### UNITED STATES ENVIRONMEN TAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE O
OFFICE OF CHEMCICAL SAFETY AND

POLLUTION PREVENTION



### Environmental Fate and Eco logical Risk Assessment

Problem Formulation

In Support of Registration Review of Propamocarb-HCl

Propamocarb-HCl (PC code: 119302, CA S No. 25606-41-1)

Completed By: Mohammed Ruhman, PhD, Agronomist Justin Housenger, Biologist

Environmental Risk Branch 5

Environmental Fate a nd Effects Division



### September 20, 2011 Carbamate Moiety



### H+ N H 3 

### C

CH 3 

## CH 3 

## Cl 

### N H O O

1

### Table of Contents

1. Purpose ........................................................................................................................ 4

2. Problem Formulation .................................................................................................. 4 2.1 Nature of Regulatory Action ..................................................................................... 4

2.2 Previous Risk Assessments ....................................................................................... 4

3. Stressor Source and Distribution ................................................................................ 6

3.1 Mechanism of Action ................................................................................................ 6 3.2 Overview of Pesticide Usage .................................................................................... 7 3.3 Environmental Fate and Transport .......................................................................... 12

4. Ecological Effects ..................................................................................................... 20 4.1 Aquatic and Terrestrial Effects ............................................................................... 20

4.2 Incident Database Review ....................................................................................... 26 4.3 Ecosystems Potentially at Risk ............................................................................... 26 4.4 Assessment Endpoints ............................................................................................ 27 4.5 Conceptual Model ................................................................................................... 27

5. Analysis Plan ............................................................................................................ 31

5.1 Stressors of Concern ............................................................................................... 31 5.2 Measures of Exposure ............................................................................................. 31

5.3 Measures of Effect .................................................................................................. 32 5.4 Integration of Exposure and Effects ....................................................................... 34 5.5 Endangered Species Assessments ........................................................................... 34 5.6 Drinking Water Assessment ................................................................................... 34 5.7 Monitoring Data ...................................................................................................... 35

5.8 Clean Water Act ...................................................................................................... 35 5.9 Endocrine Disruptor Screening Program (EDSP) ................................................... 36 5.10 Uncertainty and Preliminary Identification of Data Gaps .................................... 37 Bibliography ..................................................................................................................... 41

2

### List of Tables

Table 1 Propamocarb-HCl labeled vegetables use patterns and application parameters based on the latest revised labels submitted in 2010 (MxR = Maximum single Application Rate (lb a.i/A), MxNA= Maximum Number of Applications, Mx SRT= Maximum seasonal rate (lb a.i/A), MnAI= Minimum Application Intervals in days) ........................................................................... 8 Table 2 Propamocarb-HCl labeled turf and orname ntals use patterns and application parameters based on the latest revised labels submitted in 2010 ( MSR = Maximum single Application Rate (lb a.i/A), MNA = Maximum Number of Applications, MSRT = Maximum seasonal rate (lb a.i/A),

MAI = Minimum Application Intervals in days) .............................................................................. 9 Table 3 Screening Level Estimates of Agricult ural Uses of Propamocarb-HCl (119302) sorted alphabetically

.............................................................................................................................. .. 11 Table 4 Summary of physicochemic al properties of Propamocarb-HCl ...................................... 13 Table 5 Summary of abiotic laboratory de termined properties of Propamocarb-HCl .................. 14 Table 6 Summary of acceptable fate and transport properties for propamocarb-HCl .................. 17

Table 7 Terrestrial fiel d dissipation studies da ta for Propamocarb-HCl ...................................... 18 Table 8 Test Species Evaluated for Assessing Pote ntial Acute and Chronic Ecological Effects of Propamocarb-HCl ......................................................................................................................... 20 Table 9 Measures of Ecological Eff ects and Exposure for Propamocarb-HCl ............................ 33 Table 10. Environmental fate Data Requirements for Propamocarb-HCl ................................... 38 Table 11 Ecological Effects Data Requirements for Propamocarb-HCl ...................................... 39



### List of Figures

Figure 1 Screening Level Estimates of Agricultural Uses of Propamocarb-HCl ......................... 11 Figure 2 Propamocarb-HCl vegetable usage data from 1998 to 2008 (Pounds a.i Applied) ...... 12 Figure 3 A conceptual model for Propam ocarb-HCl effects on aquatic organisms ..................... 29 Figure 4 A conceptual model of Propamocar b-HCl effects on terrestrial organisms ................... 30



