Table 22: 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 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).

7.1.2 Occupational Handler Cancer Risks Cancer risks were calculated by multiplying the LADD to the Q1* (8.75 x 10 4 (mg/ kg/ day) 1 ), as described in <IP_ADDRESS>. HED considered two distinct populations in the cancer risk assessment  private growers at 10 use events per year and commercial applicators with a use pattern of 30 days per year. The Agency has defined a range of acceptable cancer risks based on a policy memorandum dated August 14, 1996, by Office of Pesticide Programs Director Dan Barolo. This memo refers to a predetermined quantified "level of concern" for occupational carcinogenic risk. 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 carcinogenic risks are in this range for occupational handlers, increased levels of 90 personal protection are warranted as is commonly applied with noncancer risk estimates (e. g., additional PPE or engineering controls). Carcinogenic risks that remain above 1 x 10 4 at the highest level of mitigation appropriate for that scenario remain a concern.

Cancer risks for private growers (i. e., 10 applications per year) were calculated for different exposure scenarios at different levels of personal protection. 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 growers 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. 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 general, the cancer risk estimates would lead to less restrictive measures when compared to the noncancer results. Table 23 below provides a summary of the cancer risks that have been calculated for private growers and commercial applicators.

Table 23: 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 Table 23: 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 91 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 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 Table 23: 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 92 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 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 Table 23: 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 93 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 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).

7.2 Postapplication Exposures and Risks Workers can be exposed to carbaryl residues by entering previously treated areas to perform activities. Exposure varies with the specific tasks (i. e., transfer coefficient), the level of carbaryl residue in the environment (i. e., DFR or TTR depending upon crop), and the duration of the activity. Calculations were completed using the same approaches as already outlined above for the residential postapplication risk assessments (Section 4.4.3: Residential Postapplication Risks).

An administrative approach, the Restricted Entry Interval (REI), is used by the Agency to manage risks for postapplication workers doing hand labor activities that require direct contact with treated plants. The REI is the amount of time required between application of a pesticide and engaging in a task or activity in a treated field that it takes for residues to dissipate to an appropriate level. Current labels for carbaryl specify REIs of 12 hours after application for all crop/ cultural practice combinations. In other cases (e. g., use of a combine or other mechanical harvesting) such as those 94 specified in the Agency's Worker Protection Standard (40CFR170) where no contact will occur, the Agency does not rely on the REI approach but adheres to the guidance included in §170.110.( c)( 3) that allows for entry if the criteria are met. The Agency also considers short term excursions for people for such activities as unclogging machinery as stipulated in the guidance included in §170.112.( c). The Agency encourages the use of viable engineering controls and other means to reduce exposures provided they are not overly burdensome for actual workers. Generally, it should also be noted that the use of personal protective equipment or other types of equipment to reduce exposures for postapplication 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).

As with the occupational handlers, a scenario driven approach is used to assess risks for reentry workers. The Agency's Policy 003.1 Science Advisory Council For Exposure Policy Regarding Agricultural Transfer Coefficients is used to define the scenarios. This policy presents various transfer coefficients which represent the range of activities associated with 18 distinct crop/ agronomic groupings based on different types of job tasks or activities needed to produce fruits, vegetables, grains, and other crops. In this scheme, carbaryl uses were identified in all of the crop groupings included in the policy. As such, all agronomic crop group/ transfer coefficients included in this policy were used to calculate postapplication risks for carbaryl.

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

[Note: This assessment includes the latest transfer coefficients for nursery crops which have been recently submitted by ARTF and reviewed by the Agency. Additionally, the transfer coefficient for fruit tree hand thinning has been reduced from original policy estimates based on a reinterpretation by the Agency of the dataset upon which it was based.] 95 Data and Assumptions A series of assumptions and exposure factors served as the basis for completing the occupational postapplication risk assessments, as described below. The assumptions and factors used in the risk calculations are consistent with current Agency policy for completing occupational exposure assessments (e. g., Exposac Policy 3 and guidelines for handling DFR data). The assumptions and factors used in the risk calculations include:

C Many assumptions and factors which are common to both handler and postapplication risk assessments are detailed in Section 7.1: Occupational Handler Risk Assessment (e. g., body weight). One major difference is that in the handler assessment, many different combinations of application rates and crop acres treated were considered but in the postapplication assessment, generally only maximum application rates were considered.

C Four dislodgeable foliar residue (DFR) studies were submitted that meet current Agency guidelines for sampling techniques and data quality. These studies were conducted with carbaryl by the Agricultural Re entry Task Force (ARTF) using Iwata's DFR sampling method on tobacco (harvesting), olives (pruning), sunflowers (scouting), and cabbage (weeding). [Note: Aventis Crop Science is a member of the ARTF so there are no data compensation issues associated with the use of these data.] The percent of transferability averaged approximately 16 percent of the application rate for the crops. A turf transferrable residue (TTR) study was also completed by Aventis Crop Science using the ORETF roller method. The percent of transferability averaged approximately 1.1 percent for turf measurements at three different sites. HED used the values from these five studies for all postapplication crops and scenarios as the transferability is in the appropriate range for use in risk assessments.

C Short term noncancer risks were calculated by comparing single day exposures based on the dissipation of carbaryl residues (i. e., single day risks were calculated based on daily DFR dissipation values over time). With the intermediate term postapplication risk calculations, 30 day averages based on DFR dissipation and an appropriate duration for the endpoint were used to calculate postapplication risks. In the long term 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. The endpoints used are the same as those described above for the dermal component in the handler assessments (i. e., NOAEL of 20 mg/ kg/ day from 21 day dermal rat toxicity study using technical material  target MOE = 100 and LOAEL of 3.1 mg/ kg/ day from a chronic dog feeding study with a dermal absorption factor defined in rats  target MOE = 300).

C A standard 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.

C When the available DFR data were extrapolated to other crops, the data were adjusted for differences in application rate using a simple proportional approach. Carbaryl specific residue dissipation data were extrapolated to crops where no data were available. The tobacco DFR data were used to complete all assessments for the crop/ activity combinations included in the bunch/ bundle, sugarcane, and vine/ trellis agronomic crop groups. The olive DFR data were used to complete all assessments for the crop/ activity combinations included in all of the tree fruit and 96 nut crop groups. The sunflower DFR data were used to complete all assessments for the crop/ activity combinations in the tall field/ row crop group. No extrapolation was required in this assessment. The cabbage study was based on groundboom application, which is thought to be much more prevalent in the overall use pattern for carbaryl. The cabbage DFR data were 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. The turf TTR data were used to complete all assessments for the crop/ activity combinations for the turf agronomic crop group. No extrapolation was required in this assessment.

° There were several scenarios for which no appropriate exposure data are 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. The scenarios include: transplanting many crops including in the ornamental and forestry industry; thinning some crops such as hops; some partially mechanized operations that also involve human contact (e. g., cotton harvesting where module builders and trampers are used); various operations with Christmas trees such as pruning or baling; and various operations with nut production such as sweeping for harvest.

° Aventis Crop Science is in the process of conducting a biomonitoring study with postapplication workers on key crops of concern (i. e., apples and cherries). The activities that were monitored included hand thinning of apples and hand harvest of both apples and cherries. Based on discussions with Aventis Crop Science, the preliminary results indicate that levels are similar to those predicted in the Agency's occupational postapplication risk assessment.

7.2.1 Occupational Postapplication Noncancer Risks 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 24 below provides a summary of the noncancer risks that have been calculated for each crop group and each duration of exposure. The information presented includes the short term MOEs on the day of application, the day after application where the short term MOEs meet or exceed the target of 100, the intermediate term MOEs based on 30 day average exposures, and chronic MOEs also based on 30 day average exposures (only for a limited number of scenarios).

