The results show: 1) The acute RQs exceed freshwater fish acute, acute restricted use, and acute endangered species LOCs for all maneb uses ( acute RQ ranges from 1.13 to 4.71). No chronic LOCs are exceeded for freshwater fish from maneb's uses.. 2) The freshwater invertebrates' acute RQs exceed acute, acute restricted use, and acute endangered species LOCs for maneb's use on apples, tomatoes and peppers. Restricted use and acute endangered species LOCs are exceeded for all maneb uses ( acute RQ ranges from 0.4 to 1.65). 3) The estuarine/ marine fish acute RQs exceed acute, acute restricted use, and acute endangered species LOCs for maneb uses on tomatoes and peppers. Restricted use and acute endangered species LOCs are exceeded for all maneb uses ( acute RQ ranges from 0.26 to 1.1). 4) The estuarine/ marine invertebrate acute RQs exceed acute, acute restricted use, and acute endangered LOCs for all maneb uses ( acute RQ ranges from 15.87 to 65.97). There are currently no estuarine/ marine invertebrates listed as endangered species. 5) All maneb's use patterns exceed acute risk LOCs for nonvascular aquatic plants ( acute RQ ranges from 3.55 to 14.77). There are no nonvascular aquatic plants listed as endangered species. 33 0.01 0.1 1 10 100 Risk Quotient Potato ( Maine, only) Apples Pepper ( a) Tomato ( b)

Sites Estuarine/ Marine Fish Acute Freshwater Invertebrates Acute Freshwater Fish Acute Aquatic Non Vascular Plants Acute Estuarine/ Marine Invertebrates Acute Freshwater Fish Chronic Maneb Aquatic Risks Based on PRZM EXAMS Modeling Figure VI 2 RQ greater or equal to 1.0 exceeds aquatic plant acute and acute endangered species LOCs. RQ greater or equal to 0.5 exceeds aquatic animal acute, acute restricted use and acute endangered species LOCs. RQ greater or equal to 0.1 exceeds aquatic animal acute restricted use and acute endangered species LOCs RQ greater or equal to 0.05 exceeds aquatic animal acute endangered species LOCs RQ greater or equal to 1 exceeds aquatic animal chronic LOCs. There are currently no estuarine/ marine invertebrates or non vascular aquatic plant species listed as endangered species. a East of the Mississippi River ( 1.6 lb ai/ A is a W. of Miss. R. rate for peppers. 2.4 lb ai/ A 6 times every 7 days is the E. of Miss. R. rate   the scenario is FL) b East of the Mississippi River 34 c. Aquatic Risk Assessment Dose/ response slope values for the toxicological endpoints ( see Table V 1) used to calculate aquatic RQs for maneb complex were reported in the studies used to determine these endpoints. EFED estimated the highest maneb complex aquatic EEC expected from drift and runoff would be 197.9 ppb. Based on this residue level and individual laboratory studies EFED estimated the likelihood of adverse maneb complex effects to individual organisms across taxa. These chance estimates show there is high likelihood ( that is, 57 to 100%) of adverse acute effects to individual freshwater and estuarine/ marine aquatic organisms from maneb complex. EFED calculated this range using Equation VI 1. For the highest peak maneb complex the results show:

1) The acute RQs exceed freshwater fish acute, acute restricted use, and acute endangered species LOCs for all maneb uses ( acute RQ ranges from 1.13 to 4.71). The highest peak maneb complex aquatic EEC expected from drift and runoff is 197.9 ppb. This value is the estimated aquatic concentrations based on maneb's applications to tomatoes. At this concentration the likelihood of adverse maneb complex effects to individual freshwater fish is 1 in 1 or 100%. EFED calculated this chance estimate using a freshwater fish acute LC 50 = 42 ppb and slope = 2.8 from MRID No. 40706001 and LC k = 197.9 ppb using equation VI 1. No chronic LOCs are exceeded for freshwater fish from maneb's uses.

2) The freshwater invertebrates' acute RQs exceed acute, acute restricted use, and acute endangered species LOCs for maneb's use on apples, tomatoes and peppers. Restricted use and acute endangered species LOCs are exceeded for all maneb uses ( acute RQ ranges from 0.4 to 1.65). At the peak maneb complex aquatic EEC expected from drift and runoff of 197.9 ppb, the likelihood of adverse maneb complex effects to individual freshwater invertebrates is 4 in 5 or 80%. EFED calculated this chance estimate using a freshwater invertebrate acute LC 50 = 120 ppb and slope = 4.2 from MRID No. 40749402 and LC k = 197.9 ppb.

3) The estuarine/ marine fish acute RQs exceed acute, acute restricted use, and acute endangered species LOCs for maneb uses on tomatoes and peppers. Restricted use and acute endangered species LOCs are exceeded for all maneb uses ( acute RQ ranges from 0.26 to 1.1). At the peak maneb complex aquatic EEC expected from drift and runoff of 197.9 ppb, the likelihood of adverse maneb complex effects to individual estuarine/ marine fish is more than 1 in 2 or 57%. EFED calculated this chance estimate using a estuarine/ marine fish acute LC 50 = 180 ppb and slope = 4.2 from MRID No. 40943101 and LC k = 197.9 ppb.

4) The estuarine/ marine invertebrate acute RQs exceed acute, acute restricted use, and acute endangered LOCs for all maneb uses ( acute RQ ranges from 15.87 to 65.97). There are currently no estuarine/ marine invertebrates listed as endangered species. At the peak maneb complex aquatic EEC expected from drift and runoff of 197.9 ppb, the likelihood of adverse maneb complex effects probit k = ( log LC  log LC ) * slope + probit 50%

k = new percentage mortality k 50 Equation VI 1 35 to individual estuarine/ marine invertebrate is 1 in 1 or 100%. EFED calculated this chance estimate using a estuarine/ marine invertebrate acute LC 50 = 3 ppb and slope = 3.5 from MRID No. 41000002 and LC k = 197.9 ppb.

5) All maneb's use patterns exceed acute risk LOCs for nonvascular aquatic plants ( acute RQ ranges from 3.55 to 14.77).. There are no nonvascular aquatic plants listed as endangered species. At the peak maneb complex aquatic EEC expected from drift and runoff of 197.9 ppb, the likelihood of adverse maneb complex effects to individual nonvascular aquatic plants is 1 in 1 or 100%. EFED calculated this chance estimate using a nonvascular aquatic plants LC 50 = 13.4 ppb; LC k = 197.9 ppb; and slope = 4.8 from MRID No. 40943501.

These chance estimates show there is high likelihood ( that is, $ 57 %) of adverse acute effects to individual freshwater and estuarine/ marine aquatic organisms. EFED expects adverse effects to these aquatic organisms at maximum predicted maneb complex aquatic exposure levels. Incident reported data supports this expectation in at least one report from EIIS ( see below). EFED does not have acute toxicity data to estimate the likelihood of adverse effects to vascular aquatic plants.

i. Incidents The Ecological Incident Information System ( EIIS) ( see Appendix V for background information) reported maneb in three fish kill incidents. An incident ( Incident No. B000 223), occurring in August, 1973, reported by the Oregon Department of Agriculture showed some fish in a 15 acre pond had been killed. Presumably drift from an aerial application of maneb and endosulfan to potatoes caused the kill. No analyzes of the dead fish was provided. Both maneb and endosulfan are very highly toxic to freshwater fish [ maneb rainbow trout LC50 = 42.0 ppb and endosulfan rainbow trout LC50 = 0.37 ppb ( US EPA. 2001)] and both pesticides could have been responsible for the fish kill, if in fact the kill was pesticide related. However, the inadequate information provided with this reported incident and the lack of laboratory analyzes makes it difficult to charge this fish kill to either pesticide.

The second maneb related incident ( Incident No. I003826 030) occurred in June, 1994 and was reported by the North Carolina Department of Agriculture. The owner of a 2.5 acre commercial fishpond filed a complaint of a fish kill in the pond because of drift from applications of maneb, trifluralin, imazaquin, pendimethalin, and acephate aerially applied to corn and soybean fields near the pond. The owner felt the fish kill was a result of drift from these pesticides. The North Carolina Department of Agriculture investigated this complaint and took samples for analyzes but the sampling evidence did not confirm the presence of maneb or the other pesticides listed in the samples taken. Based on the investigation and the analysis of samples, it is unlikely that maneb contributed to this fish kill.

The final maneb related incident ( Incident Nos. I002200 001 and I003596 001), occurring in August, 1994, was reported by the Maine Department of Agriculture. In this incident roughly 10,000 newly released brook trout were killed in a pond that borders New Brunswick, Canada and Maine. Three pesticides ( maneb, esfenvalerate, and chlorothalonil) recently applied to potatoes surrounding this 36 pond were suspected in this fish kill. Tissue samples of the fish confirmed the presence of all three pesticides ( maneb at 169 ppb, esfenvalerate at 4.2 ppb, and chlorothalonil at 20 ppb) in the fish. These fish samples were taken from both the pond and brooks feeding the pond. Again, as in the first incident, all three of these pesticides are very highly toxic to freshwater fish. Maneb's rainbow trout LC50 is 42.0 ppb, esfenvalerate's rainbow trout LC50 is 0.26 ppb ( Hicks, L. May, 1995) and chlorothalonil's rainbow trout LC50 is 42.3 ppb ( US EPA. 1998)]. The submitter of the incident report pointed out there were severe thunderstorms in the area preceding the fish kill which suggest pesticide runoff was a cause in this kill. Based on sampling evidence, EFED believes maneb was contributory cause in this fish kill.

ii. Endocrine Disruptors Chronic testing in freshwater fish showed reduced hatchability, fish survival and length of fry being the endpoints affected in fathead minnow. See Appendix III for a detailed listing of the study and results. These effects noted in a freshwater fish species may be a result of hormonal disruptions. Based on these effects in freshwater fish, EFED recommends maneb be subjected to more definitive testing to better characterize effects related to its potential endocrine disruption. This testing should occur when EPA develops suitable screening and testing protocols, considered under the Agency's EDSP.

iii Endangered Species Based on available screening level information there is a potential concern for maneb's acute effects on listed freshwater and estuarine/ marine animals should exposure actually occur. There are no nonvascular aquatic plant or estuarine/ marine invertebrate species on the endangered species list. EFED does not have toxicological data to evaluate the chronic endangered/ threatened species risk to freshwater invertebrates or estuarine/ marine fish from maneb's use. Based on EFED's maneb complex calculated RQs, EFED expects the chronic risks to endangered and threatened species of freshwater fish to be low. The highest freshwater fish chronic RQ calculated is 0.66 which is below the chronic LOC of 1. 37 VII. Terrestrial Exposure and Risk a. Hazards Summary ( Acute/ Chronic)

Maneb is categorized as practically nontoxic to avian species on an acute oral basis ( Northern bobwhite quail LD 50 > 2,150 mg/ kg). Avian subacute dietary tests were conducted using Northern bobwhite quail and mallard duck as test species. The maneb dietary LC 50 for birds ranged from greater than 5,000 ppm in mallard ducks to greater than 10,000 ppm in bobwhite quails. This categorizes maneb as practically nontoxic to avian species on a subacute dietary basis. In a maneb avian reproduction study using the mallard duck, chronic toxic effects were seen which included: a reduction in the number of hatchlings as percentages of eggs laid, eggs set, and live 3 week old embryos, and a reduction in the number of 14 day old survivors as a percentage of eggs set. The reproduction NOAEC/ LOAEC is 20/ 100 ppm. A Northern bobwhite quail reproduction study was classified as supplemental because a LOAEC was not determined. At the highest dose tested ( 500 ppm) no adverse effects were noted. Collectively, the mallard is the more sensitive species for the EBDC's, and will be used for risk assessment purposes. Mallard duck reproduction NOAECs for mancozeb and metiram are 10 ppm and 50 ppm, respectively. Bobwhite quail NOAECs for mancozeb and metiram are 125 300 ppm and > 500 ppm, respectively.

Maneb is practically nontoxic to small mammals on an acute oral basis with LD 50 > 5,000 mg/ kg in tests done on laboratory rats. Results from chronic 2 generation reproduction study for maneb show a parental and fetal toxicity at a LOAEL of 300 ppm ( NOAEL = 75 ppm) with paternal parental toxicity resulting in significant increase in lung weight ( both generations) and liver weight in F1 ( one generation removed from the original parent generation) and an increased incidence of diffuse follicular epithelial hypertrophy/ hyperplasia ( lesions on the organs' surfaces) in F1. Fetal toxicity, at this test concentration ( 300 ppm), was also noted based on a slight delay in the startle response in the offspring ( NOAEL = 75 ppm).

Currently, EFED does not assess risk to non target insects using risk quotient methodology. Results of acceptable studies are used for recommending appropriate label precautions. Since maneb was determined to be practically nontoxic to honey bees ( LD 50 > 12 µ g/ bee) no bee precautionary labeling is required on maneb product labeling.

EFED has not received any non target terrestrial plant studies and is unable to assess the risk to nontarget terrestrial plants as a result of maneb's uses. The submission of Tier I seedling emergence and vegetative vigor studies for a TEP are being recommended to evaluate this risk.

For a more detailed listing and explanation of maneb's hazards to all terrestrial organisms, see Appendix III. 38 Table VII 1: Toxicological Endpoints Used to Determine Risk Quotients ( RQs) for Maneb Type of Toxicity Organism Species Toxicological Endpoint Chronic Bird mallard duck ( Anas platyrhynchos) NOAEC = 20 ppm Chronic Mammal laboratory rat ( Rattus norvegicus) NOAEL = 75 ppm b. Exposure Summary Terrestrial exposure was evaluated using estimated environmental concentrations generated from the FATE version 5.0 model that calculates the decay of a chemical applied to foliar surfaces for single or multiple applications. The model assumes initial concentrations on plant surfaces based on Kenaga predicted maximum and mean residues as modified by Fletcher et al. ( 1994) and assumes 1st order dissipation. Kenaga estimates and an explanation of the model with sample output are presented in Appendix II. A 3.2 day half life was used as the foliar dissipation half life for maneb. The selection of this half life was based on the highest value provided in the half life listing of Willis and McDowell, 1987 for maneb. This half life value is based on total foliar residues not dislodgeable foliar residues and was determined in a study by Rhodes, 1977 performed on tomatoes. EFED use the half life listing values provided in Willis and McDowell, 1987 for modeling purposes to estimate total foliar residues half lives.

c. Risk Quotients The acute risk to terrestrial animals from maneb's use are a low risk concern since maneb has been determined to be practically nontoxic to birds and mammals on an acute basis. Acute RQs were not generated for birds or mammals. Chronic concerns to terrestrial animals are exceeded when the RQ reaches 1.0. Below ( figures VII 1 through VII 4) are graphs representing maneb's potential chronic risks to non target terrestrial birds and mammals. These graphs show the chronic RQs EFED expects from terrestrial animals feeding on the food items listed. 39 1 10 100 1,000 Risk Quotient ( RQ)

Turf Almonds Apples Cranberry Grapes Onion & Garlic Onion ( green)/ Tomato PepperGrapes Bananas Corn ( pop & sweet)

Sites Mean for Fruits, Pods, Seeds, and Large Insects Max. for Fruits, Pods, Seeds, and Large Insects Mean for Tall grass Mean for Broadleaf/ Forage Plants & Small Insects Mean for Short grass Max. for Tall grass Max. for Broadleaf/ Forage Plants & Sma Max. for Short grass Maneb Avian Chronic Risk Maximum and Mean Risk Figure VII 1 40 1 10 100 Risk Quotient ( RQ)

Potato ( Maine, only) Potato Beans ( dried) Corn ( pop & sweet) Fig Papaya Cucumber, etc. Eggplant/ Sugar Beets Pepper Broccoli, etc. Tomato Kale Ornamentals Collards/ Turnip Mustard ( GA & TN, only)

