OMA002: A mixer/ loader/ applicator study was performed by the Outdoor Residential Exposure Task Force (ORETF) using Dacthal as a surrogate compound to determine "generic" exposures to individuals applying a pesticide to turf with a low pressure "nozzle gun" or "hand gun" sprayer. Dermal and inhalation exposures were estimated using wholebody passive dosimeters and breathing zone air samples on OVS tubes. Inhalation exposure was calculated using an assumed respiratory rate of 17 Lpm for light work (NAFTA, 1999), the actual sampling time for each individual, and the pump flow rate. All results were normalized for lb ai handled. A total of 90 replicates were monitored using 17 different subjects. Four different formulations of dacthal [75% wettable powder (packaged in 4lb and 24 lb bags), 75% wettable powder in water soluble bags (3 lb bag), 75% water dispersible granules ( 2 lb bag) and 55% liquid flowable (2.5 Gal container)] were applied by five different LCOs to actual residential lawns at each site in three different locations (Ohio, Maryland, and Georgia) for a total of fifteen replicates per formulation. An additional ten replicates at each site were monitored while they performed spray application only using the 75 percent wettable powder formulation. A target application rate of 2 lb ai/ acre was used for all replicates (actual rate achieved was about 2.2 lb ai/ acre). Each replicate treated a varying number of actual client lawns to attain a representative target of 2.5 acres (1 hectare) of turf. The exposure periods averaged five hours twenty one minutes, five hours thirty nine minutes, and six hours twenty four minutes, in Ohio, Maryland and Georgia, respectively. Average time spent spraying at all sites was about two hours. All mixing, loading, application, adjusting, calibrating, and spill clean up procedures were monitored, except for typical end of day clean up activities, e. g. rinsing of spray tank, etc. Dermal exposure was measured using inner and outer whole body dosimeters, hand washes, face/ neck washes, and personal air monitoring devices. All test subjects wore one piece, 100 percent cotton inner dosimeters beneath 100 percent cotton long sleeved shirt and long pants, rubber boots and nitrile gloves. Gloves are typically worn by most LCOs, and required by many pesticide labels for mixing and loading. Overall, residues were highest on the upper and lower leg portions of the dosimeters In general, concurrent lab spikes produced mean recoveries in the range of 78 120 percent, with the exception of OVS sorbent tube sections which produced mean recoveries as low as 65.8 percent. Adjustment for recoveries from field fortifications were performed on each dosimeter section or sample matrix for each study participant, using the mean recovery for the closest field spike level for each matrix and correcting the value to 100 percent. The unit exposure values are presented in Table 9 below. [Note the data were found to be lognormally distributed. As a result, all exposure values are geometric means.] 44 Table 9: Unit Exposure Values Obtained From ORETF LCO Studies (MRID 449722 01) Type (mg exp./ lb ai handled) Dermal Inhalation Single Layer, No Gloves Single Layer, Gloves Double Layer, Gloves LCO Push Granular Spreader 0.35 0.22 0.11 0.0071 LCO Turfgun (WP Formulation) No Data 0.65 0.36 0.0066 All unit exposure values are geometric means except inhalation value for granular spreader. Double layer value calculated using a 50% protection factor. Turfgun, no glove data were not back calculated using a 90 percent protection factor as it is deemed unreliable. WP formulation in WSP packaging used for turfgun assessment as the unit exposures for this scenario were slightly higher than for the other scenarios and deemed representative of current products/ packaging.

Pesticide Handler Exposure Database (PHED) Version 1.1 (August 1998): Chemical specific data for assessing human exposures during pesticide handling activities were submitted to the Agency in support of one occupational exposure scenario for the reregistration of carbaryl. It is the policy of HED to combine submitted chemical specific data with that from the Pesticide Handlers Exposure Database (PHED) Version 1.1 when appropriate to assess handler exposures for regulatory actions 4 . The scenario/ chemical specific study submitted has no corresponding scenario in PHED, therefore, unit exposure values from the study are used to calculate exposure and risk for the use pattern. For all other remaining scenarios, data from PHED were used to complete the assessment.

PHED was designed by a task force of representatives from the U. S. EPA, Health Canada, the California Department of Pesticide regulation, and member companies of the American Crop Protection Association. PHED is a software system consisting of two parts  a database of measured exposure values for workers involved in the handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data. Currently, the database contains values for over 1,700 monitored individuals (i. e., replicates)

Users select criteria to subset the PHED database to reflect the exposure scenario being evaluated. The subsetting algorithms in PHED are based on the central assumption that the magnitude of handler exposures to pesticides are primarily a function of activity (e. g., mixing/ loading, applying), formulation type (e. g., wettable powders, granulars), application method (e. g., aerial, groundboom), and clothing scenarios (e. g., gloves, double layer clothing).

Once the data for a given exposure scenario have been selected, the data are normalized (i. e., divided by) by the amount of pesticide handled resulting in standard unit exposures (milligrams of exposure per pound of active ingredient handled). Following normalization, the data are statistically summarized. The distribution of exposure values for each body part (e. g., chest upper arm) is categorized as normal, lognormal, or "other" (i. e., neither normal nor lognormal). A central tendency value is then selected from the distribution of the exposure values for each body part. These values are the arithmetic mean for normal distributions, the geometric mean for lognormal distributions, and the median for all "other" distributions. Once selected, the central tendency values for each body part are composited into a "best fit" exposure value representing the entire body. 45 The unit exposure values calculated by PHED generally range from the geometric mean to the median of the selected data set. To add consistency and quality control to the values produced from this system, the PHED Task Force has evaluated all data within the system and has developed a set of grading criteria to characterize the quality of the original study data. The assessment of data quality is based on the number of observations and the available quality control data. These evaluation criteria and the caveats specific to each exposure scenario are summarized in Appendix C, Table C1. While data from PHED provide the best available information on handler exposures, it should be noted that some aspects of the included studies (e. g., duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled uses in all cases. HED has developed a series of tables of standard unit exposure values for many occupational scenarios that can be utilized to ensure consistency in exposure assessments. Unit exposures are used which represent different levels of personal protection as described above. Protection factors were used to calculate unit exposure values for varying levels of personal protection if data were not available.

2.1.3 Occupational Handler Exposure and Non Cancer Risk Estimates The occupational handler exposure and non cancer risk calculations are presented in this section. Noncancer risks were calculated using the Margin of Exposure (MOE) which is a ratio of the body burden to the toxicological endpoint of concern. Body burden values are calculated by first calculating exposures by considering 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 as appropriate to calculate dose levels (i. e., body burdens). MOEs were then calculated.

Daily Exposure: The daily exposure, daily dose and hence the risks, to handlers were calculated as described below. The first step was to calculate daily exposure (dermal or inhalation) using the following formula:

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). 46 Inhalation exposure values were calculated in a similar manner. The only difference is that unit exposure values representing the inhalation route were used that were calculated using PHED and standard human breathing rates (29 liters/ minute and an 8 hour exposure). [Note: In some cases, the above equation has been substituted by an algorithm excerpted from the Agency's SOPs For Residential Exposure Assessment (chapter 9) that calculates exposures based on the percent of active ingredient applied (e. g., pet treatment calculations). It should also be noted that HED has agreed to use the NAFTA recommended values for breathing rate rather than the existing rate in Series 875 Group A (i. e., previously known as Subdivision U). Series 875 Group A recommends an inhalation rate of 29 L/ min. The new NAFTA recommended inhalation rates are 8.3, 16.7, and 26.7 L/ min for sedentary activities (e. g., driving a tractor), light activities (e. g., flaggers and mixer/ loaders < 50 lb containers), and moderate activities (e. g., loading > 50 lb containers, handheld equipment in hilly conditions), respectively. These inhalation reduction factors are 3.5 for tractor drivers, 1.7 for mixer/ loaders and flaggers, and 1.1 for handheld equipment. These changes in exposure factors will be programmed into the next version of the handler exposure data base and are characterized in this document for regulatory risk management decisions.]

Daily Dose: Daily dose (inhalation or dermal) was then calculated by normalizing the daily dermal exposure value by body weight and accounting for dermal absorption (i. e., a biologically available dose resulting from dermal exposure was then calculated). For adult handlers using carbaryl, an average adult body weight of 70 kg was used for all exposure scenarios because all scenarios were occupational and the toxic effect was seen in males and females. Additionally, a dermal absorption factor of 12.7 percent was used for all chronic duration dermal calculations based on an absorption study in rats. A 21 day dermal administration toxicity study in rats was used to calculate risks for short and intermediate term dermal exposure. In cases such as this, a default value of 100 percent is used in the calculation. It should also be noted that there is no specific inhalation absorption factor that is available for carbaryl. Therefore, a factor of 100 percent has been used for all calculations. Daily dose was calculated using the following formula:

Where:

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, also referred to as ADD); 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); Absorption Factor = A measure of the flux or amount of chemical that crosses a biological boundary such as the skin (% of the total available absorbed); and Body Weight = Body weight determined to represent the population of interest in a risk assessment (kg).

The handler exposure assessment does not include any dietary or drinking water inputs. 47 Margins of Exposure: Finally, the calculations of daily dermal dose and daily inhalation dose received by handlers were then compared to the appropriate endpoint (i. e., NOAEL or LOAEL) to assess the total risk to handlers for each exposure route within the scenarios. Short and intermediate term dermal MOEs were calculated using a NOAEL of 20.0 mg/ kg/ day defined in the rat 21 day dermal toxicity study (Table 1). Short term inhalation MOEs were calculated using a NOAEL of 1.0 mg/ kg/ day defined in the rat developmental neurotoxicity and rat acute neurotoxicity studies (Table 1). Intermediate term inhalation MOEs were calculated using a NOAEL of 1.0 mg/ kg/ day defined in a subchronic neurotoxicity study in rats. Additionally, when required for a limited number of scenarios, chronic dermal and inhalation MOEs were calculated using a LOAEL of 3.1 mg/ kg/ day that was defined in a 1 year dog feeding study. All MOE values were calculated separately for dermal and inhalation exposure levels using the formula below:

Where:

MOE = Margin of exposure, value used by the Agency to represent risk or how close a chemical exposure is to being a concern (unitless); ADD = (Average Daily Dose) or 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 or LOAEL = Dose level in a toxicity study, where no observed adverse effects occurred (NOAEL) in the study or the lowest dose level where an adverse effect occurred (LOAEL) in the study (mg pesticide active ingredient/ kg body weight/ day).

It is important to present risk values for each route of exposure (i. e., dermal or inhalation) in each scenario because it makes determining appropriate risk mitigation measures easier. For example, if overall risks are driven by dermal exposures and not inhalation, it would not advisable to require respirators as they may marginally reduce overall risks. It is also important to present overall risk estimates for each scenario considered by calculating total MOEs. A total MOE was calculated because common toxicity endpoints were used to calculate dermal and inhalation risks for each exposure duration. The following formula is 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 A margin of exposure (MOE) uncertainty factor of 100 is considered an appropriate risk level for the short and intermediate term risk assessments because a NOAEL was used as the basis for the 48 assessment. A margin of exposure (MOE) uncertainty factor of 300 is considered an appropriate risk level for the chronic risk assessment because a LOAEL was selected from the1 year dog feeding study as the basis for the assessment.

Noncancer Risk Summary: All of the noncancer risk calculations for occupational carbaryl handlers completed in this assessment are included in Appendix C (Tables 1  9). The specifics of each of table included in Appendix C are described below. A summary of the results for each exposure scenario is also provided below (please refer to Appendix C for more details).

C Appendix C/ Table 1: Sources of Exposure Data Used in the Occupational Carbaryl Handler Exposure and Risk Calculations Describes the sources and quality of the exposure data used in all of the occupational handler calculations.

C Appendix C/ Table 2: Input Parameters For Carbaryl Occupational Handler Exposure and Risk Calculations Presents the numerical unit exposure values and other factors used in the occupational handler risk assessments.

C Appendix C/ Table 3: Margins of Exposure For Carbaryl Occupational Handler Risk Assessment At The Baseline Level of Personal Protection Risk values are presented for each exposure duration considered in the assessment (i. e., short, intermediate, and chronic duration exposures). Represents typical work clothing or a long sleeved shirt and long pants with no respiratory protection. No chemical resistant gloves are included in this scenario. Note that some scenarios have no baseline dermal exposure values (see notes on Tables 1 and 2). [Note: The calculations from this table have been used to develop the summary in Tables 7, 8, and 9.]

C AppendixC/ Table 4: Margins of Exposure For Carbaryl Occupational Handler Risk Assessment At The Minimum Level of Personal Protection Risk values are presented for each exposure duration considered in the assessment (i. e., short, intermediate, and chronic duration exposures). Represents the baseline scenario with the use of chemical resistant gloves and PF 5 respirators. [Note: The calculations from this table have been used to develop the summary in Tables 7, 8, and 9.]

C Appendix C/ Table 5: Margins of Exposure For Carbaryl Occupational Handler Risk Assessment At The Maximum Level of Personal Protection Risk values are presented for each exposure duration considered in the assessment (i. e., short, intermediate, and chronic duration exposures). Represents the baseline scenario with the use of an additional layer of clothing (e. g., a pair of coveralls), chemical resistant gloves, and a PF 10 respirator. [Note: The calculations from this table have been used to develop the summary in Tables 7, 8, and 9.]

C Appendix C/ Table 6: Margins of Exposure For Carbaryl Occupational Handler Risk Assessment Using Engineering Controls Risk values are presented for each exposure duration considered in the assessment (i. e., short, intermediate, and chronic duration 49 exposures). Represents the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods there are no known devices that can be used to routinely lower the exposures for these methods. [Note: The calculations from this table have been used to develop the summary in Tables 7, 8, and 9.]