Table 24: Summary of Carbaryl Noncancer Postapplication Worker Risks Crop Group Result Type Exposure Descriptor 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 Table 24: Summary of Carbaryl Noncancer Postapplication Worker Risks Crop Group Result Type Exposure Descriptor Very Low Low Medium High Very High 97 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 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 Table 24: Summary of Carbaryl Noncancer Postapplication Worker Risks Crop Group Result Type Exposure Descriptor Very Low Low Medium High Very High 98 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 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 99 7.2.2 Occupational Postapplication Exposure and Risk Estimates for Cancer Cancer risks for private growers (i. e., 10 exposures/ year) and commercial farmworkers (i. e., 30 exposures/ year) were calculated for different crop groups as described above and summarized in Table 25 below. Current label requirements specify 12 hour REIs. For all scenarios, cancer risks are <1x10 4 on the day of application (i. e., at the current REI). Likewise, cancer risks are <1x10 6 on the day of application for most crop/ activity scenarios with private growers and also for low to medium exposures for commercial farmworkers. In fact, risks for all scenarios were in the 10 6 range in all but two scenarios for commercial farmworkers participating in very high exposure activities (e. g., sweetcorn handharvesting) on the day of application. In these three cases, risks were in the 10 5 range on the day of application. For private growers, it takes approximately 5 days for risks to decline to <1x10 6 for crop/ activity combinations that exceed 1x10 6 on the day of application. For commercial farmworkers, it takes approximately 8 days for risks to reach the target level of concern of <1x10 6 . The 1996 Barolo memo which focused on cancer risk management should be considered in the interpretation of these results. Current label requirements appear to be adequate for all postapplication cancer risks if the 10 4 range is used for risk management. If the 10 6 risk range is considered, it also appears that the current REI appears adequate to address cancer risks for many crop/ activity combinations. However, for higher exposure situations, longer duration REIs are predicted. In all cases, REIs predicted based on cancer risks are less restrictive or similar (i. e., within a day or two for commercial farmworkers) than those predicted based on the noncancer effects of carbaryl. In no cases do cancer risks indicate more restrictive REIs than for noncancer risks calculated for the corresponding crop/ activity exposure scenario.

Table 25: Summary of Carbaryl Cancer Postapplication Worker Risks Crop Group Result Type Exposure Descriptor (From Policy 003)

Very Low Low Medium High Very High Low Berry Private Grower Day 0 Risk NA 1.7 x 10 7 NA 6.2x 10 7 NA Private Grower Days < 1x10 6 NA 0 NA 0 NA Com.. Farmworker Day 0 Risk NA 5.0 x 10 7 NA 1.9x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 0 NA 4 NA Bunch/ Bundle Private Grower Day 0 Risk NA 7.4 x 10 8 9.6x 10 7 1.5x 10 6 NA Private Grower Days < 1x10 6 NA 0 0 2 NA Com.. Farmworker Day 0 Risk NA 2.2 x 10 7 2.9x 10 6 4.4x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 0 5 8 NA Low /Med. Field/ Row Crops Private Grower Day 0 Risk NA 3.1x 10 8 4.7x 10 7 7.8x 10 7 NA Private Grower Days < 1x10 6 NA 0 0 0 NA Com.. Farmworker Day 0 Risk NA 9.3x 10 8 1.4x 10 6 2.3x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 0 2 5 NA Table 25: Summary of Carbaryl Cancer Postapplication Worker Risks Crop Group Result Type Exposure Descriptor (From Policy 003)

Very Low Low Medium High Very High 100 Tall Field/ Row Crops Private Grower Day 0 Risk NA 1.2 x 10 7 5.0 x 10 7 1.2 x 10 6 2.1 x 10 5 Private Grower Days < 1x10 6 NA0 0 223 Com.. Farmworker Day 0 Risk NA 3.7 x 10 7 1.5 x 10 6 3.7 x 10 6 8.5 x 10 5 Com.. Farmworker Days < 1x10 6 NA 0 3 10 31 Cut Flowers Private Grower Day 0 Risk NA 1.0 x 10 6 1.7 x 10 6 2.9 x 10 6 NA Private Grower Days < 1x10 6 NA 0 3 6 NA Com.. Farmworker Day 0 Risk NA 3.1 x 10 6 5.0 x 10 6 8.7 x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 6 9 12 NA Sugarcane Private Grower Day 0 Risk NA NA 5.6 x 10 7 1.1 x 10 6 NA Private Grower Days < 1x10 6 NA NA 0 1 NA Com.. Farmworker Day 0 Risk NA NA 1.7 x 10 6 3.3 x 10 6 NA Com.. Farmworker Days < 1x10 6 NA NA 3 6 NA Decid. Fruit Trees Private Grower Day 0 Risk 2.1 x 10 8 2.1 x 10 7 NA 6.3 x 10 7 NA Private Grower Days < 1x10 6 0 0NA0NA Com.. Farmworker Day 0 Risk 6.3 x 10 8 6.3 x 10 7 NA 1.9 x 10 6 NA Com.. Farmworker Days < 1x10 6 0 0NA6NA Evergreen Fruit Trees Private Grower Day 0 Risk 5.2 x 10 8 5.2 x 10 7 1.6 x 10 6 NA NA Private Grower Days < 1x10 6 0 0 5 NA NA Com.. Farmworker Day 0 Risk 1.6 x 10 7 1.6 x 10 6 4.7 x 10 6 NA NA Com.. Farmworker Days < 1x10 6 0 5 16 NA NA Nut Trees Private Grower Day 0 Risk NA 1.7 x 10 7 NA 8.7 x 10 7 NA Private Grower Days < 1x10 6 NA 0 NA 0 NA Com.. Farmworker Day 0 Risk NA 5.7 x 10 7 NA 2.6 x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 0 NA 10 NA Turf/ Sod Private Grower Day 0 Risk NA 8.1 x 10 8 NA 2.7 x 10 6 NA Private Grower Days < 1x10 6 NA 0 NA 2 NA Com.. Farmworker Day 0 Risk NA 2.4 x 10 7 NA 8.0 x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 0 NA 4 NA Table 25: Summary of Carbaryl Cancer Postapplication Worker Risks Crop Group Result Type Exposure Descriptor (From Policy 003)

Very Low Low Medium High Very High 101 Root Veg. Private Grower Day 0 Risk NA 1.2 x 10 7 6.2 x 10 7 1.0 x 10 6 NA Private Grower Days < 1x10 6 NA 0 0 0 NA Com.. Farmworker Day 0 Risk NA 3.7 x 10 7 1.9 x 10 6 3.1 x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 0 4 6 NA Cucurbit Veg. Private Grower Day 0 Risk NA 2.1 x 10 7 6.2 x 10 7 1.0 x 10 6 NA Private Grower Days < 1x10 6 NA 0 0 0 NA Com.. Farmworker Day 0 Risk NA 6.2 x 10 7 1.9 x 10 6 3.1 x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 0 4 6 NA Fruiting Veg. Private Grower Day 0 Risk NA 2.1 x 10 7 2.9 x 10 7 4.1 x 10 7 NA Private Grower Days < 1x10 6 NA 0 0 0 NA Com.. Farmworker Day 0 Risk NA 6.2 x 10 7 8.7 x 10 7 1.2 x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 0 0 1 NA Brassica Private Grower Day 0 Risk NA 8.3 x 10 7 1.7 x 10 6 2.1 x 10 6 NA Private Grower Days < 1x10 6 NA 0 3 4 NA Com.. Farmworker Day 0 Risk NA 2.5 x 10 6 5.0 x 10 6 6.2 x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 5 9 10 NA Leafy Veg. Private Grower Day 0 Risk NA 2.1 x 10 7 6.2 x 10 7 1.0 x 10 6 NA Private Grower Days < 1x10 6 NA 0 0 0 NA Com.. Farmworker Day 0 Risk NA 6.2 x 10 7 1.9 x 10 6 3.1 x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 0 4 6 NA Stem/ stalk Veg. Private Grower Day 0 Risk NA 2.2 x 10 7 3.7 x 10 7 7.4 x 10 7 NA Private Grower Days < 1x10 6 NA 0 0 0 NA Com.. Farmworker Day 0 Risk NA 6.7 x 10 7 1.1 x 10 6 2.2 x 10 6 NA Com.. Farmworker Days < 1x10 6 NA 0 1 4 NA Vine/ trellis Private Grower Day 0 Risk NA 2.1 x 10 7 4.1 x 10 7 2.1 x 10 6 4.1 x 10 6 Private Grower Days < 1x10 6 NA0 0 48 Com.. Farmworker Day 0 Risk NA 6.2 x 10 7 1.2 x 10 6 6.2 x 10 6 1.2 x 10 5 Com.. Farmworker Days < 1x10 6 NA 0 1 10 13 Table 25: Summary of Carbaryl Cancer Postapplication Worker Risks Crop Group Result Type Exposure Descriptor (From Policy 003)