Sites Mean for Fruits, Pods, Seeds, and Large Insects Max. for Fruits, Pods, Seeds, and Large Insects Mean for Tall grass Mean for Broadleaf/ Forage Plants & Small Insects Mean for Short grass Max. for Tall grass Max. for Broadleaf/ Forage Plants & S Max. for Short grass Maneb Avian Chronic Risk Maximum and Mean Risk Figure VII 2 These chronic RQs are derived from EECs based on the maximum and mean residue estimates ( see Appendix II) EFED expects on these food items following maneb's applications to various sites shown. For example, the chronic RQ for birds feeding on short grass as a result of maneb being applied to turf is over 200 at maximum residue levels and over 90 at mean residue levels ( see figure VII 1). As can be seen from these graphs, all maneb's uses exceed chronic LOCs for birds and for mammals. As a result of maneb's applications to turf, the chronic exceedances to birds range from a high RQ of 265 ( figure VII 1) from birds feeding on short grass low of 8 ( figure VII 1) from birds feeding on fruits, pods, seeds and large insects. 41 1 10 100 Risk Quotient ( RQ)

Turf Almonds Apples Cranberry Grapes Onion & Garlic Onion ( green)/ Tomato PepperGrapes Bananas Corn ( pop & sweet)

Sites Mean for Fruits, Pods, Seeds, and Large Insects Max. for Fruits, Pods, Seeds, and Large Insects Mean for Tall grass Mean for Broadleaf/ Forage Plants & Small Insects Mean for Short grass Max. for Tall grass Max. for Broadleaf/ Forage Plants & Smal Max. for Short grass Maneb Mammalian Chronic Risk Maximum and Mean Risk Figure VII 3 For mammals, the range of RQ exceedances, from maneb turf applications, is from a high of 71 ( figure VII 3) from birds feeding on short grass to a low of 2 ( figure VII 3) from birds feeding on fruits, pods, seeds and large insects. These potential risks are based on maneb's current use patterns at maximum application rates and minimum intervals between applications. It should also be noted that the applications of maneb to ornamentals and turf assumed 3 applications per crop cycle since the labeling did not indicate the number of applications that could be made. Even at this relatively low number of applications chronic LOC exceedances are high. 42 1 10 Risk Quotient ( RQ)

Potato ( Maine, only) Potato Beans ( dried) Corn ( pop & sweet) Fig Papaya Cucumber, etc. Eggplant/ Sugar Beets PepperBroccoli, etc. Tomato Kale Ornamentals Collards/ Turnip Mustard ( GA & TN, only)

Sites Mean for Fruits, Pods, Seeds, and Large Insects Max. for Fruits, Pods, Seeds, and Large Insects Mean for Tall grass Mean for Broadleaf/ Forage Plants & Small Insects Mean for Short grass Max. for Tall grass Max. for Broadleaf/ Forage Plants & Smal Max. for Short grass Maneb Mammalian Chronic Risk Maximum and Mean Risk Figure VII 4 The assumption of 100 gallons of finished spray per acre treated was also an assumption made for the application of maneb to ornamentals. If lower finished spray rates are used then the pounds of maneb applied per acre are even greater than assumed which would increase the potential risk to nontarget organisms. For some sites, there are geographic limitations on the use pattern. For example, the charts ( figures VII 1 through VII 4) will provide two use patterns for maneb's application to grapes. One use pattern pertains to applications of maneb to grapes east of the Rocky Mountains at higher application rates providing greater risk and the other listing of grapes pertains to maneb applications west of the Rocky Mountains. Please refer to Table II 1, above, for additional geographic limitations.

For a more detailed listing and explanation of maneb's risk to all terrestrial organisms, see Appendix IV. 43 Maneb's Residue from Potato Use Based on Fate v. 5.0 Modeling 0 100 200 300 400 500 600 1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 Day ppm Maneb's Avian NOAEC = 20 ppm Maneb's Mammalian NOAEL = 75 ppm Maximum Residue on Short Grass Maximum Residue on Broadleaf / Forage Plants & Small Insects Maximum Residue on Tall grass Mean Residue on Short grass Mean Residue on Broadleaf / Forage Plants & Small Insects Mean Residue on Tall grass Maximum Residue on Fruits, Pods, Seeds, and Large Insects Mean Residue on Fruits, Pods, Seeds, and Large Insects Figure VII 5 d. Terrestrial Risk Assessment The annual estimate of maneb total domestic usage averaged approximately 2,500,000 pounds active ingredient ( a. i.) for over 600,000 US acres treated. Approximately 550,000 lbs ai of maneb is applied annually to 120,000 acres of US potatoes. ( EPA use data 1987 1996) ( BEAD's Quantitative Usage Analysis for Maneb dated 10/ 1/ 1998). Maneb can be applied at the maximum rate of 1.6 lb ai/ A, 7 times per season every 5 days during the foliar stages of potatoes. In the state of Maine, maneb can be applied at the maximum rate of 1.6 lb ai/ A, 10 times per season every 5 days during the foliar stages of potatoes ( see table 1, above). Pheasant, partridge, pigeon, dove, duck, geese, songbirds, antelope, and cottontail rabbits feed in potato fields on insects, vegetation in the treated area, or on the potato plants throughout the potato growing season ( Gusey and Maturdo, 1972) which lasts 90 140 days ( depending upon the potato variety) from late Spring to early Fall. Figure VII 5, based on the maximum application rate of 1.6 lb ai/ A, applied 7 times per season every 5 days, represents an example of the maneb residues that can be expected on various avian and mammalian food items over time after an initial maneb application to potatoes on Day 1 and six subsequent application at 5 day intervals. Maneb's avian and mammalian reproductive NOAEC ( 20 ppm) and NOAEL ( 75 ppm), respectively, are also indicated in Figure VII 5 as horizontal lines. Residue levels above these lines pose a potential risk of adverse reproductive effects to the birds and/ or mammals feeding on these food items. For birds feeding on short grass this potential risk begins on Day1 44 ( maneb residues = 384 ppm) and continues through Day 46 ( maneb residues = 23 ppm) for a total exposure risk period of 46 days. For mammals, this same potential risk from feeding on short grass also begins on Day1 and continues through Day 40 ( maneb residues = 83 ppm) for a total chronic exposure risk period of 40 days.

Maneb's use on potatoes is one example of the potential chronic risk posed by maneb's use to wildlife. Figure VII 6 provides the potential chronic risk to birds and mammals from maneb's use on turf which can be applied at a maximum single application rate of 17.4 lb ai/ A (~ 11 times higher than the potato rate) every 7 days. The number of applications of maneb to turf is not specified on the labeling and as a result an assumption of 3 applications per season is being made although this could be an under estimate. For birds feeding on short grass this potential risk begins on Day1 ( maneb residues = 4,176 ppm) and continues through Day 40 ( maneb residues = 24 ppm) for a total exposure risk period of 40 days. For mammals, this same potential risk from feeding on short grass also begins on Day1 and continues through Day 34 ( maneb residues = 86 ppm) for a total exposure risk period of 34 days. 45 Maneb's Residue from Turf Use Based on Fate v. 5 Modeling 0.1 1 10 100 1000 10000 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 Day ppm Maneb's Avian NOAEC = 20 ppm Maneb's Mammalian NOAEL = 75 ppm Maximum Residue on Short Grass Maximum Residue on Broadleaf / Forage Plants & Small Insects Maximum Residue on Tall grass Mean Residue on Short grass Mean Residue on Broadleaf / Forage Plants & Small Insects Mean Residue on Tall grass Maximum Residue on Fruits, Pods, Seeds, and Large Insects Mean Residue on Fruits, Pods, Seeds, and Large Insects Figure VII 6 16 Rate reductions determined by randomly imputing application rates into ELL Fate spreadsheet program until the avian chronic risk to birds from maneb residues on short grass is less than or equal to 1.

46 Although potatoes and turf are used as examples of the wildlife exposure that can be expected from maneb's registered uses, all the sites maneb is currently being used on ( see Table II 1) would have comparable exposure levels with similar potential risks to wildlife.

In this screening level assessment, maneb's high application rates combined with repeat applications are a major reason why avian and mammalian LOCs are exceeded. Single application rates range from 1.2 lb ai/ A on collards, turnips, and mustard to 17.4 lb ai/ A on turf. Labeling allows repeat applications at these maximum rates for all maneb's uses. These high applications rates with repeat applications increases the exposure of maneb to nontarget organism. High exposure is the reason for high RQs. One way to grasp the impact of the high exposure is to use modeling to estimate the reductions needed to reduce the EECs below the LOCs. Using modeling to calculate EECs below LOCs is simply a rough estimate but does provide some insight into the extent maneb's application rates contributes to potential chronic risk to birds and mammals.

To reduce the exposure risk to birds and mammals from manebs's use on potatoes, the maximum single application rate would need to be reduced from the current 1.6 lb ai/ A to 0.05 lb ai/ A ( see figure VII 7) 16. This calls for a 32 fold decrease in the maximum application rate of maneb on potatoes. A combination of rate drops with a decrease in the number of applications per growing season could also be used to lessen the EECs. However, to reduce the potential chronic EEC exposure risk, essentially only 1 maneb application could be made to potatoes at a maximum application rate of 0.08 lb ai/ A ( see figure VII 8). This translates to a 20 fold application rate decrease and cuts out all multiples applications. Current labeling allows seven maneb applications on potatoes. 47 Maneb Chemical Name: Potatoes Use non granular Formulation Inputs lbs a. i./ acre 0.05 Application Rate days 3.2 Half life days 5 Application Interval 7 Maximum # Apps./ Year Outputs 56 Day Average Maximum Concentration Concentration ( PPM) ( PPM) 7.70 18.13 Short Grass 3.53 8.31 Tall Grass 4.33 10.20 Broadleaf plants/ Insects 0.48 1.13 Seeds 5000 Acute LC50 ( ppm) Avian 20 Chronic NOAEC ( ppm)

Chronic RQ Acute RQ ( Max. res. mult. apps.) 0.91 0.00 Short Grass 0.42 0.00 Tall Grass 0.51 0.00 Broadleaf plants/ Insects 0.06 0.00 Seeds 5000 Acute LD50 ( mg/ kg) Mammalian 75 Chronic NOAEL ( mg/ kg)

1000 g mammal 35 g mammal 15 g mammal Chronic RQ Chronic RQ Chronic RQ ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) 0.04 0.00 0.16 0.00 0.23 0.00 Short Grass 0.02 0.00 0.07 0.00 0.11 0.00 Tall Grass 0.02 0.00 0.09 0.00 0.13 0.00 Broadleaf plants/ Insects 0.00 0.00 0.01 0.00 0.01 0.00 Seeds Figure VII 7: Maneb Estimated Reduction in Application Rate to Potatoes. ( Libelo. 1999) 48 Maneb Chemical Name: Potatoes Use non granular Formulation Inputs lbs a. i./ acre 0.08 Application Rate days 3.2 Half life days 5 Application Interval 1 Maximum # Apps./ Year Outputs 56 Day Average Maximum Concentration Concentration ( PPM) ( PPM) 1.76 19.20 Short Grass 0.81 8.80 Tall Grass 0.99 10.80 Broadleaf plants/ Insects 0.11 1.20 Seeds 5000 Acute LC50 ( ppm) Avian 20 Chronic NOAEC ( ppm)

Chronic RQ Acute RQ ( Max. res. mult. apps.) 0.96 0.00 Short Grass 0.44 0.00 Tall Grass 0.54 0.00 Broadleaf plants/ Insects 0.06 0.00 Seeds 5000 Acute LD50 ( mg/ kg) Mammalian 75 Chronic NOAEL ( mg/ kg)

1000 g mammal 35 g mammal 15 g mammal Chronic RQ Chronic RQ Chronic RQ ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) 0.04 0.00 0.17 0.00 0.24 0.00 Short Grass 0.02 0.00 0.08 0.00 0.11 0.00 Tall Grass 0.02 0.00 0.10 0.00 0.14 0.00 Broadleaf plants/ Insects 0.00 0.00 0.01 0.00 0.02 0.00 Seeds Figure VII 8: Maneb Estimated Reduction in Application Rate and Number of Applications to Potatoes. ( Libelo. 1999) 49 Temporal Chronic Risk Exceedances from Maneb Residue on Short Grass 1 15 29 43 57 71 85 99 113 127 141 155 169 183 197 Papaya Bananas Onion & Garlic Cucumber, etc.

Potato ( Maine, only)

Onion ( green)/ Tomato C orn ( pop & sweet) ( East of...

Eggplant/ Sugar Beets Grapes ( East of the Rocky ...

Pepper ( East of the Mississip.. Broccoli, etc.

Pepper ( West of the Mississip.. Potato Almonds Apples Collards/ Turnip ( GA & TN, ...

Beans ( dried) Turf Tomato ( West of the Missis... Cranberry Grapes ( West of the Rocky... Ornamentals Corn ( pop & sweet)( West of...

Mustard ( GA & TN, only) Kale Fig Sites Days Birds ( NOAEC = 20 ppm) Mammals ( NOAEL = 75 ppm)

Figure VII 9 In addition to maneb's use on potatoes, maneb is also use on numerous other sites ( see Table II 1, above). Each of these groupings represent a unique use pattern based on rates of application, number of applications allowed per crop cycle or season, and minimum intervals between applications. The above risk assessment, using potatoes as an example, could be extended to each of these separate crop groupings but the conclusions for these other crop groupings would be similar to the conclusions drawn from the example of maneb's use on potatoes. In other words, all maneb's uses represent an extended potential chronic risk to birds and mammals and maneb's exposure in the environment is a major part of this risk concern.

As another example, showing the potential temporal chronic risks to birds and mammals from maneb's current uses is provided in Figure VII 9. Figure VII 9 shows the number of days maneb residues on short grass would exceed chronic LOCs for birds and mammals. For example, the maneb residues on short grass resulting from maneb's use pattern on potatoes would present a potential chronic risk to birds feeding on short grass for 46 days after the first application. This same potato use would present a potential chronic risk for 40 days to mammals feeding on short grass. 50 i. Incidents There are no incidents for maneb listed in the Ecological Incident Information System ( EIIS) data base dealing with adverse effects to terrestrial non target organisms. Even though maneb, on an acute basis, appears to pose a low risk to terrestrial animals, the chronic LOCs for terrestrial animals ( birds and mammals) are exceeded for all maneb use patterns. The incident reports submitted to EPA primarily deal with field mortality of wildlife. Chronic problems that affect wildlife from the use of maneb and it's degradate, ETU, would be expected to be largely unnoticed in the field and thus incident reports, as a result of chronic exposure, would not be anticipated.

ii. Endocrine Disruptors The avian reproductive studies reviewed by EFED noted maneb reproductive effects. EFED noted effects such as a decreases in the number of hatchlings as percentages of eggs laid, eggs set, and live 3 week old embryos, and a decrease in the number of 14 day old survivors as a percentage of eggs. HED noted maneb mammalian effects, from a reproductive study. Effects noted in rats were male parental toxicity resulting in significant increase in lung weight ( both generations) and liver weight ( F1 generation) with lesions noted on these organs in the F1 generation. These effects noted in both birds and mammals may be a result of hormonal disruptions. Based on these effects in birds and mammals, EFED recommends subjecting maneb to more definitive testing to better characterize effects related to its potential endocrine disruptor activity when the Agency's EDSP develops screening and testing methods.

iii. Endangered Species Based on available screening level information there is a potential concern for maneb's chronic effects on listed birds and mammals should exposure actually occur. EFED expects maneb poses a low acute risk to nontarget insects because maneb is practically nontoxic to honeybees, ( acute contact LD 50 > 12 µ g/ bee). Also, there is no incident data reporting adverse effects to honeybees from maneb's use. However, EFED does not assess risk to bees using RQs because a screening level RQ assessment method for estimating the risk to bees is not available. EFED has not developed an exposure design for bees to estimate the risk using a risk quotient method. The Agency does not currently have enough data to perform a screening level assessment for maneb's effects on listed nontarget terrestrial plants. Tier I seedling emergence [ guideline 122 1( a)] and vegetative vigor [ guideline 122 1( b)] studies have not been submitted for a maneb. EFED recommends these studies be submitted for review to evaluate the acute toxicity of maneb to endangered/ threatened species of terrestrial plants. Currently, EFED does not perform assessments for chronic risk to plants. 51 APPENDIX I: Notes on Fate Studies and Modeling & Additional Fate Data a. Notes on Fate Studies i. Aqueous medium studies Guidance for hydrolysis and aqueous photolysis require Parent EBDC to be applied at concentrations within the solubility range. It was established that any part of Parent EBDC that goes into solution will completely decompose, by hydrolytic reactions, into a suite of multi species residue; the EBDC complex. Reported levels of Parent EBDCs that decompose in water were near 2 ppm for metiram and in the range of 6 22 ppm for mancozeb and 6 200 ppm for maneb. Additionally, particle size reduction ( i. e. sonication) is believed to cause an increase in the level susceptibility of parent EBDCs to decomposition. In most studies, levels used in aqueous media studies were near this critical range of susceptibility, parent was determined by CS 2 and suspensions were prepared using ultrasonic. Therefore, calculated hydrolysis and/ or photolysis half lives are affected by:

( 1) Occurrence of hydrolytic decomposition during preparation of stock solution; indicated by the presence of high concentrations of transient species and degradates at time zero. Use of accurately measured nominal concentration can overcome this problem as it can be considered as time zero concentration of the test substance.