C Appendix C/ Table 7: Combined Short Term Margins Of Exposure For Carbaryl Occupational Handler Risk Assessment Presents combined dermal and inhalation MOEs with each possible combination of dermal and respiratory protection considered in this assessment. Results for exposure durations # 30 days are only included in this table based on the use of the developmental neurotoxicity and acute neurotoxicity studies in rats to define the NOAEL for this duration. [Note: See tables 3 through 6 for calculations of specific MOE values.]

C Appendix C/ Table 8: Combined Intermediate Term Margins Of Exposure For Carbaryl Occupational Handler Risk Assessment Presents combined dermal and inhalation MOEs with each possible combination of dermal and respiratory protection considered in this assessment. Results for exposure durations >30 days up to several months are only included in this table based on the use of a subchronic neurotoxicity study in rats to define the NOAEL for this duration. [Note: See tables 3 through 6 for calculations of specific MOE values.]

C Appendix C/ Table 9: Combined Chronic Margins Of Exposure For Carbaryl Occupational Handler Risk Assessment Presents combined dermal and inhalation MOEs with each possible combination of dermal and respiratory protection considered in this assessment. Results for exposures that occur essentially each working are only included in this table based on the use of a chronic dog feeding study to define the LOAEL for this duration. [Note: See tables 3 through 6 for calculations of specific MOE values.]

Tables 1 through 6 of Appendix C provide the inputs and illustrate how the calculations were performed to define the noncancer risks (i. e., Margins of Exposure or MOEs) for carbaryl handlers. The exposure data and other factors which were used represent the best sources of data currently available to the Agency for completing these kinds of assessments. For example, maximum application rates were derived directly from carbaryl labels. The recent use and usage report was also reviewed to define average application rates for each crop or group of crops considered. Exposure factors (e. g., body weight, amount treated per day, protection factors, etc.) are all standard values that have been used by the Agency over several years and are derived from peer reviewed sources whenever possible (e. g., Exposure Factors Handbook). The unit exposure values are the best available estimates of exposure. Some unit exposure values are high quality while others represent low quality, but the best available, data. Data quality should be considered in the interpretation of the uncertainties associated with each risk value presented. Please identify these scenarios based on information provided in Appendix C/ Table 1. Additionally, it should be noted that the animal grooming scenario with dusts calculations were based on the SOPs For Residential Exposure Assessment (i. e., 10% of applied is considered equivalent to the dermal exposure). This 50 calculation should be considered only as a rangefinder.

Tables 7, 8, and 9 in Appendix C provide the overall results of the risk assessment for each distinct exposure duration considered because they contain the combined risk values for each scenario using several combinations of personal protection (e. g., short term combined MOEs are presented in Table 7). When protective measures are used to reduce risks it is appropriate to consider how each method will reduce the associated risks and the burden associated with the use of that method (e. g., gloves are thought to routinely reduce risks from dermal exposures by 90 percent based on the Agency protection factor for gloves). It should be noted that there were several scenarios which were identified for which no appropriate exposure data are known to exist. These include:

C Animal Grooming Dust Application; C Dust applications in agriculture (not included on handler tables in Appendix C but considered a major data gap); C Handheld Fogging For Mosquito and Other Pest Treatments; C Power Backpack Application; C Tree Injection; and C Drenching/ dipping seedlings [Note: The mixing/ loading component only of this scenario has been addressed quantitatively.]

Short term and Intermediate term Risk Summary: Short term and intermediate term risks were calculated for different exposure scenarios at different levels of personal protection as illustrated in Tables 7 and 8 of Appendix C, respectively. The results and trends for both the short term and intermediate term calculations are identical because all exposure inputs were similar and the NOAEL values of 20 mg/ kg/ day for dermal exposures and 1 mg/ kg/ day for inhalation exposures are the same for both durations. The only difference is the source of the NOAELs selected for the inhalation risk assessment. The short term values were determined based on rat developmental neurotoxicity and acute neurotoxicity studies while the intermediate term NOAEL was defined using a subchronic neurotoxicity study in rats. Therefore, for economy, the results for both shortand intermediate term occupational handlers have been summarized together in this section. [Note: If risk estimates were altered because of additional data or other reason, then separate sections would be presented as appropriate.]

In most scenarios, MOEs meet or exceed the required uncertainty factor of 100 at some level of personal protection. For the most part, current label requirements for personal protection (single layer clothing, gloves, and no respirator) appear to be generally inadequate for most scenarios except 51 for operations where exposures and/ or the amount of chemical used is low. Table 10 summarizes the results for short term and intermediate term occupational handlers. [Note: Scenarios where MOEs are still of concern (i. e., <100) for any personal protection considered are highlighted and the minimum required PPE is also highlighted if it exceeds current label requirements.]

Table 10: Summary of Short/ Intermediate Term Occupational Handler Noncancer Risks Scenario Rate (lb ai/ acre)

[unless noted] Area Treated (acres/ day)

[unless noted] Risk Summary MOEs Min. Req. PPE Mixer/ Loaders 1a Dry Flowable: Aerial/ Chemigation 1 2 (wheat/ corn) 2 5 (veg., stone fruit, 24C on oysters) 1200 350 363 726 498 1244 EC EC 1b Dry Flowable: Airblast 7.5 16 (various fruit & nut trees) 5 (nuts) 1.1 3 (pome & stone fruit, grapes) 40 40 40 1360 2902 101 143 391 EC SL/ GL/ PF5 Baseline 1c Dry Flowable: Groundboom 1.5 2 (wheat/ corn) 2 (strawberry/ veg) 8 (turf/ golf courses) 4 (turf/ golf courses) 200 80 40 40 2177 2902 107 2721 108 EC Baseline EC Baseline 1d Dry Flowable: High Press HW/ ROW Sprayer 4 lb ai/ 100 gal (poultry) 1000 gal 430 Baseline 1e Dry Flowable: Low press./ High Vol. Turfgun 4 8 (LCO on turf) 5 430 860 Baseline 1f Dry Flowable: Wide area aerial 2 (rangeland/ forestry) 7500 58 MOE < 100 2a Granular: Aerial Application 2 (corn) 2 (corn) 1200 350 688 146 EC SL/ GL/ PF5 2b Granular: Solid broadcast spreader 1.5 (wheat/ corn) 2 (wheat/ corn) 2 (vegetables) 6 (turf/ golf courses) 9 (turf/ golf courses) 200 200 80 40 40 110 256 206 138 284 Baseline SL/ GL/ PF5 Baseline Baseline SL/ GL/ PF5 3a Liquid: Aerial/ Chemigation 1.5 2 (wheat, max corn) 1 (avg. corn) 5 (stone fruit) 2 (vegetables) 1200 1200 350 350 57 76 114 78 103 All MOEs < 100 EC MOE< 100 DL/ GL/ PF10 3b Liquid: Airblast Application 16 (Citrus 24C in California) 7.5 (Citrus) 5 (Nuts) 1.1 3 (Grapes, pome & stone fruit) 40 40 40 40 100 168 149 248 677 DL/ GL/ PF10 SL/ GL/ PF5 SL/ GL/ NR SL/ GL/ NR 3c Liquid: Groundboom 1.5 (wheat) 2 (corn) 2 (strawberries) 8 (turf/ golf courses) 4 (turf/ golf courses) 200 200 80 40 40 168 126 186 157 186 SL/ GL/ PF5 SL/ GL/ PF5 SL/ GL/ NR SL/ GL/ PF5 SL/ GL/ NR 3d Liquid: High Press HW/ ROW Sprayer 4 lb ai/ 100 gal (poultry) 1000 gal 745 SL/ GL/ NR Table 10: Summary of Short/ Intermediate Term Occupational Handler Noncancer Risks Scenario Rate (lb ai/ acre)

[unless noted] Area Treated (acres/ day)

[unless noted] Risk Summary MOEs Min. Req. PPE 52 3e Liquid: Low press./ High Vol. Turfgun 4 8 (LCO on turf) 5 745 1489 SL/ GL/ NR 3f Liquid: Wide area aerial 2 (Range/ Forestry) 0.016 (Mosquito adulticide) 0.15 (Mosquito adulticide) 1 (Mosquito adulticide) 7500 7500 7500 7500 9 248 121 18 MOE < 100 SL/ GL/ NR EC MOE < 100 3g Liquid: Wide area ground 0.016 (Mosquito adulticide) 0.15 (Mosquito adulticide) 1 (Mosquito adulticide) 3000 3000 3000 621 112 45 SL/ GL/ NR SL/ GL/ PF5 MOE < 100 4a Wettable Powders: Aerial 1 2 (Wheat/ corn) 5 (stone fruit) 2 (vegetables) 1200 350 350 40 80 55 137 All MOEs < 100 MOE < 100 EC 4b Wettable Powders: Airblast 16 (Citrus 24C in California) 1.1 7.5 (Citrus, nuts, grapes, pome & stone fruit) 40 40 150 320 2180 EC EC 4c Wettable Powders: Groundboom 1.5 2 (wheat/ corn) 2 (strawberries) 4 8 (turf/ golf courses) 200 80 40 240 320 599 299 599 EC EC EC 4d Wettable Powders: High Press HW/ ROW Sprayer 4 lb ai/ 100 gal (poultry) 1000 gal 102 SL/ GL/ PF5 4e Wettable Powders: Low press./ High Vol. Turfgun 4 (LCO on turf) 8 (LCO on turf) 5 5 102 205 SL/ GL/ PF5 SL/ GL/ PF5 4f Wettable Powders: Wide area aerial 2 (Range/ Forestry) 7500 6 MOE< 100 Applicators 5a Aerial: Agricultural uses, liquid sprays 1 1.5 (wheat/ avg. corn) 2 (max corn) 5 (stone fruit) 2 (vegetables, 24C on oysters) 1200 1200 350 350 113 170 85 116 292 EC MOE< 100 EC EC 5b Aerial: Wide area uses, liquid sprays 2 (Range/ Forestry) 0.016 0.15 (Mosquito adulticide) 1 (Mosquito adulticide) 7500 7500 7500 14 181 1700 27 MOE< 100 EC MOE< 100 5c Aerial: Agricultural uses, granular applications 2 (corn) 2 (corn) 1200 350 21 72 MOE< 100 MOE< 100 6a Airblast: Agricultural uses 16 (Citrus 24C in California) 2 7.5 (Citrus, nuts, grapes, pome & max. stone fruit) 1.1 (avg. stone fruit) 40 40 40 105 224 841 123 EC EC SL/ GL/ PF5 6b Airblast: Wide area uses, liquid sprays 0.016 (Mosquito adulticide) 0.15 (Mosquito adulticide) 1 (Mosquito adulticide) 3000 3000 3000 113 150 22 SL/ GL/ PF5 EC MOE< 100 Table 10: Summary of Short/ Intermediate Term Occupational Handler Noncancer Risks Scenario Rate (lb ai/ acre)

[unless noted] Area Treated (acres/ day)

[unless noted] Risk Summary MOEs Min. Req. PPE 53 7 Groundboom 1.5 2 (Wheat, corn) 2 (Strawberries) 4 8 (Turf/ golf course) 200 80 40 122 162 304 152 304 Baseline Baseline Baseline 8 Solid broadcast spreader (granular) 1. 5 2 (Wheat, corn) 2 (Strawberries) 4 8 (Turf/ golf course) 200 80 40 103 138 258 115 172 Baseline Baseline Baseline 9 Aerosol Can 0. 01 lb ai/ can 2 cans 324 Baseline 10 Trigger pump sprayer 0. 01 lb ai/ can 1 can 8772 SL/ GL/ NR 11 Right of way sprayer 1. 5 lb ai/ 100 gallons 1000 gallons 199 SL/ GL/ NR 12 High pressure handwand 4 lb ai/ 100 gallons 1000 gallons 66 MOE< 100 13 Animal groomer, liquid application 0.01 lb ai/ dog 8 dogs 9.7 MOE< 100 14 Animal groomer, dust application (see App C/ Table 3) 0.2 lb ai/ dog 8 dogs 8750 Baseline (dermal exp only)

15 Granulars & baits applied by hand 9 (Ornamentals & gardens) 1 3.8 MOE< 100 16 Granulars & baits applied by spoon 9 (Ornamentals & garderns) 1 75.1 MOE< 100 Mixerr/ Loader/ Applicators 17 Low pressure, high volume turfgun (ORETF Data) 8 (LCO Use on turf) 4 (LCO Use on turf) 5 5 94 104 MOE< 100 SL/ GL/ PF5 18a Wettable powder, low pressure handwand 1 lb ai/ 1000 ft 2 (poultry house) 2% solution (ornamentals) 20,000 ft 2 40 gallons 8.3 135 MOE< 100 SL/ GL/ PF5 18b Liquids, low pressure handwand 1 lb ai/ 1000 ft 2 (poultry house) 2% solution (ornamentals) 20,000 ft 2 40 gallons 127 1699 SL/ GL/ PF5 SL/ GL/ NR 19 Backpack sprayer 1 lb ai/ 1000 ft 2 (poultry house) 2% solution (ornamentals) 20,000 ft 2 40 gallons 42 565 MOE< 100 Baseline 20 Granular, bellygrinder 9 (Turf) 1 27 MOE< 100 21 Granular, push type spreader 9 (Turf) 5 124 SL/ GL/ PF5 22 Handheld fogger No data No data No data No data 23 Power backpack No data No data No data No data 24 Granular, backpack 9 (Ornamentals) 1 1562 DL/ GL/ NR 25 Tree injection No data No data No data No data 26 Drench/ dipping forestry/ ornamentals 1.5 lb ai/ 100 gallons (Ornamental/ seedling dip) 100 gallons 199 SL/ GL/ NR 27 Sprinkler can 2% solution (Ornamentals) 10 gallons 226 Baseline Table 10: Summary of Short/ Intermediate Term Occupational Handler Noncancer Risks Scenario Rate (lb ai/ acre)

[unless noted] Area Treated (acres/ day)

[unless noted] Risk Summary MOEs Min. Req. PPE 54 Flaggers 28a Flagger: liquid sprays 2 (Corn) 2 (Vegetables) 1200 350 249 111 EC Baseline 28b Flagger: granular applications 2 (Corn) 2 (Vegetables) 1200 350 101 345 Baseline Baseline Baseline = Long pants, long sleeved shirts, no gloves SL = Single layer clothing with or without gloves (GL or NG) DL = Double layer clothing (i. e., coveralls over SL) with or without gloves (GL or NG) EC = Engineering controls NR = No respirator PF5 = Protection factor 5 respirator PF10 = Protection factor 10 respirator Current label = SL/ GL/ NR Min. Req. PPE = level of PPE where MOEs > 100, where current label is exceeded or no adequate PPE is found, results are bold. MOEs which never exceed 100 are for highest feasible type of mitigation (e. g., engineering control in most cases).

