For metaldehyde uses, the Agency identified several major occupational exposure scenarios based on the types of equipment and techniques that potentially can be used for metaldehyde applications. The scenarios associated with metaldehyde use were classified as having short term and intermediate term exposures ( up to 30 days and 30 days to several months, respectively). The quantitative exposure/ risk assessment developed for occupational handlers was based on the following scenarios:

Mixing/ Loading ( 1a) Mixing/ loading liquid concentrates for chemigation applications ( PHED data); ( 1b) Mixing/ loading liquid concentrates for groundboom applications ( PHED data); ( 1c) Mixing/ loading liquid concentrates for airblast applications ( PHED data); ( 2) Loading granulars for tractor drawn spreader applications ( PHED data);

Applicator ( 3) Applying sprays via groundboom equipment ( PHED data); ( 4) Applying sprays via airblast equipment ( PHED data); ( 5) Applying granulars via tractor drawn spreader ( PHED data);

Mixer/ Loader/ Applicator Page 55 of 80 ( 6) Mixing/ loading/ applying liquid concentrates with low pressure handwand ( ORETF data for ground directed applications*); ( 7) Mixing/ loading/ applying liquid concentrates with a handgun sprayer ( LCO ORETF data*); ( 8) Mixing/ loading/ applying liquid concentrates with hose end sprayer ( ORETF data for applications to turfgrass*); ( 9) Mixing/ loading/ applying liquid concentrates with sprinkling can ( ORETF data for hose end applications to turfgrass as surrogate data*); ( 10) Mixing/ loading/ applying liquid concentrates with pump trigger sprayer ( ORETF pump trigger data*); ( 11) Applying granulars by hand ( PHED data); ( 12) Loading/ applying granulars via belly grinder ( PHED data); ( 13) Loading/ applying granulars via push type spreader ( ORETF data*); and ( 14) Applying ready to use liquid/ paste formulations via squeeze bottle or tube ( ORETF pump trigger data as surrogate data*).

[* Note: Lonza, the technical registrant is not a member of the ORETF and as such, the use of ORETF data may be subject to data compensation.]

For each of these scenarios, risk calculations were completed based on three levels of personal protection that were defined based on different combinations of the following:

$ Baseline: no respiratory protection;

$ PF5 respirator: quarter face cup style dust/ mist filtering respirator which is presumed to reduce respiratory exposure 80% from baseline;

$ PF10 respirator: a half or full face respirator equipped with a dust/ mist filter, which is presumed to reduce respiratory exposure at least 90% from baseline;

$ Engineering Controls: use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids.

Data and Assumptions A series of assumptions and exposure factors served as the basis for completing the occupational handler risk assessments. The inputs are consistent with current Agency policy for completing occupational exposure assessments ( e. g., PHED Surrogate Exposure Guide and Exposac Policy 9: Standard Values for Daily Acres Treated in Agriculture). [ Note: PHED is a database that contains monitored field data used for assessments. See Section <IP_ADDRESS> Residential Handler Risk Assessment above for further information.]

$ Average body weight of an adult handler is 70 kg as described in the residential handler assessments ( see Section <IP_ADDRESS>). Page 56 of 80 $ An 80 percent protection factor ( i. e., PF5) was used to represent a quarter face cup style respirator. Additionally, a 90 percent protection factor ( i. e., PF10) was used to represent a typical half/ full face cartridge air purifying respirator.

$ Proposed label maximum use rates and use information specific to residential products as specified in the use closure memo and associated attachments ( Bloom, 2005).

$ The average occupational workday is assumed to be 8 hours.

$ The daily areas to be treated were defined for each handler scenario ( in appropriate units) by determining the amount that can be reasonably treated in a single day ( e. g. acres). The factors used for the metaldehyde assessment are the same as those detailed in the HED Science Advisory Committee on Exposure Policy 9: Standard Values for Daily Acres Treated in Agriculture.

$ There were several scenarios which were identified for which no directly applicable exposure data are known to exist. These include: applying ready touse liquids/ pastes with a squeeze bottle or tube and liquid concentrates applied with a sprinkling can. As such, exposure data which closely approximate these activities were used to estimate risks from these exposure scenarios. Consequently, the estimates based on these values should be considered to have a higher degree of uncertainty associated with them.

Handler Exposure Assessment As no chemical specific handler exposure data were submitted in support of the reregistration of metaldehyde, an exposure assessment for each use scenario was developed using surrogate values calculated using the Pesticide Handlers Exposure Database ( V 1.1) or data from Outdoor Residential Exposure Task Force ( ORETF).

Occupational handler scenarios were assessed using the short and intermediate term endpoints for inhalation exposures. Dermal exposures were not assessed since no toxicological endpoint of concern was identified for the dermal route of exposure. The short term inhalation endpoint is a NOAEL of 30 mg/ kg/ day, based on a chronic oral toxicity study in dogs. The intermediate term inhalation endpoint is a NOAEL of 10 mg/ kg/ day, also based on a chronic oral toxicity study in dogs. The inhalation absorption rate was assumed to be 100 percent. The uncertainty factor ( UF) for both the inhalation endpoints is 100 ( 10X for intraspecies variability and 10X for interspecies extrapolation).

Daily inhalation dose levels ( mg/ kg/ day) were calculated and used to calculate Margins of Exposure ( MOEs) for baseline attire, personal protective equipment ( respirators), and engineering controls using the short and intermediate term toxicological endpoints for inhalation. All calculations were completed based on current EPA policies pertaining to the completion of occupational exposure/ risk assessments ( e. g., rounding and acceptable data sources).

Calculating Dose from Inhalation Exposure Page 57 of 80 Daily inhalation dose is calculated using the following formula [ Note: The same formula is applied regardless of the risk mitigation level. Only the unit exposure levels vary with different levels of risk mitigation.]:

DDaily Inhalation = [ UE x ( 1 mg/ 1000 Fg) x AR x A x ( IA/ 100)] / BW Where:

DDaily Inhalation = Daily absorbed dose ( mg/ kg/ day) resulting from inhalation exposure; UE = Unit exposure ( Fg/ lb ai handled) excerpted from PHED surrogate exposure table or ORETF data, AR = Application rate ( pounds active ingredient per acre; A = Area treated ( acres per day) based on the application equipment type; IA = Inhalation absorption factor (%); and BW = Body weight ( kg) based on the body weight of an average adult, since the endpoint is non sex specific.