Very Low Low Medium High Very High 102 Nursery/ Ornamentals Private Grower Day 0 Risk NA 4.5 x 10 8 7.2 x 10 8 1.7 x 10 7 NA Private Grower Days < 1x10 6 NA 0 0 0 NA Com.. Farmworker Day 0 Risk NA 1.4 x 10 7 2.2 x 10 7 5.0 x 10 7 NA Com.. Farmworker Days < 1x10 6 NA 0 0 0 NA 7.3 Occupational Risk Characterization Characterization of the occupational risks is included below for both handlers and for postapplication exposures.

Handlers: The occupational handler assessment for carbaryl is complex in that three different types of noncancer risk calculations were required based on the recently selected endpoints. The durations of exposure that were considered for noncancer toxicity were short term ( 30 days), intermediate term (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 application days per year) and for those who may more actively use carbaryl such as a commercial applicator (i. e., 30 application days per year). Cancer calculations were completed as well for every scenario that has been identified for both private growers and commercial applicators. For all of the different types of endpoints selected (except chronic where a limited number of calculations were completed), the Agency identified exposures that fit into 28 different scenarios which are defined based on the equipment used to make applications or the type of formulation used. Within each of these categories, different application rates and acres treated values were considered to evaluate the broad range of applications that may occur with each kind of equipment (e. g., a groundboom may be used for turf or agriculture). All totaled, 128 different crop/ rate/ acres combinations were considered within the 28 scenarios for the short and intermediate term toxicity categories plus 4 chronic crop/ rate/ acre combinations. The overall result is that 4 sets of 128 calculations each (516 total calculations) were completed for occupational carbaryl handlers. Finally, it should be noted that each calculation was completed at different levels of personal protection to allow for a more informed risk management decision. Even given the scope of the calculations that have already been completed, it is likely that there are some uses of carbaryl that have not been quantitatively addressed in this document either through lack of exposure data or other information and because carbaryl is such a widely used chemical. These scenarios will be addressed by the Agency when they are identified as carbaryl progresses through the reregistration process. Readers are also encouraged to evaluate novel scenarios by considering the range of estimates already completed as it is likely that many uses could be quantitatively assessed by reviewing those calculations as a wide array of chemical use combinations and equipment types have already been considered. 103 The data that were used in the carbaryl occupational handler risk assessment represent the best data and approaches that are currently available. While some of the data which have been used may not be of optimal quality, they represent the best available data for the scenario in question. In many cases, the Pesticide Handlers Exposure Database (PHED) was used to develop the unit exposure values. The quality of the data included in PHED vary widely from scenarios that meet guideline requirements for studies to others where a limited number of poor quality datapoints are available. The results for each scenario should be reviewed in the context of the quality of these data. In addition to PHED, the Agency used a number of studies to define unit exposure values. Generally, the quality of these studies is excellent. Most, except for the trigger sprayer data, are very recent and based on the newest analytical requirements and monitoring techniques. PHED unit exposure values represent a central tendency of the data (i. e., geometric mean, median or arithmetic mean depending upon the distribution of the data). As such, the values based on the recent studies also are measures of central tendency (e. g., the geometric means were selected from each study for assessment purposes in most cases). Along with the unit exposure values used in the assessment, other inputs include application rates and daily acres treated values. Selected application rates represent a range for each major market in which carbaryl is used including agriculture, turf (lawncare, golf courses, etc.), ornamentals, and for wide area applications such as mosquito control. Many application rates also represent maximum amounts that are allowed by the label for certain settings. Where available, average use rates were also used to provide for a more informed risk management decision. The application rates that were selected for use in the risk assessment were defined based on labels, information provided by the Aventis Crop Science at the September 24, 1998 SMART Meeting for carbaryl, and based on various analyses of carbaryl use patterns completed by the Agency's Biological and Economic Analysis Division. The other key input for completing handler risk assessments used for defining how much chemical can be used in a day is how much can be treated in a day which is generally expressed as the number of acres treated per day. The values that were used for this parameter represent the latest Agency thinking on this issue. In fact, the Science Advisory Council For Exposure recently updated the policy for these inputs (July 2000 Exposure SAC Policy 9: Standard Values for Daily Acres Treated in Agriculture). These most recent values have been used for the calculations.

In addition to the key sources of information considered above, there are many underlying factors that may impact the overall results of a risk assessment. For example, the protection factors used for adding additional levels of dermal and respiratory protection may impact the overall risk picture. The factors used in this assessment by the Agency are the ones that have been used for several years. Other such factors may include the fact that average application rates have been generally used to represent typical application rates to calculate ranges of risks when it is clear that the two values could differ greatly. The Agency has taken this approach because the data required to define typical application rates within each crop are generally unavailable. There are also exposure monitoring issues that should be considered. For example, in many cases the data included in PHED are based on the use of cotton gloves for hand exposure monitoring which are thought by many to overestimate exposure because they potentially retain residues more than human skin would over time (i. e., they may act like a sponge compared to the actual hand). A similar issue was noted with the carbaryl specific dog grooming study that used the handwash approach to monitor exposure after shampooing several dogs. These intangible elements of the risk assessment reflect many of the hidden uncertainties associated with exposure data. The overall impacts of these uncertainties is hard to quantify. The factor to again consider is that the Agency used the best available data to complete the risk assessment for carbaryl.

In summary, the Agency believes that the risk values presented in this occupational assessment 104 represent the highest quality results that could be produced given the exposure, use, and toxicology data that are available. Certainly risk managers and other interested parties should consider the quality of individual inputs when interpreting the results and make decisions accordingly. It is difficult to ascertain where on a distribution the values which have been calculated fall because the distributional data for exposure, application rates, acres treated and many other parameters are unrefined. The Agency does believe, however, that the risks represent conservative estimates of exposure because maximum application rates are coupled with large acreage estimates to define risk estimates that likely fall in the upper percentiles of the actual exposure distributions. Additionally, risk estimates are thought to be conservative even when measures of central tendency are combined because values that would be considered to be in the lower percentile aspect of any input parameter have not been used in the calculations.

Postapplication: Like the occupational handler risk assessment discussed above, the postapplication worker risk assessment for carbaryl is also complex in that three different types of noncancer risk calculations were required based on the recently selected endpoints along with cancer risk calculations using a linear, low dose extrapolation model. For all of the different types of endpoints selected (except chronic where a limited number of calculations were completed), the Agency identified exposures that fit into 18 different crop groups which are defined essentially based on the nature of the crop where a work activity would take place. Within each of these crop groups, ranges of transfer coefficients were considered to reflect differences in exposures that would be associated with the variety of cultural practices that are required to produce the crop/ product. All totaled, 54 different cultural practices were considered within the 18 crop groups for each toxicity category. The overall result is that 4 sets of 54 calculations each (216 plus a few chronic values) were completed for postapplication workers. Finally, it should be noted that each calculation was completed at different days after application to reflect residue dissipation over time in the environment and to allow for a more informed risk management decision. Even given the scope of the calculations that have already been completed, it is likely that there are some uses of carbaryl that have not been quantitatively addressed in this document either through lack of exposure data or other information and because carbaryl is such a widely used chemical. These scenarios will be addressed by the Agency when they are identified as carbaryl progresses through the reregistration process. Readers are also encouraged to evaluate novel scenarios by considering the range of estimates already completed as it is likely that many uses could be quantitatively assessed by reviewing existing calculations as a wide array of crop/ activity combinations have already been considered.