Chronic Risk Summary: MOEs were calculated for only a limited number of exposure ornamental use scenarios where the Agency believes that this kind of exposure pattern may exist. These calculations were also completed at different levels of personal protection as illustrated in Table 11 (Table 9 of Appendix C summarized below). For most scenarios (3 of 5), MOEs meet or exceed the required uncertainty factor of 300 at some level of personal protection. The granular hand application scenarios are problematic. The uncertainty factor of 300 is required for the chronic exposure scenarios because a LOAEL and not a NOAEL was used for risk assessment purpose as defined in a chronic dog feeding study using carbaryl. It is Agency policy to apply an additional factor of 3 to the overall uncertainty factor when using a LOAEL for risk assessment purposes.

Table 11: Summary of Chronic Occupational Handler Noncancer Risks Scenario Rate (lb ai/ acre)

[unless noted] Area Treated (acres/ day)

[unless noted] Risk Summary MOEs Min. Req. PPE Applicators 15 Granulars & baits applied by hand 9 (Ornamentals & gardens) 1 4.7 MOE< 300 16 Granulars & baits applied by spoon 9 (Ornamentals & garderns) 1 92.6 MOE< 300 Mixer/ Loader/ Applicators 18a Wettable powder, low pressure handwand 2% solution (ornamentals) 40 gallons 302 DL/ GL/ PF10 18b Liquids, low pressure handwand 2% solution (ornamentals) 40 gallons 3206 SL/ GL/ NR Table 11: Summary of Chronic Occupational Handler Noncancer Risks Scenario Rate (lb ai/ acre)

[unless noted] Area Treated (acres/ day)

[unless noted] Risk Summary MOEs Min. Req. PPE 55 19 Backpack sprayer 2% solution (ornamentals) 40 gallons 781 Baseline Baseline = Long pants, long sleeved shirts, no gloves SL = Single layer clothing with or without gloves (GL or NG) DL = Double layer clothing (i. e., coveralls over SL) with or without gloves (GL or NG) EC = Engineering controls NR = No respirator PF5 = Protection factor 5 respirator PF10 = Protection factor 10 respirator Current label = SL/ GL/ NR Min. Req. PPE = level of PPE where MOEs > 300, where current label is exceeded or no adequate PPE is found, results are bold. MOEs which never exceed 300 are for highest feasible type of mitigation (e. g., PPE in most cases).

2.1.4 Occupational Handler Exposure and Risk Estimates for Cancer.

The occupational handler exposure and cancer risk calculations are presented in this section. Cancer risks were calculated using a linear low dose extrapolation approach in which a Lifetime Average Daily Dose (LADD) is first calculated and then compared with a Q1* that has been calculated for carbaryl based on dose response data in the appropriate toxicology study (Q1* = 8.75 x 10 4 (mg/ kg/ day) 1 ). Absorbed average daily dose (ADD) levels were used as the basis for calculating the LADD values. Section 2.1.3 above describes how the ADD values were first calculated for the noncancer MOE calculations. These values also serve as the basis for the cancer risk estimates. Dermal and inhalation ADD values were first added together to obtain combined ADD values. LADD values were then calculated and compared to the Q1* to obtain cancer risk estimates.

Lifetime Average Daily Dose: After the development of the ADD values, the next step required to calculate the carcinogenic risk is to amortize these values over the working lifetime of occupational handlers based on use patterns, this results in the LADD for that use. Product labels limit use to every 7 to 10 days or a seasonal "lb ai per acre" limit. Also, according to available use/ usage data, on average, carbaryl is applied more than once per year for most crops. Based on this information and due to the number and variety of target insects and crops registered for carbaryl applications, the Agency considered two distinct populations in the cancer risk assessment including private growers at 10 use events per year and commercial applicators that would have a more frequent use pattern of 30 days per year. Finally, a 35 year career and a 70 year lifespan was used to complete the calculations. LADD values were calculated using the following equation:

LADD ADD TreatmentFrequency Days year WorkingDuration Lifetime = × × 365 / Where:

Lifetime Average Daily Dose = The amount as absorbed dose received from exposure to a 56 pesticide in a given scenario over a lifetime (mg pesticide active ingredient/ kg body weight/ day, also referred to as LADD); Average Daily Dose = 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, also referred to as ADD); 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 (35 years); Lifetime = The average life expectancy of an individual (70 years).

Cancer Risks : Finally, cancer risk calculations were completed by comparing the LADD values calculated above to the Q1* for carbaryl (Q1* = 8.75 x 10 4 (mg/ kg/ day) 1 , see Table 1 for further information). The Agency considered more typical users in these calculations (i. e., private growers at 10 events per year) as well as more frequent users that might represent commercial applicators (i. e., 30 events per year). Cancer risk values were calculated using the following equation:

Risk LADD Q = × 1 * 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, lowdose response cancer risk calculations (mg/ kg/ day) 1 .

The Agency has defined a range of acceptable cancer risks based on a policy memorandum issued in 1996 by then office director, Mr. Dan Barolo. This memo refers to a predetermined quantified "level of concern" for occupational carcinogenic risk. In summary, this policy memo indicates occupational carcinogenic risks that are 1 x 10 6 or lower require no risk management action. For those chemicals subject to reregistration, the Agency is to carefully examine uses with estimated risks in the 10 6 to 10 4 range to seek ways of cost effectively reducing risks. If 57 carcinogenic risks are in this range for occupational handlers, increased levels of personal protection would be warranted as is commonly applied with noncancer risk estimates (e. g., additional PPE or engineering controls). Carcinogenic risks that remain above 1.0 x 10 4 at the highest level of mitigation appropriate for that scenario remain a concern.

Cancer Risk Summary All of the cancer risk calculations for occupational carbaryl handlers completed in this assessment are included in Appendix C (Tables 10 and 11). The specifics of each of table included in Appendix C are described below. A brief summary of the results for each exposure scenario is also provided below.

C Appendix C/ Table 10: Carbaryl Occupational Handler Risks For Private Growers Presents cancer risks for combined dermal and inhalation for private growers (i. e., 10 applications per year) with each possible combination of dermal and respiratory protection considered in this assessment.

C Appendix C/ Table 11: Carbaryl Occupational Handler Risks For Commercial Applicators Presents cancer risks for combined dermal and inhalation for commercial applicators (i. e., 30 applications per year) with each possible combination of dermal and respiratory protection considered in this assessment.

Tables 1 through 6 of Appendix C should also be considered as they illustrate how the route specific ADD values were calculated which are the basis for the cancer risk values. These route specific ADD values were added and applied to the Q1* value to calculate the cancer risks as described above.

Cancer risks for private growers (i. e., 10 applications per year) were calculated for different exposure scenarios at different levels of personal protection (Table10 of Appendix C). All scenarios for private growers have risks that are <1x10 4 at some level of personal protection specified in the Barolo memo. In fact, for all but one scenario (Scen 4f: Mixing/ loading Wettable Powders for wide area aerial applications) cancer risks are <1x10 4 at current label requirements for personal protection. If a 1x10 6 risk level is specified as a concern, results are similar in that risks for a majority of scenarios are <1x10 6 at current label requirements. In fact, only 8 of the 128 scenarios considered for private applicators have cancer risks >1x10 6 (and less than 1x10 4 ) even when the most protective ensembles of either protective clothing or engineering controls are considered. As with the risks calculated for private growers, cancer risks for commercial applicators (i. e., 30 applications per year) were calculated for different exposure scenarios at different levels of personal protection (Table 11 of Appendix C). Again, risks for all but one scenario (Scen 4f: Mixing/ loading Wettable Powders for wide area aerial applications) are less than the 1x10 4 level specified in the Barolo memo at current label requirements for personal protection (i. e., risks for this scenario are < 1x10 4 if additional protective clothing or equipment is used). If a 1x10 6 risk level is specified as a concern for commercial applicators, results indicate that risks for about half of the scenarios considered are <1x10 6 at current label requirements and that only 21 of the 128 scenarios considered have cancer risks >1x10 6 (and less than 1x10 4 ) even when the most protective ensembles of either protective clothing or engineering controls are considered. In 58 general, the cancer risk estimates would lead to less restrictive measures when compared to the noncancer results. Table 12 below provides a summary of the cancer risks that have been calculated for private growers and commercial applicators.

Table 12: Summary of Occupational Handler Cancer Risks For Private Growers and Commercial Applicators Scenario Rate (lb ai/ acre)

[unless noted] Area Treated (acres/ day)

[unless noted] Risk Summary Private Growers Commercial Applicators Risk Min. Req. PPE Risk Min. Req. PPE Mixer/ Loaders 1a Dry Flowable: Aerial/ Chemigation 1 2 (wheat/ corn) 5 (stone fruit) 2 (vegetables, 24C on oysters) 1200 350 350 3.7 to 7.4x10 8 5.4x10 8 1.0x10 6 EC EC SL/ GL/ PF10 1.1 to 2.2x10 7 1.6x10 7 6.5x10 8 EC EC EC 1b Dry Flowable: Airblast 16 (Citrus, 24C in CA) 1.1 7.5 (grapes, various fruit & nut trees) 40 40 1.0x10 6 6.9x10 8 to 4.7x10 7 Baseline Baseline 5.9x10 8 1.4 to 9.3x10 7 EC DL/ GL/ PF10 1c Dry Flowable: Groundboom 2 (corn) 1.5 (wheat) 2 (strawberry/ veg) 8 (turf/ golf courses) 4 (turf/ golf courses) 200 200 80 40 40 4.7x10 7 6.3x10 7 2.5x10 7 5.0x10 7 2.5x10 7 Baseline Baseline Baseline Baseline Baseline 1.0x10 6 3.7x10 8 7.5x10 7 1.0x10 6 7.5x10 7 DL/ GL/ NR EC Baseline DL/ GL/ PF5 Baseline 1d Dry Flowable: High Press HW/ ROW Sprayer 4 lb ai/ 100 gal (poultry) 1000 gal 6.3x10 8 Baseline 1.9x10 7 Baseline 1e Dry Flowable: Low press./ High Vol. Turfgun 4 8 (LCO on turf) 5 3.1 to 6.3x10 8 Baseline 9.4x10 8 to 1.9x10 7 Baseline 1f Dry Flowable: Wide area aerial 2 (rangeland/ forestry) 7500 4.6x10 7 EC 1.4x10 6 All < 1x10 6 2a Granular: Aerial Application 2 (corn) 2 (corn) 1200 350 5.0x10 7 3.3x10 7 SL/ GL/ PF5 Baseline 9.5x10 7 9.9x10 7 DL/ GL/ PF5 Baseline 2b Granular: Solid broadcast spreader 1.5 2 (wheat/ corn) 2 (vegetables) 6 9 (turf/ golf courses) 200 80 40 1.4 to 1.9x10 7 7.6x10 8 1.1 to 1.7x10 7 Baseline Baseline Baseline 4.3 to 5.7x10 7 2.3x10 7 3.4 to 5.1x10 7 Baseline Baseline Baseline 3a Liquid: Aerial/ Chemigation 1 (avg. corn) 1.5 (wheat) 2 (corn) 5 (stone fruit) 2 (vegetables) 1200 1200 1200 350 350 9.7x10 7 9.9x10 7 8.5x10 7 9.5x10 7 4.9x10 7 SL/ GL/ PF5 DL/ GL/ PF5 SL/ GL/ NR SL/ GL/ PF5 SL/ GL/ NR 1.1x10 6 1.4x10 6 7.2x10 7 1.1x10 6 8.6x10 7 All < 1x10 6 All < 1x10 6 EC All < 1x10 6 DL/ GL/ PF5 3b Liquid: Airblast Application 16 (citrus, 24C in CA) 1.1 7.5 (grapes, various fruit & nut trees) 40 40 4.5x10 7 3.1x10 8 to 2.1x10 7 SL/ GL/ NR SL/ GL/ NR 1.0x10 6 9.3x10 8 to 6.4x10 7 SL/ GL/ PF5 SL/ GL/ NR 3c Liquid: Groundboom 1.5 2 (wheat/ corn) 2 (strawberries) 4 8 (turf/ golf courses) 200 80 40 2.1 to 2.8x10 7 1.1x10 7 1.1 to 2.3x10 7 SL/ GL/ NR SL/ GL/ NR SL/ GL/ NR 6.4 to 8.5x10 7 3.4x10 7 3.4 to 6.8x10 7 SL/ GL/ NR SL/ GL/ NR SL/ GL/ NR 3d Liquid: High Press HW/ ROW Sprayer 4 lb ai/ 100 gal (poultry) 1000 gal 2.8x10 8 SL/ GL/ NR 8.5x10 8 SL/ GL/ NR 3e Liquid: Low press./ High Vol. Turfgun 4 8 (LCO on turf) 5 1.4 to 2.8x10 8 SL/ GL/ NR 4.2 to 8.5x10 8 SL/ GL/ NR Table 12: Summary of Occupational Handler Cancer Risks For Private Growers and Commercial Applicators Scenario Rate (lb ai/ acre)