The calculations of the daily inhalation dose of metaldehyde received by handlers are used to assess the inhalation risks to those handlers. Short and intermediate term MOEs, regardless of the exposure scenario, were calculated using the following formula:

MOE = NOAEL ( mg/ kg/ day) / Dose Inhalation ( mg/ kg/ day)

Non cancer Occupational Handler Risks For all short and intermediate term occupational handler scenarios, risks were not of concern even without the use of a respirator ( i. e., MOEs   100). In fact, for all scenarios, MOEs are much greater than 1000 without the use of a respirator ( e. g.   10000). [ Note: Current metaldehyde labels do not require the use of a respirator.] Table 17 summarizes the results for both short term and intermediate term occupational handlers. Page 58 of 80 Table 17  Summary of Short and Intermediate term Occupational Handler Non cancer Risks Inhalation Short term MOEs Inhalation Intermediate term MOEs Exposure Scenario Crop or Target ARa ( lb ai/ acre) Area Treated Daily ( acres) b Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf Mixer/ Loader Mixing/ Loading Liquid Concentrates for Chemigation Applications ( 1a) watercress 2.1 350 2400 12000 24000 34000 790 4000 7900 11000 Mixing/ Loading Liquids Concentrates for Groundboom Applications ( 1b) Turf ( golf course green + turf) 1 10 180000 880000 1800000 2500000 58000 290000 580000 840000 Mixing/ Loading Liquids Concentrates for Airblast Applications ( 1c) watercress 2.1 40 21000 100000 210000 300000 6900 35000 69000 100000 ornamentals 3.5 80 4400 22000 44000 220000 1500 7400 15000 74000 Loading Granulars for Tractor Drawn Spreader Applications ( 2) grass grown for seed 1.6 80 9700 48000 97000 480000 3200 16000 32000 160000 Page 59 of 80 Table 17  Summary of Short and Intermediate term Occupational Handler Non cancer Risks Inhalation Short term MOEs Inhalation Intermediate term MOEs Exposure Scenario Crop or Target ARa ( lb ai/ acre) Area Treated Daily ( acres) b Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf turf, citrus,

Brassica,

lettuce, tomato, strawberry 1 80 15000 77000 150000 770000 5100 26000 51000 260000 berries, artichoke,

prickly pear cactus 0.8 80 19000 97000 190000 970000 6400 32000 64000 320000 Applicator Applying Sprays via Groundboom Equipment ( 3) turf ( golf course green + turf) 1 10 280000 1400000 2800000 4900000 95000 470000 950000 1600000 Applying Sprays via Airblast Equipment ( 4) watercress 2.1 40 5600 28000 56000 56000 1900 9300 19000 19000 ornamentals 3.5 80 6300 31000 63000 34000 2100 10000 21000 11000 Applying Granulars via Tractor Drawn Spreader ( 5) grass grown for seed 1.6 80 14000 68000 140000 75000 4600 23000 46000 25000 Page 60 of 80 Table 17  Summary of Short and Intermediate term Occupational Handler Non cancer Risks Inhalation Short term MOEs Inhalation Intermediate term MOEs Exposure Scenario Crop or Target ARa ( lb ai/ acre) Area Treated Daily ( acres) b Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf turf, citrus,

Brassica,

lettuce, tomato, strawberry 1 80 22000 110000 220000 120000 7300 36000 73000 40000 berries, artichoke,

prickly pear cactus 0.8 80 27000 140000 270000 150000 9100 46000 91000 50000 Mixer/ Loader/ Applicator ornamentals 3.5 5 44000 220000 440000 NF 15000 74000 150000 NF Mixing/ Loading / Applying Liquid Concentrates with Low Pressure Handwand ( ORETF data for ground directed application) ( 6) turf 1 5 160000 780000 1600000 NF 52000 260000 520000 NF Mixing/ Loading / Applying Liquid Concentrates with a Handgun Sprayer ( LCO ORETF data)

( 7) ornamentals 3.5 5 80000 330000 800000 NF 27000 110000 270000 NF Page 61 of 80 Table 17  Summary of Short and Intermediate term Occupational Handler Non cancer Risks Inhalation Short term MOEs Inhalation Intermediate term MOEs Exposure Scenario Crop or Target ARa ( lb ai/ acre) Area Treated Daily ( acres) b Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf turf 1 5 280000 1200000 2800000 NF 93000 390000 930000 NF Ornamenttals 3.5 0.023 ( spot trt.) 1500000 7700000 15000000 NF 510000 2600000 5100000 NF Mixing/ Loading/ Applying Liquids with a Hose end Sprayer ( ORETF data for turfgrass applications) ( 8) turf 1 0.023 ( spot trt.) 5400000 27000000 54000000 NF 1800000 9000000 18000000 NF ornamentals 3.5 0.023 ( spot trt.) 1500000 7700000 15000000 NF 510000 2600000 5100000 NF Mixing/ Loading / Applying Liquids with a Watering Can ( using ORETF hose end data for turfgrass applications) ( 9) turf 1 0.023 ( spot trt.) 5400000 27000000 54000000 NF 1800000 9000000 18000000 NF Applying Ready to Use Formulations via Trigger Pump Sprayer ornamentals 3.5 0.023 ( spot trt.) 1400000 6900000 14000000 NF 460000 2300000 4600000 NF Page 62 of 80 Table 17  Summary of Short and Intermediate term Occupational Handler Non cancer Risks Inhalation Short term MOEs Inhalation Intermediate term MOEs Exposure Scenario Crop or Target ARa ( lb ai/ acre) Area Treated Daily ( acres) b Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf Brassica,

lettuce, tomato, strawberry 1 0.023 ( spot trt.) 4800000 24000000 48000000 NF 1600000 8000000 16000000 NF ( ORETF) ( 10) berries, artichoke 0.8 0.023 ( spot trt.) 6000000 30000000 60000000 NF 2000000 10000000 20000000 NF ornamentals 3.5 0.023 ( spot trt.) 56500 280000 570000 NF 18000 93000 180000 NF grass grown for seed 1.6 0.023 ( spot trt.) 120000 610000 1200000 NF 41000 200000 410000 NF turf, citrus,