### APENDICIES

Appendix A: Issues Associated with Current Labels for Propamocarb-HCl Appendix B: Fate Data for Propamocarb-HCl

3

## 1. Purpose

The purpose of this problem formulation is to provide the foundation for the ecological risk assessment being conducted for the register ed uses of Propamocarb-hydrochloride (Propamocarb-HCl). As such, it articulates the pu rpose and objectives of the risk assessment, evaluates the nature of the problem, and provides a plan for analyzing the data and characterizing ecological risk (EPA, 1998). Add itionally, this problem formulati on is intended to identify data gaps, uncertainties, and potenti al assumptions needed to ad dress those uncertainties in characterizing the ecological risk associated with the registered uses of Propamocarb-HCl.

Propamocarb-HCl is a member of the carbamate fam ily of fungicides. The chemical was initially registered in 1984 for use on turf and ornamental and currently has uses on potatoes, lettuce, cucurbits, and fruiting vegetables (such as to matoes peppers), in addition to the original registration on turf, and ornamentals. Propamocarb-H Cl is used as a liquid foliar spray prepared from the EC formulation. The chemical is used to control late blight ( Phytophthora infestans )

, early blight ( Altemaria solani ), downy mildews, Phytophthora fruit rots, Pythium blight, Pythium damping off, root rot, dollar spot, brown pa tch, leaf spot, gray leaf spot, red thread, and
Rhizoctonia

.



## 2. Problem Formulation

2.1 Nature of Regulatory Action

The Food Quality Protection Act of 1996 manda ted the EPA to implement a new program, i.e., registration review ( http://www.epa.gov/oppsrrd1/registration_review/ ). All pesticides

distributed or sold in the Unite d States generally must be regi stered by EPA. The decision to register a pesticide is based on th e consideration of scientific data and other factors showing that

it will not cause unreasonable risk s to human health, workers, or the environment when used as directed on the product label. Th e registration review program is intended to ensure that, as the ability to assess risk evolves and as policies a nd practices change, all registered pesticides continue to meet the statutory standard of no unreasonable advers e effects to human health and the environment. Changes in science, public poli cy, and pesticide use practices will occur over time. Through the new registration review progr am, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely.

As part of the implementation of the new Regist ration Review program purs uant to Section 3(g) of the Federal Insecticide, Fungi cide and Rodenticide Act (FIFRA), the Agency is beginning its evaluation to determine whether Propamocarb-HC l continues to meet the FIFRA standard for registration. This problem formulation, for the e nvironmental fate and ecological risk assessment chapter in support of the registra tion review, is intended for the initial docket ope ning, the public phase of the review process.



### 2.2 Previous Risk Assessments

Propamocarb-HCl has been registered since 1984, and has been subjec t to two main risk

4assessments (Section 3), several Section 18 a ssessments and a chapter drafted for the reregistration eligibility decision (RED). Previous assessments serve as the basis for this problem formulation and a summary of the two prim ary assessments are included hereunder:

. (1) EFED's chapter for the RED of this chemical (dated August 1995) 1 . This chapter covered Propamocarb-HCl uses on ornamental lawns and turf, ornamental sod farms (turf), ornamental herbaceous plants, and ornamental w oody shrubs and vines. At the time of the RED, the Agency had adequate data availabl e to assess the acute ecological hazard of Propamocarb-HCl but did not have sufficient data to assess chronic toxicity. The Agency therefore had required chronic avian reproduction, invertebrate life-cycle, and hydrolysis and photo degradation studies.

In the EFED RED chapter, Propamocarb-HCl usage yielded risk quotients (RQs) that

exceeded the acute risk levels of concern (LOCs) for birds and mammals with multiple applications on turf. Additionally, the use of Propamocarb-HCl on ornamentals resulted in RQs exceeding acute risk LOCs for birds and ma mmals. For aquatic organisms, all uses of propamocarb-HCl did not exceed acute or chroni c LOCs for freshwater and estuarine/marine

fish. Acute LOCs were not exceeded for freshw ater invertebrates but chronic risk could not

be characterized due to a lack of a chroni c freshwater invertebra te study. The RQ for

estuarine/marine invertebrates exceeded the acu te risk LOC for the use on ornamentals. Available aquatic plant toxici ty studies show low toxicity from Propamocarb-HCl use and there were no LOC exceedances for aquatic pl ants. An additional aquatic plant study, however, was requested to evaluate the toxicity of Propamocarb-HCl to Lemna gibba

.