The data that were used in the carbaryl postapplication worker risk assessment represent the best data and approaches that are currently available. The latest Agency transfer coefficient values have been used to complete this assessment including the recently submitted ARTF studies on greenhouse workers. Most of the values in the current Agency policy are based on the work of the Agricultural Reentry Task Force (ARTF) of which, Aventis Crop Science is a member. The current Agency policy is interim in nature but represents all of the data that have been submitted by the ARTF and evaluated by the Agency. The work of the ARTF is still ongoing so additional data may become available to refine the exposure estimates as more data are submitted to the Agency. Also, it is possible that there are exposure scenarios that have not been addressed by the Agency because the transfer coefficient model is not appropriate as there is little or no foliar contact associated with the activity. There are also potentially, partially mechanized activities that could lead to exposure where the Agency has no information. These will need to be carefully considered in the reregistration process. In addition to the exposure inputs for specific activities (i. e., transfer coefficients), the Agency used 4 carbaryl specific 105 DFR (Dislodgeable Foliar Residue) dissipation studies and a single TTR (Turf Transferable Residue) study to calculate risks for all postapplication workers in every region in the country. It is standard practice for the Agency to use these kinds of studies in this manner but it is likely that additional cropand region specific data could be used to further refine the risk assessment. Several other key pieces of data and information were considered in the development of the postapplication risk values including use and usage information and exposure frequency in the cancer risk assessment. For many agricultural crops, the maximum application rate is low (e. g., 1.5 to 2 lb ai/ acre) in many crops. As a result, postapplication risks were generally calculated at maximum rate levels because of the already inherent complexity of the assessment and because it is likely that results may not be extremely sensitive to changes in this value.

In addition to the key sources of information considered above, there are many underlying factors that may impact the overall results of a risk assessment. For example, subtle differences between activities in similar crops within each of the 18 agronomic groups considered in the assessment may not be accurately reflected in the current transfer coefficient values. The use of 4 DFR studies to represent all crops and all regions within the country could lead to results that do not reflect actual use practices and conditions in some parts of the country. Additionally, the exposure frequency values that were used for private growers and professional farmworkers tend to be supported by available data but could be refined if data on work patterns and regional carbaryl use becomes available. As with the handler assessment above, the intangible elements reflect many of the hidden uncertainties associated with exposure data. The overall impacts of these uncertainties is hard to quantify. The factor to again consider is that the Agency used the best available data to complete the risk assessment for carbaryl.

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

8.0 HUMAN AND DOMESTIC ANIMAL INCIDENT DATA REVIEW Data on incidents of adverse reactions in humans exposed to carbaryl were evaluated from several sources, including OPP's Incident Data System, Poison Control Centers, California Department of Pesticide Regulation, National Pesticide Telecommunications Network and the open literature. The data from the Incident Data System indicated that a majority of cases from carbaryl exposure involved dermal reactions. A number of cases involved asthmatics and people who experienced hives and other 106 allergic type reactions. According to California data, about half of the cases involved skin and eye effects in handlers. About a quarter of the skin reactions were due to workers that were exposed to residues on crops. Reports from the literature are very limited but tend to support the finding that carbaryl has irritant properties.

The Poison Control Center cases involving non occupational adults and older children showed an increased risk in five of the six measures reported. These cases were almost twice as likely to require serious health care (hospitalization or treatment in a critical care unit) and were two and a half times more likely to experience major medical outcome (life threatening effects or significant residual disability) as compared to other pesticides. This pattern of increased risk was not seen among occupational reports or in young children. This may mean careless handling by non professionals is a particular hazard.

Five case reports suggested that carbaryl may be a cause of chronic neurological or psychological problems. Some of these effects appear to be consistent with those reported from organophosphate poisoning. However, unlike organophosphates, no controlled studies have been undertaken. If such effects occur as a result of over exposure to carbaryl, they appear to be relatively rare. The effects reported among the five case reports are too inconsistent to draw any conclusions, but do suggest the need for further study.

Carbaryl appears capable of causing dermal and allergic type reactions. Data support the need for personal protective equipment and eye protection for handlers for field workers who may have extensive exposure to carbaryl. Labels for products should advise that carbaryl can cause sensitizing effects in some people.

Based on an evaluation of limited incident data on domestic animals in IDS, it is recommended that all labels for carbaryl products used on cats contain the age restriction stated in PR Notice 96 6 (should not be used in kittens less than 12 weeks of age).

A detailed discussion of the incident data is presented in Appendix 2.

9.0 DATA NEEDS Toxicology data gaps ° 90 day inhalation study in rats with cholinesterase measurements Product chemistry data gaps ° A review of the labels and supporting residue data indicate that several label amendments are required. Details are provided in the Product and Residue Chemistry Chapters (DP Barcode: D240989) dated November 14, 2000.

° The requirement for acceptable enforcement methods which determine residues of concern in plant and livestock commodities remains outstanding.

° The requirements for storage stability data are not satisfied for purposes of reregistration. 107 Additional data are required depicting the storage stability of carbaryl per se in an oilseed, processed commodities of an oily crop, and a dried fruit stored for up to 10 months. In addition, the registrant is relying on earlier magnitude of the residue studies that are not supported by the existing storage stability data; therefore, additional storage stability data are required. The required data must reflect storage intervals of 18 months for alfalfa commodities, 15 months for potatoes, 17 months for cottonseed, 22 months for wheat commodities, and 33 months for rangeland grass. In addition, if the registrant wishes to rely on the previously submitted sugar beet processing study, information pertaining to sample conditions and intervals for the study must be submitted.

° For the purpose of reregistration, the requirements for storage stability data for carbaryl residues in livestock commodities are partially satisfied. Additional information on the storage intervals prior to analysis for metabolite residues in the cattle feeding study is required.

° Separate tolerances on many commodities need to be reassigned concomitant with establishing tolerances for the appropriate crop group and subgroup. The recommended changes are summarized in Table C under "Tolerances Needed Under 40 CFR §180.169( a), crop group/ subgroup tolerances" of the Product and Residue Chemistry Chapters.

° The data submitted are not adequate to support the use of granular (G) formulations of carbaryl on leafy vegetables. Residues of carbaryl found in leaf lettuce were not consistent. Both samples of lettuce from the 10% G treatment had substantially higher residues (37.01 and 47.22 ppm) than one of the samples treated with the FlC (23.25 ppm). Additionally, all residues were significantly above the current tolerance of 10 ppm and all residue data submitted in support of the tolerance in lettuce (< 8.85 ppm). No explanation for the higher residues was given by the registrant. The registrant may elect to repeat the side by side trial on leaf lettuce again or submit a rationale for the results of the leaf lettuce study.

° Data are required depicting residues of carbaryl in/ on grass forage harvested immediately (0 day) following the last of two applications of carbaryl (WP or FlC) at 1.5 lb ai/ A to pasture. A total of 12 field trials are required in areas throughout the U. S.

° Adequate data are available to reassess the tolerances for residues of carbaryl in/ on dried beans, cowpeas, lentils and peas with pods. These data support the establishment of crop subgroup tolerances for edible podded legume vegetables (6A), and for dried, shelled pea and bean except soybean (6C). However, additional residue data are required if the registrant seeks tolerances for residues in/ on succulent, shelled pea and bean commodities. A total of 12 tests, six tests each on a succulent, shelled cultivar of bean and garden pea, are required to support a tolerance for residues in/ on the succulent, shelled pea and bean crop subgroup (6B). The registrant is referred to OPPTS GLN 860.1500 for the number and distribution of tests required. 108 ° Adequate data are available to reassess the tolerance for wheat forage and straw. However, the Agency now considers wheat hay a significant RAC for feed purposes (OPPTS GLN 860.1000 Table 1.). A full set of 20 field trials as specified in OPPTS GLN 860.1500 are required depicting carbaryl residues in/ on wheat hay. When all the field trials are complete, PHIs and tolerances for hay based on the field trial data should be proposed. Data on wheat hay will be translatable to proso millet hay.