Brassica,

lettuce, tomato, strawberry 1 0.023 ( spot trt.) 190000 980000 1900000 NF 65000 330000 650000 NF Applying Ready to Use Granular by Hand ( 11) berries, artichoke,

prickly pear cactus 0.8 0.023 ( spot trt.) 240000 1200000 24000000 NF 80000 410000 800000 NF Page 63 of 80 Table 17  Summary of Short and Intermediate term Occupational Handler Non cancer Risks Inhalation Short term MOEs Inhalation Intermediate term MOEs Exposure Scenario Crop or Target ARa ( lb ai/ acre) Area Treated Daily ( acres) b Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf ornamentals 3.5 1 9700 48000 97000 NF 3200 16000 32000 NF grass grown for seed 1.6 1 21000 110000 210000 NF 7100 35000 71000 NF turf, citrus,

Brassica,

lettuce, tomato, strawberry 1 1 34000 170000 340000 NF 11000 56000 110000 NF Loading/ Applying Granulars via Belly Grinder ( 12) berries, artichoke,

prickly pear cactus 0.8 1 42000 210000 420000 NF 14000 71000 140000 NF ornamentals 3.5 5 16000 82000 160000 NF 5500 27000 55000 NF grass grown for seed 1.6 5 36000 180000 360000 NF 12000 60000 120000 NF Loading/ Applying Granulars via Push Type Spreader ( ORETF) ( 13) turf, citrus,

Brassica,

lettuce, tomato, strawberry 1 5 58000 290000 580000 NF 19000 96000 190000 NF Page 64 of 80 Table 17  Summary of Short and Intermediate term Occupational Handler Non cancer Risks Inhalation Short term MOEs Inhalation Intermediate term MOEs Exposure Scenario Crop or Target ARa ( lb ai/ acre) Area Treated Daily ( acres) b Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf Baselinec PF 5 Respiratord PF 10 Respiratore Eng Controlf berries, artichoke,

prickly pear cactus 0.8 5 72000 360000 720000 NF 24000 120000 240000 NF ornamentals 3.5 0.023 ( spot trt.) 1400000 6900000 14000000 NF 460000 2300000 4600000 NF Brassica,

lettuce, tomato, strawberry 1 0.023 ( spot trt.) 4800000 24000000 48000000 NF 1600000 8000000 16000000 NF Applying Ready to Use Liquid/ Paste Formulations via Squeeze Bottle or Tube ( ORETF pumptrigger data)

( 14) berries, artichoke 0.8 0.023 ( spot trt.) 6000000 30000000 60000000 NF 2000000 10000000 20000000 NF a Application rates are the maximum application rates determined from EPA registered labels for metaldehyde b Amount handled per day values are HED estimates of acres treated or amount handled per day based on Exposure SAC SOP # 9 " Standard Values for Daily Acres Treated in Agriculture," industry sources, and HED estimates.

c Baseline inhalation is no respirator.

d 80% respirator is quarter face dust/ mist respirator ( that provides an 80% protection factor).

e 90% respirator is half face or full face respirator with a dust/ mist filter ( that provides a 90% or higher protection factor).

f Engineering controls is closed mixing/ loading system, or enclosed cab, or enclosed cockpit. Page 65 of 80 Occupational Handler Cancer Risks Metaldehyde is classified as " suggestive evidence of carcinogenic potential,@ however, cancer risks were not calculated for metaldehyde, since no cancer endpoint was identified.

9.2. Short/ Intermediate/ Long Term Postapplication Risk The exposures typically considered for occupational post application workers result from dermal contact with treated plants which occurs as workers engage in various job tasks such as harvesting. Occupational post application exposures were not assessed for metaldehyde because no dermal hazard was identified. Inhalation exposures are thought to be negligible in outdoor post application scenarios since metaldehyde has low vapor pressure and the dilution factor outdoors is considered infinite. In addition, under the Worker Protection Standard for Agricultural Pesticides   WPS   ( 40 CFR 170) greenhouses must be appropriately ventilated ( ventilation criteria are provided) following pesticide applications so that post application inhalation exposures are minimal. [ Note: The current restricted entry intervals specified on various metaldehyde labels range from 12 to 24 hours. The results of this assessment do not impact those current REIs.]

10.0 Data Needs and Label Requirements 10.1. Toxicology

Developmental neurotoxicity study ( rat)

90 day inhalation toxicity study ( rat)

Mutagenicity battery 10.2. Residue Chemistry

All end use product labels must be amended such that they are consistent with the use patterns supported by the available field trials. Crop uses currently not being supported should be deleted from all labels.

The proposed GC/ MS tolerance enforcement method will be forwarded to ACB for an Agency method validation trial.

Additional field trials are required on leafy lettuce ( 2 tests), spinach ( 6 tests), celery ( 6 tests) and peppers ( 9 tests) to support permanent tolerances on the leafy and fruiting vegetable crop groups. Page 66 of 80

Field trial data are required on the following crop groups and individual crops: root and tuber vegetables ( group 1), leaves of root and tuber vegetables ( group 2), bulb vegetables ( group 3), legume vegetables ( group 6), foliage of legume vegetables ( group 7), cucurbit vegetables ( group 9), pome fruits ( group 11), stone fruits ( group 12), tree nuts ( group 14), grass forage, fodder and hay ( group 17), nongrass animal feeds ( group 18), and herbs and spices ( group 19), asparagus, avocado, banana, coffee, cotton, cranberry, kiwifruit, grape, mint, okra, and papaya.

Processing studies are required on apple, sugar beet, cotton, grape, mint, plum, and potato.

A reference standard for metaldehyde must be submitted to the National Pesticide Standards Repository.

A field accumulation in rotational crop study is required.

10.3. Occupational and Residential Exposure

Turf dissipation study ( TTR). The TTR data is requested to ensure that intermediate term exposure estimates are commensurate with the agreed upon use interval.

References:

Bloom, J. 2005. Memorandum: Use Closure Memorandum for Metaldehyde PC# 053001. Dated March 1, 2005 Booze TF, Oehme FW. An Investigation of Metaldehyde and Acetaldehyde Toxicities in Dogs. Fundamentals of Applied Toxicology 1986 April 6( 3): 440 446.

HED, Metaldehyde; DP Barcode: none. Dated March 11, 1997 Page 67 of 80 Appendix A: Relevant Toxicology Executive Summaries Page 68 of 80 Developmental Toxicity Studies EXECUTIVE SUMMARY: In a developmental toxicity study [ MRID 41656001], female Sprague Dawley Crl: CD( SD) BR rats [ 25/ group] were administered metaldehyde [ 99%] via gavage at dose levels of 0 [ Mazola ® corn oil], 25 mg/ kg/ day, 75 mg/ kg/ day, and 150 mg/ kg/ day from gestation day 6 through gestation day 15.

