Page 1 of 57 OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

A ugust 4 , 2015
PC Code: 034805
MEMORANDUM DP Barcode: 427965

SUBJECT: Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposu re Assessments for Ziram

FROM: Elyssa Arnold , Biologist Ron Parker, Senior Environmental Engineer
Environmental Risk Branch 2 Environmental Fate and Effects Division ( 7507P)

James Breithaupt, Agronomist David Bays, Biologist
Risk Assessment and Scienc e Support Branch Antimicrobials Division (7510P)

REVIEWED Melissa Panger, Senior Science Advisor

BY: Jim Lin , Environmental Engineer
Environmental Risk Branch 2 Environmental Fate and Effects Division ( 7507P)

THROUGH: Brian Anderson, Branch Chief
Envi ronmental Risk Branch 2 Environmental Fate and Effects Division ( 7507P)

Laura Parsons, Associate Branch Chief Risk Assessment and Support Branch (RASSB) Antimicrobials Division (7510P)

TO: Khue Nguyen, Chemical Review Manager Kelly Ballard

, Acting Team Leader Neil Anderson, Branch Chief Risk Management and Implementation Branch 1
Pesticide Re

- e valuation Division (7508P)Page 2 of 57 

# Table of Contents

1. Executive Summary

................................ ................................ ................................ ................ 3

2. Introduction

................................ ................................ ................................ ............................. 4

3. Use Characterization

................................ ................................ ................................ ............... 5

4. Conclusions from Previous Risk Assessments

................................ ................................ ....... 7
4.1. Ecological Risk Assessment

................................ ................................ ............................. 7
4.2. Drinking Water Exposure Assessments

................................ ................................ ........... 8

4.3. Clean Water Act Programs

................................ ................................ ............................... 9
5. Environmental Fate and Transport

................................ ................................ .......................... 9
5.1. Transformation Products

................................ ................................ ................................ 12

6. Receptors

................................ ................................ ................................ ............................... 15

6.1. Effects to Aquatic Organisms

................................ ................................ ........................ 15

6.2. Effects to Terrestrial Organisms

................................ ................................ .................... 16

6.3. Ecological Incidents

................................ ................................ ................................ ....... 17

7. Exposure Pathways of Concern

................................ ................................ ............................ 18

8. Analysis Plan

................................ ................................ ................................ ........................ 18

8.1. Stressors of Concern

................................ ................................ ................................ ....... 18

8.2. Measures of Exposure

................................ ................................ ................................ .... 19

8.3. Measures of Effect

................................ ................................ ................................ ......... 20

8.4. Endangered Species Assessments

................................ ................................ .................. 20
8.5. Endocrine D isruptor Screening Program

................................ ................................ ....... 21

9. Preliminary Identification of Data Gaps

................................ ................................ ............... 21
9.1. Environmental Fate

................................ ................................ ................................ ........ 21
9.2. Effects

................................ ................................ ................................ ............................. 22

10. References

................................ ................................ ................................ .......................... 31

10.1. Submitted Environmental Fate Studies

................................ ................................ ...... 32

10.2. Submitted Ecological Toxicity Studies

................................ ................................ ...... 35 Appendix A. SIP Modeling Results

................................ ................................ .............................. 38 Appendix B. STIR Modeling Results

................................ ................................ ........................... 39 Appendix C. Summary of Ziram and Thiram Fate and Transport Data

................................ ....... 40 Appendix D. Ziram, Thiram, and Ferbam Ecotoxicity Data

................................ ........................ 44 Appendix E. Thiram

– Preliminary Identification of Data Gaps

................................ .................. 53Page 3 of 57 

# 1. Executive S ummary

The Environmental Fate and Effects Division (EFED) has completed the preliminary problem
formulation for the ecological risk, environmental fate, endangered species, and drinking water assessments to be conducted as part of the registration review of ziram (PC 034805)

. The problem formulation describes the methods plan ned 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, ecological effects

, potential risks associated with the use, and
uncertain ties uniq ue to the risk assessment of ziram

. This document also identifies additional
studies that would be beneficial to the conduct of an ecological risk assessment. This problem
formulation includes discussion of ziram degradation into thiram (PC 079801)

, w hich is more persistent than parent ziram. The problem formulation for thiram can be found under DP427810 (USEPA, 2015)

.

The ziram Reregistration Eligibility Decision ( RED ) was completed in 200 4

. The RED
concluded that there was risk of adverse effects t o aquatic invertebrates, fish, birds, and mammals from exposure to ziram

. With the exception of mammals, chronic risk could not be assessed due to a lack of toxicity data. Data submitted following the RED will be incorporated into the registration review r isk assessment.

The following are the needed data and uncertainties for ziram . See the thiram problem
formulation for a complete description of the data needs and uncertainties for the major degradate thiram (USEPA, 2015). Appendix E also contains the pre liminary identification of data gaps from the thiram problem formulation. A ssessment of a cute exposure to ziram r equires
data on ziram ; thiram dat a a re not a sufficient substitute. Assessment of c hronic exposure resulting from ziram uses may be assessed u sing toxicity data o n either ziram or thiram.

Data Needs

• Environmental f ate and t ransport d ata ( waste water treatment plant ( WWTP ) studies for antimicrobial uses) 1

, 2



### o WWTP biodegradation tests ( 835.3110 , 835.3220, 835.3240, 835.3280 , TGAI) 2



### o Modified Act iva ted Sludge Respiration Test ( OECD 209 or 850.3300 , TGAI)

• Ecotoxicity d ata on z iram

o Aquatic plant studies

1 These data were also required of sodium and potassium dimethyldithiocarbamate salts earlier in registration review. The data could potentially be bridged b etween any of these three compounds.

2 The results of the ASRI test will determine which of these four biodegradation tests is/are anticipated to be required. If the ASRI test EC50 is less than or equal to 20 mg/L, then either the (i)Biodegradation in Acti vated Sludge Study or (ii) Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units or (iii) the Porous Pot Test is expected to be required. If the ASRI test EC50 is greater than 20 mg/L, then the registrant would likely be required to conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation

Test

– Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no fu rther testing would be expected to be required. If, however, the antimicrobial fails the Ready Biodegradability study, then the a) Biodegradation in Activated Sludge or b) Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units, or c) the Por ous Pot study would likely be required.Page 4 of 57 

###  OCSPP 850.4500: Algal toxicity, studies with freshwater diatom Navicula pelliculosa and marine diatom Skeletonema costatum

 OCSPP 850.4550: Cyanobacter ia toxicity

o Avian studies

 OCSPP 850.2100: Avian acute toxicity

, passerine species

o Terrestrial invertebrate studies 3



###  Non

- guideline (Tier 1) : Honey bee adult acute oral toxicity

 Non

- guideline (Tier 1) : Honey bee larvae acute toxicity

 Non

- guideline (Tier 1): Honey bee adult chronic oral toxicity

 Non

- guideline (Tier 1): Honey bee larvae chronic toxicity

 Non

- guideline (Tier 2): Semi

- field testing for pollinators (tunnel or colony
fe eding studies)

 Non

- guideline (Tier 2): Field trial of residues in pollen and nectar

 OCSPP 850.3040 (Tier 3): Field testing for pollina t ors

o Terrestrial plan t studies

 850.4100: Seedling emergence

 850.4150: Vegetative vigor

• Ecotoxicity Data on Degradate T hiram 4



### o Aquatic animal studies

 OCSPP 850.1350: Mysid chronic toxicity

 OCSPP 850.1400 : Estuarine/marine fish early

- life stage toxicity

Other Major Uncertainties

For many of the agricultural uses of ziram, the labels do not specify the annual maximum application rate, number of applications, or minimum retreatment intervals when multiple applications are permitted. A bsence of such information on the labels may result in conservative assumptions for modeling of use patterns in the registration review risk assessment

.

The acute endpoints for freshwater fish and freshwater and estuarine/mari ne invertebrates are lower or approximately equal to the chronic NOAEC values for those taxa (see Section 6.1 for details) . These results are unusual, and the explanation is not clear based on the information available in the study reports. Additional info rmation to clarify these inconsistencies in the aquatic toxicity data is requested.



# 2. Introduction

Ziram, Zinc

- bis(dimethyldithiocarbamate), is a dimethyldithiocarbamate fungicide and antimicrobial registered for use on stone fruits, pome fruits, nut crops , vegetables, and commercially grown ornamentals. Dimethyldithiocarbamate fungicides are non

- systemic and act by concomitant inhibition of spore germination and mycelial growth through multi

- site

3 Tier 2 and 3 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 based on Tier I studies of individual bees.

4 This list includes the subset of studies requested in the thiram problem formulation (USEPA, 2015) that are also important for the risk assessment of ziram.Page 5 of 57 

### interference of enzyme processes associated with respiration

. Ziram is also used as an antimicrobial in industrial adhesives, caulking, and latex paint. Ferbam (PC Code: 034801), a related dithiocarbamate, and ziram have a common degradate

– thiram . Thiram (PC Code: 079801) is also a regist ered dithiocarbamate fung icide. Because ferbam degrades very quickly (much more quickly than ziram) to thiram, ferbam and thiram are being assessed together during registration review. Although ziram is being assessed separately, the ziram assessment will rely heavily on the ferba m/thiram PF and assessment during registration review ( DP427810; USEPA, 2015)

.

There are four active Section 3 registration s for ziram in the United States. One is a technical

grade manufacturing

- use product (EPA Reg. No. 70506

- 179) , two are water dispe rsible granule formulations for use as agricultural fungicides (45728

- 1 2 and 70506

- 173) , and one is a technical

grade antimicrobial product (45728

- 14) . There are also three active special local needs labels for dormant application on blueberries , one in Ne w Jersey and two in Michigan

. There are no registe red co

- formulated products with ziram.

EFED evaluated the most recent ecological risk assessments for ziram in association with the update d toxicity, exposure, and usage information to determine if suffici ent data are available and if further updates are needed to support registration review. Recent risk assessments include
the 200 1 EFED RED Chapter ( USEPA, 2001 ) and a 2008 endangered species assessment on the
California Red

- legged Frog (USEPA, 2008) . In ad dition, EFED considered the latest Agency science policies and risk assessment methodologies.



# 3. Use Characterization

Ziram used in agriculture is applied as a foliar spray via aerial and ground application methods.
The two labeled Section 3 end

- use produ cts are Ziram Granuflo (EPA Reg. No. 45728

- 1 2) and Ziram 76DF Fungicide (EPA Reg. No. 70506

- 17 ), both are 76% a.i. water dispersible granule
formulations. Ziram targets a variety of fungal diseases and is registered for use on almonds, apples, apricots, bl ueberries, cherries, Christmas tree plantations, conifers, grapes, nectarines, ornamentals, peaches, pears, pecans, and tomatoes. The single maximum application rate is 7.6
lbs active ingredient per acre ( a.i./A ) on peaches and nectarines. Ziram can also b e used as an antimicrobial in the formulation of latex paint, paper and paperboard, paper coatings, water reduced industrial materials, adhesives, industrial yarns and fabrics, and dried films. Ziram was previously registered for use as a rabbit repellent for outdoor foliar applications to ornamentals

. The primary agricultural uses for ziram are on almonds (20

- 35% of crop treated, 900,000 lbs a.i./yr), apples (15

- 20% of crop treated, 400,000 lbs a.i./yr), apricots (35

- 70% of crop treated, 30,000 lbs a.i./yr ), blueberries (30

- 40% of crop treated, 80,000 lbs a.i./yr), nectarines (25

- 35% of crop treated, 50,000 lbs a.i./yr), peaches (30

- 40% of crop treated, 200,000 lbs a.i./yr), and pears (20

- 35% of crop treated, 100,000 lbs a.i./yr) (USEPA, 2014)

.

Table 1 lists the maximum use patterns for the labeled agricultural use sites. EFED will use application scenarios that result in maximum exposure scenarios for a giv en use for the risk

assessment. For labels that do not inc lude a maximum annual or seasonal application rate, maximum number of applications, o r minimum retreatment interval, conservative assumptions
will be made as illustrated in the following examples:Page 6 of 5 7 

### • A maximum single application rate is specified with a re

- ap plication interval of 7 days without specifying a maximum annual rate may result in an assumption of 52 applications with 7

- day intervals;

• A label that does not specify an application interval may result in assumptions of short application intervals such a s 1

- or 3

- day intervals.

Table 1 . Maximum Use Patterns for Current Uses of Ziram

Use Max Single App. Rate (lbs a.i./A) Max App

. Rate per
CC (lbs a.i./A) Max #
of App. per CC Max App. Rate per

Year (lbs a.i./A) Max # of App. p er

Ye ar Min

Retreatment Interval (days) Application

Methods

Almond 6.1 24.3 NS NS NS NS Aerial &

g round spray

Apple 4.6 32.2 7 NS NS NS Aerial & ground spray

Apricot 6.1 24.4 4 NS NS NS Aerial & ground spray

Blueberry 3.0 15.2 NS NS NS NS Aerial & ground s pray 2.3 NS NS NS NS NS Ground spray

Cherry 4.6 18.4 4 NS NS NS Aerial & ground spray

Christmas

tree plantations 6.1 6.1 1 NS NS NS Aerial & ground spray

Conifer plantations
& nurseries 6.1 NS NS NS NS 3 Aerial & ground spray

Grape 3 NS NS NS NS 7 Ae rial & ground spray

3 21.3 NS NS NS 7 Ground spray

Nectarine 7.6 45.6 6 NS NS NS Aerial & ground spray

Ornamentals 6.1 NS NS NS NS 3 Aerial & ground spray

Peach 7.6 45.6 6 NS NS NS Aerial & ground spray

Pear

– East
of the
Rockies 4.6 32.2 7 NS NS NS Aerial & ground spray

Pear

– West
of the
Rockies 4.6 18.4 4 NS NS NS Aerial & ground spray

Pecan 6.1 36.6 6 NS NS 21 Ground spray

Tomato 3 18.0 NS NS NS 7 Ground spray

N S = N ot S pecified; App.=A pplications ; CC=C rop C ycle



### A map of estimated annual use f or ziram in 2012 is presented in Figure 1

.Page 7 of 57 

### Figure 1

. Estimated Agricultural Use for Z iram (USGS, 2012 )



# 4. Conclusions from Previous Risk Assessments

4.1. Ecological Risk Assessment

Recent ecological risk assessments for ziram include the 200 1 EFED RED chapt er (DPs 276759, 260984, 260985) (USEPA, 2001) and a 2008 endangered species assessment on the California
Red

- legged Frog (CRLF) (USEPA, 2008)

. The RED concluded that there was risk of adverse
effects to aquatic invertebrates, fish, birds, and mammals from exposure to ziram

. With the exception of mammals, chronic risk could not be assessed due to a lack of toxicity data. ThePage 8 of 57 

### CRLF assessment concluded that registered uses of ziram were likely to adversely affect the
CRLF based on both direct and indirect effe cts. Figure 2 and Table 2 summarize the potential
risks identified in previous assessments and the supporting evidence

.

Figure 2 . Graphic Summary of Potential Risks of Current Uses

Table 2 . Evidence of Risk t o Taxonomic Groups from Ziram Uses

Predominant Evidence of Negligible Risk Predominant Evidence of Risk

None Mammals: Acute and chronic risk LOC exceedances for
listed and non

- listed species from a single application.

Fish and aquatic invertebrates: Ac ute risk LOC
exceedances for listed and non

- listed freshwater fish, freshwater invertebrates, and estuarine/marine invertebrates. No chronic toxicity data available.



### Limited Evidence of Negligible Risk Limited Evidence of Risk

Aquatic plants: No LOC exce edances for green algae. Toxicity data not available for other aquatic plant species. Birds: Acute risk LOC exceedances for listed species only. No chronic toxicity data available.

Terrestrial invertebrates: Ziram is practically non

- toxic to adult honey b ees on an acute contact exposure basis. No other toxicity data available. Terrestrial plants: No toxicity data available. Two incidents reported.