Tier I Terrestrial plant toxici ty studies (Seedling Emergence and Vegetative Vigor) showed significant reductions in dry weight (tomato, 24.3%; cabbage , 20.4%; and oat, 22.4%), and length (cucumber, 7.1%; and soybean, 9.2% ), however none of these reductions exceeded

25% and therefore Tier II studi es are not required. An acute honey bee contact study was not

submitted in order to evaluate the risk of Propamocarb-HCl exposure to terrestrial invertebrates. This study was required by the RED because the Agency had concerns that the high use on field-grown orname ntals would exceed the Levels of Concern (LOC) for endangered birds, mammals, estuarine and ma rine animals. Label changes for PropamocarbHCl use or additional ecological data on seed ling emergence, aquatic plant and honeybee contact studies have been require d through a Data Call-in (DCI).

A mitigation measure was described in EFED’s “Transmittal of EFED RED for the List C Chemical Propamocarb Hydrochloride” (EPA, J une, 1995). The label indicated that the maximum application rate for turf was 8.19 lb s a.i/A. It did not limit the number of applications per year. The registrant indicated that they were willing to limit applications to three per year at 8.19 lbs a.i/A or to 6 per year at 4.1 lbs a.i/A. Based on the available toxicity data, these rate s do not result in exceedances of LOCs for non-target organisms. In addition, The RED recommended the followi ng language be placed on Propamocarb-HCl product labels to mitigate aquatic exposure:

“Do not apply directly to water, or to areas where surface water is pres ent or to intertidal

1 http://www.epa.gov/oppsrrd1/REDs/3124red.pdf

5areas below the mean high water mark. Do not contaminate water when cleaning equipment or disposing of equi pment washwaters or rinsate.”

(2) EFED chapters covering the proposed new uses of Propamocarb-HCl to the following crops:

a. Potatoes (EFED; DP# D259522, D265954, D226118, D253789, D221659, and D252192, June 2000). This assessment conc luded that the restricted use and endangered species LOCs were exceeded for birds, but there were no other acute or chronic LOC exceedances for terrestrial or aquatic organisms.

b. Cucurbits, lettuce, peppers, and tomato es (EFED; DP# D293626, January, 2004).

This assessment concluded that the chronic LOC for birds was exceeded in the use on lettuce, but there were no further acute or chronic LOC exceedances for terrestrial and aquatic organisms.

In both the 2000 and 2004 new use assessments; chronic data for freshwater invertebrates and

estuarine/marine fish and invertebrates were stil l not available. Terrest rial plant studies only assessed two plants (wheat and cucumber) and, while th e study was classified as supplemental, the toxicity of Propamocarb-HCl was higher than th e maximum rate used for all uses at the time

of these assessments.



## 3. Stressor Source and Distribution

3.1 Mechanism of Action

Propamocarb-HCl is a member of the carbama te family of fungicides (FRAC, 2010a; ETN, 1997). The chemical is a systemic fungicide with protective qualities ag ainst several oomycete (water molds) species (e.g. Phytophthora spp., Pythium spp., Bremia lactucae [lettuce downy mildew], and Pseudoperonospora cubensis [cucurbit downy mildew]). These diseases may cause seed, seedling, and root and stem rots, and foliar diseases in many edible crops and ornamental plants. The mode of action of Pr opamocarb-HCl is classified by the Fungicide Resistance Action Committee (FRAC, 2010a) as a "Group 28" fungicide, with a low to medium risk of resistance. Because resistance to pr opamocarb-HCl has been identified in greenhouse

isolates of Pythium spp. (Pest Management Guidelines , 201la; FRAC. 2010b) resistance management strategies have been recommende d with its use (BEAD Memo, April, 2011). The fungicide works by disrupting the formation of f ungal cell walls by interfer ing with the synthesis of phospholipids and fatty acids. It affect s mycelial cell growth, spore production, and germination. Disease control is mainly by pr otection as Propamocarb-HC l has little curative

action once an infection has started. 2

Propamocarb-HCl is formulated with other fungi cide active ingredients including chlorothalonil or fluopicolide. The mode of action for chlorothal onil is related to its function as a multi-site inhibitor of several enzymes that control metabolic processes and spore germination. Specifically, it reduces fungal intracellular glutat hione molecules to alternate forms which cannot

