### 2 

# Table of Contents

1. Executive Summary

................................ ................................ ................................ .............. 3
2. Introduction

................................ ................................ ................................ ........................... 8
3. Use Characterization

................................ ................................ ................................ ............ 8
3.1 Labelled Use

................................ ................................ ................................ ........................ 8
3.2 Usag e

................................ ................................ ................................ ................................ .. 12
4. Conclusions from Previous Risk Assessments

................................ ................................ .. 12
4.1 Ecological Risk Assessment

................................ ................................ .............................. 13 4.1 Drinking Water Exposure Assessments

................................ ................................ .............. 13
4.2 Clean Water Act Programs

................................ ................................ ................................ 14
5. Environmental Fate and Transport

................................ ................................ .................. 15
5.1 Mancozeb

................................ ................................ ................................ ........................... 15
5.2 The Major Mancozeb Degradate: Ethylenethiourea (ETU)

................................ ............... 26
5.3 Determination of the Stressor of Concern for Ecological Risk Assessment

..................... 31
6. Receptors

................................ ................................ ................................ ............................. 35
6.1 Effects to Aquatic Organisms

................................ ................................ ............................ 35
6.2 Effects to Terrestrial Organisms

................................ ................................ ........................ 39
6.3 Ecological Incidents

................................ ................................ ................................ ........... 42
7. Exposure Pathways of Concern

................................ ................................ ......................... 44
8. Analysis Plan

................................ ................................ ................................ ....................... 46
8.1 Stressor s of Concern

................................ ................................ ................................ .......... 46
8.2 Measures of Exposure

................................ ................................ ................................ ........ 46
8.3 Measures of Effect

................................ ................................ ................................ ............. 46
9. End angered Species Assessments

................................ ................................ ...................... 47
10. Endocrine Disruptor Screening Program

................................ ................................ ......... 48
11. Preliminary Identification of Data Gaps

................................ ................................ .......... 48
11.1 Environmental Fate

................................ ................................ ................................ ..... 48
11.2 Effects

................................ ................................ ................................ ......................... 49
12. References

................................ ................................ ................................ ............................ 61

### 3 

# 1. Executive S ummary

The Environmental Fate and Effects Division (EFED) has completed the problem formulation for the ecological risk, environmental fate, endangered species, and drinking water assessments to be conducted as part of the registrati on review of mancozeb . The problem formulation describes the
methods planned to be used during the completion of drinking water and ecological r isk assessments in support of registration review and provide s an ove rview of the environmental fate, ecologica l effects , and potential risks associated with the use of mancozeb as well as uncertain ties unique to risk assessment of mancozeb . This document also identifies additional studies that would be beneficial to the conduct of an ecological risk assessment to parent mancozeb and the primary degradation product, ethylenethiourea (hereafter referred to as ETU)

. Major environmental fate and ecological effects uncertainties and the associated data needs related to the

assessment are stated hereunder :

Uncertainties and Data Gaps

Environmental Fate

In the current data base for mancozeb, a major uncertainty exists on the identification of the un

extracted residues ( UER ). These residues appear to form at high levels with very limited degradation

. Additionally, problems exist in characterization of the residues since thin layer chromatography ( TLC ) prevents accurate identification/quantification. Reduction of these uncertainties is expected with submission of requested data. Hereunder is a list of r equested
studies:

Hydrolysis (OCSPP 835.2120) : A new guideline hydrolysis study for a mancozeb active ingredient to which solubility is known (pre

- determined by a guideline study) with concentration below this pre

- determined solubility . In this study, th e starting residues, just after dissolution should be characterized and tracked to the end of the study.

Aerobic soil metabolism (OCSPP 835.4100) : A new guideline study for ETU (ETU as the test substance) in two soils from areas where the pesticide is use d with varied pH, organic matter content and cation exchange capacity

Aerobic Aquatic metabolism (OCSPP 835.4300) : A new guideline study for ETU in two water/sediment systems

Anaerobic Aquatic metabolism (OCSPP 835.4400) : Two new guideline stud ies for ma ncozeb parent and ETU in two water/sediment systems. Not e that it may be possible to obtain the data for ETU from the parent study.

In these studies, the registrant is requested to better characterize and if possible identify the un

extracted residues. This is because these residues were found to be more toxic than the parent compound in submitted sediment toxicity studies . Additionall y, complete identification / quantification of all degradates is expected along with tracking their formation and decline. Lastly, the following should be observed:

### 4 (1) The maximum single application rate for m ancozeb ranges from 4.9 to 17.5 lbs a.i/A, therefo re, the application rate to the aerobic soil and aquatic studies may be conducted with a concentration at or below the predetermined solubility (expected to be 13 ppm as reported) . At this solubility, mancozeb as a parent is not expected to be present ; t he refore, the parent residue is what is applied to the soil/sediment and it should be analyzed before application and throughout the study duration. Due to the fact that there are transient species forming early

, it
is recommended that shorter intervals are chosen for the first week of the study;

(2) The objective of metabolism studies is to track the formation/decline of all transient species/degradates of mancozeb residue s applied to the soil /sediment ; and

(3) For all metabolism studies requested for mancozeb res idues and ETU, the registrant should show efforts to extract and identify residues that may be left associated with soil or sediment following EFED un

- extracted residues guidance 1



### .

ECM/ILV (OCSPP 835.6100) : The registrant is requested to submit environmental chemistry method and associated independent laboratory validation (ECM/ILV) studies for determination of mancozeb and ETU in soil and mancozeb only in water.

Ecological Effects

The following uncertainties are identified for mancozeb:

Extent of Toxicity to Larval and Juvenile Honey bees

Currently, there are data available that characterize the acute contact and acute oral toxicity of mancozeb to adult honey bees. The extent to which mancozeb exerts toxic effects on honey bee
larvae o r juvenile honey bees is unknown. Further toxicity data that is recommended below is needed to characterize this uncertainty.

Extent of Toxicity of un

- extracted residues to other sediment

- dwelling invertebrates

As this assessment will show, the un

- extra cted residues of mancozeb form immediately after introduction in an aerobic aquatic system and steadily increase to approximately 28% of the applied radioactivity after 7 days

, and from there to over 40% after 105 days. Sediment dwelling
invertebrates are expected to be exposed to these residues as part or all of their life cycle is spent in contact with the sediment and pore water. Currently, there are two subchronic (10

- day) sediment toxicity studies, one conducted with parent mancozeb and the other wit h the un

- extracted residues of mancozeb. Both studies are conducted with the freshwater midge ( Chironomus

tentans ). The data indicate enhanced toxicity by approximately an order of magnitude of the un

extracted residues as compared to parent mancozeb. I t is an uncertainty as to the sensitivity of other sediment dwelling invertebrates such as the freshwater amphipod, Hyalella azteca , and the

1 URL: http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/environmental_fate_tech_team/Unextrac ted_Residues_in_Lab_Studies.htm

### 5 estuarine/marine amphipod, Leptocheirus plumulosus . It is also an uncertainty the extent of toxicity that chronic exposures , beyond 10 days

, of these un

- extracted residues would have to sub

lethal measures of effects including reproductive endpoints.

Extent of toxicity and bioavailability of un

- extracted residues to terrestrial organisms

As this assessment will show, the un

- extracted residues of mancozeb form immediately after introduction into an aerobic soil system (up to 46% of the applied radioactivity) at Day 0 and increase steadily therefore to approximately 65% after 7 days. It is an uncertainty if similar formation rates are observed when mancozeb is sprayed on foliage. Additionally, it is an uncertainty the extent of the toxicity and bioavailability of these residues to terrestrial taxa

, like birds, mammals, and terrestrial inver tebrates. Although available ecotoxicity studies show that the major mancozeb degradate, ETU, is less toxic to terrestrial organisms as compared to parent mancozeb, maximum ETU residues in the soil reach approximately 13% after 1 day before steadily
decli ning with time thereafter. Hereunder is a list of requested studies:

Avian Acute Oral Toxicity Test (OCSPP 850.2100). Currently there are no available acute oral toxicity studies for mancozeb that are suitable for quantitative risk assessment and are th erefore
recommended. Please see Section 11.2 for further details.

Avian Dietary Toxicity Test (OCSPP 850.2200). Two subacute dietary toxicity studies are recommended to characterize the dietary toxicity route of exposure to birds which will allow the estimation of acute dietary

- based risk to birds feeding on mancozeb contaminated food items. Previously, no subacute dietary toxicity studies to birds have been submitted for mancozeb. Two studies are recommended, one with an upland game bird species (n orthern bobwhite quail) and one with a waterfowl species (mallard duck).

Seedling Emergence and Seedling Growth (OCSPP 850.4100) : There is currently one available Tier I Seedling Emergence study available for mancozeb which is classified as acceptable. However, this study tested at an application rate of 0.02 lbs a.i/A. Mancozeb is associated with single application rates as high a s 4.9 lbs a.i/A for food crops (pome fruits and cranberries) and
17.5 lbs a.i/A for non

- food uses (turf). A new study is requested that tests mancozeb at the highest maximum single application rate in order to estimate risk to listed and non

- listed species of terrestrial plants.

Vegetative Vigor (OSCPP 850.4150) : There is currently one available Tier I Vegetative Vigor study available for mancozeb which is classified as acceptable. However, this study tested at an application rate of 0.02 lbs a.i/A. Mancozeb is associated with single application rates as high as 4.9 lbs a.i/A for food crops (pome fruits and cranberries) and 17.5 lbs a.i/A for non

- food uses (turf). A new study is requested that t ests mancozeb at the highest maximum single application

rate in order to estimate risk to listed and non

- listed species of terrestrial plants.

Non

- Guideline Study (OECD TG 213) (Tier 1): Honey Bee Adult Acute Oral Toxicity. Honey
b ees can be exposed to p esticides through multiple pathways including contact with sprays and dusts and through ingestion of residues in food/water ( e.g ., pollen/nectar and water used to maintain colony temperature). Worker bees foraging on flowers for pollen and nectar can be

### 6 r epeatedly exposed to residues in pollen and nectar either through direct contamination of these matrices by foliar sprays

. Residues can in turn be brought back to bee colonies where in

- hive bees including young adult and developing brood ( i.e ., eggs, larv ae and pupae) may be exposed. EPA guidance on assessing the risk of pesticides to bees identifies a suite of laboratory

- based studies intended to facilitate screening for potential acute and chronic effects to individual adult and larval
bees as part of a tiered approach

. 2 

### Acceptable acute contact toxicity data are available for adult honey bee exposures to mancozeb ; however, data are not available for oral toxicity to adults on an acute exposure basis. Certain classes of chemicals have indicated differe ntial toxicity depending on the route of exposure. An acute oral toxicity test to adult honey bees would address this uncertainty. No protocol needs to be submitted to the Agency before the initiation of this study as guidance for its parameters is docume nted in OECD Test Guideline 213. Pending the results of this study, higher tiered ( e.g. semi

- field) studies as well as residue studies may be required.

Non

- guideline Study ( OECD TG 237 ) (Tier 1) : Honey Bee Larvae Acute Oral Toxicity 3 

### As noted above, EPA guidance on assessing the risk of pesticides to bees identifies a suite of laboratory

based studies intended to facilitate screening for potential acute and chronic effects to individual adult
and larval bees. Acceptable acute contact toxicity data are available for adult honey bee exposures to
mancozeb ; however, data are not available for larval toxicity. Honey bee larvae have been sometimes shown to be more sensitive to chemicals than adults and therefore this study, along with a hon ey bee larval chronic toxicity, are recommended to address this uncertainty. No protocol needs to be
submitted to the Agency before the initiation of this study as guidance for its parameters are well
documented in OECD Test Guideline 237

. Pending the re sults of this study, higher tiered ( e.g. semi

field) studies as well as residue studies may be required.



### Non

- guideline Study (Tier 1) : Honey Bee Larvae Chronic Oral Toxicity. As mentioned above, EPA guidance on assessing the risk of pesticides to bees identifies a suite of laboratory

- based studies intended to facilitate screening for potential acute and chronic effects to i ndividual adult
and larval bees. T here are currently no data available to characterize the acute or chronic toxicity to honey bee l arvae. EFED recommends that a protocol (following the OECD draft test guideline document, February 25, 201 4 ) 4 

### be submitted for review and approval by the Agency prior to initiation of this study. Pending the results of this study, higher tiered ( e.g. sem i

- field) studies as well as residue studies may be required.

Non

- guideline Study: Honey Bee Adult Chronic Oral Toxicity (Tier 1 ). As discussed above, EPA guidance on assessing the risk of pesticides to bees identifies a suite of laboratory

- based
studies intended to facilitate screening for potential acute and chronic effects to individual adult
and larval bees. The 10

- day toxicity study with young adul t bees provides no

- observed adverse effect level (NOAEL) and lowest

- observed adverse effect level (LOAEL) for assessing chronic
effects , including mortality as well as sub

- lethal effects such as food consumption . Risk estimates
based on these data will be considered along with other lines of evidence to determine whether

2 Available online at: http://www2.epa.gov/sites/production/files/2014

- 06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf

3 Depending on the design of the “Honey Bee

– 21

- day repeated dose chronic larval toxicity” study, a 72

- hour L D 50 value may be derived from this study. If that is possible, it would obviate the need for this study.

4 http://www.oecd.org/ chemicalsafety/testing/Draft_GD_honeybee_larval_tox_repeated_exposure_25_February_201 4.pdf

### 7 higher

- tier studies are needed at the whole colony level. EFED recommends that the registrant
submit a protocol and consult with the Agency prior to study initiation.

Non

- guideline Study : Field Trial of Residues in Pollen and Nectar (Tier 2) : If the Tier 1 bee toxicity data and screening level risk assessment indicates potential risk to bees, refinement of exposure estimates for residues in pollen and nectar may be needed.

. Specificall y, the s creening level exposure concentrations that are estimated in Tier 1 for pollen and nectar are intended to be conservative. Measurement of residues in pollen and nectar would allow for more accurate exposure analysis when applications are made at b loom. T his chemical is of low toxicity to adults,
but applications at bloom could contaminate pollen and nectar that adult foragers bring back to the
colonies , resulting in potential expos ur e s to the brood. If this study is considered necessary based on the results of the Tier 1 risk assessment, EFED recommends that the registrant submit a protocol and consult with the Agency prior to study initiation.

Non

- guideline Study: Semi

- Field Testing for Pollinators (Tunnel or Colony Feeding Studies) (Tier 2). Screening level and refined Tier 1 risk assessments with the honey bee larvae may indicate the need to progress to higher tier toxicity testing under semi

- field conditions. In evaluating the effects of mancoz eb on honey bees at the colony level, there are uncertainties relating effects to individual bees to that at the colony level. Semi

- field testing data can be used to address these uncertainties with either a tunnel or colony feeding study experiment design

. If this study is considered necessary based on the results of the Tier 1 risk assessment, EFED recommends that the registrant submit a protocol and consult with the Agency prior to study initiation.

850.3040: Field Testing for Pollinators (Tier 2 or 3) : Screening level and refined Tier 1 risk assessments with the honey bee larvae may indicate the need to progress to higher tier toxicity testing under field condition s

. In evaluat ing the effects of mancozeb on honey bees at the colony
level , t he re are un certainties relat ing effects to individual bees to that at the colony level. Field testing data can be used to address these uncertainties. If this study is considered necessary based on the results of the Tier 1 risk assessment, EFED recommends that the registrant submit a protocol and consult with the Agency prior to study initiation.

Aquatic Plant Toxicity Test using Lemna spp. (OCSPP 850.4400): There is currently no toxicity study available with a vascular aquatic plant conducted for mancozeb. Further analysis in
this assessment (presented in Section 5) will show a rapid degradation of parent to the primary degradate ETU. Within 6 hours, parent mancozeb relative concentrations fall from approximately 80% to approximately 40% of the applied ra dioactivity while concentrations of ETU increase during this time. After 1 day, relative water column concentrations of parent in an aerobic aquatic system was determined to be 10%. Despite this rapid transformation, an available algal toxicity study con ducted with the freshwater green algae ( Selenastrum capricornutum ) indicates a 96

- hr
EC 50 

### of 47 μg a.i/L and a 96

- hr NOAEL of 22 μg a.i/L. It is noted that this study was initiated with parent mancozeb. Previous risk assessments have identified peak surf ace water EECs up to 4 fold higher than this, suggesting parent mancozeb, despite its rapid degradation, has enough time to elicit a toxic effect to aquatic plants. Additionally, it is noted that the aforementioned study was a static system, and percent r ecoveries of the test substance ranged 65

- 80% of nominal at hour 0,
17

- 21% at hour 48, and 1.3

– 7.3% at test termination. Despite the clear degradation of the test substance in the lab, current labels permit mancozeb to be applied up to 15 times at inter vals as

### 8 low as every 4 days. Therefore, even with a rapid transformation to degradates that will be shown in this assessment to be less toxic than parent, it is indicated in the available algal toxicity study that mancozeb can elicit toxic effects, at env ironmentally relevant concentrations that may be present at levels that would make up for its decomposition

.

A study with the vascular aquatic plant Lemna gibba is recommended to address this uncertainty.

Algal Toxicity (Freshwater diatom) (OCSPP 850.4500) : There is currently no algal toxicity study with a freshwater diatom submitted for mancozeb. As discussed above, a study with a freshwater green algae species indicated toxicity that would be above the level of concern when
risk is esti mated using peak surface water EECs. This study is being recommended to address the potential increased sensitivity of freshwater diatoms as compared to other algal species.

Algal Toxicity (Marine diatom) (OCSPP 850.4500) : There is currently no algal t oxicity study
with a marine diatom submitted for mancozeb. As discussed above, a study with a freshwater green algae species indicated toxicity that would be above the level of concern when risk is estimated using peak surface water EECs. This study is being recommended to address the potential increased sensitivity of marine diatoms as compared to other algal species.

Cyanobacteria ( Anabaena flos

- aquae ) toxicity (OCSPP 850.4 5 50) : There is currently no algal toxicity study with a cyanobacteria species submitted for mancozeb . As discussed above, a study with a freshwater green algae species indicated toxicity that would be above the level of concern when risk is estimated using peak surface water EECs. This study is being recommended to address the pote ntial increased sensitivity of cyanobacteria as compared to other algal species.



# 2. Introduction

Mancozeb [ CAS name: [[I ,2

- ethanediylbis[carbamodithioato]](2

- )] manganese mixture with [[ I, 2

- ethanediylbis[carbamodithioato]](2

- )]zinc. ; IUPAC name: Manganese ethylenebis (dithiocarbamate) (polymeric) complex with zinc salt; CAS number 8018

- 01

- 7 ; PC Code 0 14504 ; and molecular formula C 4 

### H 8 

### MnN 2 

### S 4 

### Zn ], is an ethylene bis dithiocarbamate (EBDC) non

- systemic fungicide with protective action on contact. T he specific mode of action ( MOA) is unknown and is classified by the code M3 (multi

- site action) by the Fungicide Resistance Action Committee (F RAC 5 

### ).



# 3. Use Characterization

**3.1 Labelled Use** 

Based on a sample of twenty six section 3 and forty four 24(c) labels, mancozeb i s for m u lated as

e i t h er a d ry flowable, flow a ble c o n cen t r a t e, wettable powder, or d u s t and applied as a liquid spray using gro u nd, a i r c

r a

ft, or through irrigation systems (chemiga t i on). In addition,

5 Fungicide Resistance Action Committee: URL: http://www.frac.info/docs/default

- source/publications/frac

- code

list/frac

- code

- list

- 2015

- finalC2AD7AA36764.pdf (accessed June, 2015)

### 9 mancozeb is used as dip treatment and to treat seed and seed pieces in many crops. Table 1 contains a summary of section 3 labelled uses.

Table 1 Mancozeb use patterns

Crop Use Pattern Application Parameters 1

Notes 2 MSR MNA MTR MAI
Asparagus: Crowns dip treatment Refer to Text Pre

- plant crowns dip treatment Asparagus: Crop 1.60 4 6.4 10 A/G Foliar sprays; AP W= Pre

- plant & Post

- harvest
Bananas & Plantains 2.40 10 24.4 14 A/G Foliar sprays & C Brassica Veg.: Broccoli/ Cabbage 1.6 6 9.6 7 A/G Foliar sprays & C Capri fig: Dip treatment Refer to T ext In the Summer to prepare for pollination
Cereal Grains 3 1.63 3 4.9 7 A/G Foliar sprays & C Christmas tree plantations 3.2 NS NS 7 A/G Foliar sprays & C; APW= Spring/early Summer Conifers plantations/nurseries 1.5 NS NS 7 A=A e rial/G=Ground Foliar Sprays Corn (unspecified, field sweet/pop) 1.22 15 18.3 4 A/G Foliar sprays & C Cranberry 4.9 3 14.7 7 A/G Foliar sprays & C Cucurbit Vegetables 4 2.43 8 19.4 7 A/G Foliar sprays & C
Fennel 1.63 8 13.0 7 A/G Foliar sprays & C Forestry 5 3.2 NS NS 7 A/G Foliar sprays & C; APW= Spring/early Summer Fruiting Vegetables 6 : Peppers W 1.6 6 9.6 7 A/G Foliar sprays & C Peppers E 2.4 8 19.2 7
Tomatoes W 1.6 4 6.4 7 A/G Foliar sprays & C ; A P W= Post

- transplant at seedling stage in addition to Foliar Tomatoes E 2.44 7 17.1 7 Garlic & Onion: dried; Shallot 2.44 10 24.4 7 A/G Foliar sprays & C
Ginseng 1.6 12 19.2 7 A/G Foliar sprays & C Grapes: West of the Rockies 2.0 3 6.0 7 A/G Foliar sprays & C; APW= Start when Shoots 1⁄2 to 1 1⁄2 inch long. In CA don’t apply after bloom East of the Rockies 3.2 6 19.2 7
Lettuce: California 1.6 4 6.4 7 A/G Foliar sprays & C All other States 1.6 6 9.6 7
Nut Trees: Almonds 4.8 3 14.4 7 A/G Foliar sprays & C; AP W: Delayed dormant through petal fall Walnuts 1.82 10 18.2 7
Ornamentals 7 : Cut F /Greenhouse NS 20 NS 3? G=Ground Foliar Sprays/C= Chemigation
All others 1.6 20 32.0 7 A/G Foliar sprays & C

Pome Fruits 8 4.88 4 19.5 7 A/G Foliar sprays & C
Peanuts 1.6 10 16.0 7 A/G Foliar sprays & C Potatoes: Crop 1.63 7 11.4 5 A/G Foliar sprays & C Seed pieces Refer to Text Pre

- plant crowns dip treatment Seed Treatments: Many crops Refer to Text Pre

- plant seed treatments Sugar beet 1.6 7 11.2 7 A/G Foliar sprays & C

Tropical/Subtropical Fruits 9 2.0 14 28 7 A/G Foliar sprays & C
Turf 10 : COM/IND/RREC 17.5 4 70 10 A/G Foliar sprays & C
Turf 11 : Golf course/Cold Season
Golf course/Warm Season
Turf : Sod Farms 17.4 4 69.6 10 A/G Foliar sprays & C

1 Application Parameters: MSR= maximum single rate (lbs a.i./acre), MNA = maximum number of applications, MTR = maximum total rate (lbs a.i./acre/year), and MAI = Minimum application intervals in days. Note: Any label that species application/crop cycle should be modified as it is assumed in this table to be per year;

2 Abbreviations for Notes: A =A e rial/ G =Ground Sprays/ C =Chemigation; A P W = Application Window

3 Cereal Grains: Barley, Oats, Triticale, Wheat, Rye;

### 10 Crop Use Pattern Application Parameters 1

Notes 2 MSR MNA MTR MAI

4 Cucurbit Vegetables: cucumber, cantaloupe, pumpkin, Momordica spp., Melons (honeydew, citron melon, casaba melon, Crenshaw melon, watermelon, Musk melon) and Winter/Summer Squash; Gourds (edible & Chi nese wax);

5 Forestry: Douglas fir forestry and shelterbelt;

6 Fruiting Vegetables: Peppers and tomatoes : West/East of the Mississippi River;

7 Ornamentals : shade trees, ground cover plants, herbaceous plants, non

- flowering plants, woody shrubs and vines and Ornamentals: Cut F/Greenhouse= Ornamental cut flower/foliage in Greenhouse;

8 Pome Fruits: Apples, Crabapples, Pears and Quince;

9 Tropical/Subtropical Fruits: Papaya, Atemoya, Canistel, Cherimoya, Mamey, Mango, Papaya, Sapodilla, Sapota (white),
Cus tard/Star/Sugar Apples; noting that the stated rate s are for most of these tropical fruit trees. Some of these fruit trees ha ve lower rate and/or a 14

- day application intervals;

10 Turf : COM/IND/RREC : commercial/in dustrial/recreational noting that turf in residential settings and athletic fields are excluded; and

11 Turf: Golf Courses : It is noted that the RED document states that one less application for warm season grasses and No Arial or chemigation (only few labels abide by this requirements).



### Dip Treatment

This application will be calculated (in lbs a.i/A), considered as an application at the planting date/depth and added to application (s) labeled for the crop, if any. Labelled dip treatment are for the following crops:

(1) 

### Asparagus: Crowns di p treatment (for crown rot): In one of the label s , the treatment is
described as follows: (a) P repare the dipping suspension ( 1 .0 Ib

. a.i/ 1 00 gal of water) in a clean
tank ; (b) Pack pre

- washed crowns loosely into a burlap bag and soak, with gentle agitation, in the fungicide solution for 5 minutes; and (c ) Remove bag, drain well, and p lant crowns as soon as possible

. The m aximum specified for preparing 100 gallons of the dipping suspension ranges from 0.814 to 1.0 pound of a.i

. For future modeling, the registrant is requested to specify how many pounds of crowns that may be treated with the 100 gallons dipping suspension, how many pound of treated crowns needed to plant one acre and what to do with dipping suspension after treatment;

(2) 

### Capri fig: Dip treatment (for molds and f usariurn) : In one of the label s , the treatment is described as follows: (a) Prepare the dipping suspension ( 4.0 Ib. a.i/100 gal of water) ; (b) Prepare mamme figs by making a shallow cut through the eye and then han d dividing to av oid wasp injury; and (c) Submerge mamme figs in the fungicide suspension for a minimum of 15 minutes. The fungicide suspension should be stirred frequently to prevent settling out and f resh dipping solution should be used after treating 4 or 5 batches of f igs. After treatment, figs should be drained prior to placement in trees. For future modeling, the registrant is requested to specify how many pounds of figs that may be treated with the 100 gallons dipping suspension, how many pound of treated figs needed for one acre and what to do with dipping suspension after treatment; and

(3) 

### Potato pieces: Dip treatment: Pre

- plant seed/seed pieces dip tank is prepared @ 0.08 lbs
a.i/100 lbs of seeds /seed pieces. In future modeling the ra te in lbs a.i/A will be cal culated based on BEAD maximum seeding rate (lbs of seeds/seed pieces needed to plant one acre). Again, the registrant is requested to specify what to do with the dipping suspension after treatment.

### 11 Seed Treatment

This application will be calculated (in lb s a.i/A) using BEADs maximum seeding rate for each crop, considered as an application at the planting date/depth and added to application(s) labeled for the crop, if any. Labelled seed treatment are for the following cro ps (rate per 100 lbs of seeds):
Barl e y (0.2100); Corn (0.2719); Cotton (0.3156); Flax (0.3602); Oats (0.3150); Peanuts (0.81), Rice (0. 2094 ); Rye (0.1801); Safflower (0.1063); Sorghum (0.2271); Tomatoes (0.430); Triticale (0.1650); and Wheat (0.1625).