## 4.2. Drinking Water Exposure Assessments

The drinking water exposure assessment for ziram was updated in 2010 b ased on label changes resulting from the RED (USEPA, 2010)

. Maximum Tier 2 exposure estimates for the residues of
concern in surface water were 312 μ g/L (1

- in

- 10

- year peak), 61.4 μg/L (1

- in

- 10

- year annual mean) , and 27.9 μg/L (mean 26

- year) using the PRZM and EXAMS models . Residues ofPage 9 of 57 

### concern included the degradate thiram. For ground water, screening level exposure estimates

were 0.03 μg/L for both acute and chronic exposure using the SCI

- GROW model.



## 4.3. Clean Water Act Programs

Ziram is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 5 

### No Total Maximum Daily Load (TMDL) criteria have been developed for ziram. 6 

### Aquatic life benchmarks have been established for ziram and are
available at http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm . Any data submitted or otherwise located as part of the registration review process may be used to up date aquatic life benchmarks if applicable.



# 5. Environmental Fate and Transport

Ziram ( Zinc bis (dimethyldithiocarbamate)) is slightly to moderately persistent in the environment with exposure to the degradate thiram ( tetramethylthiram disulfide) extend ing the duration of exposure. Generally ziram degrades rapidly via hydrolysis and photodegradation.

D egradation is somewhat slower in aerobic soil and slower still in anaerobic soil and water. Half

lives are generally from a few days to a few weeks in soil and water; field studies show some residues may persist for months after application. Thiram degrades by similar pathways as ziram

, but hydrolysis, aerobic metabolism, and anaerobic metabolism tend to be somewhat slower than
for ziram

.

Hydrolysis of zira m is pH dependent, with hydrolytic decomposition being faster at the lower pH

values . The calculated half

- lives were 0.173, 17.7, and 151 hours (

∼ 6 days) at pH’s 5, 7, and 9, respectively. Study periods for hydrolysis were ≤72 hours for the pH 5 and 7 buff ered solutions, for the pH 9 buffered solution, the study period was 30 days. It is noted that the major product in the pH 9 solution is not a true degradation or decomposition product.

In aqueous photolytic conditions, ziram degraded with a half

- life of 8.7 hours, as opposed to the dark control that did not degrade substantially during the same study period (24 hours).

In a soil photolysis study, ziram was applied at two treatment rates of approximately 15 and 3 ppm to sandy loam soil samples that were incubated aerobically for up to 72 hours. Both irradiated treatment rates show similar degradation half

- life of ziram at about 8

- 9 hours. In contrast, the dark controls had half

- lives of about 16

- 24 hours. The soil was acidic, which may have promoted hydr olysis and confounded the results. It is acknowledged, however, that in water, photolysis is also important. This is an indication that on soils, it may be important too. The dark control showed much slower degradation rates than the exposed sample.

5 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

6 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant _group_name=PESTICIDESPage 10 of 57 

### In a n aerobic sandy loam soil study, ziram dissipated with a half

- life of 1.75 days. Samples were incubated for up to 60 days. EFED has some concerns regarding the results obtained from this study because it was also conducted on a soil at a lower pH (5.4). Th is pH may raise the rate of degradation of ziram by promoting hydrolysis. However, the major degradate observed in this study, 1,1

- dimethylurea (10.5% at day 30) was not observed in the hydrolysis study, and the degradates observed in the hydrolysis study were not present in large quantities in this study. Therefore, hydrolysis is likely not affecting the rate in this study. In the study, seven minor degradates were detected (<10%) and CO 2 

### accounted for 48.3% of the applied at 60 days.

In an anaerobic soil metabolism study, ziram was applied to an aerobic sandy loam soil and incubated for one day, after which approximately 1⁄3 of the radioactivity was undegraded parent. The samples were then flooded and submitted under a nitrogen atmosphere. It was found tha t under anaerobic conditions ziram degraded at a decreased speed, compared to the aerobic
conditions. The half

- life was 14.1 days under anaerobic conditions. Up to 10 minor degradates (at <10%) were detected. At the end of the 30 day anaerobic incubation, 35.2% of the applied

was CO 2



### .

Observed half

- lives (0.17

- 42 hours) are generally fast under the expected use condition, generating major volatiles such as carbon disulfide (CS 2 

### ), carbon dioxide (CO 2 

### ), and carbon oxide sulfide or carbonyl sulfide (COS). La boratory studies suggest that ziram hydrolyzed very rapidly and yielding CS 2 

### (≥80% of applied ziram) at pH 5 and pH 7 but degraded (t 1/2 

### =151 hours) moderately at pH 9. Nonvolatile metabolite thiram (13.8% of applied ziram) at pH 7 and DDC (≈67.0 % of appli ed ziram) at pH 9 were also formed during the hydrolysis experiments. Other major persis tent degradation products (≥18% ) of ziram were identified as DMF and DMTF in aqueous and soil photolysis studies. D egradation is somewhat slower in aerobic soil
and slo wer still in anaerobic soil and water. Half

- lives are generally from a few days to a few weeks in soil and water; field studies show some residues may persis t for months after application.

Rapid degradative processes of parent ziram suggest that it would not persist in environment. However, in alkaline medium, ziram and its nonvolatile metabolites dimethyldithiocarbamic acid (DDC), N.N

- dimethylformamide (DMF), and N.N

- dimethylthioforamide (DMTF) are likel y to be more persistent . The uncertainties related t o the persistence of DDC, DMF, and DMTF could be a concern for the soils of arid and semiarid regions.

Laboratory and field data suggest that ziram is not very mobile, and neither leaching nor volatility are expected to play an important role in the diss ipation of ziram. The degree of adsorption of ziram in the studied soils was found not to be a function of the amount of organic matter (r 2 

### = 0.31) rather than the amount of clay contents (r 2 

### = 0.96) of the soils. Volatilization is not expected to be a maj or route of dissipation due to ziram’s low vapor pressure. The major degradates of ziram are volatiles, and are not expected to persist in soil or water. Therefore, subsurface mobility of ziram will be minimal.

In terrestrial dissipation studies, ziram ( Ziram 76DF ® 

### ) dissipation appeared to be biphasic, with faster degradate initially following application, followed by a slower degradat ion until the end of the study. Required data for aquatic dissipation and bioaccumulation are not available for ziram,
how ever, a rapid hydrolysis of ziram under a neutral pH suggests that ziram would not persist long enough in water to cause substantial bioaccumulation in aquatic species.Page 11 of 57 

### Table 3 summarize s the chemical and environmental fate properti es of ziram. A detailed description of the available data can also be found in Appendix C

. Details on the chemical properties and environmental fate parameters of the major degradate thiram can be found in the thiram problem formulation (USEPA, 2015).

Tab le 3

. Chemical Properties and Environmental Fate Parameters of Ziram

Parameter Value Description Source

Selected Physical/Chemical Parameters

Molecular mass (molecular formula) 305.8 g/mol

( C 6 H 12 N 2 S 4 Zn) NA (Calculated)

Vapor pressure ( 25 °C) 0.018 mPa L ow potential for
volatilization PPDB

Aqueous solubility (2 0 ° C) 0.97 mg/L Soluble PPDB

Henry’s Law Constant (2 0 °C) 5.6 x 10

- 8 Pa

- m 3 /mol

2. 3 x 10

- 6 (dimensionless) Low potential for
volatilization (Calculated)

Log octanol

- to

- water partition coefficient (l og K OW ) 1.65 Moderately hydrophobic PPDB

Persistence

Hydrolysis half

- life (2 5 ° C) pH 5: 0.07 d pH 7: 0.74 d pH 9: 6.3 d Rapid degradation MRID 43866701

Aqueous photolysis half

- life (25 ° C) 0.43 d Rapid degradation MRID 44097701

Soil photolysis half

- life (25 ° C) 0.3 d Rapid degradation MRID 43642501

Aerobic soil metabolism half

- life (25°C) 3.5, 4.4, 4.9, 5.3 d Rapid degradation MRI Ds 43985801, 46622302,
47005202

A na erobic soil metabolism half

- life (25 ° C) 14.1 d NA MRID 44228402

A erobic aquatic metaboli sm half

- life (water column) (25 ° C) River 0.3 d (DT 90 = 1.0 d)

Pond 0.2 d (DT 90 = 0.7 d) Rapid degradation in water column; ziram
not detected in
sediment. MRID 46045903

A na erobic aquatic metabolism half

- life (25 ° C) NA NA NA

Mobility

Freundlich soil

- wate r partition coefficients (K F ); organic carbon

normalized Freundlich coefficients (K FOC ) Kd: 5.7 ml/g (2.9

- 68.1)

Koc: 314

- 3732 ml/g Slightly to moderately
mobile MRID 43873501

NA: Not AvailablePage 12 of 57 

## 5.1. Transformation Products

The main decomposition products of hy drolysis observed for ziram are volatile: CS 2 

### (maximum of 96.8% of the applied after 1 hour in the pH 5 solution, 81.6% at 72 hours in the pH 7 solution, and 16.43% at 21 hours in the pH 9 solution) and COS (maximum of 18.6% of the applied 30 days after tr eatment in the pH 9 solution). One non

- volatile product is DDC (appeared to be a transient component, it was 11.6% at 0.117 hour in the pH 5, but decreased substantially by 1 hour post

- treatment, at 0.15%; it was also present in the pH 9 solution at a maxi mum of 66.7% at 30 days post

- treatment). DDC is not a true degradation product of ziram, but an analogous salt. Thiram, another major, non

- volatile hydrolysis product is often formed rapidly and is of toxicological concern. Thiram was found to be up to 13. 78% of the applied at 4 hours post

treatment in the pH 7 solution. It had decreased to 11.0% by 72 hours, the final test interval.

In an aqueous photolysis study, about 15 degradates were observed during the study period. The major degradates (>10%) after 24 hours of irradiation were DMF (N,N

- dimethylformamide: 23.7% of the applied), and DMTF (N,N

- methylthioformamide: 18.1% of the applied). The patterns of formation/decline of these degradates did not reveal whether they would persist or degrade after 24 h ours under the described experimental conditions.

In the soil photolysis study, degradate profiles are similar (up to 10 degradates). The only degradate at >10% was thiram, at 2 7.3 % in the 24 hour study. However, the pattern of
formation/decline of thiram suggests that the level was declining toward 10%. Also, the persistence of thiram oxide was considered to be an artifact of the test solvent acetonitrile (CH 3 

### CN).

In the aerobic sandy loam soil study described above, the major degradate observed was 1,1

- dimethylurea (10.5% at day 30). Seven minor degradates were also detected (<10%) and CO 2 

### accounted for 48.3% of the applied at 60 days.

Ziram ’s major degradates are detailed in Table 4

.Page 13 of 57 

### Table 4

. Ziram and Its Environmental Transformation Products

Code Nam e/ Synonym Chemical Name Chemical Structure Study Type MRID Maximum %AR (day) A Final %AR (study length)

PARENT

Ziram Zinc bis (dimethyldithiocarbamate)

CAS No.: 137

- 30

- 4

C 9 H 18 FeN 3 S 6

Formula: C 6 H 12 N 2 S 4 Zn
MW: 305.813 g/mol

MAJOR TRANSFORMATION PROD UCTS

Thiram T etramethylthiram disulfide

CAS No.: 137

- 26

- 8

Formula: C 6 H 12 N 2 S 4 MW: 240.43 g/mol Hydrolysis 43866701 13.8% (4 hrs) 11.0% (72 hrs) 72 hours

Soil photolysis 44228041 Sandy Loam

27. 3 % (24 hrs ) 24 hours

Aerobic soil 46622302 49.4 % (1 hr )

0 .3% (28 days ) 28 days

Anaerobic soil 44228402 1.03 % (0 days)

0 .41 % (30 days) 30 days

Terrestrial Field

Dissipation 44548301

44548302
46545601 Sand (NC)

Sandy Loam (CA)

Aerobic aquatic 46045903 47.5% (6 hrs) 2.3% (7 days) 101 days

DDC D imethyldithiocarbamic acid Hydrolysis pH 5 43866701 11.6% (0.12 hrs) 0.15 % (1 hr) 72 hours

DMTF N,N

- methylthioformamide Soil Photolysis 44228401 3.06% (16 hrs ) 2.99% (24 h rs) 24 hours

Aqueous Photolysis 44097701 1 8.1% (18 h rs ) 24 hoursPage 14 of 57 Code Nam e/ Synonym Chemical Name Chemical Structure Study Type MRID Maximum %AR (day) A Final %AR (study length)

DMF N,N

- dimethylformamide Soil Photolysis 44228401 4.51% (24 hrs ) 24 hours

Aqueous Photolysis 44097701 23.7 % (24 h rs) 24 hours

COS Carbonyl sulfide Hydrolysis pH 9 43806701 18.6% (30 days) 30 days

1,1

- dimethylurea 1,1

- dimethylurea Aerobic Soil 4398580 1 10.5% (30 days) 5.25% (60 days) 60 days

CS 2 Carbon disulfide Hydrolysis pH 5 Hydrolysis pH 7 43866701 96 .8% (1 hr) 86.6% (72 hrs ) 72 hours

CO 2 Carbon dioxide Aerobic Soil 43985801 48.3% (60 d ays ) 60 days Aerobic Aquatic 46045903 82.3% (101 d ays ) 101 days

### 15 

# 6. Receptors

Table 5 and Table 6 provide a summary of the aquatic and terrestrial taxonomic groups, respectively, and most sensitive surrogate species tested to characterize the potential acute and chronic ecological effects of ziram

. A complete list of the ecotoxicity data available for ziram, major degradate thiram

, and the related dithiocarbamate ferbam can be found in Appendix D

. Discussion of available thiram toxicity data and tables of the most sensitive endpoints for thiram
can be found in the thiram problem formulation (USEPA, 2015).



## 6.1. Effects to Aquatic Organisms

Ziram is highly to very highly toxic to freshwater and estuarine/marine fish and aquatic invertebrates on an acute exposure basis. Chronic effects on growth and reproduction are seen consistently across tested aquatic species with a NOAEC of approximately 0.02 mg a.i./L. The
fathead minnow LC 50 

### value is an order of magnitude lower than the NOAEC value from the full life cycle study. The daphnid and mysid LC 50 

### values are both very close to the chronic NOAEC
value s for those species. These results are unusual, and the explanation is not clear based on the information available in the study reports and DERs. Probit s lopes for the daphnid and mysid

acute data were 2.0 and 2.3, respecti vely. No slope is available for the fathead minnow study. The acute studies in question were all performed in the early 1990s, while the chronic studies were performed between 2006 and 2008. Differences in analytical methods between these time periods may provide some explanation. Additional information to clarify these inconsistencies in the aquatic toxicity data is requested.

Effects on biomass were observed on tested vascular and non

- vascular aquatic plant species.