[unless noted] Area Treated (acres/ day)

[unless noted] Risk Summary Private Growers Commercial Applicators Risk Min. Req. PPE Risk Min. Req. PPE 59 3f Liquid: Wide area aerial 2 (Range/ Forestry) 0.016 (Mosquito adulticide) 0.15 (Mosquito adulticide) 1 (Mosquito adulticide) 7500 7500 7500 7500 3.0x10 6 8.5x10 8 7.9x10 7 1.5x10 6 All < 1x10 6 SL/ GL/ NR SL/ GL/ NR All < 1x10 6 9.1x10 6 2.5x10 7 6.8x10 7 4.5x10 6 All < 1x10 6 SL/ GL/ NR EC All < 1x10 6 3g Liquid: Wide area ground 0.016 (Mosquito Adulticide) 0.15 (Mosquito adulticide) 1 (Mosquito adulticide) 3000 3000 3000 3.4x10 8 3.2x10 7 6.0x10 7 SL/ GL/ NR SL/ GL/ NR EC 1.0x10 7 9.5x10 7 1.8x10 6 SL/ GL/ NR SL/ GL/ NR All < 1x10 6 4a Wettable Powders: Aerial 1.5 (Wheat) 2 (Corn  max) 1 (Corn  typ) 5 (stone fruit) 2 (vegetables) 1200 1200 1200 350 350 4.6x10 7 6.1x10 7 3.1x10 7 4.4x10 7 1.8x10 7 EC EC EC EC EC 1.4x10 6 1.8x10 6 9.2x10 7 1.3x10 6 5.3x10 7 All < 1x10 6 All < 1x10 6 EC All < 1x10 6 EC 4b Wettable Powders: Airblast 16 (Citrus 24C in California) 7.5 (Citrus) 5 (Nuts) 3 (Pome & stone fruit) 2 (Grapes) 1.1( Avg. stone fruit) 40 40 40 40 40 40 1.6x10 7 7.6x10 8 1.0x10 6 6.2x10 7 8.8x10 7 4.9x10 7 EC EC SL/ GL/ PF5 SL/ GL/ PF5 SL/ GL/ NR SL/ GL/ NR 4.9x10 7 2.3x10 7 1.5x10 7 9.2x10 8 1.0x10 6 5.7x10 7 EC EC EC EC DL/ GL/ PF5 DL/ GL/ PF5 4c Wettable Powders: Groundboom 1.5 (wheat) 2 (corn) 2 (strawberries) 8 (turf/ golf courses) 4 (turf/ golf courses) 200 200 80 40 40 7.6x10 8 1.0x10 7 8.3x10 7 8.1x10 8 8.3x10 7 EC EC SL/ GL/ PF5 EC SL/ GL/ PF5 2.3x10 7 3.1x10 7 1.2x10 7 2.4x10 7 1.2x10 7 EC EC EC EC EC 4d Wettable Powders: High Press HW/ ROW Sprayer 4 lb ai/ 100 gal (poultry) 1000 gal 4.4x10 7 SL/ GL/ NR 5.2x10 7 DL/ GL/ PF5 4e Wettable Powders: Low press./ High Vol. Turfgun 4 (LCO on turf) 8 (LCO on turf) 5 5 2.2x10 7 4.4x10 7 SL/ GL/ NR SL/ GL/ NR 6.6x10 7 6.2x10 7 SL/ GL/ NR SL/ GL/ PF5 4f Wettable Powders: Wide area aerial 2 (Range/ Forestry) 7500 3.8x10 6 All < 1x10 6 1.1x10 5 All < 1x10 6 Applicators 5a Aerial: Agricultural uses, liquid sprays 1 2 (wheat/ corn) 5 (stone fruit) 2 (vegetables, 24C on oysters) 1200 350 350 1.6 to 3.2x10 7 2.3x10 7 9.2x10 8 EC EC EC 4.7 to 9.5x10 7 6.9x10 7 2.8x10 7 EC EC EC 5b Aerial: Wide area uses, liquid sprays 2 (Range/ Forestry) 0.016 (Mosquito adulticide) 0.15 (Mosquito adulticide) 1 (Mosquito adulticide) 7500 7500 7500 7500 2.0x10 6 1.6x10 8 1.5x10 7 9.8x10 7 All < 1x10 6 EC EC EC 5.9x10 6 4.7x10 8 4.4x10 7 3.0x10 6 All < 1x10 6 EC EC All < 1x10 6 5c Aerial: Agricultural uses, granular applications 2 (corn) 2 (corn) 1200 350 6.2x10 7 1.8x10 7 EC EC 1.9x10 6 5.5x10 7 All < 1x10 6 EC 6a Airblast: Agricultural uses 16 (Citrus 24C in California) 7.5 (Citrus) 5 (Nuts) 3 (Pome & stone fruit) 2 (Grapes) 1.1 (Avg pome & stone fruit) 40 40 40 40 40 40 2.7x10 7 1.3x10 7 9.9x10 7 1.0x10 6 6.9x10 7 3.8x10 7 EC EC DL/ GL/ PF5 Baseline Baseline Baseline 8.2x10 7 3.9x10 7 2.6x10 7 1.5x10 7 1.0x10 7 7.9x10 7 EC EC EC EC EC SL/ GL/ NR Table 12: Summary of Occupational Handler Cancer Risks For Private Growers and Commercial Applicators Scenario Rate (lb ai/ acre)

[unless noted] Area Treated (acres/ day)

[unless noted] Risk Summary Private Growers Commercial Applicators Risk Min. Req. PPE Risk Min. Req. PPE 60 6b Airblast: Wide area fogger 0.016 (Mosquito adulticide) 0.15 (Mosquito adulticide) 1 (Mosquito adulticide) 3000 3000 3000 4.1x10 7 1.9x10 7 1.3x10 6 Baseline EC All < 1x10 6 8.6x10 7 5.8x10 7 3.9x10 6 SL/ GL/ NR EC All < 1x10 6 7 Groundboom 1.5 2 (Wheat/ corn) 2 (Strawberries) 8 (Turf/ golf course) 4 (Turf/ golf course) 200 80 40 40 1.3 to 1.7x10 7 6.9x10 8 1.4x10 7 6.9x10 8 Baseline Baseline Baseline Baseline 3.9 to 5.2x10 7 2.1x10 7 4.1x10 7 2.1x10 7 Baseline Baseline Baseline Baseline 8 Solid broadcast spreader (granular) 1.5 2 (Wheat/ corn) 2 (Strawberries) 4 8 (Turf/ golf course) 200 80 40 1.3 to 1.7x10 7 6.7x10 8 1.0 to 1.5x10 7 Baseline Baseline Baseline 3.8 to 5.0x10 7 2.0x10 7 3.0 to 4.5x10 7 Baseline Baseline Baseline 9 Aerosol Can 0.01 lb ai/ can 2 cans 8.7x10 8 Baseline 2.6x10 7 Baseline 10 Trigger pump sprayer 0.01 lb ai/ can 1 can 3.1x10 9 SL/ GL/ NR 9.4x10 9 SL/ GL/ NR 11 Right of way sprayer 1.5 lb ai/ 100 gallons 1000 gallons 4.3x10 7 Baseline 4.1x10 7 SL/ GL/ NR 12 High pressure handwand 4 lb ai/ 100 gallons 1000 gallons 6.6x10 7 SL/ GL/ PF5 1.1x10 6 All < 1x10 6 13 Animal groomer, liquid application 0.01 lb ai/ dog 8 dogs 3.1x10 6 All < 1x10 6 9.4x10 6 All < 1x10 6 14 Animal groomer, dust application 0.2 lb ai/ dog 8 dogs 3.5x10 9 Baseline 1.0x10 8 Baseline 15 Granulars & baits applied by hand 9 (Ornamentals & gardens) 1 8.0x10 6 All < 1x10 6 2.4x10 5 All < 1x10 6 16 Granulars & baits applied by spoon 9 (Ornamentals & garderns) 1 4.6x10 7 SL/ GL/ NR 1.2x10 6 All < 1x10 6 Mixerr/ Loader/ Applicators 17 Low pressure, high volume turfgun (ORETF Data) 8 (LCO Use on turf) 4 (LCO Use on turf) 5 5 3.1x10 7 6.1x10 7 SL/ GL/ NR SL/ GL/ NR 9.7x10 7 9.2x10 7 DL/ GL/ PF5 SL/ GL/ NR 18a Wettable powder, low pressure handwand 1 lb ai/ 1000 ft 2 (poultry house) 2% solution (ornamentals) 20,000 ft 2 40 gallons 3.1x10 6 3.0x10 7 All < 1x10 6 SL/ GL/ NR 9.2x10 6 9.0x10 7 All < 1x10 6 SL/ GL/ NR 18b Liquids, low pressure handwand 1 lb ai/ 1000 ft 2 (poultry house) 2% solution (ornamentals) 20,000 ft 2 40 gallons 2.1x10 7 1.2x10 8 SL/ GL/ PF5 SL/ GL/ NR 6.2x10 7 3.5x10 8 SL/ GL/ PF5 SL/ GL/ NR 19 Backpack sprayer 1 lb ai/ 1000 ft 2 (poultry house) 2% solution (ornamentals) 20,000 ft 2 40 gallons 7.0x10 7 4.8x10 8 DL/ GL/ PF5 Baseline 2.2x10 6 1.4x10 7 All < 1x10 6 Baseline 20 Granular, bellygrinder 9 (Turf) 1 1.1x10 6 All < 1x10 6 3.4x10 6 All < 1x10 6 21 Granular, push type spreader 9 (Turf) 5 4.0x10 7 Baseline 8.2x10 7 SL/ GL/ NR 22 Handheld fogger No data No data No data No data No data No data 23 Power backpack No data No data No data No data No data No data 24 Granular, backpack 9 (Ornamentals) 1 1.9x10 8 DL/ GL/ NR 5.8x10 8 DL/ GL/ NR 25 Tree injection No data No data No data No data No data No data Table 12: Summary of Occupational Handler Cancer Risks For Private Growers and Commercial Applicators Scenario Rate (lb ai/ acre)

[unless noted] Area Treated (acres/ day)

[unless noted] Risk Summary Private Growers Commercial Applicators Risk Min. Req. PPE Risk Min. Req. PPE 61 26 Drench/ dipping forestry/ ornamentals 1.5 lb ai/ 100 gallons (Ornamental/ seedling dip) 100 gallons 1.1x10 7 SL/ GL/ NR 3.2x10 7 SL/ GL/ NR 27 Sprinkler can 2% solution (Ornamentals) 10 gallons 1.3x10 7 Baseline 4.0x10 7 Baseline Flaggers 28a Flagger: liquid sprays 2 (Corn) 2 (Vegetables) 1200 350 7.2x10 7 2.1x10 7 Baseline Baseline 3.5x10 7 6.3x10 7 EC Baseline 28b Flagger: granular applications 2 (Corn) 2 (Vegetables) 1200 350 2.1x10 7 6.1x10 8 Baseline Baseline 6.2x10 7 1.8x10 7 Baseline Baseline Baseline = Long pants, long sleeved shirts, no gloves SL = Single layer clothing with or without gloves (GL or NG) DL = Double layer clothing (i. e., coveralls over SL) with or without gloves (GL or NG) EC = Engineering controls NR = No respirator PF5 = Protection factor 5 respirator PF10 = Protection factor 10 respirator Current label = SL/ GL/ NR Min. Req. PPE = level of PPE where cancer risks > 1x10 6 , where current label is exceeded or no adequate PPE is found, results are bold. Risks which never exceed 1x10 6 are for highest feasible type of mitigation (e. g., engineering control in most cases).

2.1.5 Summary of Risk Concerns and Data Gaps for Handlers Generally, most scenarios have risks associated with them that meet or exceed the Agency's uncertainty factors for noncancer risk assessments (i. e., 100 for short term and intermediate term and 300 for chronic) and requirements for cancer risk results (i. e., range of 1x10 6 to 1x10 4 as defined by Office Director Barolo in 1996) at some level of personal protection. Current carbaryl labels typically require that handlers wear long pants, long sleeved shirts, and gloves. Respirators are generally not required. For most scenarios, the noncancer risks for this personal protection ensemble do not meet Agency risk requirements and additional levels of personal protection are required to achieve Agency risk targets. In fact, in many cases engineering controls such as closed loading systems or closed cab tractors are needed. The Agency does have risk concerns over the use of carbaryl in some agricultural and other occupational settings (i. e., MOEs at any level of personal protection are <100 or <300, depending on the duration). As would be expected, these scenarios with the highest associated risk also have high daily chemical use amounts based on application rates or high acreages treated or the exposures for the scenarios in question are relatively high. Generally, the areas that appear to be problematic include: large acreage aerial and chemigation applications in agriculture or for wide area treatments such as mosquito control; airblast applications at higher rates; pet grooming; and the use of certain handheld equipment for applications to turf or gardens (e. g., bellygrinder). This general trend was essentially the same regardless of the noncancer toxicity endpoints which were considered (e. g., short term, intermediate term). Risks for corresponding scenarios based on cancer concerns were generally less than noncancer results across all scenarios. In fact, in all but one scenario, cancer risks were <1x10 4 at current carbaryl label requirements of single layer clothing, gloves, and no respirator. 62 Several data gaps were also identified in many different use areas that include: dust use for animal grooming and in agriculture; various specialized hand equipment application methods (e. g., powered backpack, power hand fogger, and tree injection); and nursery operations such as seedling dips.