24(c) Labels

The LUIS report contains forty four 24(c) labels for local use in the following states: CA (Two for walnuts); ID (One for Carrot); OR (Two

, carrot/ vegetables, refer to Table 2 below); WA (Three:
One for Brassica v egetables, b eet (un

- specified) /carrots/ vegetables, refer to Table 2 , below)

, Two
for p ears) ; and all others ( 36 labels ) are for Tobacco including: CT (5); GA (1); IN (3); KY (2);
MA (2); MD (2); MO (3); NC (3); OH (3); PA (3); SC (3); TN (2); VA (4) , refer to Table 2 for
the application parameters for crops covered by the se 24 (c) labels.

Table 2 A summary of the application parameters for 24(c) labels (for abbreviation refer to the labelled use table, above)

Crop Use Pattern Application Parameters

Notes MSR MNA MTR MAI

Beet (un

- specified) 1.5 8 12.0 7 A =A e rial/ G =Ground Foliar Sprays (OR & WA)
Brassica Vegetables 1.5 12 18.0 7 A/G Foliar sprays & C= Chemigation (WA)

Carrot 1.5 12 18 7 A/G Foliar sprays & C (OR & WA) Swiss Chard, Coriander, Arugula “Roquette”, Spinach, Parsley, Parsnip, Dill, Endive 1.5 12 18 7 A/G Foliar Sprays (OR & WA); Lettuce: only A Crucifer (assumed= all Brassica Vegetables ) 1.5 6 9 7 A/G Sprays (OR)

Leek and Onion 1.5 12 18 7 A/G Sprays (OR & WA); Leek: Only A

Tobacco 2.0 NS NS 5 G= Pre

- plant seed bed and Foliar



### It is important to note that labelled uses summarized above are based on most, not all , mancozeb labels. Additionally, application parameters are chosen from labels containing the highest rates and minimum application intervals. It is also noted that many labels do not contain necessary information for application. The registrants are requested to check the labelled summary Tables and information above and provide necessary addition(s)/ correction(s). In addition, it is necessary to modify their labels accor dingly. In future modeling and in the absence of the required information, EFED will use the most conservative parameters. Labels should contain the following
information:

(1) Maximum single and yearly not crop cycle, application rate, maximum number of application and minimum application intervals;

### 12 (2) Timing of application or information that can be used for determining the application window; and

(3) Application procedure(s) for each crop.



## 3.2 **Usage**

From the mancozeb BEAD chemical profile (BCP) drafted by the B iological and Economic Analysis Division ( 01/22/2015 ) mancozeb use in terms of pounds a.i. applied in the U.S. h a s remained fairly constant during the 1998

- 2012 time frame with very s light decreases in years (2006

- 2009). Similar t r ends were found for total area treated

. During t h e 1998

- 2012 time frame, appro x imate l y 6.4 million pounds a.i. were applied on average annually to treat 4.5
million acres at an overall average a.i. application rate of 1.4 l b s a.i. per acre. During the 2008

- 2012 time frame, approximately 6 millio n pounds a.i. were applied annually on average to treat 4 million acres a t overall average a.i. application ra t e of 1.5 l b s a.i. per acre.



# 4. Conclusions from Previous Risk Assessments

Two main risk assessments were conducted for mancozeb and its main degradate ETU:

(1) Environmental Fate and Ecological Risk Assessment for Mancozeb, Section 3 Reregistration for Control of Fungal Diseases on Numerous Crops, a Forestry Use on Douglas Firs, Ornamental Plantings, and Turf (Phase 3 Respons e),” dated June, 2005 which was accompanied by the Environmental Fate and Ecological Risk Assessment for Ethylenethiourea (ETU) a Common Degradate of the Ethylenebisdithiocarbamate fungicides (EBDCs): Metiram, Mancozeb, and Maneb (Phase 3 Response),” dated June , 2005. The two documents were prepared by EFED for the Reregistration Eligibility Decision for Mancozeb ( RED) ( Document 738

- R

- 04

- 012 dated September, 2005) ;

(2) Risks of Mancozeb and Maneb Uses to the Federally Listed California Red Legged Frog ( Rana aurora draytonii ) dated October, 2007

.

This problem formulation updates aspects of these r ecent risk assessments

, includ ing the following:

• Changes in labelled use patterns following the RED required mitigation measures which included: use patterns that a re ineligible for reregistration and changes in application rates, procedure and intervals for some crops;

• New crop registrations following issuance of the RED document in 2005 which included addition of new crops and c hanges in application intervals; and

• Modify the previous assignments for the stressor of concern following new submittals
i ncluding:

### 13 o Fate studies with better characterization/quantification of mancozeb residues;

o New ecological toxicity studies for ETU

, the major degradate of mancozeb; and

o New sediment toxicity studies on mancozeb and the un

- extracted residues.



## 4.1 **Ecological Risk Assessment**

As stated previously, t he Agency had completed two main ecological risk assessments on
mancozeb in addition to several updates for new uses that serve as a basis for this problem
formulation

. It is important to note that the previous ecological risk assessments conservatively
considered the stressor to be the “ mancozeb complex ’ which was defined to include all of the
mancozeb residues : ethyle ne thio

- urea (ETU), ethylene urea (EU), Ethylene

- bis

- isothiocyanate
sulf ide (EBIS), Hydantoin (HYD) and the un

- extracted residues (UER)

. Previous risk findings are
summarized in Table 3

.

Table 3

. Summary of risk concerns i dentified for m ancozeb in previous a ssessments *

Birds Mammals Terr.
Plants Terr.
Inverts Fish BCF Aquatic
Inverts Aquatic
Plants Groundwater
Contamination Persistence Degrad at es of Concer n

Yes 1 Yes 1 Uncertain 2 NA 3 Yes No 4 No Yes Yes 5 Yes 6 Mancozeb C omplex

* “ Yes ” = at least one LOC has been exceeded in previous assessments; “ No ” = LOCs have not been exceeded in previous assessments; “ NA ” = RQs have not been calculated previously

1 Chronic RQs exceeded LOC for certain uses

2 Available studies are conducted at rates of 0.02 lbs a.i/A, several orders of magnitude below the current maximum use rates permitted.

3 RQs were not previously calculat ed for terrestrial invertebrate

4 Due to the very low K OW of 22; noting that a fish bio

- accumulation study was previously waived

5 Based on ETU, the degradate of concern of mancozeb which is characterized by high solubility and low K OC (288 L/kg)
6 Based on only mineralization of the “Mancozeb C omplex” to CO 2

.



## 4.1 **Drinking Water Exposure Assessments**

Ethylenethiourea (ETU) is the common degradate of all Ethylene

- bis

- dithiocarbamates (EBDCs) fungicides including mancozeb. ETU, a group B2 carcinogen, was established to be the drinking water stressor resulting from the use of all EBDCs. Several EFED dri nking water assessments were generated covering original/additional new uses of all or any of the EBDCs for the estimated drinking water concentrations (EDWCs) of ETU for use in human risk assessments (DP Barcode: 290057 dated May 7, 2003; DP Barcode: D290 057 dated August 26, 2004; DP Barcodes: 323141/3
d ated August 11, 2006; DP Barcode: 397306 dated July 3, 2012; and DP Barcode: 420706 d ated September 8, 2014).

### 14 For surface water, estimated drinking water concentrations ( EDWCs ) were calculated using the
li nked PRZM and EXAMS simulation models on the assumption of very rapid degradation of the parent EBDC pesticide to ETU on a mole per mole basis. Following the submission of a two

- year targeted ETU monitoring study by the EBDC Task force, the chronic long term average EDWC was based on monitoring while the acute EDWC remained to be based on PRZM/EXAMS modeling. For ground water, a single acute/chronic EDWC was derived from community water system intake concentrati on of a targeted groundwater monitoring study conducted by the EBD C
Task F orce from 1999 to 2003 . Targeted monitoring data were submitted under MRIDs 455703

- 01, 457083

- 01, 458364

- 01 and 461454

- 01

. Table 4 contains a summary of the current Tier II
EDWCs of ETU which was used for human health drinking water risk assessment

.

Table 4

. Tier II EDWCs (in ppb of ETU ) for human health drinking water risk assessment

Stressor Acute EDWC Surface Water ( PRZM/EXAMS Modeling ) Chronic Surface Water EDWC (Monitoring de tection limit) for Non

cancer / Cancer chronic Acute and Chronic Ground
Water EDWC (Monitoring)



### ETU 25.2* 0.1 0.21

* This is the highest value in a range of EDWC values which are expected to be between 0.1 ppb (the detection limit) and 25.2 ppb (the highest peak value after adjustment by the then 0.87 national PCA).



### Requested d ata

, from this registration review for mancozeb and ETU will be considered for the determination of EDWCs for ETU resulting from mancozeb degradation. An updated drinkin g water assessment may be needed as part of the future Registration Review process. If a new drinking water assessment i s needed, EFED will include recently revised percentage crop area (PCA) factors, revised drift factors as well as the use of current SWCC and PRZM

- GW models to determine EDWCs in surface and ground waters, respectively. Use of monitoring data for the acute and chronic ground water EDWCs will be dependent on modeled PRZM

- GW EDWCs

. EFED
will consider the use of PFAM model for mancozeb us e on cranberries.



## 4.2 **Clean Water Act Programs**

Mancozeb and its major degradate ETU were not identified as a cause of impairment for any water bodies listed as impaired under sectio n 303(d) of the Clean Water Act and no Total Maximum Daily Load (TMDL) criteria have been developed for the two chemicals (Refer to URL: http://iaspub.epa.gov/tmdl_waters10/attains_nati on_cy.cause_detail_303d?p_cause_group_id=88
5 , accessed 03 / 08/2015 )

.

A summary of fish/invertebrates acute/chronic a quatic benchmarks have been established only
for ETU (Table 5 ). However, no acute non

- vascular/vascular plants aquatic benchmarks or Office of Water aquatic life criteria (maximum & continuous concentrations) were established
for either mancozeb or ETU (Refer to URL: http://www.epa.gov/oppefed1/ecorisk_d ers/aquatic_life_benchmark.htm , accessed 03/08/2015).

Table 5 OPP Aquatic l ife b enchmarks for fresh water (μg / L) for ETU

### 15 Fish Invertebrates

Acute 1 Chronic 2 Acute 3 Chronic 4

> 251 , 000 37 , 320 134 , 500 2

1 Benchmark = Toxicity value x LOC. For acute fish, toxicity value is generally the lowest 96

- hour LC50 in a standardized test (usually with rainbow trout, fathead minnow, or bluegill), and the LOC is 0.5.

2 Benchmark = Toxicity value x LOC. For chronic fis h, toxicity value is usually the lowest NO A EC from a life

cycle or early life stage test (usually with rainbow trout or fathead minnow), and the LOC is 1.

3 Benchmark = Toxicity value x LOC. For acute invertebrate, toxicity value is usually the lowest 48

- or 96

- hour
EC 50 or LC 50 in a standardized test (usually with midge, scud, or daphnids), and the LOC is 0.5.

4 Benchmark = Toxicity value x LOC. For chronic invertebrates, toxicity value is usually the lowest NOAEC from a
life

- cycle test with invertebrates (usually with midge, scud, or daphnids), and the LOC is 1.



### Any data submitted or otherwise located as part of the registration review process may be used to update aquatic life benchmarks, if applicable.



# 5. Environmental Fate and Transport

**5.1 Mancozeb** 

Mancozeb is a polymer coordination complex of zinc and manganese e thylene bis di

- thio carbamate ions (referred to hereafter as EBDC ions ) containing: 77.6% EBDC as an anion in
coordination with two cations : 20% Mn +2 

### and 2.4% Zn +2



### . Hereunder is the monomer unit chemical structure, Formula and molecular weight

Formula: (C 4 

### H 6 

### MnN 2 

### S 4 

### )x (Zn)y ; where x=1 and y=1/11= 0.090909 ; Formula Weight = 265.3 x 1 + 65.4 x 0.0 909 = 271.25 g mole

- 1 

### ;

The 2

- D structure for two monomer units, formula and molecular weight are as follows: C

C S

S S S

[Mn +2 ] [Zn +2 ]

X Y

X:Y= 10:1 

### N

N

H H

Mancozeb

### 16 Formula: C 8 

### H 12 

### MnN 4 

### S 8 

### Zn; Formula Wt.: 541.05 g mole

- 1 

### (National Institute of Health Open Chemistry Database ; URL: http://pubchem.ncbi.nlm.nih.gov/search/#collection=compounds&query_type=text&query=%22
MANCOZEB%22 1



### Mancozeb polymer has a unique water solubility property as it decomposes in water within hours at acid, neutral

, and alkaline conditions. Complete decompo sition of the polymer structure into monomeric units appears to be dependent on the concentration of the polymer. This solubility was reported, by the re gistrant, to be equal 0.6 ppm . However, this value was claimed later, by the registrant, to be 13 ppm. In other reports, the solubility of mancozeb was reported to be 6.2 ppm @ pH 7.5 and 25 o 

### C and 6.0 ppm , respectively 6



### . It appears that solubility is dependent on the
source of the mancozeb and that t he process of decomposition by water is probably related to breakage of the polymeric chains into monomeric units as shown in Figure 1

. In this respect, the process of decomposition is probably associated with abiotic hydrolysis and therefore the whole process may be referred to as decomposition/hydrolysis. Additionally, it is important to note that parent studies should be conducted using mancozeb with a predetermined solubility.

Figure 1 Expected decomposition /hydrolysis process for mancozeb in water



### Mancozeb Monomer ( EBDC anion ) 

# + Mn +2 

### & Zn +2



### The length of the polymer chains

, of the mancozeb active ingredient

, may be related to the particle size of the active ingredient which may be related to the manufacturing/formulation processes

. Finer particle size is expected to contain shorter polymer chains causing more susceptibility to the process of decomposition int o shorter or monomeric chains by solution /hydrolysis in water.

In the field, mancozeb is expected to be applied into moist plant foliage and reach, upon application
and later due to wash

- off, a moist soil system. In addition lesser quantities are expected to reach aquatic systems by drift (usually estimated to be 4

- 16% depending on type of application ). Therefore, the process of decomposition /hydrolysis of mancozeb into its monomeric units is expected to occur in soil and water/sediment. The maximum single application rate of mancozeb

range s from 4.88 lbs. a.i/acre (in crops other than turf) to 17.5 lbs. a.i/acre (in turf). Upon application, the maximum expected concentrations of mancozeb in the soil system will probably
be < 2.4 to 8.6 ppm depending on how much of the applied reach es the soil . The concentration in aquatic systems is expected to be lower . In contrast, reported solubility of 0.6 to 13 ppm suggests

6 Tomlin, C.D.S. (Ed.). The Pesticide Manual

- World Compendium , 11 th ed., British Crop Protection Council, Surrey, England 1997; and Wauchope R. D. et al . 1991. Rev Environmental Contamination Toxicology 123: 1

- 36. 

## N C

N H

H S -



## N C S - 

## N



## Mancozeb Polymer

### 17 that the decomposition /hydrolysis process is important and that its importance will probably depe nd on the nature of the polymer and the availability of moisture. In dry conditions the importance of this process is expected to be relatively lower than moist conditions.

Based on the fact that mancozeb

, as a polymer

, is expected to be short lived in th e environment . It is necessary to obtain exposure data for mancozeb as well as the residues forming in soil and water/sediment systems following the decomposition/hydrolysis process.

(a) Physical Chemical Properties and A biotic Transformation

P hysical and c hemical properties and abiotic transformation of mancozeb are included in Table 6

.

Table 6 Physical/chemical properties and abiotic transformation of mancozeb

Based on a hydrolysis study, parent (polymeric mancozeb) degraded with a half

- life of 0.8 to 1.4 days in aqueous sterilized media in the dark in acid, neutral and alkaline conditions ( Table 6 ) . The

re sults of the study suggest that abiotic hydrolysis caused degradation of the monomeric units of
mancozeb polymeric units that is expected to form initially upon dissolving the polymer in water

. Therefore, the fate of mancozeb po lymer chains appear s to be affected significantly by two processes. The first process i s the breakdown of polymeric parent into monomeric units of EBDCs
with the loss of the metal ions ( Figure 1 , above) upon dissolution in water . The second is abiotic hydrolysis of the monomeric units

. The combined decomposition/ hydrolysis

, results in the
formation of t he m ajor transformation products observed in the hydrolysis study (EBIS, E T U

, EU
and HYD ) . Although the study gives certainty that mancozeb parent is highly affect ed by hydrolysis, there are many uncertainties in this study that prevents accurate conclusions on the hydrolysis p rofile for polymeric mancozeb and resultant residues

. Uncertainties are because Property Value Reference

n - octanol

- Water Coefficient (K OW ) 21 ; based on its reported log of 1.33 USDA 1

Vapor Pressure Registrant Data: <2.10 x 10

- 8 torr (MRID 457365

- 03) HSDB: 1.3 x10

- 10 torr @ 25 o C HSDB 2

Henry's Law constant <2.31 x 10

- 9 and 1.4 x 10

- 11 atm. m 3 mole

- 1 @ 25 o C, respectively & USDA = 1.52 x 10

- 11 (Based on solubility of 13 ppm) Calculated &
USDA

Hydrolysis half

- life (t 1⁄2) 0.8 to 1.4 days @ pHs 5,7 and 9 and 25 o C Major Transformation Products: ETU, EU, EBIS , HYD and others (Identified/quantified by TLC) 3 000971

- 62 supplemented w/
402582

- 01 (S) 4

Aqueous photolysis t 1⁄2 Stable (Based on data and UV/Visible spectra were absorption maxima occurring at 200 & 282 nm noting that the visible light ranges from 400 to 700 nm) 001621

- 03 (A) 4

Soil photolysis t 1⁄2 Stable (Based on d ata and UV/Visible spectra) 002639

- 07 (A) 4

1 USDA Database: URL http://www.ars.usda.gov/SP2UserFiles/ad_hoc/12755100DatabaseFiles/PesticidePropertiesDatabase/IndividualPesticideFiles/MANCOZ EB.
TXT

2 HSDB Database: URL: http://toxnet.nlm.nih.gov/cgi

- bin/sis/search2/f?./temp/~DYF5Kf:1

3 Transformation products identification was done using two TLC solvent systems with variable results and nearly 20% of the radioactivity was not identified. Refer to Figure 2 for structures and chemical names of transformation products.

4 A= Acceptable; S= Supplemental

### 18 transformation products were identifie d/ quantified by TLC alone ( the a ppropriateness and adequacy of the TLC methodology is questionable)

, and 20% of the radioactivity was not identified. Therefore, the registrant is requested to submit a new hydrolysis study for a mancozeb active ingredient to which solubility is known ( pre

- determined by a guideline stud y ) with starting concentration below this pre

- determined solubility

.

Furthermore , d ata in Table 6 indicate that mancozeb is not expected to partition into the air from
dr y/w et soils or from water ( low vapor pressure and Henry’s Law constant). However, it could
move with drift. For this reason, the California Department of Pesticide R egulation (C DPR ) is recommending air monitoring for mancozeb and ETU (Refer to the 2014 CDPR r ecommendation
document 7 

### ). Most likely, air transport will be related to drifted parent especially in California dry
conditions. The n

- octanol

- water partitioning coefficient suggests low bio

- concentration potential
for mancozeb in aquatic organisms like fi sh and data on UV/Visible absorption maxima for mancozeb suggest photolysis in water/on soil are not important in dissipation of mancozeb in the
environment

.

(b) Biotic Transformation

A s stated previously, fate data will be presented for mancozeb and major constituents of mancozeb
residues . A summary of th is data is presented in Table 7

.

Table 7 Summary of environmental fate properties of mancozeb and residues

.

Property Value for Mancozeb Parent & Residues MRID Reference 1

Aerobic soil t 1⁄2 @ 20 o C (End of study (EOS)= 120 day) Mancozeb parent Observed in Hours in Speyer 2.3: A sandy loam soil from Germany; pH= 6.5 and organic carbon “O.C” = 0.71%); Observed in Hours in Speyer 2.2: A loamy sand soil from Germany; pH= 5.7 and O.C= 2.17%; and Observed in Ho urs in Senozan: A silty loam soil from France; pH= 5.8 and O.C= 0.99%

Mancozeb residues (Range in the three soils) Degradates: EBIS : Max 25

- 29% @ <1 d to nearly 1% at 14 d then declined to EOS; ETU: 14

- 25% @ 1 d then
declined to 1

- 2% @ EOS; EU: 12

- 14% @ 1 d then sharply declined to nearly 1% @ EOS; Un

- identified ( UN

ID consisting of 8

- 12 degradates) : 7

- 22 %
Un

- extracted Residues (UER): Max 55

- 71% @ 7

- 28 d
declined to 49

- 62% @ EOS Mineralization to CO 2 : Max range 44

- 50% @ EOS 457445

- 01 (S)

Aerobic Aquatic t 1⁄2 @ 25 o C EOS= 105 days Mancozeb Parent 16 Hours in a water/loamy sand sediment from the Rhine River, Switzerland (water: pH 8.0

- 8.2, total organic carbon 2.6 mg/L ; sediment: pH=6.9, O.C= 1.4% and CEC=2.8 meq/100g); and
16 Hours in a water/loamy sand sediment from 462043

- 01 ( A)

7 URL: http://www.c dpr.ca.gov/docs/emon/pubs/tac/recomm/mancozeb_recomm_2014.pdf

### 19 Property Value for Mancozeb Parent & Residues MRID Reference 1
Ormalingen pond, Switzerland (water: pH 7.4, total organic carbon 1.1 mg/L ; sediment: pH=6.7, O.C= 5.0% and CEC=7.1 meq/100g)

Mancozeb residues (Range in the two systems) Degradates: EBIS : Max 9

- 13% @ < 1 d to nearly 1% at 30 d then declined to no detection @ EOS; ETU: 42

- 52%
@ <1

- 2 d then declined to <1% @ EOS; EU: 23

- 32% @ 30 d in the river system then sharply declined to nearly 1% @ EOS and was 32% @ 59 d then declined to only 23% in the pond system; U n

- identified ( UN

- ID consisting of two degradates) : 20

- 23% @ 7

- 14 d then declined to 3

- 5% @ EOS
Un

- extracted Residues (UER): Max 35

- 44% @ 30 d to
EOS Mineralization to CO 2 : Max 43% @ EOS in the river system and only 18% @ EOS in the pond system

Anaerobic Aquatic t 1⁄2 @ 25 o C Study suggests possible longer half

- lives than the aerobic conditions; if no study is submitted, the
mancozeb residues will be considered stable. 402582

- 03 (U)
Study Classification: A= Acceptable; S= Supplemental and U= Un

- acceptable



### Data in Table 7 suggest that [ 14 

### C] mancozeb parent degraded with in hours under aerobic soil
conditions when applied at a nominal rate of 3.3 ppm. The study suggests the effect of the following processes on the polymeric chains of mancozeb :

• D ecomposition /hydrolysis of the polymer chains of mancozeb, by water

, into EBDC ions ; and

t ransformation of the EBDC ions into a residue containing several degradation products by
h ydrolysis/biotransformation ;

• F ormation of substantial amounts of un

- iden t ified/un

- extracted residue (UER ) ; and

• Mineralization of the mancozeb residues into CO 2



### .

The process of decomposition/hydrolysis appears to s tart in the step of preparing the stock solution of mancozeb polymer as indicated by two observations: reduction of mancozeb concentration from 96.7% in the stock solution to 92% at time zero and the rapid disappearance of mancozeb, as a parent, within hours of application to the soil. In fact, decomposition half

- lives were much shorter
than the hydrolysis half

- lives determined in the hydrolysis study possibly due to the use of EDTA as part of the extraction system (EDTA affects parent solubility by removing the Mn and Zn associated with the EBDC ligand ). Hydrolysis/biotransformation appear to cause transformation
of the EBDC units into the mancozeb residues consisting of the following major transformation products: EBIS , ET U

, EU and un

- identified degradates

. P artitioning of significant amounts of the
mancozeb residues into the soil resulted in the formation of substan tial amounts of an UER

. Finally, mineralization of part of the mancozeb residues resulted in production of CO 2



### .

### 20 Observed decomposition/degradation in two aerobic water/sediment systems were similar to that
observed in the soil systems. It appears that p rocesses involved in these systems are similar to
those suggested earlier for the aerobic soil systems. In the two systems, p arent decomposes rapidly (within hours) with the formation of the mancozeb residues consisting of degradates EBIS, ETU,
EU

, Glycol urea (H ydantoin “HYD”), UER and CO 2



### .

(c) Mobility

Data for mobility w as estimated from a supplemental a dsorption/desorption study and a leaching study ( Table 8 ) . C alculations were based on radioactivity adsorbed to the soils used in these two
studies. This is because mancozeb degraded very quickly forming the mancozeb residues

. Therefore, calculated Koc values are for the total mancozeb re sidues . It is noted that th ere were problems with these two studies such as the use of formulated product rather than the active ingredient. No new adsorption/desorption studies are requested at this time . Average adsorption
coefficient data suggest that the m ancozeb residues as a w hole are expected to be slightly mobile.
It is however noted that this conclusion may be applied to the mancozeb residues and chemicals
in th ese residues may vary in mobility.

Table 8 Summary of the transport properties for the mancozeb residues

Property Value for Mancozeb Parent & Residues MRID Reference 1

Adsorption Coefficient (Koc) ( Adsorption/desorption study) 5,288 mL/g for a Sandy soil from GA (O.M= 0.9%, pH= 5.7 and CEC= 4 meq/100g); 1,534 mL/g for a Sandy loam soil from GA (O.M= 2.8%, pH= 5.9 and CEC= 6 meq/100g);

892 mL/g for a S ilt loam soil from PA (O.M= 3.5 %, pH= 6.4 and CEC= 10 meq/100g); and 1,707 mL/g for a Clay loam soil from MS (O.M= 2.5 %, pH= 7.4 and CEC= 13 meq/100g) 402 229

- 01 (S)

Adsorption Coefficient (Koc) (Leaching study) 1,642 mL/g for a Sandy loam soil;
1 ,000 mL/g for a S ilt loam soil ; and

860 mL/g for a Silt loam soil 405883

- 02 (S)

Average value 1,846 mL/g Range of values 860

- 5,288 mL/g
Study Classification: S= Supplemental



### (d) Field Dissipation

A dissipation half

- life (DT 50 

### ) of 3 days was reported for a silty clay loam soil under Philippine field conditions using soil column receiving natural rainfall (a total of 12" in 21 days). CS 2



### - determined mancozeb remained on the top 2.5 and no leaching was observed under the conditions of the experiment. ETU and EU were the only degradation products whereas un

- extractable
residues were not characterized and accounted for 38

- 70% of the total residues (Calampang S. et al , 19 93. International J. of Pest Management, 39 (2) 161

- 166).

### 21 (e) Bio concentration

Mancozeb is associated with very low K OW 

### value of 2 2

. A f ish bioaccumulation study was previously waived for mancozeb based on the expected low bioconcentration as indicated from the
K OW 

### value

.


### (f) Transformation Products

Mancozeb polymer reaching soil (directly and by wash

- off) and aquatic systems (by drift) is expected to decompose /hydrolyze/bio

- transform rather quickly in the water present in these systems. Initial p roducts are expected to include negatively charged monomeric EBDC units and positively charged Mn and Zn ions. Monomeric EBDC units are expected to be highly vulnerable to abiotic hydrolysis a nd biotransformation resulting in the formation of the intermediate transformation product EBIS. With time, EBIS appears to degrade rather quickly into ETU that appears to degrade into EU, HYD and other un

- identified chemical species (UN

- ID) . In the

presen ce of a solid phase such as soil/sediment and organic matter particles, substantial part of this residue is expected to partition into the soil phase and become un

- extractable (UER). Data also
show that part(s) of the mancozeb residues are expected to be m ineralized into CO 2 

### ( Figure 2 ).

### 22 F igure 2 Transformation profile for mancozeb in soil and aquatic systems (refer to abbreviations below)

.