There were six deaths [ all pregnant; high dose level only], which occurred between gestation days 7 and 8. Clinical signs attributed to treatment were observed at the highdose level in those dams that died and included ataxia [ all six], rapid respiration [ 5 dams], twitching [ 4 dams], tremors [ 3 dams], prostration [ 1 dam], abdominal breathing [ 1 dam], hyperactivity [ 1 dam], paresis of the hind legs [ 1 dam], pallor [ 2 dams], perioral encrustation [ 3 dams], and perinasal encrustation [ 2 dams]. Decreased body weight [ 96% of control] was observed at the high dose level only on gestation day [ GD] 9. Bodyweight gain was significantly decreased [ 74% of control] initially [ GD 6 9] and throughout the dosing period at the high dose level. Although dams at the mid dose level displayed only a slightly lower body weight gain during the dosing period [ 91% of control] compared to the control, based on their pre dose body weight gain [ 115% of control], the decrease is considered treatment related. A compensatory weight gain was noted during the post dosing period at the high dose level. Corrected body weight gain at the high dose level was slightly [ 94% of control] lower than the control value. Food consumption was decreased at the high dose level during the dosing period and increased significantly during the post dosing period at the mid and high dose levels.

Treatment related necropsy findings in the dams dying on test included thinning of the stomach wall [ 1 dam], ulceration of the glandular [ 2 dams] and nonglandular [ 2 dams] portion of the stomach, red/ brown lungs [ 6 dams], dilated renal pelvis [ 2 dams], and hydronephrosis [ 1 dam]. Additionally, perioral encrustation [ 6 dams], perinasal encrustation [ 5 dams], and paravertebral hemorrhage [ 1 dam] were observed in those dying on test. There were no adverse effects observed on maternal liver weight or gravid uterine weight.

There were no abortions, and the pregnancy rate was comparable among the groups. The numbers of corpora lutea, implantation, live fetuses, and resorptions [ both total and per dam], as well as pre and post implantation losses were comparable among the groups. There was one dead fetus [ high dose]. Fetal body weights and the sex ratio were comparable among the groups. There were no statistically significant or dose related differences in the incidence of fetal malformations or variations [ external, visceral, and skeletal].

The maternal toxicity NOAEL is 75 mg/ kg/ day, and the maternal toxicity LOAEL is 150 mg/ kg/ day, based on mortality, clinical signs of toxicity [ ataxia, tremors, twitching, rapid respiration], decreased body weight gain during dosing, and decreased food consumption during dosing. The NOAEL for developmental toxicity is 150 mg/ kg/ day, the highest dose tested. Page 69 of 80 This guideline developmental toxicity study is classified Acceptable, and it satisfies the guideline [ OPPTS 870.3700; § 83 3( a)] for a developmental toxicity study in the rodent.

EXECUTIVE SUMMARY: In a developmental toxicity study [ MRID 41590501], female New Zealand white rabbits [ 16/ group] were administered metaldehyde [ 99%] via gavage at dose levels of 0 [ Mazola ® corn oil], 10 mg/ kg/ day, 40 mg/ kg/ day, and 80 mg/ kg/ day from gestation day 6 through gestation day 18.

There were no treatment related deaths or clinical signs of toxicity. Body weight gains were extremely variable, and there was no dose response. All groups, including the control, displayed negative corrected body weight gains but there was no dose response. Food consumption was decreased at all dose levels during the dosing period compared to the control, but there was no dose response.

Necropsy findings were comparable among the groups. There were no adverse effects observed on maternal liver weight or gravid uterine weight.

There were no abortions, and the pregnancy rate was not adversely affected by treatment. The numbers of corpora lutea, implantation, live fetuses, resorptions [ both total and per dam], and dead fetuses, as well as pre and post implantation losses were comparable among the groups. Fetal body weights and the sex ratio were comparable among the groups. There were no statistically significant or dose related differences in the incidence of external or visceral malformations, but a slightly higher incidence of skeletal malformations [ 5 fetuses in 3 litters] was observed at the high dose level compared to the control and lower dose groups [ 1 fetus/ group]. This latter finding is considered attributable to the greater number of fetus examined at the high dose level [ 140 fetuses in 16 litters] compared to the other groups [ 112 fetuses/ 12 litters; 104 fetuses/ 13 litters; and 107 fetuses/ 13 litters in the control, low and mid dose groups, respectively]. External, visceral, and skeletal variations were comparable among the groups.

The maternal toxicity NOAEL is 80 mg/ kg/ day, the highest dose tested. The NOAEL for developmental toxicity is 80 mg/ kg/ day, the highest dose tested.

This guideline developmental toxicity study is classified Acceptable, and it satisfies the guideline [ OPPTS 870.3700; § 83 3( b)] for a developmental toxicity study in the rodent. NOTE: Although no maternal or developmental effects were observed, the dose levels are considered adequate based on effects observed in the range finding study. All does [ 5/ group] in the 200, 350 and 500 mg/ kg/ day groups died [ following 1 or 2 doses] or were sacrificed moribund [ gestation days 8 12], and one doe at 100 mg/ kg/ day died. A repeat study at higher dose levels would not provide useful data. This is supported by the results in the rat. The maternal NOAEL in the rat developmental toxicity study is 75 mg/ kg/ day, based on mortality, clinical signs of toxicity [ ataxia, tremors, twitching, rapid respiration], decreased body weight gain during dosing, and decreased food consumption during dosing at the LOAEL of 150 mg/ kg/ day. The NOAEL for developmental toxicity is 150 mg/ kg/ day, the highest dose tested. Page 70 of 80 Reproduction Studies EXECUTIVE SUMMARY: In a 2 generation reproduction study [ MRID 42823101], 28 male/ 28 female F0 CD ® rats/ sex/ group were administered metaldehyde [> 99% a. i.] via the diet for 10 weeks prior to mating and through gestation and lactation of one litter at dose levels of 0 ppm, 50 ppm, 1000 ppm, and 2000 ppm [ F0 males: 0, 3.4, 69.37, and 138.36mg/ kg/ day; F0 females: 0, 4.16, 80.81, and 160.42 mg/ kg/ day; F1 males: 0, 3.23, 64.93, and 133.53 mg/ kg/ day; F1 females: 0, 4.03, 80.51, and 164.15 mg/ kg/ day]. Rats were mated, one male with one female. The resulting F1 litters were weaned at day 28 post partum. The F1 generation [ 28 rats/ sex/ group] was administered the test material at the same dose levels as F0 animals and mated in a similar manner, avoiding sibling matings. The resulting F2 litters were weaned at day 28 post partum.