2 http://www.agf.gov.bc.ca/pesticid es/infosheets/propamocarb_hcl.pdf

6participate in essential enzymatic reactions. Chlorothalonil is also toxic to fungal cell

membranes. 3 In contrast to both Propamo carb-HCl and chlorothalonil, fluopicolide is novel in its anti-oomycete properties from other fungicides in that it affects the release and motility of zoospores and the germination of cysts, as well as mycelial growth and s porulation. It has also been shown to specifically modi fy the spatial and cellular dist ribution of proteins labeled by antibodies specific for animal cytoskeleton associ ated proteins spectrin. Cytoskeletal proteins such as actins, tubulins, integrins and spectrins provi de structural stability to cells as they form a network sustaining the plasma membrane. Fluop icolide may interfere and destabilize this network leading to cell disorganization. 4



### 3.2 Overview of Pesticide Usage

Labeled Uses

Propamocarb-HCl is formulated as water miscible concentrate (WMC) or suspended concentrate (SC) alone or mixed with othe r fungicide including fluopicolide or chlorothalonil. The chemical is applied as a liquid spray or as diluted drench di rectly into the soil or foliage (one label) and/or through label specified irrigation systems. There are eight labels for Propamocarb-HCl, three for use on vegetables and five for use on turf and ornamentals. These labels are listed hereunder:

Vegetable labels (1) Propamocarb-HCl alone:

a. 55260-10 Label: Promess Fungicide; water miscib le concentrate formulation (WMC) with 66.8% Propamocarb-HCl

b. 264-678 Label: Previcur Flex; water miscible concentrate (WMC) fo rmulation with 66.5% Propamocarb-HCl (2) Propamocarb-HCl with fluopicolide

a. 59639-142 Label: V-10162 Premix; suspended c oncentrate (SC) formation with 55.4% Propamocarb-HCl and 5.54% fluopicolide

Turf & Ornamentals labels

(1) Propamocarb-HCl alone:

a. 55260-9 Label: Advan Proplant® Turf and Ornamental; water miscible concentrate (WMC) formulation with 66.8% Propamocarb-HCl (2010 Revised Label)

b. 432-942 Label: Banol; water miscible concentrate (WMC) formulation with 66.5% Propamocarb-HCl (2010 Revised Label)

c. 83070-8 Label: Advan propamocarb HCl; water mi scible concentrate (WMC) formulation with 66.8% Propamocarb-HCl (2010 Revised Label) (2) Propamocarb-HCl with fluopi colide or chlorothalonil

a. 59639-143 Label: V-10162 VPP Fungicide; suspended concentrate (SC) formulation with 55.4% Propamocarb-HCl and 5.54% fluopicolide

b. 432-961 Label: Banol C Fungicide: water dispersi ble concentrate (WDC) formulation with 30.5% Propamocarb-HCl and 30.5% chlorothalonil

3 http://www.agf.gov.bc.ca/pesticid es/infosheets/chlorothalonil.pdf

4 http://www.epa.gov/opprd001/factsheets/fluopicolide-newchemical.pdf

7As stated above, Propamocarb-HCl is formulated with either chlorothalonil (for turf & ornamentals use) or fluopicolide (for vegeta ble use). Chlorothalonil is a member of the chloronitrile class of fungi cides. It is a board spectrum cont act or protectant fungicide with a long acting residual activity. It he lps to prevent in fection by fungi when applied as a protective barrier on plant surfaces. In contrast, fluopico lide is a member of th e benzamide class of fungicides and it is used to cont rol certain diseases on cucurbits, lettuce, and fruiting vegetables.

A summary of currently labeled agricultural us e patterns for Propamocarb-HCI is shown in

Table 1 for field vegetable crops. Table 1 summarizes the application parameters and application methods which includes aerial, ground and chemigation.