EBDC anion 

# + Mn +2 

### & Zn +2



### EBIS (A Transitional Degradate)



## NH

NH C S 

## NH

NH C O

ETU + EU + HYD + UN

- ID + UER

Mancozeb Residues

CO 2

· EBIS= Ethylene bis isothiocyanate sul fide (5,6

- Dihydro

- 3H

- imidazol(2,1

- C)

- 1,2,4

- dithiazole

- 3

- thione ;

· ETU= Ethylene thio urea (2

- Imidazolidinethione) ; CH 3 H 6 N 2 S ; CAS No.: 96

- 45

- 7; Mol. Wt. : 102.16 g mole

- 1

· EU= Ethylene urea (2

- Imidazolidinone) ; CH 3 H 6 N 2 O ; CAS No.: 120

- 93

- 4; Mol. Wt. : 86.09 g mole

- 1

· HYD= Hydantoin or Glycol urea (2.4

- (3H,5H)

- Imidazoledione) ; CH 3 H 4 N 2 O 2 ; CAS No.: 461

- 72

- 3 ; Mol . Wt. : 100 g mole

- 1

· UN

- ID= un

- identified degradates;

· UER= Un

- extracted/Unidentified Residue



### Figure 3 contains a summary of the observed total degradates and the UER in the aerobic soil system. 

### N C

N H

H S -



### N C S - 

### N



## Mancozeb Polymer

N

S N C S C S Hydrolysis/biotransformation (Within Hours)

Hydrolysis/biotransformation ( 90 th percentile t 1⁄2= >1 d in soil and <1

- 4 days in water/sediment systems)

### 23 Figure 3 Observed degradates and UE R in three soil system s (in percent of the applied radioactivity as parent equivalent with dotted line representing the average)

In the aerobic soil system, a suite of degradates (E B I S, ETU, EU and unidentified degradates)
form s and reach es maximum of nearly 50% of the applied rather quickly (within one day)

. Following this maximum and within four weeks , a sharp decline of this suite follows to reach levels of <5% of the applied parent. The sharp decline of the degradate suite appears to coincide
with the formation of persistent un

- identified/un

- extracted residues (UER)

. The UER reaches a maximum of nearly 65% of the applied within one week and stays nearly stable to the end of the study ( Figure 3 ). Figure 4 shows the formation/degradation profile of the various constituents of
the observed degradate suite

.

Figure 4 Formation and decline of the major degradates of mancozeb in aerobic soils (The figure represents averages from three soils and is truncated at 21 days as all degradates were below 5% of the applied radioactivity after 21 days ) 0 25 50 75

0 20 40 60 80 100 120% of Applied Radioactivity



### Time in Days UER

EBIS+ETU+EU+UN-ID Degradates

0 5 10 15 20 25 30

0 5 10 15 20% of the AppliedRadioactivity



### Time in Days EU

EBIS UN

- ID 

### ETU

### 24 Data in Figure 4 suggest the following: (a) EBIS is a transitional degradate that forms immediately following application to the soil
with a 90 th 

### percentile half

- life ( from maximum formation ) of 0.6 days (range 0.3

- 0.6 days). Similarly, the UN

- ID degradates form at the same time with a 90 th 

### percentile half

- life (from maximum formation) of 8 days (range 1

- 8 days). This suggests that these un

- identified degradates forms from parent mancozeb immediately upon application; and

(a) ETU and EU degradates reach their maximum within one day (just after the sharp decline
of EBIS ) suggesting their formation from EBIS . Although the maximums for these two degradates occ ur nearly at the same time, their level of formation were different ( ETU
maximums range from 15

- 25% of the applied while EU maximums range f rom 12

- 14% of the applied). The 90 th 

### percentile half

- life (from maximum formation) was 19 days (range
4.4

- 18.2 days) for ETU and was 2 .7 days (range 1.7

- 2.7 days) for EU.

Figure 5 contains a summary of the observed total degradates and the UER in two aerobic water/sediment soil system s

.

Figure 5 Observed degradates and UER in two aerobic water/sediment systems

In the aerobic water/sediment systems, a suite of degradates ( EBIS , ETU, EU , HYD and unidentified degradates) forms and reaches maximum of nearly 75 % of the applied rather quickly (within two day s ). Following this maximum

, a gradual decline of this suite continues to reach
levels of 28% of the applied parent in the pond system and 3% in the river system . The gradual decline of the degradate suite appears to coincide with the formation of relatively persistent un

identified/un

- extracted residues (UER). The UE R reaches a maximum of nearly 40 % of the applied
within one month and stays nea rly stable to the end of the study ( Figure 5 ). It is noted that formation levels of the UER with time were the same in both pond and river system. 0 25 50 75

0 20 40 60 80 100% of Applied Radioactivity

Time in Days

Pond: UER River: UER UER Average

Pond: All Degradates River: All Degradates Average: All degradates

### 25 Figure 6 shows the formation/degradation profile of the various constituents of the observed degradate suit e in the water/sediment systems

.

Figure 6 Formation and decline of the major degradates of mancozeb in aerobic water/sediment systems (The figure represents averages for river /pond )

Data in Figure 6 suggest the following:

(b) EBIS is a transitional degradate that forms immediately following application to the water/sediment systems with a 90 th 

### percentile half

- life (from maximum formation) of 8 days ( 0.3 days in the river system and 4 days in the pond system ) ;

(c) UN

- ID degradates for m immediately at levels of nearly 10% and increase gradually withi n two weeks to 23% then decline slowly to 5% at 1 05 days. The 90 th 

### percentile half

- life (from maximum formation) was 70 days ( 55 days in the river system and 41 days in the pond system). This suggests that these degradates forms from parent mancozeb immediately upon application as well as from residues later;

(d) ETU reach ed the maximum within one to two day (just after the sharp decline of EBIS ) suggesting its formation from EBIS . The half

- life (from maximum formation) was 5 days (SFO= Single 1 st 

### order) in the river system and 9 days (SFO) in the pond system. It is important to note that much longer single 1 st 

### order half

- lives for ETU were estimated from metiram studies (7 days in a river system and 264 days in a pond system); 0 10 20 30 40 50

0 10 20 30 40 50 60% of Applied Radioactivity



### Time in Days EIBS

EU ETU

Decline to 23% @ 105 d

### 26 (e) EU appears to increase gradually but slowly (within one month) into a plateau (30

- 32%) and very slowly declines t o 23% by the end of the 105

- day study . The 90 th 

### percentile half

life (from maximum formatio n) was 229 days (range 9 days in the river system a nd 117 days in the pond system);

(f) HYD reached the maximum of 12% in the river system and 14% in the pond system in a
7

- 14 day period then declined to non

- detection

.



## 5.2 **The Major Mancozeb Degradate**  **: Ethylenet**  **hiourea (ETU)**

ETU is a common metabolite/degradate of the EBDC fungicides (EBDCs) including mancozeb. As a mancozeb degradate, ETU can be anticipated to be found wherever this fungicide is used. In an agricultural setting, ETU is introduced into the environment in three ways following application
of mancozeb fun gicide. First , ETU may be added with the applied formulation as it may form in these formulations as a result of particle size reduction (i.e. colloidal milling) and/or due to unfavorable storage . In EBDCs, up to 13% of the active ingredient w as found to b e converted to
ETU

. Second , ETU is produced from hydrolytic/biotic degradation of parent mancozeb following its application to soils and/or after reaching water bodies by drift. Third , ETU may be produced from further hydrolysis/biotransformation of transi ent species in pore water/water bodies and possibly from soil/sediment bound residue of mancozeb. Rapid hydrolysis/biotransformation of mancozeb parent and/or residues are expected to be the major processes that control ETU production in soils and water bo dies. In addition, slow biotic degradation of un

- extracted (UER)
mancozeb residue s may also contribute to the production of ETU in the long term. It is noted that the slow production of ETU from mancozeb UER is uncertain as the identity of these residues is
unknown.

As stated above, ETU is produced mainly from decomposition/ hydrolytic/biotic degradation of parent mancozeb. Laboratory data on hydrolysis of mancozeb suggest that hydrolysis may be one of the major processes in ETU production. However, data presented are uncertain as identification of transient species and degradates were largely dependent on the TLC methods which was affected by poor separation of degradates and the occurrence of degradation caused by the solvent systems employed. Therefore, a new hydrolysis study is requested for mancozeb in which all degradation products, including ETU are tracked.

In the aerobic soil system, hydrolytic/biotic degradation of parent mancozeb appear s to produce
ETU. The m aximum observed in three soils range s from 6

- 9% (15

- 29% of parent equivalent) ( Figure 7 )

### 27 Figure 7 Formation and decline of ETU in a mancozeb aerobic soil study (three soils)

Similarly ETU was observed to be produced in the aerobic aquatic systems from hydrolytic/biotic degradation of parent mancozeb. In these systems, maximum s observed range d from 17

- 20 % ( 45

- 52 % of parent equivalent) ( Figure 8 )

Figure 8 Formation and decline of ETU in a mancozeb aerobic aquatic study (two systems) 0 2 4 6 8 10

0 20 40 60 80 100 120% ETU *



### Time in Days

Speyer 2.1 Speyer 2.2 Senozan Average

0 5 10 15 20

0 20 40 60 80 100% ETU

Time in Days

Pond: ETU River: ETU Average: ETU

### 28 Finally, ETU may also be introduced to the environment from its extensive use as accelerator in synthetic rubber production and as vulcanizing agent in some poly

- ethers production.
Environmental contamination from these industrial uses are not within the FIFRA stat utory framework and to will not be covered by the future risk assessment.

(a) Physical/Chemical and Abiotic Transformation

The chemical structure, physical/chemical characteristics and abiotic transformation of ETU are
summarized in Table 9

.

Table 9 Chemical structure, physical/chemical characteristics and abiotic transformation of ETU

Data in Table 9 indicate that ETU is a low molecular

- weight chemical that is highly soluble in water. The high vapor pressure of ETU suggests partitioning into the air can be an important route of its dissipation in the environment, especially from dry surfaces. The rela tively low Henry’s Law constant suggests possible low volatilization of ETU into the air from wet soil and water. ETU has
a low K ow 

### value suggesting that it will not be significantly bio

- concentrated by aquatic organisms such as fish. Abiotic process such as hydrolysis and photolysis are not expected to be important in dissipation of ETU in the environment.

(b) Biotic Transformation

Fat e data for ETU is extracted from parent studies and/or ETU studies w h ere ETU is the test
substance. A summary of this data are presented in Table 10

. Property Value Reference

Identity/Structure

CAS Number (Name): 96

- 45

- 7 (2

- Imidazolidinethione) Molecular Weight ( Formula) 102.2 g mole

- 1 (C 3 H 6 N 2 S)

n - octanol

- Water Coefficient (K OW ) 0.2 MRID 406510

- 01 (A) 1 Vapor Pressure 5.01x10

- 3 torr Neely WB & Blau GE 2

Henry's Law constant 3.4X10

- 7 atm. m 3 mole

- 1 Meylan WM & Howard
PH 3 Water Solubility 20,000 ppm @ 20 o C and 90,000 ppm @ 60 o C Hydrolysis half

- life (t 1⁄2) Stable @ 25 o C and pH 5, 7, and 9 MRID 404661

- 03 (A) 1

Aqueous photolysis t 1⁄2 Stable in pH 7 buffered water ( Ross and Crosby 3 reported that the Maximum ETU absorb a nc e lies at 240 nm) MRID 404661

- 02 (A) 1

Soil photolysis t 1⁄2 Stable (Based on Data and UV/Visible spectra) MRID 404661

- 01(A) 1

1 Study Classification: A= Acceptable; S= Supplemental

2 Neely WB and Blau GE 1985. Environmental Exposure from Chemicals. Boca Raton, FL: CRC Press pp. 31

3 Meylan WM & Howard PH 1991. Environ Toxicol Chem 10: 1283

- 93 (Fragment constant estimation method) 

### NH

NH C S

### 29 Table 10 Summary of environmental fate properties of ETU

Property Value MRID Reference 1

Aerobic soil t 1⁄2 (Parent Study: @
20 o C and End of study (EOS)= 120 day) ; ETU study @ 25 o C and End of study (EOS)= 7 day) From Parent Study:
1 8.2 days in Speyer 2.3: A sandy loam soil from Germany; pH= 6.5 and organic carbon “O.C” = 0.71%);
4.4 days in Speyer 2.2: A loamy sand soil from Germany; pH= 5.7 and O.C= 2.17%;
10.7 days in Senozan: A silty loam soil from France; pH= 5.8 and O.C= 0.99%
Note: ETU: Max 14

- 25% @ 1 d then declined to 1

- 2%
@ EOS

From ETU Study: 1.6 days in Collamer s ilt loam soil from Wayne Co., NY; pH= 6.1, organic matter= 3.6% and CEC= 13 meq/100g;
and
1 .4 days in Oakville s and soil from Wayne Co., NY; pH= 6.8, organic matter= 2.1% and CEC= 6 meq/100g;

Note: t 1⁄2= 3.2 days was observed in Collamer silt loam
soil when soil mo isture was reduced from 70 to 40% of
the soil water holding capacity Major Degradates: EU was only tracked with Max of 3

- 3.4% @ <1

- 2 d ays and then declined to <0.2

- 0.3% @
EOS
Un

- extracted Residues (UER); Mineralization to CO 2 and Mass Balance : Not determined Parent Study:
457445

- 01 (S) ;

ETU Study:
452251

- 01 (S) &
451464

- 01 (S)

Aerobic Aquatic t1⁄2 @ 25 o C From Parent Study:
5 days in a water/loamy sand sediment from the Rhine River, Switzerland (water: pH 8.0

- 8.2, total organic carbon 2.6 mg/L ; sediment: pH=6.9, O.C= 1.4% and CEC=2.8 meq/100g); and
9 days in a water/loamy sand sediment from Ormalingen pond, Switzerland (water: pH 7.4, total organic carbon 1.1 mg/L ; sediment: pH=6.7, O.C= 5.0% and CEC=7.1 meq/100g)
Note: ETU Max 42

- 52% @ <1

- 2 d then declined to <1%
@ EOS

From ETU Study: No Acceptable study Parent Study:
462043

- 01 (A)

Anaerobic Aquatic t1⁄2 @ 25 o C Studies suggest longer half

- lives than the aerobic conditions; if no study is submitted, ETU will be
considered stable 001633

- 35
000888

- 20&
402582

- 03 (U)
Study Classification: A= Acceptable; S= Supplemental and U= Un

- acceptable



### Data in Table 10 suggest the following:

(1) ETU degraded under aerobic soil conditions with a 90 th 

### percentile t1⁄2 of 12 days (n=5). Only EU degradate was tracked and observed at levels ranging from 3

- 3.4% of the applied

### 30 radioactivity. The study demonstrated vulnerability of ETU to biodegradation in the soil system ;

(2) ETU degraded under aerobic water sediment systems with a 90 th 

### percentile half

- life of 13 days;
and

(3) Observed half

- lives of ETU in the soil system is much shorter than those observed in the water/sediment systems.

Due to deficiencies in submitted anaerobic aquatic studies, ETU will be considered stable unless a new study is submitted that indicates otherwise. In requested studies, ETU and degradates should
be tracked with the latest available analytical procedures. In addition, extraction method should

prove to be appropriate as per EFED un

- extracted re sidues guidance 8



### .

(c) Mobility

Data for mobility were estimated from a supplemental adsorption/desorption study ( Table 11 ). It is noted that there were problems with th is study such as the possibility of occurrence of degradation of ETU before conducting the e xperiment . The study was classified as supplemental following registrant submittal of data suggesting that the applied test substance included significant quantities of ETU.

Table 11 Summary of the transport prop erties for ETU

Property Value for Mancozeb Parent & Residues MRID Reference 1

Adsorption Coefficient (Koc) (Adsorption/desorption study) 150 mL/g for a Sandy soil from GA (O.M= 0.9 %, pH= 5.7 and CEC= 4 meq/100g);
57 mL/g for a Sandy loam soil from GA (O.M= 2.8%, pH= 5.9 and CEC= 6 meq/100g);
42 mL/g for a Silt loam soil from PA (O.M= 3.5%, pH= 6.4 and CEC= 10 meq/100g); and
34 mL/g for a Clay loam soil from MS (O.M= 2.5%, pH= 7.4 and CEC= 13 meq/100g) 002588

- 96
And
0009 71

- 58 (S)

Average value 71 mL/g Range of values 34

- 150 mL/g
Study Classification: S= Supplemental



### Based on data presented in Table 11 , ETU is expected to be highly mobile in most soils (Average
K oc 

### = 7 1 mL/g).

(d) Field Dissipation

Dissipation half

- lives ( DT 50 

### s) of 1 to 6 days and <7 days were observed in fine sand and silt loam field soils (Supplemental stud ies : Accession No s . 255229 and 000889

- 23).

8 URL: http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/environmental_fate_tech_team/Unextrac ted_Residues_in_Lab_Studies.htm

### 31 (e) Bioconcentration

ETU is associated with very low K OW 

### values of 2. Fish bioaccumulation study was previously
waived for ETU based on the expected low bioconcentration as indicated from K OW.



### (f) Transformation Products

ETU is a result of abiotic/biotic degradation of m ancozeb /mancozeb residues reaching soil directly
and by wash

- off and reaching aquatic systems by drift . ETU itself is not expected to be affected by hydrolysis/direct photolysis in soils or aquatic systems. In contrast, ETU is expected to be highly affected by aerobic biodegradation in soils and to a lesser extent in biologically active aquatic media. M any degradation products were thought to be forming as a result of ETU degradation such as EU (2

- Imidazolidone; CAS No. 107

- 15

- 3); HYD or Glycolylurea ( 2,4

- (3H,5H)

- Imidazoledione; CAS No. 461

- 72

- 3); IMID (2

- Im idazoline; CAS No. 504

- 75

- 6); GLY (Glycine= Amino acetic acid; CAS No. 56

- 40

- 6); J.B (Jaffe’s Base=1

- (4,5

- Dihydro

- 1H

- imidazol

2

- yl)

- imidazolidin

- 2

- thion; CAS No. 484

- 92

- 4 ); EDA (Ethylenediamine) and CO 2



### . However, only
EU and HYD were confirmed since the results of the TLC method are considered not reliable due to problems stated earlier. The degradation products of ETU will be corrected based on the results of requested new studies.



## 5.3 **Determination of the Stressor of Concern for Ecological Risk Assessm**  **ent**

Chemical species intensity and timing of exposure and toxicity are used to determine the stressor of concern for the future ecological risk assessment.

Exposure

In the soil system, mancozeb reaching the soil indirectly upon application and later fr om wash

- off is expected to degrade into multi chemical species or the mancozeb residues . The timeline for the change in the chemical species in of the mancozeb residues in the soil is summarized in Figure 9

.

### 32 Figure 9 Expected relative changes in the chemical constituents of the mancozeb residues with time in the aerobic soil system (average of three soils)

.

Data in Figure 9 suggest that chemical species that may reach aquatic systems by run

- off from the
soil include significant amounts of th e UER and less e r amounts of ETU, EU and UN

- ID degradates. In contrast, mancozeb reaching aquatic systems

, by drift

, is expected to also degrade
into the mancozeb residues producing similar chemical species with different concentrations and

at a different t ime

- line as shown in Figure 10

.

Figure 10 Expected relative changes in the chemical constituents of the mancozeb residues
with time in aerobic aquatic system s (Average of two systems)

.

Data in Figure 10 suggest that the constituents of the mancozeb residues will be dominated by

un

- degraded parent, EBIS and ETU at the short term and EU and the UER at the long term

. 0% 20% 40% 60% 80% 100%

0 0.06 1 7 14 28 63 120% of Applied Radioactivity



### Time in Days



### Parent EBIS ETU EU Un-ID UER CO2

0% 20% 40% 60% 80% 100%

0 0.25 1 2 7 14 30 59 105% of Applied Radioactivity



### Time in Days



### Parent EBIS ETU EU Un-ID UER CO2 HYD

### 33 Therefore, aquatic exposure will be associated with un

- degraded parent from drift alone

, EBIS

, ETU and EU at the short term and the UER and EU at the long term. Based on expected aquatic

exposure, a mancozeb residues consisting from parent, ETU and EU are important at the short
term and a mancozeb residues containing UER and EU at the long ter m.

Toxicity

The toxicity of the major degradates EBIS, ETU, EU and UER is considered hereafter to decide on which of these degradates may be included in the stressor.

As noted above, there is a relatively robust data set available to characterize the a cute and chronic toxicity of ETU to aquatic taxa. These data are further discussed in Section 7 of this assessment. A comparatively smaller dataset exists for EU and only for acute exposure. These
data are summarized in Table 12 below alongside the endp oints derived from parent mancozeb studies. For the transient degradate EBIS, there is no registrant submitted data available, and
therefore t he structural activity relationship (SAR) tool ECOSAR (v 1.1) was employed to estimate the toxicity to taxa where no data are available. The results below indicate that for taxa for which registrant submitted studies are available for as well as ECOSAR estimates for where there are gaps in the dataset for EU, that ETU and EU are generally at least one order of magni tude less toxic than parent mancozeb and usually two or more orders of magnitude less
toxic. As shown in Table 12 , the transient degradate EBIS is estimated to elicit toxicity similar to that of parent mancozeb and for some taxa is estimated to be more toxic than parent
mancozeb.

Table 12. Summary of r egistrant s ubmitted and ECOSAR estimates of the various degradation product of m ancozeb

Taxa 
Stressor (data source) FW Fish
LC 50 FW
Invert LC 50 FW fish NOAEC FW invert
NOAEC E/M
fish
LC 50 E/M
invert
LC 50 E/M
Fish
NOAEC FW Green Algae
Parent Mancozeb (registrant submitted data) 0.91 1.04 0.001 0.02 1.6 0.009 0.047

ETU (registrant submitted data) >502 26.9 Study in
review >895 7.8 23

EU (registrant submitted data) >122 985 119

EU (Substituted ureas ECOSAR class) 2735 8624 5.57 204 94.2 1351 4.07 156

EU (Amides ECOSAR class) 7183 855 22.7 272 17.6 1428 21.6

E BIS (Thiocarbamate, di (substitute ECOSAR class) 0. 18 0.62 0.015 1 0.041** 0.1 0

*May not be soluble at this level to elicit estimated effect **Estimated using an acute to chronic ratio



### As shown in Figure 10 above, upon entering the water column, mancozeb shows a rapid transformation within 6 hours to ETU, at which point the relative concentration of parent remaining is approximately 40%. This decomposition continues where by after 1 day, total parent

mancoz eb is less than 10% while ETU and EU residues make up a combined 70 %. The toxicity

### 34 of the un

- extracted residues, that along with EU, comprise the majority of residues in the water/sediment system after 30 days, is characterized only to freshwater sediment

- dwelling organisms (see Section 6 for more details). While their toxicity to other taxa represent an uncertainty, the extent to which the un

- extracted residues would be bioavailable to water column organisms is expected to be low. More likely, these pel agic organisms would be exposed to relatively stable concentrations of EU which registrant submitted studies show to be less toxic than
mancozeb on an acute basis and ECOSAR estimates show to be less toxic than mancozeb on a chronic exposure basis

What f ollows is a summarization of the ecological stressor of concern for each taxa :

Ecological stressor of concern (aquatic organisms):

• The total residues of un

- degraded m ancozeb parent plus EBIS for acute exposure: the source of mancozeb parent and EBIS is expected to be from drifted parent alone as mancozeb reaching the soil system and resultant transient species ( i.e.

, EBIS ) and degradates ETU and EU forming in the soil are not expected to rea ch aquatic systems by run

- off because they are short lived

. Additionally, it is noted that at most (per Figure 10 ), EU is 27X less acutely toxic than parent (based on freshwater invertebrate data), and at Day 1, EU is present at about 6X that of parent,

so its contribution to overall toxicity would be very limited.

• For chronic exposure : UER that forms following degradation of drifted parent and that carried by run

- off from the UER forming in the soil system.

Ecological stressor of concern (terrestrial fol iar residues for birds and mammals):

• Parent mancozeb residues on various food items for both acute and chronic risk noting that this will be conservative because the possible occurrence of degradation by moisture will reduce exposure due to the production of the less toxic degradates ETU and EU. It is also noted that this degradation applies to parent mancozeb behavior on soil. It is an uncertainty as to whether mancozeb follows a similar dissipation pattern on foliage and therefore it is assumed that, w ithout data to suggest otherwise, these residues would be available for ingestion by avian and mammalian species.

Ecological stressor of concern (terrestrial foliar residues for honey bees):

• The discussion above relating to parent mancozeb residues on va rious food items for both and chronic risk also apply to honey bees via direct contact spray toxicity. As mancozeb does not exhibit systemic properties, its residues would not be expected to be present in pollen and

nectar.

In contrast, the drinking water stressor is ETU, the major degradate of mancozeb forming in aquatic systems from drifted parent and ETU that forms in the soil and transported to these systems by run

- off

.

### 35 

# 6. R eceptors

As described in the Agency's Overview Document (U.S EPA, 2004), the most sensitive endpoint for each taxonomic group will be used to calculate risk quotients (RQs). Assessment endpoints include direct toxic effects on the survival, reproduction, and growth of terrestrial and aquatic life
as well as indirect effects such as reduction in prey base and/or modification of habitat. Acute and chronic toxicity data from studies submitted by pesticide registrants along with the available open literature are used to evaluate the potential direct effects of mancozeb to the aquatic and terrestrial receptors identified in this section. This includes toxicity data on the technical grade active ingredient, degradates, and when available, formulated products. The open literature studies are identified through EPA's ECOTOX database ( http://cfpub.epa.gov/ecotox/ ), which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and
wildlife.



## 6.1 **Effects to Aquatic Organisms**

A summary of the availa ble eco

- toxicity information and the incident information for mancozeb
is provided below. Table 1 3 provides a summary of the taxonomic groups and the surrogate species tested to help understand potential acute and chronic ecological effects of mancozeb

. I n addition, the table provides a preliminary overview of the potential acute toxicity of mancozeb by providing the acute toxicity classifications.

T here are several acute toxicity studies available to characterize the toxicity of mancozeb to
freshwater fish. Acute LC 50 

### endpoints range from 0.91 to 9.3 mg a.i/L, which classifies mancozeb as highly toxic to freshwater fish on an acute exposure basis. Clinical signs of toxicity that were observed in studies included loss of equilibrium , bulging eyes, and resting on the bottom of the tank. These effects generally occurred at concentrations where at least one mortality was observed. Chronic early life stage and chronic full life cycle toxicity tests are available for freshwater fish.
The chronic NOAEC val ues determined for the ELS study and full life cycle study were within a factor of 2 (2.19 and 1.35 μg a.i/L, respectively). It is noted that parent mancozeb will not be associated with long persisting residues in the water column as indicated in the prev ious discussion (Section 5.3). While the NOAEC was based off of survival effects for the ELS study, the number of eggs per female per day was the most sensitive endpoint for the fish full life cycle. There were no clinical signs of toxicity observed in either study.