Table 5

. Summary of Most Sensitive To xicity Endpoints for Aquatic Organisms Exposed to Ziram

Taxonomic

Group Study Type Test
Substance

(% a.i.) Surrogate Species Toxicity Value

measured mg a.i./L (Acute Toxicity Category or Most Sensitive Endpoints ) MRID and Study
Classification

Aquatic Ver tebrates

Freshwater
fish Acute TGAI (99.0%) Fathead minnow ( Pimephales promelas ) 96

- hr LC 50 = 0.008 (Very highly toxic) 05003523 Supplemental

Chronic (Early

- l ife

Stage) TGAI (98.2%) Fathead minnow 3 3

- d NOAEC = 0.101

33

- d LOAEC = 0.195 (Post

- hatch survi val) 46893104 Acceptable

Chronic (Full Life

Cycle) TGAI (98.2%) Fathead minnow 275

- d NOAEC 0.024

275

- d LOAEC = 0.051 (F 0 length and weight) 47435501 Supplemental

Estuarine/
marine fish Acute TGAI (98.9%) Sheepshead Minnow ( Cyprinodon variegat u s ) 96

- hr L C 50 = 0.84 (Highly toxic) 43781601 Acceptable

Chronic TGAI (98.2%) Sheepshead Minnow 3 4

- d NOAEC = 0.027
34

- d LOAEC = 0.058 (Larval length and dry weight) 46856401 Acceptable

### 16 Taxonomic

Group Study Type Test
Substance

(% a.i.) Surrogate Species Toxicity Value

measured mg a.i./L (Acute Toxicity Category or Most Sensitive Endpoints ) MRID and Study
Classification

Aquatic Invertebrates

Freshwater
invertebrates Acute TGAI (98.9%) Water Flea ( Daphnia magna ) 48

- hr EC 50 = 0.048 (Very highly toxic) 42386305 Acceptable

Chronic TGAI (98.2%) Water Flea 21

- d NOAEC = 0.039

21

- d LOAEC = 0.078 (Length) 46823301 Acceptable

Estuarine/

marine
invertebrates Acute (Shell Deposition) TGAI (98.0%) Eastern Oy ster ( Crassostrea

virginica ) 96

- hr EC 50 = 0.077 (Very highly toxic) 43781602 Acceptable

Acute TGAI (98.0%) Mysid Shrimp ( Mysidopsis bahia ) 96

- hr LC 50 = 0.014 (Very highly toxic) 43781603 Acceptable

Chronic TGAI (98.2%) Mysid Shrimp 27

- d NOAEC = 0.016

2 7

- d LOAEC = 0.027 (Reproduction and dry weight) 46893103 Supplemental

Aquatic Plants

Aquatic plants and algae Vascular TGAI (98.2%) Duckweed ( Lemna gibba ) 7

- d NOAEC = 0.0 3 5

7

- d EC 50 = 0.37 (Biomass) 46823302 Acceptable

Non

vascular TGAI (98.0%) Green A lgae ( Pseudokirchneriella subcapitata ) 120

- hr NOAEC < 0.038
120

- hr EC 50 = 0.067 (Biomass) 43833901 Acceptable



## 6.2. Effects to Terrestrial Organisms

Ziram is moderately toxic to birds and mammals on an acute exposure basis. In chronic studies,
the most sensi tive endpoints for birds were measures of reproductive output and viability while the most sensitive endpoints for mammals were growth related. Toxicity studies on birds may provide some insight into whether ziram’s repellency properties for rabbits also a pply to birds. A decrease in body weight and food consumption was observed for the first week following dosing in the avian acute oral study on the bobwhite quail (MRID 41725701). Decreases in body weight gain were observed in dietary studies on both the b obwhite quail (at 2600 mg/kg

- diet) and
mallard duck (at 650 mg/kg

- diet, the lowest concentration tested) (MRIDs 42386301

, 42386302). These effects were more pronounced and observed at lower doses for the mallard duck than for the bobwhite quail. Effects on body weight and food consumption were not observed in the avian reproduction study on the mallard duck , which was conducted at concentrations up to 64 mg/kg

- diet (MRID 47286501 ). No acceptable avian reproduction study is available for the bobwhite quail.

Ziram is practically non

- toxic to honey bees on an acute contact exposure basis. No other toxicity data are available for terrestrial invertebrates.

Minimal effects were observed in Tier I terrestrial plant toxicity tests, including a 16% reduction
in soybean height in the seedling emergence study and 12 and 13% reductions in tomato and ryegrass dry weight, respectively, in the vegetative vigor study.

### 17 Table 6

. Summary of Most Sensitive Toxicity Endpoints for Terrestrial Organisms Exposed to
Ziram

Taxon omic

Group Study Type Test
Substance

(% a.i.) Surrogate Species Toxicity Value
measured a.i. (Acute Toxicity Categor y or Most Sensitive Endpoints ) MRID and Study
Classification

Birds Acute Oral TGAI (98.5%) Bobwhite quail ( Colinus virginianus ) LD 50 = 97 mg/kg

- bw (Moderately toxic) 41725701 Acceptable

Sub

- acute

dietary TGAI (98.5%) Mallard duck ( Anas platyrhynchus ) LC 50 = 5156 mg/kg

- diet (Practically non

- toxic) 42386302 Acceptable

Chronic TGAI (98.8%) Mallard duck NOAEC = 29 mg/kg

- diet LOAEC = 64 mg/kg

- diet Eggs set, eggs set/eggs laid, embryo viability, hatchability,14

- day survivors/
eggs set 47286501 Acceptable

Mammals 1 Acute Oral TGAI (98.5%)

Laboratory rat ( Rattus norvegicus ) LD 50 = 320 mg/kg

- bw (Moderately toxic) 41340401 Acceptable

Acute
Inhala tion TGAI (98.5%) LC 50 = 0.06 mg/L (Toxicity Category II) 41442001 Acceptable

Chronic (2

- generation reproduction) TGAI (97.8%) NOAEC=14.8 mg/kg

- bw/day LOAEC=37.5 mg/kg

- bw/day (F0 & F1 body weight, body weight gain, food

consumption) 43935801 Acceptable

Terrestrial
Invertebrates Acute

contact TGAI (98.5%) Honey bee ( Apis mellifera ) 48

- hr LD 50 > 200 μg/bee (Practically non

- toxic) 41667901 Acceptable

Terrestrial

Plants Seedling Emergence TEP (76.6%) Monocot: None NOAEC > 6.0 lb/A

IC 25 > 6.0 lb/A

(No effects) 46893101 Acceptable Dicot: Soybean NOAEC < 6.0 lb/A

IC 25 > 6.0 lb/A (Height)

Ve getative Vigor TEP (76.6%) Monocot: Ryegrass NOAEC < 6.1 lb/A

IC 25 > 6.1 lb/A

(Dry weight) 46893102 Acceptable

Dicot: Tomato NOAEC < 6.1 lb/A

IC 25 > 6.1 lb/A

(Dry weight)

1 Mammalian toxicity endpoints are provided and reviewed by the U.S. EPA Office of Pesticide Programs Health
Effects Division (HED).



## 6.3. Ecological Incidents

The ecological incident information system (EIIS) is an OPP database that houses ecological
incidents that ha ve 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, and results of any chemical residue analysis or other analyses conducted during incident investiga tion. EIIS incidents are categorized

### 18 according to the certainty that the incident resulted from pest icide exposure. The Avian Monitoring System (AIMS) is a database administered by the American Bird Conservancy that contains publicly available data on repo rted avian i ncidents involving pesticides. Many of the
incidents listed in this database are also in the EIIS. Additionally, the U.S. EPA Office of Pesticide Progr ams Incident Data System (IDS) compiles aggregate incidents reported to the agency. These rep orts do not include detailed information about the incidents. An absence of reports does not necessarily equate to an absence of incidents given the nature of incident reporting.

EIIS returned one terrestrial plant incident in California attributed to zir am with “possible” certainty. Incident I013563

- 012 occurred in March 1999 when a registered agricultural use of ziram was applied to apricots, along with the fungicide fenbuconazole. Forty acres of apricots were damaged, resulting in a loss of yield.

As of March 30, 2015, AIMS identified no ecological incidents involving ziram.

Registrants reported one aggregate plant incident with ziram in 2002 . Unless additional
information on this aggregated incident becomes available, it will be assumed to be

repre sentative of registered uses of ziram in the risk assessment.



# 7. Exposure Pathways of Concern

The environmental fate properties and use patterns of ziram indicate that direct spray, spray drift,
and runoff represent potential transport mechanisms to aqu atic and terrestrial organisms. Drinking water and inhalation exposure pathways were screened using the SIP (Screening Imbibition Program) and STIR (Screening Tool for Inhalation Risk) screening methods . SIP results indicated that drinking water alone is not a potential exposure pathway of concern for
birds or mammals (see Appendix A ). STIR results showed t hat droplet inhalation may be an exposure pathway of concern for both birds and mammals, but exposure via vapor inhalation is not likely to be significant (s ee Appendix B ). SIP and STIR are described in detail at: http://www.epa.gov/oppefed1/models/terrestrial/index.htm

.



# 8. Analysis Plan

8.1. Stressors of Concern

Ziram and its major degradate thiram, which is also a registered active ingredient (PC 079801), are the stressors of concern for both the ecological and drinking water risk assessments for registration review. Thiram is the only major degradate of ziram expected to maintain the
toxicit y of the parent compound. The degradates COS, CS 2 

### , and CO 2 

### , are volatile compounds and are not expected to persist in water or soil. CS 2 

### may cause respiratory distress to wildlife in
the immediate area if it is if inhaled. 7 

### This exposure pathway for CS 2 

### wi ll be considered in the
risk assessment.

7 See http://www.epa.gov/ttnatw01/hlthef/carbondi.html#ref1 and

### 19 

## 8.2. Measures of Exposure

Conventional Uses

EFED will use standard available models to evaluate potential exposures to aquatic and terrestrial organisms as described at http://www.epa.gov/oppefed1/models/water/index.htm and http://www.epa.gov/pesticides/science/models_db.htm

. A cute exposure will be assessed with modeling inputs based on parent ziram properties (acute exposure estimates to thiram are substantially less) and c hronic exposure will be assessed by assignment of the fate properties of
thiram to the total residues of concern. Th is methodolo gy provides a protective assessment of chronic exposure for chronic risk.

T he Surface Water Concentration Calculator (SWCC) is currently the model typically use d to estimate aquatic exposure. T

- REX and TerrPlant are currently models typically used to esti mate terrestrial exposure. Ziram’s use as a rabbit repellent and thiram’s use as a rabbit, rodent, and deer repellent will be considered when characterizing potential exposure to terrestrial animals.

See Section 6.2 of the thiram problem formulation (USEPA , 2015) for details on the available toxicity data addressing the repellent properties of thiram to avian species.

In addition, E

- FAST may be used to assess industrial uses of ziram as an antimicrobial. E

- FAST
is described in detail at http://www.epa.gov/oppt/exposure/pubs/efast.htm

.

Ziram has not be detected in either surface or groundwater in the USGS NAWQA or other monitoring programs. Rapid hydrolysis makes detection in water unlikely.

A ntimicrobial Uses

The only label for with antimicrobial uses of ziram is Reg. No. 45728

- 14, which contains uses in latex paint (0.98

- 2.94 % ai w/w) , paper and paperboard (surface treatment at 0.49 % ai w/w)

, paper coatings at 0.098 % ai w/w) , adhesives (fo r packaging at 0.18

- 0.49 % ai w/w) , industrial yarns and fabrics (1.23 % ai w/w) , dried films (e.g. caulk and grout at 0.18

- 0.49 % ai w/w ), and wall board (for short

- term spoilage protection at 0.39

- 0.49 % ai w/w)

. Based on the summary of registered uses of Ziram from Reg. No. 45728

- 14 and the chemical, physical, and environmental fate properties in Table 3

, the Agency has developed conceptual model diagrams for exposure of ecological organisms to ziram. Ziram is related to t he dimethyl dithiocarbamate compounds

t hiram and f erbam ; it generally degrade s rapidly, is associated with water in the presence of sediment, and do es not significantly move from water or soil into air by volatility. In a WWTP

, the primary route o f dissipation is expected to be hydrolysis, which primarily forms dimethylamine (DMA) and carbon disulfide (CS 2 

### )

. DMA is considered to be an inert material for

non

- food uses 8 

### and CS 2 

### is volatile and moves from water into air.

Chemicals that are releas ed down

- the

- drain can typically take from a few to several hours to reach wastewater treatment plant intakes following their discharge and from several hours to

http://www.atsdr.cdc.gov/toxprofiles/tp.asp?id=474&tid=84 for additi onal information on carbon disulfide.

8 http://iaspub.epa.gov/apex/pesticides/f?p=INERTFINDER:3:0::NO::P3_ID:7544

### 20 roughly a day following their discharge down

- the

- drain to subsequently be discharged from

waste water treatment plants to surface water. Data on WWTP dissipation have not been submitted for ziram, however, the primary routes of dissipation are expected to be partitioning to water with some degradation and subsequent outflow in effluent.

The Agenc y has created conceptual models for potential routes of environmental exposure which are included in “Conceptual Models for Environmental Exposure Pathways of Antimicrobial
Pesticides ,” (EPA

- HQ

- OPP

- 2014

- 0638

- 0002), found in the docket at www.regulations.gov

, EPA

- HQ

- OPP

- 2014

- 0638

. The Agency does not consider the wall board or treated adhesives in packaging uses to create environmental exposure because the treated materials are not anticipated to come into contact with water.

Use sites and corresponding figures of conceptual model diagrams are as follows:

• Industrial yarns and fabrics (slide 1 6 )

• Dried film s ( e.g., caulks, sealants, slide 18)

• Paint preservation (slides 24 and 25)

• Paper manufacturing (slide 26)



## 8.3. M easures of Effect

Toxicity data presented in Section 6 of this problem formulation will be used to calculate risk quotients. T oxicity data for the major degradate thiram wi ll also be used for chronic risk quotients when the endpoints are more sensitive than those for ziram . Thiram toxicity data can be
found in Appendix D and in the thiram problem formulation for registration review ( USEPA,
2015 ). Any additional information s ubmitted by the registrant or found in the open literature prior to con duct of the risk assessment will also be considered. The open literature studies are identified using EPA’s ECOTOXicology database ( ECOTOX) (USEPA, 2007), which employs a
literature sea rch 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.



## 8.4. Endangered Species Assessments

Consistent with EPA’s responsibility under the Endangered Species Act (ESA), the Agency will

eva luate 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) re port, 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

pes ticide risk assessments that EPA and the Services must conduct in connection with their obliga tions under the ESA and FIFRA. EPA will address concerns specific to ziram in connection with the development of its final registration review decision for ziram.

### 21 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 Int erim 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 o f 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 N ational 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 ziram does not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conduct ed during registrati on review. While the agencies continue to develop a common method for ESA analysis, the planned risk assessment for the registration review of ziram will describe the level of ESA analysis completed for this particular registration review case. This assess ment 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 implemented t he scientific methods necessary to complete risk assessments for listed species and their designated critical habitats, these methods will be applied to subsequent analyses of ziram as part of completing this registration review.



## 8.5. Endocrine Disruptor Scree ning Program

Ziram was not included in the first group of 67 chemicals issued an orde r to conduct Tier 1 EDSP testing . Ziram is on the second list of chemicals for Tier 1 screening

. For additional information the EDSP program, visit http://www.epa.gov/endo/

.



# 9. Preliminary Identification of Data Gaps

9.1. Environmental Fate

Table 7 identifies environmental fate studies by MRID that offer data for each guideline requirement, as wel l as study classifications and whether or not further data are needed in order to support risk assessment.

Independently validated environmental chemistry methods (ECM/ILV) for measuring thiram in soil and water are available. While separate methods are not available for ziram itself, the thiram methods are fully adequate to assess residues from a ziram treated field.

### 22 Table 7 . Submitted Environmental Fate Data for Ziram

OCSPP
Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are Additional

Data Needed to
Conduct Risk
Assessment?

835.2120 Hydrolysis 43866701 Acceptable No

835.2240 Aqueous photolysis 44097701 Acceptable No

835.2410 Soil photolysis 43642501 Acceptable No

835.4100 Aerobic soil metabolism 43985801
46622302 Acceptab le Supplemental No

835.4200 Anaerobic soil metabolism 44228402 Acceptable No

835.4300 Aerobic aquatic metabolism 46045903 In Review Only if study in
review is found to be unacceptable.

835.4400 Anaerobic aquatic
metabolism None NA No

835.1230

835.1240 Adsorption/ desorption and leaching 43873501 Acceptable No

835.6100 Terrestrial field dissipation 44548301

44548302
46545601 Supplemental Supplemental

Acceptable No

850.1730 Fish bioconcentration None NA No

850.6100 Analytical method in soil None NA No Analytical method in water None NA



## 9.2. Effects

Table 8 and Table 9 identif y ecological effects studies by MRID that offer data for each guideline requirement, as well as s tudy classifications and whether or not further data are needed in order to support risk assessment. Rationale for the additional non

- guideline data requested is presented below the tables.