2.1.6 Recommendations For Refining Occupational Handler Risk Assessment In order to refine this occupational risk assessment, data on actual use patterns including rates, timing, and acreages treated would better characterize carbaryl risks. Exposure studies for many equipment types that lack data or that are not well represented in PHED (e. g., because of low replicate numbers or data quality) should also be considered based on the data gaps identified above and based on a review of the quality of the data used in this assessment. Risk managers should consider that the risks associated with current label requirements for personal protection generally do not meet Agency risk targets.

2.2 Occupational Postapplication Exposures and Risks The Agency uses the term "postapplication" to describe exposures to individuals that occur as a result of working in an environment that has been previously treated with a pesticide (also referred to as reentry exposure). The agency believes that there are distinct job functions or tasks related to the kinds of activities that occur in previously treated areas such as harvesting vegetables in a treated field. Job requirements (e. g., the kinds of jobs to cultivate a crop), the nature of the crop or target that was treated, and the how chemical residues degrade in the environment can cause exposure levels to differ over time. Each factor has been considered in this assessment. The scenarios that serve as the basis for the risk assessment are presented in Section 2.2.1: Occupational Postapplication Exposure Scenarios. The exposure data and assumptions that have been used for the calculations are presented in Section 2.2.2: Data and Assumptions For Occupational Postapplication Exposure Scenarios. The calculations and the algorithms that have been used for the noncancer elements of the risk assessment as well as the calculated risk values are presented in Section 2.2.3: Occupational Postapplication Exposure and Noncancer Risk Estimates while the analogous information using the Q1* for cancer estimates are presented in Section 2.2.4: Occupational Postapplication Exposure and Risk Estimates For Cancer. Section 2.2.5: Summary of Occupational Postapplication Risk Concerns and, Data Gaps presents the overall risk picture for carbaryl. Finally, recommendations are presented in Section 2.2.6: Recommendations For Refining Occupational Postapplication Risk Assessment.

2.2.1 Occupational Postapplication Exposure Scenarios Carbaryl uses are extremely varied as it can be used in agriculture, on ornamentals, on turf (golf courses and lawns) and on companion animals (e. g., on dogs and cats). As a result, a wide array of individuals can potentially be exposed by working in areas that have been previously treated. The Agency is concerned about these kinds of exposures one could receive in the workplace. The purpose of this section is to explain how postapplication exposure scenarios were developed for each occupational setting where carbaryl can be used. Exposure scenarios can be thought of as ways of categorizing the kinds of exposures that occur related to the use of a 63 chemical. The use of scenarios as a basis for exposure assessment is very common as described in the U. S. EPA Guidelines For Exposure Assessment (U. S. EPA; Federal Register Volume 57, Number 104; May 29, 1992).

The agency uses a concept known as the transfer coefficient to numerically represent the post application exposures one would receive (i. e., generally presented as cm 2 /hour). The transfer coefficient concept has been established in the scientific literature and through various exposure monitoring guidelines published by the U. S. EPA and international organizations such as Health Canada and OECD (Organization For Economic Cooperation and Development). The establishment of transfer coefficients also forms the basis of the work of the Agricultural Reentry Task Force, of which, Aventis is a member. The transfer coefficient is essentially a measure of the contact with a treated surface one would have while doing a task or activity. These values are defined by calculating the ratio of an exposure for a given task or activity to the amount of pesticide on leaves (or other surfaces) that can rub off on the skin resulting in an exposure. For postapplication exposures, the amounts that can rub off on the skin are measured using techniques that specifically determine the amount of residues on treated leaves or other surfaces (referred to as transferable residues) rather than the total residues contained both on the surface and absorbed into treated leaves. Transfer coefficients can be illustrated by the following example. Consider two vegetable fields where the amount of chemical on treated leaf surfaces that can rub off on the skin is the same. One field has been treated with chemical A while the other field has been treated in a similar manner with chemical B. If an individual harvests the same vegetables for a day in each field, the exposures the individual would receive would be similar. The transfer coefficient would also be similar for each field and chemical because the ratio of exposure to residue would be the same. If the same individual would do another activity in those fields such as scout the vegetables for pests or tie the vegetables, the exposures would be different as would the resulting transfer coefficients because the activity that resulted in the exposures is different. In this example, three distinct transfer coefficients could be determined for vegetable crops: harvesting; scouting; and tying. The Agency has developed a series of standard transfer coefficients that are unique for variety of job tasks or activities that are used in lieu of chemical and scenario specific data.

As with the handler risk assessment process, the first step in the post application risk assessment process is to identify the kinds of individuals that are likely to be exposed to carbaryl after application. In order to do this in a consistent manner, the Agency has developed a series of general descriptions for tasks that are associated with post application exposures. The Agency also considers whether or not individuals are exposed to pesticides as part of their employment (referred to as occupational risk assessments). Common examples include: agricultural harvesters, scouting activities in agriculture, crop maintenance tasks (e. g., irrigating, hoeing and weeding), and turf maintenance (golf course mowing and sod harvesting). 64 The next step in the risk assessment process is to define how and when chemicals are applied in order to determine the level of transferable residues to which individuals could be exposed over time. Wherever available, use and usage data are included in this process to define values such as application rates and application frequency. The Agency always completes risk assessments using maximum application rates for each scenario because what is possible under the label (the legal means of controlling pesticide use) must be evaluated, for complete stewardship, in order to ensure the Agency has no concern for the specific use. Additionally, whenever the Agency has additional information, such as typical or average application rates or frequency data, it uses the information to further evaluate the overall risks associated with the use of the chemical. In order to define the amount of transferable residues to which individuals can be exposed, the Agency relies on chemical and crop specific studies as described in the Agency guidelines for exposure data collection (Series 875, Occupational and Residential Exposure Test Guidelines: Group B Postapplication Exposure Monitoring Test Guidelines). The Agency has also developed a standard modeling approach that can also be used to predict transferable residues over time in lieu of chemical and scenario specific data (best described in the Agency's SOPs For Residential Exposure Assessment). All scenarios were evaluated using carbaryl specific DFR dissipation data.

Next, assessors must understand how exposures to carbaryl occur (i. e., frequency and duration) and how the patterns of these occurrences can alter the effects of the chemical in the population after being exposed (referred to as dose response). The Agency believes that carbaryl exposures can occur from over a single day up to every working day depending on the crop and industry being considered. This is supported by the fact that several areas within a work environment may be treated at different times. For example, parts of agricultural fields in a localized area might be treated over several weeks because of an infestation with a concurrent need for hand labor activities. Therefore, individuals working in those fields might be exposed from contact with treated foliage over an extended period of time that could be categorized as an intermediate term exposure as they work on different sections of fields. Three different types of noncancer risk calculations were required for each exposure duration considered. The durations of exposure that were considered for noncancer toxicity were short term ( 30 days), intermediateterm (30 days up to several months), and chronic (every working day). A complete array of calculations was completed for all identified exposure scenarios using the short and intermediateterm endpoints because the Agency believes that carbaryl uses fit the criteria for both of these durations. The only calculations that were completed using the chronic endpoint were limited and those associated with the greenhouse and floriculture industries where these kinds of exposures may occur. Cancer risks were also calculated using a linear, low dose extrapolation model (i. e., Q1*) for both private growers (i. e., 10 days per year) and for those who may more actively use carbaryl such as a professional farmworker (i. e., 30 days per year). Inhalation exposures are thought to be negligible in outdoor postapplication scenarios because of the low vapor pressure and due to the infinite dilution expected outdoors. As such, inhalation postapplication exposures are not considered in this assessment.

The use of personal protective equipment or other types of equipment to reduce exposures for post application workers is not considered a viable alternative for the regulatory process except in specialized situations (e. g., a rice scout will wear rubber boots in flooded paddies). This is described in some detail in the Agency's Worker Protection Standard (40CFR170). As such, an 65 administrative approach is used by the Agency to reduce the risks and is referred to as the Restricted Entry Interval or REI. The REI is a measure of the amount of time required to pass after application of a pesticide before engaging in a task or activity in a treated field. Postapplication risk levels are generally calculated in the risk assessment process on a chemical, crop, and activityspecific basis. To establish REIs, the Agency considers postapplication risks on varying days after application. [Note: Current labels specify REIs of 12 hours after application for all crop/ cultural practice combinations while Pre Harvest Intervals (PHIs) are less than 7 days for most crops with some as long as 28 days.]

The Agency has used the basic approach described above since the mid 1980s for calculating postapplication risks to pesticides. From that time to the present, several revisions and modifications were made to Agency policies as data which warranted such changes became available. In 1995, the Agency issued a Data Call In for postapplication agricultural data that prompted the formation of the Agricultural Reentry Task Force (ARTF), of which Aventis is a member. This task force has generated a number of exposure studies and associated documents that are currently under review by the Agency. The work of the ARTF is not yet complete, however, sufficient data were available from the group that warranted a significant interim change in Agency policy related to the data which were already available as the efforts of the ARTF paralleled the Agency push for tolerance reassessment stipulated by the timelines established by FQPA. As a result of the need for the revision and using the latest data, the Agency developed a revised policy on August 7, 2000 entitled Policy 003.1 Science Advisory Council For Exposure Policy Regarding Agricultural Transfer Coefficients. The revision to this policy entailed linking worker activities to more specific crop/ agronomic groupings and making better use of the available occupational postapplication exposure data. In the new policy, transfer coefficients were selected to represent the activities associated with 18 distinct crop/ agronomic groupings based on different types of vegetables, trees, berries, vine/ trellis crops, turf, field crops, and bunch/ bundle crops (e. g., tobacco). In this new scheme which the Agency uses to develop scenarios for occupational postapplication exposures, carbaryl uses were identified in all of the crop groupings in the policy. These crop groups include:

C Low Berry (e. g., lowbush blueberries, cranberries, strawberries); C Bunch/ bundle (e. g., bananas, hops, tobacco); C Field/ row crops, low/ medium (e. g., alfalfa, barley, beans, cotton, peanuts, peas); C Field/ row crops, tall (e. g., corn, sorghum, sunflowers); C Cut flowers (e. g., floriculture crops); C Sugarcane; C Trees/ fruit, deciduous (e. g., apples, apricots, cherry, peaches, pears); C Trees/ fruit, evergreen (e. g., avocados, Christmas trees, citrus); C Trees/ nut (e. g., almonds, hazelnuts, macadamia, pecans, walnuts); C Turf/ sod (e. g., golf courses, sod farms); C Vegetable/ root (e. g., beets, carrots, onions, potatoes, turnips); C Vegetable/ cucurbit (e. g., cantelope, cucumber, squash, watermelon); C Vegetable/ fruiting (e. g., eggplant, pepper, tomato, okra); C Vegetable/ head and stem brassica (e. g., brocolli, cauliflower, brussel sprouts, cauliflower); C Vegetables/ leafy (e. g., collards, greens, lettuce, parsley, spinach, napa); 66 C Vegetables/ stem and stalk (e. g., artichoke, asparagus, pineapple); C Vine/ trellis (e. g., blackberries, blueberries, grapes, kiwi, raspberries); and C Nursery crops (e. g., container and B& B ornamentals).

Within each agronomic group, a variety of cultural practices are required to maintain the included crops. These practices are varied and typically involve light to heavy contact with immature plants as well as with more mature plants. The Agency selected transfer coefficient values in its revision of Policy 003 to represent this range of exposures within each agronomic group. In the policy, transfer coefficients were placed in 1 of 5 generic categories based on the exposures relative to that group. These 5 categories include: very low exposure, low exposure, medium exposure, high exposure, and very high exposure. Numerical values were not necessarily assigned to each category for each crop group. Selections depended upon the actual agronomic practices that were identified by the Agency for each group (i. e., some groups had 2 assigned transfer coefficients while others had 5). Carbaryl can be used in each of the agronomic crop groupings described above. As such, all agronomic crop group/ transfer coefficients were used to calculate postapplication risks for carbaryl. [Note: Specific transfer coefficient values are included in Appendix E of this document which contains all of the calculations. The transfer coefficient values which have been used are excerpted directly from Agency policy 003. The nursery crop group data have not yet been formally included in EPA Policy 3. However, the studies in this area submitted by ARTF have been reviewed and used since they will be integrated into Policy 3 in a short timeframe.]

The revised policy on transfer coefficients has been significantly expanded to more closely link job practices to one of 18 crop/ agronomic groups as indicated above. It has also more clearly defined the scope of the policy as the types of tasks/ job functions that should be addressed using transfer coefficients are more clearly defined and described. The policy also describes which kinds of jobs result in exposures that cannot be addressed with transfer coefficients such as hand harvesting asparagus (i. e., because there is no foliar contact) or those that are of special concern such as vacuuming while harvesting tree nuts. The revised policy also describes in more detail those exposures that are considered to be negligible as outlined in HED Exposure SAC Policy 11: Mechanized Agricultural Practices and Post Application Exposure Assessments (e. g., mechanical harvesting). It should be noted that mechanical harvesting and other similar low/ no exposure activities should be addressed by the guidance contained in Policy 11 which is based on the Worker Protection Standard guidance for such activities (40CFR 170). If there are exposures that are of special concern, then additional data or characterization in the risk mitigation phase of the reregistration process should be considered. Exposures that are thought to be out of the scope of Policy 003 for carbaryl are presented below. A discussion of associated mechanized practices is also provided. 67 2.2.2 Data and Assumptions for Occupational Postapplication Exposure Scenarios A series of assumptions and exposure factors served as the basis for completing the occupational postapplication worker risk assessments. Each assumption and factor is detailed below on an individual basis. In addition to these values, transfer coefficient values were used to calculate risk estimates. Several chemical specific residue dissipation studies were also submitted which were used in the development of the risk values . The transfer coefficients were taken from the Agency's revised policy entitled Policy 003.1 Science Advisory Council For Exposure Policy Regarding Agricultural Transfer Coefficients (August 7, 2000). Each of these factors are presented below.

