 MO 1.96 3.26 1.50 3.32 10.04 NA NA CA 3.19 6.10 7.98 5.10 22.37 NA NA All NA NA NA NA NA 19.56 78.3 Bayer MOE on Day 2 in CA = 125. MOEs for their total dose estimates based on geometric means are 100 in MO and 44.7 in CA.[ Note: Agency values based on 6 to 10 year olds.]

<IP_ADDRESS> Noncancer Risks Based On Biological Monitoring Data The results of this study were presented by the investigators as the absorbed dose of carbaryl for each individual ( µ g/ kg/ day) which, in turn, were used by the Agency to calculate statistical summaries of the data for different groups. These statistical summaries were then used to calculate risk estimates. As described above, the dose values can be calculated in different manners that include ( 1) ignoring mass balance in the excretion profile and using the daily values as reported ( i. e., Individual Daily Dose); ( 2) 78 correcting daily values for mass balance with a 50 percent factor ( i. e., Individual Daily Dose Corrected For Mass Balance); and ( 3) adding daily dose estimates together over the monitoring period ( i. e., Post Application Total Dose). A scientific case can be made for calculating dose levels to be used in risk assessment in each manner. However, the Agency believes that the total dose approach is the most appropriate because it is the most conservative with regard to contributions from exposure on previous days and it accounts for mass balance. It should also be considered that the use of individual values may likely underestimate dose because of the lack of correction for mass balance making the results incomplete. The individual values which have been corrected for mass balance also appear to be appropriate for risk analysis. However, there is little difference between corrected highest daily values and total dose estimates. As described earlier, noncancer risks were calculated by comparing absorbed dose estimates to the short term oral endpoint. The calculated noncancer risks based on Bayer's approach and the Agency's approach are summarized below in Table 20.

Table 20: Noncancer Risk Estimates For Carbaryl Based On Suburban Resident Biomonitoring Study Statistic Used Noncancer MOEs Applicator Nonapplicator adult All Children 4 to 5 years old 6 to 10 years old 11 to 15 years old 16 to 17 years old MOEs Calculated Based On Post Application Total Dose Values ( Agency Recommended Method)

Avg. 52.5 124.0 20.3 22.4 12.8 31.7 268.9 Min. 673.0 1494.8 1796.0 1796.0 1030.6 358.2 533.6 Max. 18.3 25.8 1.0 4.6 1.0 7.6 158.3 Median 76.6 146.8 62.0 45.6 54.0 62.1 337.3 25th % tile 228.3 328.8 128.4 81.4 120.6 118.2 158.3 75th % tile 36.7 103.3 26.5 25.5 25.4 27.4 27.6 95th % tile 19.6 60.8 7.7 6.1 4.8 11.9 8.9 99th % tile 18.5 30.3 1.7 4.8 1.2 8.2 7.7 MOEs Calculated Based On Individual Daily Dose Values Not Corrected For Mass Balance ( Bayer Calculation Method)

Avg. 209.9 495.9 81.2 89.7 51.1 126.9 1075.5 Min. NA NA NA NA NA 4032.3 NA Max. 39.2 79.4 2.2 7.9 2.2 14.7 416.7 Median 386.9 743.5 369.0 221.7 373.8 381.0 1207.0 25th % tile 934.6 1675.0 826.5 619.2 704.2 871.5 2585.7 75th % tile 180.6 360.4 124.7 100.4 130.2 122.9 763.4 95th % tile 54.9 193.8 21.6 17.4 17.5 25.3 496.3 99th % tile 45.4 82.6 5.4 10.2 2.7 16.8 430.5 79 It is clear that the manner in which noncancer risks are calculated has an impact on the resulting risks. For both calculation techniques, however, the Agency has a concern ( i. e., MOEs< 100) at the upper percentiles of exposure regardless of how the dose estimate was calculated for adult applicators and children alike ( e. g., 95th % tile and up). In the Agency's approach, risks are still of concern based on whatever measure of central tendency is considered for all populations except older children. If single day values are considered ( Bayer's approach), risks are not of concern based on geometric mean values but are of concern if the arithmetic mean is considered for children under 10 years of age. Risks are of most concern for applicators and the youngest children because they have the highest dose levels as would be expected ( i. e., applicators are in proximity to product and young children spent time outdoors on treated lawns). In summary, the biological monitoring study clearly illustrates that exposures leading to risks of concern for applicators and younger children can occur in households where carbaryl is used. Additionally, risks are of concern at the highest percentiles of exposure ( 95th % tile and up) regardless of how dose estimates are calculated. It should be kept in mind that the Agency's approach could overestimate exposures because of adding daily dose estimates together. It should also be noted that Bayer's approach does not account for mass balance as defined in the pharmacokinetic analysis of the excretion profile for carbaryl.