( 2) An increase of hydrolytic reactions caused by reduction of particle size by sonication; and ( 3) Nonspecificity of CS 2  determination for Parent EBDC in the presence of its hydrolytic residue because it was experimentally proven that CS 2 evolves from at least one of its constituents; EBIS.

( 4) influence of the presence of metal ions on solubility of Parent EBDC ( i. e decomposition to EBDC complex). These metal ions are introduced to the system from chemicals present in buffer solutions.

In studies were the solvent DMSO is used, no half life could be calculated for EBDCs because no Parent EBDC would be present at time zero. This solvent appears to cause complete breakage of the EBDC complex into various transformation products dominated by ETU. This means that such studies can only be used to identify effects of pH or photon energy and aging on the suite of EBDC complex present at time zero.

ii. Soil/ sediment studies Problems associated with soil sediment/ studies include:

( 1) Degradation of Parent EBDC, by decomposition in water, before time zero and when the application suspension is prepared. In most cases, resultant application suspensions were dominated by EBDC complex. Analysis was not always performed for suspensions just before application.

( 2) Extraction systems ( i. e., acetonitrile/ water or methanol/ water) appear to affect the integrity of 52 0 5 10 15 20 25 30 Time ( days) 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% 90.0% 100.0%

% of Applied Radioactivity Sandy Loam Soil Loamy Sand Soil Silty Loam Soil Approximation 0 10 20 30 40 50 60 Time ( days) 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% 90.0% 100.0%

% of Applied Radioactivity Sandy Loam Soil Loamy Sand Soil Silty Loam Soil Approximation the parent. Therefore, resultant suite of EBDC complex( in the extraction solution) was at least partly artificial and can not be used to represent the suite that might form in the environment. The use of different extraction systems made it difficult to compare results obtained from different soils.

( 3) EBDC complex has high affinity to soil and no characterization was conducted for the resultant bound species. Therefore, bound species are suspicious of containing active species that can be precursors for the degradate of concern ETU. For example, In maneb aerobic soil studies, bound species degraded after reaching a plateau in the range of 70 90%. Production of degradates and CO 2 , increased after the bound species reach the described plateau. Figure 1 shows bound radioactivity distribution with time as reported for soils in three aerobic soil studies. Definitive trend for degradation of the bound species is not apparent and is probably related to the short duration of the experiments.

( 4) Nonspecificity of CS 2  determination for Parent EBDC in the presence of its hydrolytic complex because it was experimentally proven that CS 2 evolves from at least one of its constituent; EBIS.

( 5) Chromatographic separation between Parent EBDC and various species in its residue was not conclusive and solvents used appear to affect the integrity of parent and some degradates and/ or transient species.

Figure 1. Change of bound radioactivity with time in four aerobic soils treated with maneb. 53 After considering the difficulties stated above, it is expected that species present in fate studies are those shown in Figure 2. Consequently, species expected to be present in compartments of the natural environment are those shown in Figure 3. 54 0 7 14 21 28 35 42 Time ( days); Four Applications at days: 0, 7, 14 and 21 0 1 2 3 4 5 6 7 8 EECs for Maneb Parent ( ppm)

EECs for Parent based on Hydrolysis halflife of 0.1 day b. Notes on Modeling i. EECs for Parent maneb EECs for Parent maneb are presented in the Figure 4. Data for EECs were calculated using the slope of the line for 0.1 day ( Table IV. 2); the estimated hydrolysis half. Other assumptions included:

 Application rate of 4.8 lbs a. i/ Acre applied four times at 7 day intervals;

 All applied material reached the soil and mixed with top 2" giving a zero time concentration of 7.1 ppm.

 Enough moisture is present to complete hydrolytic reactions.

Data indicate that soil EECs of parent maneb are expected to be below 0.1 ppm (. 1.4% of the applied) within one day of the first application and to completely degrade just before the second application. The same is repeated after each of the four application with negligible amounts being left within one day from the last application. This data are believed to represent concentrations in soil environments where most of the pesticide is applied. However, higher EECs is expected in dry conditions and in soils with very low water holding capacity.

Considering that only a small fraction of the applied material would reach water bodies by drift, maneb complex, not parent, is the species expected to be found in water bodies affected by drift.

Figure 4. EECs for parent maneb following four applications of 4.8 lbs a. i/ acre applied four times at 7 day intervals.

ii. Background Information on the PRZM and EXAMS models & the Index Reservoir Scenario The linked PRZM and EXAMS models are used in this case as a second tier screen designed to estimate the pesticide concentrations found in water for use in drinking water assessments. They provide high end values on the concentrations that might be found in a small drinking water reservoir 55 due to the use of pesticide. The Drinking Water Index Reservoir scenario includes a 427 acres field immediately adjacent to a 13 acres reservoir, 9 feet deep, with continuous site specific flow. This amount can be reduced due to degradation in field and the effect of binding to soil. Spray drift is equal to 6.4% of the applied concentration from the ground spray application and 16% for aerial applications.

The PRZM/ EXAMS modeling system with the Index Reservoir scenario also makes adjustments for the percent cropped area. While it is assumed that the entire watershed would not be treated, the use of a PCA is still a screen because it represents the highest percentage of crop cover of any large watershed in the US, and it assumes that the entire crop is being treated. Various other conservative assumptions of this scenario include the use of a small drinking water reservoir surrounded by a runoff prone watershed, the use of the maximum use rate and no buffer zone.

iii. Background Information on SCIGROW SCI GROW is a screening model which the Office of Pesticide Programs ( OPP) in EPA frequently uses to estimate pesticide concentrations in vulnerable ground water. The model provides an exposure value which is used to determine the potential risk to the environment and to human health from drinking water contaminated with the pesticide. The SCI GROW estimate is based on environmental fate properties of the pesticide ( aerobic soil degradation half life and linear adsorption coefficient normalized for soil organic carbon content), the maximum application rate, and existing data from small scale prospective ground water monitoring studies at sites with sandy soils and shallow ground water.

Pesticide concentrations estimated by SCI GROW represent conservative or high end exposure values because the model is based on ground water monitoring studies which were conducted by applying pesticides at maximum allowed rates and frequency to vulnerable sites ( i. e., shallow aquifers, sandy, permeable soils, and substantial rainfall and/ or irrigation to maximize leaching). In most cases, a large majority of the use areas will have ground water that is less vulnerable to contamination than the areas used to derive the SCI GROW estimate. SCIGROW provides a groundwater screening exposure value to be used in determining the potential risk to human health from drinking water contaminated with the pesticide. SCIGROW estimates likely groundwater concentrations if the pesticide is used at the maximum allowable rate in areas where groundwater is exceptionally vulnerable to contamination. In most cases, a large majority of the use area will have groundwater that is less vulnerable to contamination than the areas used to derive the SCIGROW estimate.

c. Additional Fate Data The following are additional fate data maneb complex mobility:

First study ( MRID 000658 59):

14C maneb mobility was investigated by the TLC method in which determined R f values ranged from 0.0 to 0.43 ( Table1). These values were taken to indicate immobility to medium mobility of the test 56 substance which is believed to be a mixture of maneb degradation products ( maneb was not identified even at time zero).

Table 1. Soil characteristics and the adsorption parameters of the soils used in the 1st adsorption/ desorption study.

Soil Name Celeryville muck Lakeland SL Barnes CL Hagerstown SiCL Norfolk SL Textural Class Muck soil Sandy Loam Clay Loam Silty Clay Loam Sandy Loam Clay Not determined 12% 34.4% 39.5% 11%

pH ( water) 5.0 6.4 7.4 6.8 5.1 Field Capacity 113.0% 8.5% 28.5 25.8% 6.5%

Organic Carbon 52.56% 0.52% 4.01% 1.45% 0.08%

R f 0.00 0.10 0.17 0.42 Mobility Class Immobile Slight Medium Second study ( MRID 405852 03):

A 30 day aged 14C maneb complexs were slightly mobile in a column ( 30 cm length, 5 cm diameter) of loamy sand soil leached with 51 cm ( 20 inches, 1 L) of water for 24 hours. The radioactivity profile was used, for this RED, to calculate K d ( 35.7) and K oc ( 1,692). Only 2.6% of the applied radioactivity was recovered in the leachate. ETU and EU ( present in the 30 day aged soil in un quantified amounts) exhibited mobility and were the major components in the leachate; ETU, EU, and three unidentified degradates were isolated in the leachate at 1.8, 0.2, and < 0.6% of the radioactivity applied to the soil column, respectively. The majority of the radioactivity ( 93.3% of radioactivity applied to the column) remained in the upper 10 cm ( 4 inches) of the soil column. In the soil column, ETU, EBIS, carbimid, and five unidentified degradates were isolated.

Third study ( MRID 400472 01):

14C maneb complex exhibited variable mobility in four different texture soils in columns ( 12" long, 3'' diameter) leached with constant/ simulated 20" rainfall using de ionized water. The radioactivity profile was used, for this RED, to calculate the K d and K oc values presented in Table2. Data indicate that maneb complexes ( a mixture of degradates not parent) can be classified as immobile, low, and medium mobile in sand, sandy loam, and clay loam/ silty loam, respectively. The radioactivity depth profile showed that most of the applied radioactive residues were found at the top one inch segment of the soil columns. Radioactivity found in the leachate ranged from 9.5 to 32% of the applied. Neither maneb nor its known two degradate ETU/ EU were identified in any of the leachates as radioactivity in these leachates were left unidentified. 57 Table 2. Soil characteristics and the adsorption parameters of the soils used in the 3rd study.

Source Georgia Georgia Pennsylvania Mississippi Soil Textural Class Sand Sandy Loam Clay Loam Silt Loam Clay 4% 14% 28% 10%

pH ( water) 6.5 5.8 7.0 7.7 Field Capacity 7.8% 14.1% 29.1% 17.4%

C. E. C ( meq/ 100 g) 3.8 9.1 15.7 7.6 Organic Carbon 0.12% 0.93% 1.63% 0.58%

K ad 7.46 9.10 6.97 2.23 K oc 6,412 978 428 400 Mobility Class Immobile Low Medium Fourth/ fifth study ( MRID 455959 01/ 02):

In the 4th study, 14C maneb, aged for five hours in the application solution, was studied in duplicate Speyer 2.1 soil columns that were leached with 200 mm ( 393 ml) of water over a period of two days. Each 30 cm. soil column was purged with CO 2 to remove oxygen and was fortified with 0.621 mg of the aged 14C maneb. Total 14C residues were not identified but were nearly 54% of the applied radioactivity in the top 6 cm soil layer and ranged from 9 2%, in the four segments below the top layer. Total [ 14C] residues recovered in the leachate accounted for nearly 13% of the applied. In this leachate, 14C maneb was not detected but two of its transformation products EU ( 3.5 3.8%) and ETU ( 0.1 0.2%) were identified. Additionally, five unknown radioactive fractions were detected in the leachate, with the metabolite with the highest concentration totaling 2.7 2.9% of the applied. None of the other four degradates exceeded 1.0% of the applied. Estimated K ad / K oc and related soil characteristics for this soil are included in Table 3.

Soil column leaching experiments were conducted in the 5th study using three soils ( Speyer 2.1/ 2.2 and 2.3) and the same procedure used in the fourth study. However, the source of 14C maneb was from the active ingredient of a wettable powder formulation ( MRID 455959 02). Following leaching, total [ 14C] residues in the soil ( all layers) ranged from 76.6 to 84.3% of the applied from each duplicate soil column and total [ 14C] residues in the leachate ranged from 1.5 to 4.7%.

In the Speyer 2.1 soil, total [ 14C] residues were 71.6 73.8% of the applied radioactivity in the top 6 cm soil layer and were 4.9%, 2.7 3.0%, 1.4 1.7%, and 0.9 1.2%, respectively, in the four segments below the top layer proceeding from top to bottom. [ 14C] Residues in the soil were not identified. A total of 3.4 4.7% of the applied was recovered in the leachate. Radioactivity detected in the leachate was comprised of seven unknown fractions, with no single fraction detected at greater than 58 1.5% of the applied. The material balance was 85.3% and 89.0% of the applied for the duplicate columns.

In the Speyer 2.2 soil, total [ 14C] residues were 70.5 74.5% of the applied radioactivity in the top 6 cm soil layer and were 2.5 4.2%, 1.1 1.2%, 0.4 0.6%, and 0.3%, respectively, in the four segments below the top layer proceeding from top to bottom. [ 14C] Residues in the soil were not identified. A total of 1.5 1.6% of the applied was recovered in the leachate. Radioactivity detected in the leachate was comprised of seven unknown fractions, with no single fraction detected at greater than 0.6% of the applied. The material balance was 78.2% and 80.5% of the applied for the duplicate columns.

In the Speyer 2.3 soil, total [ 14C] residues were 67.5 67.9% of the applied radioactivity in the top 6 cm soil layer and were 4.8 6.9%, 3.5 4.4%, 1.6 2.4%, and 0.8 1.7%, respectively, in the four segments below the top layer proceeding from top to bottom. [ 14C] Residues in the soil were not identified. A total of 2.1 3.9% of the applied was recovered in the leachate. Radioactivity detected in the leachate was comprised of seven unknown fractions, with no single fraction detected at greater than 2.5% of the applied. The material balance was 83.3% and 84.1% of the applied for the duplicate columns.

Estimated K ad / K oc and related soil characteristics for the three German soils are included in Table 3.

Table 3. Soil characteristics and the adsorption parameters of the soils used in the 4th/ 5th studies.