Table 1 Propamocarb-HCl labeled vegetables use patterns and application parameters based on the latest revised labels submitted in 2010 (MxR = Maximum single Application Rate (lb a.i/A), MxNA= Maximum Number of Applications, Mx SRT= Maximum seasonal rate (lb a.i/A), MnAI= Minimum Application Intervals in days)

Use Pattern MxSR MxN* MxSRT MnAI COMMENTS

59639-142 Label: V-10162 Premix; SC formation with 55.4% Propamocarb-HCl and 5.54% fluopicolide

Cucurbits 0.9 4 3.4 10 - Not for use in greenhouses

- Aerial, ground, and chemigation applications allowed only through center pivot or solid set irrigation

systems Lettuce 1.1 4 3.4 10

Fruiting vegetables 0.9 4 3.4 7

55260-10 Label: Promess Fungicide; WMC formulation with 66.8% Propamocarb-HCl

Cucurbits 0.9 5 4.5 7 Aerial, ground (banded and broadcast), and chemigation applications. In case of chemigation, apply only through center pivot, motorized-lateral move, traveling gun, solid set or portable and drip irrigation

systems. Lettuce 1.5 NR 6.0 5

Peppers 0.9 NR 4.5 7

Tomatoes 1.1 NR 5.6 7

264-678 Label: Previcur Flex; WMC formulati on with 66.5% Propamocarb-HCl

Cucurbits 0.9 5 4.5 7 Aerial, ground (banded and broadcast), and chemigation applications. In case of chemigation, apply only through center pivot, motorized-lateral move, traveling gun, solid set or portable and drip irrigation

systems. Lettuce 1.5 4 6.0 5 Peppers 0.9 5 4.5 7

Tomatoes 1.1 5 5.6 7

Potatoes 0.9 5 4.5 7

* NR= Not Reported

It is important to note that two of the labels for vegetable crops include greenhouse application, namely, 55260-10 Promess and 264-678 Previcur Fl ex. Both labels include one pre-seeding application to rock-wool cubes seed bed or one pr e-seeding and one seedling applications to soilsoilless seed beds, and drip/drench/foliar applications to plants after transp lanting. The list of greenhouse vegetables includes cucurbits, leaf lettu ce, peppers and tomatoes. With the exception of lettuce, labels call for a total of six or seve n applications: one (in case of rock-wool cubes seedbed) or two (in case of seed beds with and without soil) pr e-seeding applica tions and four drip/drench applications to plants after transpla nting (all four crops). In case of lettuce, an additional two foliar applications may be made to plants after transplanting. Maximums for each cropping season were set to be 11.6 lbs. a.i./A with 6,000 plants, 9.4 lbs. a.i./A with 10,000 plants, and 27.1 lbs. a.i./A with 14,000 plants. Howe ver, label instructions needs to be clarified

8as per notes provided in Appendix A.

Propamocarb-HCl is also labeled for use on turf and ornamentals. A summary of these labeled

uses is included in Table 2. The table summarizes the application parameters and the application methods which include ground app lication for turf, soil drench (or foliar in one label) and chemigation for ornamentals.

Table 2 Propamocarb-HCl labeled turf and ornamental s use patterns and application parameters based on the latest revised labels submitted in 2010 ( MSR = Maximum single Application Rate (lb a.i/A), MNA = Maximum Number of Applications, MSRT = Maximum seasonal rate (lb a.i/A),

MAI = Minimum Application Intervals in days)

Use Pattern and Labels* MSR MNA MSRT MAI COMMENTS

55260-9 Label: Proplant® Turf and Ornamental; WMC formulation with 66.8% Propamocarb-HCl (2010 Revised Label)

Turf 8.2 NR 24.5 7

No application through any irrigation

system. Ornamentals: seeding & transplanting 45.9 NR 25.5 NR

Ornamentals: transplanting cuttings 81.7 NR 25.5 NR

Ornamentals: potting 4” pot 127.9 NR 25.5 21

Ornamentals: Woody ornamentals 63.8 NR 25.5 90

59639-143 Label: V-10162 VPP Fungicide; SC formulation with 55.4% Propamocarb-HCl and 5.54% fluopicolide

Turf 2.12 2 4.25 14

- No chemigation on turf - For chemigation to ornamentals, apply only through micro-irrigation, drip, overhead, or motorized calibrated equipment. Ornamentals: Foliar 4.25 2 NR 14

Ornamentals : Drench for flat beds 212.4 2 NR 14

Ornamentals: Potting 4”

pot 228.0 2 NR 14 5” pot 194.6 2 NR 14 6” pot 202.7 2 NR 14 8” pot 190.0 2 NR 14 10” pot 243.2 2 NR 14 12” pot 253.4 2 NR 14