The assumptions and factors used in the risk calculations include:

C There are many factors that are common to handler and postapplication risk assessments such as body weights, duration, and ranges of application rates. Please refer to the assumptions and factors in Section 2.1.2 for further information concerning these values which are common to both handler and postapplication risk assessments. In the postapplication risk assessment, generally only maximum application rates were considered because of the complexity of the calculations (i. e., short term, intermediate term, chronic, and cancer endpoints for each of the agronomic groups contained in Policy 003). [Note: The transfer coefficient in Policy 003 for tree fruit thinning has been reduced since the issuance of the policy from 8000 cm2/ hour to 3000 cm2/ hour based on a re evaluation of the data from the cited study. This modification has been made in the tree fruit group and any other scenarios which have used this value.]

C The available dislodgeable foliar residue and turf transferable residue data for were used to complete all postapplication risk assessments. The chemical specific residue data are described in detail below and summarized in Appendix D. These data indicate that the percent of transferability averages approximately 16 percent of the application rate for the agricultural crops using the Iwata aqueous solution/ leaf punch method and approximately 1.1 percent for the turf measurements taken using the new ORETF roller method. Given these values, the Agency has used them for all postapplication crops and scenarios as the transferability is in the appropriate range for use in risk assessments.

C Aventis Crop Science is in the process of conducting a biomonitoring study for carbaryl during apple and peach thinning and harvesting activities. Based on discussions with Aventis scientists, it appears the preliminary results of this study essentially confirm the dose levels calculated in the Agency's assessment of these practices. A complete review of these data will be completed once they have been submitted to the Agency. 68 C The use of common engineering controls as well as personal protective equipment or clothing is not considered a practical solution for mitigating postapplication worker risks as described in the Agency's Worker Protection Standard (40CFR170). Of course, when well recognized mechanized options are available such as for harvesting the Agency considers them in the overall risk picture for each applicable crop/ chemical/ cultural practice combination (i. e., mechanized operations are also discussed in 40CFR170 and in the Agency's recently revised transfer coefficient policy 003). In lieu of PPE or engineering controls to mitigate risks, the Agency uses an administrative approach by establishing Restricted Entry Intervals which are essentially the time it takes for chemical residues to dissipate to levels where jobs can be done at exposure levels that are not a concern.

C Exposures were calculated to reflect chemical specific residue dissipation rates over time coupled with surrogate transfer coefficients as outlined in the Agency's revised policy. Carbaryl is used in virtually every aspect of agriculture but only 4 dislodgeable foliar residue studies were submitted that meet current Agency guidelines for sampling techniques and data quality. Studies identified in the literature such as those completed by Zweig on strawberries in 1984 (t1/ 2 = 4.1 days) and Iwata in 1979 on lemons and oranges at 11.5 lb ai/ acre (t1/ 2 = 14 days and t1/ 2 = 22 days, respectively) were considered qualitatively by the Agency to confirm the more current data. [Note: The Iwata data indicate a longer ½ life than seen in the current data. This is probably due to the high application rate compared to the current carbaryl labels.] The chemical specific dissipation data used in this current assessment were generated in studies completed by the ARTF as part of their data generation effort. These studies were conducted using Iwata's DFR sampling method on tobacco, olives, sunflowers, and cabbage. A turf transferable residue (TTR) study was also completed by the ORETF using the new roller method. The Agency uses transfer coefficients in different agronomic groups as described above to complete risk assessments. The 5 DFR and TTR studies were used as the transferable residue source term for each of these groups. These data were extrapolated to other groups based on the nature of the crop and application method. For example, the olive data were used to calculate risks for all tree crops because airblast (which was used in the olive study) would be the application method of choice for tree crops, the rates are similar, and the plant canopies are similar (i. e., can impact light and precipitation levels which in turn impact DFRs). A more complete description of how the data have been used is provided below.

C As described in the handler section and throughout the document, short term noncancer risks were calculated by comparing single day exposures. This same approach was used in the postapplication assessment where single day exposures based on the dissipation of carbaryl residues were calculated to complete the short term risk assessment (i. e., single day risks were calculated based on daily DFR dissipation values over time). The intermediate and chronic postapplication risk calculations, however, differ from the handler calculations for these extended periods. In a handler assessment, the exposures are the same from day to day because there is no residue dissipation involved (i. e., if one sprays whether it is the 1 st or the 50 th day in a row using the same equipment, the exposures would be similar because the source of exposure is similar). In postapplication assessments, the source term is expected to diminish because of residue dissipation. Hence, for the intermediate term and chronic 69 postapplication risk assessments, averages based on DFR dissipation and an appropriate duration for the endpoint were used to calculate postapplication risks. In the intermediateterm assessment, a 30 day average was used to calculate risks because the HIARC identified exposures longer than 30 days as intermediate term in nature. In the chronic assessment, a 30 day average was used based on the likelihood that carbaryl could be sprayed at least once a month in the ornamental industry (which are the only scenarios identified as chronic by the Agency). There are many approaches that can be used in the calculation of intermediateterm postapplication risks including using single day dose levels like in the short term assessment and just comparing them to the intermediate term endpoint. This is effective as a screening approach but is unlikely to actually occur based on simple probability (e. g., finding a freshly treated field 30 days in a row would be less likely than working in a field where residues are dissipating over time).

C Risks were calculated using the generic transfer coefficients that represent many different types of cultural practices. Transfer coefficients are thought to be generic (i. e., specific to a crop/ activity combination but independent of the chemical used to generate them). Several values, however, included in the Agency's revised policy were developed using carbaryl data. Because carbaryl can be used so widely, every crop/ cultural practice combination represented by different transfer coefficients included in the Agency policy was completed.

C A pseudo first order kinetics analysis was used to analyze carbaryl residue dissipation over time as outlined in the Agency's draft Series 875 Postapplication Exposure Monitoring Guidelines. A more sophisticated curve fitting approach was not warranted because the correlation coefficients in the analysis were appropriate and the data have been used generically to extrapolate to a variety of other crops where decay rates and mechanisms may differ (i. e., any sophistication gained with a curve fitting technique would be lost in an extrapolation to another crop).

C When the Agency extrapolated the available DFR data to other crops, it adjusted the data for differences in application rate using a simple proportional approach. This approach seems to be the most appropriate given the data which are available. This approach is commonly used in Agency postapplication risk assessments.

C The exposure frequency values for the postapplication cancer risk assessment are intended to consider the exposures of professional farmworkers and those growers/ users who do their own hand labor (e. g., harvesting as well as other cultural activities) concurrently with carbaryl applications. As a result, cancer risks for all postapplication scenarios have been assessed using 30 days per year for professional farmworkers and 1/ 3rd of that for private growers analogous to the handler assessment completed above.

C In postapplication cancer risk assessments, the Agency uses a tiered approach. In this case LADD (Lifetime Average Daily Dose) levels were calculated by amortizing single day exposures which are the same values used in the short term assessment over a lifetime using the 10 and 30 days per year frequency values. This may introduce a level of conservatism into the assessment. However, it does not appear that cancer risks would drive decisions for 70 postapplication exposure scenarios because of the concerns for reentry workers from noncancer risks. Therefore, the analysis was not refined further. Potential refinements may have included the use of an average exposure to amortize over a lifetime or the area under the appropriate DFR curve could be integrated and amortized.

Postapplication Studies: A total of five studies are described in this section.. One study, conducted by the Aventis Corporation, quantifies carbaryl specific turf transferable residues in 3 different states. The other studies were all conducted by the ARTF for use in defining generic transfer coefficients. Carbaryl is one of the compounds that was selected by the ARTF as a surrogate chemical for their efforts. These studies quantified residue dissipation and exposure during tobacco harvesting, during scouting in sunflowers, while weeding cabbage, and while pruning olive trees. The DFR component of those studies has been extracted for chemical specific use in this risk assessment. The transfer coefficients used in this assessment are from Agency's interim transfer coefficient policy developed by HED's Science Advisory Council for Exposure using proprietary data from the Agricultural Re entry Task Force (ARTF) database (policy # 3.1). Each study can be identified with the following information. Detailed information is provided in Tables 1 through 8 of Appendix D. Tables 1 through 7 contain results from individual studies while Table 8 contains a summary of the critical data and statistical results. The studies which have been used in this assessment are identified below followed by a brief summary of each:

C "Determination of Dermal and Inhalation Exposure To Reentry Workers During Harvesting In Tobacco, Study Number: ARF024" EPA MRID 450059 11; Report dated July 20, 1999; Authors; Dennis R. Klonne, Susan C. Artz, Cassie Prochaska, Aaron Rotondaro; Sponsor: Agricultural Reentry Task Force; Performing Laboratories: Field Grayson Research LLC and Analytical  Morse Laboratories.

C "Determination of Dermal and Inhalation Exposure To Reentry Workers During Pruning of Olive Trees, Study Number: ARF033" EPA MRID 451751 02; Report dated February 8, 2000; Authors; Dennis R. Klonne, Randy Fuller, Richard Honeycutt; Sponsor: Agricultural Reentry Task Force; Performing Laboratories: Field  HERAC, Inc. and Analytical  Morse Laboratories.

C "Determination of Dermal and Inhalation Exposure To Reentry Workers During Scouting in Sunflower, Study Number: ARF022" EPA MRID 450059 09; Report dated September 28, 1999; Authors; Dennis R. Klonne, Eric Bruce, Susan Artz, Casey Howell; Sponsor: Agricultural Reentry Task Force; Performing Laboratories: Field  ABC Laboratories and Analytical  Maxim Technologies. 71 C "Determination of Dermal and Inhalation Exposure To Reentry Workers During Weeding In Cabbage, Study Number: ARF037" EPA MRID 451917 01; Report dated May 30, 2000; Authors; Dennis R. Klonne, Randy Fuller, Tami Belcher; Sponsor: Agricultural Reentry Task Force; Performing Laboratories: Field  Excel Research Services and Analytical  Maxim Technologies.

C "Carbaryl: Determination of Transferable Residues From Turf Treated With Dragon® Sevin® Liquid" EPA MRID 451143 01; Report dated November 4, 1999; Author; Thomas C. Mester; Sponsor: Aventis Corporation; Performing Laboratory: ABC Laboratories.

[Note to Risk Managers: There are no data compensation issue associated with the use of the ARTF data in the carbaryl risk assessment because the Aventis Corporation, the registrant for carbaryl, is a member of the ARTF. The task force has submitted proprietary data that were generated using carbaryl. It is the intention of HED's Science Advisory Council for Exposure that the transfer coefficient policy will be periodically updated to incorporate additional information about agricultural practices in crops and new data on transfer coefficients. Much of this information will originate from exposure studies currently being conducted by the ARTF, from further analysis of studies already submitted to the Agency, and from studies in the published scientific literature.]

MRID 450059 11 (tobacco DFR data): This study contained a human exposure element which was reviewed separately by the Agency during the development of the revised policy 003 on transfer coefficients. The DFR component of the data only has been summarized below for use in the carbaryl risk assessment. The field phase of this study was conducted at a single site near Zebulon, North Carolina which is in a major growing region for flue cured tobacco. The field phase of the study was conducted during the period from July 1 to August 13, 1998. Sample analyses were completed by October, 1998. A tractor mounted groundboom sprayer was used to make 2 applications of Sevin XLR Plus, a liquid flowable formulation, 8 days apart at an application rate of 2 lb ai/ acre. Spray volume was 20 gallons of water per acre. The tobacco plants were approximately 4.5 feet tall and were spaced approximately 2 feet within each row while the rows were spaced 4 feet apart (i. e., ~5400 plants/ acre). No significant precipitation was observed in this study until at least 7 days after application.

Triplicate DFR samples were collected out to 35 days after the last application using the Iwata method (i. e., a total surface area sampled of 400 cm2/ sample collected with a 1 inch diameter Birkestrand leaf punch and dislodged with a 0.01 percent Aerosol solution). The Limit of Quantitation (LOQ) in this study was 1 µg/ sample or 0.0025 µg/ cm 2 . There were still measurable residues 35 days after application. The percent transferability of the 0 day sample was 19 percent of the application rate. Average field recovery over all fortification levels was 114 percent with a coefficient of variation of 6.1. The results of the study are presented in detail in Table 1 of Appendix D. The results of the pseudo first order statistical analysis of the data presented in Appendix D are summarized below in Table 13. 72 Table 13: Tobacco DFR Dissipation Data (MRID 450059 11) Location App. Rate (lb ai/ acre) App. Method Corr. Coeff. Slope (Ln TTR vs. t) [T0] (µg/ cm 2 ) T1/ 2 (days) Day 0 (% trans.) NC 2 Groundboom 0.957 0.205 4.26 3.4 19.0 MRID 451751 02 (olive DFR data): This study contained a human exposure element which was reviewed separately by the Agency during the development of the revised policy 003 on transfer coefficients. The DFR component of the data only has been summarized below for use in the carbaryl risk assessment. The field phase of this study was conducted at a single site near Terra Bella, California which is in a major growing region for olives. The field phase of the study was conducted during the period from November 2 to November 17, 1998. Sample analyses were completed by January, 1999. A typical airblast sprayer was used to make a single application of Sevin XLR Plus, a liquid flowable formulation, at an application rate of 7.65 lb ai/ acre. Spray volume was 758 gallons of water per acre. The olive trees were approximately 20 feet tall and were spaced approximately 28 feet within each row while the rows were spaced 28 feet apart (i. e., ~56 trees/ acre). No significant precipitation was observed in this study until at least 7 days after application.