Table 8

. Submitted Aquatic Ecological Effects Data for Ziram

OCS PP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are Additional

Data Needed to
Conduct Risk
Assessment? Current Additional Data

Need

850.1010 Freshwater
invertebrate acute toxicity 42386305 Acceptable No None 1
47405701 Accep table

850.1025
850.1035

850.1045

850.1055 Saltwater
invertebrate acute toxicity 40228401 Supplemental

No None 1 43781602 Acceptable

43781603 Acceptable

47405702 Acceptable

850.1075 Freshwater fish acute toxicity TN 1021 Supplemental

No No ne 1 00138214 Supplemental

00138215 Supplemental

### 23 OCS PP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are Additional

Data Needed to
Conduct Risk
Assessment? Current Additional Data

Need

05003523 Supplemental

42386303 Acceptable

42386304 Acceptable

47307901 Acceptable

850.1075 Saltwater fish acute toxicity 40228401 Supplemental No None 43781601 Acceptable

850.1300 Freshwater
invertebrate

life cycle 46823301 Acceptable No None 1

850.1350 Saltwater
invertebrates

life cycle 46893103 Supplemental No None 1

850.1400 Freshwater fish early

- life stage 46893104 Acceptable No None 1

850.1400 Saltwater fish early

- life stage 46856401 Acceptable No None

850.1500 Fish life cycle 47435501 Supplemental No None 1

850.1735 Whole sediment 10

- d
freshwater
invertebrate None NA No None. Ziram is not expected to accumulate in
sediment.

850.1740 Whole sediment 10

- d
estuarine/mari ne

invertebrate None NA No None. Ziram is not expected to accumulate in
sediment.

850.4400 Aquatic plant Toxicity Test using Lemna spp. 46823302 Acceptable No None

850.4500 Algal toxicity 43833901 Acceptable Yes Studies with two additional species will

r educe uncertainty in the
assessment of risk to non

vascular plants . Suggested species are the freshwater
diatom Navicula pelliculosa and the marine
diatom Skeletonema

costatum

.

850.4550 Cyanobacteria None NA Yes A cyanobacteria will reduce uncertainty in the
assessment of risk to non

vascular plants.

1 The acute endpoints for freshwater fish and freshwater and estuarine/marine invertebrates are lower or approximately equal to the chronic NOAEC values for those taxa. Additional information to clarify these inconsistencies in the aquatic toxicity data is requested.

### 24 Table 9

. Submitted Terrestrial Ecological Effects Data for Ziram

OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are Additional

Data Needed to
Conduct Risk
Assess ment? Current Additional

Data Need

850.2100 Avian oral toxicity 41725701 Acceptable Yes A study with a passerine species will reduce uncertainty in the
assessment of risk to
birds

.

850.2200 Avian dietary toxicity 42386301 Acceptable No None 42386302 A cceptable

850.2300 Avian reproduction 47286501 Acceptable No None. While no acceptable data are
available for bobwhite quail, studies of other
dithiocarbamates indicate
that the mallard is more
sensitive.

Non

guideline Avian inhalation None NA No While STIR indicated a potential risk to birds from droplet inhalation, this exposure pathway is

expected to be minor compared to dietary exposure and a study is not requested at this time.

850.3020 Honey bee acute contact toxicity 00036935 Acceptable No None 41667901 Acceptable

850.3030 Honey bee residue on foliage None NA No None. Acute contact toxicity endpoint is >11 μg/bee.

850.3040 Field testing for pollinators (Tier III) None NA Yes See justification tables
below for additional
details.

Non

guide line

(Tier I) Honey bee adult acute oral toxicity None NA Yes An adult acute oral study will reduce uncertainty in

the risk assessment for pollinators. See justification tables below

for additional details.

Non

guideline

(Tier I) Honey bee larvae

acute to xicity None NA Yes A larvae acute study will reduce uncertainty in the
risk assessment for

pollinators. See justification tables below

for additional details.

### 25 OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are Additional

Data Needed to
Conduct Risk
Assess ment? Current Additional

Data Need

Non

guideline

(Tier I) Honey bee adult chronic 10d toxicity None NA Yes An adult chronic oral

s tudy will reduce uncertainty in the risk
assessment for pollinators. See justification tables below

for additional details.

Non

guideline

(Tier I) Honey bee larvae chronic toxicity None NA Yes A larvae chronic study will reduce uncertainty in

the risk ass essment for pollinators. See justification tables below

for additional details.

Non

guideline (Tier II) Semi

- field testing for pollinators (tunnel or colony feeding studies) None NA Yes See justification tables
below for additional
details.

Non

guidelin e (Tier II) Field trial of residues in pollen
and nectar None NA Yes See justification tables
below for additional
details.

850.4100 Seedling Emergence 46893101 Acceptable Yes Studies are needed at the maximum application rate
of 7.6 lb a.i./A. The previo usly submitted
studies were conducted at
6.1 lb a.i./A. Effects seen
in those studies and incident reports indicate

that risk to terrestrial plants may be a concern. 850.4150 Vegetative Vigor 46893102 Acceptable Yes



### Study Title: Pollinator Acute Oral Toxicity, Adult Rationale for Requiring the Data Terrestrial invertebrates are likely to be impacted if exposed to pesticides in various use settings. Pesticide residues may be transferred to pollen and/or nectar of treated plants and subsequently broug ht back to the hive. Therefore, potential acute effects to adult honeybees and other pollinators from oral exposure to some pesticides could exist. Currently available toxicity studies do not address possible effects of oral exposure on adult terrestrial i nsect 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 honeybees and other insect pollinators.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for terrestrial invertebrates using the honeybee as a surrogate test species. The guidance discusses Tier I laboratory

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

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

- protection/pollinator

- risk

-

### 26 assessment

- guidance . Additional guidance on the honeybee oral toxicity test design can be found in

OECD Test Guideline 213 http://www.oecd

- ilibrary.org/environment/test

- no

- 213

- honeybees

- acute

oral

- toxicity

- test_9789264070165

- en

. Practical Utility of the Data

How will the data be used?

The Tier I acute oral toxicity d ata on adult bees serve as a foundation for the screening

- level assessment of potential risk to non

- target organisms such as federally listed threatened or endangered

and non

- listed terrestrial invertebrate insects, including po llinators, from acute 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

effects on a broad range of taxa. This study will also provide information with which to compare whether oral toxicity estimates differ from contact toxicity estimates obtained from other Tier I studies. If acute oral effects data for adult honeybees and insect pollinators 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 registr ation 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 pre sume risk which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in use restrictions.

Study Title: Pollinator Acute Oral Toxicity, Larvae Rationale for Requiring the Data

Terrestrial invertebrates ar e likely to be impacted if exposed to pesticides in various use settings. 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 adverse effects to developing bees and other insect pollinators 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 poll en 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 bee brood.

The Office of Pesticide Programs has made available a guidance regard ing ecological testing for terrestrial invertebrates using the honeybee as a surrogate test species. The guidance discusses Tier I laboratory

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

- level risk ass essment 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 guidance on larval honeybee toxicity test design can be found in OECD Test

Guideline 237 http://www.oecd

- ilibrary.org/environment/test

- no

- 237

- honey

- bee

- apis

- mellifera

- larval

toxicity

- test

- single

- exposure_9789264203723

- en

. Practical Utility of the Data

How will the data be used? The Tier I acute oral toxicity d ata on honeyb ee larvae serve as a foundation for the screening

- level assessment of potential risk to non

- target organisms such as federally listed threatened or endangered

and non

- listed terrestrial invertebrate insects, including pollinators, and/or modify their desig nated critical habitat from acute 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 effects on terrestrial spe cies and whether there is a differential sensitivity of larval bees

### 27 relative to adult bees. If acute oral effects data for larvae are not available, risks to terrestrial insects from acute oral exposure will be assumed.

How could the data impact the Agenc y’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 affec t 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 res trictions.

Study Title: Pollinator Chronic Oral Toxicity, Adult Rationale for Requiring the Data Terrestrial invertebrates are likely to be impacted if exposed to pesticides in various use settings. Pesticide residues may be transferred to pollen an d/or nectar of treated plants and subsequently brought back to the hive. Therefore, potential chronic effects to adult honeybees and other pollinators from oral exposure to some pesticides could exist. Currently available toxicity studies do not address po ssible 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. 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 chronic oral toxicity of this compound to adult honeybees and other pollinators.

The Office of Pesticide Programs has made available a gu idance regarding ecological testing for invertebrates with the honeybee. The guidance discusses Tier I laboratory

- based chronic oral toxicity studies of individual adult honeybees as a critical component of the screening

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

- protection/pollinator

- risk

- assessment

- guida nce . Study design elements

for the chronic 10

- day oral toxicity test with honeybees are similar to the OECD Test Guideline 213 acute oral toxicity test http://www.oecd

- ilibrary.org/environment/test

- no

- 213

- honeybees

- acute

- oral

toxicity

- test_9789264070165

- en

. Practical Utility of the Data

How will the data be used? The Tier I chronic oral toxicity 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 invertebrate insects, including pollinators, from chronic 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 broad range of terrestrial species, par ticularly insect pollinators and to determine whether adult toxicity differs substantially from other life stages evaluated in other Tier I tests. If chronic oral effects data for adults are not available, risks to terrestrial insects from chronic oral

exp osure 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 ef fects to non

- target species or is likely to adversely affect listed threatened or endangered 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.

### 28 Study Title: Pollinator Chronic Oral Toxicity, Larvae Rationale for Requiring the Data Terrestrial invertebrates are likely to be impacted if exposed to pesticides in various use settings

. 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 oral exposure to pe sticide 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 honeybee larvae differ in sensitivity from adult bees following chronic exposure.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for invertebrates with the honeybee. The guidance discusses Tier 1 laboratory

- based chronic oral toxicity studies of individual honeybee larvae as a critical component of the scr eening

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

- p rotection/pollinator

- risk

- assessment

- guidance

. Additional information on larval honeybee 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_201 3.pdf

. Practical Utility of the Data

How will the data be used? The Tier I chronic oral toxicity d ata on bee larvae serve as a foundation for t he screening

- level assessment of potential risk to non

- target organisms including federally listed threatened or endangered

and non

- listed terrestrial invertebrate insects, including pollinators, from chronic 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 broad range of terrestrial species, particularly inse ct 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 oral effects data for larvae are not available, risks to terrestrial insects from
chron ic 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: Pollinator Tier II Semi

- Field Toxicity Testing (tunnel/enclosure 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 pesticides in various use settings. 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 . Screening

- level (Tier I) studies of individual bees do not address possib le effects and/or exposure to pesticide residues at the

### 29 colony

- level. 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 whether bee colonies ma y 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 exposure as pesticide residues in pollen/nectar of treated plants.

The Office of Pesti cide Programs has made available a guidance regarding ecological testing for invertebrates with the honeybee. The guidance describes the tiered testing process and can be found at: http://www2.epa.gov/pollinator

- protection/pollinator

- risk

- assessment

- guidance . Additional information on honeybee colony studies under semi

- field conditions can be found in the OECD Guidance 75 http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono%28

. 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 studies of individual bee s 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 insect pollinators at the whole colony level, may result for the use of pesticides and will help to refine ri sk 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 whether continued registration of a pesticide is likely to result in unreasonable adverse effects to non

- target sp ecies 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.

Study Title: Pollinator Tier II Semi

- Field Toxicity Testing (feeding studies)
Rationale for Requiring the Data
Pesticide residues may be transferred to pollen and/or nectar of treated plants a nd subsequently brought back to the hive, and may adversely affect developing brood (egg, larvae, and pupae) and adult bees

. Tier II feeding 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 based on Tier I studies of individual bees. Feeding studies utilize free foraging bee colonies that are “dosed” with specific quantities of test material and represent a means of ensuring exposure to the test material through spiked pollen and/or sugar solutions fed to the colony while still allowing the bees to forage freely. Since bee colonies are not confined to enclosures, colonies can be exposed for longer duration periods without subjecting the bees to stress that typically results from Tier II tunnel studies. Available toxicity studies of individual bees (Tier 1) conducted to support screening

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

- l evel. 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 whether bee colonies may be negatively affected where bees are free foraging and have t he option to collect/consume alternative forage items beyond the

### 30 spiked food. Since multiple dose levels can be more readily tested, feeding studies can help to define

dose

- response relationships at the whole colony level.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for invertebrates with the honeybee. The guidance describes the tiered testing process and can be found at: http://www2.epa.gov/pollinator

- protection/pollinator

- risk

- assessment

- guidance

. Additional information

on honeybee colony feeding studies can be found in the EPPO Guidance 170 at: http ://www.nationalbeeunit.com/index.cfm?pageId=187

.

Practical Utility of the Data

How will the data be used? Tier II colony feeding data will be used to assess potential risk to non

- target organisms including listed

and non

- listed terrestrial social invert ebrate species. The colony feeding study is designed to represent potential field

- level exposure and account for hive dynamics using longer duration exposure periods than are possible in Tier II tunnel studies. The study will be used to determine whether p otential adverse effects to insect pollinators at the whole colony level when bees are able to forage naturally beyond the spiked food. Results from the feeding study will help to refine the screening

- level risk
assessment for beneficial terrestrial invert ebrates that were based on Tier I studies on individual bees. Since feeding studies can help to define a dose

- response relationship at the colony level, the studies can provide a means of determining exposure thresholds below which the likelihood of advers e effects on colonies may be low.

How could the data impact the Agency’s future decision

- making? Tier II colony

- level data will be used to refine screening

- level risk estimates derived using Tier I laboratory

- based data on individual bees. The Tier II da ta 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

e ndangered 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.

Study Tit le: Residues in Pollen and Nectar Rationale for Requiring the Data Terrestrial invertebrates are likely to be impacted if exposed to pesticide residues in various use settings. Pesticide residues may be transferred to pollen and/or nectar of treated plan ts and subsequently brought back to hive where 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 from 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 water, 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 da ta for crops and application methods of concern.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for invertebrates with the honeybee. The guidance can be found at: http://www2.epa.gov/pollinator

protection/pollinator

- risk

- assessment

- guidance

. Practical Utility of the Data

### 31 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 understanding of expo sure 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 on model

- genera ted 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 es timates of exposure which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in use
restrictions.



# 10. References

United States Environmental Protection Agency ( USEPA). 2001. Federoff, N.E., J. Melendez,
and F. Khan. EFED RED Chapter for Ziram . DP B arcode s 276759, 260984, 260985. U.S. Environmental Protection Agency, Office of Prevention, Pesticides, and Toxic Substances, Environmental Fate and Effects Division. Memorandum to the Special
Review and Reregistra tion Division. Oct. 23 , 200 1.

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs

. U.S. Environmental Protection Agency, Office of Pesticide Programs,
Environmen tal Fate and Effects Division . Available at http://www.epa.gov/espp/consultation/ecorisk

- overview.pdf

USEPA. 2007 . ECOTOXicology Database. Office of Research and Development National
Health and Environmental Effects Research La boratory’s (NHEERL’s) Mid

- Continent Ecology Division (MED). http://cfpub.epa.gov/ecotox/

USEPA. 2008. Woodard, V. and M. Barrett. Risk of Ziram Use to Federally Threatened
California Red

- legged Frog ( Rana auror a draytonii ). U.S. Environmental Protection Agency, Office of Pesticide Programs, Environmental Fate and Effects Division . Oct. 16, 2008.

USEPA. 2010

. Barrett, M

. Ziram Drinking Water Assessment for Updated Use Patterns . DP

B arcode 323411

. U.S. Environme ntal Protection Agency, Office of Prevention, Pesticides, and Toxic Substances, Environmental Fate and Effects Division.
Memorandum to the Health Effects Division. Feb. 18, 2010

.

USEPA. 2014. Screening Level Usage Analysis (SLUA) for Ziram (034805). U.S. Environmental Protection Agency, Office of Pesticide Programs, Biological and Economic Analysis Division. Jun. 20, 2014.