Available data indicate that mancozeb is moderately toxic to estuarine/marine fish on an acute exposure basis with an LC 50 

### of 1.6 mg a.i/L. There were no reported clinical signs of toxicity during th e course of the study. Despite the study being classified as supplemental, there was evidence of test substance stability issues during the course of the study with percent recoveries ranging from 43

– 50%.

There is currently one chronic early life stage with the estuarine/marine fish spec ies, Sheepshead minnow (MRID 48627702), that is currently in review.

### 36 Acute and chronic toxicity studies are available to characterize effects on freshwater invertebrates. On an acute exposure basis, mancozeb is classified as moderately toxic with an EC 50 

### of 1.04 mg
a.i/L. A chronic life cycle study conducted with formulated (77.1% a.i) mancozeb indicated a NOAEC of 18 μg a.i/L based on significant (p<0.05) effects on mortality and reproduction (total number of live young).

Available data for character ization the acute toxicity of mancozeb to estuarine/marine invertebrates indicate the chemical is very highly toxic on an acute exposure basis with a LC 50 

### value of 9.49 μg a.i/L. Despite being classified as supplemental, the study review indicates that
th e control appeared to be contaminated with test substance. Correspondence that was attached to the review of the study dated in May, 1989, indicated that the issue of control contamination had been discussed between the Rohm and Haas Company and EPA. At that time, EPA stated that because no control mortality occurred, no further testing would be needed. An examination of the analytical data indicates that mancozeb was detected in the control samples at 2.31 μg a.i/L at test initiation, 1.05 μg a.i/L at 4 8 hours, and no detected at 96 hours (test termination). Given that no control mortality occurred, and no other notable deviations from guideline recommendations were present, this study is considered suitable for risk assessment purposes.

There is one c hronic life cycle toxicity study available for estuarine/marine invertebrates (mysid shrimp) that is currently in review (MRID 48627701).

There is one study available to characterize the toxicity of mancozeb to aquatic non

- vascular plants, specifically to freshwater green algae. No studies are available for vascular aquatic plants or for freshwater and estuarine/marine diatoms and cyanobacteria.

T 

### able 13. Summary of the Most Sensitive Endpoints from Aquatic Toxicity Studies for Mancozeb

Taxonomic

Group Study Type

–

Test Material Surrogate Species Toxicity Value (all units in terms
of measured
active ingredient) 2 Acute Toxicity Classification Source (Classification)

Freshwater fish 1 Acute

- TGAI Rainbow trout ( Oncorhynchus mykiss ) 96

- hr LC 50 : 0.91 mg/L (0.77

– 1.1; N/A) Highly toxic 45934701 (Supplemental)

Acute

- formulation Rainbow trout ( Oncorhynchus mykiss ) 96

- hr LC 50 : 1.1 mg/L (0.90

– 1.43, N/A) Moderately
toxic 40467501 (Supplemental)

Chronic (Early life stage)

- TGAI Fathead
minnow ( Pimephales promelas ) 28

- day NOAEC: 2.19 μg/L;
LOAEC (survival): 4.56 μg/L -- 43230701 (Acceptable)

Chronic (Full life cycle)

- TGAI Fathead
minnow ( Pimephales promelas ) 215

- day NOAEC 1.35 μg a.i/L; LOAEC (number of eggs, number of eggs/female/day) -- 49030601 (Acceptable)

Freshwater
invertebrates Acute

- TGAI Water flea ( Daphnia

magna ) 48

- hr EC 50 : 1.0 4 mg a.i/L (0.87

– 1.32; N/A) Moderately
toxic 40467503 (Supplemental)

### 37 Taxonomic

Group Study Type

–

Test Material Surrogate Species Toxicity Value (all units in terms
of measured
active ingredient) 2 Acute Toxicity
Classification Source (Classification)

Chronic

- formulation 21

- d NOAEC: 18 μg a.i/L; LOAEC (mortality and
total number of young): 81 μg
a.i/L -- 46023702 (Supplemental)

Estuarine/marine
fish Acute

- TGAI Sheepshead
minnow ( Cyprinodon variegatus ) 96

- hr LC 50 : 1.6 mg a.i/L(N/A; N/A) Moderately
toxic 41844901 (Acceptable)

Chronic

- TGAI Study in review (48627702)

Estuarine/marine
invertebrates Acute

– formulation Mysid shrimp ( Americamysis
bahia ) 96

- hr LC 50 : 9.49 μg/L (8.26

– 11.4; N/A) Very highly
toxic 41822902 (Supplemental)

Acute

- TGAI Eastern oyster ( Crassostrea virginica 96

- hr EC 50 : 1.60 mg a.i/L (1.40

– 1.80; N/A) Moderately
toxic 40885102 (Acceptable)

Chronic

- TGAI Mysid shrimp Study in review (MRID 48627701)

Sediment

Dwelling
Invertebrates Subchronic Spiked
sediment system

- TGAI

Freshwater midge ( Chironomus
dilutus ) Sediment:
NOAEC/LOAEC (mortality and dry weight): 8.17/15.7 mg TRR/kg dw
Pore water:
NOAEC/LOAEC (mortality): 1.92/5.25 mg
TRR/L -- 47410101 (Acceptable)

Subchronic Spiked
sediment system

– Non

extractable
residues Sediment : NOAEC/LOAEC (mortality): 0.912/19.3 mg TRR/kg dw

Pore water: NOAEC: 0.083 mg TRR/kg
LOAEC (mortality): 0.18 mg TRR/L -- 47410102 (Acceptable)

Aquatic plants and algae Non

vascular 2

- TGAI Freshwater Green Algae ( Selenastrum capricornutum) 96

- hour EC 50 ( cell density) : 47 μg/L (42

– 51 ; N/A )

96

- hr NOAEC: 22 μg/L -- 43664701 (Acceptable)

1 Freshwater fish may be surrogates for aquatic

- phase amphibians.

2 (95% confidence intervals; slope) if available

3 En dpoints expressed in terms of mean measured active ingredient

### 38 Additionally, there are 9 studies available to characterize the acute and chronic toxicity of the primary degradate of mancozeb, ETU, to aquatic organisms ( Table 14 )

. As alluded to earlier,

a cute toxicit y studies with freshwater fish and invertebrates, es tuarine/marine fish and invertebrates, and aquatic plants indicate that ETU is generally less toxic than parent m ancozeb by at least an order of magnitude, depending on the taxa.

Table 14

. Summary of Endpoints from Aquatic Toxicity Studies for the Mancozeb Degradate
ETU

Taxonomic Group (study type) Surrogate Species 2 Toxicity Value 1 Acute Toxicity
Classification Source (Classification)

Freshwater fish 2 (acute toxicity) Rainbow trout ( Oncorhynchus mykiss ) 96

- hr LC 50 : >502 mg/L (N/A; N/A) Practically

non

- toxic 45910401 (Acceptable)

Bluegill sunfish ( Lepomis

ma c r ochirus ) 96

- hr LC 50 : >988 mg a.i/L Practically

non

- toxic 47441202 (Acceptable)

Freshwater
invertebrates (acute toxicity) Water flea ( Daphnia magna ) 48

- hr EC 50 : 26.9 mg a.i/L (19.6

– 38.5; 1.92) Slightly toxic 45910402 (Acceptable)

Freshwater
invertebrates (chronic toxicity) Study in review

Estuarine/marine
fish (acute toxicity Sheepshead minnow ( Cyprinodon variegatus ) 96

- hr LC 50 : >895 mg a.i/L (N/A; N/A) Practically

non

- toxic 47441201 (Acceptable)

Estuarine/marine
invertebrates (acute toxicity) Mysid shrimp ( Americamysis
bahia ) 96

- hr LC 50 : 7.8 mg a.i/L (5.1

– 10.9; N/A) Moderately
toxic 47441204 (Acceptable)

Estuarine/marine
invertebrates (acute toxicity) Eastern oyster ( Crasso s trea virginica ) 96

- hr >110 mg a.i/L (N/A; N/A) Practically

non

- toxic 47474301 (Acceptable)

Aquatic plants Freshwater green algae ( Pseudokirchneriella subcapitata ) 72

- hr EC 50 (cell density): 23.0 mg a.i/L (N/A; N/A)
72

- hr NOAEC: 5.0 mg a.i/L -- 45910403 (Acceptable)

Duckweed ( Lemna gibba ) 7

- d EC 50 : >960 mg a.i/L
7

- d NOAEC: 230 mg a.i/L
7

- d LOAEC (frond density and growth rate): 480 mg a.i/L -- 47441203

1 Concentrations expressed in terms of mean measured active ingredient.

2 Freshwater fish may be surrogates for aquatic

- phase amphibians.



### T here are 3 studies available to characterize the acute toxicity to the degradate of ETU (itself a degradate of mancozeb) ethylene urea (EU) to freshwater fish, invertebrates, and green algae ( Table 15 ). The available acute toxicity study for freshwater fish, while not testing as high as the study with ETU, indicates that EU is practically non

- toxic to fish on an acute exposure basis. For freshwater invertebrates and freshwater green algae, available data indicate that EU is at least one order of magnitude less toxic as compared to ETU and at least 2 orders of magnitude less toxic than parent mancozeb.

### 39 Table 15. Summary of Endpoints from Aquatic Toxicity Studies for the ETU Degradate Ethylene Urea (EU)

Taxonomic Group (study type) Surrogate Species 1 Toxicity Value 1 Acute Toxicity
Classification Source (Classification)

Freshwater fish 2 (acute toxicity) Rainbow trout ( Oncorhynchus mykiss ) 96

- hr LC 50 : >122 mg/L (N/A; N/A) Practically

non

- toxic 46462902 (Acceptable)
Freshwater
invertebrates (acute toxicity) Water flea ( Daphnia magna ) 48

- hr EC 50 : >985 mg/L Practically

non

- toxic 46462903 (Acceptable)

Aquatic plants Freshwater green algae ( Pseudokirchneriella subcapitata ) 96

- hr EC 50 : > 119 mg/L
96

- hr NOAEC: 119 mg/L -- 46462904 (Acceptable)

1 Concentrations expressed in terms of mean measured active ingredient

. 2 Freshwater fish may be surrogates for aquatic

- phase amphibians.



## 6.2 **Effects to Terrestrial Organisms**

Available data are inadequate to fully characterize the acute oral and sub

- acute dietary risk of mancozeb to avian species. Three studies are currently available, and despite being classified as supplemental, have deficiencies that limit their utility in a quantitative risk assessment.

In a study conducted with the Japanese quail ( Coturnix japonica , MRID 00080717) , the study was initially planned as an avian dietary test, but changed to a multiple dose oral study. The age, gender, and source of the tes t animals was not provided , four animals per treatment level (as opposed to 10) were used, and regurgitation occurred at certain test concentrations during the course of the study. Therefore, it is uncertain as to what level of test substance the test bir ds actually received. Similarly, in a multiple

- dose oral toxicity study conducted with the mallard duck (MRID 00080716), test bird age, gender, and source were also unspecified . Additionally, differing numbers of animals were used depending on the concen tration (all below the guideline

recommended 10 animals per treatment group), as well as regurgitation occurring at the two highest treatment levels. This study was classified as supplemental but has limited utility on quantitative risk assessment given t he uncertainty of the doses that test birds received at the two highest treatment groups. Finally, mancozeb was tested with multiple acute oral doses to sparrow ( Passer sp.), starlings ( Sturnus vulgaris ), and pheasants ( Phaisanus sp.) (MRID 00036094). The starlings and sparrows were wild caught and the pheasants were obtained from an unknown commercial rearer. No age or gender information was given and there was a reduced number of birds per treatment level than the guideline

– recommended number. The se deficiencies, despite a study classification of supplemental limit its use in quantitative risk assessment.

There are no subacute dietary toxicity studies available for mancozeb.

A chronic avian reproduction study conducted with the mallard duck (MR ID 41948401) indicated several effects at the highest treatment concentration (1000 ppm) including reduced egg production, early and late embryo viability, hatchability, and 14

- day hatching weight. Similarly, in the bobwhite quail study (MRID 44238001), 1 4

- day hatching weight was also significantly reduced at the highest treatment concentration (1000 ppm) although this was the only adverse

### 40 effect observed during the study. There were no clinical signs of toxicity observed at any treatment
level in both st udies.

An acute oral toxicity study with mancozeb on the Norway rat ( Rattus norvegicus ) (MRID 00142522) indicated that mancozeb is practically non

- toxic to mammals on an acute exposure
basis with an LD 50 

### of >5000 mg a.i/kg

- bw. In a 2

- generation reprodu ction study , (MRID 41365201), significant (p<0.05) decrease s in parental body weight were observed at the highest treatment level (1200 ppm) along with increased relative thyroid weights and increased incidence of thyroid follicular cell hyperplasia.

Ti er I seedling emergence and vegetative vigor studies are available for mancozeb (MRID 47486102 and 47486101, respectively). Both studies tested a single application rate of 0.02 lbs a.i/A. In the seedling emergence study, there were no effects that were observed to be greater than a 25% reduction from that of the negative control. For ryegrass, the most sensitive monocot, there was a 19% reduction in dry weight and therefore a definitive NOAEC could not be established. There were no significant reductio n for dicots. In the vegetative vigor study, definitive EC 25 

### and NOAEC values could not be determined due to a lack of toxicity. It is noted that the maximum single application rate of mancozeb ranges from 4.88 lbs. a.i/acre (in crops other than turf) to 17.5 lbs. a.i/acre (in turf), which range from 2

– 4 orders of magnitude larger, respectively, than the
rates assessed in the available studies.

In an acute contact toxicity study that assessed multiple chemicals, bees of unknown age and

source were exp osed to mancozeb via a bell

- jar vacuum duster. The doses at which bees were exposed is not available from the DER, nor was there any further information about the husbandry conditions, experimental test design, and raw data. The 96

- hr LD 50 

### was determined as 179 μg a.i/bee. The utility of this study in quantitative risk assessment is limited however give n that the test substance was not applied to the thorax of the honey bee as in guideline recommended acute contact toxicity studies. Furthermore, critical information about the test organism and experimental conditions are missing from the study review. Acute oral toxicity data, as well as
studies to characterize the toxic effect to honey bee larvae are not available.

In an acute contact and reproductiv e study (MRID 45577201) with the predatory mite ( Typhlodromus pyri ), primary leaves of common beans were used as the treatment substrate. Mites were then exposed to 6 treatment concentrations plus a negative control and after 14 days, the
resid u e concentration to cause lethality to 50% of the population (LR 50 

### ) was determined. Additionally, NOAEC and LOAEC values were determined for the mean number of eggs hatched per female. The LR 50 

### ( mortality) and NOAEC (reproduction) determined in this study we re 0.1 lb a.i/A and <0.02 lb a.i/A, respectively.

In a subchronic toxicity test conducted with the earthworm ( Eisenia fetida ), test organisms were exposed to varying concentrations of TGAI mancozeb for 28

- days. There were no effects on mortality or bod y weight. The number of surviving offspring per adult was significantly (p<0.05) reduced at the two highest treatment concentrations.

### 41 Table 16

. Summary of the Most Sensitive Endpoints from Terrestrial Toxicity Studies for
Mancozeb

Taxonomic

Group Study Type Surrogate Species Toxicity Value (all units in terms of

measured active

ingredient) 2,3 Acute Toxicity
Classification Source (Classification)

Birds 1 Acute Oral No data adequate for quantitative risk assessment

Sub

- acute dietary No data previously submitted

Chronic Mallard duck quail ( Anas platyrhynchos ) NOAEC = 125 ppm (14

- day old hatchling weight, egg production, hatchability, embryo viability )
LOAEC = 1000 ppm -- 41948401 ( Acceptable )

Mammals Acute Oral Norway rat ( Rattus norvegicus ) 14

- day LD 50 > 5000 mg/kg bw (N/A; N/A) Practically

non

- toxic 00142522 (Acceptable)

Chronic (2

- generation reproduction) Norway rat ( Rattus norvegicus ) NOAEC (parental body weight) = 120

ppm LOAEC = 1200 ppm -- 41365201 (Acceptable)

Insects Acute contact

- TGAI Honey bee ( Apis mellifera ) 96

- hr LD 50 : 179 μg
a.i/bee Practically

non

- toxic 00018842 (Acceptable)

Terrestrial plants Seedling Emergence (Tier I) Monocot

– Ryegrass EC 25 > 0. 02 lbs a.i/A
NOAEC (dry weight)
= <0.02 lbs a.i/A

-- 47486102 (Acceptable) Dicot

– None EC 25 : >0.02 lbs a.i/A
NOAEC = 0.02 lbs
a.i/A

Vegetative Vigor (Tier I) Monocot

- None EC 25 >0.02 lbs a.i/A
NOAEC = 0.02 lbs
a.i/A 47486101 (Acceptable)
Dicot

- None EC 25 >0. 02 lbs a.i/A
NOAEC = 0.02 lbs
a.i/A

1 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

2 Concentrations expressed in terms of active ingredient.

3 An N/A under endpoint means that there was not a most sensitive species tested.



### Additionally, there are six studies available to characterize the toxicity of ETU to terrestrial organisms. In two acute oral studies with the zebra finch and bobwhite quail (MRID 48437501
and 4834001 , respectively ), ETU was not associated with any mortalities during the course of the study. In two su bacute dietary toxicity studies with the bobwhite quail and mallard duck (MRIDs 48417801 and 48417802, respectively), ETU did not cause mortality in all treatment concentrations. In the bobwhite quail study, there was a reduction in mean body weight chang e in the three highest treatment concentrations as we all as a significant (p<0.05) reduction in mean body weight in the two highest treatment concentrations. In the study with the mallard duck, there was a significant (p<0.05) decrease in mean body weigh t that was determined at all treatment
concentrations.

### 42 There are two chronic avian reproduction studies conducted with ETU on the bobwhite quail (MRID 48819701) and mallard duck (MRID 48819702) that are currently in review.

Table 17

. Summary of Endpoints from Terre strial Toxicity Studies for the ETU

Taxonomic Group (study type) Study Type Surrogate Species Toxicity Value (all units in terms of
measured active ingredient) 2 Acute Toxicity
Classification Source (Classification)

Birds 1 Acute oral toxicity Bobwhite quail ( Colinus virginianus) 14

- d LD 50 >2250 mg/kg

- bw (N/A; N/A) Practically

non

- toxic 48343001 (Acceptable)

Zebra finch ( Taeniopygia
guttata ) 14

- d LD 50 >2250 mg/kg

- bw (N/A; N/A) Practically

non

- toxic 48437501 (Acceptable)

Subacute dietary toxicity Bobwhite quail ( Colinus virginianus) 8

- d LC 50 > 5620 mg/kg

- bw (N/A; N/A) Practically

non

- toxic 48417801 (Acceptable)

Mallard duck ( Anas platyrhynchos ) 8

- d LD 50 > 5620 mg/kg

- bw (N/A; N/A) Practically

non

- toxic 48417802 (Acceptable)

Chronic
avian reproduction Bobwhite quail ( Colinus virginianus Study in review (MRID 48819701)

Mallard duck ( Anas platyrhynchos ) Study in review (MRID 48817702)

1 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

2 Range of numbers within parentheses refers to the 95% confidence limit of the point estimate value ; followed by probit slope estimate if available



## 6.3 **Ecological Incidents**

The ecological incident information system (EIIS) is an EFED

- maintained database that houses

ec ological incidents that have been reported to the Agency. When available, EIIS includes date and location of an incident, type and magnitude of effects observed in various species, use(s) of pesticides known or suspected of contributing to the incident, a nd results of any chemical residue analysis or other analyses conducted during incident investigation. EIIS incidents are categorized according to the certainty that the incident resulted from pesticide exposure. The OPP

- maintained Incident Database Syst em (IDS) and the Aggregate Incident Database provide incident counts at the chemical and product level but do not provide the narrative information contained in EIIS. The
Avian Incident Monitoring System (AIMS) is a database administered by the American B ird Conservancy that contains publicly available data on reported avian incidents involving pesticides. Many of the incidents listed in this database are also in the EIIS. Searches of the incident databases
were conducted in February , 2014.

A search of the IDS, AIMS , and Aggregate Incident Database returned no reported wildlife incidents involving mancozeb

.

A search EIIS returned six incidents ranging in dates from 1970 to 2002. A summarization of the incidents with information regarding the date, location, taxa of organisms involved, certainty that

### 43 mancozeb was responsible for the incident, and other information is tabulated below ( Table 18 )

. Three incidents involved freshwater fish with the other half involving terrestrial plant damage. In all but two instances, the likelihood of mancozeb being responsible for the incident was reported as unlikely or possible. These two “possible” incidents are without any confirmatory chemical residue analysis. In the remaining two incidents classifi ed as “probable,” there was a chemical residue analysis conducted that confirmed the presence of mancozeb.

There were no reported wildlife incidents in any of the aforementioned databases for ETU.

Table 18

. Summary of reported wildlife incident for mancozeb in EIIS.

Incident
number Year Taxa Affected Location Certainty Legality Other narrative information

B0000

- 233 1970 Freshwater
fish Washington Unlikely Misuse (accidental) - Large fish kill reported near Chewelah, WA

- Resulted from an aerial application of flowable sulfur,
Dithane M

- 45 (Mancozeb), and
thiodan

- Witnesses reported seeing the aircraft continue its spraying
even when it was over the river

- No residue analysis for
mancozeb but residues of
endosulfan f ound in fish sample suggest mancozeb was not the

cause. I000799

- 008 1992 Freshwater
fish North
Carolina Unlikely Undetermined

- Small pond has fish kill reported after airblast sprayer used to treat apple orchard
drifted

- Orchard had been treated with Thiodan, fenarimol, and
mancozeb

- Water and soil samples were
taken but not fish tissues

- Analysis indicated that soil detects were present for
mancozeb but it is unlikely that it is responsible for the
observed fish kil l due to endosulfan (thiodan) having
restrictions around water and its presence in the water and soil samples
I008745

- 004 1995 Freshwater
fish Prince
Edward
Island (Canada) Probable Misuse (accidental) - Rohm and Haas company reported the incident where spray tank filled with Dithane DF (mancozeb) fungicide
overturned with as much as 36 kg entering a nearby stream

- 30,000

– 35,000 fish found dead in nearby salmon hatchery

- No analyses were made of the

### 44 Incident
number Year Taxa Affected Location Certainty Legality Other narrative information

fish or water but the fish were reported dead the morning after
the contaminated water reached a salmon hatchery
I014406

- 002 1996 Terrestrial plants Washington Possible Undetermined

- This incident was reported in the 1996 Annual Report of Pesticide Incident Reporting and Tracking Review Panel by
the Wa shington State Department of Health.

- It was alleged that an onion field was damaged by an aerial application of diazinon, metalaxyl, mancozeb, and
chlorothalonil.
I013884

- 013 1998 Terrestrial plant s Washington Probable Registered use

- This incident is from the 1999 Annual Report from the Washington State Department
of Health and Pesticide Incident Reporting and Tracking Review
Panel.

- Person complained of spray drifting over her neighbor’s
fence and onto her fruit and vegetable garden.

- Chemical analysis of sample shows a trace of the applied pesticide
I014597

- 034 2002 Terrestrial plants Oregon Possible Registered use

- Mancozeb and fludioxonil applied as a seed treatment to potatoes

- Report states that 240 acres
were treated and 100 acres were damaged, having miscellaneous symptoms

- No chemical analysis was
conducted to confirm



# 7. Exposure Pathways of Concern

The environmental fate properties and use patterns of mancozeb indicate that direct spray, spray drift, and runoff (mainly in events accompanied by erosion), represent potential transport
mechanisms of mancozeb residues to aquatic and terrestrial organisms. Leaching to groundwater is an important pathway for ETU, th e drinking water degradate of concern, and however,

a tmospheric deposition are not important pathways for th is chemical.

Other Exposure Pathways to Terrestrial Species

Drinking Water Exposure

### 45 The S creening I mbibition P rogram (SIP v.l.0), Released June 15, 2010) was used to calculate an upper bound estimate of exposure using mancozeb’s solubility (6.2 mg/L), the most sensitive chronic avian toxicity endpoint ( northern bobwhite quail NOAEC of 125 ppm ) and the most
sensiti ve acute and chronic mammalian toxicity endpoints (Norway rat LD 50 

### of > 5000 mg a.i/kg

bw and Norway rat NOAEL 120 ppm , respectively). Acute exposure for birds was not estimated due to the uncertainties in the available acute toxicity studies (multiple ora l doses as opposed to single oral doses, regurgitation, small number of test birds per treatment level). Drinking water exposure alone was not determined to be a potential pathway of concern for chronic avian exposure and acute and chronic mammalian expo sure. Due to insufficient data for birds for acute exposure, risk could not be precluded.

Although drinking water exposure alone does not appear to be of concern ( with the exception to acute exposure to birds) , when aggregated with other exposure path ways (dietary food sources, dermal, inhalation)

, drinking water may contribute to a total exposure that has a potential for
effects on non

- target animals. Because there is a high degree of conservatism in the SIP 1.0 exposure estimate, there is a limited e xpectation that use scenarios not triggering a SIP 2.0 concern would contribute significantly to aggregate risks from water plus diet when a refined water exposure model is incorporated in the actual quantitative risk assessment. Detailed information
about SIP v.l.0 as well as t he tool can be found on the EPA's website at http://www.epa.gov/pesticides/science/models/pg.htm#terrestrial

.

Inhalation Exposure

The S creening T ool for I nhalation R isk (STIR v.l.0, November 19, 2010) was used to calculate an upper bound estimate of exposure using mancozeb’s vapor pressure ( 1 .32 x10

- 10 

### torr ) and molecular weight (265 g/mol) for vapor phase exposure as well as the maximum application rate and method of application for spray drift. STIR incorporates results from several toxicity studies including acute oral and inhalation rat toxicity endpoints obtained from the "six pack," of core
studies for technical and formulated products ( rat or al LD 50 

### = > 5000 mg a.i/kg

- bw and inhalation
LC 50 

### = >5.14 mg/L) . Acute inhalation exposure to birds cannot be estimated due to aforementioned uncertainties with the available avian acute oral toxicity studies. Based on the results of the STIR model, inhal ation exposure alone was not determined to be a potential pathway
of concern for mammalian species on an acute basis.

Inhalation exposure via spray drift and/or vapor

- phase of mancozeb alone does not appear to be of

concern (although the conclusions for birds is an uncertainty) . The analysis of the inhalation route in STIR does not consider that aggregation with other exposure pathways such as dietary, dermal, or drinking water may contribute to a total exposure that has a p otential for effects to non

- target animals. However, the Agency does consider the relative importance of other routes of exposure may be potentially significant contributors to wildlife risk (US EPA, 2004). Detailed information about STIR v.l.0, as well as the tool, can be found on the EPA's website at: http://www.epa.gov/pesticides/science/models/pg.htm#terrestrial

Dermal exposure

### 46 Potential exists for mancozeb dermal exposure to terrestrial wildlife. At the present time, the Agency does not have a method to quantify levels of dermal exposure from chemical applications, but is actively working on a screening tool to account for this route of exposure.

Exposure resulting from bioaccumulation

Mancozeb is associated with a K OW 

### value of 22 ( log K OW 

### = 1.3 ) . Based on its low potential for
bio

- concentration in aquatic organisms such as fish, a fish bioaccumulation study was previously
waived.



# 8. Analysis Plan

**8.1 Stressors of Concern** 

i. Ecological Risk Assessment

Please see the section entitled “ Determination of Mancozeb Residues of Ecological Concern ” in Section 5.3 of this problem formulation for a detailed rationale for identifying the stressor of

concern for the registration review ecological risk assessment

.

ii. Drinking Water

The stressor of concern for drinking water is Ethylenethiourea (ETU , a group B2 carcinogen )

, the common degradate of all Ethylene

- bis

- dithiocarbamates (EBDCs) fungicides including mancozeb.