Triplicate DFR samples were collected out to 14 days after application using the Iwata method (i. e., a total surface area sampled of 400 cm2/ sample collected with a 1 inch diameter Birkestrand leaf punch and dislodged with a 0.01 percent Aerosol solution). The Limit of Quantitation (LOQ) in this study was 1 µg/ sample or 0.0025 µg/ cm 2 . There were still measurable residues 14 days after application. The percent transferability of the 0 day sample was 3.6 percent of the application rate. Average field recovery over all fortification levels was 109.7 percent with a coefficient of variation of 4.8. The results of the study are presented in detail in Table 2 of Appendix D. The results of the pseudo first order statistical analysis of the data presented in Appendix D are summarized below in Table 14.

Table 14: Olive DFR Dissipation Data (MRID 451751 02) Location App. Rate (lb ai/ acre) App. Method Corr. Coeff. Slope (Ln TTR vs. t) [T0] (µg/ cm 2 ) T1/ 2 (days) Day 0 (% trans.) CA 7.65 Airblast 0.913 0.0988 3.067 7 3. 6 MRID 450059 09 (sunflower DFR data): This study contained a human exposure element which was reviewed separately by the Agency during the development of the revised policy 003 on transfer coefficients. The DFR component of the data only has been summarized below for use in the carbaryl risk assessment. The field phase of this study was conducted at a single site near Northwood, North Dakota which is in a major growing region for sunflowers. The field phase of the study was conducted during the period from July 20 to August 25, 1998. Sample analyses were completed by December, 1998. A fixed wing aircraft was used to make 2 applications of Sevin XLR Plus, a liquid flowable formulation, 7 days apart at an application rate of 1.5 lb ai/ acre. Spray volume was 3 gallons of water per acre. The sunflower plants were approximately 4 feet tall and were spaced approximately 0.5 feet within each row while the rows were spaced 2.5 feet apart (i. e., ~35000 plants/ acre). No significant precipitation was observed in this study until at least 14 days after application.

DFR samples were collected out to 28 days after the last application using the Iwata method (i. e., a 73 total surface area sampled of 400 cm2/ sample collected with a 1 inch diameter Birkestrand leaf punch and dislodged with a 0.01 percent Aerosol solution). The Limit of Quantitation (LOQ) in this study was 1 µg/ sample or 0.0025 µg/ cm 2 . There were still measurable residues 28 days after application. The percent transferability of the 0 day sample was 32 percent of the application rate. Average field recovery over all fortification levels was 93.1 percent with a coefficient of variation of 9.1. The results of the study for each site are presented in detail in Table 3 of Appendix D. The results of the pseudo first order statistical analysis of the data presented in Appendix D are summarized below in Table 15.

Table 15: Sunflower DFR Dissipation Data (MRID 450059 09) Location App. Rate (lb ai/ acre) App. Method Corr. Coeff. Slope (Ln TTR vs. t) [T0] (µg/ cm 2 ) T1/ 2 (days) Day 0 (% trans.) ND 1.5 FW Aerial 0.986 0.134 5.35 5.2 31.8 MRID 451917 01 (cabbage DFR data): This study contained a human exposure element which was reviewed separately by the Agency during the development of the revised policy 003 on transfer coefficients. The DFR component of the data only has been summarized below for use in the carbaryl risk assessment. The field phase of this study was conducted at a single site near Fresno, California which is in a major growing region for cabbage. The field phase of the study was conducted during the period from September 29 to November 10, 1999. Sample analyses were completed by May, 2000. A tractor drawn groundboom sprayer was used to make 2 applications of Sevin XLR Plus, a liquid flowable formulation, 7 days apart at an application rate of 2.07 lb ai/ acre. Spray volume was 31.1 gallons of water per acre. The cabbage plants were approximately 8 to 10 inches tall and were spaced approximately 1 feet within each row while the rows were spaced 3 feet apart (i. e., ~15000 plants/ acre). No significant precipitation was observed in this study. All irrigation was in furrow which is not believed to impact DFR levels.

Triplicate DFR samples were collected out to 35 days after the last application using the Iwata method (i. e., a total surface area sampled of 400 cm2/ sample collected with a 1 inch diameter Birkestrand leaf punch and dislodged with a 0.01 percent Aerosol solution). The Limit of Quantitation (LOQ) in this study was 1 µg/ sample or 0.0025 µg/ cm 2 . There were still measurable residues 35 days after application in 1 of the 3 samples collected while all samples on day 28 contained detectable residues. The percent transferability of the 0 day sample was 10.9 percent of the application rate. Average field recovery over all fortification levels was 97.2 percent with a coefficient of variation of 8.3. The results of the study for each site are presented in detail in Table 4 of Appendix D. The results of the pseudo first order statistical analysis of the data presented in Appendix D are summarized below in Table 16.

Table 16: Cabbage DFR Dissipation Data (MRID 451917 01) Location App. Rate (lb ai/ acre) App. Method Corr. Coeff. Slope (Ln TTR vs. t) [T0] (µg/ cm 2 ) T1/ 2 (days) Day 0 (% trans.) CA 2.07 Groundboom 0.956 0.190 2.46 3.6 10.6 74 MRID 451143 01 (turf transferable residue data): A TTR study was conducted at individual sites in three states using the ORETF roller sampling method. The locations were in California, Georgia, and Pennsylvania. Tall fescue was the variety in California and Pennsylvania. Bermudagrass was the variety in Georgia. Field work took place over three week intervals at each site. Applications were made and samples were collected essentially in October of 1998 in California and Georgia while the Pennsylvania study was completed essentially in May 1999. Two applications were made 7 days apart at each site. All applications in this study were completed at a rate of 8.17 lb ai/ acre. In California and Georgia, applications were made with typical groundboom sprayers using approximately 55 and 31 gallons of water per acre, respectively. In Pennsylvania, the applications were made with a CO2 powered sprayer in approximately 45 gallons of water per acre. All applications were made using Dragon Sevin Liquid which is a flowable concentrate formulation that contains carbaryl at a nominal concentration of 21 percent by weight or 2 lb ai/ gallon.

There was approximately from 1 inch up to 2.7 inches of irrigation water on the day of the final application at each site. Additionally, on the day of the final application, rain was noted that ranged in accumulations from 0.2 to 1.23 inches. California and Pennsylvania also received additional rain in the week after the last application (i. e., both events < 1 inch). It could not be determined, based on the study data, if the rain and irrigation events on the day of the last application at each site occurred prior to or after the application. Mowing events were also noted in the data except in Georgia where no mowing was done. The other sites were mowed prior to the last application and at some point at least 6 days after the last application.

Triplicate TTR samples were collected using the ORETF roller method at 8 intervals out to 14 days after the last application. All but two samples at each site were collected during the 1 st week of the study. The Limit of Quantitation (LOQ) for carbaryl residues was 2 µg/ sample which is equivalent to 0.00035 µg/ cm 2 based on a sample surface area of 5690 cm 2 . Average field recovery values across levels from all sites was greater than 90 percent. Additionally, the variability in the field recovery data as defined using the coefficient of variation was also low (< 10) except for the Georgia site where the CV was 28. However, at the Georgia and Pennsylvania sites, the dosespecific recovery value that closest approximated the field sample levels warranted that the results be corrected by the investigators (i. e., 119 % in Georgia and 89% in Pennsylvania, respectively). Residue levels were not corrected for recovery at the California site. In all cases, residue levels exceeded the LOQ even at 14 days after application. The results of the study for the California, Georgia, and Pennsylvania sites, respectively, are presented in Tables 5, 6, and 7 of Appendix D. The data and the results of the pseudo first order statistical analysis of the data presented in Appendix D are summarized below in Table 17. 75 Table 17: TTR Dissipation Data Measured Using ORETF Roller In 3 States (MRID 451143 01) Location App. Rate (lb ai/ acre) App. Method Corr. Coeff. Slope (Ln TTR vs. t) [T0] (µg/ cm 2 ) T1/ 2 (days) Day 0 (% trans.) CA 8.17 Groundboom 0.971 0.543 0.927 1.3 1. 0 GA 8.17 Groundboom 0.887 0.168 1.12 4.1 1. 2 PA 8.17 CO2 0.984 0.248 1.12 2.8 1. 2 The Georgia data were used to calculate short term and intermediate term risks because of the added persistence (i. e. to consider a 30 day average residue). Note that intermediate term risks could not even be calculated for PA and CA data because of the shorter decay time. The California data were used to calculate cancer risks because of the quicker dissipation which may represent more typical uses.

2.2.3 Occupational Postapplication Exposure and Noncancer Risk Estimates The occupational postapplication exposure and non cancer risk calculations are presented in this section. Noncancer risks were calculated using the Margin of Exposure (MOE) which is a ratio of the body burden to the toxicological endpoint of concern. Body burden values were determined by first calculating exposures by considering transferable residue levels in areas where people work (i. e., the potential sources of exposure) and the kinds of jobs or tasks required to produce agricultural commodities or to maintain other areas such as golf courses. These factors are represented by DFR or TTR concentrations and transfer coefficients. Exposures were calculated by multiplying these factors by an 8 hour work day. Exposures are then normalized by body weight and adjusted for dermal absorption to calculate absorbed dose (i. e., body burdens). MOEs were then calculated. Postapplication risks diminish over time because carbaryl residues eventually dissipate in the environment. As a result risk values were calculated over time based on changing residue levels.

Dissipation Kinetics: The first step in the postapplication risk assessment was to complete an analysis of the available dislodgeable foliar and turf transferable residue (DFR) data. All residue data generated in the referenced studies are summarized in Appendix D as well as in Tables 13 through 17 above. As discussed in Section 2.2.2 above, data from the 4 DFR studies were used to calculate risks for all agronomic crop groups. Best fit DFR levels were calculated based on empirical data using the equation D2 16 from Series 875 Occupational and Residential Test Guidelines: Group B Postapplication Exposure Monitoring Test Guidelines. The summary of the available chemical specific DFR data, presented in tables 13 through 17 above, were developed based on a semilog regression of the empirical dissipation data using a commercial spreadsheet linear regression function. Half lives were calculated using the algorithm (T1/ 2 = Ln 2/ slope). The results of those statistical analyses were used to calculate best fit concentrations over time using the following pseudo first order equation: 76 Where:

Cenvir( t) = dislodgeable foliar or turf transferable residue concentration ( g/ cm 2 ) that represents the amount of residue on the surface of a contacted leaf surface that is available for dermal exposure at time (t); Cenvir( o) = dislodgeable foliar or turf transferable residue concentration ( g/ cm 2 ) that represents the amount of residue on the surface of a contacted leaf surface that is available for dermal exposure at time (0); e =natural logarithms base function; PAIt = postapplication interval or dissipation time (e. g., days after treatment or DAT); and M = slope of line generated during linear regression of data [ln( Cenvir) versus postapplication interval (PAI)].

In cases where no chemical specific residue dissipation data are available, the Agency typically uses a generic dissipation model to complete risk calculations. In this case, the Agency determined that it is more appropriate, however, to extrapolate using carbaryl specific dissipation data in the risk assessment for other currently labelled crops than it is to use the generic dissipation model. This approach is consistent with current Agency policies for generating transferable/ dislodgeable residue data. The existing residue data were extrapolated to the currently labelled crops as follows:

C Tobacco DFR Data: These data have been used to complete all assessments for the crop/ activity combinations included in the bunch/ bundle, sugarcane, and vine/ trellis agronomic crop groups defined in the Agency's revised transfer coefficient policy 003. This extrapolation was completed because of similarities in application methods between the study and selected crop groups, the crop canopy, and application rates (i. e., between the study and current labels).

C Olive DFR Data: These data have been used to complete all assessments for the crop/ activity combinations included in all of the tree fruit and nut crop groups defined in the Agency's revised transfer coefficient policy 003. This extrapolation was completed because of similarities in application methods between the study and selected crop groups, the crop canopy, and application rates (i. e., between the study and current labels).

C Sunflower DFR Data: These data have been used to complete all assessments for the crop/ activity combinations in the tall field/ row crop group defined in the Agency's revised transfer coefficient policy 003. No extrapolation was required in this assessment. An additional consideration was that the cabbage study was based on groundboom application and not aerial application. Groundboom applications are thought to be much more prevalent in the overall use pattern for carbaryl. 77 C Cabbage DFR Data: These data have been used to complete all assessments for the crop/ activity combinations included in the berry, cut flower, low/ medium field and row, and all vegetable (i. e., stem/ stalk, brassica, leafy, fruiting, cucurbits, root) agronomic crop groups defined in the Agency's revised transfer coefficient policy 003. This extrapolation was completed because of similarities in application methods between the study and selected crop groups, the crop canopy, and application rates (i. e., between the study and current labels).

C Turf TTR Data: These data have been used to complete all assessments for the crop/ activity combinations for the turf agronomic crop group defined in the Agency's revised transfer coefficient policy 003. No extrapolation was required in this assessment.

Daily Exposure: The next step in the risk assessment process was to calculate dermal exposure values (remembering that inhalation exposures are not assessed for these scenarios) on each post application day after application using the following equation (see equation D2 20 from Series 875 Occupational and Residential Test Guidelines: Group B Postapplication Exposure Monitoring Test Guidelines and Residential SOP 3.2: Postapplication Dermal Potential Doses From Pesticide Residues On Gardens):

DE( t) (mg/ day) = (TR( t) (µg/ cm 2 ) x TC (cm 2 /hr) x Hr/ Day)/ 1000 (µg/ 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 transferable residue at time (t) where the longest duration is dictated by the decay time observed in the studies (µg/ cm 2 ); TC = Transfer Coefficient (cm 2 /hour); and Hr/ day = Exposure duration meant to represent a typical workday (hours).

Note that the (TR( t)) input may represent levels on a single day after application in the case of shortterm risk calculations. For intermediate term calculations, rolling 7 day average concentrations were calculated based on the applicability of the toxicology data (i. e., intermediate term endpoint is applied to exposures >30 days). In the limited number of chronic calculations, a 30 day average was also used based on a likely frequency between applications.