<IP_ADDRESS> Cancer Risks Based On Biological Monitoring Data The Agency also used the absorbed dose estimates to calculate cancer risks for applicators and non applicator adults. Cancer risks were calculated by assuming the dose estimates represent a single day of exposure per year over a lifetime of 70 years, 50 of which are involved in gardening. The allowable number of days of exposure allowed per year over that 50 years of gardening in a lifetime were then calculated using 1x10 6 as an acceptable risk limit ( Table 21).

Table 21: Cancer Risk Estimates For Carbaryl Based On Suburban Resident Biomonitoring Study Statistic Used Risks Calculated Based On 1 Day Expo/ Yr. Allowable Expo Days/ Year Under Target App. Risks Non app Adult Risks App. Non app Adult Cancer Risks Calculated Based On Post Application Total Dose Values ( Agency Recommended Method)

Avg. 3.26E 008 1.38E 008 31 72 Min. 2.54E 009 1.15E 009 > 365 > 365 Max. 9.35E 008 6.64E 008 11 15 Median 2.24E 008 1.17E 008 45 86 25th % tile 7.50E 009 5.21E 009 133 192 75th % tile 4.66E 008 1.66E 008 21 60 95th % tile 8.75E 008 2.82E 008 11 35 99th % tile 9.25E 008 5.65E 008 11 18 Cancer Risks Calculated Based On Individual Daily Dose Values Not Corrected For Mass Balance ( Bayer Calculation Method) Table 21: Cancer Risk Estimates For Carbaryl Based On Suburban Resident Biomonitoring Study Statistic Used Risks Calculated Based On 1 Day Expo/ Yr. Allowable Expo Days/ Year Under Target App. Risks Non app Adult Risks App. Non app Adult 80 Avg. 8.16E 009 3.45E 009 123 290 Min. NA NA NA NA Max. 4.37E 008 2.16E 008 23 46 Median 4.43E 009 2.30E 009 226 > 365 25th % tile 1.83E 009 1.02E 009 > 365 > 365 75th % tile 9.48E 009 4.75E 009 105 210 95th % tile 3.12E 008 8.84E 009 32 113 99th % tile 3.77E 008 2.07E 008 26 48 It is clear, as with the deterministic assessments described above, that cancer risks are not the key concern for the Agency compared with the noncancer MOEs which have been calculated. When the allowable number of exposure days per year are calculated over a 50 year lifetime, the lowest estimate based on the Agency's calculation approach was 11 days per year which exceeds carbaryl use frequency as defined in the Sevin User Survey and the Residential Exposure Joint Venture survey of residential use. In this case, the manner in which risks are calculated ( i. e., single day versus total dose) does not substantively impact the results.

4.4.5 Residential Risk Characterization Characterization of each of the individual components of the residential assessment is provided below. The Agency also urges readers to consider the results presented in this document in the context of associated probabilistic assessments should they become available.