432-942 Label: Banol ; WMC formulation with 66.5% Propamocarb-HCl (2010 Revised Label)

Turf 8.2 4 25 7 Do not apply through any type of irrigation system

Ornamentals: Seeding & Seedlings 45.9 Single application values (column to the left) are calculated from the labels and may be used only in the case of ONE application. However, in case of TWO applications, the maximum single application per season should be 64 .3 lb a.i./A/application giving a Maximum of 128.6 lb a.i./A/season with intervals ranging from 7-90 days. Ornamentals: Transplanted cuttings 81.7

Ornamentals: Potting (4” pots) 128

Ornamentals: Woody ornamentals 63.8

432-961Label: Banol C Fungicide: WDC formulation with 30 .5% Propamocarb-HCl an d 30.5% chlorothalonil

Turf 8.5 NR 25.5 7-14
May be applied via ground equipment or hydraulic backpack sprayer Ornamentals: Seeding & Seedlings 47.7 1 25.5 N/A

Ornamentals: Transplanted cuttings 85.1 1 25.5 N/A Ornamentals: Potting 133.2 NR 25.5 42

Ornamentals: Woody ornamentals 66.5 NR 25.5 90

83070-8 Label: Advan Propamocarb; WMC formulation with 66.8% Propamocarb-HCl (2010 Revised Label)

Turf 8.2 NR 24.5 7 Do not apply through any type of irrigation system. Ornamentals: seeding & transplanting 45.9 NR 25.5 N/A

9Use Pattern and Labels* MSR MNA MSRT MAI COMMENTS

Ornamentals: transplanting cuttings 81.7 NR 25.5 N/A

Ornamentals: potting 4” pot 127.9 NR 25.5 21

Ornamentals: Woody ornamentals 63.8 NR 25.5 90

Use Pattern and Labels: hereunder notes on Each Label

55260-9 Label

1 Turf: Only for use on golf courses & sod farms (excluding AZ)

2 Ornamentals: commercially-grown in greenhouses and container-grown in nurseries.

59639-143 Label

1 Turf: Only for use on commercial turf, golf co urse turf, residential turf, & sod farms

2 Ornamentals: Not specified if only ornamentals that are commercially-grown in greenhouses and container-grown

in nurseries.

432-942 Label

1 Turf: Only for use on golf & sod farms; Not for use on sod farms in AZ

2 Ornamentals: Not to be used for field grown ornamentals but the label did not specify if only ornamentals that are commercially-grown in greenhouses and container-grown in nurseries.

432-961Label

1 Turf: Only for use on golf courses, sod farms, and non-residential lawns, Not for sale or use in CA and not for use on sod farms in AZ. Use on home lawns is prohibited: Do not use on home lawns and turf sites associated with apartment buildings, daycare centers, pla ygrounds, playfields, recreational park athletic fields, athletic fields allocated on or next to schools (i.e., elementary, mi ddle, and high schools), campgrounds, churches, and theme parks. Do not use on sod farms at app lication rates greater than 13 lb a.i./ acre/year. Note for intervals 7-14= 7-day for the 6 fl oz application and 14-dayfor the 8 fl oz application

2 Ornamentals: Not specified if only ornamentals that are commercially-grown in greenhouses and container-grown

in nurseries.

83070-8 Label

1 Turf: type of turf is not specified; assume all types of tu rf, Not for use in CA and not for use on sod farms in AZ.

2 Ornamentals: Not specified if only ornamentals that are commercially-grown in greenhouses and container-grown

in nurseries.

3 NR = Not reported; N/A = Not applicable

As shown in Table 2 , many issues were identified in labels for this use especially instructions related to application to ornament al plants. Label issues are differe nt from one label to the other but are currently being discussed with respective regist rants and these issues are discussed in Appendix A

.

Usage Data

Propamocarb-HCl was first registered for use on turf and ornaments in 1984. Use on potatoes was added on the year 2000 while use on fruiting ve getables, lettuce, potatoes, and cucurbits was

added in 2004.