° Adequate residue data are available on olives provided that use directions for olives are amended to remove the statement allowing the use of summer oil as an adjuvant. Alternatively, two additional field trials are required supporting the use of a carbaryl summer oil tank mix.

° The registrant intends to support a tolerance for residues of carbaryl in/ on imported pineapples (Aventis Crop Science personal communication with C. Olinger, 9/ 24/ 98 SMART meeting). Residue data are required depicting residues in/ on pineapples following application of carbaryl at the maximum use rate and minimum PHI. Five trials must be submitted, three from Costa Rica and two from Mexico.

° Additional data are required depicting carbaryl residues in/ on cotton gin byproducts derived from cotton treated at the maximum labeled rate and harvested 28 days after the final application using commercial equipment (stripper and mechanical picker). At least three field trials representing each type of harvesting (stripper and picker) are required.

° The registrant does not intend to support carbaryl uses on avocados, barley, maple sap, oats, rye, and sweet sorghum; however, IR 4 has indicated (Correspondence from K. Dorschner, IR 4 Project, 9/ 15/ 94) that they may fulfill the residue data requirements for some of these commodities. These data have not been submitted.

° The reregistration requirements for magnitude of the residue in livestock commodities are not fulfilled. Additional data are required to support dermal and poultry house uses.

Occupational/ Residential Exposure Data Gaps Residential Exposure ° For the postapplication risk assessments, there are no data on the amount of residues transferrable from treated pets to humans. Additional residue data on turf would help refine the hand to mouth and object to mouth toddler exposures.

Occupational Exposure ° For the occupational handler risk assessments, several exposure data gaps were identified, including: 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. 109 ° For occupational postapplication risk assessments, several data gaps exist, such as an incomplete dislodgeable foliar residue database and a lack of exposure data on partially mechanized cultural practices where there is a potential for exposure.

° There are also many kinds of mechanized activities that do not involve foliar contact that have not been addressed in this risk assessment. The scenarios include: transplanting many crops including in the ornamental and forestry industry; thinning some crops such as hops; some partially mechanized operations that also involve human contact (e. g., cotton harvesting where module builders and trampers are used); hand weeding some crops such as wheat; various operations with Christmas trees such as pruning or baling; and various operations with nut production such as sweeping for harvest. APPENDIX 1: Toxicology Profile Appendix 1/ Table 1: Toxicology Profile of Carbaryl Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.3100 90 Day oral toxicity rodents N/ A 870.3150 90 Day oral toxicity in nonrodents N/ A 870.3200 21/ 28 Day dermal toxicity with technical carbaryl 45630601( 2002) acceptable/ nonguideline 0, 20, 50, 100 mg/ kg/ day systemic NOAEL = 20 mg/ kg/ day systemic LOAEL = 50 mg/ kg/ day based on decreased RBC cholinesterase in males and females and brain cholinesterase in males dermal NOAEL = 100 mg/ kg/ day dermal LOAEL not established 870.3200 21/ 28 Day dermal toxicity with Sevin® XLR Plus (44.82% a. i.) 45630602 (2002) unacceptable/ nonguideline 0, 20, 50, 100 mcL/ kg/ day (0, 9.6, 24, 48 mg/ kg/ day) systemic NOAEL = 50 mcL/ kg/ day (24 mg/ kg/ day) systemic LOAEL = 100 mcL/ kg/ day (48 mg/ kg/ day) based on decreased body weight gain dermal NOAEL = 100 mcL/ kg/ day (48 mg/ kg/ day) dermal LOAEL not established 870.3200 21/ 28 Day dermal toxicity with Sevin® 80S (80.07% a. i.) 45630603 (2002) unacceptable/ nonguideline 0, 20, 50, 100 mg/ kg/ day systemic NOAEL = 20 mg/ kg/ day systemic LOAEL = 50 mg/ kg/ day based on decreased RBC cholinesterase in males and females dermal NOAEL = 100 mg/ kg/ day dermal LOAEL not established 870.3250 90 Day dermal toxicity N/ A 870.3465 90 Day inhalation toxicity N/ A 870.3700a Prenatal developmental in rats 44732901 (1998) acceptable/ guideline 0, 1, 4, 30 mg/ kg/ day (oral gavage) Maternal NOAEL = 4 mg/ kg/ day LOAEL = 30 mg/ kg/ day based on clinical signs, decreased body weight gain (BWG) and food consumption Developmental NOAEL = 4 mg/ kg/ day LOAEL = 30 mg/ kg/ day based on decreased fetal body weight and incomplete ossification of multiple bones 870.3700b Prenatal developmental in rabbits 44904202 (1999) Acceptable/ guideline 0, 5, 50, 150 mg/ kg/ day (oral gavage) Maternal NOAEL = 5 mg/ kg/ day LOAEL = 50 mg/ kg/ day based on decreased BWG and plasma cholinesterase inhibition (ChEI) Developmental NOAEL = 50 mg/ kg/ day LOAEL = 150 mg/ kg/ day based on decreased fetal weight Appendix 1/ Table 1: Toxicology Profile of Carbaryl Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.3800 Reproduction and fertility effects 45448101 (2001) acceptable/ guideline 0, 75, 300, 1500 ppm (4.67, 31.34, and 92.43 mg/ kg/ day for F0 males; 0, 5.56, 36.32, and 110.78 mg/ kg/ day for F0 females; 0, 5.79, 23.49, and 124.33 mg/ kg/ day for F1 males; and 0, 6.41, 26.91, and 135.54 mg/ kg/ day for F1 females averaged over the premating period) Parental NOAEL = 300 ppm (23.49 31.34 mg/ kg/ day for males and 26.91 36.32 mg/ kg/ day for females) Parental LOAEL = 1500 ppm (92.43 124.33 mg/ kg/ day for males and 110.78 135.54 mg/ kg/ day for females) based on decreased body weight, weight gain, and feed consumption Reproductive toxicity NOAEL is $ 1500 ppm (92.43 124.33 mg/ kg/ day for males and 110.78 135.54 mg/ kg/ day for females) Reproductive toxicity LOAEL not be established Offspring NOAEL = 75 ppm (4.67 5.79 mg/ kg/ day for males and 5.56 6.41 mg/ kg/ day for females). Offspring LOAEL = 300 ppm (23.49 31.34 mg/ kg/ day for males and 26.91 36.32 mg/ kg/ day for females) based on increased numbers of F2 pups with no milk in the stomach and decreased pup survival.