No treatment related clinical signs of toxicity or mortality were observed in F0 males at any time point or in F0 females during the pre mating and mating periods or during gestation. However, at 2000 ppm, three F0 dams were sacrificed moribund during the lactation period [ lactation days 16 18; days 110, 110, 113 on test] due to bilateral hindlimb paralysis. No treatment related clinical signs of toxicity or mortality were observed in F1 males at any time point or in F1 females during the pre mating and mating periods. However, during gestation/ lactation, three F1 dams [ 2000 ppm] were found dead [ days 95, 101, and 125]. The 2000 ppm F1 dam that was found dead on day 95 displayed ataxia, labored breathing, cold extremities, and pallor on day 94. An additional 2000 ppm F1 female [ nongravid] displayed prostration, tremors, abdominal breathing, and rapid respiration on day 102 but survived until terminal sacrifice [ day 134]. The author stated that the relationship of these latter signs to treatment was unclear. The cause of death of two of the F1 females was not determined [ third female due to septic emboli to various organs]. None of the other deaths [ F0 male and 2 F0 females at 50 ppm, 2 F1 females at 50 ppm, and one F1 male at 1000 ppm] was considered treatment related. No additional treatment related clinical signs were noted.

F0 parental animals Body weights for the treatment groups were similar to control throughout the study for both sexes. During the pre mating dosing period, there were no consistent adverse effects on body weight gain in either sex. Body weight gains of the F0 high dose males were decreased initially [ weeks 0 1 ( 91% of control)] and during weeks 5 6 ( 89% of control) and weeks 8 9 ( 75% of control). During weeks 2 3, there was an apparent dose related increase in body weight gain in males at the mid ( 112% of control) and high dose ( 114% of control) levels. F0 females displayed a decrease in body weight gain [ 66% of control] during weeks 2 3 at the high dose level, although statistical significance was not attained, and the standard deviation exceeded the group mean. Food consumption was not affected in either sex.

There were no consistent, treatment related, adverse effects on body weights or bodyweight gains of the F1 parental animals during the pre mating dosing period, although both sexes at the high dose displayed a smaller body weight gain during weeks 9 10 Page 71 of 80 [ males 83%; females 65% of control] than control. Food consumption was comparable among the groups [ both sexes] throughout the study.

At sacrifice, necrosis and hemorrhage in the spinal cord and vertebra luxation were observed in the three high dose F0 dams that displayed hindlimb paralysis. An additional F0 dam at 2000 ppm displayed spinal cord lesions microscopically.

At necropsy, no treatment related adverse effects were observed in F1 animals at any dose level.

At 2000 ppm, F1 males displayed increased relative liver weights [ 15%] and F1 females displayed increased absolute [ 12%] and relative [ 11%] liver weights. These organ weight changes were not accompanied by histopathological lesions and may be attributed to adaptation to the test material. NOTE: Liver weights were not determined for F0 animals.

F0 Generation. No apparent adverse effect was observed on fertility, and the mating and gestation indices were comparable among the groups. Pre coital intervals were not reported. The duration of gestation was comparable among the groups. The number of live pups was comparable among the groups. The number of pups born dead/ dying by day 1 was not affected by treatment. Litter size was slightly lower at the high dose level [ Day 0 ( 13.6), Day 4 precull ( 13.3), Day 21 ( 7.5)] compared to the control [ Day 0 ( 13.7), Day 4 precull ( 13.5), Day 21 ( 7.8)] and other dose groups [ Day 0 ( 14.0 and 13.8), Day 4 precull ( 13.7 and 13.8), Day 21 ( 7.7 and 7.9) for low and mid dose groups, respectively] throughout the weaning period. The live birth index and the viability index were comparable among the groups, but the lactation index was slightly lowered [ 89%] at the high dose level compared to the control [ 99%] and other dose groups [ 99%]. At the highdose level, a slightly lower pup body weight was observed on lactation days 7 [ males 96%/ females 95% of control] and 21 [ 95% of control], although statistical significance was not attained for either timepoint. Body weight gains were slightly lower for both sexes at the high dose level [ 94% 95% of control] compared to the control throughout lactation. The sex ratio was comparable among the groups. F1 Generation. No apparent, treatment related, adverse effect was observed on fertility, and the mating and gestation indices were comparable among the groups. Pre coital intervals were not reported. The duration of gestation was comparable among the groups. The high dose group had the fewest females [ 22] with live born pups [ 27 control and 23 each at the low and mid dose levels]. The number of live pups was comparable among the groups. The number of pups born dead/ dying by day 1 was not affected by treatment. Litter size was comparable among the groups, and the live birth index, viability index, and the lactation index were comparable among the groups. At the high dose level, a slightly lower pup body weight was observed on lactation days 1 [ males 93%/ females 93% of control], 7 [ females 95% of control], and 21 [ males 93%/ females 92% of control], although statistical significance was attained only at the day 21 timepoint. Body weight gains were slightly lower for both sexes at the high dose level [ 91% 93% of control] compared to the control throughout lactation. The sex ratio was comparable among the groups. Page 72 of 80 The NOAEL for parental toxicity is 1000 ppm [ males 65 mg/ kg/ day; females 81 mg/ kg/ day) and the parental LOAEL is 2000 ppm [ males 133 mg/ kg/ day; females 160 mg/ kg/ day], based on mortality ( F0 and F1 females), clinical signs ( hindlimb paralysis in F0 females), and histopathology ( spinal cord necrosis and hemorrhage, and vertebra luxation in F0 females and increased liver weight in both sexes [ F1].

The NOAEL for reproductive toxicity is 2000 ppm [ males 133 mg/ kg/ day; females 160 mg/ kg/ day], the highest dose tested.

The NOAEL for offspring toxicity is 1000 ppm [ males 65 mg/ kg/ day; females 81 mg/ kg/ day) and the LOAEL for offspring toxicity is 2000 ppm [ males 133 mg/ kg/ day; females 160 mg/ kg/ day], based on decreased pup body weight/ bodyweight gain [ F1 and F2 pups].