## 8.2 **Measures of Exposure**

EFED will use the most current accepted models to evaluate potential exposures to aquatic and terrestrial organisms as described at http://www.epa.gov/pesticides/science/models_db.htm

. Aquatic Exposure EECs will be estimated for the total toxic residues of parent plus EBIS , the stressor for the water column of the aquatic system. Additionally, sediment only EECs for the
UER will b e estimated, by modeling, using its observed maximum concentration in the soil system as an application rate and the observed half

- lives to represent degradation. PFAM will be used to
estimate relevant surface water concentrations for the use on cranberrie s.

The Agency is aware of ETU monitoring conducted by the EBDCs Task Force and will consider this data and any other available federal and state agencies data in the future registration review
risk assessment.



## 8.3 **Measures of Effect**

Toxicity data presented in Section 3 of this problem formulation will be used to calculate risk quotients. Any additional information submitted by the registrant or found in the open literature prior to conduct of the risk assessment wi ll also be considered. The open literature studies are

### 47 identified using EPA’s ECOTOXicology database ( ECOTOX) , which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The
evaluation of both sources of data can also provide insight into the direct and indirect effects of pesticides on biotic communities from loss of species that are sensitive to the chemicals and from changes in structure and functional characteristics of the affected communities.



# 9. Endangered Species Assessments

Consistent with EPA’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally listed threatened and endangered (listed) species from registered uses of pesticides in accordance with the Joint Interim Approaches developed to implement the recommendations of the April 2013 National Academy of Sciences (NAS) report, Assessing Risks to Endangered and Threatened Species from Pesticides

. The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations
under the ES A and FIFRA. EPA will address concerns specific to mancozeb in connection with the development of its final registration review decision for mancozeb

.

In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries (the Services), and USDA released a white paper containing a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. These Interi m Approaches were developed jointly by the agencies in response to the NAS recommendations, and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences
between the EPA and the Services. Details of the joint Interim Approaches are contained in the November 1, 2013 white paper

, Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the Nat ional Academy of Sciences April 2013 Report.

Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, this ecological problem formulation supporting the Preliminary Work Plan for mancozeb does not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted during registrat ion review. While the agencies continue to develop a common method for ESA analysis, the planned risk assessment for the registration review of mancozeb will describe the level of ESA analysis completed for this particular registration review case. This a ssessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists, once the scientific methods being developed by the agencies have been fully vetted. Once the agencies have fully developed and implemen ted the scientific methods necessary to complete risk assessments for listed species and their designated critical habitats, these methods will be applied to subsequent analyses of
mancozeb as part of completing this registration review.

### 48 

# 10. Endocrine Disrup tor Screening Program

Mancozeb was not included in the first group of 67 chemicals issued an order to conduct Tier 1
EDSP testing. For additional information the EDSP program, visit http://www.epa.gov/endo/

.


# 11. Preliminary Identification of Data Gaps

**11.1 Environmental Fate** 

Due to the complex nature of polymeric mancozeb and the state of science when some of t he studies were conducted, difficulties were observed in these studies includ e :

(1) Parent degradation in the p reparation steps of parent for the experiments. For example, in one mancozeb aerobic soil study, the starting purity of the parent was 87% decreased to 59.2% when measured at time zero. High quantities of the degradate ETU at this time were related to degr adation before initiation of the study;

(2) H igh percentage of the un

- identified radioactivity remained un

- extracted in the soil/sediment. For example, in an aerobic soil study the level of un

- extracted un

- identified residue reached maximums of 80% of the ap plied;

(3) Methods used for extraction have had degradation effects on polymeric parent and possibly monomeric segments of the parent. For example, extraction in one study appeared to cause some degree of conversion of parent into ETU even in the presence of chemicals that is believed to minimize such effects;

(4) Solvents including water appeared to cause hydrolytic decomposition of the polymeric parent
into un

- identified residue (possibly monomeric species); and

(5) Particle size reduction and presence of metal i ons (that may replace zinc ion in the structure) are thought to increase hydrolytic decomposition and degradation rate.

The Agency understand s difficulties that relates to the nature of the chemical and therefore request only studies that are expected to produce data with less uncertainties giving the advances in science
since these studies were conducted

. Table s 19 and 20 identif y environmental fate studies by
MRID for mancozeb and its main degradate ETU , respectively, along with their study
classifications . The table s also show where additional data are needed to support the future risk

assessment.

Table 19. Submitted environmental fate data for mancozeb

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classification Are data needed to conduct risk assessment?

835.2120 Hydrolysis 000971

- 62 Supplemented by
402582

- 01 Supplemental Yes for Mancozeb a.i
835.2240 Aqueous photolysis 001621

- 03 Acceptable No

### 49 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classification Are data needed to conduct risk assessment? 835.2410 Soil photolysis 002639

- 07 Acceptable No
835.4100 Aerobic soil metabolism 457445

- 01 Supplemental No
835.4200 Anaerobic soil metabolism No acceptable study No
835.4300 Aerobic aquatic metabolism 462043

- 01 Acceptable No
835.4400 Anaerobic aquatic metabolism No acceptable study Yes for Mancozeb a.i

835.1230
835.1240 Adsorption/ desorption and leaching 402229

- 01
And 405883

- 02 Supplemental No

835.1410 Volatility

– laboratory Waived based on low vapor pressure and inhalation toxicity No

835.6100 Terrestrial field dissipation 409236

- 01
With 445241

- 01 Published Article No
835.8100 Volatility

- field Not required No
850.1730 Fish bio

- concentration Waived because mancozeb K ow 22 No

850.6100 Environmental chemistry
method in soil /validation (ECM/ILV) None submitted YES

850.6100 Environmental chemistry
method in water/validation (ECM/ILV ) None submitted YES



### Table 20. Submitted environmental fate data for mancozeb major degradate ETU

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classification Are data needed to conduct risk assessment?

835.2120 Hydrolysis 404661

- 03 Supplemental No
835.2240 Aqueous photolysis 404661

- 02 Acceptable No
835.2410 Soil photolysis 404661

- 01 Acceptable No

835.4100 Aerobic soil metabolism 452251

- 01 &
451464

- 01 Supplemental Yes for ETU
as test substance
835.4200 Anaerobic soil metabolism No acceptable study No

835.4300 Aerobic aquatic metabolism No acceptable study Yes for ETU
as test substance

835.4400 Anaerobic aquatic metabolism No acceptable study Yes for ETU
as test substance
835.1230
835.1240 Adsorption/ desorption and leaching 002588

- 96
And 000971

- 58 Supplemental No
835.1410 Volatility

– laboratory No acceptable study No at this time

835.6100 Terrestrial field dissipation 00 2552

- 29
And 000889

- 23 Supplemental No
850.1730 Fish bio

- concentration Waived because mancozeb K ow 2 No

850.6100 Analytical method in soil (ECM/ILV) None submitted Yes
Analytical method in water (ECM/ILV) ECM: 448804

- 01 *
ILV : 451514

- 01 Acceptable No

* URL: http://www2.epa.gov/sites/production/files/2014

- 12/documents/448804

- 01

- w.pdf



## 11.2 **Effects**

### 50 Table s 21

- 25 identify ecological effects studies by MRID that offer data fo r each guideline requirement for parent mancozeb and the degradation products in the aquatic medi a and terrestrial
environment , respectively, as well as study classifications and whether or not further data are needed in order to support risk assessment.

Currently there are no available acute oral toxicity studies for mancozeb that are suitable for quantitative risk assessment. Three acute studies for birds have been previously submitted. In a study conducted with the Japanese quail ( Corturnix japoni ca ) the study was initially planned as an avian subacute dietary test, but changed to a multiple dose oral study, a design that does not fulfill the 40CFR Part 158 standard for an acute oral study. Additionally, the age, gender, and
source of the test ani mals was not provided, four animals per treatment level (as opposed to the guideline

- recommended ten) were used, and regurgitation occurred at multiple test concentrations during the course of the study. Therefore, it is uncertain as to what level of test substance the test birds actually received at these doses where observations of regurgitation occurred. Similarly, in a multiple

- dose oral toxicity study (as opposed to the guideline

- recommended single dose) conducted with the mallard duck ( Anas platyrhy nchos ), test bird age, gender, and source were unspecified as well as differing numbers of animals were used per treatment group (all below the guideline

- recommended ten animals per treatment group), and regurgitation occurring at the two highest treatmen t levels. Finally, mancozeb was tested with similar multiple acute oral dose regimens to sparrows ( Passer domesticus ), starlings ( Sturnus vulgaris ), and pheasants ( Phasianus
colchicus ). The starlings and sparrows were wild caught and the pheasants were o btained from an undisclosed commercial rearer. No age or gender information was given and there was a reduced number of birds per treatment level than the guideline

– recommended number. These collective deficiencies, despite study classifications of suppl emental limit their use in quantitative risk assessment. Two studies (one with the mallard duck or bobwhite quail and one with a passerine species) are recommend to characterize the acute oral toxicity to birds which will allow the
estimation of acute dos e

- base risk to birds feeding on mancozeb contaminated food items. Given that mortalities were observed in the available studies, and considering the high and frequent applications permitted by labels, it is determined that this data will have an overall a dded value n
the risk assessment.

Current records indicate the submission of an acute oral toxicity study with a passerine species ( canary, Serinus canaria , MRID 48515401). A preliminary review of this study indicate s that
th ere was regurgitation observed at four of the five treatment groups. The observation of regurgitation occurred in a dose

- dependent manner with no observation at the lowest treatment group (259 mg a.i/kg

- bw) and 60, 80, 100, and 100% of the birds at the 432, 720, 1200, and 2000 mg a.i/kg

- bw, respectively. While there were 2 mortalities observed at the highest treatment group, and one mortality in each of the 432, 720 , and 1200 mg a.i/kg

- bw treatment groups, it is an uncertainty as to what dose the birds regurgita ted actually received in these groups where regurgitation was observed . EFED guidance ( “Guidance for use when regurgitation is observed in avian acute toxicity studies with passerine species,” April 2012 9 

### ) recommends to proceed to conducting a dietary stu dy to examine if changing the route of exposure would make the
achievement of an acute estimate of toxicity potentially more feasible.

9 Available online at: http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/terrestrial_biology_tech_team/tbtt_regur g_acute_passerine.htm

### 51 Table 21

. Submitted Aquatic Ecological Effects Data for Mancozeb

OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are data needed
to conduct risk

assessment? Justification and Assumptions EPA
will Make in
Absence of Data

850.1010 Freshwater invertebrate acute toxicity 40467502 Invalid

No

-- 40467503 Acceptable

46656601 Invalid

850.1025
850.1035
850.1045
850.1055 Saltwater invertebrate acute toxicity 41822901 Supplemental

No

-- 41822902 Supplemental

40586801 Supplemental

40885102 Acceptable

40586803 Supplemental

40885101 Acceptable

850.1075 Freshwater fish acute toxicity 45935701 Supplemental

No

-- 45934702 Supplemental

40467501 Supplemental

00080719 Supplemental

00085459 Invalid

00097101 Supplemental

00091747 Acceptable

850.1075 Saltwater fish acute toxicity 41844902 Invalid

No

-- 41844901 Acceptable

40586802 Supplemental

40586804 Supplemental

850.1300 Freshwater invertebrate life cycle 46023702 Supplemental No --

850.1350 Saltwater invertebrates life cycle 48627701 Study in review N/A --

850.1400 Freshwater fish early

- life stage 43230701 Acceptable No



### -- 46023701 Invalid
Saltwater fish early

- life stage 48627702 Study in review N/A



### --

850.1500 Fish life cycle

saltwater fish 49030601 Acceptable No

--

### 52 OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are data needed
to conduct risk

assessment? Justification and Assumptions EPA
will Make in
Absence of Data

850.1735 Whole sediment Acute Toxicity Invertebrates,
Freshwater 10 47410101 Acceptable

No

--

850.1735 Whole sediment Acute Toxicity Invertebrates, Freshwater (with un

extracted residues) 47410102 Acceptable

850.4400 Aquatic plant Toxicity Test using Lemna spp. No data available Yes

--

850.4500 Algal toxicity 43664701 Acceptable Yes

-- 40845001 Invalid



### Table 22

. Aquatic Ecological Effects Data for ETU

OCSPP
Guideline Data Requirement Submitted Studies (MRID) Study
Classifications Are data needed for risk

assessment ?

850.1010 Freshwater invertebrate acute toxicity 45910402 Acceptable No

850.1025 Saltwater invertebrate acute toxicity 47474301 Acceptable N/A

850.1035 Saltwater invertebrate acute toxicity 47441204 Acceptable N/A

850.1075 Freshwater fish acute toxicity 45910401 Acceptable No

47441202 Acceptable N/A

Saltwater fish acute toxicity 47441201 Acceptable N/A

850. 1300 Freshwater invertebrate life cycle 46462901 In review

850.4400 Aquatic plant toxicity test using Lemna spp. 47441203 Acceptable N/A

850.4500 Algal toxicity 45910403 Supplemental No



### Table 23

. Aquatic Ecological Effects Data for EU

10 Also known as “Whole Sediment: Subchronic Freshwater Inverte brates,” as per EFED Guidance Document Entitled “Toxicity Testing and Ecological Risk Assessment Guidance for Benthic Invertebrates.” April 2014.

### 53 OCSPP
Guideline Data Requirement Submitted Studies (MRID) Study
Classifications Are data needed for risk

assessment ?

850.1075 Freshwater
invertebrate acute toxicity 46462902 Acceptable No

850.1010 Freshwater
invertebrate acute toxicity 46462903 Acceptable No

850.4500 Algal toxicity 46462904 Acceptable No



### Table 24

. Submitted Terrestrial Ecological Effects Data for Mancozeb

OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are data
needed for risk

assessment ? Justification and Assumptions EPA
will Make in
Absence of Data

850.2100 Avian oral toxicity 00036094 Supplemental

Yes

-- 00080716 Supplemental

00080717 Supplemental

850.2200 Avian dietary toxicity No data available Yes --

850.2300 Avian reproduction 44159501 Acceptable

No --
41948401 Acceptable

41566702 Invalid

44238001 Acceptable

850.3020 Honey bee acute

contact toxicity 00018842 Acceptable No --

850.3030 Honey Bee toxicity of residues on foliage No data available No

--

850.6200 Earthworm
Subchronic Toxicity 46023704 Supplemental No --

Non

- Guideline Study (Tier 1) Honey bee adult acute oral toxicity

No data available Yes*

Non

- guideline Study (Tier 1) Honey bee adult
chronic oral toxicity Yes*

Non

- Guideline Study (Tier 1) Honey bee larvae
chronic oral toxicity Yes*

Non

- guideline Study (Tier 2) Field trial of residues in pollen
and nectar Yes*

### 54 OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are data
needed for risk

assessment ? Justification and Assumptions EPA
will Make in
Absence of Data

850.3040 (Tier 2 or 3) Field Testing for
Pollinators Yes*

Non

- guideline Semi

- field study with the Honey
bee Yes* --

Non

- guideline Predatory mite

– Acute contact and reproductive test 45577201 Supplemental No --

850.4100 /4150 S eedling
E mergenc e 47486101 Acceptable
Yes Studies need to apply
mancozeb at the maximum single application rates 850.4150 Vegetative Vigor 47486102 Acceptable



### Table 25

. Terrestrial Ecological Effects Data for ETU

OCSPP
Guideline Data Requirement Submitted Studies (MRID) Study
Classifications Are data needed for risk

assessment ?

850. 2100 Avian oral toxicity 47769701 Acceptable No

48437501 Acceptable No

850.2100 Avian dietary toxicity 48417801 Acceptable No

48417802 Acceptable No

850.2300 Avian reproduction 48819701 Acceptable No

48819702 Acceptable No * These studies may be required based on results of Tier 1 bee studies and risk assessment.



## Data Justification Tables for Non

- Codified Exposure and Effects Studies with
Bees

Study Title: Honey bee Adult Acute Oral Toxicity Rationale for Requiring the Data Terrestrial invertebrates are likely to be impacted if exposed to pesticides in various use settings. With eusocial bees, pesticide residues may be transferred to pollen and/or nectar of treated plants and subsequently brought back to the hive. Therefore, potential acute effects to adult honey bee s and other
insect pollinators from oral exposure to some pesticides could exist. Curre ntly available toxicity studies do not address possible effects of oral exposure on adult terrestrial insect survival. Because of the potential for pollen and nectar to be contaminated with pesticide residues, and subsequently brought back to the hive, it is important to determine the acute oral toxicity of this compound to adult honey bee s and other insect pollinators.

### 55 The Office of Pesticide Programs has made available a guidance regarding ecological testing for bees using
the honey bee as a surrogate t est species. The guidances discusses Tier I laboratory

- based acute oral toxicity studies of individual adult bees as a critical component of the screening

- level risk assessment process for examining potential adverse effects from specific routes of exposu re. The guidance can be found at: http://www2.epa.gov/pollinator

- protection/pollinator

- risk

- assessment

- guidance

. Additional guidance on
the honey bee oral toxicity test design can be found in OECD Test Guideline 213 ( http://www.oecd

ilibrary.org/d ocserver/download/9721301e.pdf?expires=1423074617&id=id&accname=guest&checksum
=2F0764FCB4DCF01D32382952A2E995C3 ) Practical Utility of the Data
How will the data be used?
The Tier 1 acute oral toxicity d ata on adult honey bees serve as a foundation for t he screening

- level assessment of potential risk non

- target organisms such as federally listed threatened or endangered and non

listed terrestrial invertebrate insects, including pollinators, from acute oral exposures to pesticides. The
data will be used t o reduce uncertainties associated with the risk assessment for terrestrial invertebrates and will improve EPA’s understanding of the potential direct and indirect effects on a broad range of taxa. This study will also provide information with which to comp are whether oral toxicity estimates differ from contact toxicity estimates obtained from other Tier 1 studies. If acute oral effects data for adult honey bees are not available, risks to terrestrial insects from acute oral exposure will be assumed.

How could the data impact the Agency’s future decision

- making? The data will inform the determination required under FIFRA or the ESA as to whether continued registration of a pesticide is likely to result in unreasonable adverse effects to non

- target species or is likely to adversely affect listed threatened or endangered species and/or modify their designated critical habitat. Without these data, EPA may need to presume risk

, which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in use restrictions.

Study Title: Honey bee Larvae Acute Oral Toxicity Rationale for Requiring the Data Terrestrial invertebrates are likely to be impacted if exposed to pesticides in various use settings. With
eusocial bees, pesticide residues may be transferred to pollen and/or nectar of treated plants and subsequently brought back to the hive where developing larvae and pupae may be exposed. Therefore, potential adverse effects to developing bees could result from exposure to pesticide residues. Available toxicity studies do not address possible effects on brood (larvae and pupae) survival/development . Because of the potential for pollen and nectar to be contaminated with pesticide residues, and subsequently broug ht back to the hive, it is important to determine the acute toxicity of this compound to bee brood.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for bees using
the honey bee as a surrogate test species. Th e guidances discusses Tier I laboratory

- based acute toxicity
studies of individual honey bee larvae as a critical component of the screening

- level risk assessment process for examining potential risks from specific routes of exposure. The guidance be found at: http://www2.epa.gov/pollinator

- protection/pollinator

- risk

- assessment

- guidance . Additional guidance on
larval honey bee toxicity test design can be found in OECD Test Guideline 237 ( http://www.oecd

ilibrary.org/docser ver/download/9713171e.pdf?expires=1422485600&id=id&accname=guest&checksum
=D8E07C2B1DF77BF096C3B29F55BF86A7 ). In some cases, information pertaining to acute toxicity to honey bee larvae may be obtained with the chronic honey bee larval test thereby negatin g the need for separate acute and chronic larval toxicity tests.

### 56 Practical Utility of the Data
How will the data be used?
The Tier 1 acute toxicity d ata on honey bee larvae serve as a foundation for the screening

- level assessment of potential risk to non

- target organisms including federally listed threatened or endangered and non

- listed
terrestrial invertebrates , including pollinators, and/or modify th eir designated critical habitat from acute exposures to pesticides. The data will be used to reduce uncertainties associated with the risk assessment for terrestrial invertebrates and will improve EPA’s understanding of the potential effects on terrestria l species and whether there is a differential sensitivity of larval bees relative to adult bees. If acute effects data for larvae are not available, risks to terrestrial insects from acute exposure will be assumed

.

How could the data impact the Agency’s future decision

- making? The data will inform the determination required under FIFRA or the ESA as to whether continued registration of a pesticide is likely to result in unreasonable adverse effects to non

- target species or is likely to adversely affect li sted threatened or endangered species and/or modify their designated critical habitat. Without these data, EPA may need to presume risk which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in use restri ctions.

Study Title: Honey Bee Adult Chronic Oral Toxicity Rationale for Requiring the Data Terrestrial invertebrates are likely to be impacted if exposed to pesticides in various use settings. With eusocial bees, p esticide residues may be transferred to pollen and/or nectar of treated plants and subsequently brought back to the hive. Therefore, potential chronic effects to adult honey bees and other pollinators from oral exposure to some pesticides could exist. Currently available toxicity studies do not address possible lethal and sublethal effects of chronic oral exposure on adult terrestrial invertebrates and will assist in determining whether the sensitivity of adult bees differs from that of earlier life stages.
Beca use of the potential for pollen and nectar to be contaminated with pesticide residues, and subsequently brought back to the hive, it is important to determine the chronic oral toxicity of this compound to adult honey bee s and other pollinators.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for bees using the honey bee as a surrogate test species. The guidances discusses Tier I laboratory

- based chronic oral toxicity studies of individual adult honey bee s as a c ritical component of the screening

- level risk assessment process for examining potential risks from specific routes of exposure. The guidance can be
found at: h ttp://www2.epa.gov/pollinator

- protection/pollinator

- risk

- assessment

- guidance . Although study design elements for the chronic 10

- day oral toxicity test with honey bees are similar to the OECD TG 213 acute oral toxicity test ( http://www.oecd

ilibrary.org/docserver/download/9721301e.pdf?expires=1422484908&id=id&accname=guest& checksum
=C38495D2A570AC2216CFB1F223D24AA7 ), EPA requires that the proposed protocol for this study be submitted for review and approval by EPA prior to initiating the test

. Practical Utility of the Data
How will the data be used?
The Tier 1 chronic toxic ity d ata on adult bees serve as a foundation for the screening

- level assessment of potential risk to non

- target organisms including federally listed threatened or endangered species and non

listed terrestrial invertebrates , including pollinators, from chro nic oral exposures to pesticides. The data
will be used to reduce uncertainties associated with the risk assessment for terrestrial invertebrates and will improve EPA’s understanding of the potential direct and indirect lethal and sublethal effects on a b road range of terrestrial species, particularly insect pollinators and to determine whether adult toxicity differs

### 57 substantially from other life stages evaluated in other Tier 1 tests. If chronic oral effects data for adults are not available, risks to te rrestrial insects from chronic exposure will be assumed.

How could the data impact the Agency’s future decision

- making? The data will inform the determination required under FIFRA or the ESA as to whether continued registration of a pesticide is likely to result in unreasonable adverse effects to non

- target species or is likely to adversely affect listed threatened or endan gered species and/or their designated critical habitat. Without these data, EPA may need to presume risk which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in use restrictions. Study Title: Honey Bee Larvae Chronic Oral Toxi city Rationale for Requiring the Data Terrestrial invertebrates are likely to be impacted if exposed to pesticides in various use settings. For
eusocial bees, pesticide residues may be transferred to pollen and/or nectar of treated plants and subsequently brought back to the hive where larvae and pupae may be exposed. Therefore, potential effects to developing bees could result from chronic exposure to pesticide residues. Available toxicity studies do not address possible chronic effects on brood (larvae and pupae) survival. Because of the potential for pollen and nectar to be contaminated with pesticide residues, and subsequently brought back
to the hive, it is important to determine chronic larval/pupal toxicity and whether adult emergence is adversely affected. This study will provide information on whether honey bee larvae differ in sensitivity from adult bees following chronic exposure.

The Offic e of Pesticide Programs has made available a guidance regarding ecological testing for bees using
the honey bee as a surrogate test species. The guidances discusses Tier I laboratory

- based chronic toxicity
studies of individual honey bee larvae as a critical component of the screening

- level risk assessment process for examining potential risks from specific routes of exposure. The guidance can be found at: http://www2.epa.gov/pollinator

- protection/pollinator

- risk

- assessment

- guidance

. Additional information
on larval honey bee toxicity repeat exposure test design can be found in the OECD draft guidance ( http://www.oecd.org/env/ehs/testing/Draft_GD_honeybees_rep_exp_for_2nd_CR_25_November_2013.p
df

). Although study design elements for the chronic 21

- day toxicity test with honey bee larvae h ave been drafted, EPA requires that the proposed protocol for this study be submitted for review and approval by EPA prior to initiating the test. Practical Utility of the Data
How will the data be used? The Tier 1 chronic toxicity d ata on bee larvae serve as a foundation for the screening

- level assessment of potential risk to non

- target organisms including federally listed threatened or endangered and non

- listed terrestrial invertebrates, including insect pollinators, from chronic exposures to pesticides. These data will
be used to reduce uncertainties associated with the risk assessment for terrestrial invertebrates and will improve EPA’s understanding of the potential direct and indirect lethal and sublethal effects on a broad

ra nge of terrestrial species, particularly insect pollinators. These data will also assist in determining whether early life stages of the bee differ in their sensitivity to pesticides relative to adults. If chronic effects data
for larvae are not available , risks to terrestrial insects from chronic exposure will be assumed.

How could the data impact the Agency’s future decision

- making? The data will inform the determination required under FIFRA or the ESA as to whether continued registration of a pesticide is likely to result in unreasonable adverse effects to non

- target species or is likely to adversely affect listed threatened or endangered species and/or modify their designated critical habitat. Without these data, EPA may need to presume risk which wil l limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in use restrictions.

### 58 Study Title: Semi

- field Testing for P ollinators (tunnel or colony feeding studies) Rationale for Requiring the Data Tier II studies are conditional on the outcome of the screening

- level assessment where acute and/or chronic risk levels of concern have been exceeded for terrestrial invertebrates. Terrestrial invertebrates are likely to be impacted if exposed to pesticid es in various use settings. For eusocial bees, pesticide residues may be transferred to pollen and/or nectar of treated plants and subsequently brought back to the hive and may adversely affect developing brood (egg, larvae, and pupae) and adult bees. Sc reening

- level (Tier 1 ) studies of individual bees do not address possible effects and/or exposure to pesticide residues at the colony

- level. Because of the potential for pollen and nectar to be contaminated with pesticide residues, and subsequently brough t back to the hive, it is important to determine whether bee colonies may be negatively affected under relatively controlled exposure conditions of a semi

- field study. In addition to providing effects data, these studies can provide data on pesticide resid ues in pollen/nectar of treated plants.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for bees using

the honey bee as a surrogate test species. This guidance describes the tiered testing process and can be found

at: http://www2.epa.gov/pollinator

- protection/pollinator

- risk

- assessment

- guidance , Additional info rmation on
honey bee colony studies under semi

- field conditions can be found in the OECD Guidance 75 ( http://www.oecd.org/officialdo cuments/publicdisplaydocumentpdf/?cote=env/jm/mono% 282007%2922&do clanguage=en ). Due to the complexities of this study, EPA requires that the proposed protocol for this study be submitted for review EPA prior to initiating the test. Practical Utility of the Data

How will the data be used? Tier II colony

- level data will be used to assess potential risk to non

- target organisms including listed and

non

- listed terrestrial social invertebrate species and to determine whether effects observed in the screening

level (Tier I) laboratory

- based studi es of individual bees are evident in colony

- level studies under semi

- field
conditions. The Tier II semi

- field test of whole colonies is a relatively controlled study, i.e ., bees are confined to a specific area, that is designed to represent potential field

- level exposure and account for hive dynamics, which are not achievable from other pollinator studies. This study will be used to determine whether adverse
effects to in sect pollinators at the whole colony level, may result for the use of pesticides and will help to refine risk estimates derived in the screening

- level risk assessment for beneficial terrestrial invertebrates. Measured residues in pollen/nectar can also be used to refine risk estimates derived from model

- based or default values in the screening

- level assessment.