Residential Handler Risks Based On Deterministic Approaches: The residential handler assessment for carbaryl is complex in that calculations were completed for 54 different equipment and application rate scenarios. Unlike the occupational assessments, only short term exposures were considered for handlers because homeowner use patterns are not believed by the Agency to lead to intermediate term exposures because of their sporadic nature. Cancer risks were calculated using a linear, low dose extrapolation model ( i. e., Q1*) for typical residential users ( 1 event/ year). Cancer risks were also considered by calculating the number of days exposure that would be required per year to achieve a cancer risk of 1x10 6 to illustrate risk levels from another perspective. All totaled, when each type of calculation is considered, 108 different crop/ application method calculations were completed for residential handlers.

The data that were used in the in the carbaryl residential handler assessment represent the best data and approaches that are currently available. For most of the major use patterns, carbaryl specific 81 data or data generated by the Outdoor Residential Exposure Task Force were used. These data generally are considered to be high quality by the Agency and the best source of information available for the scenarios where they were used. Carbaryl specific data were used to address the garden and tree/ ornamental scenarios with several types of equipment and formulations including liquid trigger sprayers, dusts, and liquid sprays using low pressure handwand and hose end sprayers. Carbaryl specific data were also available for dusting dogs. The ORETF data for hose end sprayer applications to turf and granular applications to turf were also used to address those scenarios. In the remaining scenarios, the Pesticide Handlers Exposure Database ( PHED) was used to develop the unit exposure values. The quality of the data included in PHED vary widely from scenarios that meet guideline requirements for studies to others where a limited number of poor quality datapoints are available. All data that have been used may not be of optimal quality but represent the best available data.

The inputs for application rate and other use/ usage information ( e. g., area treated and frequency of use) used by the Agency were supported by the available carbaryl labels and information supplied by the Bayer Corporation at the September 24, 1998 SMART Meeting. It is also very clear that because carbaryl is such as widely used chemical that it is likely every potential exposure scenario has not been captured because of differences in use pattern.

There are also many uncertainties in the assessment that are common with the occupational assessment as well. These factors and their impacts on the results should be considered as well in the interpretation of the results for residential handlers.

In summary, with respect to residential handler risks, the Agency believes that the values presented in this assessment represent the highest quality results that could be produced given the exposure, use, and toxicology data that are available. However, there are certain elements where additional data are required. For example, it is difficult to ascertain where on a distribution certain input values may fall because the distributional data for exposure, application rates, acres treated and many other parameters are unrefined.

Residential Postapplication Risks Based On Deterministic Approaches: Like the residential handler assessment discussed above, the postapplication residential assessment for carbaryl is also complex in that noncancer MOE calculations were required along with cancer risk calculations using a linear, low dose extrapolation model. Carbaryl residues persist in the environment as indicated in the available DFR and TTR data for extended periods where intermediate term along with short term noncancer risk estimates are required. Cancer risks were calculated only for adults per current Agency policy.

The general population can be exposed through many different pathways that result from uses on lawns and turf, in gardens, on ornamental plants, and from treated pets. People can also be exposed from mosquito adulticide applications and uses in oyster beds. Carbaryl labels do not currently allow for indoor residential uses ( e. g., crack and crevice). Settings where such exposures could occur would include around personal residences and in other areas frequented by the general public including parks, ball fields, golf courses, and playgrounds. To represent the wide array of possible exposures, the Agency relies on the scenarios that have been defined in the SOPs For Residential Exposure Assessment and 82 accompanying documents such as the overview presented to the FIFRA Science Advisory Panel. For turf uses, the Agency considered adults and toddlers ( 3 year olds) in the assessments. Adult activities included lawncare/ maintenance and also golfing. Toddler MOEs were calculated for playing on turf ( using exposure data from the Jazzercize model) and also addressed nondietary ingestion ( hand/ objectto mouth and soil ingestion). Exposures from tree and garden uses were evaluated by considering adults and youth aged children ( 10 to 12 years old) doing gardening activities such as weeding and harvesting for different crops. Transfer coefficients from the fruiting vegetable crop group and the deciduous tree crop group were used, as described in the SOPs For Residential Exposure Assessment to represent exposures for these scenarios. MOEs from treated pets were evaluated for toddlers again for whom exposures may occur from dermal contact and hand to mouth behavior. Adulticide mosquito applications were considered by first defining how much residues are deposited on the ground after a mosquito control application then using the same methods approaches from the lawncare assessment to address adults doing heavy yardwork or golfing and also children playing on treated turf.