Soil Name Speyer 2.1 Speyer 2.2 Speyer 2.3 Soil Textural Class Sand Loamy sand Sandy loam 14C maneb source Pure a. i ( a. i) from a wettable powder formulation Clay 4% 5% 8%

pH ( water) 6.1 6.0 6.9 C. E. C ( meq/ 100 g) 4.9 9.7 9.5 Organic Carbon 0.70% 2.29% 1.34%

K ad 3.18 10.21 25.96 13.72 K oc 454 1,459 1,133 1,024 Mobility Class Medium Low 59 APPENDIX II: Hoerger Kenaga Estimates & Fate v. 5.0 Model a. Hoerger Kenaga Estimates EFED uses Hoerger and Kenaga estimates ( 1972) as changed by Fletcher and other researchers ( 1994) to estimate the residues on plants and insects. Hoerger Kenaga categories represent preferred foods of various terrestrial vertebrates. Upland game birds prefer fruits and bud and shoot tips of leafy crops. Hares and hoofed mammals consume leaves and stems of leafy crops. Rodents consume seeds, seedpods and grasses; and various birds, mammals, reptiles and terrestrial phase amphibians consume insects. Terrestrial vertebrates also may contact pesticides applied to soil by swallowing pesticide granules or pesticide laden soil when foraging. Rich in minerals, soil comprises 5 to 30% of dietary intake by many wildlife species ( Beyer and Conner).

Hoerger and Kenaga based pesticide environmental concentration estimates on residue data correlated from more than 20 pesticides on more than 60 crops. These estimates are representative of many geographic regions ( 7 states) and a wide array of cultural practices. Hoerger Kenaga estimates also considered differences in vegetative yield, surface to mass ratio and interception causes. In 1994, Fletcher, Nellessen and Pfleeger reexamined the Hoerger Kenaga simple linear model ( y= B1x, where x= application rate and y= pesticide residue in ppm) to decide whether the terrestrial EEC's were accurate. They compiled a data set of pesticide day 0 and residue decay data involving 121 pesticides ( 85 insecticides, 27 herbicides, and 9 fungicides from 17 different chemical classes) on 118 species of plants. After analyzes, their conclusions were that Hoerger Kenaga estimates needed only minor changes to increase the predictive values. They recommended an increase for forage and fruit categories from 58 to 135 ppm and from 7 to 15 ppm, respectively. Otherwise, the Hoerger Kenaga estimates were accurate in predicting the maximum residue values after a 1 lb ai/ acre application. Mean values represent the arithmetic mean of values from samples collected the day of pesticide treatment. The values in the table below are the predicted 0 day maximum and mean residues of a pesticide that may occur on selected avian, mammalian, reptilian or terrestrial phase amphibian food items. These predicted residues occur immediately following a direct single application at a 1 lb ai/ acre application rate. For pesticides applied as a nongranular product ( for example, liquid or dust), EFED compared the estimated environmental concentrations ( EECs) on food items following product application to LC 50 values to assess risk. EFED based the estimated environmental concentrations of ETU on food items on Kenaga maximum and mean predicted values.

Estimated Environmental Concentrations on Avian and Mammalian Food Items ( ppm) Following a Single Application at 1 lb ai/ A)

Food Items EEC ( ppm) Predicted Maximum Residue1 EEC ( ppm) Predicted Mean Residue1 Short grass 240 85 Tall grass 110 36 Broadleaf/ forage plants and small insects 135 45 Fruits, pods, seeds, and large insects 15 7 1 Predicted maximum and mean residues are for a 1 lb ai/ a application rate and are based on Hoerger and Kenaga ( 1972) as modified by Fletcher et al. ( 1994). 60 b. Fate v. 5.0 Model Terrestrial Exposure Values The model assumes a first order decay to fix the concentration at each day after first application based on the concentration resulting from the first and more applications. The model calculates decay from the first order rate equation:

CT = Cie kT or in integrated form: ln ( CT/ Ci) =  kT Where:

CT = concentration at time T on day zero Ci = concentration in parts per million ( ppm) present initially ( on day zero) on the surfaces. The model calculates Ci based on Kenaga and Fletcher by multiplying the application rate, in pounds active ingredient per acre. The model multiplies the application rate by 240 ( mean of 85) for short grass, 110 ( mean of 36) for tall grass, and 135 ( mean of 45) for broad leaf plants and insects and 15 ( mean of 7) for seeds. The model converts extra applications from pounds active ingredient per acre to PPM on the plant surface and the addition mass added to the mass of the chemical still present on the surfaces on the day of application.

k= degradation rate constant determined from studies of hydrolysis, photolysis, microbial degradation, etc. Since degradation rate is reported by half life, the model calculates the rate constant from the half life ( k = ln 2/ T1/ 2). Choosing the degradation rate and half life to use in terrestrial exposure calculations is open for debate and should be done by a qualified scientist.

T= time, in days, since the start of the simulation. The first application is on day 0. The simulation runs for the number of days entered by the modeler.

The program calculates concentration on each surface on a daily interval for the number of days entered by the modeler. The modeler chooses the days based on the guidance provided in Urban, 2000. The modeler uses the following formula with acute exposure addition of 30 days or the chronic exposure addition of 60 days:

maximum number of applications crop cycle or season minimum interval between applications ( days) + 30 or 60 days *

The model calculates maximum and mean EECs based on the maximum and mean Kenaga Fletcher values listed in Table 1 above. These EECs are the maximum amounts collecting on each day during the interval chosen. The model calculates these EECs for the different food item groupings. 61 c. Fate v. 5.0 Model Sample Outputs for Maneb RUN No. 2 FOR maneb ON apples *** INPUT VALUES ***  RATE(#/ AC) APPLICATIONS HALF LIFE AVIAN( ppm) MAMMALIAN( mg/ kg) ONE( MAX) NO. INTERVAL ( DAYS) LC50 NOAEC LD50 NOAEL  4.800( 6.136) 4 7 3.2 ******* 20.000 ******* 75.000 MAXIMUM & 58 DAY AVERAGE KENAGA/ FLETCHER RESIDUES: 95th% ( mean) in ppm  SHORT BROADLEAF TALL SEED GRASS & INSECTS GRASS FRUIT ____________________ ________________ ________________ ________________ MAX1472.61( 521.55) 828.34( 276.11) 674.95( 220.89) 92.04( 42.95) ____________________ ________________ ________________ ________________ AVE 144.46( 229.44) 76.48( 186.95) 61.18( 25.49) 11.90(

ENDPOINT SHORT GRASS RQ BR LEAF& INS RQ TALL GRASS RQ SEED FRUIT RQ ________ _______________ _______________ _______________ ______________ AV CHRON 73.63( 26.08) 41.42( 13.81) 33.75( 11.04) 4.60( 2.15) MA CHRON 19.63( 6.95) 11.04( 3.68) 9.00( 2.95) 1.23( .57)

Below are lists of daily Kenaga Flether pesticide residue values for four avian/ mammalian food groupings for maneb use on turf Values are in parts per million ( ppm).

SHORT BROADLEAF TALL SEED GRASS & INSECTS GRASS FRUIT DAILY DAILY DAILY DAILY VALUES VALUES VALUES VALUES DAY 95% MEAN 95% MEAN 95% MEAN 95% MEAN ___ _______________ _______________ _______________ _______________

1 4176.00 1479.00 2349.00 783.00 1914.00 626.40 261.00 121.80 2 3362.70 1190.96 1891.52 630.51 1541.24 504.41 210.17 98.08 3 2707.80 959.01 1523.14 507.71 1241.08 406.17 169.24 78.98 4 2180.44 772.24 1226.50 408.83 999.37 327.07 136.28 63.60 5 1755.79 621.84 987.63 329.21 804.74 263.37 109.74 51.21 6 1413.84 500.74 795.29 265.10 648.01 212.08 88.37 41.24 7 1138.49 403.22 640.40 213.47 521.81 170.77 71.16 33.21 8 5092.76 1803.69 2864.68 954.89 2334.18 763.91 318.30 148.54 9 4100.92 1452.41 2306.77 768.92 1879.59 615.14 256.31 119.61 10 3302.25 1169.55 1857.51 619.17 1513.53 495.34 206.39 96.32 11 2659.12 941.77 1495.75 498.58 1218.76 398.87 166.19 77.56 12 2141.24 758.36 1204.45 401.48 981.40 321.19 133.83 62.45 13 1724.23 610.66 969.88 323.29 790.27 258.63 107.76 50.29 14 1388.42 491.73 780.99 260.33 636.36 208.26 86.78 40.50 15 5294.02 1874.97 2977.89 992.63 2426.43 794.10 330.88 154.41 16 4262.99 1509.81 2397.93 799.31 1953.87 639.45 266.44 124.34 17 3432.75 1215.77 1930.92 643.64 1573.34 514.91 214.55 100.12 18 2764.20 978.99 1554.87 518.29 1266.93 414.63 172.76 80.62 19 2225.86 788.33 1252.05 417.35 1020.19 333.88 139.12 64.92 20 1792.36 634.80 1008.21 336.07 821.50 268.85 112.02 52.28 21 1443.29 511.17 811.85 270.62 661.51 216.49 90.21 42.10 62 22 1162.20 411.61 653.74 217.91 532.68 174.33 72.64 33.90 23 935.86 331.45 526.42 175.47 428.94 140.38 58.49 27.30 24 753.60 266.90 423.90 141.30 345.40 113.04 47.10 21.98 25 606.83 214.92 341.34 113.78 278.13 91.02 37.93 17.70 26 488.65 173.06 274.86 91.62 223.96 73.30 30.54 14.25 27 393.48 139.36 221.33 73.78 180.35 59.02 24.59 11.48 28 316.85 112.22 178.23 59.41 145.22 47.53 19.80 9.24 29 255.14 90.36 143.52 47.84 116.94 38.27 15.95 7.44 30 205.45 72.76 115.57 38.52 94.16 30.82 12.84 5.99 31 165.44 58.59 93.06 31.02 75.83 24.82 10.34 4.83 32 133.22 47.18 74.94 24.98 61.06 19.98 8.33 3.89 33 107.27 37.99 60.34 20.11 49.17 16.09 6.70 3.13 34 86.38 30.59 48.59 16.20 39.59 12.96 5.40 2.52 35 69.56 24.64 39.13 13.04 31.88 10.43 4.35 2.03 36 56.01 19.84 31.51 10.50 25.67 8.40 3.50 1.63 37 45.10 15.97 25.37 8.46 20.67 6.77 2.82 1.32 38 36.32 12.86 20.43 6.81 16.65 5.45 2.27 1.06 39 29.25 10.36 16.45 5.48 13.40 4.39 1.83 .85 40 23.55 8.34 13.25 4.42 10.79 3.53 1.47 .69 41 18.96 6.72 10.67 3.56 8.69 2.84 1.19 .55 42 15.27 5.41 8.59 2.86 7.00 2.29 .95 .45 43 12.30 4.35 6.92 2.31 5.64 1.84 .77 .36 44 9.90 3.51 5.57 1.86 4.54 1.49 .62 .29 45 7.97 2.82 4.48 1.49 3.65 1.20 .50 .23 46 6.42 2.27 3.61 1.20 2.94 .96 .40 .19 47 5.17 1.83 2.91 .97 2.37 .78 .32 .15 48 4.16 1.47 2.34 .78 1.91 .62 .26 .12 49 3.35 1.19 1.89 .63 1.54 .50 .21 .10 50 2.70 .96 1.52 .51 1.24 .40 .17 .08 51 2.17 .77 1.22 .41 1.00 .33 .14 .06 63 APPENDIX III: Ecological Hazards Assessment a. Overview The toxicity testing required does not test all species of birds, fish, mammals, invertebrates, and plants. EFED uses only two surrogate species for birds ( Bobwhite quail and mallard ducks) to represent all bird species ( over 900 in the US). EFED uses three species of freshwater fish ( rainbow trout, bluegill sunfish and fathead minnow) to act as surrogate test species for all freshwater fish species ( over 900 in the US). One estuarine fish species ( sheepshead minnow) serves as surrogate for all estuarine and marine fish ( over 300 in the US). The surrogate species for terrestrial invertebrates is the honeybee. For freshwater invertebrates the surrogate species is usually the waterflea ( Daphnia magna). For estuarine and marine invertebrates the surrogate species are mysid shrimp and eastern oyster. EFED uses these four species to represent all invertbrates species ( over 10,000 in the US). For plants, there are ten surrogate species used for all terrestrial plants and five surrogate species used for all aquatic plants. There are over 20,000 plant species in the US which includes flowering plants, conifers, ferns, mosses, liverworts, hornworts and lichens. There are over 27,000 species of algae worldwide.

The surrogate species testing scheme used in this assessment assumes that a chemical's method of action and toxicity found for avian species is similar to that in all reptiles ( over 300 species in the US). The same assumption applies to amphibians ( over 200 species in the US) and fish. EFED assumes the tadpole stage of amphibians has the same sensitivity as a fish. Therefore, EFED considers the results from toxicity tests on surrogate species are applicable to other member species within their class and extrapolates this toxicity to reptiles and amphibians. EFED got the US species numbers noted in this section from: http:// www. natureserve. org/ summary ( NatureServe: An online encyclopedia of life [ web application]. 2000) and the worldwide species number from Ecological Planning and Toxicology, Inc. 1996.

b. Toxicity to Terrestrial Animals i. Birds, Acute, Subacute and Chronic An acute oral toxicity study using the technical grade of the active ingredient ( TGAI) is required to establish the toxicity of maneb to birds. The avian oral LD 50 is an acute, single dose laboratory study designed to estimate the quantity of toxicant required to cause 50% mortality in a test population of birds. The preferred test species is either the Mallard Duck, a waterfowl, or Bobwhite quail, an upland gamebird. The TGAI is administered by oral intubation to adult birds, and the results are expressed as LD 50 milligrams ( mg) active ingredient ( a. i.) per kilogram ( kg). Toxicity category descriptions are as follows ( Brooks, 1973):

If the LD50 is less than 10 mg a. i./ kg, then the test substance is very highly toxic. If the LD50 is 10 to 50 mg a. i./ kg, then the test substance is highly toxic. If the LD50 is 51 to 500 mg a. i./ kg, then the test substance is moderately toxic. If the LD50 is 501 to 2,000 mg a. i./ kg, then the test substance is slightly toxic. 64 If the LD50 is greater than 2,000 mg a. i./ kg, then the test substance is practically nontoxic.

Study results are in the table below.

Table 1. Avian Acute Oral Toxicity  Maneb Species % ai LD50 ( mg/ kg) Toxicity Category MRID/ Author/ Year Classification Northern bobwhite ( Colinus virginianus) 86 ( doses were adjusted to 100% ai) > 2,150 practically nontoxic 40657001/ D. Fletcher/ 1988 Core The avian acute oral toxicity of maneb is > 2150 mg/ kg, categorizing maneb as slightly to practically nontoxic to birds. The guideline 71 1( a) is fulfilled ( MRID 40657001).

Two dietary studies using the TGAI are required to establish the toxicity of maneb to birds. These avian dietary LC 50 tests, using the Mallard Duck and Bobwhite Quail, are acute, eight day dietary laboratory studies designed to estimate the quantities of toxicant required to cause 50% mortality in the two respective test populations of birds. The TGAI is administered by mixture to juvenile birds' diets for five days followed by three days of " clean" diet, and the results are expressed as LC 50 parts per million ( ppm) active ingredient ( a. i.) in the diet. Toxicity category descriptions are as follows ( Brooks, 1973):

If the LC50 is less than 50 ppm a. i., then the test substance is very highly toxic. If the LC50 is 50 to 500 ppm a. i., then the test substance is highly toxic. If the LC50 is 501 to 1,000 ppm a. i., then the test substance is moderately toxic. If the LC50 is 1001 to 5,000 ppm a. i., then the test substance is slightly toxic. If the LC50 is greater than 5,000 ppm a. i., then the test substance is practically nontoxic.

Study results are tabulated below.