How could the data impact the Agency’s future decision

- making? The data will inform the determination required under FIFRA or the ESA as to whethe r continued registration of a pesticide is likely to result in unreasonable adverse effects to non

- target species or is likely to adversely affect federally listed threatened or endangered species or their designated critical habitat. Without these data, EPA may need to presume risk which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in significant use restrictions.

### 59 Study Title: Field Testing for Pollinators Rationale for Requiring the Data Tier III studies are conditional on the outcome of the screening

- level assessment (Tier 1) where acute and/or
chronic risk levels of concern have been exceeded for terrestrial invertebrates and where Tier II studies either
under semi

- field tunnel condition s and/or feeding studies have indicated potential adverse effects at the colony level. Available toxicity studies from lower

- tier studies do not address possible effects and/or exposure to pesticide residues at the colony

- level under actual pesticide use conditions and where specific uncertainties regarding the likelihood of exposure and/or effects remain. Full

- field studies also provide an opportunity to measure residues in pollen and nectar as well as various matrices (beebread, honey, wax)
within the c olony to obtain a more realistic understanding of exposure.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for bees using
the honey bee as a surrogate. This guidance describes the tiered testing process and can be found at http://www2.epa.gov/pollinator

- protection/pollinator

- risk

- assessment

- gui dance

. Additional information on honey bee colony studies under full

- field conditions can be found in the OCSPP 850.3040 ( http://www.regulations.gov/#!documentDe tail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 0018 ). Useful guidance is also available through OCSPP 850.2500 (Field Testing of Terrestrial Wildlife http://www.epa.gov/ocspp/pubs /frs/publications/Test_Guidelines/series850.htm ) Although design element
for the full

- field colony

- level study are available through the 850.3040 and 850.2500, EPA requires that the proposed protocol for this study be submitted for review and approval by EPA prior to initiating the test; the protocol should attempt to address specific uncertainties identified in lower

- tier studies. Practical Utility of the Data
How will the data be used? Tier III colony

- level data will be used to further characterize potential risk to non

- target organisms including
listed and non

- listed terrestrial social invertebrate species and to refine screening

- level risk estimates that
were based on individual bee re sponses. The semi

- field test is a controlled study that is designed to represent potential field

- level exposure under relatively controlled conditions and account for hive dynamics, which
are not achievable from lower

- tier pollinator studies. This study will be used to determine whether adverse effects to insect pollinators at the whole colony level, may result for the use of pesticides and will help to refine the screening

- level risk estimates for beneficial terrestrial invertebrates. This study will al so be used to determine whether more refined (Tier 3) studies are needed to characterize risk.

How could the data impact the Agency’s future decision

- making? The data will inform the determination required under FIFRA or the ESA as to whether continued registration of a pesticide is likely to result in unreasonable adverse effects to non

- target species or is likely to adversely affect federally listed threatene d or endangered species or their designated critical habitat. Without these data, EPA may need to presume risk which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in significant use restrictions.

### 60 Study Title: Residues in Pollen and Nectar Rationale for Requiring the Data 

### Terrestrial invertebrates are likely to be impacted if exposed to pesticides residues in various use settings. Pesticide residues may be transferred to pollen and/or nectar of treated plants and subsequently brought back to hive all life stages may be exposed. For some pesticides, the quantification of pollinator

- relevant residues in treated flowering plants is needed, since pollinators will be exposed to residues fro m either current or prior season applications (due to the potential for residues to accumulate in plants and trees). Residues in edible/transportable

- to

- hive parts of treated trees and plants, including (where appropriate), but not limited to, guttation w ater, sap/resins, whole plant tissue ( e.g., leaves, stems), as well as blooming, pollen

- shedding, and nectar producing parts ( i.e. , flowers and, if present, extra

- floral nectaries) of plants may inform the potential for risk. Studies should be designed to provide residue data for crops and application methods of concern.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for bees using the honey bee as a surrogate. This can be found at: http://www2.epa.gov/pollinator

protection/pollinator

- risk

- assessment

- guidance

. Since residue studies are intended to provide exposure data in multiple matrices and under specific application conditions, EPA requires that the protocol is submitted for review and approval by EPA prior to initiation of the study. Practical Utility of the Data
How will the data be used?
Measured residue d ata will be used to refine conservative estimates of pesticide exposure and reduce uncertainties associated with the Tier I exposure assessment by providing direct measurements of pesticide concentrations resulting from actual use settings. Measured residues may provide a more realistic
understa nding of exposure through contact or ingestion with which to calculate risk quotients for individual bees as well as to characterize exposure to the colony. If measured residue data are not available, risk
estimates for terrestrial insects will be based o n model generated or default values used to support the screening

- level assessment.

How could the data impact the Agency’s future decision

- making? The data will inform the determination required under FIFRA or the ESA as to whether continued registration of a pesticide is likely to result in unreasonable adverse effects to non

- target species or is likely to adversely affect federally listed threatened or endangered species or their designated critical habitat. Without these data, EPA will have to rely on conservative estimates of exposure which may limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in use restrictions.

### 61 

# 12. References

Food and Agriculture Organization of the United Nations. 2000. FAO PESTICIDE DISPOSAL
SERIES 8. Assessing Soil Contamination: A Reference Manual. Appendix 2. Parameters of pesticides that influence processes in the soil. Editorial Group, FAO Information Division: Rome, 2000. http://www.fao.org/DOCREP/003/X2570E/X2570E00.htm

.

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs . United States Environmental Protection Agency (USEPA). Environmental Fate

an d Effects Division. Office of Pesticide Programs. Available at http://www.epa.gov/espp/consultation/ecorisk

- overview.pdf (accessed 02/19/2014)

.

USEPA. 200 6

. Standard Soil Mobilit y Classification Guidance

. Memorandum from D onald Brady dated April 21, 2006

.

USEPA. 2010. Guidance for Reporting on the Environmental Fate and Transport of the Stressors of Concern in Problem Formulations for Registration Review, Registration Review Risk Assessments, Listed Species Litigation Assessments, New Chemical Risk Assessments, and Other Relevant Risk Assessments. Memorandum from Donald Brady dated January 25, 2010 ( http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/endangered_spec ies_reregistration_workgroup/esa_reporting_fate.htm ).

### 62 

# Appendix A

. Mancozeb Fate and Ecological Effects Bibliography

PC Code 014504 Mancozeb Fate/Chemistry Bibliography

161

- 1 Hydrolysis

MRID Citation Reference

64926 Rohm and Haas Company (1970) Degradation of Dithane M

- 45 in Sterile Water Systems: RAR Memorandum No. 593. (Unpublished study re ceived Aug 2, 1972 under 1F1050; CDL:091882

- B)

88918 Haines, L.D. (1973) The Hydrolytic Decomposition of Dithane M

- 45 at Room Temperature: TR 3923

- 73

- 25. (Unpublished study, includ ing letter dated Dec 7, 1973 from W.R. Lyman to V.H. Unger, received Dec 9, 1981 under 707

- 78; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:070525

- D)

8891 9 Cruickshank, P.A.; Jarrow, H.C. ( 1973) Ethylenethiourea degrada tion. Journal of Agricultural and Food Chemistry 21(3):333

- 335. (Also in unpublished submission received Dec 9, 1981 under 707

- 78; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL: 07052 5

- E)

88921 Graham, W.H.; Bornak, W.E. (1972) Greenhouse Studies with C^14I

- Ethylene Thiourea on Potatoes a nd Tomatoes and Photodecomposi tion in Water: Laboratory 23 Res earch Report No. 23

- 52. (Unpub lished study received Dec 9, 1981 under 707

- 78; submitt ed by Rohm & Haas Co., Philadelphia, Pa.; CDL:070525

- G)

88922 Ross, R.D.; Crosby, D.G. (1973) Photolysis of ethylenethiourea. Journal of Agricultural and Food Ch emistry 21(3):335

- 337. (Also i n unpublished submission received Dec 9, 1981 under 707

- 78; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:070525

- H)

97111 Rohm and Haas Company (1970) Degradation of Dithane M

- 45 in Sterile Water Systems: RAR Memorandum No. 593. (Unpublished study r e ceived Aug 1, 1971 under 1F1050; CDL:091880

- I)

97155 Schindler, F.J.; Clark, R.H. (1967) Decomposition of Soluble and Insoluble Ethylenebisdithiocarbamates in Aqueous Systems: Lab

- oratory 57 Research Report #57

- 18. (Unpublished study received Jan 3, 19 74 under 707

- 78; submi tted by Rohm & Haas Co., Phila delphia, Pa.; CDL:120481

- B)

97159 Rohm and Haas Company (1970) Degradation of Dithane M

- 45 in Sterile Water Systems: RAR Memorandum No. 593. (Unpublished study re ceived Jan 3, 1974 under 707

- 78; CDL:120481

- G)

00097162 Haines, L.D. (1973) The Hydrolytic Decomposition of Dithane M

- 45 at Room Temperature: Technical Report No. 3923

- 7 3

- 25. (Unpub lished study received Jan 3, 1974 under 707

- 78; submitted by Rohm and Haa s Co., Philadelphia, Pa.; CDL:120481

- K)

154985 Korotkova, O. (1976) Razlozhenie fungitsidov

-- proizvodnykh ditio

- karbaminovoy kisloty (obzor literatury) [Decomposition of such fungicides as derivatives of

### 63 dithiocarbamic acid (literature re

- view)]. Khim. Sel'sk. Khoz. 12(11):869

- 874, 1974. Abstracted in Pest. Abs. 76

- 0215.

40258201 Haines, L. (1975) Supplement to the Hydrolytic Decomposition of Dithane M

- 45 at Room Temperature: Lab Project ID: TR 3923

- 73

- 25. Unpublished study prepared by Rohm and Haas C o. 6 p.

40258202 Haines, L. (1973) The Hydrolytic Decomposition of Dithane M

- 45 at Room Temperature: Lab Project ID: 3923

- 73

- 25. Unpublished study prepared by Bristol Dev. Ag. Chem. Research. 35 p.

40381930 Haines, L. (1985) Stability of WP EBDC Spray Slurries and Rate of Ethylenethiourea Formation: Rept. No. 31L

- 85

- 11. Unpublished study prepared by Rohm and Haas Co. 60 p.

40466103 Carpenter, M. (1987) Hydrolysis as a Function of pH AT 25 ?degree| C OF ?Carbon 14|

- Ethylenethiourea: ABC Final Report No . 36287. Unpublished study prepared by Analytical Bio

- Chemistry Labs., Inc. 543 p.



# 161

- 2 Photodegradation

- water

MRID Citation Reference

147111 Yeh , S. (1985) Water Photolysis Study of Mancozeb: Technical Report No. 31L

85

- 13. Unpublished study prepared by Rohm and Haas Co. and Biospherics, Inc. 178 p.

154985 Korotkova, O. (1976) Razlozhenie fungitsidov

-- proizvodnykh ditio

- karbaminovoy kisloty (ob zor literatury) [Decomposition of such fungicides as derivatives of dithiocarbamic acid (literature review)]. Khim. Sel'sk. Khoz. 12(11):869

- 874, 1974. Abstracted in Pest. Abs. 76

- 0215

00162103 Yeh, S. (1985) Water Photolysis Study of Mancozeb: Technical Report No. 31L

85

- 13. Unpublished study prepared by Rohm and Haas Co. and Biospherics, Inc. 232 p.

40466102 Carpenter, M.; Fennessey, M. (1987) Determination of the Photolysis Rate of ?Carbon 14|

- Ethylenethiourea in pH 7 Aqueous Solution: ABC Re

- amended Final Report No. 36288. Unpublished study pre

- pared by Analytical Bio

- Chemistry Labs., Inc. 658 p.

88921 Graham, W.H.; Bornak, W.E. (1972) Greenhouse Studies with C^14I

- Ethylene Thiourea on Potatoes a nd Tomatoes and Photodecomposi tion in Water: Laborat ory 23 Res earch Report No. 23

- 52. (Unpub lished study received Dec 9, 1981 under 707

- 78; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:070525

- G)



# 161

- 3 Photodegradation

- soil

MRID Citation Reference

### 64 147112 Randazzo , D. (1985) Soil Photolysis Study of Mancozeb: Technical Report No. 31L

- 85

- 14. Unpublished study prepared by Rohm and Haas Co. 31 p.

162104 Randazzo, D. (1985) Soil Photolysis Study on Mancozeb: TR 31L

- 85

- 24. Unpublished study prepared by Rohm and Haas Co. 165 p.

40466101 Carpenter, M. (1987) Determination of the Photolysis Rate of Ethy lenethiourea (ETU) on the Surface of Soil: ABC Final Report No. 36289. Unpublished study prepared by Analytical Bio

- Chemistry Labs., Inc. 504 p.



# 162

- 1 Aerobic soil metabolism

MRID Citation Reference

88929 Fisher, J.D. (1969?) Dissipation Stu dies of Dithane M

- 45 and Ethyl ene Thiourea in Soil and Their Effects on Microbial Activity: Laboratory 11

-- Research Report No.
11

- 223. (Unpublished study received Dec 9, 1981 under 707

- 78; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:070527

- C)

162105 Randazzo, D. (1986) Aerobic and Anae robic Soil Metabolism of Manco zeb: Technical Report No. 310

- 86

- 23. Unpublished study prepared by Rohm and Haas Co. 467 p.

40838701 Schweitzer, M. (1988) Response to the U.S. EPA Review of the Mancozeb Aerobic Soil Metabolism Study: Techni cal Report No. 34C

- 88

- 53. Unpublished study prepared by Rohm and Haas Co. 18 p.

45145201 Wright, M. (2000) Aerobic Soil Metabolism of (carbon

- 14) Mancozeb in Soil: Lab Project Number: XBL 99041: RPT00605. Unpublished study prepared by XenoBiotic Laborato ries, Inc. 157 p.

45744501 Volkel, W. (2001) Degradation Rate of (Carbon 14)

- Mancozeb in Three Soils Incubated Under Aerobic Conditions: Lab Project Number: 773346: TR34

- 01

- 03. Unpublished study prepared by RCC Ltd. 32 p.

87575 Rohm and Haas Company (1 967) Persistence of Dithane M

- 45 Residues in Soil. (Unpublished study, including letter dated Jun 21, 1967 from W.E. Bornak to E.M. Swisher, received Dec 9, 1981 under 707

- 78; CDL:070521

- A)

93257 Rohm & Haas Company (1965) Interim Report: First Year Study of the Persistence of Rohm & Haas Pesticides in Soil under Normal Use Conditions. (Unpublished study received Nov 2, 1965 under 6F0476; CDL:090532

- D)



# 162

- 2 Anaerobic soil metabolism

MRID Citation Reference

162105 Randazzo, D. (1986) Aerobic and Anae robic Soil Metabolism of Manco zeb: Technical Report No. 310

- 86

- 23. Unpublished study prepared by Rohm and Haas Co. 467 p.

### 65 41177101 Olson, G.; Kesterson, A.; Lawrence, L. (1989) Anaerobic Metabolism of ?Carbon 14|Mancozeb in Silt Loam Soil: Report No. 1198: Project No. 272. Unpublished study prepared by Pharmacology and Toxicology Research Laboratory. 65 p.



# 162

- 3 Anaerobic aqu atic metabolism

MRID Citation Reference

88820 Swan, L.H. (1978) Degradation of Dithane M

- 45 (Mancozeb) and Ethylenethiourea under Anaerobic Aquatic Conditions: TR 34F

- 78

- 6. Includes method 1853

- 1 dated Jul 19, 1973. (Unpublished study received Dec 9, 1981 under 707

- 78; submitted by Rohm & Haas Co., P hiladelphia, Pa.; CDL:070528

- A)

88916 Rohm and Haas Company (1970) Degradation of Dithane M

- 45 in Sterile Water Systems: RAR Memorandum No. 593. (Unpublished study received Dec 9, 1981 under 707

- 78; CDL:070525

- B)

40258203 Swan, L. (1978) Supplement to the Degradation of Dithane M

- 45 and ETU under Anaerobic Aquatic Conditions: Lab Project ID: TR 34F

- 78

- 06. Prepared by Rohm and Haas Co. 5 p.

45945101 Muller

- Kallert, H. (1994) (Carbon 14)

- Mancozeb: Degradation and Metabolism in Aquatic Systems: Lab Proje ct Number: RCC PROJECT 317970: 317970. Unpublished study prepared by RCC Umweltchemie Ag. 156 p.



# 162

- 4 Aerobic aquatic metabolism

MRID Citation Reference

45945101 Muller

- Kallert , H. (1994) (Carbon 14)

- Mancozeb: Degradation and Metabolism in Aquatic Systems: Lab Project Number: RCC PROJECT 317970: 317970. Unpublished study prepared by RCC Umweltchemie Ag. 156 p.

46204301 Volkel , W. (1995) (14C)

- Mancozeb: Degradation and Metabolism in Aquatic Systems. Project Number: 361462. Unpublished study prepared by RCC Umweltchemie Ag. 156 p.

88920 Rohm and Haas Company (19??) Degradation of C^14I Ethylene Thiourea in Water: TR 23

- 71

- 22. ( Unpublished study received Dec 9, 1981 under 707

- 78; CDL:070525

- F)

45744501 Volkel, W. (2001) Degradation Rate of [14C]

- MANCOZEB in Three Soils Incubated Under Aerobic Conditions. Unpublished Study Performed by RCC Ltd., Itingen, Switzerland; Sponsored a nd Submitted by Rohm and Haas Company, Spring House, PA. RCC Study No. 773346, Report No. TR34

- 01

- 03. Experiment initiated August 29, 2000 and Completed January 26, 2001 (p.8). Final Report Issued January 31, 2001.



# 163

- 1 Leach/adsorption/desorption

### 66 MRID Citation Reference

65531 Adler, I.L. (1971) A Study of the Leaching of C^14I

- Dithane M

- 45 and/or Metabolites in Soil: Laboratory 23 Research Report 23

- 31. (Unpublished study received Apr 26, 1974 under 707

- 78; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:224658

- A)

88821 Rohm and Haas Company (19??) Soil Adsorption Studies with C^14I Ethylene Thiourea: Tech. Rept. #23

- 71

- 19. (Unpublished study received Dec 9, 1981 under
707

- 78; CDL:070528

- C)

88822 Rohm and Haas Company (19??) Soil Adsorption Studies with C^14I Dithane M

45: Tech. Rept. #23

- 71

- 20. (Unpublished study re

- ceived Dec 9, 1981 under 707

- 78; CDL:070528

- D)

88925 Adler, I.L. (1972) Decomposition of Ethylene Thiourea Residues under Field Co nditions: TR 23

- 72

- 31. (Unpublished study, in cluding letter dated Sep 26, 1972 from I.L. Adler to W.R. Lyman, received Dec 9, 1981 under 707

- 78; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:070525

- L)

97154 OR
77154 Satterthwaite , S.T. (19??) Laboratory Soil Runoff Study with ^14IC Dithane M

- 45: Laboratory 11 Metabolism Group Memorandum Report No. 29. (Unpublished study received Jan 3, 1974 under 707

- 78; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:120481

- A)

97157 Rohm a nd Haas Company (19??) Soil Adsorption Studies with C^14I Dithane M

45: Laboratory 23 Technical Report No. 23

- 71

- 20. (Un

- published study received Jan 3, 1974 under 707

- 78; CDL:120481

- E)

97158 Rohm and Haas Company (19??) Soil Adsorption Studies with C^1 4I Ethylene Thiourea: Laboratory 23 Technical Report No. 23

- 71

- 19. (Unpublished study received Jan 3, 1974 under 707

- 78; CDL: 120481

- F)

146370 Rohm And Haas Co. (19??) Soil Adsorption Studies With (carbon

- 14) Dithane M

45: Report No. 23

- 71

- 20. Unpublishe d study. 10 p.

40222901 Yeh, S. (1986) Batch Soil Adsorpti on/Desorption of Mancozeb: Bio spherics No. 86E204AD; Technical Report No. 310

- 86

- 62. Unpub lished study prepared by Biospherics, Inc. 143 p.

40222902 Yeh , S. (1986) Batch Soil Adsorption/Desorption of Ethylenethio

- urea (ETU): [Mancozeb Supplement]: Biospherics No. 86E205AD; Technical Report No. 310

- 86

- 63. Unpublished study prepared by Biospherics, Inc. 100 p.

40588302 40588301 Schweitzer, M. (1988) Leac hing Characteristics of Soil Incorporated Mancozeb following Aerobic Aging: Technical Report: 34C

- 88

- 26. Unpublished study prepared by A nalytical Bio

- Chemistry Labora tories, Inc. 547 p.

-



# 164

- 1 Terrestrial field dissipation

MRID Citation Reference

### 67 71625 Nixon, W.B. (1981) Tank Mix Soil Dissipation Studies: Ridomil^(R)I/ Bravo^(R)I; Ridomil^(R)I/Difolatan^(R)I; Ridomil^(R)I/Dithane M

- 45^(R)I: Report No. EIR

81003. (Unpublished study received Apr 15, 1981 under 100

- 607; submitt ed by Ciba

- Geigy Corp., Greens boro, N.C.; CDL:070010

- A)

71627 Ciba

- Geigy Corporation (1980) ?Tank Mix Soil Dissipation Studies with Various Chemicals|: AG

- A 4801 I, II A. (Compilation; unpublished study, including AG

- A 4801 I, II, III, 2nd Report A, 4802 I, II, III, 4802 I, II, III, Second Report B..., received Apr 15, 1981 under 100

- 607; CDL:070010

- E)

87576 Rohm & Haas Company (1977) A Summary of the Results of Analysis of Soil and Water Samples for Residues Due to Dithane M

- 45: TR 34F

- 77

- 03. (Compilation; unpublished study received Dec 9, 1981 under 707

- 78; CDL:070521

- B; 070522)

140829 Rohm and Haas Company (19 77) ?Dithane M

- 45 Residues in Soil|. (Compilation; unpublished study received Dec 9, 1981 under 707

- 78; CDL:070523

- A; 070524)

148126 Bornak, W. (1967) Persistence of Dithane M

- 45 Residues in Soil: Report No. 526. Unpublished study prepared by Rohm and H aas Co. 14 p.

40923601 Schweitzer, M.; Zogorski, W. (1988) Manco zeb Terrestrial Field Dis sipation: Technical Report No. 34C

- 88

- 54. Unpublished study prepared by Rohm and Haas Co., i n cooperation with Pan

- Agricul tural Associates and Environ

- Bio

- Tech, Ltd. 630 p.

44524101 Esterly, D. (1998) Recalculation of the ETU Soil Half

- Life in California Soil Dissipation Studies of Mancozeb Supplement No. 1 to MRID 40923601: Lab Project Number: MTF

- 98

- 02. Unpublished study prepared by E.I. du Pont de Nemours and Co. 43 p.

44996201 Babbit, B.; Kleiner, A.; Lennon, G. (1999) Dissipation of Soil Residues of Dimethomorph: Lab Project Number: RES 99

- 073. 02: RES 99

- 081: RES 97

- 012. Unpublished study prepared by American Cyanamid Co. 593 p.

97156 Fisher, J.D. (1969) Di ssipation S tudies of Dithane M

- 45 and Eth ylene Thiourea in Soil and Their Effects on Microbial Activity: Laboratory 11

-- Research Report No.
11

- 223. (Unpublished study received Jan 3, 1974 under 707

- 78; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:1 20481

- D)



# 164

- 2 Aquatic field dissipation

MRID Citation Reference

87576 Rohm & Haas Company (1977) A Summary of the Results of Analysis of Soil and Water Samples for Residues Due to Dithane M

- 45: TR 34F

- 77

- 03. (Compilation; unpublished study received Dec 9, 1981 under 707

- 78; CDL:070521

- B; 070522)

140829 Rohm and Haas Company (19 77) ?Dithane M

- 45 Residues in Soil|. (Compilation; unpublished study received Dec 9, 1981 under 707

- 78; CDL:070523

- A; 070524)



# 165

- 1 Confined rotational crop

MRID Citation Reference

### 68 44621901 Robinson, R.; Hanauer , R. (1998) (Carbon 14)

- RH

- 3866: Confined Rotational Crop Study: Lab Project Number: RPT00399: XBL96026: 34P

- 96

- 27A. Unpublished study prepared by XenoBiotic Labs., Inc., Centre Analytical Labs., Inc. and American Agricultural Services, Inc. 600 p.



# 165

- 2 Field rotational crop

MRID Citation Reference

45709501 Winkler, V.; Chisholm, K. (2002) Rotational Crop Plant Back Interval (PBI) Restrictions for Moncut Fungicide Use on Potatoes: Lab Project Number: R

- 3052: VW030602: E642.03

- 87. Unpubl ished study prepared by Gowan Co. 21 p. {OPPTS 860.1900} 

# 166

- 2 Ground water

- small retrospective

MRID Citation Reference

45708301 or 46145401 (2003) Bedosky , S. (2002) EBDC/ETU Task Force National Drinking Water Monitoring Survey: Lab Project Number: ETU

- 0201: 6942: ETU

- 2000

- 01. Unpublished study prepared by LFR Levine

- Fricke. 353 p.



# Non

- Guideline Studies

MRID Citation Reference

4334 Rohm & Haas Company (1964) Interim Report: First Year Study of the Persistence of Rohm & Haas Pesticides in Soil under Normal Use Conditions. (Unpublished study received Jan 28, 1966 under 6F0472; CDL:090524

- AB)

88928 Doneche, B.; Sequin, G. (1976) Degr adation of Mancozebe (Coordina tion Product of Zinc Ion with Manganese Ethylene

- bis

- dithiocar

- bamate: MBL

- 1756. Translation of: La degradation du mancozebe (produit de coordination de l'ion zinc avec l'ethylene

bis

- di

- thiocarbamate de manganese). Academie des Sc iences. Comptes Rendus Hebdomadaires des Seances 280(May 21):2265

- 2268. (Unpub lished study received Dec 9, 1981 under 707

- 78; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:070527

- B)

88927 Adler, I.L. (1973) Ethylenethiourea Levels in Dithane M

- 45 Spray Slurries and Spray Deposits: TR 23

- 73

- 20. (Unpublished study, including letter dated Jun 28, 1973 from I.L. Adler to W.R. Lyman, received Dec 9, 1981 under 707

- 78; submitted by Rohm & Haas Co ., Philadelphia, Pa.; CDL:070527

- A)

129284 Haines, L.; Burnett, T.; Wilson, D. (1982) The Octanol/Water Partition Coefficients of Dithane M

- 45, M

- 2 2, Z078 and Ethy lenethiourea: Technical Report No. 31F

- 82

- 26.

### 69 (Unpublished study received May 13, 1983 unde r 707

- 78; submitted by Rohm & Haas Co., Philadelphia, PA; CDL:071597

- B)

41841901 Weeks, J. (1990) Simulation of the Environmental Fate of Mancozeb and Its Degradation Product ETU U nder Conditions of Use in Cali fornia: Lab Project Number: JO

- 9 1

- 78. Unpubl ished study prepar ed by Labat

- Anderson, Inc. 179 p.