Daily Dose and Margins of Exposure: The use of dissipation data and the manner in which daily postapplication dermal exposure values were calculated are inherently different than with handler exposures. Once daily exposure values are calculated, the calculation of daily absorbed dose and the resulting Margin of Exposure values use the same algorithms that are described above for the handler exposures (See Section 2.1.3). These calculations are completed for each day or appropriate block of time after application. 78 Noncancer Risk Summary: All of the noncancer risk calculations for occupational carbaryl handlers completed in this assessment are included in Appendix E. The specifics of each of table included in Appendix E are described below. A summary of the results for each crop/ activity combination considered for each timeframe is also provided below.

C Appendix E/ Table 1: Inputs For Carbaryl Occupational Postapplication Risk Assessment Presents the numerical unit exposure values and other factors used in the occupational handler risk assessments.

C Appendix E/ Table 2: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Low Berry Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 4: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Bunch/ Bundle Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 6: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Short/ Medium Field Row Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively). C Appendix E/ Table 8: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Tall Field Row Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 10: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Cut Flower Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively). [Note: Table 10 also contains chronic risk values.]

C Appendix E/ Table 12: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Sugarcane Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 14: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Deciduous Tree Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 16: Carbaryl Occupational Postapplication Noncancer Risk 79 Assessment For Evergreen Tree Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 18: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Tree Nut Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 20: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Turf Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 22: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Root Vegetable Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 24: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Cucurbit Vegetable Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 26: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Fruiting Vegetable Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 28: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Brassica Vegetable Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 30: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Leafy Vegetable Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 32: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Root Vegetable Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively). C Appendix E/ Table 34: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Vine Crop Group Risk values are presented for each exposure duration 80 considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 36: Carbaryl Occupational Postapplication Noncancer Risk Assessment For Nursery Stock Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively). [Note: Table 36 also contains chronic risk values.]

It should be noted that there were several scenarios for which no appropriate exposure data are known to exist or ongoing transfer coefficient studies have not yet been submitted (e. g., ARTF nursery and ornamental data). The scope of the Agency's revised policy 003 for transfer coefficients should also be considered as it only quantitatively addresses risks where the transfer coefficient model is appropriate (i. e., where foliar contact is known to exist). There are many kinds of potential exposure pathways that do not involve foliar contact that have not been addressed in this risk assessment (as defined in policy 003, refer to that document for a complete list). The scenarios include:

C Transplanting many crops including in the ornamental and forestry industry;

C Thinning some crops such as hops;

C Some partially mechanized operations that also involve human contact (e. g., cotton harvesting where module builders and trampers are used, see below); C Hand weeding some crops such as wheat;

C Various operations with Christmas trees such as pruning or baling; and C Various operations with nut production such as sweeping for harvest.

[Note: Additional DFR data on different crops could refine exposure and risk estimates.]

Mechanized practices can be divided into fully mechanized activities that meet the definition of "No contact" in the Agency's Worker Protection Standard (WPS) and mechanically assisted practices with potential for exposure. In the case of fully mechanized activities, the Agency does not complete a quantitative exposure assessment but addresses these types of potential exposures qualitatively by allowing early entry as described in the WPS. 81 "A worker may enter a treated area during a restricted entry interval if the agricultural employer assures that both of the following are met: (1) The worker will have no contact with anything that has been treated with the pesticide to which the restricted entry interval applies including, but not limited to, soil, water, air, or surfaces of plants; and (2) no such entry is allowed until any inhalation exposure level listed in the labeling has been reached or any ventilation criteria established by § 170.110 (c)( 3) or in the labeling have been met."

In cases of partially mechanized activities where the potential for exposure exists, the Agency assesses the resulting exposures similarly to those resulting from hand labor activities for "high exposure potential" activities (i. e., transfer coefficients are used to represent exposures associated with the activity). Partially mechanized activities with "low exposure potential" are assessed qualitatively. Available use and usage information have been used to characterize the predominance of these activities that meet the fully mechanized (" No contact") and the mechanically assisted definitions in the risk assessment to allow risk managers flexibility in their decisions with regard to various segments of the exposed population for carbaryl. The Agency also acknowledges that there is some potential for exposure because individuals engaged in fully mechanized activities have short term excursions from the protected area for various reasons (e. g., unclogging machinery or equipment inspection for breakage). In these cases, the WPS § 170.112( c) Exception for short term activities applies.

The level of concern for all assessments is established by the uncertainty factor that is associated with a specific duration of exposure. Uncertainty factors are defined for occupational exposures under FIFRA and account for intra species sensitivity and inter species extrapolation. In other cases, like carbaryl, additional factors can also be required (i. e., 3x) because a Lowest Observed Adverse Effect Level (i. e., LOAEL) has been selected as the dose level upon which the risk assessment is based and not on the No Observed Adverse Effect Level (i. e., NOAEL). In this case, three distinct durations of exposure were considered for postapplication workers including: short term ( 30 days), intermediate term (> 30 days to several months), and chronic (essentially every working day). The toxicological endpoints and uncertainty factors which have been applied to each exposure duration are those described in Section 1.3/ Table 1. The results for each exposure duration are presented separately below.

Noncancer short term, intermediate term, and chronic risks were calculated for different crop groups as described above. Table 18 below provides a summary of these risks for each crop/ activity combination considered. For each crop group/ activity combination, the short term MOE value at the current REI of 12 hours is presented (i. e., the Day 0 MOE) as well as the number of days required for short term MOEs to reach the Agency's uncertainty factor of 100. Additionally, the intermediate term and chronic MOEs which have been calculated using 30 day average exposures based on the dissipation of carbaryl residues are also included. The uncertainty factor for intermediate term exposures is 100 and for chronic exposures is 300. 82 Current label requirements specify 12 hour REIs. For all but the lowest exposure scenarios in some crops, short term MOEs are of concern (i. e., less than the required uncertainty factor of 100) at the current REI. Generally, short term MOEs meet or exceed the Agency uncertainty factor in the range of 3 to 5 days for lower to medium exposure activities and from 8 to 12 days after application in most higher exposure scenarios. Intermediate term MOEs are not of concern generally for low to medium level exposures but are of concern for higher level exposures such as harvesting in some crops. Chronic exposures are of concern for the cut flower industry but not for general greenhouse and nursery production activities.

Table 18: Summary of Carbaryl Noncancer Postapplication Worker Risks Crop Group Result Type Exposure Descriptor (See Appendix E)

Very Low Low Medium High Very High Low Berry ST MOE Day 0 NA 184 NA 49 NA Days For ST MOE > UF NA 0 NA 4 NA IT 30 Day Avg MOE NA 991 NA 264 NA Bunch/ Bundle ST MOE Day 0 NA 411 32 21 NA Days For ST MOE > UF NA 0 6 8 NA IT 30 Day Avg MOE NA 2365 182 118 NA Low /Med. Field/ Row Crops ST MOE Day 0 NA 982 65 39 NA Days For ST MOE > UF NA 0 3 5 NA IT 30 Day Avg MOE NA 5286 352 211 NA Tall Field/ Row Crops ST MOE Day 0 NA 245 61 25 <1 Days For ST MOE > UF NA 0 4 11 +30 IT 30 Day Avg MOE NA 970 242 97 6 Cut Flowers ST MOE Day 0 NA 30 18 11 NA Days For ST MOE > UF NA 7 9 12 NA IT 30 Day Avg MOE NA 159 99 57 NA Chronic MOE NA 194 121 69 NA Sugarcane ST MOE Day 0 NA NA 55 27 NA Days For ST MOE > UF NA NA 3 7 NA IT 30 Day Avg MOE NA NA 315 158 NA Decid. Fruit Trees ST MOE Day 0 1455 146 NA 49 NA Days For ST MOE > UF 0 0 NA 8 NA IT 30 Day Avg MOE 4450 445 NA 148 NA Table 18: Summary of Carbaryl Noncancer Postapplication Worker Risks Crop Group Result Type Exposure Descriptor (See Appendix E)

Very Low Low Medium High Very High 83 Evergreen Fruit Trees ST MOE Day 0 582 58 19 NA NA Days For ST MOE > UF 0 6 17 NA NA IT 30 Day Avg MOE 1780 178 59 NA NA Nut Trees ST MOE Day 0 NA 175 NA 35 NA Days For ST MOE > UF NA 0 NA 11 NA IT 30 Day Avg MOE NA 534 NA 107 NA Turf/ Sod ST MOE Day 0 NA 312 NA 10 NA Days For ST MOE > UF NA 0 NA 14 NA IT 30 Day Avg MOE NA 1505 NA 46 NA Root Veg. ST MOE Day 0 NA 245 49 29 NA Days For ST MOE > UF NA 0 4 7 NA IT 30 Day Avg MOE NA 1322 264 159 NA Cucurbit Veg. ST MOE Day 0 NA 147 49 29 NA Days For ST MOE > UF NA 0 4 7 NA IT 30 Day Avg MOE NA 793 264 159 NA Fruiting Veg. ST MOE Day 0 NA 147 105 74 NA Days For ST MOE > UF NA 0 0 2 NA IT 30 Day Avg MOE NA 793 566 396 NA Brassica ST MOE Day 0 NA 37 18 15 NA Days For ST MOE > UF NA 6 9 11 NA IT 30 Day Avg MOE NA 198 99 79 NA Leafy Veg. ST MOE Day 0 NA 147 49 29 NA Days For ST MOE > UF NA 0 4 7 NA IT 30 Day Avg MOE NA 793 264 159 NA Stem/ stalk Veg. ST MOE Day 0 NA 137 82 41 NA Days For ST MOE > UF NA 0 1 5 NA IT 30 Day Avg MOE NA 788 473 236 NA Table 18: Summary of Carbaryl Noncancer Postapplication Worker Risks Crop Group Result Type Exposure Descriptor (See Appendix E)

Very Low Low Medium High Very High 84 Vine/ trellis ST MOE Day 0 NA 147 74 15 7 Days For ST MOE > UF NA 0 2 11 14 IT 30 Day Avg MOE NA 793 396 79 40 Nursery/ Ornamentals ST MOE Day 0 NA 669 421 184 NA Days For ST MOE > UF NA 0 0 0 NA IT 30 Day Avg MOE NA 3604 2266 991 NA Chronic MOE NA 4399 2765 1210 NA ST = Short term, IT = Intermediate term, 30 Day Avg.= Average exposure level over 30 day interval. NA = Exposure descriptor not applicable for that crop group. UF = uncertainty factor or target MOE of 100.

2.2.4 Occupational Postapplication Exposure and Risk Estimates for Cancer The occupational exposure and cancer risk calculations for postapplication workers are presented in this section. Cancer risks were calculated using a linear low dose extrapolation approach in which a Lifetime Average Daily Dose (LADD) is first calculated and then compared with a Q1* that has been calculated for carbaryl based on dose response data in the appropriate toxicology study (Q1* = 8.75 x 10 4 (mg/ kg/ day) 1 ). Absorbed average daily dose (ADD) levels were used as the basis for calculating the LADD values. Section 2.1.3 above describes how the ADD values were first calculated for the noncancer MOE calculations. These values also serve as the basis for the cancer risk estimates. Dermal and inhalation ADD values were first added together to obtain combined ADD values. LADD values were then calculated and compared the Q1* to obtain cancer risk estimates.

LADD and Cancer Risk Calculations: The use of dissipation data and the manner in which daily postapplication dermal exposure values were calculated are inherently different than with handler exposures. Once daily exposure values are calculated, the calculation of LADD (Lifetime Average Daily Dose) and the resulting cancer risks use the same algorithms that are described above for the handler exposures (See Section 2.1.4).

To reiterate, occupational carcinogenic risks that are 1 x 10 6 or lower require no risk management action based on the 1996 Barolo memo. For those chemicals subject to reregistration, the Agency is to carefully examine uses with estimated risks in the 10 6 to 10 4 range to seek ways of cost effectively reducing risks. If carcinogenic risks are in this range for postapplication workers, an increase in time after application prior to allowing a reentry activity would be warranted as is commonly applied to noncancer risk estimates. 85 Cancer Risk Summary All of the cancer risk calculations for carbaryl postapplication workers are included in Appendix E (various tables). The specifics of each of table included in Appendix E are summarized below.

C Appendix E/ Table 1: Inputs For Carbaryl Occupational Postapplication Risk Assessment Presents the numerical unit exposure values and other factors used in the occupational handler risk assessments.

C Appendix E/ Table 3: Carbaryl Occupational Postapplication Cancer Risk Assessment For Low Berry Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 5: Carbaryl Occupational Postapplication Cancer Risk Assessment For Bunch/ Bundle Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 7: Carbaryl Occupational Postapplication Cancer Risk Assessment For Short/ Medium Field Row Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 9: Carbaryl Occupational Postapplication Cancer Risk Assessment For Tall Field Row Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 11: Carbaryl Occupational Postapplication Cancer Risk Assessment For Cut Flower Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 13: Carbaryl Occupational Postapplication Cancer Risk Assessment For Sugarcane Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 15: Carbaryl Occupational Postapplication Risk Assessment For Deciduous Tree Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 17: Carbaryl Occupational Postapplication Cancer Risk Assessment 86 For Evergreen Tree Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 19: Carbaryl Occupational Postapplication Cancer Risk Assessment For Tree Nut Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 21: Carbaryl Occupational Postapplication Cancer Risk Assessment For Turf Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 23: Carbaryl Occupational Postapplication Cancer Risk Assessment For Root Vegetable Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 25: Carbaryl Occupational Postapplication Cancer Risk Assessment For Cucurbit Vegetable Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 27: Carbaryl Occupational Postapplication Cancer Risk Assessment For Fruiting Vegetable Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).

C Appendix E/ Table 29: Carbaryl Occupational Postapplication Cancer Risk Assessment For Brassica Vegetable Crop Group Risk values are presented for each exposure duration considered in the assessment (i. e., short term and intermediate term duration exposures, respectively).