Table 2. Avian Subacute Dietary Toxicity  Maneb Species % ai LC50 ( ppm) Toxicity Category MRID/ Author/ Year Study Classification Bobwhite Quail ( Colinus virginianus) assumed to be 100% > 10,000 practically nontoxic 00104264/ R. Fink/ 1975 Supplemental1 Mallard Duck ( Anas platyrhynchos) assumed to be 100% > 10,000 practically nontoxic 00098561/ Truslow Farms, Inc../ 1975 Supplemental2 Mallard Duck ( Anas platyrhynchos) 86 ( doses were adjusted to 100% ai) > 5,000 practically nontoxic 40657002/ D. Fletcher/ 1988 Core 1 Although classified supplemental, the study was found to fulfill the guideline requirement ( see Maneb 1988 Registration Standard). 2 Study was classified supplemental, but upgradeable if growth data and dose mortality could be provided. 65 With LC50 values ranging from greater than 5,000 ppm for mallard ducks to greater than 10,000 ppm for bobwhite quail, maneb is considered to be practically nontoxic to birds. Guideline 71 2( a) for bobwhite is fulfilled ( MRID 00104264). Guideline 71 2( b) for mallard duck is also considered fulfilled ( MRID 40657002).

Avian reproduction studies using the Bobwhite Quail and Mallard Duck are laboratory tests designed to estimate the quantity of toxicant required to adversely affect the reproductive capabilities of a test population of birds. The TGAI is administered by mixture to breeding birds' diets throughout their breeding cycle. Test birds are approaching their first breeding season and, generally, are 18 to 23 weeks old. The onset of the exposure period is at least 10 weeks prior to egg laying. Exposure period during egg laying is generally 10 weeks with a withdrawal period of three additional weeks if reduced egg laying is noted. Results are expressed as No Observed Adverse Effect Concentration ( NOAEC) and various observable effect levels, such as the Lowest Observable Adverse Effect Concentration ( LOAEC), quantified in units of parts per million of active ingredient ( ppm) in the diet. Study results are tabulated below .

Table 3. Avian Reproduction  Maneb Species/ Study Duration % ai NOAEC/ LOAEC ( ppm) LOAEC Endpoints MRID/ Author/ Year Classification Northern bobwhite ( Colinus virginianus) / 22 weeks 91.0 > 500 ( highest dose tested)/ LAOEC not determined not determined 43586501/ Beavers et. al./ 1995 Supplemental1 Mallard Duck ( Anas platyrhynchos) / 22 weeks 91.0 20/ 100 Reduction in the number of hatchlings as percentages of eggs laid, eggs set, and live 3 week old embryos, and a reduction in the number of 14 day old survivors as a percentage of eggs set. 43586502/ Beavers et. al./ 1995 Core 1 study was classified supplemental because a NOAEC was not established.

The avian reproduction study using mallard duck resulted in a LOAEC of 100 ppm based on a reduction in the: ( 1) number of hatchlings as percentages of eggs laid, ( 2) number of eggs set; ( 3) number of live 3 week old embryos; and ( 4) number of 14 day old survivors as a percentage of eggs set when compared to the control. The NOAEC is 20 ppm. The guideline 71 4( b) is fulfilled ( MRID 43586502).

The avian reproduction study using bobwhite resulted in a NOAEC greater than 500 ppm, the highest dose tested. This study was classified supplemental because an NOAEC was not established. Although a core study is not available, the mallard has been shown to be more the more sensitive of the two species, and will be used for risk assessment purposes. Additional reproductive testing is not required. Guideline 71 4( a) is considered fulfilled ( MRID 43586501). 66 ii. Mammals, Acute and Chronic 1. Acute Oral Toxicity Testing Wild mammal testing is required on a case by case basis, depending on the results of lower tier laboratory mammalian studies, intended use pattern and pertinent environmental fate characteristics. In most cases, rat or mouse toxicity values obtained from the Agency's Health Effects Division ( HED) substitute for wild mammal testing. The toxicity values used in this assessment were taken from HED's Tox One Liner, and the final Hazard Identification Assessment Review Committee ( HIARC) reports on maneb ( dated 11/ 15/ 99 and 11/ 27/ 01). The results indicate that maneb is practically nontoxic to mammals on an acute oral basis with LD 50 value greater than 5,000 mg / kg ( see Table 4, below). The toxicity values ( LD 50 and NOAEL) appearing in the shaded areas of the tables will be used to calculate the acute and chronic mammalian risk quotients ( RQ's) in subsequent sections. Toxicity category descriptions are the following ( Brooks, 1973):

If the LD50 is less than 10 mg a. i./ kg, then the test substance is very highly toxic. If the LD50 is 10 to 50 mg a. i./ kg, then the test substance is highly toxic. If the LD50 is 51 to 500 mg a. i./ kg, then the test substance is moderately toxic. If the LD50 is 501 to 2,000 mg a. i./ kg, then the test substance is slightly toxic. If the LD50 is greater than 2,000 mg a. i./ kg, then the test substance is practically nontoxic.

Table 4. Mammalian Acute Toxicity  Maneb Species % ai Test Type LD50 ( mg/ kg) Toxicity Category) Affected Endpoints MRID Technical laboratory rat ( Rattus norvegicus) laboratory not reported oral  single dose > 5,000 practically nontoxic mortality 41975601 2. Acute Dermal and Inhalation Toxicity Testing In addition to acute oral routes of exposure, terrestrial vertebrates entering treatment area may be acutely exposed to maneb through other routes of exposure. Results of toxicological testing indicate maneb is a Category III toxicant to rats via the inhalation route ( LC50> 1.3 mg/ L; MRID 41975603) and to rabbits via the dermal route of exposure ( LD50 > 2000 mg/ kg; MRID 41975602).

Toxicity category descriptions associated with inhalation routes of exposure include the following ( US EPA CFR. Part 156):

If the LC50 is less than or equal to 0.05 mg/ liter, then the test substance is in Toxicity Category I. If the LC50 is greater than 0.05 mg/ liter through 0.5 mg/ liter, then the test substance is in Toxicity Category II. If the LC50 is greater than 0.5 mg/ liter through 2.0 mg/ liter, then the test substance is in Toxicity Category III If the LC50 is greater than 2.0 mg/ liter, then the test substance is in Toxicity Category IV. 67 Toxicity category descriptions associated with dermal routes of exposure include the following ( US EPA CFR. Part 156):

If the LD50 is less than or equal to 200 mg/ kg, then the test substance is in Toxicity Category I. If the LD50 is greater than 200 through 2,000 mg/ kg, then the test substance is in Toxicity Category II. If the LD50 is greater than 2,000 through 5,000 mg/ kg, then the test substance is in Toxicity Category III If the LD50 is greater than 5,000 mg/ kg, then the test substance is in Toxicity Category IV.

3. Mammalian Feeding, Reproductive and Developmental Toxicity Testing Based on a 13 week maneb feeding study in rats ( see Table 5), thyroid effects, namely, increased thyroid weights and follicular cell hyperplasia ( abnormal increase) in males and decreased thyroxine ( a thyroid hormone) levels in both sexes were noted at a LOAEL of 400 ppm ( NOAEL = 80 ppm) ( MRID No. 40982601). In a maneb developmental study on rats, treatment related developmental effects caused by maneb resulted in increased post implantation ( embedding of fertilized egg in uterine lining) loss, increased resorption ( total and resorption per dam), and decreased fetal viability at a LOAEL of 1,000 ppm ( NOAEL = 200 ppm) ( MRID No. 42520001). A two generation reproductive study on rats using maneb provided a LOAEL of 300 ppm ( NOAEL = 75 ppm) for paternal toxicity causing an increase in lung weight in both generations ( F0, parent and F1, first generation of offspring) and liver weight in F1. An increased incidence of diffuse follicular epithelial hypertrophy/ hyperplasia was also noted in F1. Fetal effects based on slight delay in the startle response in the offspring were also noted at a LOAEL of 300 ppm ( NOAEL = 75 ppm) in this twogeneration reproductive study ( MRID No. 42049401). 68 Table 5. Mammalian Feeding, Developmental and Reproductive Chronic Toxicity  Maneb Technical Species/ Study Duration % ai Test Type NOAEL/ LOAEL Toxicity ( mg/ kg/ day) Affected Endpoints MRID laboratory rat ( Rattus norvegicus) / 13 weeks 77.9 Feeding 5/ 24 ( 80/ 400 ppm) male 6/ 30 ( 80/ 400 ppm) female Based on thyroid effects ( increased thyroid weights and follicular cell hyperplasia in males) and decreased T 4 ( thyroxine, a thyroid hormone). 40982601 laboratory rat ( Rattus norvegicus) / gestation ( days 6 15) 90.4 Developmental 20/ 100 ( 400/ 2,000 ppm) 1 ( maternal) 20/ 100 ( 200/ 1,000 ppm) 1 ( developmental) mat.  based on increased clinical signs ( soft stool), decreased body weight gain and decreased food consumption dev.  based on increased post implantation ( embedding of fertilized egg in uterine lining) loss, increased resorption ( total and resorption per dam), and decreased fetal viability 42520001 laboratory rat ( Rattus norvegicus) / 2 generation 87.3 Reproductive ( 75/ 300 ppm) 2 ( parental) ( 300/ 1,200 ppm) 2 ( reproductive) ( 75/ 300 ppm) 2 ( fetal) parental ( paternal)  based on a significant increase in lung ( both generations) and liver ( F1) weight and an increased incidence of diffuse follicular epithelial hypertrophy/ hyperplasia ( F1) parental ( maternal)  based on decreased body weight/ body weight gain and food consumption reproductive  based on delayed vaginal opening in the F1 female offspring fetal  based on slight delay in the startle response in the offspring 42049401 1 ppm conversion based on: 1 mg/ kg/ day = 20 ppm in adult rats, and 10 ppm in younger rats. ( Nelson, 1975) 2 ppm value provided in study review iii. Insect Acute Contact A honey bee acute contact study using the TGAI is required for maneb because its outdoor use will result in honey bee exposure. The acute contact LD 50 , using the honey bee, Apis mellifera, is an acute contact, single dose laboratory study designed to estimate the quantity of toxicant required to cause 50% mortality in a test population of bees. The TGAI is administered by one of two methods: whole body exposure to technical pesticide in a nontoxic dust diluent; or, topical exposure to technical pesticide via micro applicator. The median lethal dose ( LD 50 ) is expressed in micrograms of active ingredient per bee (: g a. i./ bee). Toxicity category descriptions are as follows:

If the LD50 is less than 2 : g a. i./ bee, then the test substance is highly toxic. If the LD50 is 2 to less than 11 : g a. i./ bee, then the test substance is moderately toxic. If the LD50 is 11 : g a. i./ bee or greater, then the test substance is practically nontoxic Study results are tabulated below. 69 Table 6. Non target Insect Acute Contact Toxicity  Maneb Species % ai LD50 ( µ g/ bee) Toxicity Category MRID/ Author/ Year Study Classification Honey bee ( Apis mellifera) not reported > 12.09 practically nontoxic 00036935/ Atkins et. al./ 1975 Core The LD 50 for maneb is greater than 12.09 : g per bee, classifying maneb as practically nontoxic to bees. Guideline ( 141 1) is fulfilled ( MRID 00036935).

iv. Insect Residual Contact Honey bee toxicity of residues on foliage study is required on an end use product for any pesticide intended for outdoor application when the proposed use pattern indicates that honey bees may be exposed to the pesticide and when the formulation contains one or more active ingredients having an acute contact honey bee LD 50 which falls in the moderately toxic or highly toxic range. Since maneb is practically nontoxic to honey bees a honey bee toxicity of residues on foliage ( Guideline 141 2) is not required.

v. Terrestrial Field Testing No studies were submitted and no studies are required.

c. Aquatic Organism Toxicity i. Toxicity to Freshwater Animals 1. Freshwater Fish, Acute Two freshwater fish toxicity studies using the TGAI are required to establish the toxicity of maneb to fish. The preferred test species are rainbow trout ( a coldwater fish; Guideline 72 1c) and bluegill sunfish ( a warmwater fish; Guideline 72 1a). End use product testing was required to support the cranberry use ( see Maneb 1988 Registration Standard). EFED subsequently allowed TEP testing ( with 80% WP) to fulfill TGAI testing requirements. Justification provided by the registrant was that the end use product had greater solubility in water than the TGAI.. The toxicity values ( LC 50 ) appearing in the shaded area of the tables will be used to calculate the acute aquatic risk quotients ( RQ's) in subsequent sections. Toxicity category descriptions are as follows ( Brooks, 1973):

If the LC50 is less than 0.1 ppm a. i., then the test substance is very highly toxic. If the LC50 is 0.1 to 1.0 ppm a. i., then the test substance is highly toxic. If the LC50 is greater than 1 and up through 10 ppm a. i., then the test substance is moderately toxic. If the LC50 is greater than 10 and up through 100 ppm a. i., then the test substance is slightly toxic. If the LC50 is greater than 100 ppm a. i., then the test substance is practically nontoxic.

Study results are tabulated below. 70 Table 7. Freshwater Fish 96 hr Acute Toxicity  Maneb Species/ Flow through or Static % ai LC50 ( ppm)/ ( measured/ nominal) Toxicity Category MRID / Author/ Year Study Classification End Use Product Bluegill sunfish ( Lepomis macrochirus) / static 80.0 WP 0.27 ( mean measured) 0.17 ( lowest measured highly toxic 40749401/ R. Sugatt/ 1988 Core Rainbow Trout ( Oncorhynchus mykiss) / static 80.0 WP 0.052 ( lowest measured 0.042 ( based on active ingredient) slope = 2.8 ( p < 0.05) very highly toxic 40706001/ R. Sugatt/ 1988 Supplemental1 Bluegill sunfish ( Lepomis macrochirus) / static 80.0 ( Dithane M 22) 0.979 ( nominal) highly toxic 00097240/ McCann. & Pitcher/ 1973 Supplemental2 Bluegill sunfish ( Lepomis macrochirus) / static 5.6 Tide Maneb 68 ( nominal) slightly toxic 00052557/ J. McCann/ 1968 Supplemental2 Bluegill sunfish ( Lepomis macrochirus) / static 80.0 ( DuPont Mannate) 0.99 ( nominal) highly toxic 00090291/ McCann & Pitcher/ 1973 Supplemental2 1 Study classified supplemental because high variability in measured concentrations; weights of fish not given; O2 less than recommended; study should have been flow through. 2 The McCann studies were not conducted according to acceptable protocols: the toxicity end points were not based on measured concentrations and/ or the information was provided as a reference source with no supporting data or statistical analysis.

Since one of the LC 50 values ( for rainbow trout) falls below 0.1 ppm, maneb is characterized very highly toxic to fish on an acute basis. In the studies conducted by Sugatt, a substantial decrease in test substance between the beginning and the end of the tests was noted. For example, in the rainbow trout study the concentration of maneb decreased as much as 55% of the nominal at the zero hour measurement, and the final measurements only averaged 13.1% of the nominal value ( range was 9.6% to 22.5%). Because estimation of the actual exposures of the fish was not possible, EFED based the study results on final ( lowest) measurement concentrations. Guidelines 72 1( a) for the TGAI and 72 1( b) for the TEP of maneb are fulfilled ( MRID 40749401). Guidelines 72 1( c) for the TGAI and 72 1( d) for the TEP of maneb are not fulfilled. A core study is required to fulfill these guideline requirements and, as mentioned above, testing with the 80% WP formulation can fulfill the requirements for both TGAI and TEP testing.

2. Freshwater Fish, Chronic A freshwater fish early life stage test using the TGAI is required for maneb because the end use product may be transported to water from the intended use site, and acute aquatic toxicity values are less than 1 ppm. Acceptable freshwater test species are rainbow trout, brook trout, coho salmon, Chinook, bluegill, brown trout, lake trout, northern pike, fathead minnow, white sucker and channel catfish. The fish early life stage is a laboratory test designed to estimate the quantity of toxicant required to adversely effect the reproductive capabilities of a test population of fish. The TGAI is administered into water containing the test species, providing exposure throughout a critical life 71 stage, and the results are expressed as a No Observed Adverse Effect Concentration ( NOAEC) and LOAEC ( Lowest Observed Adverse Effect Concentration). The toxicity value ( NOAEC) appearing in the shaded area of the table will be used to calculate the chronic aquatic risk quotients ( RQ's) in subsequent sections. The guideline 72 4( a) for early life stage fish testing is fulfilled ( MRID 41346301). Testing results are summarized below.