44418601 Carbone, J.; Hurt, S. (1997) Geneec Modeling of Surface Water Concentrations of Mancozeb and ETU and Preliminary Drinking Water Risk Assessment: Lab Project Number: 97R

- 1100. Unpublished study prepared by Rohm and Haas Co. 30 p.

46145401 Bedosky, S. (2003) EBDC/ETU Task Force National Drinking Water Monitoring Survey:Final Report. Project Number: ETU/2000/01, ETU/0301, 004/06942/04. Unpublished study prepared by Levine

- Fricke, Inc., Enviro

- Tes t Laboratories (ETL), and Morse Laboratories. 572 p.

47434901 Diepenhorst, P. (1996) Validation of the Analytical Method DLA

- 206.5 Penncozeb 80 WP, Determination of Active Ingredient. Project Number: ATO/DL/96/010, ATO/DL/96/008. Unpublished study prepare d by Elf Atochem Agri B.V. 38 p.



## ETU Studies PC Code 600016 : MRID No. (DER file reference )

Hydrolysis

404661

- 03 Carpenter, M. (1987) Hydrolysis as a Function of pH AT 25? Degrees C OF ?Carbon 14|

- Ethylenethiourea: ABC Final Report No. 36287. Unpublished study prepared by Analytical Bio

- Chemistry Labs., Inc. 543 p.

Photolysis in Water

404661

- 02 (2082324) Carpenter, M.; Fennessey, M. (1987) Determination of the Photolysis Rate of ?Carbon 14|

- E thylenethiourea in pH 7 Aqueous Solution: ABC Re

- amended Final Report No. 36288. Unpublished study pre

- pared by Analytical Bio

- Chemistry Labs., Inc. 658 p.

Photolysis on Soil

404661

- 01 (2082324) Carpenter, M. (1987) Determination of the Photolysis Rate of Ethylenethiourea (ETU) on the Surface of Soil: ABC Final Report No. 36289. Unpublished study prepared by Analytical Bio

- Chemistry Labs., Inc. 504 p.

Aerobic Soil Metabolism

452251

- 01 Wright, M. (2000) Aerobic Soil Metabolism Degradation Rate Determination for Ethylenethiourea (ETU) on Soil: Lab Project Number: XBL 99045: RPT00643: AR98197. Unpublished study prepared by Xenobiotic Labs., Inc. 160 p.

4515464

- 01 Wright, M. (2000) Aerobic Soil Metabolism Degradation for Ethylemethiourea (ETU) on Soil: Report of Degradation Rate Determination for ETU on New York Silt Loam Soil at 70% and 40% Normal Moisture Holding Capacity and 25 (degrees) C: Lab Project Number: XBL 99045: RPT00598: KP

- 98

- 39. Unpublished study prepared by XenoBiotic Laboratories. 123 p.01

- Jun

- 2000

### 70 Volatility

- Laboratory

42301501 Obrist, J. (1992) Laboratory Volatility Studies on ?carbon 14|

- ETU: Final Report: Lab Project Number: HLA 6101

- 109. Unpublished study prepared by Hazleton Laboratories America, Inc. 24 p. 04

- May

- 1992

ECMs and ILVs

448804

- 01 Bruns, G.; Tauber, R.; Gottschalk, R. (1999) Validation of the Method of Analysis for Ethylenethiourea (ETU) in Water by LC/MS/MS: Lab Project Number: ETU01ETL: ETL99RH01.PRO: 99RHC42.REP. Unpublished study prepared by Enviro

- Test Laboratories. 146 p.

451514

- 01 Connolly, P. (2000) Independent Laboratory Analytical Method: Method for the Analysis of Ethylenethiourea (ETU) in Water by LC/MS/MS (MS 178.00) Revision 2: Lab Project Number: 002

- 342: 00P

- 002

- 342: MS 178.00. Unpublished st udy prepared by Centre Analytical Laboratories, Inc. 88 p. {OPPTS 850.7100}

Monitoring Data

45570301 Bedosky, S. (2001) EBDC/ETU Task Force National Drinking Water Monitoring Survey: Lab Project Number: ETU

- 2000

- 01: ETU

- 0101: 6942. Unpublished study prep ared by LFR Levine Fricke. 394 p. 21

- Dec

- 2001

45708301 Bedosky, S. (2002) EBDC/ETU Task Force National Drinking Water Monitoring Survey: Lab Project Number: ETU

- 0201: 6942: ETU

- 2000

- 01. Unpublished study prepared by LFR Levine

- Fricke. 353 p. 28

- Jun

- 2002

45836401 Bedosky, S. (2002) EBDC/ETU Task Force National Drinking Water Monitoring Study: Interim Report: Lab Project Number: ETU

- 2000

- 01: ETU

- 0202: 6942. Unpublished study prepared by LFR Levine

- Fricke, Enviro

- Test Laboratories, and Morse Laboratories 3 66 p. 13

- Jan

2003

46145401 Bedosky, S. (2003) EBDC/ETU Task Force National Drinking Water Monitoring Survey:Final Report. Project Number: ETU/2000/01, ETU/0301, 004/06942/04. Unpublished study prepared by Levine

- Fricke, Inc., Enviro

- Test Laboratories (ET L), and Morse Laboratories. 572 p.
05

- Dec

- 2003

46319901 Ollinger, J. (2004) EBDC/ETU Task Force Response to U.S. EPA's Draft Science Chapter for the Environmental Fate and Ecological Risk Assessment for Ethylenethiourea (ETU) Dated June 2, 2004. Project Number: EBDC/FQPA/2004/01. 38 p. 15

- Jul

- 2004

46480002 Ollinger, J. (2005) EBDC/ETU Task Force Response to U.S. EPA's Draft Science Chapter for the Environmental Fate and Ecological Risk Assessment for Ethylenethiourea (ETU) Dated October 20, 2004. Projec t Number: EBDC/FQPA/2005/01. Unpublished study prepared by EBDC/ETU Task Force. 24 p. 23

- Feb

- 2005

### 71 

# 054401 Mancozeb Eco Effects Bibliography

850.2100 71

- 1 Avian Single Dose Oral Toxicity

36094 three species treated

– 3 products Robinson, D.; Shillam, K.W.G. (1966) Toxicity of Dithane S.35, Di

- thane M.45 and Stam F.34 to Wild Birds: Report No. 1694/66/222. (Unpublished study received Jun 11, 1970 under 0F0932; prepared by Huntingdon Research Centre, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:091587

- U)

80717 Harper, K.H.; Palmer, A.K. (1965) Toxicity of Dithane M

- 45 to the Japanese Quail (~Conturnix japonica~): 1152/65/69. (Unpub lished study received Nov 9, 1965 under 6F0467; prepared by Huntingdon Research Centre, England, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:090519

- C)

48515401 Hubbard, P.; Beavers, J. (2011) Mancozeb (Dithane M45): An Acute Oral Toxicity Study with the Canary (Serinus canaria). Project Number: 422/103, 2010/5. Unpublished study prepared by Wildlife International, Ltd. 63 p.



## 850.2200 71

- 2 Avian Dietary Toxicity

80716 Harper, K.H.; Palmer, A.K. (1964) Toxicity of Dithane M 45 to the M allard Duck: 1000/64/215:2. (Unpublished study received Nov 9, 1965 under 6F0467; prepared by
H untingdon Research Centre, Eng land, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL: 090519

- B)

80717 Harper, K.H.; Palmer, A.K. (1965) Toxicity of Dithane M

- 45 to the Japanese Quail (~Conturnix japonica~): 1152/65/69. (Unpub lished study received Nov 9, 1965 under 6F0467; prepared by Huntingdon Research Centre, England, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:090519

- C)

98649 or 129287 Harper, K.H.; Palmer, A.K. (1965) Toxicity of Dithane M.45 to the Japanese Quail (?~Coturnix japonica~?): 1152/65/69. (Unpublished study received Sep 8, 1965 under
707

- 78; prepared by Huntington Research Centre, England, submitted by Rohm & Haas Co., Phila delphia, Pa.; CDL:131575

- A)



## 850.2300 71

- 4 Avian Reproduction

41566701 Hakin, B; Norman, A. (1990) The Effe ct of Dietary Inclusion of Man cozeb on Reproduction in the Mallard Duck: Lab Project Number: HRC 59/89384: R&H 88RC

0096. Unp ublished s tudy prepared by Hun tingdon Research Centre, Ltd. 195 p.

41566702 Hakin, B. ; Norman, A. ; Chanter, D. (1990) The Effect of Dietary Inclusion of Mancozeb on Reproduction in the Bobwhite Quail: Lab Project Number: HRC 60/89385: R&H 88RC

- 0102. Unpublished study prepared by Huntingdon Research Centre, Ltd. 333 p.

41936801 Milligan, D. (1991) The Effect of Dietary Inclusion of Mancozeb on Reproduction in the Mallard: Total Production Results by Pen: Lab Project Number: 88RC

- 096A. Unpublished study prepared by Huntingdon Research Centre Ltd. 11 p.

41948401 Beavers, J.B., G. Marselas, G.J. Smith and M.J. Jaber (1991) Mancozeb: A One

Generation Reproduction Study with the Mallard (Anas platyrhynchos). Prepared by

### 72 Wildlife International Ltd., Easton, MD. Laboratory Project No. 129

- 144 . Submitted by
Rohm and Haa s Company, Spring House, PA.

41936802 Milligan, D. (1991) The Effect of Dietary Inclusion of Mancozeb in the Bobwhite Quail: Total Product ion Results by Pens: Lab Proje ct Number: 88RC

- 102A. Unpublished study prepared by Huntingdon Research Centre, Ltd. 17 p.

42957501 Cameron, D. (1993) The Effect of Dietary Inclusion of Mancozeb on Reproduction in the Bobwhite Quail: Lab Project Number: 60/89385: 88RC

- 102B. Unpublished study prepared by Huntingdon Research Centre Ltd. 10 p.

43473401 Beavers, J.; Marsel as, G.; Smith, G.; et al. (1994) Mancozeb: A One

- generation Reproduction Study with the Mallard (Anas platyrhynchos): Supplement II: Lab Project Number: 89RC

- 0152C : 129

- 144. Unpublished study prepared by Wildlife International Ltd. 12 p.

44159501 Mitchel l, L.; Haberlein, D.; Beavers, J. et al. (1996) Mancozeb (Dithane): A Reproduction Study with the Northern Bobwhite (Colinus virginianus): Amended: Lab Project Number:
422

- 101. Unpublished study prepared by Wildlife International Ltd. 219 p.

44238001 Pel frene, A. (1997) Mancozeb: Reproduction in the Bobwhite Quail: Reissued Report: Lab Project Number: PWT 99/920944: PWT 99. Unpublished study prepared by Huntingdon Life Sciences Ltd. 383 p.



## 850.1075 72

- 1 Acute Toxicity to Freshwater Fish

80718 Harper, K.H.; Ball, I.R.; O'Neill, K.J. (1965) The Acute Toxicity of a Fungicide, Dithane
M

- 45, to the Rainbow Trout,~Salmo~ ?~gairdnerii~Richardson, a Cold Water Fish: 1233/65/150 . (Un

- published study received Nov 9, 1965 under 6F0467; prepared by Hunti ngdon Research Centre, England, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:090519

- D)

80719 Harper, K.H.; Ball, I.R. (1965) The Acute Toxicity of a Fungicide, Dithane M

- 45, to the Goldfish, ~Carassius auratus~: 1305/65/22. (Unpublished study rec eived Nov 9, 1965 under 6F0467; prepared by Huntingdon Research Centre, England, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:090519

- E)

85459 Harper, K.H.; Ball, I.R. (1965) The Acute Toxicity of a Fungicide, Dithane M

- 45, to the Catfish,~Ictalur us nebulosus~: 1377/65/ 295. (Unpublished study received Nov 9, 1965 under 6F0467; pre

- pared by Huntingdon Research Centre, England, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:090519

- F)

97100 Harper, K.H.; Ball, I.R. (1965) The Acute Toxicity of a Fungicide, Dithane M

- 45, to the Catfish~Ictalurus nebulosus~?: 1377/65/295. (Unpublished study received Jan 10, 1969 under 707

- 93; prepared by Huntingdon Research Centre, England, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:004348

- F)

97101 Harper, K.H.; Ball, I.R. (1965) The Acute Toxicity of a Fungicide, Dithane M

- 45, to the Rainbow Trout~Salmo gairdnerii~Richardson, a Cold Water Fish: 1233/65/150

. (Unpublished study received Jan 10, 1969 under 707

- 93; prepared by Huntingdon Research Cen

- t re, England, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:004348

- G)

97147 McCann, J.A. (1967) ?Ditahane M

- 45: Bluegill (?~Lepomis macrochirus ): Test Nos. 58 & 55. (U.S. Agricultural Research Service, Pesticides Regulation Div., Animal Biology Lab oratory; unpublished study; CDL:108279

- A)

### 73 97173 McCann, J.A.; Pitcher, F. (1973) ?Dith ane M

- 45: Bluegill (?~Lepomis macrochirus )|: Test No . 544. (U.S. Environmental Pro tection Agency, Pesticides Regula tion Div., Animal Biology Labo ratory; unpublished stu dy; CDL:128295

- A)

40118501 US EPA (1980) Biological Report of Analysis of Dithane

- 45; 96

- hour LC50 (Bluegill): Static Jar Test 2444. Unpublished study prepared by Terrestrial and Aquatic Biology Laboratory. 5 p.

118502 US EPA (1980) Biological Report of Analysis of Dithane

- 45; 96

- hour LC50 (Rainbow Trout): Static Jar Test 2447. Unpublished study prepared by Terrestrial and Aquatic Biology Laboratory. 5 p.

40467501 Bowman, J. (1987) Acute Toxicity of Dithane Flowable (F 45) to Rainbow Trout (Salmo gairdneri): Final Report: ABC Laboratory Project ID #36281: Rohm and Ha as Report No. 87RC

- 0056. Unpub lished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 17 p.

43917215 Toy, R. (1991) CME 151/Mancozeb 90/600 g/ kg WP (SYS50586): Acute Toxicity to Salmo Gairdneri and Daphnia magna: Lab Project Number: SBGR.90.159: 4467. Unpublished study prepared by Shell Research Ltd. 37 p.

43917216 mixture Toy, R.; Gray, A. (1991) Dimethomorph: CME 151/Mancozeb 90/600 g/kg WP (SYS50579): Acute Toxicity to Oncorhynchus mykiss and Daphnia magna: Lab Project Number: SBGR.90.250: 4901. Unpublished study prepared by Shell Research Ltd. 34 p.

43917217 mixture Toy, R.; Gray, A. (1992) Dimethomorph: Acute Toxicity of Dimethomorph/Man cozeb 75/667 g/kg WP (SYS50588 R) to Oncorhynchus mykiss, Daphnia magna and Selenastrum capricornutum: Lab Project Number: SBGR.92.177: 5640. Unpublished study prepared by Shell Research Ltd. 42 p.

44950503 Rhodes, J.; Bucksath, J. (1998) Acute Flow

- Thro ugh Toxicity of Dithane/RH

- 117,281 DG Blend to Rainbow Trout (Oncorhynchus mykiss): Lab Project Number: 43357: 97RC

0128: 95P

- 278. Unpublished study prepared by ABC Laboratories, Inc. 110 p.

45934701 Rhodes, J. (2000) Acute Toxicity of Dithane M

- 45 to the Rainbow Trout (Oncorhynchus mykiss) Determined Under Flow

- Through Test Conditions: Lab Project Number: 46040: 00RC

- 0114. Unpublished study prepared by ABC Laboratories, Inc. 77 p. {OPPTS 850.1075}

4 5934702 Rhodes, J. (2000) Acute Toxicity of Dithane M

- 45 to the Bluegill Sunfish (Lepomis macrochirus) Determined Under Flow

- Through Test Conditions: Lab Project Number: 46041: 00RC

- 0115. Unpublished study prepared by ABC Laboratories, Inc. 75 p. {OPPTS 85 0.1075}

46020903 45910401 Zok, R. (2001) Acute Toxicity Study on the Rainbow Trout (Oncorhynchus mykiss Walbaum 1792) in a Static System (96 Hours). Project Number: 12F0533/005042, 146099. Unpublished study prepared by BASF Aktiengesellschaft. 43 p.

461 61001 Douglas, M.; Handley, J.; Macdonald, I. (1987) The Acute Toxicity of Mancozeb Technical to Rainbow Trout (Salmo gairdneri). Project Number: PWT/63/B/88167. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 24 p.

46023701 Wuthrich, M. (199 3) Dithane DG: 21

- Day Prolonged Toxicity Study in the Rainbow Trout Under Flow

- Through Conditions. Project Number: 336060, 93/RC/1021. Unpublished study prepared by RCC Umweltchemie Ag. 67 p.

46056401 Dickson, J.; Knight, B. (1998) Dithane/RH

- 7281 80 EP (10:1): Determination of Acute Toxicity (LC50) to Rainbow Trout (96h, Continous Flow). Project Number: 16697,

### 74 97RC/0214, 392008. Unpublished study prepared by Inveresk Research International. 42 p.

4681 8701 Jatzek, J. (2006) BAS 551 09 F: Acute Toxicity Study on the Rainbow Trout (Onchorhynchus mykiss) in a Static System over 96 Hours. Project Number: 12F0411/045074, 2006/1010690. Unpublished study prepared by BASF Aktiengesellschaft, Experimental Toxico logy and Ecology. 45 p.

5001997 Hashimoto, Y., J. Fukami (1969) Toxiocity of Orally and Topically Applied Pesticide Ingredients to Carp, Cyprinus carpio Linne. Botyu

- Kagaku . Scientific Pest Control. 34(2): 6366.

47729301 Kramer, V. (2009) Rationale for Classification of Existing Sheepshead Minnow Acute Toxicity Studies as Core MRID No. 41844901 and Bluegill Acute Toxicity Study as Core: MRID No. 45934702. Project Number: MZTF/2009/01, 96R/1010. Unpublished study prepared b y Dow AgroSciences, LLC. 31 p.



## Non Guideline Fish Acute Toxicity

46144601 Madsen, T. (2002) Mancozeb: Static Acute Toxicity Tests Conducted with Ten Species of Freshwater Fish Exposed in a Sediment

- Water System. Project Number: 47737. Unpublished study prepared by Analytical Bio

- Chemistry Labs, Inc. 120 p.



## 72

- 2 Acute Toxicity to Freshwater Invertebrates

40118503 US EPA (1980) Biological Report of Analysis of Dithane

- 45; 48

- hour EC50 (Daphnia magna): Jar Test 2460. Unpublished study prepared by Terrestrial and Aquatic Biology Laboratory. 3

40467502 Forbis, A. (1987) Acute Toxicity of Dithane Flowable (F

- 45) to Da phnia magna: Final Report: ABC Laboratory Project ID #36282: Rohm and Haas Report #87RC

0041. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 17 p.

40467503 Forbis, A. (1987) Acute Toxicity of Dithane M

- 45 Fungicide to Daphnia m agna: Final Report: ABC Laboratory Project ID #36322: Rohm and Haas Report #87RC

0044. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 16 p.

43917215 Toy, R. (1991) CME 151/Mancozeb 90/600 g/kg WP (SYS50586): Acute Toxicity to S almo Gairdneri and Daphnia magna: Lab Project Number: SBGR.90.159: 4467. Unpublished study prepared by Shell Research Ltd. 37 p.

43917216 Toy, R.; Gray, A. (1991) Dimethomorph: CME 151/Mancozeb 90/600 g/kg WP (SYS50579): Acute Toxicity to Oncorhynchus my kiss and Daphnia magna: Lab Project Number: SBGR.90.250: 4901. Unpublished study prepared by Shell Research Ltd. 34 p.

43917217 Toy, R.; Gray, A. (1992) Dimethomorph: Acute Toxicity of Dimethomorph/Mancozeb 75/667 g/kg WP (SYS50588 R) to Oncorhynchus myk iss, Daphnia magna and Selenastrum capricornutum: Lab Project Number: SBGR.92.177: 5640. Unpublished study prepared by Shell Research Ltd. 42 p.

### 75 44950502 Madsen, T.; Leak, T. (1998) Acute Toxicity of Dithane/RH

- 117,281 DG Blend to Daphnia magna: Lab Proj ect Number: 44179

- 97: 97RC

- 0068. Unpublished study prepared by ABC Laboratories, Inc. 79 p.

45934703 Rhodes, J. (2001) Acute Toxicity of IR6141 M to the Water Flea, Daphnia magna, Under Flow

- Through Test Conditions: Lab Project Number: 43612. Unpublished study prepared by ABC Laboratories, Inc. 62 p. {OPPTS 850.1010}

46020901 Hisgen , M. (2003) Reg No. 146099: Determination of the Acute Effect on the Swimming Ability of the Water Flea Daphnia Magna Straus: Final Report. Project Number: 00/0533/50/1. Unpublished study prepared by BASF Aktiengesellschaft. 25 p.

46096901 Mancozeb + Zoxa mide Buchanan, J.; Knight, B.; Dickson, J. (1998) Dithane/RH

- 7281 80WP (10:1): Determination of Acute Toxicity (EC50) to Daphnia (48h, Continuous Flow). Project Number: 16564, 97RC/0215, 392029. Unpublished study prepared by Inveresk Research International. 42 p.

46656601 Slabbert. J.L. (1994) Determination of the Acute Toxicity of Sanachem Technical Mancozeb (sancozeb) to the Water Flea (Daphnia pulex). Division of Water Technology. CSIR, Building 21, Pretoria, South Africa, Laboratory Report Number: 0003D, Submitted by Dow Chemical Co., Study ID:0003D, Full Study Completion Date: May 11 through May 27, 1994.



## 850.1735 Whole sediment: acute freshwater invertebrates

47410101 Hughes, C. (2007) Mancozeb: Whole Sediment Acute Toxicity Test with Midge Larvae (Chironomus dilutus): Amended Final Report. Project Number: 60700, 2005/02. Unpublished study prepared by ABC Laboratories, Inc. 70 p.

47410102 Hughes, C. (2008) Non

- Extractable Residues of Mancozeb: Whole Sediment Acute Toxicity Test w ith Midge Larvae (Chironomus dilutus). Project Number: 60701, 2005/01, RS/19750. Unpublished study prepared by ABC Laboratories, Inc. 80 p.



## 72

- 3 Acute Toxicity to Estuarine/Marine Invertebrates

97161 Bentley, R.E. (1973) Acute Toxicity of Dithane M

- 45 to Grass Shrimp (Palaemonetes vulgaris) and Fiddler Crab (Uca pugilator). (Unpublished study received Jan 3, 1974 under 707

- 78; prepared by Bionomics, Inc., submitted by Rohm & Haas Co., Philadelphia, Pa .; CDL:120481

- J)

40586801 Ward, G. (1988) Acute Toxicity of Dithane M

- 45 Fungicide to Mysid Shrimp (Mysidopsis bahia) under Static Conditions: Rohm and Haas Company Protocol No. 87P

- 258: Rohm and Haas Report No. 87RC

- 0065. Unpublished study prepared by Environmental Science and Engineering, Inc. 49 p.

40586802 Ward, G. (1988) Acute Toxicity of Dithane M

- 45 Fungicide to Sheepshead Minnow (Cyprinodon variegatus) under Static Conditions: ESE No. 87369

- 0200

- 2130. Unpublished study prepared by Environmental Science and Engineering, Inc. 45 p.

40586803 Ward, G. (1988) Acute Toxicity of Dithane Flowable F

- 45 to Mysid Shrimp (Mysidopsis bahia) under Static Conditions: Laboratory Project ID ESE No. 87369

- 0500

- 2130. Unpublished study prepared by Environmental S cience and Engineering, Inc. 50 p.

### 76 40885101 Manning, C. (1988) Dithane F

- 45: Acute Toxicity on Shell Growth of the Eastern Oyster (Crassostrea virginica): ESE No. 89328

- 0300

- 2130: 88RC

- 0049. Unpublished study prepared bt Environmental Science and Engine ering, Inc. 409
p.

40885102 Manning, C. (1988) Dithane M

- 45: Acute Toxicity on Shell Growth of the Eastern Oyster (Crassostrea virginica): ESE No. 89328

- 0200

- 2130: 88RC

- 0048. Unpublished study prepared by Environmental Science and Engineering, Inc. 421
p.

41822901 Scott Ward, G.; Leak, T. (1990) Acute Toxicity of Dithane M

- 45 Fungicide to Mysids (Mysidopsis b ahia) Under Flow

- through Condi tions: Lab Project Number: 893 28

- 0500

- 2130: 88RC

- 0069. Unpub lished study prepared by Hunter/ESE, Inc. 288 p.

41822902 Ward, G.S. and T. Leak (1990) Acute Toxicity of Dithane ® F

- 45 Fungicide to Mysids (Mysidopsis bahia) Under Flow

- Through Conditions. Laboratory Project ID.
89328

- 0600

- 2130. Rohm and Haas Report No. 88RC

- 0073. Prepared by Hunter/ESE, Inc., Gainesvi lle, Fl. Submitted by Rohm and Haas Company, Spring House, PA.


## 850.1740 Whole sediment: acute marine invertebrates

47499601 Aufderheide, J. (2008) Mancozeb: Whole Sediment Acute Toxicity with a Marine Amphipod (Leptocheirus plumulosus). Project Num ber: 63400, 2007/03. Unpublished study prepared by ABC Laboratories, Inc. 69 p.


## 850.1075 Fish acute toxicity test Marine/Estuarine species

40586804 Ward, G. (1987) Acute Toxicity of Dithane Flowable F

- 45 to Sheeps

- head Minnow (Cyrinodon variegatus) und er Static Conditions: Laboratory Project ID ESE No. 87369

- 0400

- 2130. Unpublished study prepared by Environmental Science and Engineering, Inc. 45 p.

41844901 Manning, C.; Ward, G.; Leak, T. (1990) Acute Toxicity of Dithane M

- 45 Fungicide to Sheepshead Minnows (Cyprinodon variegatus) Under Flow

- Through Conditions: Lab Project Number: 89328

- 0800

- 21 30: 88RC

- 0068. Unpublished study prepared by Hunter/ESE, Inc. 224 p.

41844902 Manning, C.; Ward, G.; Leak, T. (1990) Acute Toxicity of Dithane F

- 45 Fungicide to Sheepshead Minnows (Cyprinodon variegatus) Un

- der Flow

- Through Conditions: Lab Project Number: 89328

- 0700

- 2130 88RC

- 0072. Unpublished study prepared by Hunte r/ESE, Inc. 254 p.

47729301 Kramer , V. (2009) Rationale for Classification of Existing Sheepshead Minnow Acute Toxicity Studies as Core MRID No. 41844901 and Bluegill Acute Toxicity Study as Core: MRID No. 45934702. Project Number: MZTF/2009/01, 96R/1010 . Unpublished study prepared by Dow AgroSciences, LLC. 31 p.

48243201 Ollinger, J.; Kramer, V. (2010) Rationale for Classification of Existing Sheepshead Minnow Acute Toxicity Studies as Core: MRID No. 41844901 and Bluegill Acute Toxicity Study as Core: M RID No. 45934702: (Mancozeb) . Project Number: MZTF/2010/01. Unpublished study prepared by Mancozeb Task Force and Dow Agrosciences, LLC. 26
p.