870.4100a Chronic toxicity in rodents N/ A 870.4100b Chronic toxicity in dogs 40166701 (1987) 0, 125, 400, 1250 ppm (0, 3.1, 10, 31.3 mg/ kg/ day)

42022801 (1991) 0, 20, 45, 125 ppm (5 weeks) (M: 0, 0.59, 1.43, 3.83; F: 0, 0,64, 1.54, 4.11 mg/ kg/ day) Together, the studies are Acceptable/ guideline MRID 40166701: NOAEL = not established in females LOAEL = 125 ppm based based on plasma and brain ChEI MRID 42022801: NOAEL = 45 ppm in males LOAEL = 125 ppm in males based on plasma ChEI 870.4200 Carcinogenicity in mice 42786901 (1993) Acceptable/ guideline 0, 100, 1000 or 8000 ppm (M: 0, 14.73, 145.99, 1248.93 mg/ kg/ day; F: 0, 18.11, 180.86, 1440.62) systemic LOAEL = 1000 ppm based on increased intracytoplasmic droplets in bladder in males and females, chronic progressive nephropathy in males; NOAEL = 100 ppm RBC ChEI LOAEL for males = 1000 ppm , for females = 8000 ppm; NOAEL = 100 ppm for males, 1000 ppm for females plasma ChEI for males and females LOAEL > 8000 ppm; NOAEL $ 8000 ppm brain ChEI for males and females LOAEL = 8000 ppm; NOAEL = 1000 ppm increase in vascular tumors in all treated males and in females at 8000 ppm increase in adenomas, multiple adenomas, carcinomas of kidney in males at 8000 ppm increase in hepatic neoplasms (adenomas, carcinomas, one hepatoblastoma) in females at 8000 ppm Appendix 1/ Table 1: Toxicology Profile of Carbaryl Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.4300 Chronic Toxicity/ Carcinogenicity in rats 42918801 (1993) Acceptable/ guideline 0, 250, 1500 & 7500 ppm (M: 0, 10, 60.2, 349.5 mg/ kg/ day; F: 0, 12.6, 78.6, 484.6 mg/ kg/ day) systemic LOAEL = 1500 ppm in females based on decreased BW and BWG; 7500 ppm in males based on increased clinical signs, decreased BW, BWG and food consumption, increase in cataracts, clinical pathology changes, organ weight changes, nonneoplastic changes; NOAEL = 250 ppm in females and 1500 ppm in males plasma ChEI LOAEL = 7500 ppm in males and females; NOAEL = 1500 ppm RBC ChEI LOAEL = 1500 ppm in males and females; NOEL = 250 ppm brain ChEI LOAEL = 7500 ppm in males and females; NOEL = 1500 ppm at 7500 ppm, increase in liver adenomas in females, increase in benign transitional cell papillomas and transitional cell carcinomas in males and females, transitional cell carcinoma in kidney of one male, increase in benign thyroid follicular cell adenomas in males, follicular cell carcinoma in one male Bacterial reverse mutation test 870.5100 41370303 (1989) Acceptable/ guideline 5 1000 ug/ plate No evidence of mutagenicity in strains TA1535, TA 1537, TA1538, TA98 and TA100 with and without metabolic activation In vitro mammalian chromosome aberration test (Chinese hamster ovary cells) 870.5385 41370304 (1989) Acceptable/ guideline without S9 activation: 5 100 ug/ mL, harvest at 20 hrs.; with S9 activation: 25 300 ug/ mL, harvest at 30 hrs Increase in chromosome aberrations with S9 activation In vitro mammalian chromosome aberration test 870.5385 41370302; 41420201 (1989) Unacceptable/ guideline S9 activation: 1 300 ug/ mL in 3 trials; without S9 activation: 1 300 ug/ mL in 2 trials Results provide no clear indication of a mutagenic response, however study had several deficiencies Mammalian erythrocyte micronucleus test 870. 5395 44069301 (1996) Unacceptable/ guideline single oral gavage dose of 50, 100, 200 mg/ kg Carbaryl did not induce a clastogenic or aneugenic effect, however there was no convincing evidence that MTD was achieved Unscheduled DNA synthesis 870.5550 41370301; 41810601 (1989) Acceptable/ guideline 0.5  25.0 ug/ mL Negative 870.6200a Acute neurotoxicity screening battery in rats MRID: 43845201 43845204 (1995) Acceptable/ guideline 0, 10, 50, 125 mg/ kg (oral gavage) Separate study for ChEI: 0, 10, 30, 50 mg/ kg; ChEI done 1, 8, 24, 48 hrs postdosing Systemic LOAEL = 10 mg/ kg based on decreased RBC, plasma, blood, brain ChEI; NOAEL < 10 mg/ kg Appendix 1/ Table 1: Toxicology Profile of Carbaryl Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.6200b Subchronic neurotoxicity screening battery in rats MRID: 44122601 (1996) Acceptable/ guideline 0, 1, 10, 30 mg/ kg/ day (oral gavage) LOAEL for neurotoxicity = 10 mg/ kg/ day based on increased FOB changes; NOAEL = 1 mg/ kg/ day LOAEL for ChEI = 10 mg/ kg/ day based on decreased plasma, blood, RBC, brain ChEI; NOAEL = 1 mg/ kg/ day 870.6300 Developmental neurotoxicity in rats 44393701 (1997) Acceptable/ guideline 0, 0.1, 1.0, 10 mg/ kg (oral gavage) Maternal NOAEL = 1.0 mg/ kg/ day LOAEL = 10 mg/ kg/ day based on decreased BWG; FOB changes; RBC, plasma, whole blood, brain ChEI Offspring tentative NOAEL = 1.0 mg/ kg/ day tentative LOAEL = 10 mg/ kg/ day based on alterations in morphometric measurements (measurements were not done at lower doses)

870.7485 Metabolism and pharmacokinetics in rats 43332101 (1994) Acceptable/ guideline 1 mg/ kg (single and repeated oral doses; intravenous dose) and 50 mg/ kg (single oral dose) Absorption was complete at all doses. At 168 hrs., post dose, negligible percentages of dose in any tissues. Kidney and blood contained highest concentrations of radioactivity. Excretion mostly through urine. A metabolic scheme with conjugated and non conjugated metabolites was proposed.

870.7485 Metabolism and pharmacokinetics in rats 44402501 (1997) Acceptable/ nonguideline 50 mg/ kg (single oral radiolabeled dose); daily oral radiolabeled dose of 2 mg/ kg for 7 days followed by 83 daily unlabeled doses of 0, 250, 1500 or 7500 ppm; males only In all dosing regimens, urinary and fecal excretion was 93 103% of administered dose and tissue levels of radioactivity were minimal at 168 hrs. post dosing. Two major metabolites in tissues at 6 hrs. post dosing were naphthyl sulfate and naphthyl glucuronide, however quantitation was not possible. A total of 23 and 20 components were identified in the urine and feces, respectively. The sulfate conjugation pathway appears to be saturable following a 83 day feeding at 7500 ppm. BW and food consumption were decreased at 7500 ppm. Increases in kidney, spleen and thyroid weights were observed at 1500 and 7500 ppm. Non neoplastic changes in liver, thyroids and kidneys were observed at 7500 ppm.

870.7600 Dermal penetration in rats 43552901 (1995) 43.9% a. i. Acceptable 35.6, 403, 3450 ug/ cm 2 % absorbed at 10 hrs.: 12.7, 7.44 and 1.93 at 35.6, 403 and 3450 ug/ cm 2 , respectively 870.7600 Dermal penetration in rats 43339701 (1994) 80.1% a. i. Acceptable 63, 626, 3410 ug/ cm 2 % absorbed at 10 hrs: 8.90, 0.62 and 0.48 at 63, 626 and 3410 ug/ cm 2 , respectively Special studies in mice 43282201 (1994) Acceptable/ nonguideline male mice: single radiolabeled dose of 75 mg/ kg; pretreatment with 8000 ppm unlabeled carbaryl for 2 wks., then single radiolabeled dose of 75 mg/ kg Negative for DNA binding in liver Appendix 1/ Table 1: Toxicology Profile of Carbaryl Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results Special studies in mice 43832601 (1994) Acceptable/ nonguideline continuation of MRID 43282201 in liver from mice treated at 8000 ppm, increase in microsomal protein, cytochrome P450, ethoxyresorufin O deethylase, pentoxyresorufin O depentylase, and testosterone hydrolases indicates phenobarbital type of induction of metabolizing enzymes Special study in mice 45281801, 45281802, 45236603 (1998 1999) Acceptable/ nonguideline 0, 10, 30, 100, 300, 1000 and 4000 ppm (0, 1.8, 5.2, 17.5, 51.2, 164.5 and 716.6 mg/ kg/ day) There was no evidence of neoplastic or preneoplastic changes in vascular tissue in heterozygous p53 deficient male mice treated with carbaryl for six months.