Table 8. Freshwater Fish Early Life Stage Toxicity  Maneb Species/ Static or Flow through Study Duration % ai NOAEC/ LOAEC ( ppb)/ ( measured/ nominal) Endpoints Affected MRID/ Author/ Year Study Classification Fathead minnow ( Pimephales promelas) / flowthrough 35 days 87.3 6.1/ 12 ( mean measured) 1 Hatchability, fish survival and length of fry 41346301/ W. A. McAllister./ 1989 Core 1 mean values ranged 58 to 77% of the nominal. The authors reported that due to the low water and organic solvent solubility of maneb, as well as its rapid hydrolysis rate, an electronically controlled toxicant delivery apparatus was developed to automatically provide fresh test stock solutions at six hour intervals.

A freshwater fish life cycle test using the TGAI is required for maneb because the end use product is expected to be transported to water from the intended use site and any EEC is equal to or greater than one tenth of the NOAEC in the fish early life stage or invertebrate life cycle test. The PRZMEXAMS modeled peak EECs for selected sites in maneb's current use patterns range from 47.6 ppb for potato applications to 197.9 ppb for tomato applications. The preferred test species is fathead minnow. The freshwater fish life cycle test ( Guideline 72 5) has not been fulfilled. A core study for this guideline is required to be submitted.

3. Freshwater Invertebrates, Acute A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the toxicity of maneb to aquatic invertebrates. The preferred test organism is Daphnia magna, but early instar amphipods, stoneflies, mayflies, or midges may also be used. End use product testing was required to support the cranberry use ( see Maneb 1988 Registration Standard). EFED subsequently allowed TEP testing ( with 80% WP) to fulfill TGAI testing requirements. The toxicity value ( EC 50 ) appearing in the shaded area of the table will be used to calculate the acute risk quotients ( RQ's) in subsequent sections. Study results are tabulated below. 72 Table 9. Freshwater Invertebrate Acute Toxicity  Maneb Species/ Static or Flowthrough Duration % ai EC50 ( ppm)/ ( nominal/ measured) Toxicity Category MRID/ Author/ Year Study Classification Daphnid ( Daphnia magna)/ static ( 48 hr.) 80 WP 0.31( mean measured) 0.12 ( lowest measured) slope = 4.2 ( p < 0.05) highly toxic 40749402/ R. Sugatt/ 1988 Core Since the EC 50 is less than 1 ppm maneb is categorized very highly toxic to freshwater aquatic invertebrates on an acute basis. Since a substantial decrease in test substance concentration was noted between the beginning and end of the test ( final values averaged 34% of nominal), test results were based on final measured concentrations. Guideline 72 2 ( a and b) are considered fulfilled ( MRID 40749402).

4. Freshwater Invertebrate, Chronic A freshwater aquatic invertebrate life cycle test using the TGAI was reserved in the 1988 Registration Standard pending results of environmental fate data such as hydrolysis, photplysis and aquatic field dissipation and studies on technical maneb. This study is required because the end use product is expected to be transported to water from the intended use site, and the following conditions are met: ( 1) the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent, ( 2) the aquatic acute LC 50 or EC 50 is less than 1.0 ppm, and ( 3) the EEC in water is equal to or greater than 0.01 of any acute EC50 or LC50 value. The preferred test species is Daphnia magna. The guideline ( 72 4) is not fulfilled.

5. Freshwater Field Studies No studies were submitted and no studies are required.

ii. Toxicity to Estuarine and Marine Animals 1. Estuarine and Marine Fish, Acute Acute toxicity testing with estuarine and marine fish using the TGAI is required for maneb because the end use product is expected to reach the marine/ estuarine environment because of its use in coastal counties. The preferred test organisms are the sheepshead minnow. End use product testing was required to support the cranberry use ( see Maneb 1988 Registration Standard). EFED subsequently allowed TEP testing ( with 80% WP) to fulfill TGAI testing requirements. Justification provided by the registrant was that the end use product had greater solubility in water than the TGAI. The toxicity value ( LC 50 ) appearing in the shaded area of the table will be used to calculate the acute 73 risk quotients ( RQ's) in subsequent sections. Study results are tabulated below.

Table 10. Summary of acute 96 hr toxicity tests for Estuarine/ Marine Fish  Maneb Species/ static or flowthrough % a. i. LC50) ppm/ ( measured/ nominal) Toxicity Category MRID/ Author/ Year Classification End Use Formulation Atlantic Silverside/ ( Menidia menidia)/ flowthrough 84.8 ( 80% WP) 0.23( mean measured) 0.18 ( lowest measured) slope = 4.2 highly toxic 40943101/ S. Manning/ 1988 Core Based on the results of this test, maneb is categorized highly toxic to estuarine fish. The study authors noted that measured concentrations were variable ( 69 to 89% of the nominal), and attributed this to the poor solubility of the test material in sea water. The study fulfills Guideline 72 3( a and d) ( MRID 40943101).

2. Estuarine and Marine Fish, Chronic An estuarine/ marine fish early life stage toxicity test using the TGAI is required for maneb because the end use product is expected to be transported to the estuarine/ marine environment from the intended use site, and the following conditions are met: the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent and the EEC in water is equal to or greater than 0.01 of any acute LC 50 or EC 50 value. The preferred test species is sheepshead minnow. The guideline ( 72 4a) estuaine/ marine fish is not fulfilled. A core study is required to be submitted for this guideline.

3. Estuarine and Marine Invertebrates, Acute Acute toxicity testing with estuarine/ marine invertebrates using the TGAI is required for maneb because the end use product is expected to reach the marine/ estuarine environment because of it use in coastal counties. The preferred test species are mysid shrimp and eastern oyster. End use product testing was required to support the cranberry use ( see Maneb 1988 Registration Standard). EFED subsequently allowed TEP testing ( with 80% WP) to fulfill TGAI testing requirements. The toxicity value ( EC 50 ) appearing in the shaded area of the table will be used to calculate the acute risk quotients ( RQ's) in subsequent sections. Study results are tabulated below.

Table 11 . Estuarine/ Marine Invertebrate Acute Toxicity  Maneb Species/ Static or Flow through % a. i. 96 hour EC50 ( ppm)/ ( measured/ nominal) Toxicity Category MRID/ Author/ Yea r Study Classification End Use Formulation Eastern oyster ( Crassostrea virginica)/ flowthrough ( shell deposition) 84.8 ( 80% WP) 0.64 ( mean measured) 0.28 ( lowest measured) highly toxic 41000001/ S. Manning/ 1989 Core Table 11 . Estuarine/ Marine Invertebrate Acute Toxicity  Maneb Species/ Static or Flow through % a. i. 96 hour EC50 ( ppm)/ ( measured/ nominal) Toxicity Category MRID/ Author/ Yea r Study Classification 74 Mysid ( Americamysis bahia)/ flowthrough 84.8 ( 80% WP) 0.003( estimated) slope = 3.5 very highly toxic 41000002/ S. Manning/ 1988 Supplemental1 1 high variability in measured concentrations; analytical procedures were not able to detect maneb below 5 ppb..

Since the mollusc EC 50 is less than 1 ppm, maneb is considered to be highly toxic to the mollusc on an acute basis. Guideline 72 3( b) for the TGAI acute toxicity to estuarine/ marine organism mollusk is fulfilled ( MRID No. 41000001). Since the nominal to measured concentrations varied significantly in this test ( authors attributed to low solubility of material), EFED based the study results on the lowest measured concentrations. The study fulfills Guideline 72 3( b and e) ( MRID 41000001).

Based on a supplemental study with mysid shrimp, maneb may be characterized as very highly toxic to estuarine invertebrates. There was high variability in measured concentrations in this study ( estimated at 13 to 17% of nominal); the study authors attributed this to the poor solubility of the test material. Since three of the four actual measured concentrations were only estimates ( not verified by recovery methods), the only assumption that could be drawn from the study was that the LC50 value is below 5 ppb, and probably about 3 ppb. Guideline 72 3 ( c and f) is not fulfilled.

4. Estuarine and Marine Invertebrate, Chronic An estuarine/ marine invertebrate life cycle toxicity test ( Guideline 72 4b) using the TGAI is required for maneb because the end use product is expected to be transported to the estuarine/ marine environment from the intended use site, the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent, any aquatic acute LC 50 or EC 50 is less than 1.0 ppm, and the EEC in water is equal to or greater than 0.01 of any acute LC 50 or EC 50 value. The preferred test species is mysid shrimp. This guideline has not been fulfilled and a core study for this guideline is required to be submitted.

5. Estuarine and Marine Field Studies No studies were submitted and no studies are required.

iii. Toxicity to Plants 1. Terrestrial Plants Terrestrial plant Tier I seedling emergence and vegetative vigor testing of a maneb TEP is currently recommended for all pesticides having outdoor uses. For seedling emergence and vegetative vigor testing the following plant species and groups should be tested: ( 1) six species of at least four 75 dicotyledonous families, one species of which is soybean ( Glycine max) and the second is a root crop, and ( 2) four species of at least two monocotyledonous families, one of which is corn ( Zea mays). Tier I tests measure the response of plants, relative to a control, at a test level that is equal to the highest use rate ( expressed as lbs ai/ A). Tier II studies are required if the Tier I studies indicate any of the test species, when exposed to the test material, displayed a $ 25% inhibition of various growth parameters as compared to the control. Tier I seedling emergence [ guideline 122 1( a)] and vegetative vigor [ guideline 122 1( b)] studies have not been submitted for a maneb and it is recommended that these studies be submitted for review.

2. Terrestrial Plant Field Studies No studies were submitted and no studies are required.

3. Aquatic Plants Aquatic plant testing is recommended for all pesticides having outdoor uses ( Keehner. July 1999). The tests are performed on species from a cross section of the non target aquatic plant population. The preferred test species are duckweed ( Lemna gibba), marine diatom ( Skeletonema costatum), blue green algae ( Anabaena flos aquae), freshwater green alga ( Selenastrum capricornutum), and a freshwater diatom. Tier I aquatic plant testing is a maximum dose test designed to quickly evaluate the toxic effects to the test species in terms of growth and reproduction and to determine the need for additional aquatic plant testing. Tier II aquatic plant testing is a multiple dose test of the plants species that showed a phytotoxic effect to the pesticide being tested at the Tier I level. Tier II testing is aimed to determine the detrimental effect levels of the chemical on the aquatic plants which showed a greater than 50% detrimental effect in Tier I testing.

One study ( see Table 12, below) has been submitted for a maneb technical formulation using the freshwater green algae. S. capricornutum ( MRID 40943501). The EC 50 for S. capricornutum was 13.4 ppb based on growth inhibition; the NOAEC was 5 ppb. Results were based on nominal concentrations, even though the study author reported that maneb was unstable in the test media ( at 120 hours it averaged 15% of the nominal). The toxicity value ( EC 50 ) appearing in the shaded area of the table will be used to calculate the acute risk quotients ( RQ's) in subsequent sections. Guideline 123 2 ( Tier II) is not fulfilled. Guideline 122 2 ( Tier I) or Guideline 123 2 ( Tier II) aquatic plant growth testing needs to be submitted for duckweed ( Lemna gibba), marine diatom ( Skeletonema costatum), blue green algae ( Anabaena flos aquae), and a freshwater diatom. 76 Table 12: Non target Aquatic Plant Toxicity ( Tier II)  Maneb Species/ duration % A. I. EC50/ NOAEC ( ppb ai) MRID No. Author/ year Classification1 Nonvascular Plants frreshwater green algae ( Selenastrum capricornutum) / 120 hrs. 87.3 13.4/ 5.0 ( nominal) slope = 4.8 ( p < 0.05) 40943501/ Forbis, A./ 1988 Core 4. Aquatic Plant Field Studies No studies are available. In 1989 EFED recommended a Tier II study be conducted based results of the green algae toxicity coupled with expected aquatic EECs resulting in anticipated adverse effects to freshwater algae from a typical application. The study was subsequently reserved. 77 APPENDIX IV: Environmental Exposure Assessment a. Overview of Risk Quotients ( RQs)

Risk characterization integrates the results of the exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects. The Agency calls this integration the quotient method. The Agency calculates risk quotients ( RQs) by dividing exposure estimates by acute and chronic ecotoxicity values.

RQ = EXPOSURE/ TOXICITY EFED compares RQs to OPP's levels of concern ( LOCs). OPP uses these LOCs to analyze potential risk to non target organisms and the need to consider regulatory action. This method signals that a pesticide used as directed has the potential to cause adverse effects on non target organisms. LOCs currently address the following risk presumption categories: ( 1) acute risks  the risks warrant regulatory action as well as restricted use classification; ( 2) acute restricted use  the potential for acute risk exists, but the restricted use classification may mitigate the risk; ( 3) acute endangered species  the risk may adversely affect endangered species; and ( 4) chronic risk  the risk may warrant regulatory action because there is a potential for chronic risk. Currently, EFED does not perform assessments for chronic risk to plants, acute or chronic risks to non target insects, or chronic risk from granular or bait formulations to birds or mammals.

The Agency gets ecotoxicity test values ( measurement endpoints) used in the acute and chronic risk quotients from required studies. Examples of ecotoxicity values gathered from short term laboratory studies that assess acute effects are: ( 1) LC 50 ( fish and birds); ( 2) LD 50 ( birds and mammals); ( 3) EC 50 ( aquatic plants and aquatic invertebrates); and ( 4) EC 25 ( terrestrial plants). Examples of toxicity test effect levels drawn from the results of long term laboratory studies that assess chronic effects are: ( 1) LOAEL or LOAEC ( birds, fish, and aquatic invertebrates) and ( 2) NOAEL or NOAEC ( birds, fish and aquatic invertebrates). For birds, mammals, fish and aquatic invertebrates, the Agency uses the NOAEL or NOAEC as the ecotoxicity test value in assessing chronic effects, although the Agency may use other values when justified. Tabulated below are risk presumptions and the matching RQs and LOCs.

Risk quotients are index or reference values used to show potential ecological risk. There are limits with the use of risk quotients in assessing the risk to non target animals and plants. The likelihood of an adverse effect does not increase with the size of the risk quotient. ( Urban, 2000). An LOC defined as 1 ( see table below) provides the reference point for estimating the exposure to toxicity risk ( that is, risk quotient). Values at or above this reference point trigger risk concerns. A risk quotient value of 100 compared to a value of 50 does not suggest a greater risk or a risk that is more likely to occur. Both these values are above the reference point for risk of 1. The risk quotient value of 100 reflects an exposure level that is twice has high as the risk quotient value of 50. The " exposure" in the " RQ = Exposure/ Toxicity" ratio is twice has high for RQ of 100 as for the RQ of 50. Risk quotients are nonprobabilistic and have numerical and dichotomous results. The numerical result 78 drawn from the calculation either exceeds a fixed LOC or does not exceed it. ( US EPA. June 30, 1995).

Table 1. Risk presumptions for terrestrial animals based on risk quotients ( RQ) and levels of concern ( LOC).