The data that were used in the carbaryl residential postapplication assessment represent the best data and approaches that are currently available. To the extent possible, the Agency has attempted to use carbaryl specific data such as with the dislodgeable foliar residue ( DFR) data used for the garden scenarios, transferable pet residue data from the collar study, and the turf transferable residue ( TTR) data for the dermal component of the turf scenarios. When chemical specific data were unavailable, the Agency used the current approaches for residential assessment, many of which include recent upgrades to the SOPs. For example, for the toddler hand to mouth calculations, the TTR data were not used but a 5 percent transferability factor was applied to calculate residue levels appropriate for this exposure pathway. Another key approach to consider is the use of the dermal hug approach for pet products which was proposed at the September 1999 meeting of the FIFRA Science Advisory Panel. Oyster bed uses were evaluated based on guidance from Superfund and the Agency's SWIMODEL. There are also many embedded uncertainties that should be considered in the interpretation of this assessment such as those associated with the use of Jazzercize and with the nondietary ingestion calculations. Readers should consider these in the interpretation of the overall risk estimates. Readers should also consider the screening nature of the SOPs For Residential Exposure Assessment and how additional data could refine the results.

Finally, the Agency believes that the values presented in this assessment represent the highest quality results that could be produced based on the currently available postapplication exposure data. Readers of this document should consider the quality of individual inputs when interpreting the results and make decisions accordingly. It is difficult to ascertain where, on a distribution, the calculated values fall because the distributional data for exposure, residue dissipation and many other parameters are unrefined. The Agency does believe, however, that the risks represent conservative estimates of exposure because maximum application rates are used to define residue levels upon which the 83 calculations are based. Additionally, estimates are thought to be conservative even when measures of central tendency ( e. g., most transfer coefficients are thought to be central tendency) are used because values that would be considered to be in the lower percentile aspect of any input parameter have not been used in the calculations.

Residential Risks Based On Suburban Resident Biological Monitoring Study: The use of biological monitoring can be a powerful tool in the risk assessment process. However, study design issues and the representativeness of the population must be thoroughly understood in order to assure that the results are considered in the appropriate context. Additionally, technical issues associated with the interpretation of the study also need to be thoroughly understood. The Residential Exposure Joint Venture survey results indicate that carbaryl use on lawns represents about 1.2 percent of the general population. This population decreases accordingly when concurrent on vegetables or ornamentals is considered. In fact, only 18 percent of the lawn user population also uses carbaryl on their vegetables and 44 percent also use it on their ornamentals. The survey also indicated that about 50 percent of all lawn use is a spot type treatment which is not anticipated by the Agency to represent a major source of exposure. These population estimates are presented here because it is necessary to describe the nature of the population which was evaluated in the biological monitoring study. There is one caveat to this analysis in that the Agency believes that most of the exposures in the study come from either the application process or contact with treated turf because applicators and small children had the highest exposures in the study. As such, the fact that concurrent applications were made to gardens or ornamentals probably has little bearing on the overall exposure patterns. With this in mind, the Agency believes that the population evaluated in this study can easily be used to represent lawn broadcast applications as well as the concurrent application scenarios examined in the study.