N/ A Not Available APPENDIX 2: Incident Review Conclusions/ Recommendations Based on Incident Review Data on incidents of adverse reactions in humans exposed to carbaryl were evaluated from several sources, including OPP's Incident Data System, Poison Control Centers, California Department of Pesticide Regulation, National Pesticide Telecommunications Network and the open literature. The data from the Incident Data System indicated that a majority of cases from carbaryl exposure involved dermal reactions. A number of cases involved asthmatics and people who experienced hives and other allergic type reactions. According to California data, about half of the cases involved skin and eye effects in handlers. About a quarter of the skin reactions were due to workers that were exposed to residues on crops. Reports from the literature are very limited but tend to support the finding that carbaryl has irritant properties.

The Poison Control Center cases involving non occupational adults and older children showed an increased risk in five of the six measures reported. These cases were almost twice as likely to require serious health care (hospitalization or treatment in a critical care unit) and were two and a half times more likely to experience major medical outcome lifethreatening effects or significant residual disability) as compared to other pesticides. This pattern of increased risk was not seen among occupational reports or in young children. This may mean careless handling by non professionals is a particular hazard.

Five case reports suggested that carbaryl may be a cause of chronic neurological or psychological problems. Some of these effects appear to be consistent with those reported from organophosphate poisoning. However, unlike organophosphates, no controlled studies have been undertaken. If such effects occur as a result of over exposure to carbaryl, they appear to be relatively rare. The effects reported among the five case reports are too inconsistent to draw any conclusions, but do suggest the need for further study.

Carbaryl appears capable of causing dermal and allergic type reactions. Data support the need for personal protective equipment and eye protection for handlers for field workers who may have extensive exposure to carbaryl. Labels for products should advise that carbaryl can cause sensitizing effects in some people.

Based on an evaluation of limited incident data on domestic animals in IDS, it is recommended that all labels for carbaryl products used on cats contain the age restriction stated in PR Notice 96 6 (should not be used in kittens less than 12 weeks of age).

A detailed discussion of the incident data is presented below.

Human Incident Data Review A review of the human incident data on carbaryl was prepared by Dr. Jerome Blondell and Ms. Monica Spann (D267127 dated July 17, 2000).

The following data bases were consulted for the poisoning incident data on the active ingredient Carbaryl (PC Code: 056801): 1) OPP Incident Data System (IDS)  reports of incidents from various sources, including registrants, other federal and state health and environmental agencies and individual consumers, submitted to OPP since 1992.

2) Poison Control Centers  as the result of a data purchase by EPA, OPP received Poison Control Center data covering the years 1993 through 1998 for all pesticides. Most of the national Poison Control Centers (PCCs) participate in a national data collection system, the Toxic Exposure Surveillance System which obtains data from about 65 70 centers at hospitals and universities.

3) California Department of Pesticide Regulation  California has collected uniform data on suspected pesticide poisonings since 1982. Physicians are required, by statute, to report to their local health officer all occurrences of illness suspected of being related to exposure to pesticides.

4) National Pesticide Telecommunications Network (NPTN)  NPTN is a toll free information service supported by OPP. A ranking of the top 200 active ingredients for which telephone calls were received during calendar years 1984 1991 and 1995 1999 has been prepared for the categories human incidents, animal incidents, calls for information, and others.

Incident Data System There were approximately 500 reports in IDS concerning exposure of humans to carbaryl. At least 380 cases were considered minor (minimal symptoms with no residual disability) and were not included in the review. The most frequently reported symptoms were of a dermatological nature, either dermal irritation or possibly a dermal manifestation of an allergic response (e. g., hives, welts, rash, etc.). Clinical signs or symptoms less frequently reported were nausea, vomiting, diarrhea, respiratory irritation and difficulty breathing. Most of the incidents were associated with dermal exposure; however, a few resulted after inhalation of the product. There was one report of an attempted suicide. In 1993, a 21 year old man ingested about 75 ml of Beetle Bait (21.3% carbaryl, Registration Number 869 134). No information on the symptoms or outcome of the case were provided. There was also one death. In 1996, a woman with a history of chronic asthma experienced shock and severe respiratory distress after she used Mycodex Pet Shampoo (0.5% carbaryl, Registration Number 2097 8) on her dog. She was hospitalized but went into a coma and died five days later (IDS 3694 1).

Poison Control Center (PCC) Data  1993 through 1998 The PCC data base for 1993 through 1998 contained 174 cases involving occupational exposures in adults and older children (outcome determined in 90 cases), 3033 nonoccupational exposures in adults and older children (outcome determined in 1351 cases) and 2147 exposures in children under the age of six (outcome determined in 1248 cases). Cases involving exposures to multiple products were excluded. The data from cases in which the outcome was determined were compared to all other pesticides using six measures: percent with symptoms, percent with moderate or more severe outcome, percent with life threatening or fatal outcome, percent of exposed cases seen in a health care facility, percent hospitalized and percent seen in an intensive care facility.

For occupational cases, carbaryl appears to be somewhat less hazardous than all pesticides combined, as determined by five of the six measures reported. Cases involving non occupational adults and older children showed an increased risk in five of the six measures reported. In particular these non occupational cases were nearly twice as likely to require serious health care (hospitalization or treatment in a critical care unit) and were 2.5 times more likely to experience major medical outcome (life threatening effects or significant residual disability). These data suggest that some consumers are using this chemical in a careless manner. For cases involving children under six years of age, carbaryl has a similar hazard profile to all other pesticides.

California Data  1982 through 1996 Detailed descriptions of 226 cases submitted to the California Pesticide Illness Surveillance Program (1982 1996) were reviewed. In 90 of these cases, carbaryl was used alone or was judged to be responsible for the health effects. Only cases with a definite, probable or possible relationship were reviewed. Carbaryl ranked 37 th as a cause of systemic poisoning in California. The number of reports from California declined by over half from the first five years of the reporting period (1982 1986) to the last five years (1992 1996). It is difficult to determine whether some of this decline might be related to a decrease in usage because the method of collecting use information changed after 1989. Of the 90 persons reported to have illnesses, a total of 43 (48%) had systemic illnesses, 20 (22%) had eye irritation, 21 (23%) had skin irritation, 1( 1%) had respiratory illness and 5 (6%) had a combination of effects. A total of 26 workers were disabled (took time off work, 1 for more than 10 days) as the result of carbaryl exposure. Seven required hospitalization (1 5 days). Applicators were associated with the majority of the exposures. Clinical signs/ symptoms in these workers included nausea, vomiting, skin rashes, sore throat, lip swelling, chemical conjunctivitis, dizziness, eye irritation, contact dermatitis, blurry vision, chest pains, and several other symptoms.

National Pesticide Telecommunications Network On the list of the top 200 chemicals for which NPTN received calls from 1984 1991 inclusively, carbaryl was ranked 5 th with 503 incidents in humans reported and 85 incidents in animals (mostly pets). For the years 1995 through 1998, carbaryl's rank ranged from 7 th to 12 th with 110 incidents in humans reported and 26 incidents in animals. Most of the decline in reported human cases from the earlier time period is due to the reduced level of incident reporting overall. However, even taking this into account, there does appear to be some reduction in carbaryl incidents which is also reflected in the lower rankings reported for the later years (1995 1998).

Literature Summary Thirteen epidemiological studies/ case reports from the open literature were reviewed. Five case reports suggested that carbaryl may cause long term neurological or 12 Branch RA, Jacqz E (1986). Is carbaryl as safe as its reputation? Does it have a potential for causing chronic neurotoxicity in humans?. The American Journal of Medicine 80( 4): 659 664.

13 Brewer B (2000). A rare cause of acute confusional state (Letter to the Editor). Journal of Accidental Emergency Medicine 17( 1): 77.

14 Devinsky O, Kernan J, Bear DM (1992). Aggressive behavior following exposure to cholinesterase inhibitors. Journal of Neuropsychiatry 4( 2): 189 194.