Risk Presumption RQ LOC Birds Acute Risk EEC1/ LC 50 or LD 50 / ft2 or LD 50 / day3 0.5 Acute Restricted Use EEC/ LC 50 or LD 50 / ft2 or LD 50 / day ( or LD 50 < 50 mg/ kg) 0.2 Acute Endangered Species EEC/ LC 50 or LD 50 / ft2 or LD 50 / day 0.1 Chronic Risk EEC/ NOAEC 1 Wild Mammals Acute Risk EEC/ LC 50 or LD 50 / ft2 or LD 50 / day 0.5 Acute Restricted Use EEC/ LC 50 or LD 50 / ft2 or LD 50 / day ( or LD 50 < 50 mg/ kg) 0.2 Acute Endangered Species EEC/ LC 50 or LD 50 / ft2 or LD 50 / day 0.1 Chronic Risk EEC/ NOAEC 1 1 abbreviation for Estimated Environmental Concentration ( ppm) on avian/ mammalian food items 2 mg/ ft2 3 mg of toxicant consumed/ day LD 50 * wt. of bird LD 50 * wt. of bird Table 2. Risk presumptions for aquatic animals based on risk quotients ( RQ) and levels of concern ( LOC).

Risk Presumption RQ LOC Acute Risk EEC1/ LC 50 or EC 50 0.5 Acute Restricted Use EEC/ LC 50 or EC 50 0.1 Acute Endangered Species EEC/ LC 50 or EC 50 0.05 Chronic Risk EEC/ NOAEC 1 1 EEC = ( ppm or ppb) in water Table 3. Risk presumptions for plants based on risk quotients ( RQ) and levels of concern ( LOC).

Risk Presumption RQ LOC Terrestrial and Semi Aquatic Plants Acute Risk EEC1/ EC 25 1 Acute Endangered Species EEC/ EC 05 or NOAEC 1 Aquatic Plants Acute Risk EEC2/ EC 50 1 Acute Endangered Species EEC/ EC 05 or NOAEC 1 1 EEC = lbs ai/ A 2 EEC = ( ppb/ ppm) in water 79 b. Exposure and Risk to Terrestrial Animals i. Birds Since maneb is practically nontoxic to birds on an acute basis ( acute oral LD50 > 2,150 mg/ kg and acute dietary LC50 > 5,000 ppm) the acute risks to birds are expected to be low from maneb's uses and acute RQs have not been calculated. The chronic RQs for multiple broadcast applications of nongranular maneb products are tabulated below. Analysis of the results indicate that for multiple applications of maneb nongranular products, avian chronic LOCs are exceeded for all uses patterns with RQs ranging from a high of 265 from the turf use to a low of 0.4 from the maneb's uses on collards, turnips, and mustard ( Georgia and Tennessee, only). 80 Table 4: Avian Chronic Risk Quotients for Multiple Broadcast Applications of Nongranular Maneb based on a Mallard Duck ( Anas platyrhynchos) NOAEC of 20 ppm.

Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 34.8 98 695 1,963 Short grass 6.4/ 4 Almonds 14.7 45 295 900 Tall grass 7 day interval ground & aerial 18.4 55 368 1,104 Broadleaf plants/ Insects 2.9 6 57 123 Seeds 26.1 74 522 1,473 Short grass 4.8/ 4 Apples 11.0 34 221 675 Tall grass 7 day interval ground & aerial 13.8 41 276 828 Broadleaf plants/ Insects 2.1 5 43 92 Seeds 10.7 30 214 605 Short grass 2.4/ 10 Bananas 4.5 14 91 277 Tall grass 14 day interval ground & aerial 5.7 17 113 340 Broadleaf plants/ Insects 0.9 2 18 38 Seeds 10.3 29 205 580 Short grass 1.6/ 6 Beans ( dried)

4.3 13 87 266 Tall grass 5 day interval ground & aerial 5.4 16 109 326 Broadleaf plants/ Insects 0.8 2 17 36 Seeds 8.7 25 174 492 Short grass 1.6/ 6 Broccoli, Brussel Sprouts,

3.7 11 74 225 Tall grass 7 day interval Cabbage, Cauliflower, Endive,

4.6 14 92 277 Broadleaf plants/ Insects Kohlrabi, & Lettuce 0.7 2 14 31 Seeds ground & aerial 5.4 15 107 303 Short grass 1.2/ 3 Collards & Turnip 2.3 7 45 139 Tall grass 14 day interval ( GA & TN, only)

2.8 9 57 170 Broadleaf plants/ Insects ground & aerial 0.4 1 9 19 Seeds 10.7 30 213 603 Short grass 1.2/ 15 Corn ( pop & sweet) a 4.5 14 90 276 Tall grass 3 day interval ( including AR & LA)

5.7 17 113 339 Broadleaf plants/ Insects ground & aerial 0.9 2 18 38 Seeds 10.3 29 205 579 Short grass 1.2/ 5 Corn ( pop & sweet) b 4.3 13 87 266 Tall grass 3 day interval ( excluding AR & LA)

5.4 16 109 326 Broadleaf plants/ Insects ground & aerial 0.8 2 17 36 Seeds 81 Table 4 ( continued): Avian Chronic Risk Quotients for Multiple Broadcast Applications of Nongranular Maneb based on a Mallard Duck ( Anas platyrhynchos) NOAEC of 20 ppm.

Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 25.9 73 517 1,460 Short grass 4.8/ 3 Cranberry 11.0 33 219 669 Tall grass 7 day interval ground & aerial 13.7 41 274 821 Broadleaf plants/ Insects 2.1 5 43 91 Seeds 8.7 25 174 492 Short grass 1.6/ 8 Cucumber, Melons,

3.7 11 74 226 Tall grass 7 day interval Pumpkin & Squash 4.6 14 92 277 Broadleaf plants/ Insects ground & aerial 0.7 2 14 31 Seeds 8.7 25 174 492 Short grass 1.6/ 7 Eggplant & Sugar Beets 3.7 11 74 226 Tall grass 7 day interval ground & aerial 4.6 14 92 277 Broadleaf plants/ Insects 0.7 2 14 31 Seeds 10.2 29 204 576 Short grass 2.4/ 1 Fig 4.3 13 86 264 Tall grass not applicable ground & aerial 5.4 16 108 324 Broadleaf plants/ Insects 0.8 2 17 36 Seeds 17.4 49 348 984 Short grass 3.2/ 6 Grapesc 7.4 23 148 451 Tall grass 7 day interval ground & aerial 9.2 28 184 553 Broadleaf plants/ Insects 1.4 3 29 61 Seeds 10.8 30 216 609 Short grass 2.0/ 3 Grapesd 4.6 14 91 279 Tall grass 7 day interval ground & aerial 5.7 17 114 342 Broadleaf plants/ Insects 0.9 2 18 38 Seeds 8.3 23 166 468 Short grass 1.6/ 2 Kale 3.5 11 70 215 Tall grass 7 day interval ground & aerial 4.4 13 88 263 Broadleaf plants/ Insects 0.7 1 14 29 Seeds 5.3 15 107 302 Short grass 1.2/ 2 Mustard ( GA & TN, only)

2.3 7 45 138 Tall grass 14 day interval ground & aerial 2.8 8 57 170 Broadleaf plants/ Insects 0.4 1 9 19 Seeds 82 Table 4 ( continued): Avian Chronic Risk Quotients for Multiple Broadcast Applications of Nongranular Maneb based on a Mallard Duck ( Anas platyrhynchos) NOAEC of 20 ppm.

Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/ Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 13.1 37 261 738 Short grass 2.4/ 10 Onion & Garlic 5.5 17 111 338 Tall grass 7 day interval ground & aerial 6.9 21 138 415 Broadleaf plants/ Insects 1.1 2 22 46 Seeds 13.1 37 261 738 Short grass 2.4/ 7 Onion ( green) & Tomato a 5.5 17 111 338 Tall grass 7 day interval ground & aerial 6.9 21 138 415 Broadleaf plants/ Insects 1.1 2 22 46 Seeds 8.9 25 179 504 Short grass 2/ 14 Papaya 3.8 12 76 231 Tall grass 14 day interval ground & aerial 4.7 14 95 284 Broadleaf plants/ Insects 0.7 2 15 32 Seeds 13.1 37 261 738 Short grass 2.4/ 6 Pepper a 5.5 17 111 338 Tall grass 7 day interval ground & aerial 6.9 21 138 415 Broadleaf plants/ Insects 1.1 2 22 46 Seeds 8.7 25 174 492 Short grass 1.6/ 6 Pepper b 3.7 11 74 225 Tall grass 7 day interval ground & aerial 4.6 14 92 277 Broadleaf plants/ Insects 0.7 2 14 31 Seeds 10.3 29 206 581 Short grass 1.6/ 10 Potato ( Maine, only)

4.4 13 87 266 Tall grass 5 day interval ground & aerial 5.4 16 109 327 Broadleaf plants/ Insects 0.8 2 17 36 Seeds 83 Table 4 ( continued): Avian Chronic Risk Quotients for Multiple Broadcast Applications of Nongranular Maneb based on a Mallard Duck ( Anas platyrhynchos) NOAEC of 20 ppm.

Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/ Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 10.3 29 206 580 Short grass 1.6/ 7 Potato 4.4 13 87 266 Tall grass 5 day interval ground & aerial 5.4 16 109 326 Broadleaf plants/ Insects 0.8 2 17 36 Seeds 8.7 25 174 491 Short grass 1.6/ 4 Tomato b 3.7 11 74 225 Tall grass 7 day interval ground & aerial 4.6 14 92 276 Broadleaf plants/ Insects 0.7 2 14 31 Seeds 6.5 18 129 365 Short grass 1.2/ 3 f Ornamentals e 2.7 8 55 167 Tall grass 7 day interval ground 3.4 10 68 205 Broadleaf plants/ Insects 0.5 1 11 23 Seeds 93.7 265 1,875 5,294 Short grass 17.4/ 3 f Turf g 39.7 121 794 2,426 Tall grass 7 day interval ground & aerial 49.6 149 993 2,978 Broadleaf plants/ Insects 7.7 17 154 331 Seeds 1 Assumes degradation using FATE version 5.0 program with a foliar dissipation ( total residue) half life of 3.2 days.

2 RQ greater or equal to 1.00 exceeds chronic LOC.

a East of the Mississippi River b West of the Mississippi River c East of the Rocky Mountains d West of the Rocky Mountains e Trees, Herbaceous Plants, Non Flowering Plants, & Woody Shrubs and Vines f The maximum number of applications per crop cycle was not specified on the labeling.

Three ( 3) applications per crop cycle are assumed for modeling purposes.

g. Residential, Commercial/ Industrial, Golf Course, Sod Farm, & Recreational 84 Maneb has numerous seed treatment uses ( see Table 1, above) the RQs from these seed treatment uses were not were calculated in this RED. Numerous seed treatment uses of mancozeb were evaluated in the mancozeb RED and no LOCs were exceeded. The avian acute LD50 of maneb ( Bobwhite quail LD50 > 2,150 mg/ kg) is practically nontoxic to birds and was greater than the avian acute LD50 for mancozeb ( English sparrow LD50 ~ 1,500 mg/ kg). Since maneb is less toxic to birds on an acute basis than mancozeb and the exposure ( rates of application) from these seed treatment uses are similar for maneb and mancozeb, EFED has determined that the acute risks to birds from eating maneb treated seeds are low.

ii. Mammals As identified in Appendix III, maneb is practically nontoxic ( rat LD50 > 5,000 mg/ kg) to mammals on an acute basis. Because of this, the acute exposure to maneb presents a low risk to mammals so RQs for acute exposure were not determined. The chronic mammalian risk quotients for multiple broadcast applications of nongranular products are tabulated below in table 5. The results indicate that chronic mammalian LOCs are exceeded for all maneb use patterns listed. 85 Table 5: Mammalian Chronic Risk Quotients for Multiple Applications of Maneb Nongranular ( Broadcast) Based on a labaratory rats ( Rattus norvegicus) NOAEL of 75 ppm h Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 9.3 26 695 1,963 Short grass 6.4/ 4 Almonds 3.9 12 295 900 Tall grass 7 day interval ground & aerial 4.9 15 368 1,104 Broadleaf plants/ Insects 0.8 2 57 123 Seeds 7.0 20 522 1,473 Short grass 4.8/ 4 Apples 2.9 9 221 675 Tall grass 7 day interval ground & aerial 3.7 11 276 828 Broadleaf plants/ Insects 0.6 1 43 92 Seeds 2.9 8 214 605 Short grass 2.4/ 10 Bananas 1.2 4 91 277 Tall grass 14 day interval ground & aerial 1.5 5 113 340 Broadleaf plants/ Insects 0.2 0.5 18 38 Seeds 2.7 8 205 580 Short grass 1.6/ 6 Beans ( dried)

1.2 4 87 266 Tall grass 5 day interval ground & aerial 1.4 4 109 326 Broadleaf plants/ Insects 0.2 0.5 17 36 Seeds 2.3 7 174 492 Short grass 1.6/ 6 Broccoli, Brussel Sprouts,

1.0 3 74 225 Tall grass 7 day interval Cabbage, Cauliflower, Endive,

1.2 4 92 277 Broadleaf plants/ Insects Kohlrabi, & Lettuce 0.2 0.4 14 31 Seeds ground & aerial 1.4 4 107 303 Short grass 1.2/ 3 Collards & Turnip 0.6 2 45 139 Tall grass 14 day interval ( GA & TN, only)

0.8 2 57 170 Broadleaf plants/ Insects ground & aerial 0.1 0.3 9 19 Seeds 2.8 8 213 603 Short grass 1.2/ 15 Corn ( pop & sweet) a 1.2 4 90 276 Tall grass 3 day interval ( including AR & LA)

1.5 5 113 339 Broadleaf plants/ Insects ground & aerial 0.2 0.5 18 38 Seeds 2.7 8 205 579 Short grass 1.2/ 5 Corn ( pop & sweet) b 1.2 4 87 266 Tall grass 3 day interval ( excluding AR & LA)

1.4 4 109 326 Broadleaf plants/ Insects ground & aerial 0.2 0.5 17 36 Seeds 86 Table 5 ( continued): Mammalian Chronic Risk Quotients for Multiple Applications of Maneb Nongranular ( Broadcast) Based on a labaratory rats ( Rattus norvegicus) NOAEL of 75 ppm h Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 6.9 19 517 1,460 Short grass 4.8/ 3 Cranberry 2.9 9 219 669 Tall grass 7 day interval ground & aerial 3.7 11 274 821 Broadleaf plants/ Insects 0.6 1 43 91 Seeds 2.3 7 174 492 Short grass 1.6/ 8 Cucumber, Melons,

1.0 3 74 226 Tall grass 7 day interval Pumpkin & Squash 1.2 4 92 277 Broadleaf plants/ Insects ground & aerial 0.2 0.4 14 31 Seeds 2.3 7 174 492 Short grass 1.6/ 7 Eggplant & Sugar Beets 1.0 3 74 226 Tall grass 7 day interval ground & aerial 1.2 4 92 277 Broadleaf plants/ Insects 0.2 0.4 14 31 Seeds 2.7 8 204 576 Short grass 2.4/ 1 Fig 1.2 4 86 264 Tall grass not applicable ground & aerial 1.4 4 108 324 Broadleaf plants/ Insects 0.2 0.5 17 36 Seeds 4.6 13 348 984 Short grass 3.2/ 6 Grapesc 2.0 6 148 451 Tall grass 7 day interval ground & aerial 2.5 7 184 553 Broadleaf plants/ Insects 0.4 0.8 29 61 Seeds 2.9 8 216 609 Short grass 2.0/ 3 Grapesd 1.2 4 91 279 Tall grass 7 day interval ground & aerial 1.5 5 114 342 Broadleaf plants/ Insects 0.2 0.5 18 38 Seeds 2.2 6 166 468 Short grass 1.6/ 2 Kale 0.9 3 70 215 Tall grass 7 day interval ground & aerial 1.2 4 88 263 Broadleaf plants/ Insects 0.2 0.4 14 29 Seeds 1.4 4 107 302 Short grass 1.2/ 2 Mustard ( GA & TN, only)