### 32 USEPA, PMRA, and CDPR. 2014. Guidance for Assessing Pesticide Risks to Bees. Office of Pesticide Programs, USEPA, Washington D.C. Hea lth Canada Pest Management Regulatory Agency, Ottawa, ON, Canada. California Department of Pesticide Regulation, Sacramento, CA. June 23, 2014.

U.S. EPA, Office of Pesticide Programs, Antimicrobial Division, Risk Assessment and Science Support Branch. A ugust 4, 2014. Conceptual Models for Environmental Exposure Pathways of Antimicrobial Pesticides. EPA

- HQ

- OPP

- 2014

- 0638

. http://www.regulations.gov/#!documentDeta il;D=EPA

- HQ

- OPP

- 2014

- 0638

- 0002

USEPA. 2015. Arnold, E. and R. Parker. Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Ferbam and Th iram

. DP B arcode 427810,
427924

. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution
Prevention

, Environmental Fate and Effects Division. Memorandum to the Pesticide Re

evaluation Division

.



## 10.1. Submitted Environmental Fate Studies

0 34805 Ziram Fate Chemistry Bibliography Revised 31 July 2014

161

- 1 Hydrolysis

MRID Citation Reference

142855 2005678 Lemal, R.; Boel, C.; Debondues, M. (1984) Ziram: Rate of Hydrolysis as a Function of pH. Unpublished study prepared by UCB, Drogenbos Laboratory. 6 p.

154985 Open Lit
DER not
located Korotkova, O. (1976) Razlozhenie fungitsidov

-- proizvodnykh ditio

- karbaminovoy kisloty (obzor literatury) [Decomposition of such fungicides as derivatives of dithiocarbamic acid (literature re

v iew)]. Khim. Sel'sk. Khoz. 12(11):869

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

- 0215.

40497301 2005677 Daly, D.; Cranor, W. (1987) Determination of Hydrolysis Rate with ?Carbon 14|

- Ziram: Final Report #33363. Unpublished study pre

- pared by Analytical Bio

- C hemistry Laboratories, Inc. 573 p.

43866701 2005689 Kim

- Kang, H. (1995) Hydrolysis of (carbon 14)

- Ziram in Water at pH 5, 6, and 9: Lab Project Number: XBL 94071: PRT00213: IDC433102. Unpublished study prepared by Xenobiotic Labs, Inc. and NPC Inc. 272 p

.



### 161

- 2 Photodegradation

- water

MRID Citation Reference

153198 2005676 Carpenter, M. (1985) Determination of Photodegradation of Ziram in Aqueous Solution: Report 33369. Unpublished study prepared by Analytical Bio

- Chemistry Labs., Inc. 53 p.

154985 Open Lit Korotkova, O. (1976) Razlozhenie fungitsidov

-- proizvodnykh ditio

- karbaminovoy kisloty (obzor literatury) [Decomposition of such fungicides as derivatives of dithiocarbamic acid (literature re

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

- 8 74, 1974. Abstracted in Pest. Abs. 76

- 0215.

44097701 2005690 Kim

- Kang, H. (1996) Aqueous Photolysis of (carbon 14)

- Ziram: Lab Project Number: XBL94073: RPT00223: IDC 433102. Unpublished study prepared by XenoBiotic Labs, Inc. 245 p.



### 161

- 3 Photod egradation

- soil

### 33 MRID Citation Reference

153199 2005675 Carpenter, M. (1985) Determination of Photodegradation of Ziram on the Surface of Soil: Report 33370. Unpublished study prepared by Analytical Bio

- Chemistry Labs., 60 p.

154985 Open Lit Kor otkova, O. (1976) Razlozhenie fungitsidov

-- proizvodnykh ditio

- karbaminovoy kisloty (obzor literatury) [Decomposition of such fungicides as derivatives of dithiocarbamic acid (literature re

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

- 874, 1974. Abstracted in P est. Abs. 76

- 0215.

44228401 2005691 Reynolds, J. (1997) Photolysis of (carbon 14) Ziram on Soil: (Final Report): Lab Project Number: 96001: RPT00296: XBL 96001. Unpublished study prepared by XenoBiotic Laboratories, Inc. 179 p.



### 162

- 1 Aerobic soi l metabolism

MRID Citation Reference

40061601 2005674 Cranor, W. (1987) Aerobic Soil Metabolism Study with [Carbon 14]

- Ziram: Final Report #33366. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 85 p.

43985801 2005692 Kim

- Kang, H. (1996) Aerobic Soil Metabolism of (carbon 14)

- Ziram: Lab Project Number: XBL 94072: RPT00225. Unpublished study prepared by XenoBiotic Labs, Inc. 180 p.

47005202 2084558 pg.
5 referenced Reibach, P. (2006) (Carbon 14)

- Ziram Fungicide Soil Metabolism. Project Number: KP/2006/44. Unpublished study prepared by Cerexagri, Inc. 11 p.

46622302 20050483 Mamouni, A. and Piccirillo, V. (2001) Degradation Rate of (Carbon 14)

- Ziram in Three Soils Incubated Under Aerobic Conditions. Project Number: 7 85744. Unpublished study prepared by RCC Umweltchemie Ag. 90 p.



### 162

- 2 Anaerobic soil metabolism

MRID Citation Reference

40061602 2005673 Cranor, W. (1987) Anaerobic Soil Metabolism Study with [Carbon 14]

- Ziram: Final Report #33367. Unpubl ished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 70 p.

44228402 2005693 Reynolds, J.; Smalley, J. (1997) Anaerobic Soil Metabolism of (carbon 14) Ziram: (Final Report): Lab Project Number: XBL96002: RPT00297: XBL 96002. Unpublished stu dy prepared by XenoBiotic Laboratories, Inc. 111 p.



### Aerobic Aquatic Metabolism

MRID Citation Reference

46045903 DER not
located Volkl, S. (2001) (Carbon 14)

- Ziram: Route and Rate of Degradation in Aerobic Aquatic Systems. Project Number: 744693. Unpublished study prepared by RCC Umweltchemie Ag. 109 p.



### 163

- 1 Leach/adsorption/desorption

MRID Citation Reference

151488 2005670
2005671 Warren, J. (1985) Leaching Characteristics of Aged Ziram: ABC Re

- port #33364. Unpublished study pre pared by Analytical Bio

- Chemistry Laboratories, Inc. 28 p.

153205 Protocol
DER not
located Analytical Bio

- Chemistry Labs., Inc. (1985) Soil/Sediment Adsorption/ Desorption: [Ziram]: Rev.
ABC Protocol #M

- 8007: Study No. 33368. Unpublished study. 13 p.

1 53206 Protocol
DER not
located Analytical Bio

- Chemistry Labs., Inc. (1985) Leaching Characteristics in Soil: ABC Protocol #M

8102: Study No. 33365. Unpublished study. 14 p.

### 34 5001190 Open Lit
DER not
located Helling, C.S.; Dennison, D.G.; Kaufman, D.D. (19 74) Fungicide movement in soils. Phytopathology 64(8):1091

- 1100.

43873501 2005694 Spare, W. (1995) Adsorption/Desorption of (carbon 14)

- Ziram: Lab Project Number: 2526: IDC 433102: 94072. Unpublished study prepared by Agrisearch Inc. 162 p.



### 164

- 1 Terrestrial field dissipation

MRID Citation Reference

40061603 2005669 Selman, F. (1987) Ziram Soil Dissipation Study: ABC Preliminary Report #35028. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. in cooperation with Morse Laboratories, Inc. 112 p.

40061604 2005668 Selman, F. (1987) Ziram Soil Dissipation Study: ABC Preliminary Report #35029. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. in cooperation with Morse Laboratories, Inc. 109 p.

44548301 2005688 Novak, R.; Binari, L. (1998) Terrestrial Field Dissipation of Ziram 76 DF Fungicide in North Carolina: Final Report: Lab Project Number: F96

- 7204: GR96255: 96

- 0030. Unpublished study prepared by Grayson Research, Ltd., EN

- CAS Analytica l Laboratories, and NPC, Inc. 428 p.

44548302 2005688 Novak, R.; Binari, L. (1998) Terrestrial Field Dissipation of Ziram 76 DF Fungicide in California: Final Report: Lab Project Number: F96

- 7203: R319601: ML96

- 0606

- ZTF. Unpublished study prepared by Re search for Hire, Morse Laboratories, Inc., and NPC, Inc. 401 p.

46545601 2030918 Reibach, P. (2005) Terrestrial Field Dissipation of Ziram. Project Number: KP/2005/13. Unpublished study prepared by Cerexagri, Inc. 20 p.

ACC
259584 2005672 Warren, J. 198 5. ABC # 33368



### Non

- Guideline Study

MRID Citation Reference

146901 protocol Protocol
2005655 Analytical Bio

- Chemistry Laboratories, Inc. (1984) "Soil/Sediment Adsorption

- Desorption": [Protocol only

-- Protocol #M

- 8007]. Un

- published study. 9 p.

146902 protocol Protocol
2005655 Analytical Bio

- Chemistry Laboratories, Inc. (1984) "Leaching Characteristics of Soil Incorporated Test Material following Aerobic Aging": [Protocol only

-- Protocol #M

- 8406]. Unpublished study. 15

p.

146903 protocol Protoc ol
2005655 Analytical Bio

- Chemistry Laboratories, Inc. (1984) "Leaching Characteristics in Soil": [Protocol only

-- Protocol #M

- 8102]. Unpublished study. 9 p.

146904 protocol Protocol
2005655 Analytical Bio

- Chemistry Laboratories, Inc. (1984) "Determinatio n of Hydrolysis Rate": [Protocol only

-- Protocol #M

- 8201]. Unpublished study. 9 p.

146905 protocol Protocol
2005655 Analytical Bio

- Chemistry Laboratories, Inc. (1984) "Determination of Photolysis Rate": [Protocol only

-- Protocol #M

- 8301]. Unpublished study . 9 p.

146906 protocol Protocol
2005655 Analytical Bio

- Chemistry Laboratories, Inc. (1984) "Determination of Photolysis Rate on the Surface of Soil": [Protocol only

-- Protocol #M

- 8304]. Unpublished study. 12 p.

146907 protocol Protocol
2005655 Analytica l Bio

- Chemistry Laboratories, Inc. (1984) "Aerobic Soil Metabolism": [Protocol only

-- Protocol #M

- 8001]. Unpublished study. 13 p.

146908 protocol Protocol
2005655 Analytical Bio

- Chemistry Laboratories, Inc. (1984) "Anaerobic Soil Metabolism": [Protocol on ly

-- Protocol #M

- 8002]. Unpublished study. 13 p.

154984 Open Lit Klisenko, M.; Vekshtein, M. (1971) Kinetics of the hydrolysis of metal complexes of dialkyldithiocarbamic and ethylenebisdithio

- carbamic acids in their dependence on the pH of the medium, a nd identification of their transformation products. J. Gen. Chem. of the U.S.S.R. 41(5):1125

- 1130.

40497300 Response Penwalt Corp. (1988) Submission of Hydrolysis Rate in Response to Groundwater Data Call

- in for Ziram. Transmittal of 1 study.

### 35 N.A. 2005 654 1990 Fate Database Oneliner Report

2005659 Protocol for Terrestrial Field Dissipation study 1986

ACC
258212 2005667 Lemal, R. 1984. Ziram Determination of Octanol Water partition coefficient

2005679 1990 Fate Data Summary

2005680 Lab Audit for Soil Dissipation Study



## 10.2. Submitted Ecological Toxicity Studies

MRID Citation

TN 1021 McCann, J.A. 1976. 24 hour LC50 with Rainbow trout and 76% ai = 300 PPB

00036935 Atkins, L., Jr.; Anderson, L.D. (1967) Toxicity of Pesticides and Other Agricultural Chemicals to Honey Bees: Laboratory Studies. (Unpublished study received Jan 30, 1969 under 9G0802; prepared by
Univ. of California

-- Riverside, Dept. of Entomology, submitted by Hercules, Inc., Agricultural Chemicals, Wilmington, Del.; CDL:093111

- D)

0013 8214 (ACC 72559) Dickhaus, S.; Heisler, E.; Reinhard. (1980) Examination for Acute Toxicity of Ziram in Rainbow

- trout at Exposition of 96 Hours in the Bath Fliud: Report ID:1

- 7

- 139

- 80. (Unpublished study received Apr 10, 1984 under 3F2964; prepared by Phar matox Forcshung und Beratung GmbH, W. Ger., submitted by
Rhone

- Poulenc, Inc., Monmouth Junction, NJ; CDL:072559

- A)

00138215 (ACC 72559) Dickhaus, S.; Heisler, E. (1980) Examination for Acute Toxicity of Ziram in Carp at Exposition of 96
Hours in the Bath Fluid: Report ID:1

- 7

- 140

- 80. (Unpublished study received Apr 10, 1984 under 3F2964; prepared by Pharmatox Forschung und Beratung GmbH, W. Ger., submitted by Rhone

Poulenc, Inc., Monmouth Junction, NJ; CDL:072559

- B)

05003523 Maloney, T.E.; Palmer, C.M. (1 956) Toxicity of six chemical compounds to thirty cultures of algae. Water and Sewage Works 103:509

- 513.

05003523 Maloney, T.E.; Palmer, C.M. (1956) Toxicity of six chemical compounds to thirty cultures of algae. Water and Sewage Works 103:509

- 513.

40228 401 Mayer, F. (1986) Acute Toxicity Handbook of Chemicals to Estuarine Organisms: EPA/600/X/86/231. Prepared by US EPA Environmental Research Laboratory, Gulf Breeze, Fl. 275 p.

41340401 Liggett, M. and S. Allan (1989) Acute oral toxicity to rats of Ziram . Huntingdon Research Centre Ltd., P.O. Box 2, Huntingdon, Cambridgeshire, PE18 6ES, England. HRC Study Report No. 89690D/UCB 315/AC, November 30, 1989.

41442001 Jackson, G. and C. Hardy (1989) Ziram Technical: Acute inhalation toxicity in rats

- 4

- hou r exposure. Huntingdon Research Centre Ltd., P.O. Box 2, Huntingdon, Cambridgeshire, PE18 6ES, England. HRC Report No. UCB 314/89684, December 4, 1989.

41667901 Cole, J. (1989) The Acute Contact Toxicity to Honeybees of Technical Ziram: Final Report: L ab Project Number: ZIR 21/891454. Unpublished study prepared by Huntingdon Research Centre, Ltd. 21 p.

41725701 Hakin, B.; Norman, A. (1989) Acute Oral Toxicity (LD50) of Ziram to the Bobwhite Quail: Lab Project Number: ZIR 17/90566. Unpublished study pre pared by Huntingdon Research Centre Ltd. 29 p.

42386301 Hakin, B.; Norman, A.; Anderson, A.; et al. (1992) The Dietary Toxicity (LC50) of Ziram Technical to the Bobwhite Quail: Final Report: Lab Project Number: ZIR 19/901457. Unpublished study prepared by Huntingdon Research Centre Ltd. 32 p.

42386302 Hakin, B.; Norman, A.; Anderson, A.; et al. (1992) The Dietary Toxicity (LC50) of Ziram Technical to the Mallard Duck: Final Report: Lab Project Number: ZIR 18/901456. Unpublished study prepared by Huntingdo n Research Centre Ltd. 32 p.

42386303 Douglas, M.; Stonehewer, R.; Macdonald, I. (1991) The Acute Toxicity of Ziram Technical to Bluegill Sunfish (Lepomis macrochirus): Final Report: Lab Project Number: ZIR 20(C)/901626. Unpublished study prepared by Hunt ingdon Research Centre Ltd. 27 p.

42386304 Douglas, M.; Bell, G.; Macdonald, I. (1991) The Acute Toxicity of Ziram Technical to Rainbow Trout (Oncorrhynchus mykiss): Final Report: Lab Project Number: ZIR 20(B)/891173. Unpublished study prepared by Hunting don Research Centre Ltd. 28 p.