This 2 generation reproduction study is classified Acceptable/ Guideline. This study satisfies the guideline requirement ( OPPTS 870.3800; § 83 4) for a 2 generation reproduction study. The original DER set the reproductive toxicity LOEL at 2000 ppm, based on decreased pup body weight and weight gain in both sexes, which is not a reproductive toxicity endpoint but an offspring endpoint. Reproductive toxicity was not observed in this study, based on the parameters examined. It is to be noted that several parameters in the current protocol that measure reproductive effects, such as age of vaginal opening and preputial separation; anogenital distance for F2 pups; implantations sites; estrous cycle length and periodicity ( F1 weanlings); and sperm measures, were not evaluated. These are included in the new protocol, which was not in effect at the time of the study.

Carcinogenicity Study  rat EXECUTIVE SUMMARY: In a chronic toxicity/ carcinogenicity study [ MRIDs 42203601], 60 Sprague Dawley CD ® rats/ sex/ dose were administered metaldehyde [ 99 %] via the diet at concentrations of 0 ppm and 0 ppm ( there were 2 control groups), 50 ppm [ males 2 mg/ kg/ day; females 3 mg/ kg/ day], 1000 ppm [ males 44 mg/ kg/ day; females 60 mg/ kg/ day], 5000 ppm [ males 224 mg/ kg/ day; females 314 mg/ kg/ day] for 104 weeks.

There was no adverse effect of treatment on survival of either sex, although females at the mid [ 60%] and high [ 58%] levels displayed a slightly greater mortality than the control groups [ 50% and 48%]. There were no apparent treatment related clinical signs of toxicity. There was a slight reduction in body weight [. 95% of control] throughout most of the study in both sexes at the high dose level compared to the control groups. During the first week, females in all treated groups displayed a dose related [ statisticallysignificant at all dose levels] decrease in body weight gain compared to the 2 control groups [ 86%/ 94%, 69%/ 75%, and 60%/ 66% of control with increasing dose]. During the same time frame, males displayed a similar dose related decrease in body weight gain, which was statistically significant at the mid [ 87% of control] and high [ 78% of control] dose level compared to one of the control groups. Food consumption was decreased at the Page 73 of 80 high dose level in both sexes during the first few weeks of the study, which suggests a palatability problem.

There were no apparent, treatment related, effects on the ophthalmological or hematological parameters monitored in either sex. Mid and high dose females displayed a statistically significant, dose related, increase in cholesterol levels throughout most of the study. Globulin values were elevated in the high dose females throughout most of the study [ weeks 26, 52, and 78] and in mid dose females only at week 78. There were no treatment related alterations in the liver enzymes monitored. There was a dose related increase in urine volume in females [ 37%, 40%, and 54% with increasing dose] at week 77 only.

Increased liver weight [ males 111% 118% of control; females 121% 132% of control] was observed in both sexes at the high dose level, although the values in males did not attain statistical significance. Females at all dose levels displayed an increase in ovarian weight, but there was no dose response, and the standard deviation of the low and highdose female groups exceeded the means.

In the liver, there was a dose related increase in hepatocellular hypertrophy in both sexes, which was statistically significant at the mid dose level in males and at the high dose level in both sexes. There was a statistically significant increase in hepatocellular adenomas in high dose females [ 10%] compared to the control and other dose groups. The majority of the liver adenomas were observed at the terminal sacrifice, and the incidence is within the historical control incidence of the testing facility [ 0% 10%]. One hepatocellular carcinoma was observed in one of the control groups and in one high dose female. The combined incidence [ adenomas and carcinomas] of liver tumors in the highdose females [ 11.7%] is slightly outside the historical control incidence of the testing facility [ 0% 10%]. Males did not display an increase in liver tumors.

The systemic toxicity NOAEL is 50 ppm [ males 2 mg/ kg/ day; females 3 mg/ kg/ day], based on hepatocellular hypertrophy and increased cholesterol in both sexes and decreased body weight gain in females at the systemic LOAEL of 1000 ppm [ males 44 mg/ kg/ day; females 60 mg/ kg/ day].

This guideline chronic toxicity/ carcinogenicity study is classified ACCEPTABLE, and it satisfies the guideline [ OPPTS 870.4300; § 83 5] for a chronic toxicity/ carcinogenicity study in the rat.

Carcinogenicity Study   mouse EXECUTIVE SUMMARY: In a carcinogenicity study [ MRID 42737201], 60 CD 1 mice/ sex/ dose were administered metaldehyde [> 99%; Lot # 5448] via the diet at concentrations of 0 ppm [ 2 control groups], 25 ppm [ males 4.0 mg/ kg/ day; females 4.8 mg/ kg/ day], 100 ppm [ males 15.9 mg/ kg/ day; females 19.7 mg/ kg/ day], and 300 ppm [ males 48.9 mg/ kg/ day; females 59.8 mg/ kg/ day] for 18 months. Page 74 of 80 There were no treatment related effects on survival or clinical signs in either sex, and body weights, body weight gains, and food consumption were comparable among the groups for both sexes.

The hematologic parameters monitored were comparable among the groups [ both sexes]. Clinical chemistry and urinalysis parameters were not monitored.

At necropsy, there were no gross lesions attributed to treatment in either sex. With the exception of liver weights in males, which displayed a dose related increase ( although statistical significance was not attained), organ weights were comparable among the groups [ both sexes].

Non neoplastic lesions: The incidence [ overall: high dose males 62% vs 30% 33% control; high dose females: 30% vs 7% 15% control] and severity of hepatocellular hypertrophy were increased in both sexes at the high dose level compared to the control groups. The majority of the mice with hepatocellular hypertrophy were diagnosed at terminal sacrifice.

Neoplastic lesions: There was no statistically significant increase in the incidence of liver tumors in either sex, although the high dose males displayed a slight increase [ 15 adenomas and 3 carcinomas] compared to both control groups [ 8 adenomas/ 1 carcinoma and 8 adenomas/ 3carcinomas].

The systemic toxicity NOAEL is 100 ppm [ 15.9 mg/ kg/ day ( males); 19.7 mg/ kg/ day ( females)], based on a significantly increased incidence of hepatocellular hypertrophy in both sexes at the LOAEL of 300 ppm [ 48.9 mg/ kg/ day ( males); 59.8 mg/ kg/ day ( females)]. No other toxicological effects were observed in either sex. The incidence of tumors was comparable among the groups [ both sexes].