0.6 2 45 138 Tall grass 14 day interval ground & aerial 0.8 2 57 170 Broadleaf plants/ Insects 0.1 0.3 9 19 Seeds 87 Table 5 ( continued): Mammalian Chronic Risk Quotients for Multiple Applications of Maneb Nongranular ( Broadcast) Based on a labaratory rats ( Rattus norvegicus) NOAEL of 75 ppm h Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/ Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 3.5 10 261 738 Short grass 2.4/ 10 Onion & Garlic 1.5 5 111 338 Tall grass 7 day interval ground & aerial 1.8 6 138 415 Broadleaf plants/ Insects 0.3 0.6 22 46 Seeds 3.5 10 261 738 Short grass 2.4/ 7 Onion ( green) & Tomato a 1.5 5 111 338 Tall grass 7 day interval ground & aerial 1.8 6 138 415 Broadleaf plants/ Insects 0.3 0.6 22 46 Seeds 2.4 7 179 504 Short grass 2/ 14 Papaya 1.0 3 76 231 Tall grass 14 day interval ground & aerial 1.3 4 95 284 Broadleaf plants/ Insects 0.2 0.4 15 32 Seeds 3.5 10 261 738 Short grass 2.4/ 6 Pepper a 1.5 5 111 338 Tall grass 7 day interval ground & aerial 1.8 6 138 415 Broadleaf plants/ Insects 0.3 0.6 22 46 Seeds 2.3 7 174 492 Short grass 1.6/ 6 Pepper b 1.0 3 74 225 Tall grass 7 day interval ground & aerial 1.2 4 92 277 Broadleaf plants/ Insects 0.2 0.4 14 31 Seeds 2.7 8 206 581 Short grass 1.6/ 10 Potato ( Maine, only)

1.2 4 87 266 Tall grass 5 day interval ground & aerial 1.5 4 109 327 Broadleaf plants/ Insects 0.2 0.5 17 36 Seeds 88 Table 5 ( continued): Mammalian Chronic Risk Quotients for Multiple Applications of Maneb Nongranular ( Broadcast) Based on a labaratory rats ( Rattus norvegicus) NOAEL of 75 ppm h Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/ Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 2.7 8 206 580 Short grass 1.6/ 7 Potato 1.2 4 87 266 Tall grass 5 day interval ground & aerial 1.5 4 109 326 Broadleaf plants/ Insects 0.2 0.5 17 36 Seeds 2.3 7 174 491 Short grass 1.6/ 4 Tomato b 1.0 3 74 225 Tall grass 7 day interval ground & aerial 1.2 4 92 276 Broadleaf plants/ Insects 0.2 0.4 14 31 Seeds 1.7 5 129 365 Short grass 1.2/ 3 f Ornamentals e 0.7 2 55 167 Tall grass 7 day interval ground 0.9 3 68 205 Broadleaf plants/ Insects 0.1 0.3 11 23 Seeds 25.0 71 1,875 5,294 Short grass 17.4/ 3 f Turf g 10.6 32 794 2,426 Tall grass 7 day interval ground & aerial 13.2 40 993 2,978 Broadleaf plants/ Insects 2.1 4 154 331 Seeds 1 Assumes degradation using FATE version 5.0 program with a foliar dissipation ( total residue) half life of 3.2 days.

2 RQ greater or equal to 1.00 exceeds chronic LOC.

a East of the Mississippi River b West of the Mississippi River c East of the Rocky Mountains d West of the Rocky Mountains e Trees, Herbaceous Plants, Non Flowering Plants, & Woody Shrubs and Vines f The maximum number of applications per crop cycle was not specified on the labeling.

Three ( 3) applications per crop cycle are assumed for modeling purposes.

g. Residential, Commercial/ Industrial, Golf Course, Sod Farm, & Recreational h. Reproductive study, based on parental ( paternal) effects resulting in a significant increase in lung ( both generations) and liver ( F1) weight and an increased incidence of diffuse follicular epithelial hypertrophy/ hyperplasia ( F1) and fetal effects resulting in a slight delay in the startle response in the offspring. 89 iii. Insects Currently, EFED does not assess risk to non target insects. Results of acceptable studies are used for recommending appropriate label precautions. Since maneb was determined to be practically nontoxic to honey bees ( LD50 > 12 µ g/ bee) no bee precautionary labeling is required on maneb product labeling.

c. Aquatic Organisms i. Overview Because monitoring data from field locations are not available for maneb, EFED based the surface water exposure EECs of maneb on screening models. EFED used Tier II modeling, the Pesticide Root Zone Model version 3.1.2 beta ( Carsel and others., 1997) and Exposure Analysis Modeling System version 2.98.04 ( Burns, 1997) ( PRZM/ EXAMS), to estimate aquatic EECs.

The PRZM/ EXAMS modeling tools used by EFED are designed to be conservative tools; with 90% of simulated sites expected to have environmental concentrations lower than the Tier II estimates. EFED uses environmental fate and transport computer models to calculate refined EECs. PRZM simulates pesticide surface water runoff on daily time steps, incorporating runoff, infiltration, erosion, and evaporation. The model calculates foliar dissipation and runoff, pesticide uptake by plants, soil microbial transformation, volatilization, and soil dispersion and retardation. EXAMS simulates pesticide fate and transport in an aquatic environment ( one hectare body of water, two meters deep with no outlet). The EECs have been calculated so in any given year, there is a 10% probability the maximum average concentration of that duration in that year will equal or exceed the EEC at the site. The Tier II model uses a single site which represents a high exposure scenario for the use of the pesticide on a particular crop use site. The model simulates weather and agricultural practice at the site over multiple years so the probability of an EEC occurring at that site can be estimated. The PRZM/ EXAMS modeling approach is an uncertain predictor of water concentrations in estuarine/ marine systems. EFED suspects, though it hasn't been empirically proved, that flushing and exchange rates within these systems may differ from those assumed in the existing surface water modeling. Sometimes, flushing and exchange may be greater than accounted for in the EXAMS model and true estuarine/ marine water concentrations may be lower. In other cases tidal entrapment of pollutants may contribute to higher effective pesticide concentrations than predicted by the model.

EFED uses the EECs for assessing acute and chronic risks to aquatic organisms. EFED uses peak EEC values to calculate acute RQs for single and multiple applications. EFED uses 21 day EECs for invertebrates and 60 day EECs for fish to calculate chronic RQs.

EFED selected boundaries used in Tier II ( PRZM/ EXAMS) modeling using Agency guidance ( WQTT/ EFED/ OPP. August, 2000) and EFED calculated degradation rate constants from review of registrant filed environmental fate studies. 90 Table 6: Maneb Acute and Chronic Risk Quotients for Freshwater Fish Based On a Rainbow Trout ( Salmo gairdneri) LC50 of 42.0 ppb and a Fathead Minnow ( Pimephales promelas ) NOAEC of 6.1 ppb. Application Rate ( lbs ai/ A)/

Number of Chronic RQ Acute RQ EEC 60 Day Applications/ Site/

( 60 Day EEC/ NOAEC) 3 ( Peak EEC/ LC50) 2 Average ( ppb) 1 EEC Peak ( ppb) 1 Interval Application Method/

0.30 2.00 1.8 84 4.8/ 4 Apples 7 day interval ground & aerial 0.34 2.69 2.1 113 1.6/ 6 Pepper a 7 day interval ground & aerial 0.16 1.13 1 47.6 1.6/ 10 Potato ( Maine, only)

5 day interval ground & aerial 0.66 4.71 4 197.9 2.4/ 7 Tomato b 7 day interval ground & aerial 1 Based on PRZM version 3.12/ EXAMS version 2.97.5 modeling. 2 RQ greater or equal to 0.5 exceeds acute high risk, acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.1 exceeds acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.05 exceeds acute endangered species LOCs.

3 RQ greater or equal to 1.00 exceeds chronic LOC.

a East of the Mississippi River ( 1.6 lb ai/ A is a W. of Miss. R. rate for peppers. 2.4 lb ai/ A 6 times every 7 days is the E. of Miss. R. rate   the scenario is FL)

b East of the Mississippi River ii. Freshwater Fish Tabulated below in Table 6 are maneb's acute and chronic risk quotients for freshwater fish. The results show all maneb uses exceed acute, acute restricted use, and acute endangered species LOCs ( acute RQ ranges from 1.13 to 4.71). No chronic LOCs are exceeded for freshwater fish from maneb's uses. EFED modeled on representative maneb uses. EFED has not developed PRZM/ EXAMS schemes for modeling all maneb uses. 91 Table 7: Maneb Acute Risk Quotients for Freshwater Invertebrate Based On a Waterflea ( Daphnia magna ) LC50 of 120 ppb. Application Rate ( lbs ai/ A)/

Number of Acute RQ Applications/ Site/

( Peak EEC/ LC50) 2 EEC Peak ( ppb) 1 Interval Application Method/

0.70 84 4.8/ 4 Apples 7 day interval ground & aerial 0.94 113 1.6/ 6 Pepper a 7 day interval ground & aerial 0.40 47.6 1.6/ 10 Potato ( Maine, only)

5 day interval ground & aerial 1.65 197.9 2.4/ 7 Tomato b 7 day interval ground & aerial 1 Based on PRZM version 3.12/ EXAMS version 2.97.5 modeling. 2 RQ greater or equal to 0.5 exceeds acute high risk, acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.1 exceeds acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.05 exceeds acute endangered species LOCs.

a East of the Mississippi River ( 1.6 lb ai/ A is a W. of Miss. R. rate for peppers. 2.4 lb ai/ A 6 times every 7 days is the E. of Miss. R. rate   the scenario is FL)

b East of the Mississippi River iii. Freshwater Invertebrates Tabulated below in Table 7 are maneb's acute risk quotients for freshwater invertebrates. The results show that acute, acute restricted use, and acute endangered species RQs exceed LOCs for maneb's use on apples, tomatoes and peppers. Restricted use and acute endangered species LOCs are exceeded for all maneb uses ( acute RQ ranges from 0.40 to 1.65). 92 Table 8: Maneb Acute Risk Quotients for Estuarine/ Marine Fish Based On a Atlantic silverside ( Menidia menidia ) LC50 of 180 ppb. Application Rate ( lbs ai/ A)/

Number of Acute RQ Applications/ Site/

( Peak EEC/ LC50) 2 EEC Peak ( ppb) 1 Interval Application Method/

0.47 84 4.8/ 4 Apples 7 day interval ground & aerial 0.63 113 1.6/ 6 Pepper a 7 day interval ground & aerial 0.26 47.6 1.6/ 10 Potato ( Maine, only)

5 day interval ground & aerial 1.10 197.9 2.4/ 7 Tomato b 7 day interval ground & aerial 1 Based on PRZM version 3.12/ EXAMS version 2.97.5 modeling. 2 RQ greater or equal to 0.5 exceeds acute high risk, acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.1 exceeds acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.05 exceeds acute endangered species LOCs.

a East of the Mississippi River ( 1.6 lb ai/ A is a W. of Miss. R. rate for peppers. 2.4 lb ai/ A 6 times every 7 days is the E. of Miss. R. rate   the scenario is FL)

b East of the Mississippi River iv. Estuarine/ Marine Fish Tabulated below in Table 8 are maneb's acute risk quotients for esturarine/ marine fish. The results show that acute, acute restricted use, and acute endangered species RQs exceed LOCs for maneb's use on tomatoes and peppers. Restricted use and acute endangered species LOCs are exceeded for all maneb uses ( acute RQ ranges from 0.26 to 1.1). 93 Table 9: Maneb Acute Risk Quotients for Estuarine/ Marine Invertebrates Based On a Mysid Shrimp ( Americamysis bahia ) LC50 of 3.0 ppb. Application Rate ( lbs ai/ A)/

Number of Acute RQ Applications/ Site/

( Peak EEC/ LC50) 2 EEC Peak ( ppb) 1 Interval Application Method/

28.00 84 4.8/ 4 Apples 7 day interval ground & aerial 37.67 113 1.6/ 6 Pepper a 7 day interval ground & aerial 15.87 47.6 1.6/ 10 Potato ( Maine, only)

5 day interval ground & aerial 65.97 197.9 2.4/ 7 Tomato b 7 day interval ground & aerial 1 Based on PRZM version 3.12/ EXAMS version 2.97.5 modeling. 2 RQ greater or equal to 0.5 exceeds acute high risk, acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.1 exceeds acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.05 exceeds acute endangered species LOCs.

a East of the Mississippi River ( 1.6 lb ai/ A is a W. of Miss. R. rate for peppers. 2.4 lb ai/ A 6 times every 7 days is the E. of Miss. R. rate   the scenario is FL)

b East of the Mississippi River v. Estuarine/ Marine Invertebrates Tabulated below in Table 9 are maneb's acute risk quotients for esturarine/ marine invertebrates. The results show that acute RQs exceed acute, acute restricted use, and acute endangered LOCs for all maneb uses ( acute RQ ranges from 15.87 to 65.97). There are currently no estuarine/ marine invertebrates listed as endangered species. 94 Table 10: Maneb Acute Risk Quotients for Aquatic Non Vascular Plants Based On a Green Algae ( Selenastrum capricornutum ) LC50 of 13.4 ppb. Application Rate ( lbs ai/ A)/

Number of Acute RQ Applications/ Site/ ( Peak EEC/ LC50) 2 EEC Peak ( ppb) 1 Interval Application Method/

6.27 84 4.8/ 4 Apples 7 day interval ground & aerial 8.43 113 1.6/ 6 Pepper a 7 day interval ground & aerial 3.55 47.6 1.6/ 10 Potato ( Maine, only)

5 day interval ground & aerial 14.77 197.9 2.4/ 7 Tomato b 7 day interval ground & aerial 1 Based on PRZM version 3.12/ EXAMS version 2.97.5 modeling.

2 RQ greater or equal to 1.0 exceeds acute high risk LOCs.

a East of the Mississippi River ( 1.6 lb ai/ A is a W. of Miss. R. rate for peppers. 2.4 lb ai/ A 6 times every 7 days is the E. of Miss. R. rate   the scenario is FL)

b East of the Mississippi River d. Exposure and Risk to Non target Plants: Aquatic Plants Exposure to non target aquatic plants may occur through runoff or spray drift from adjacent treated sites or directly from such uses as aquatic weed or mosquito larvae control. EFED assesses an aquatic vascular plant risk for acute risk from the surrogate duckweed Lemna gibba. EFED makes nonvascular aquatic plant acute risk assessments using either algae or a diatom, whichever is the most sensitive species. So far, there are no known nonvascular plant species on the endangered species list. Runoff and drift exposure is computed from PRZM/ EXAMS. EFED calculates the risk quotient by dividing the pesticide's initial or peak concentration in water by the plant EC 50 value.

Shown in Table 10 are the acute risk quotients for freshwater, nonvascular green alga ( Selenastrum capricornutum). All maneb's use patterns exceed acute risk LOCs for nonvascular aquatic plants ( acute RQ ranges from 3.55 to 14.77). 95 e. Endangered Species Based on available screening level information there is a potential concern for maneb's acute effects on listed freshwater and estuarine/ marine animals and chronic effects on listed birds and mammals should exposure actually occur. EFED expects maneb poses a low acute risk to nontarget insects because maneb is practically nontoxic to honeybees, ( acute contact LD 50 > 12 µ g/ bee). Also, there is no incident data reporting adverse effects to honeybees from maneb's use. However, EFED does not assess risk to bees using RQs because a screening level RQ assessment method for estimating the risk to bees is not available. EFED has not developed an exposure design for bees to estimate the risk using a risk quotient method. The Agency does not currently have enough data to perform a screening level assessment for maneb's effects on listed nontarget terrestrial plants or vascular aquatic plants. EFED did not assess chronic risks to freshwater invertebrates, or estuarine/ marine fish due to lack of data. There are no nonvascular aquatic plants or estuarine/ marine invertebrate species on the endangered species list.