### 36 42386305 Douglas, M.; Bell, G.; Macdonald, I. (1991) The Acute Toxicity of Ziram Technical to Daphnia magna: Final Report: Lab Project Number: ZIR 20(A)/901625. Unpublished study prepared by Huntingdon
Research Centre Ltd. 2 5 p.

43781601 Machado, M. (1995) Ziram

-- Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under
Flow

- Through Conditions: Final Report: Lab Project Number: 95

- 6

- 5949: 13561.0395.6106.505. Unpublished study prepared by Springborn Labs, Inc. 77 p.

43781602 Dionne, E. (1995) Ziram

-- Acute Toxicity to the Eastern Oyster (Crassostrea virginica) Under Flow

Through Conditions: Final Report: Lab Project Number: 95

- 7

- 5965: 13561.0395.6108.504. Unpublished study prepared by Springborn Labs, Inc. 83 p.

4378 1603 Machado, M. (1995) Ziram

-- Acute Toxicity to Mysids (Mysidopsis bahia) Under Flow

- Through Conditions: Final Report: Lab Project Number: 95

- 7

- 5967: 13561.0395.6107.515. Unpublished study prepared by Springborn Lab., Inc. 81 p.

43833901 Hoberg, J. (1995 ) Ziram

-- Toxicity to the Freshwater Green Alga, Selenastrum capricornutum: Amended Final Report: Lab Project Number: 95

- 7

- 5971: 13561.0395.6101.430. Unpublished study prepared by Springborn Labs, Inc. 77 p.

43935801 Nemec, M.D. (1996) A dietary two

- genera tion reproduction and developmental neurotoxicity study of ziram in rats, WIL Research Laboratories, Inc., 1407 George Road, Ashland, OH 44805

- 9281. Laboratory study number WIL

- 223003, January 30, 1996.

46622301 Frey, L.; Martin, K.; Beavers, J.; et. al. (2000) Ziram Technical: A Reproduction Study with the Northern Bobwhite: Final Report. Project Number: 299/104. Unpublished study prepared by Wildlife International, Ltd. 163 p.

46823301 Palmer, S.; Kendall, T.; Krueger, H. (2006) Ziram: A Flow

- Through Li fe

- Cycle Toxicity Test With The Cladoceran (Daphnia magna): Final Report. Project Number: 602A/101. Unpublished study prepared by Cerexagri, Inc. and Taminco, n.v. 57 p.

46823302 Desjardins, D.; Kendall, T.; Krueger, H. (2006) Ziram: A 7

- Day Static

- Renewa l Toxicity Test with Duckweed (Lemna gibba G3): Final Report. Project Number: 602A/105. Unpublished study prepared by Cerexagri, Inc. and Taminco, n.v. 44 p.

46856401 Sutherland, C.; Kendall, T.; Krueger, H. (2006) Ziram: An Early Life

- Stage Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus): Final Report. Project Number: 602A/104. Unpublished study prepared by Wildlife International, Ltd. 73 p.

46893101 Porch, J.; Krueger, H. (2006) Ziram: A Toxicity Test to Determine the Effects of the Tes t Substance on Seedling Emergence of Ten Species of Plants Grown Under Greenhouse Conditions: Final Report. Project Number: 602/102, KP/2006/21, 602/080505/SEEDEM/10/SUB602. Unpublished study prepared by Wildlife International, Ltd and Cerexagri, Inc. 138 p. 46893102 Porch, J.; Krueger, H. (2006) Ziram: AToxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants Grown Under Greenhouse Conditions: Final Report. Project Number: 602/103, KP/2006/22, 602/080505/VE GVIG10/GH/SUB602. Unpublished study prepared by Wildlife International, Ltd and Cerexagri, Inc. 175 p.

46893103 Sutherland, C.; Kendall, T.; Krueger, H. (2006) Ziram: A Flow

- Through Life

- Cycle Toxicity Test With Saltwater Mysid (Mysidopsis bahia): Final R eport. Project Number: 602A/102A. Unpublished study prepared by Wildlife International, Ltd. 72 p.

46893104 Palmer, S.; Kendall, T.; Krueger, H. (2006) Ziram: An Early Life

- Stage Toxicity Test with Fathead Minnow (Pimephales promelas): Final Report. Proje ct Number: 602A/103A. Unpublished study prepared by Wildlife International, Ltd. 66 p.

47286501 Temple, D.; Martin, K.; Beavers, J.; et al. (2007) Ziram: A Reproduction Study with the Mallard: Final Report. Project Number: 602/104, KP/029/01, KP/2006/45. Unpublished study prepared by Cerexagri, Inc., Taminco, n.v. and Wildlife International, Ltd. 263 p.

47307901 Palmer, S.; Kendall, T.; Krueger, H. (2007) Ziram: A 96

- hour Flow

- Through Acute Toxicity Test With the Bluegill (Lepomis macrochirus): Final Repo rt. Project Number: 602A/107. Unpublished study prepared by Wildlife International, Ltd. 37 p.

47405701 Palmer, S.; Kendall, T.; Krueger, H. (2008) (Carbon 14)

- Ziram: A 48

- hour Flow

- Through Acute Toxicity Test with the Cladoceran (Daphnia magna): Final Re port. Project Number: 602A/108. Unpublished study prepared by Wildlife International, Ltd. 38 p.

47405702 Palmer, S.; Kendall, T.; Krueger, H. (2008) (Carbon 14)

- Ziram: A 96

- hour Flow

- Through Acute Toxicity Test with the Saltwater Mysid (Americamysis bahi a): Final Report. Project Number: 602A/109. Unpublished study prepared by Wildlife International, Ltd. 37 p.

### 37 47435501 Palmer, S.; Kendall, T.; Krueger, H. (2008) Ziram: A Flow

- Through Life

- Cycle Toxicity Test with the Fathead Minnow (Pimephales promelas). Project Number: 602A/106A, RL/13/2/1. Unpublished study prepared by Wildlife International Ltd. 131 p.

48115201 Piccirillo, V. (2010) Response to Data Evaluation Record for: A Reproduction Study on Mallard Duck with Ziram (MRID 47286501). Project Number: 2010/1. Unpublished study prepared by VJP Consulting, Inc. 6 p.

48115701 Sutherland, C.; Kendall, T.; Krueger, H. (2006) Ziram: A Flow

- Through Life

- Cycle Toxicity Test with the Saltwater Mysid (Mysidopsis bahia). Project Number: 602A/102A. Unpublished st udy prepared by Wildlife International, Ltd. 23 p.

### 38 

# Appendix A. SIP Modeling Results

Table 1. Inputs

Parameter Value

Chemical name Ziram
Solubility (in water at 25 o C; mg/L) 0.967

Mammalian LD 50 (mg/kg

- bw) 320

Mammalia n test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg

- bw) 14.8 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg

- b w) 97 Avian test species northern bobwhite quail Body weight (g) of "other" avian species Mineau scaling factor 1.15

Mallard NOAEC (mg/kg

- diet) 29 Bobwhite quail NOAEC (mg/kg

- diet)

Table 2. Mammalian Resu lts

Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 0.1663 0.1663 Adjusted toxicity value (mg/kg

- bw) 246.1314 11.3836 Ratio of exposure to toxicity 0.0007 0.0146

Conclusion* Drinking water exposure alone is NOT a potential

concer n 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) 0.7833 0.7833 Adjusted toxicity value (mg/kg

- bw) 69.8817 1.4388

Ra tio of exposure to acute toxicity 0.0112 0.5444

Conclusion* Drinking water exposure alone is NOT a potential
concern for birds 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 anima ls.

### 39 

# Appendix B

. STIR Modeling Results

Input

Application and Chemical Information

Enter Chemical Name Ziram

Enter Chemical Use Fungicide Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) air

Enter Chemical Molecular Weight (g/mole) 307.5 Enter Chemical Vapor Pressure (mmHg) 1.35E

- 07 Enter Application Rate (lb a.i./acre) 7.6

Toxicity Properties

**Bird**

Enter Lowest Bird Oral LD 50 (mg/kg bw) 97 Enter Mineau Scaling Factor 1. 15 Enter Tested Bird Weight (kg) 0.178

**Mammal**

Enter Lowest Rat Oral LD 50 (mg/kg bw) 320

Enter Lowest Rat Inhalation LC 50 (mg/L) 0.06 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 ) 2.23E

- 03

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 2.81E

- 04

Adjusted Inhalation LD 50 1.01E

- 01

Ratio of Vapor Dose to Adjusted Inhalation LD 50 2.77E

- 03 Exposure not Lik ely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 7.30E

- 01 Ratio of Droplet Inhalation Dose to Adjusted Inhalation
LD 50 7.20E+00 Proceed to Refinements



### Results Mammalian (0.015 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 2.23E

- 03

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 3.53E

- 04

Adjusted Inhalation LD 50 3.57E+00

Ratio of Vapor Dose to Adjusted Inhalation LD 50 9.88E

- 05 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalatio n Dose (mg/kg) 9.18E

- 01 Ratio of Droplet Inhalation Dose to Adjusted Inhalation
LD 50 2.57E

- 01 Proceed to Refinements

### 40 

# Appendix C . Summary of Ziram and Thiram Fate and Transport Data

I. Abiotic Degradation

161

- 1 Hydrolysis

The media was continu ously exposed to light from a xenon arc lamp for 15 days forming volatile products and thiram. The main difference in degradation between irradiated and dark samples was the rate and extent of formation of volatile products.

Sterilized deionized ultra

- fil tered (DIUF) water was used in this study. It appears that the samples were not buffered at any specified pH. The initial pH was about 6 and decreased throughout the study for both the dark control and the exposed sample. The irradiated samples pH decrease d to an average of 4.5 at 15 days, while the dark control samples pH did not change as much, remaining at an average of 5.8 after 15 days. The study author suggests that the pH of test solutions became more acidic indicating the formation of acidic product s. The previous study
indicated that the half

- lives for hydrolysis of ferbam at pHs 5

– 7 did not differ much, with rates of
about 8

– 12 minutes.

The major degradates of ferbam were volatile, mainly CS 2 

### (44.6% of the applied), and CO 2 

### (28.6%). Following 15 days of incubation, volatile products accounted for 73.6% of the applied radioactivity for irradiated samples compared to 31.4% for dark samples. Degradation to volatile products was rapid in dark samples through day 2 but slowed thereafter, whereas in irradiated samples, degradation to volatile products continued. The major non

- volatile degradate was tetramethylthiuram disulfide (TMTD) which accounted for a maximum of 63.3% of the applied radioactivity at day 1, and decreased to 1.1% by day 7 and 0.5% of the applied radioactivity at day 15. The degradation half

- life for TMTD was 4.7 days.

A difference in the degradation pattern between irradiated and dark samples was the rate and extent degradation of thiram, and of formation of volatile products. In t he dark controls, thiram was a maximum of 73.1% at day 1, and decreased more slowly (compared to the irradiated sample) to 61.1% of the applied radioactivity by day 15 post

- treatment. For dark samples, CS 2 

### accounted for 27.3% of the applied radiocarbon and 3.5% CO 2



### .

Two additional products were found exceeding 10% of the applied radiocarbon, designated as A and B and characterized as polar, water soluble and acidic in nature. Degradate A increased from 7.7% of the applied radiocarbon (day 1) to a maximum o f 16.0% (day 3) then decreased to 9.0% following 15 days of irradiation; degradate B, found only in significant amounts in the irradiated samples, increased from 1.4% (day 2) to a maximum of 11.9% of applied radiocarbon on day 15.

161

- 3 Photodegradation o n Soil

It appears that parent ferbam degraded so quickly that even immediately post

- treatment, the only degradate extractable both from the irradiated sample and the dark control was Thiram. The rate of degradation appeared to be similar for Thiram in b oth irradiated sample and dark control. Thiram was the only extractable degradate for irradiated and dark samples. This degradate (in

### 41 irradiated samples) comprised a mean of 82.5% of the applied radioactivity at day 0 (84.5% dark control), and 17.2% at d ay 15 (20.7% dark).

On the other hand, the amount of volatiles and their relative proportion was much more different. Following 15 days of incubation, volatile products accounted for 38.5% of the applied radioactivity for irradiated samples and 15.8% for dark control samples. Major volatile degradates in the irradiated and dark samples were 14 

### CO 2 

### , and 14 

### CS 2 

### . After 15 days of incubation, 14 

### CS 2 

### comprised of 44.6% of the applied radioactivity in the irradiated samples and 27.3% in the dark control samples. After 15 days of incubation, 14 

### CO 2 

### comprised of 28.6% of the applied radioactivity in the irradiated samples and 3.5% in the dark control samples.

II. Metabolism

162

- 1 Aerobic Soil Metabolism

The primary degradate was tetramethylthiuram (TMTD), which was a mean (of two replicates) of 77.9% of the applied radioactivity at the initial test interval (0 hours). TMTD (also commonly known as thiram), degraded further, with a half

- life of 4.9 days. Thiram comprised a mean (2 replicates) of 77.9% of the app lied radioactivity at hour 0, 67.1% at hour 4, 50.1% at day 1, 43.8% at day 2, 33.9% at day 4, 23.4% at day 7, 17.3% at day 14, 15.3% at day 21, 7.7% at day 45, 5.8% at day 93, and 2.6% at day 150.

Volatile metabolites included CO 2 

### (accounted for 56.4% of the initially applied radiocarbon at 150 days post

- treatment), and 14 

### CS 2 

### (accounted for 5.5% of the initially applied radiocarbon at 150 days post

- treatment). Several minor degradates were observed none of which exceeded 1.2% of the applied radiocarbon. Soil bound residue reached a maximum of 49.9% (mean of two replicates) of the applied radiocarbon at day 7, then decreased to 26.3% by day 150. Material balances ranged from 90.5% to 101.6% of the initially applied radioactivity.

162

- 2 Anaerobic Soil Me tabolism

One primary degradate was tetramethylthiuram (TMTD, thiram), which was a mean (of two replicates) of 33.8% of the applied radioactivity at the initial test interval (0 hours). Thiram degraded further, with a half

- life of 184 days. Thiram accou nted for 33.8% (mean of 2 replicates) of the applied radiocarbon, following dosing, 28.1% at day 3, 30.2% at day 7, 27.9% at day 14, 15.7% at day 21, 17.5% at day 51, 16.8% at day 93, 8.9% at day 134, 7.4% at day 182, 10.9% at day 272, and 8.1% at day 364.

One other major degradate was Co

- DMDTC [cobalt (II)dimethyldithiocarbamate], which was a mean (of two replicates) of 39.6% of the applied radioactivity at the initial test interval (0 hours).

Co

- DMDTC, degraded further, with a half

- life of 269 days. Co

- DMDTC reached a level of 39.6% (a mean of two replicates) of the applied radiocarbon, 38.3% at day 3, 40.9% at day 7, 41.8% at day 14, 46.5% at day 21, 36.2% at day 51, 31.2% at day 93, 36.9% at day 134, 29.1% at day 182, 18.3% at day 272, and 16.8% at da y 364.

A total of five unknown degradates were detected, of which only one degradate was observed at a level >10% of the applied radiocarbon. This degradate comprised 11.7% (mean of two replicates) of the applied radiocarbon at day 0 in the water samples , then decreased to 2.8% by

### 42 day 7. Following day 7, the water samples were not analyzed due to low levels of radiocarbons (≤3% of the applied radiocarbon). Soil

- bound residue ranged from 11.0 to 16.1% (mean of replicates) of the applied radiocarbon betwe en Day 0 and Day 182 and decrease to 6.6 and 5.6% (mean of replicates) on Day 272 and 364, respectively.

The major volatile metabolites formed during this Anaerobic Metabolism were CS 2 

### and CO 2 

### which accounted for a total of 50.7% and 7.5% of the initially applied radioactivity, respectively.

The overall material balance throughout the study was 95.8± 5.2 (mean± standard deviation) of the applied radiocarbon.