Reported Usage data were obtained for the two major use patterns as follows:

(1) Usage on vegetables: usage data were obtained from the Screening Level Usage Analysis (SLUA, date November 23, 2010) ( Table 3 and Figure 1) . This estimated usage is derived from a variety of published and proprietary s ources that are available to the Agency. The data, reported on an aggregate and site (crop) ba sis, reflect annual fluctuations in use patterns as well as the variability in using data fr om various information sources including USDANASS (United States Department of Agricultur e's National Agricultural Statistics Service,

102001 to 2008 data), Private Pesticide Market Research (2001 to 2008 data), and the California DPR (Department of Pes ticide Regulation, 2000 to 2008 data)

Table 3 Screening Level Estimates of Agricultural Uses of Propamocarb-HCl (119302) sorted alphabetically

Crop Total Lbs. of a.i Used Percent Crop Treated

Average Maximum

Cantaloupes 1,000 <1 <2.5

Cucumbers 70,000 30 45

Lettuce 200,000 25 35

Peppers 6,000 5 15

Potatoes 9,000 <1 <2.5
Pumpkins 6,000 10 15
Squash 8,000 10 15

Tomatoes 1,000 <1 <2.5

Watermelons 3,000 <2.5 5

Figure 1 Screening Level Estimates of Agri cultural Uses of Propamocarb-HCl

As per BEAD report (BEAD 2011), which was base d on private market survey data from 2006- 2008, the annual vegetable usage (excluding eggpla nt because data are not available) for Propamocarb-HCl averaged approximately 240,000 pounds for treating 220,000 acres (GtK Kynetec, 2006-2008). Based on the same source, Propa mocarb-HCl is typically applied at a rate

11of 0.7-1.4 pounds a.i/A as it varies from one vegetable crop to the other. The same data suggest that the top crops, in terms of total pounds of active ingredient applied were lettuce (52%), cucumbers (37%), squash (3%), peppers (3%), a nd pumpkins (3%). These crops ranked similarly in terms of the total area treated except cucumb ers ranked higher (46%) th an lettuce (40%). The states with the most usage in terms of pounds a.i applied were California (53%), Michigan (24%), Georgia (7%), Florida (5%), Texas (2%) , and Indiana (2%); Other States (7%). These listed States were also the highest in terms of the total area treated.

A very broad overview of the historical usage data of Propamocarb-HCl can be summarized as

follows:

• Prior to 2005, agricultural usage was limited to potatoes and tomatoes;

• From 1998-2008, the use on potatoes and tomatoes has decreased with no use reported on

tomatoes since 2001.

• Overall, usage has increased substantially in recent years due to the 2004 registration of lettuce, cucurbits, and fruiting vegetables (Figure 2)

Figure 2 Propamocarb-HCl vegetable usage data from 1998 to 2008 (Pounds a.i Applied)

0 350,000

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Other

Tomatoes

Potatoes

Cucumbers

Lettuce

Source: GfK Kynetec, 1998-2008 Other includes: squash, pepper, pumpkins, watermelons, and cantaloupes.

(2) Usage on turf and ornamentals: According to pesticide usage surveys for turf and ornamentals, usage on golf courses has been declining since the peak of approximately 85,000 pounds in 2002 to just under 10,000 pounds in 2006 (Kline and Company; 1999- 2006). Usage by lawn care operators and in nur sery/greenhouse sites was only reported in 2006, accounting for approximately 4,000 pounds each (Kline and Company; 1999-2006).



### 3.3 Environmental Fate and Transport

Two sets of studies were submitted for the phys iochemical properties, laboratory fate in abiotic/biotic systems, laboratory m obility, and field dissipation. The 1 st set was conducted

12between 1976 and 1988 while the 2 nd set of studies was conducted between 1995 and 2002. Data from the two sets are in general agreemen t on the physiochemical and abiotic fate of Propamocarb-HCl. Based on these data, a summaryof the physicochemical properties of the

chemical is included in Table 4

.