This guideline carcinogenicity study is classified ACCEPTABLE/ Guideline. However, the dose levels were not considered adequate for assessing the carcinogenic potential of metaldehyde, and a supplementary study was performed [ MRID 44625101; separate DER]. In the 90 day mouse study [ not submitted to the Agency] performed to determine dose levels to be used in the current study, mortality was said to have been observed at 3000 ppm and 10000 ppm and dose related increases in liver weight and hepatic lesions were reported in both sexes at $ 300 ppm. The supplemental carcinogenicity study [ MRID 44625101] was performed using one dose level of metaldehyde [ 1000 ppm]. At 1000 ppm, there was a treatment related increase in the incidence of hepatocellular adenomas in both sexes when compared to controls. Dosing was considered adequate based on the increased incidence of liver lesions [ liver single cell/ focal/ multifocal necrosis ( males) and hepatocellular eosinophilic cell foci ( females)] in both sexes, in addition to hepatocellular hypertrophy ( both sexes), which was the only treatmentrelated finding in the current study at 300 ppm. When all the information, including the 90 day study ( MRID 43297701), are considered together, MRID 42737201 and MRID 44625101 satisfy the guideline requirement [ OPPTS 870.4200; § 83 2] for a carcinogenicity study in the mouse. Page 75 of 80 In a carcinogenicity study [ MRID 44625101], metaldehyde (% a. i., batch/ lot #)] was administered to 60 Crl: CD 1 ®  ( ICR) BR mice/ sex/ dose via the diet at dose levels of 0, 0, and 1000 ppm [ equivalent to 0, 0, 135 mg/ kg bw/ day ( males)/ 163 mg/ kg bw/ day ( females)] for at least 78 weeks.

There were no compound related effects on mortality, clinical signs, body weight, food consumption, or hematology in either sex. With the exception of the liver, organ weights were comparable to those of the control groups for both sexes. Liver weights were increased significantly in both sexes at 1000 ppm compared to both of their respective control groups. Gross and histologic pathology findings were comparable among the groups for both sexes, with the exception of the liver. Hepatocellular hypertrophy was observed in both sexes at 1000 ppm. Males at 1000 ppm displayed single cell necrosis, focal or multifocal necrosis, pigment accumulation, and sinusoidal. Females at 1000 ppm displayed a small increase in the incidence of hepatocellular eosinophilic cell foci. There was a significant increase in the incidence of hepatocellular adenomas in both sexes [ males: 4 and 5 vs 14; females: 1 and 0 vs 5], with the males displaying the greater effect. Males also displayed a slight increase in hepatocellular carcinomas [ 2 and 2 vs 4] compared to both control groups.

Under the conditions of this study, at the only dose of metaldehyde tested [ 1000 ppm; 135 ( males)/ 163 ( females) mg/ kg/ day)], increased liver weight ( both sexes), hepatocellular hypertrophy ( both sexes), liver single cell/ focal/ multifocal necrosis ( males), liver pigment accumulation ( males), sinusoidal histiocytosis ( males), hepatocellular eosinophilic cell foci ( females), and hepatocellular adenomas ( both sexes) were observed. The NOAEL is not established in the current study. However, based on a previous mouse carcinogenicity study in the same strain of mouse [ MRID 42737201], in which an increased incidence of hepatocellular hypertrophy was observed in both sexes at the highest dose tested [ 300 ppm; 48.9 ( males)/ 59.8 ( females) mg/ kg/ day], the NOAEL is 100 ppm [ 15.9 ( males)/ 19.7 ( females) mg/ kg/ day], with the LOAEL based on an increased incidence of hepatocellular hypertrophy in both sexes.

At the dose tested in the current study, there was a treatment related increase in the incidence of hepatocellular adenomas in both sexes when compared to the controls. Dosing was considered adequate based on the increased incidence of liver lesions [ liver single cell/ focal/ multifocal necrosis ( males) and hepatocellular eosinophilic cell foci ( females)] in both sexes, in addition to the hepatocellular hypertrophy observed in the previous study at 300 ppm.

This carcinogenicity study in the mouse is Acceptable/ non guideline. It is non guideline since only one dose level was tested. The study was performed as a supplement to a previous 18 month mouse carcinogenicity study [ MRID 42737201] and should be considered along with the previous study. Together, the two studies satisfy the guideline requirement for a carcinogenicity study [ OPPTS 870.4200; OECD 451] in mice. Page 76 of 80 STUDIES FOR ENDPOINT SELECTION:

Chronic Oral Toxicity Study  dog EXECUTIVE SUMMARY In a chronic oral toxicity study ( MRID 46378401), metaldehyde ( 98.3% a. i.; batch # 30202) was administered once daily for 52 consecutive weeks to groups of 4 male and 4 female Beagle dogs at dose levels of 10, 30, and 90 mg/ kg/ day. The amount of test material given was adjusted to each dog's actual body weight weekly.

There were three deaths [ one each sex at 30 mg/ kg/ day and one female at 90 mg/ kg/ day], which occurred between weeks 37 and 46. Treatment related clinical signs were observed from week one on at the high dose and included ataxia, emesis, tremor, twitching, and salivation. The incidence and severity of these clinical signs lessened with time from week 19, although 1 or 2 animals continued to display salivation throughout the study. One high dose female displayed lateral position early in the study, reduced motility during most of the study, and convulsion and vocalization during week 46. Agitation was displayed by one high dose female during weeks 6 9 and 24 52. Body weight was slightly lower in the treated dogs [ males 83% 93%; females 81% 94%] throughout most of the study, although a dose response was not always evident. At study termination, male body weights were 84%, 88%, and 83% and female body weights were 96%, 90%, and 81% of control with increasing dose. During the first week on test, males displayed decreased body weight gains at all dose levels, although the decrease was inversely related to dose [ 47%, 66%, and 74% of control with increasing dose]. Only the mid dose females displayed a decrease in body weight gain initially [ 36% of control]. During the 0 13 week interval, males at all dose levels [ 75%, 83%, and 57% with increasing dose] and females at the mid [ 63%] and high [ 79%] dose levels displayed decreased bodyweight gains compared to the controls. Food consumption was not adversely affected. Food efficiency values were not provided.