An analysis was completed that compared varying exposure statistics for the different groups of individuals in the biological monitoring study to the deterministic scenarios that were included in the Agency's assessment. For most of the homeowner applicator scenarios, the biological monitoring data for applicators exceeds the body burden estimates which were calculated in the deterministic assessment regardless of the exposure statistic selected. In most cases, the results are within a factor of 5 or so indicating good basic agreement between the two approaches. Results are similar for the post application scenarios when they are compared to the non applicator adults and children of various age from the biomonitoring study. In most cases, the results are again within a factor of 5 or so indicating good basic agreement between the two approaches. It should also be pointed out that on or near the day of application that body burden estimates from the deterministic approaches generally exceed those from the biological monitoring study supporting the conservative ( screening level) nature of the assessment approaches. There was a significant level of discussion in this document concerning the methods used to calculate absorbed carbaryl dose estimates from the biological monitoring study. In fact, three distinct options were considered that included Bayer's approach based on using single day values and not correcting them for mass balance. The others included correcting single day values for mass balance and adding daily values together to get total dose estimates. As discussed previously, the Agency opted to recommend the use of total dose estimates for regulatory purposes but did an evaluation that compared that approach to the values that would be anticipated if daily estimates were corrected for mass balance. Essentially, the results show that there is little or no difference between the use of total dose estimates ( i. e., adding over days) and adjusting single day estimates for mass balance as would be anticipated. In 7 Pierce JP et al ( 1989). Tobacco Use in 1986  Methods and Basic Tabulations from Adult Use of Tobacco Survey. U. S. Department of Health and Human Services Publication Number OM90 2004. Office on Smoking and Health, Rockville, Maryland.

84 fact, the average difference between the two methods was about 10 to 12 percent. Another analysis which was completed compared the results of the biomonitoring study with other recognizable population based biological monitoring studies identified in the scientific literature ( i. e., various publications related to NHANES & NHEXAS). For both adults and children the biological monitoring data representing post application exposures are within 2 orders of magnitude of each other. Differences are greatest for children and applicator adults after an application because they have recently been exposed and the population based monitoring results likely represent something closer to background levels from the diet and drinking water. Agreement between the pre exposure samples and the population based studies is better ( i. e., within a factor of 3 or so in most cases). [ Note: Bayer arrived at essentially the same conclusion.]

In summary, the biological monitoring study is very useful in that it can be used to evaluate the range of exposures that are expected in a treated residential environment. The data also support the deterministic assessments which have been completed for carbaryl as body burden values calculated in those assessments are similar to the biological monitoring data. The population which was monitored also resembles the general population as there is good agreement between the pre exposure dose values and general population monitoring data available from NHANES and NHEXAS.

4.4.6 Exposure From The Use of Tobacco Noncancer risks from carbaryl residues contained in tobacco products have been calculated based on a pyrolysis study in tobacco. In assessing exposure through use of tobacco, HED has assumed that the greatest exposure to carbaryl would come from cigarettes. Further, HED has assumed that the average U. S. smoker smokes 15 cigarettes per day. 7 Based on a pyrolysis study submitted by the registrant, residues of carbaryl total approximately 44.58 ppm in combined side stream and main stream tobacco smoke ( Memorandum from Thurston Morton dated September 29, 1998, D230407). Since this is a composited sample of main stream and side stream smoke, it greatly exaggerates the actual exposure to the smoker, whose primary route of exposure is via main stream smoke. HED further assumes that 100 percent of that inhaled is absorbed ( i. e., that none of the residue is exhaled along with the smoke). These assumptions result in an extreme overestimate of actual likely exposure. With the assumptions regarding residue levels and smoking frequency, and assuming an average body weight of 70 kg, HED estimated that exposure to carbaryl will not exceed 0.0096 mg/ kg/ day [ 44.58 : g/ g cigarette × 1 g/ cigarette × 15 cigarettes/ day × 1 mg/ 1000 : g ÷ 70 kg body weight = 0.0096 mg/ kg/ day].

The short term inhalation NOAEL is 1 mg/ kg/ day and is based on an developmental neurotoxicity study in the rat. Based on the inhalation NOAEL, the short term MOE for carbaryl exposure from the use of tobacco is estimated to be 104 which should be considered along with the conservative basis of the assessment. The residential target MOE is 100. The Agency has not examined intermediate or long term exposure to carbaryl ( including cancer) via tobacco due to the severity and quantity of health effects associated with the use of tobacco products which would likely make any 85 additional effects from carbaryl exposure indistinguishable from those associated with tobacco use.