15 Dickoff DJ, Gerber O, Turovsky Z (1987). Delayed neurotoxicity after ingestion of carbamate pesticide. Neurology 37( 7): 1229 1231.

16 Wiener PK, Young RC (1995). Late onset psychotic depression associated with carbaryl exposure. American Journal of Psychiatry152( 4): 646 647.

17 Savitz DA, Arbuckle T, Kaczor D, Curtis KM. (1997). Male pesticide exposure and pregnancy outcome. American Journal of Epidemiology 146( 12): 1025 1036.

18 Whorton DM, Avashia BH, Hull EQ. (1979). Testicular function among carbaryl exposed employees. Journal of Toxicology and Environmental Health 5: 929 941.

19 Wyrobek AJ, Watchmaker G, Gordon L, Wong K, Moore D 2d, Whorton D (1981). Sperm shape abnormalities in carbaryl exposed employees. Environmental Health Perspectives 40: 255 265. psychologicalproblems. 12,13,14,15,16 Two of these cases involved attempted suicides in which large doses of carbaryl containing products were ingested. Some of the effects from carbaryl exposure are consistent with those reported from organophosphate poisoning. However, no controlled studies have been conducted. If such effects occur as a result of carbaryl overexposure they appear to be relatively rare. The effects observed in the case reports are too inconsistent to draw any conclusions, but do suggest the need for further study.

Other literature articles concerned epidemiology studies to evaluate the effects of pesticides on reproduction. In the 1979 Ontario Farm Family Study by Savitz et al 17 , the effects of activities and specific pesticides on male farmer's fertility were considered. The results suggested that thiocarbamates, carbaryl and other pesticides were most strongly associated with miscarriage. The adjusted odds ratio for carbaryl used on crops was 2.1 with a 95 percent confidence interval of 1.1 to 4.1 (borderline significance). Use of carbaryl in the yard was not associated with a significantly increased risk of miscarriage and carbaryl was not a significant risk factor for preterm delivery or small for gestational age births. In a 1979 study of male workers who produced and packaged carbaryl, Whorton et al 18 concluded that there was no evidence of sperm count suppression resulting from exposure to the chemical. Whorton et al. (1979) and Wyrobek et al 19 (1981) used the same cohort in their studies to determine the effects on fertility by checking for infertile marriages and by measuring sperm counts and serum gonadotropins. The carbaryl exposed group included nearly three times as many oligospermic men as the control group. Wyrobek et al. (1981) concluded there was a non dose related, significant elevation in sperm head abnormalities compared to controls, that may not be reversible. Both of the studies had low participation rates, relied on self reporting of exposure levels, and used less than ideal control groups. 20 Senthilselvan A, McDuffie HH, Dosman JA. 1992. Association of asthma with use of pesticides. Results of a cross sectional survey of farmers. Am Rev Respir Dis 146( 4): 884 887.

21 Sharma VK, Kaur S. 1990. Contact sensitization by pesticides in farmers. Contact Dermatitis 23: 77 80. There were also two studies assessing carbaryl's potential to induce an allergic reaction. Senthilselvan et al. (1992) 20 reported on the association between self reported asthma and pesticide use in 1,939 farmers. The prevalence of asthma was significantly associated with the use of carbamate insecticides regardless of age, smoking pack years, and nasal allergic reactions. The authors concluded that the possibility of exposure to agriculture chemicals could be related to lung dysfunction in exposed farmers.

Sharma and Kaur (1990) 21 reported on 30 farmers that had contact dermatitis after using pesticides for several years. The farmers included 25 males and 5 females, between the ages of 28 and 70 years old. Patch testing was conducted on the upper back and readings were taken on the second, third, and seventh day. Allergic reactions to one or more pesticides were seen in 11 patients. One patient was sensitive to carbaryl and two patients to 3 each (2,4 D, thiram, carbaryl; pendimethalin, methyl parathion and carbofuran). Carbamates, including carbaryl, were the most frequent sensitizers. Allergic reactions did not occur in the twenty controls included in the study.

Unpublished Epidemiology Study Rhone Poulenc submitted an epidemiologic study of plant workers exposed to carbaryl titled "Standardized Mortality Ratio Analysis of Employees Exposed to Carbaryl at the RhonePoulenc Institute, West Virginia Plant", which was reviewed by Dr. Jerome Blondell (DP Barcode D194815). The results were part of a ten year vital status update undertaken by the National Institute of Occupational Safety and Health. The study included all individuals who were first hired between 1960 (when the production of carbaryl started) and through 1978. The vital status of all workers was determined through 1988 using the National Death Index.

A total of 522 employees were identified as belonging to either the production, packing/ distribution, or maintenance facilities. Follow up through 1988 showed 25 deaths, including nine due to cancer. Significantly less deaths (50%) were seen compared to the number expected. No category of death resulted in a statistically significant excess. Those categories that exhibited an excess (greater than the number of expected cases) were usually based on a single reported death with very wide confidence intervals. For brain cancer, there were two deaths (0.5 expected), but they had different histologic origin which reduces the likelihood that they were due to the same exposure. HED concluded that the epidemiologic study does not add significant new information concerning adverse health effects of carbaryl. The sample of workers was too small and the period of follow up to too short to permit definitive conclusions. Domestic Animal Incident Review The domestic animal incident review was prepared by Dr. Virginia Dobozy (D266621 dated June 12, 2000). There are approximately 69 active products containing carbaryl with use sites for dogs and cats in OPP's Reference File System (REFS). The majority of the products are 5 10% lawn and garden dusts, which may be registered for use on animal bedding and thus are included in the REFS search. Most of the powders for intentional application to dogs and cats for flea and tick control also contain 5 10% carbaryl, some in combination with pyrethrins and synergists. However, two products contain 12.5% carbaryl in combination with pyrethrins. Three products contain carbaryl (10 12.5%) in combination with 0.25% methoxylchlor. There is one shampoo which contains 0.5% carbaryl, two flea collars with either 9.5% (cats) or 17% (dogs) carbaryl and a dip for dogs with 60% carbaryl. In general, the use of powders, dips and sprays for flea and tick control in dogs and cats has been replaced within the last five years with oral (FDA regulated) or spot on formulations. As there are no spot on carbaryl preparations, it can be assumed that the use of this chemical for flea and tick control has declined.

There are 213 reports in IDS for carbaryl for domestic animals from 1991 to May, 2000. Only those incidents from 1998 (most recent year with complete data) were reviewed in order to provide an evaluation of current adverse reports in domestic animals. In 1998, there were 35 incidents in IDS involving 23 dogs, 9 cats and 1 pig. One incident involved two dogs and in three incidents, the species was not identified. Only two incidents involved products registered for use on dogs and cats. In one, an 8 week old kitten treated with Zodiac Flea and Tick Powder for Dogs developed vomiting and anorexia and died the next day. In the other, a dog was reported to have had a reaction to a shampoo with carbaryl; no other data were provided. The majority of the remaining incidents involved products containing a 5% carbaryl dust or a molluscicide which contains 2% metaldehyde and 5% carbaryl. A wide variety of clinical signs were reported. Most of the incidents were evaluated and classified as to causality (doubtful, low, moderate or high suspicion) by the ASPCA/ National Animal Poison Control Center. All were classified as doubtful or low suspicion. A summary review of incidents for a 5% carbaryl powder from one registrant, along with the one report from 1998, provided some evidence that young kittens (< 12 weeks) may be susceptible to adverse reactions to carbaryl. It is recommended that all labels for carbaryl products used on cats contain the age restriction stated in PR Notice 96 6 (should not be used in kittens less than 12 weeks of age).


[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Notices]
[Pages 47432-47433]
[FR Doc No: 2013-18764]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
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    Notice is hereby given that pursuant to the Paperwork Reduction Act
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     Dated: July 30, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-18764 Filed 8-2-13; 8:45 am]
BILLING CODE 8011-01-P