No lesions of the eyes or optic region were found, and there were no differences in the urinalysis parameters monitored in either sex. During the 13 week assessment, one highdose dog of each sex did not react to the noise test, but no effects were noted in either sex at the 26 and 52 week assessments. Increases in hemoglobin, RBC, and hematocrit were observed in both sexes at the high dose level at week 13, but only in females at week 26. Alkaline phosphatase was increased throughout the study in both sexes at the high dose level, with the magnitude of the response from control increasing with time [ both sexes]. High dose females displayed an increase in gamma GT throughout the study, but other liver enzyme activities [ AST, ALT] were not affected by treatment. Triglycerides were increased in the high dose females throughout the study compared to the control values.

At the high dose level in both sexes, liver weight was increased significantly compared to the control values. There was a dose related decrease in absolute prostate weight [ 82%, 71%, and 68% of control with increasing dose], a decrease in testes weight at the lowand high dose level, and an increase in absolute and relative lung weight in high dose Page 77 of 80 males. Increased brain weight was observed in females at the high dose level compared to the control. There were no apparent microscopic lesions in the liver, but atrophy and/ or degeneration was observed in the testes and prostate.

The lowest observed adverse effect level ( LOAEL) for metaldehyde in the dog is 30 mg/ kg/ day, based on death and atrophy of the testes and prostate. The NOAEL is 10 mg/ kg/ day.

This chronic oral toxicity study in the dog is Acceptable/ Guideline, and it satisfies the guideline requirement for a chronic oral toxicity study [ OPPTS 870.4100); OECD 452] in the dog.

21   Day Dermal Toxicity Study EXECUTIVE SUMMARY: In a 21 day dermal toxicity study [ MRID 42063401], 5 New Zealand White rabbits/ sex/ group were administered metaldehyde [ 99.0%] via dermal application [ dry powder covered with a gauze patch moistened with Milli Q ® filtered water; once a day for 6 hours, 5 days/ week] for 22 days at concentrations of 0, 100, 300, and 1000 mg/ kg/ day.

Treatment had no adverse effect on survival, clinical signs, mean body weight, bodyweight gain, food consumption, hematology, clinical chemistry, organ weights, or gross and microscopic pathology. There was no dose related increase in the incidence or severity of signs of dermal toxicity.

The NOAEL for systemic and dermal toxicity is 1000 mg/ kg/ day, the highest dose tested This guideline 21 day dermal toxicity study is classified ACCEPTABLE, and it satisfies the guideline requirement [ § 82 2; 870.3200] for a 21 day dermal toxicity study. Although fewer rabbits/ sex/ group were utilized than specified in the Guideline, this does not by itself diminish the finding of no effect at the limit dose. Page 78 of 80 Appendix B: Tolerance Reassessment Summary Page 79 of 80 TOLERANCE REASSESSMENT SUMMARY Tolerance Reassessments for Metaldehyde The current tolerance expression for metaldehyde residues is adequate. The HED Metabolism Committee has determined that the tolerance expression for residues in/ on crop commodities should include only metaldehyde per se. A summary of metaldehyde tolerance reassessments is presented in Table 5.

Tolerances Listed Under 40 CFR § 180.523:

A tolerance of " zero" has been established for residues of metaldehyde on strawberries [ 40 CFR § 180.523( a)]. No other tolerances are established.

The residue data submitted to reassess the established tolerance for strawberries is adequate to support the use of P/ T and G formulations of metaldehyde on strawberry. These data will support a tolerance of 0.10 ppm for residues in/ on strawberry. The RTU/ L formulation of metaldehyde is not currently registered for use on strawberry. However, if the registrant intends to support the use of RTU/ L formulations on strawberry, then additional field trials will be required as residues resulting from use the RTU/ L were substantially higher than from either the P/ T or G formulations.

Tolerances Needed Under 40 CFR § 180.523( a):

As detectable residues ($ 0.05 ppm) of metaldehyde were found in/ on a wide variety of crops in the limited field trials conducted at the reported 1x rates, tolerances for metaldehyde will be required on all crops and/ or crop groups with registered uses of metaldehyde. The available field trial data on broccoli, cabbage, mustard greens, lemon, orange, grapefruit, blueberry, raspberry, artichoke, prickly pear cactus, and watercress are adequate. These data will support permanent tolerances on Brassica leafy vegetables ( group 5) at 2.5 ppm, citrus fruits ( group 10) at 0.26 ppm, berries ( group 13) at 0.15 ppm, globe artichoke at 0.06 ppm, and watercress at 3.2 ppm.

The adequate residue data on tomatoes will support either a separate permanent tolerance on tomatoes at 0.24 ppm or a temporary tolerance on the crop group. If at a later date, the registant wants to support a permanent tolerance on fruiting vegetables ( group 8), additional field trials will be required on bell and non bell peppers.

The available residue data on lettuce supports a permanent tolerance of 1.73 ppm on lettuce. If the registrant wants to support a crop group tolerance on leafy vegetable, except Brassica group 4, then additional field trials will be required on leafy lettuce, spinach, and celery. Page 80 of 80 Table B1. Tolerance Reassessment Summary for Metaldehyde.

Commodity Current Tolerance ( ppm) Range of Residues ( ppm) 1 Tolerance Reassessment ( ppm) Comment/[ Correct Commodity Definition]

Tolerances Listed Under 40 CFR § 180.523( a):

Strawberry 0 < 0.05 2.42 6.25 The available residue data for the G and P/ T formulations are adequate.

Tolerances Needed under 40 CFR 180.523( a):

Artichoke, globe None < 0.05 0.0625 The available residue data are adequate.

Berry, group 13 None < 0.05 0.06 0.15 The available residue data on blueberry and raspberry are adequate.

Fruit, citrus, group 10 None < 0.05 0.103 0.26 The available residue data are adequate.

Prickly pear cactus None < 0.05 0.0625 The available residue data are adequate.

Vegetable, brassica, leafy, group 5 None < 0.05 1.00 2.5 The available residue data on broccoli, cabbage and mustard greens are adequate.

Lettuce None < 0.05 0.691 1.73 The available residue data on leafy and head lettuce are adequate.

Vegetable, fruiting, group 8 Tomato None < 0.05 0.096 0.24 The available residue data are adequate.

Watercress None 0.215 1.28 3.2 The available residue data are adequate.