III. Specific Mobility and Persistence Data for Ferbam

163

- 1 Mobility Batch Equilibrium

163

- 1 Mobility Batch Equilibrium

– Adsorption/Desorption (MRID 43787501, Supplemental)

– At this time, EFED has a batch equilibrium study for thiram, the major non

volatile degradation product of ferbam. However, this study was deemed supplemental.

14 

### C

- thiram at concentrations of 0.01, 0.04, 0.20, and 1.07 mg/L was determined to have low mobility in a sandy loam and silt loam soil, and was immobile in loamy sand and loamy silt soils. Freundlich adsorption coefficients were 54, 150, 67, and 263 for the sandy lo am, loamy sand, silt loam and loamy silt, respectively. Corresponding K oc 

### values were 2,245 (sandy loam), 24,526 (loamy sand), 6,359 (silty loam), and 12,899 (loam silt). The data from this study including the properties of each soil are shown in Table A

- 3.

Table A

- 1 . Thiram soil adsorption and mobility characteristics

. a



### Soil
characteristics Sandy loam,

NY Loamy sand, IL Silt loam, IL Loam, IA

% Clay 14.8 7.5 16.8 25.2
% Silt 29.6 9.4 59.1 33.6
% Sand 55.6 83.1 24.1 41.2 % Organic carbon 2.41 0.61 1.06 2.04 pH 6.7 4.8 6.7 7.3

K d 

### 54 150 67 263

K oc 

### 2245 24526 6359 12899

a 

### MRID 04378501

Based on Batch Equilibrium studies, ziram, at five concentrations ranging from 0.2 to 4.0 ppm and in four soil types with %OC ranging from 0.2 to 1.8, appeared to b e moderately mobile in sand, silt loam and sandy loam soils, but shows low mobility in a clay soil. The samples were equilibrated for up to 24 hours. The Freundlich, K ads 

### and K OC 

### constants ranged from 2.9 to 7.6 and 314 to 1232, respectively, for three of the soils tested. For the clay soil, K ads 

### =68.1, and

K OC 

### =3732. The Freundlich, K des 

### constants ranged from 40 to 4093 for the four soils tested.

### 43 IV. Field Dissipation

Since ferbam appears to be very labile in the environment, as shown in the aerobic soil metabolism study (MRID 44368901), and its major degradation product is thiram, two terrestrial field dissipation studies for thiram (MRID 44724501 and 44724502) will be used as surrogate studies for the ferbam data requirement.

164

- 1 Terrestrial Field Di ssipation

164

- 1 Terrestrial Field Dissipation of Thiram (MRID 44724501, Supplemental, and 44724502, Acceptable)

– Thiram was applied eight times at a nominal rate of 10.3 lbs a.i./A to turfed and bare plots of an alkaline sandy soil (pH 8.2 to 9.6) in Ca lifornia. The terrestrial field
half

- life was 27.4 days in a turfed plot and 14.4 days from a bareground plot. A similar study conducted using an acidic bareground sandy soil (pH 4.1 to 4.7) and acidic turfed loamy sand (pH 4.4 to 4.5) in North Carolina wh ere thiram was applied eight times at a rate of 10.3 lbs a.i./A/application yielded slightly longer half

- lives. The field half

- life was 36 days on the bareground plot and 62.5 days on the turfed plot.

The registrant conducted two terrestrial field dissipa tion studies for ziram. Although both studies were on bareground, they were representative of typical use sites, as well as the East and West coasts of the US. One was conducted on a sand soil in Wake County, NC (peaches), and the
other was conducted on a sandy loam soil in Tulare County, CA (almonds). The product used
was Ziram 76 DF ® 

### , which was broadcast applied nine times (at 7

- to 10

- day intervals) as a spray to bareground plots at 8 lb/A/application. Ziram, dissipated from the 0

- to 3

- inch soil depth with
initial half

- lives of 6.7 days and 5.2 days (0

- to 10

- day data in both cases) following the ninth application, at the North Carolina and California sites, respectively. The dissipation appeared to become slow after the first two weeks. The subsequent half

- lives were 144 days (15

- to 539

- day data) and 206 days (14

- to 540

- day data), respectively. These studies, however, can only be considered supplemental at this time because storage stability data were inadequate for the parent compound (both sites) an d the degradate 1,1

- dimethylurea (California site). In addition, at the North Carolina site, Hurricane Fran delivered approximately 8 inches of rain eight days following the ninth application. Furthermore, the California study presents difficulties in the interpretation of data because there was high variability in the data from day 0 to 10 days post

treatment.

### 44 

# Appendi x D

. Ziram, Thiram, and Ferbam Ecotoxicity Data

1. Toxicity to Aquatic Organisms

1.1. Aquatic Vertebrate Toxicity

1.1.1. Freshwater Fish Toxicity

Ta ble A

- 1. Acute Toxicity to Freshwater Fish

Species % ai 96

- hr LC 50 (ppm ai) Toxicity Category MRID No.
Author, Year Study

Classification

FERBAM

Bluegill sunfish
( Lepomis macrochirus ) 95 3.6 Moderately toxic 05014941 Pickering &
Henderson, 1966 Suppleme ntal

Carp ( Cyprinus carpio ) Tech 0.09 Very highly toxic 05001997

Hashimoto &
Fukami, 1969 Supplemental

Fathead Minnow
( Pimephales promelas ) 95 3.1 Moderately toxic 05014941 Pickering &
Henderson, 1966 Supplemental

THIRAM

Bluegill sunfish 99.0 0.042 Ver y highly toxic TN 996
McCann, 1968 Acceptable

Bluegill sunfish 37.5 0.21 1 Highly toxic 00002923, 00021610
Mastri, 1970 Supplemental

Bluegill sunfish 75 0.28 Highly toxic 00090294
McCann, 1972 Supplemental

Harlequin Fish ( Rasbora heteromorpha ) 80 0.007 Very highly toxic 05020144 Tooby et al., 1975 Supplemental

Rainbow trout
( Oncorhynchus mykiss ) 99.0 0.046 Very highly toxic 46249301
Peither, 2000 Supplemental

Rainbow trout 99.0 0.128 Highly toxic TN 1001
McCann, 1976 Acceptable

Rainbow trout 37.5 0. 14 1 Highly toxic 00002923, 00021610
Mastri, 1970 Supplemental

Rainbow trout 75 0.382 Highly toxic 00090293
McCann, 1972 Supplemental

ZIRAM

Bluegill sunfish 98.9 0.0097 Very highly toxic 42386303 Douglas et al., 1991 Acceptable

Bluegill sunfish 98.2 0. 57 Highly toxic 47307901
Palmer et al., 2007 Acceptable

Carp Tech 2.28 Moderately toxic 00138215
Dickhaus & Heisler,

1980 Supplemental

Fathead Minnow 99.0 0.008 Very highly toxic 05003523 Maloney & Palmer,

1956 Supplemental

Rainbow trout 76 0.23 Highly toxic TN 1021
McCann, 1976 Supplemental

### 45 Species % ai 96

- hr LC 50 (ppm ai) Toxicity Category MRID No.
Author, Year Study

Classification

Rainbow trout Tech 0.27 Highly toxic 00138214
Dickhaus et al., 1980 Supplemental

Rainbow trout 98.9 1.7 Moderately toxic 42386304 Douglas et al., 1991 Acceptable

1 Test substance: Vitavax Seed Protectant, 37.5% t hiram and 37.5% carboxin

Table A

- 2. Chronic Toxicity to Freshwater Fish

Species % ai NOAEC / LOAEC (ppm ai) Most Sensitive Endpoint MRID No.
Author, Year Study

Classification

FERBAM

No data available

THIRAM

Fathead Minnow
( Pimephales promelas ) 98.7 0. 0011 / 0.0022 1 F0 % spawning frequency, F0 egg

production, F1
time to hatch, F1

4

- wk survival 47824101 Krueger & Kendall,

2009 Acceptable

Rainbow Trout
( Oncorhynchus mykiss ) 81.2 0.012 / 0.020 2 Growth rate 46249303
Memmert, 2001 Supplemental

ZIRAM

Fa thead Minnow 98.2 0.101 / 0.195 3 Post

- hatch

survival 46893104
Palmer et al., 2006 Acceptable

Fathead Minnow 98.2 0.024 / 0.051 4 F 0 length and weight 47435501
Palmer et al., 2008 Supplemental

1 Full life cycle study, 210 days.

2 Non

- guideline 28

- day sub

- chronic study. 4 applications at 7 day intervals to 10:1 water:sediment systems.

3 Early

- life stage study, 33 days (28 days post

- hatch).

4 Full life cycle study, 275 days.



### 1.1.2. Estuarine/Marine Fish Toxicity

Table A

- 3. Acute Toxicity to Estuarine/Marine Fish

Species % ai 96

- hr LC 50 (ppm ai) Toxicity Category MRID No.
Author, Year Study

Classification

FERBAM

Longnose killifish
( Fundulus similis ) 76 0.80 Highly toxic 40228401 Mayer, 1986 Supplemental

THIRAM

Sheepshead Minnow
( Cyprinodon variegatus ) 98.3 0. 54 Highly toxic 42514401
Croudace et al., 1992 Acceptable

ZIRAM

Longnose killifish Tech 6.40 1 Moderately toxic 40228401 Mayer, 1986 Supplemental

Sheepshead Minnow 98.9 0.84 Highly toxic 43781601
Machado, 1995 Acceptable

1 48

- hr test

### 46 Table A

- 4. Chroni c Toxicity to Estuarine/Marine Fish

Species % ai NOAEC / LOAEC (ppm ai) Most Sensitive Endpoint MRID No.
Author, Year Study

Classification

FERBAM

No data available

THIRAM

No data available

ZIRAM

Sheepshead Minnow 98.2 0.027 / 0.058 1 Length and dry

w eight of larvae 46856401
Sutherland et al.,

2006 Acceptable

1 Early

- life stage study, 34 days (28 days post

- hatch).



### 1.2. Aquatic Invertebrate Toxicity

1.2.1. Freshwater Invertebrate Toxicity

Table A

- 5. Acute Toxicity to Freshwater Invertebrates

Species % ai 48

- hr EC 50 (ppm ai) Toxicity Category MRID No.
Author, Year Study

Classification

FERBAM

No data available

THIRAM

Water flea ( Daphnia

magna ) 98 0.21 Highly toxic 00164662
Husson, 1986 Acceptable

ZIRAM

Water flea 98.9 0.048 Very highly toxic 42386305 Dougla s et al., 1992 Acceptable

Water flea 98.2 0.206 Highly toxic 47405701
Palmer et al., 2008 Acceptable

Table A

- 6. Chronic Toxicity to Freshwater Invertebrates

Species % ai NOAEC / LOAEC (ppm ai) Most Sensitive Endpoint MRID No.
Author, Year Study

Classif ication

FERBAM

No data available

THIRAM

Water flea 98.7 0.020 / 0.040 Dry weight, clinical signs of toxicity 47495001 Krueger & Kendall,

2008 Acceptable

ZIRAM

Water flea 98.2 0.039 / 0.078 Length 46823301
Palmer et al., 2006 Acceptable

### 47 1.2.2. Estuarine/Ma rine Invertebrate Toxicity

Table A

- 7. Acute Toxicity to Estuarine/Marine Invertebrates

Species % ai 96

- hr EC 50 or LC 50 (ppm ai) Toxicity Category MRID No.
Author, Year Study

Classification

FERBAM
Eastern Oyster
( Crassostrea virginica ) 76 0.052 Very hig hly toxic 40228401 Mayer, 1986 Supplemental

Pink Shrimp ( Penaeus

duorarum ) 76 >40 1 Slightly toxic 40228401 Mayer, 1986 Supplemental

THIRAM

Pacific Oyster
( Crassostrea gigas ) 98.3 0.0047 1 Very highly toxic 42488301 Thompson et al.,

1992 Acceptable

Mys id Shrimp

( Americamysis bahia ) 98.3 0.00336 Very highly toxic 42488302 Thompson et al.,

1992 Acceptable

ZIRAM

Eastern Oyster 98.0 0.077 Very highly toxic 43781602
Dionne, 1995 Acceptable

Eastern Oyster Tech 1.00 Highly toxic 40228401 Mayer, 1986 Supple mental

Mysid Shrimp 98.0 0.014 Very highly toxic 43781603
Machado, 1995 Acceptable

Mysid Shrimp 98.2 0.14 Highly toxic 47405702
Palmer et al., 2008 Acceptable

Pink Shrimp Tech >5 1 Moderately toxic 40228401 Mayer 1986 Supplemental

1 48

- hr test

Table A

- 8. Chronic Toxicity to Estuarine/Marine Invertebrates

Species % ai NOAEC / LOAEC (ppm ai) Most Sensitive Endpoint MRID No.
Author, Year Study

Classification

FERBAM

Mysid Shrimp 97.6 <0.0012 / 0.0012 F 0 body length 47784401 Gallagher et al., 2009 Suppl emental

THIRAM

No data available

ZIRAM

Mysid Shrimp 98.2 0.016 / 0.027 Reproduction and dry weight 46893103
Sutherland et al.,

2006 Supplemental



### 1.3. Aquatic Plant Toxicity

Table A

- 9 . Toxicity to Aquatic Plants

Species % ai EC 50 (ppm ai) EC 05 or NOAEC
( ppm ai) MRID No.
Author, Year Study

Classification

FERBAM

No data available

THIRAM

### 48 Species % ai EC 50 (ppm ai) EC 05 or NOAEC
( ppm ai) MRID No.
Author, Year Study

Classification

Duckweed ( Lemna gibba ) 98.7 7

- d EC 50 = 1.6 NOAEC < 0.057 45441202
Sutherland et al.,

2001 Acceptable

Green algae
( Pseudokirchneriella subcapitata ) 99.0 120

- hr EC 50 = 0. 14 EC 05 = 0.003 44086001, 44086101
Coates, 1996 Acceptable

ZIRAM

Duckweed 98.2 7

- d EC 50 = 0.37 NOAEC = 0.035 46823302 Desjardins et al.,

2006 Acceptable

Green algae 98.0 120

- hr EC 50 = 0.067 NOAEC < 0.038 43833901 Hoberg, 1995 Acceptable



### 2. Toxicity to T errestrial Organisms

2.1. Avian Toxicity

Table A

- 10. Acute Oral Toxicity to Birds

Species % ai LD 50 (mg ai/kg

- bw) Toxicity Category MRID
Author, Year Study

Classification

FERBAM

No data available

THIRAM

Mallard duck (Anas

platyrhynchos) 99.0 >2800 Practi cally non

toxic 00160000
Hudson et al., 1984 Acceptable

Red

- wing blackbird
( Agelaius phoeniceus ) Tech >100 Moderately toxic 00073683, 00020560
Schafer, 1972 Supplemental

Ring

- neck pheasant
( Phasianus colchicus ) 99.0 673 Slightly toxic 00160000

Hudson et al., 1984 Supplemental

Starling ( Sturnus vulgaris ) Tech >100 Moderately toxic 00073683, 00020560
Schafer, 1972 Supplemental

ZIRAM

Bobwhite quail ( Colinus
virginianus ) 98.5 97 Moderately toxic 41725701
Hakin & Norman,