## 72

- 4 Freshwater Invertebrate Life Cycle Study

### 77 40786201 Burgess, D. (1988) Chronic Toxicity of Dithane M

- 45 to Daphnia magna under Flow

through Test Conditions: Raw Data Report #36733: Rohm and Haas Report No. 88RC

0053. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 305 p.

40953802 Burgess, D. (1988) Chronic Toxicity of Dithane M

- 45 to Daphnia magna Under Flow

through Test Conditions: Final Report No. 36733; Rohm and Haas Report No. 88RC

0053. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 341 p.

4391721 9 Toy, R.; Gray, A. (1991) Dimethomorph: CME 151/Mancozeb 90/600 g/kg WP (SYS50579): Chronic Toxicity to Daphnia magna: Lab Project Number: SBGR.91.010: 4698. Unpublished study prepared by Shell Research Ltd. 42 p.

46023702 Wuthrich, V. (1993) Influence of Dithane DG on the Reproduction of Daphnia Magna Under Flow

- Through Conditions. Project Number: 336058, 93/RC/1024. Unpublished study prepared by RCC Umweltchemie Ag. 73 p.



## 850.1350 Marine Invertebrate

- Mysid chronic toxicity test

48627701 Hicks, S. (2011) Mancozeb: Life

- Cycle Toxicity Test of the Saltwater Mysid, Americamysis bahia, Conducted Under Flow

- Through Conditions. Project Number: 2010/1, 66201. Unpublished study prepared by ABC Laboratories, Inc. 90p.



## 850.1400 Fish early

- life stage toxicity test Fresh and Marine species

40786202 or 40953801 McAllister, W. (1988) Early Life Stage Toxicity of Dithane M

- 45 to Fathead Minnows (Pimephales promelas) in a Flow

- through System: Final Report #36732: Rohm and Has Report No. 88RC

- 0052. Unpub lis hed study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 418 p.

42114601 Reinert, K. (1991) Supplemental to the Early Life

- Stage Toxicity of Dithane M

- 45 to Fathead Minnows (Pimephales promelas) in a Flow

- through System: Lab Project Number: R&H 88RC

- 0052B. Unpublished study prepared by Rohm & Haas Co. 93 p.

43230701 Rhodes, J.; Downing, J.; Bielefeld, T. (1994) Early Life

- Stage Toxicity of Mancozeb to the Fathead Minnow (Pimephales promelas) Under Flow

- Through Conditions: Lab Project Number: 4 1148. Unpublished study prepared by ABC Labs., Inc. 247 p.

43917218 Toy, R.; Gray, A. (1991) Dimethomorph: CME 151/Mancozeb 90/600 g/kg WP (SYS50579): Prolonged Toxicity to Rainbow Trout: Lab Project Number: SBGR.91.058: 4699. Unpublished study prepared by Shell Research Ltd. 29 p.

46023701 Wuthrich, M. (1993) Dithane DG: 21

- Day Prolonged Toxicity Study in the Rainbow Trout Under Flow

- Through Conditions. Project Number: 336060, 93/RC/1021. Unpublished study prepared by RCC Umweltchemie Ag. 67 p. (Repeated under Acute Toxicity section)

48627702 Hicks, S. (2011) Mancozeb: Early Life

- Stage Toxicity Test with the Sheepshead Minnow, Cyprinodon variegatus, Under Flow

- Through Conditions. Project Number: 2010/2, 66202. Unpublished study prepa red by ABC Laboratories, Inc. 78p.



## 850.1500 Full Fish life cycle toxicity

### 78 49030601 Hicks, S. (2012) Mancozeb: Life

- Cycle Toxicity Test with the Fathead Minnow, Pimephales promelas, Under Flow

- Through Conditions. Project Number: 2010/3, 66203. Unpublished study prepared by ABC Laboratories, Inc. 186p.



## 72

- 5 Aquatic Field Study

44944401 Memmert, U. (1999) Ecological Effects of Penncozeb RT 80 WP in a Freshwater Mesocosm Study: Lab Project Number: 681030. Unpublished study prepared by RCC, Ltd. 232 p.

46153001
Memmert, U. (1999) Ecological Effects of Penncozeb 80 WP in a Freshwater Mesocosm Study. Project Number: 681030. Unpublished stu dy prepared by RCC Ltd. 250 p. Laboratory: RCC Ltd., Itingen, Switzerland Study Dates: Experimental: June 17, 1998

– October 28, 1998. Study Completion Date: October 7, 199 9



## 850.4100 850.4150 122

- 1 Seed Germination/Seedling Emergence and Vegetable Vigor

44283401 Chetram, R.; Christensen, G.; Goodman, V. et al. (1997) Nontarget Terrestrial Plant Phytotoxicity Studies Using a 9%/60% WP Co

- formulation of AC 336379 (Dimethomorph) and Mancozeb: (Final Report): Lab Project Number: 954

- 96

- 107: 9 54

- 96

- 108: 954

- 96

- 149. Unpublished study prepared by ABC Laboratories California. 250 p.

47486101 Lee, B. (2008) Mancozeb: Effects of the Vegetative Vigor of Non

- Target Terrestrial Plants (Tier 1). Project Number: 2007/01, 63399. Unpublished study prepared by ABC Laboratories, Inc. 51 p.

47486102 Aufderheide, J. (2008) Mancozeb: Effects on the Seedling Emergence of Non

- Target Terrestrial Plants (Tier 1). Project Number: 63398, 2007/02. Unpublished study prepared by ABC Laboratories, Inc. 58 p.

491 83304 Martin, K.; Van Hoven, R.; Sindermann, A.; et al. (2011) Gavel (Mancozeb 66.7%, Zoxamide 8.3%) : A Tier 1 Toxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants: Final Report. Project Number: 334/127. Unpublished study prepared by Wildlife International, Ltd. 96p.

49183405 Sindermann, A.; Porch, J.; Krueger, H.; et al. (2012) Gavel (Mancozeb 66.7%, Zoxamide 8.3%): A Tier 1 Toxicity Test to Determine the Effects of the Test Substance on Seedling Emerge nce of Ten Species of Plants: Final Report. Project Number: 334/126. Unpublished study prepared by Wildlife International, Ltd. 99p.



## 122

- 2 Aquatic plant growth

40845001 Ellgehausen, H. (1982) Determination of the Toxicity of Dithane Ultra to the G reen Algae Scened esmus Subspicatus Chodat: Eval uation of EC10 AND EC50: Project No. 002125. Unpublished study prepared by RCC Research & Consulting. 15 p.

43664701 Forbis , A. (1990) Acute Toxicity of Dithane M

- 45 Fungicide to Selenastrum capricornutum Printz: Final Report: Lab Project Number: 37735: 89RC

- 0045. Unpublished study prepared by ABC Labs, Inc. 208 p.

### 79 44950501 mixture with Zoxamide Ward, C.; Murdock, C. (1998) Toxicity of Dithane/RH

- 117,281 DG Blend to Selenastrum capricornutum Printz: Lab Project Number: 44178: 97RC

- 0069. Unpublished study prepared by ABC Laboratories, Inc. 181 p.

46056403 Mixture with Zoxamide Rhodes, J. (1999) Acute Toxicity of Dithane/RH

- 7 281 (11.2:1) DG Blend to the Green Alga, Selenastrum capricornutum. Project Number: 45118, 98RC/0238. Unpublished study prepared by Analytical Bio

- Chemistry Labs., Inc. 156 p.



## 850.5400 123

- 2 Aquatic plant growth

43917217 Mixture Toy, R.; Gray, A. (1992) Dimethomorph: Acute Toxicity of Dimethomorph/Mancozeb 75/667 g/kg WP (SYS50588 R) to Oncorhynchus mykiss, Daphnia magna and Selenastrum capricornutum: Lab Project Number: SBGR.92.177: 5640. Unpublished study prepared by Shell Resea rch Ltd. 42 p.

44283402 Canez , V.; Christensen, G.; Hughes, J.; et al. (1997) Effects of a 9%/60% WP Co

formulation of AC 336379 (Dimethomorph) and Mancozeb on the Growth of Navicula pelliculosa, Selenastrum capricornutum, Anabaena flos

- aquae, Skeletonema costatum, and Lemna gibba: (F inal Report): Lab Project Number: 954

- 96

- 113: 954

- 96

- 166: 954

- 96

- 111. Unpublished study prepared by Carolina Ecotox. Inc. 457 p.

46056403 Repeated in
122

- 2 Rhodes, J. (1999) Acute Toxicity of Dithane/RH

- 7281 (11.2:1) DG Blend to the Green Alga, Selenastr um capricornutum. Project Number: 45118, 98RC/0238. Unpublished study prepared by Analytical Bio

- Chemistry Labs., Inc. 156 p.

46020902 and
45910402 Reuschenbach, D. (2000) Reg No. 146099: Determination of the Inhibitory Effect on the Cell Multiplication o f Unicellular Green Algae: Final Report. Project Number: 00/0533/60/1. Unpublished study prepared by BASF Aktiengesellschaft. 27 p.



## 141

- 1 Honey bee acute contact

44950504 Mixture with Zoxamide Milligan, D . (1997) Dithane/RH

- 117,281 DG Blend (8:1): Laboratory Oral and Contact Test with the Honeybee, Apis mellifera: Final Report: Lab Project Number: 97

- 071

- 1007: 97RC

- 0070: 1007.030.265. Unpublished study prepared by Springborn Laboratories AG. 48 p.

18842 Atkins, E.L., L.D. Anderson and E.A. Greywood (1969) Effect of Pesticides on Apiculture: Project No. 1499; Research Report CF

- 7501. (Unpublished Study Received May 8, 1971 under 1F11741; Prepared by University of California

– Riverside, Dept. of Entomology, Submitted by Ciba Agrochemical Co., Summit, New Jersey. CDL:090973

- B).

41941 Atkins, E.l., Jr. and C. Johansen (1969) Study on the Toxicity of U

- 27, 415 to Bees. (Unpublished Study Received on Unknown Date Under 0G0962; Prepared by University of California

– Riverside, Citrus Research Cen ter and Agricultural Experiment Station, Dept. of Entomology and Washington State University, Dept . of Entomology, Submitted by Upjohn Co., Kalamazoo, Michigan. CDL: 094605

- B.

1949 Johansen, C., J. Eves (1969) Bee Research Investigations, 1969: Small

- sca le Bee Poisoning Tests with Honey Bees (HB) and Alfalfa Leafcutter Bees (LB). (Unpublished Study Received September 15, 1971 Under 1F1032; Prepared by Washington State University, Submitted by Hercules, Inc., Wilmington, Delaware. CDL: 091917

- H

### 80 

## Non Guideline Studies

45212901 Ravenzwaay, B.; Ollinger, J. (2000) EBDC Fungicides Do Not Share a Common Mechanism of Toxicity with Cholinesterase Inhibitors: Lab Project Number: 2000 MECH. Unpublished study prepared by EBDU/ETU Task Force. 9 p.

45534701 Lamb, IV, J.; Hentz, K.; Matthews, S.; et al. (2001) Analysis of Common Mechanisms of Toxicity for Ethylenebisdithiocarbamates and Other Dithiocarbamates. Unpublished study prepared by BBL Sciences. 111 p.

45577201 Nienstedt, K. (2001) Dithane M

- 45 Fungi cide: An Extended Laboratory Dose Response Toxicity Test on Detached Bean Leaves with the Predatory Mite, Typhlodromus pyri Scheuten (Acari: Phytoseiidae): Lab Project Number: 01RC

- 0134: 1007.075.568: 01P

134. Unpublished study prepared by Springborn Labor atories (Europe) AG. 40 p.

46023704 Nienstedt, K. (1999) A Chronic Toxicity and Reproduction Test Exposing the Earthworm Eisenia fetida to Dithane M

- 45 in OECD Artificial Soil. Project Number: 99RC/0124, 1007/054/630. Unpublished study prepared by Spring born Laboratories (Europe) Ag. 64 p.

47164601 Moore, D.; Breton, R.; Rodney, S.; et al. (2007) Generic Problem Formulation for California Red

- Legged Frog. Project Number: 89320, 05232007. Unpublished study prepared by Cantox Environmental Inc. 87 p.

4716 4602 Holmes, C.; Vamshi, R. (2007) Data and Methodology Used for Spatial Analysis of California Red Legged Frog Observations and Proximate Land Cover Characteristics. Project Number: 3152007, WEI/252/03. Unpublished study prepared by Waterborne Environment al, Inc. (WEI). 19 p.

47327001 Ollinger, J. (2008) Mancozeb Task Force Response to EPA's California Red Legged Frog Effects Determinations for Mancozeb: "Effects Determinations for Mancozeb and Maneb Relative to the California Red

- Legged Frog and Designated Critical Habitat," October 18, 2007. Project Number: MZTF200804, MZ/TF200804. Unpublished study prepared by Mancozeb Task Force. 37 p.



# ETU Studies

850.2100 71

- 1 Avian acute oral toxicity test

48437501 Hubbard, P.; Beavers, J. (2011) Ethylenethiourea: An Acute Oral Toxicity Study with the Zebra Finch (Poephila guttata). Project Number: 697/102, 2010/2. Unpublished study prepared by Wildlife International Ltd. 60 p.

48343001 Hubbard, P.; Beavers, J. (2010) Ethylenethiourea: An Acute Oral Toxicity Study with the Northern Bobwhite. Project Number: 697/101, 2010/1. Unpublished study prepared by Wildlife International, Ltd. 57 p.



## 850.2200 71

- 2 Avian Dietary Toxicity

48417801 Hubbard, P.; Beavers, J. (2011) Ethylenethiourea: A Dietary LC 50 Study with the Northern Bobwhite. Project Number: 697/103, 2010/3. Unpublished study prepared by Wildlife International, Ltd. 66 p.

### 81 48417802 Hubbard, P.; Beavers, J. (2011) Ethylenethiourea: A Dietary LC50 Study with the Mallard. Project Number: 697/104, 2010/4. Unpublished study prepared by Wildlife International, Ltd. 65 p.



## 850.2300 71

- 4 Avian Reproduction

48819701 Temple, D.; Martin, K.; Beavers, J. et al. (2012) Ethylenethiourea: A Reproduction Study with the Nort hern Bobwhite: Final Report. Project Number: 697/107, 2010/5. Unpublished study prepared by Wildlife International, Ltd. 195p.

48819702 Temple, D.; Martin, K.; Beavers, J. et al. (2012) Ethylenethiourea: A Reproduction Study with the Mallard: Final Report. Project Number: 697/108, 2010/6. Unpublished study prepared by Wildlife International, Ltd. 196p.



## 72

- 1 Acute Toxicity to Freshwater Fish

45910401 Zok, S. (2001) Acute Toxicity Study on the Rainbow Trout (Oncorhynchus mykiss Walbaum 1792) in a Static System (96 Hours): Ethylenethiourea (ETU): Lab Project Number: 12F0533/005042: 2001/1001877: PCP06082. Unpublished study prepared by BASF Aktiengesellschaft. 44 p.

46020903 Zok, R. (2001) Acute Toxicity Study on the Rainbow Trout (Onco rhynchus mykiss Walbaum 1792) in a Static System (96 Hours). Project Number: 12F0533/005042, 146099. Unpublished study prepared by BASF Aktiengesellschaft. 43 p.



## 850.1075 Fish acute toxicity test, freshwater and marine

46462902 Palmer, S.; Kendall, T.; Krueger, H. (2001) Ethylene Urea: A 96

- Hour Static Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final Report. Project Number: 299A/115. Unpublished study prepared by Wildlife International, Ltd. 37 p.

47441201 Soucy , K. (2008) Ethylenethiourea

- Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under Static Conditions, Following OPPTS Draft Guideline 850.1075. Project Number: 13921/6105, 2007/04. Unpublished study prepared by Springborn Smithers Laboratories. 55 p.

47441202 Soucy, K. (2008) Ethylenethiourea

- Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus) Under Static Conditions, Following OPPTS Draft Guideline 850.1075. Project Number: 13921/6104, 2007/05. Unpublished study prepared by Springborn Sm ithers Laboratories. 55 p.

45910401 46020903 Zok, S. (2001) Acute Toxicity Study on the Rainbow Trout (Oncorhynchus mykiss Walbaum 1792) in a Static System (96 Hours): Ethylenethiourea (ETU): Lab Project Number: 12F0533/005042: 2001/1001877: PCP06082. Unp ublished study prepared by BASF Aktiengesellschaft. 44 p.



## 72

- 2 Acute Toxicity to Freshwater Invertebrates

45910402 Hisgen, M. (2000) Determination of the Acute Effect on the Swimming Ability of the Water Flea Daphnia magna Straus: Ethylenethiourea (ETU) : Lab Project Number: 00/0533/50/1:

### 82 2000/1017216: PCP05988. Unpublished study prepared by BASF Aktiengesellschaft. 27
p.

46020901

see 45910402 Hisgen , M. (2003) Reg No. 146099: Determination of the Acute Effect on the Swimming Ability of the Water Flea Daphnia Magna Straus: Final Report. Project Number: 00/0533/50/1. Unpublished study prepared by BASF Aktiengesellschaft. 25 p.

46462903 Palmer, S.; Kendall, T.; Krueger, H. (2001) Ethylene Urea: A 48

- Hour Static Acute Toxicity Test with the Cladoceran (Daphnia magna): Final Report. Project Number: 299A/114. Unpublished study prepared by Wildlife International, Ltd. 37 p.



## 850.1025 Oyster acute toxici ty test (shell deposition)

47474301 York, D. (2008) Ethylenethiourea

- Acute Toxicity to Eastern Oyster (Crassostrea virginica) Under Flow

- Through Conditions. Project Number: 13921/6102, 2007/02. Unpublished study prepared by EBDC/ETU Task Force. 66 p.



## 850.1035 Mysid acute toxicity test

47441204 Soucy, K. (2008) Ethylenethiourea

- Acute Toxicity to Mysids (Americamysis bahia) Under Static Conditions, Following OPPTS Guideline 850.1035. Project Number: 13921/6103, 2007/03. Unpublished study prepared by Spr ingborn Smithers Laboratories. 57 p.



## 850.1300 72

- 4 Daphnid chronic toxicity test

46462901 Graves, W.; Mank, M.; Swigert, J. (1995) Ethylene Thiourea (ETU): A Flow

- Through Life

Cycle Toxicity Test with the Cladoceran (Daphnia Magna): Final Report. Proj ect Number: 129A/116, 94RC/0001. Unpublished study prepared by Wildlife International, Ltd. 122 p.



## 850.4400 Aquatic plant toxicity test using Lemna spp. Tiers I and II

47441203 Softcheck , K. (2008) Ethylenethiourea

- 7

- Day Toxicity Test with Duckweed (Lemna gibba) Following OPPTS Draft Guideline 850.4400. Project Number: 13921/6101, 2007/01. Unpublished study prepared by Springborn Smithers Laboratories. 69 p.



## 850.5400 123

- 2 Algal toxicity, Tiers 1 and II

46462904 Palmer, S.; Kendall, T.; Krueger, H. (2001) Ethylene Urea: A 96

- Hour Toxicity Test with the Freshwater Alga (Selenastrum capricornutum): Final Report. Project Number: 299A/116. Unpublished study prepared by Wildlife Inter national, Ltd. 49 p.

46020902

see 45910403 Reuschenbach, D. (2000) Determination of the Inhibitory Effect on the Cell Multipl ication of Unicellular Green Al g a e: Ethylenethiourea (ETU): Lab Project Number: 00/0533/60/1: 2000/1017191: PCP05997. Unpublished study prepared by BASF Aktiengesellschaft. 28
p. 

## 850.7100 Data reporting for environmental chemistry methods

### 83 46623335 Tilting, N. (2004) Residues of Metiram and ETU in Potential Feed Items of Birds and Wild Mammals Following Application of Polyram WG (BAS 222 28 F) in Potatoes: (Final Report). Project Number: 136963, 13512075, 2004/1006523. Unpublished study prepared by B ASF Aktiengesellschaft and Institut fuer Biologische Analytik und Consulting IBACON. 136 p.

157594 E.I. du Pont de Nemours & Co., Inc. (1982) Manzate (IN

- 7331): Determination of Ethylenethiourea (ETU) Liquid Chromatographic Method: Method No: M20.1842(R). Unpublished study. 4 p.

45151401 Connolly, P. (2000) Independent Laboratory Analytical Method: Method for the Analysis of Ethylenethiourea (ETU) in Water by LC/MS/MS (MS 178.00) Revision 2: Lab Project Number: 002

- 342: 00P

- 002

- 342: MS 178.00. Unpublished study prepared by Centre Analytica l Laboratories, Inc. 88 p. {OPPTS 850.7100}



## Non

- Guideline Study

42610001 Ruckert, E. (1992) Letter Sent to S. Lewis, dated Dec. 28, 1992: Regarding Ethylene thiourea 104 week chronic toxicity (feeding) study in rats: Source of information from final

r eport RCC project number 256803. Prepared by EBDC/ETU Task Force. 3 p.

43641401 Weinberg, D.; Weiss, D. (1987) Response of the Maneb Data Task Force and Pennwalt Corporation to the Environmental Protection Agency's Initiation of Special Review of the EBDC Pesticides: (Risk Exposure Assessment). Unpublished study prepared by Fox, Weinb erg & Bennett. 28 p.

43641501 Weinberg, D.; Weiss, D. (1987) Response of Pennwalt Corporation to the Environmental Protection Agency's Initiation of Special Review of the EBDC Pesticides/Mancozeb: (Risk Assessment): (Includes "EBDC Special Review: Toxicological Issues"). Unpublished
st udy prepared by Fox, Weinberg & Bennett. 51 p.

44418801 Waylett, D.; Slesinski, R.; Sert, M. et al. (1997) Acute Dietary Exposure and Risk Assessment: Ethylenebisdithiocarbamates (EBDCs) and Their Common Metabolite, Ethylene Thiourea (ETU): Lab Project N umber: EBDC 97

- 01. Unpublished study prepared by Tas

- Environ. 95 p.

45225404 Hurt, S. (2000) Toxicity Endpoints and Reference Doses for Ethylenethiourea: Lab Project Number: 00R

- 1061. Unpublished study prepared by EBDC/ETU Task Force. 22
p.

45924404 Chernoff, N.; Kavlock, R.; Rogers, E.; et al. (1979) Perinatal Toxicity of Maneb, Ethylene Thiourea, and Ethylenebisisothiocyanate Sulfide in Rodents. Journal of Toxicology and Environmental Health 5: 821

- 834.

46268301 Arce, G. (2003) The Influence of Perinatal Exposure to ETU in the Development of Thyroid Effects and Other Critical Toxicological Parameters. Project Number: 2/03/EBDC. Unpublished study prepared by EBDC/ETU Task Force. 20 p.

46319901 Ollinger, J. (2004) EBDC/ETU Task Force Response t o U.S. EPA's Draft Science Chapter for the Environmental Fate and Ecological Risk Assessment for Ethylenethiourea (ETU) Dated June 2, 2004. Project Number: EBDC/FQPA/2004/01. 38 p.

### 84 46480002 Ollinger, J. (2005) EBDC/ETU Task Force Response to U.S. EPA's Dr aft Science Chapter for the Environmental Fate and Ecological Risk Assessment for Ethylenethiourea (ETU) Dated October 20, 2004. Project Number: EBDC/FQPA/2005/01. Unpublished study prepared by EBDC/ETU Task Force. 24 p.

46480003 Ollinger, J. (2005) Ethyl enebisdithiocarbamate Fungicides

- Benefits to United States Agriculture. Project Number: EBDC/FQPA/2005/03. Unpublished study prepared by EBDC/ETU Task Force. 261 p

47292002 Wuest, P.; Singh, H. (1983) Assessment of Zineb Residue Levels Through Dermal and Inhalation Exposures and its Major Metabolite [Ethylenethiourea (ETU)] in Biological Fluids: Final Report. Project Number: 59/2421/0/2/012/0. Unpublished study prepared by Pennsylvania State University and Enviro

- Bio

- Tech, Ltd. 43 p.

47432128 Wang, G. (1988) Regulatory Decision Making and the Need for and the Use of Exposure Data on Pesticides Determined to Be Teratogenic in Test Animals. Teratogenesis, Carcinogenesis, and Mutagenesis 8:117

- 126.

48 597301 Marty, M.; Chukwdebe, A.; McCoy, A. (2011) Expo sure to ETU during Different Life Stages: Kinetic Considerations. Project Number: EOGRTS/TK. Unpublished study prepared by EBDC/ETU Task Force. 18p.

49254303 Thienpont, B.; Tingaud

- Sequeira, A.; Prats, E.; et al. (2011) Zebrafish Eleutheroembryos Provide a Suitable Vertebrate Model for Screening Chemicals that Impair Thyroid Hormone Synthesis. Environmental Science & Technology 45(X): 7525

- 7532.

### 85 

## Appendix B . SIP Output

Table 1. Inputs

Parameter Value

Chemical name Mancozeb
Solubility (in water at 25 o C; mg/L) 6

Mammalian LD 50 (mg/kg

- bw) 5000 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg

- bw) 120 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg

- bw) Avian test species mallard duck Body weight (g) of "other" avian species Mineau scaling factor 1.15

Mallard NOAEC (mg/kg

- diet) 125 Bobwhite quail NOAEC (mg/kg

- diet) 125 NOAEC (mg/kg

- diet) for other bird species Body weight (g) of other avian species NOAEC (mg/kg

- diet) for 2nd other bird species Body weight (g) of 2nd other avian species

Table 2. Mammalian Results

Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 1.0320 1.0320 Adjusted toxicity value (mg/kg

- bw) 3845.8028 92.2993 Ratio of exposure to toxicity 0.0003 0.0112

Conclusion* Drinking water exposure alone is NOT a potential

concern for mammals Drinking water exposure alone is NOT a potential

concern for mammals

Table 3. Avian Results

Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 4.8600 4.8600 Adjusted toxicity value (mg/kg

- bw) 0.0000 6.2016 Ratio of exposure to acute toxicity 0.0000 0.7837

Conclusion* Due to insufficient data, risk cannot be precluded Drinking water exposure alone is NOT a potential
concern for birds

*Conclusion is for drinking water exposure alone. This does not combine all routes of exposure. Therefore, when aggregated with other routes ( i.e ., diet, inhalation, dermal), pesticide exposure through drinking water may contribute to a total exposure that has potential for effects to non

- target animals.

### 86 

## Appendix C

. STIR Output



# Input

Application and Chemical Information

Enter Chemical Name Mancozeb
Enter Chemical Use Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) ground Enter Chemical Molecular Weight (g/mole) 265 Enter Chemical Vapor Pressure (mmHg) 1.32E

- 10 Enter Application Rate (lb a.i./acre) 19

Toxicity Properties

**Bird**

Enter Lowest Bird Oral LD 50 (mg/kg bw) Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 1.58
**Mammal**

Enter Lowest Rat Oral LD 50 (mg/kg bw) 5000

Enter Lowest Rat Inhalation LC 50 (mg/L) 5.14 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35



# Output
Results Avian (0.020 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 1.88E

- 06
Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 2.37E

- 07
Adjusted Inhalation LD 50 0.00E+00
Ratio of Vapor Dose to Adjusted Inhalation LD 50 #DIV/0! #DIV/0!

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 2.01E+00 Ratio of Droplet Inhalation Dose to Adjusted Inhalation
LD 50 #DIV/0! #DIV/0!



### Results Mammalian (0.015 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 1.88E

- 06
Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 2.97E

- 07
Adjusted Inhalation LD 50 3.06E+02
Ratio of Vapor Dose to Adjusted Inhalation LD 50 9.72E

- 10 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 2.52E+00 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 8.25E

- 03 Exposure not Likely Significant