1989 Acceptable

Table A

- 11. Sub

- a cute Dietary Toxicity to Birds

Species % ai LC 50 (mg ai/kg

- diet) Toxicity Category MRID
Author, Year Study

Classification

FERBAM

Bobwhite quail Tech 2940 Slightly toxic 00106146
Fink & Reno, 1973 Supplemental

Mallard duck Tech >4640 Slightly toxic 00106 148
Fink & Reno, 1973 Supplemental

THIRAM

Bobwhite quail 95.0 3950 Slightly toxic 00022293
Hill et al., 1975 Acceptable

### 49 Species % ai LC 50 (mg ai/kg

- diet) Toxicity Category MRID
Author, Year Study

Classification

Japanese quail ( Coturnix
japonica ) 95.0 >5000 Practically non

toxic 00022293
Hill et al., 1975 Supplemental

Mallard duck 95.0 >5000 Practically non

toxic 00022293
Hill et al., 1975 Acceptable

Ring

- neck pheasant 95.0 >5000 Practically non

toxic 00022293
Hill et al., 1975 Supplemental

ZIRAM

Bobwhite quail 98.5 >5200 Practically non

toxic 42386301 Hakin et al., 1992 Acceptable

Mall ard duck 98.5 5156 Practically non

toxic 42386302 Hakin et al., 1992 Acceptable

Table A

- 12. Chronic Toxicity to Birds

Species % ai NOAEC / LOAEC (mg ai/kg

- diet) Most Sensitive Endpoint MRID No.
Author, Year Study

Classification

FERBAM

No data availab le

THIRAM

Bobwhite quail 97.5 500 / 2500 Egg production, eggs set/eggs laid, viable embryos/ eggs set, normal hatchlings/eggs
set, 14

- d survivors/eggs set, feed consumption,

14

- d survivor bodyweight, hen

bodyweight 43612502
Beavers et al., 1995 Acceptabl e

Mallard duck 97.5 <50 / 50 Egg production, eggs set/eggs laid, normal hatchlings/ eggs laid 43612501
Beavers et al., 1995 Supplemental

Mallard duck 98.7 9.6 / 39.7 Eggs set, viable embryos, live 3

- week embryos, normal hatchlings,

14

- d survivors,

eggs set/eggs laid, normal hatchlings/

live 3

- wk embryos, normal hatchlings/eggs

laid 45441201 Gallagher et al., 2001 Acceptable

### 50 Species % ai NOAEC / LOAEC (mg ai/kg

- diet) Most Sensitive Endpoint MRID No.
Author, Year Study

Classification

ZIRAM

Mallard duck 98.8 29 / 64 Eggs set, eggs set/ eggs laid, embryo viability, hatchability, 14

- day survivors, 14

-

day survivors /

eggs set 47286501 Temple et al., 2007 Acceptable



### 2.2. Mammalian Toxicity

Table A

- 13. Acute Oral Toxicity to Mammals

Species % ai LD 50 (mg ai/kg

- bw) Toxicity Category MRID
Author, Year Study

Classification

FERBAM

Laboratory rat
( Rattus norvegicus ) 91.8 > 5,000 Practically non

toxic 40561501 Reijnders, 1987 Acceptable

Laboratory rat Tech >17,000 Practically non

toxic Farm Chemicals

Handbook Unknown

THIRAM

Laboratory rat 99.0 1800 (F)
3700 (M)
2600 (M & F) Slightly toxic 00153548
Thouin, 1985 Acceptable

ZIRAM

Laboratory rat 98.5 320 Moderately toxic 41340401 Liggett & Allan,

1989 Acceptable

Table A

- 14. Acute Inhalation Toxicity to Mammals

Species % ai 4

- hr LC 50 (mg ai/L) Toxicity Category MRID
Author, Year Study

Classification

FERBAM

Laboratory rat 9 1.8 0.40 Toxicity Category

II 41508101 Hardy & Jackson,

1988 Acceptable

THIRAM

Laboratory rat Tech >0.1 Not determined 00152556
Debets, 1985 Acceptable

Laboratory rat Tech 2.60 < LC 50 < 5.04 Not determined 40216501 Maedgen & Lain,

1987 Acceptable

ZIRA M

Laboratory rat 98.5 0.06 (F)
0.08 (M) Toxicity Category

II 41442001 Jackson & Hardy,

1989 Acceptable

### 51 Table A

- 1 5. 2

- Generation Reproductive Toxicity to Mammals

Species % ai NOAEC / LOAEC (mg ai/kg

- bw) Most Sensitive Endpoint MRID No.
Author, Year Stud y
Classification

FERBAM

No data available

THIRAM

Laboratory rat 97.5 1.5 / 2.9 (M)
2.3 / 4.6 (F) F0: Mean maternal body weight & food consumption,

male food consumption 42095901
York, 1991 Acceptable

Laboratory rat 100 1.4 / 4.2 (M)
1.6 / 4.7 (F) F0 & F1: Body weight 45441203
Turck, 1997 Acceptable

ZIRAM

Laboratory rat 97.8 14.8 / 37.5 F0 & F1: Body weight, body weight gain, food

consumption 43935801
Nemec, 1996 Acceptable



### 2.3. Terrestrial Invertebrate Toxicity

Table A

- 16. Acute Contact Toxicity to Ho ney Bees

Species % ai 48

- hr LD 50 (μg ai/bee) Toxicity Category MRID
Author, Year Study

Classification

FERBAM

Honey bee ( Apis Mellifera ) Fermate

form. >12.09 Practically non

toxic 00036935
Atkins & Anderson,

1967 Acceptable

THIRAM

Honey bee Tech 73.72 P ractically non

toxic 00036935
Atkins et al., 1975 Acceptable

ZIRAM

Honey bee Zerlate

form. 46.65 Practically non

toxic 00036935
Atkins & Anderson,

1967 Acceptable

Honey bee 98.5 >200 Practically non

toxic 41667901
Cole, 1989 Acceptable



### 2.4. Terrestrial Pla nt Toxicity

No terrestrial plant toxicity data is available for ferbam or thiram.

Table A

- 17. Tier I Seedling Emergence

- Ziram (MRID 46893101; Porch & Krueger, 2006; Acceptable)

Species Seedling Height Seedling Dry Weight Emergence

NOAEC
(lbs ai/A) I C 25 (lbs ai/A) NOAEC
(lbs ai/A) IC 25 (lbs ai/A) NOAEC
(lbs ai/A) IC 25 (lbs ai/A)

Monocots

Corn (Zea mays) 6.0 >6.0 6.0 >6.0 6.0 >6.0

### 52 Species Seedling Height Seedling Dry Weight Emergence

NOAEC
(lbs ai/A) I C 25 (lbs ai/A) NOAEC
(lbs ai/A) IC 25 (lbs ai/A) NOAEC
(lbs ai/A) IC 25 (lbs ai/A)

Onion (Allium cepa) 6.0 >6.0 6.0 >6.0 6.0 >6.0

Ryegrass (Lolium perenne) 6.0 >6.0 6.0 >6.0 6.0 >6.0

Wheat (Triticum ae stivum) 6.0 >6.0 6.0 >6.0 6.0 >6.0

Dicots

Cabbage (Brassica oleracea) 6.0 >6.0 6.0 >6.0 6.0 >6.0

Lettuce (Lactuca sativa) 6.0 >6.0 6.0 >6.0 6.0 >6.0

Radish (Raphanus sativus) 6.0 >6.0 6.0 >6.0 6.0 >6.0

Soybean (Glycine max) <6.0 1 >6.0 6.0 >6.0 6.0 >6 .0

Tomato (Solanum lycopersicum) 6.0 >6.0 6.0 >6.0 6.0 >6.0

Turnip (Brassica rapa) 6.0 >6.0 6.0 >6.0 6.0 >6.0

1 Decrease in height of 16%; not statistically significant but considered biologically significant.

Table A

- 18. Tier I Vegetative Vigor

- Zira m (MRID 46893102; Porch & Krueger, 2006; Acceptable)

Species Plant Height Dry Weight Survival

NOAEC
(lbs ai/A) IC 25 (lbs ai/A) NOAEC
(lbs ai/A) IC 25 (lbs ai/A) NOAEC
(lbs ai/A) IC 25 (lbs ai/A)

Monocots

Corn (Zea mays) 6.1 >6.1 6.1 >6.1 6.1 >6.1

Onion (Allium cepa) 6.1 >6.1 6.1 >6.1 6.1 >6.1

Ryegrass (Lolium perenne) 6.1 >6.1 <6.1 2 >6.1 6.1 >6.1

Wheat (Triticum aestivum) 6.1 >6.1 6.1 >6.1 6.1 >6.1

Dicots

Cabbage (Brassica oleracea) 6.1 >6.1 6.1 >6.1 6.1 >6.1

Lettuce (Lactuca sativa) 6.1 >6.1 6.1 > 6.1 6.1 >6.1

Radish (Raphanus sativus) 1 6.1 >6.1 6.1 >6.1 6.1 >6.1

Soybean (Glycine max) 6.1 >6.1 6.1 >6.1 6.1 >6.1

Tomato (Solanum lycopersicum) 6.1 >6.1 <6.1 3 >6.1 6.1 >6.1

Turnip (Brassica rapa) 6.1 >6.1 6.1 >6.1 6.1 >6.1

1 A Tier II test was con ducted for radish because 2 plants died in the Tier I test. No effects were seen in the Tier II test up to 6.1
lbs ai/A.

2 Decrease in dry weight of 13%; not statistically significant but considered biologically significant.

3 Decrease in dry weight of 12% ; statistically significant.

### 53 

# Appendix E

. Thiram

– Preliminary Identification of Data Gaps

The following data gaps tables are from the thiram problem formulation (USEPA, 2015).



## E.1. Environmental Fate Data

Tabl e E

- 1 identifies environmental fate studies by MRID for thiram that offer data for each guideline requirement, as well as study classifications and whether or not further data are needed in order to support risk assessment.

A cceptable guideline studies on hydrolysis and adsorption/desorption have not been submitted
for thiram

. However, the supplemental data listed in the tables below can be used in conjunction with the acceptable guideline study data to quantitatively assess the environmental fate of the
chemical.

Independently validated environmental chemistry methods (ECM/ILV) for measuring thiram in soil and water are available. While separate methods are not available for ferbam, the thiram methods are fully adequate to assess residues from a ferbam treated field.

Table E

- 1 . Submitted Environmental Fate Data for Thiram

OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classification s Are Additional

Data Needed to
Conduct Risk
Assessment?

835.2120 Hydrolysis 45714101

41840601 S upplemen tal

S upplemental No

835.2240 Photodegradation in

Water 45651201
41758301 A cceptable

S upplemental No

835.2410 Photodegradation on
Soil 45724501

43661801 A cceptable

I nvalid No

835.4100 Aerobic Soil
Metabolism 43734901 A cceptable No

835.4200 Anaerobic Soi l
Metabolism 40768103 I nvalid No

835.4300 Aerobic Aquatic
Metabolism 45243401 A cceptable No

835.4400 Anaerobic Aquatic
Metabolism 43628501 A cceptable No

835.1230

835.1240 Leaching

- Adsorption/ Desorpti o n 43787501 S upplemental No

835.6100 Terrestrial Fie ld Dissipation 44724501

44724502 S upplemental

A cceptable No

### 54 

## E.2. Effects Data

Tables E

- 2 and E

- 3 identify aquatic and terrestrial ecological effects studies , respectively, by MRID that offer data for each guideline requirement, as well as study classifi cations and whether or not further data are needed in order to support risk assessment.

Table E

- 2 . Submitted Aquatic Ecological Effects Data for Thiram

OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are Additional

Data N eeded to
Conduct Risk
Assessment? Current Additional Data

Need

850.1010 Freshwater
invertebrate acute toxicity 00164662 Acceptable No None

850.1025

850.1035
850.1045
850.1055 Saltwater
invertebrate acute toxicity 42488301 Acceptable

No None

42488302 Acceptable

850.1075 Freshwater fish acute toxicity TN 996 Acceptable

No None TN 1001 Acceptable

00002923 /

00021610 Supplemental

00090293 Supplemental

00090294 Supplemental

05020144 Supplemental

46249301 Supplemental

850.1 075 Saltwater fish acute toxicity 42514401 Acceptable No None

850.1300 Freshwater
invertebrate

life cycle 47495001 Acceptable No None

850.1350 Saltwater
invertebrates

life cycle None NA Yes Data are needed to reduce uncertainty in the
assessment of chron ic risk
to estuarine/marine
invertebrates. A chronic mysid study conducted

with ferbam (MRID 47784401) did not
establish a NOAEC. A new study with thiram is
recommended.

850.1400 Freshwater fish early

- life stage 46249303 Supplemental

No None 47495002 N ot reviewed (preliminary

report for 850.1500)

### 55 OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are Additional

Data N eeded to
Conduct Risk
Assessment? Current Additional Data

Need

850.1400 Saltwater fish early

- life stage None NA Yes Data are needed to reduce uncertainty in the
assessment of chronic risk
to estuarine/marine fish.

850.1500 Fish life cycle 47824101 Acceptable No None

8 50.1735 Whole sediment 10

- d
freshwater
invertebrate None NA No None. Thiram is not expected to accumulate in
sediment.

850.1740 Whole sediment 10

- d
estuarine/marine

invertebrate None NA No None. Thiram is not expected to accumulate in
sediment.

850.4400 Aquatic plant Toxicity Test using Lemna spp. 45441202 Acceptable No None

850.4500 Algal toxicity 44086001 /

44086101 Acceptable Yes Studies with two additional species will reduce uncertainty in the
assessment of risk to non

vascular plants . Suggested

spec ies are the freshwater
diatom Navicula pelliculosa and the marine
diatom Skeletonema

costatum

.

850.4550 Cyanobacteria None NA Yes A cyanobacteria will reduce uncertainty in the
assessment of risk to non

vascular plants.



### Table E

- 3 . Submitted Terrestrial Ecological Effects Data for Thiram

OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are Additional

Data Needed to
Conduct Risk
Assessment? Current Additional Data

Need

850.2100 Avian oral toxicity 00160000 Acceptable

Yes An acceptable study with a passerine species will reduce uncertainty in the
assessment of risk to birds. 00073683/
00020560 Supplemental

850.2200 Avian dietary toxicity 00022293 Acceptable No None

850.2300 Avian reproduction 43612501 Supplemental

No N one 43612502 Acceptable

45441201 Acceptable

### 56 OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are Additional

Data Needed to
Conduct Risk
Assessment? Current Additional Data

Need

Non

guideline Avian inhalation None NA No While STIR indicated a potential risk to birds from droplet inhalation, this was only for ground applications and the inhalation toxicity endpoint

used was a l ower bound
estimate. Risk concerns

from this exposure pathway are expected to be minor compared to dietary exposure and a study is not requested at this time.

850.3020 Honey bee acute contact toxicity 00036935 Acceptable No None

850.3030 Honey bee residu e on foliage None NA No None. Acute contact toxicity endpoint is >11 μg/bee.

850.3040 Field testing for pollinators (Tier III) None NA Yes See justification tables
below for additional
details.

Non

guideline

(Tier I) Honey bee adult acute oral toxicity N one NA Yes An adult acute oral study will reduce uncertainty in

the risk assessment for pollinators. See justification tables below

for additional details.

Non

guideline

(Tier I) Honey bee larvae

acute toxicity None NA Yes A larvae acute study will
reduc e uncertainty in the
risk assessment for

pollinators. See justification tables below

for additional details.

Non

guideline

(Tier I) Honey bee adult chronic 10d toxicity None NA Yes An adult chronic oral study will reduce uncertainty in

the risk assessment for pollinators. See justification tables below

for additional details.

Non

guideline

(Tier I) Honey bee larvae chronic toxicity None NA Yes A larvae chronic study will reduce uncertainty in the
risk assessment for

pollinators. See justification tables b elow

for additional details.

### 57 OCSPP
Guideline Data Requirement Submitted
Studies (MRID) Study
Classifications Are Additional

Data Needed to
Conduct Risk
Assessment? Current Additional Data

Need

Non

guideline (Tier II) Semi

- field testing for pollinators (tunnel or colony feeding studies) None NA Yes See justification tables
below for additional
details.

Non

guideline (Tier II) Field trial of residues in pollen
and ne ctar None NA Yes See justification tables
below for additional
details.

850.4100 Seedling Emergence None NA Yes A seedling emergence study will reduce uncertainty in the
assessment of risk to

terrestrial plants.

850.4150 Vegetative Vigor None NA Yes A v egetative vigor study will reduce uncertainty in
the assessment of risk to terrestrial plants.