Table 4 Summary of physicochemical pr operties of Propamocarb-HCl

Parameter Value (Units) Source

CAS Chemical Name Propyl N -[3-(dimethylamino)propyl]carbamate hydrochloride (1:1)

Registrant data IUPAC Chemical Name Propyl 3-(dimethylamino)propylcarbamate hydrochloride

Chemical Formula Propamocarb HCl: C 9 H 21 ClN 2 O 2 (Note that Propamocarb chemical formula is: C 9 H 20 N 2 O 2 )

PC Code 119302 EPA

Chemical Structure Smiles Code: ClN(C)(C)(H)CCCNC(=O)OCCC

CAS Reg. No. Propamocarb HCl (salt) 25606-41-1

(Note that Propamocarb CAS No is 24579-73-5)

Registrant data Molecular Weight 224.73 g/mole

Solubility ( 20 o C) >700 g/L

Vapor Pressure (VP @

25 o C) 6.0x 10 -7 torr MRID 433684-

09

Dissociation Constant pka= 9 (Very weak acid) MRID 412781-

06

Henry’s Law Constant 2.5 x 10 -13 atm-m 3 -mol -1 Calculated @ 25

o C

Octanol-Water Partition Coefficient (25 o C) (log K OW; and K OW ) -0.39; 0.4

and

-1.36; 0.044 @ pH 7 412781-07 and

443049-04 H 3 C

CH 3 CH 3 H + Cl Carbamate Moiety

Data in Table 4 indicate that Propamocarb-HCl has a molecular weight of 224.7 g/mol with a high water solubility of over 700,000 ppm and an octanol/water partition coefficient (Kow) of

0.4 to 0.04 suggesting high availability for leaching ( due to high solubility) and very low potential for bioaccumulation in aquatic organism s such as fish (due to low Kow). A fish Accumulation (BCF) study confir med the prediction based on K OW . Determined concentration in

13tissue to exposure concentration in water were 1.5X for edible, 3X for non-edible. Depuration was rapid with approximately 100 % depurating within 7 days (MRID 412781-14). It is noted

that an additional fish accum ulation study was submitted and was found to be un-acceptable (MRID 458943-23).

A summary of abiotic labor atory studies for Propamocarb-HCl is included in Table 5 . The summary table contains data obtained from the two sets of studi es identified above.

Table 5 Summary of abiotic laboratory dete rmined properties of Propamocarb-HCl

Property Value (Source; Study

Classification 1 ) MRID Classification

Hydrolysis (halflife= t1⁄2, days) 1 st & 2 nd data sets Stable @ pH 5, 7 and 9 000712-97 Supplemental

Direct Aqueous Photolysis (t1⁄2, days) 1 st & 2 nd data sets

Stable The chemical does not absorb photo energy in the visible region ( λ ≥ 290 nm) 000712-96 Acceptable

Soil Photolysis (t1⁄2, days) 1 st data set

Considered Stable because degradation in dark controls was greater than irradiatedsamples which gives a halflife of 210 days in a 31-day experiment

2 nd data set

35.4 with three un-identified minor degradates (3, 4, and 9%) and 21% unidentified

bound residue 045893-18

418346-08 Supplemental

Acceptable

Based on abiotic laboratory data, Propamocarb-HC l is stable to hydrolysis and photolysis in water and on soil as registrant submitted data do not show that the chemical absorb photo energy in the visible region. The observed t1⁄2= 35 days in one of the soil photolysis studies (MRID 418346-08) can be partly explaine d by effect of the bound residue in reducing the calculated half-life of the chemical ( Table 5 ; It appears that the extraction of the parent was not complete).

Laboratory biotic fate and mobility data fo r Propamocarb-HCl were reviewed by close

examination of studies and/or the data evaluati on reports (DERs). Data obtained from the 1 st and

2 nd sets of submitted studies is included and compared for aerobic/anaerobic soil and aquatic systems. Detailed comparisons are included in Table B-1 (Appendix B ) for biotic fate studies

and in Table B-2 (Appendix B ) for mobility studies. The purpose of these two tables is:

• To identify differences in the submitted two se ts of data and possible cause(s) for such differences;

• To determine the need for additional data; and

14• To identify possible changes in the data that ma y be used to represent fate and transport of the chemical in soil and aquatic systems; the most important compartments of the environment where highest exposure is expected.

Comparing data in Tables B-1 and B-2 ( Appendix B) , the following can be stated:

• There are differences in the extraction syst ems used for soils and sediments: the 1 st set of

studies used methanol base extraction while the 2 nd set of studies used acetonitrile base extraction. As a result, the unidentified bound re sidues observed in aerobic soil systems were significantly different. Maximums of uniden tified bound residues were reached within 13 to 30 days to levels ranging from 20 to 38% in the 1 st set and were reached within 30 to 120 days to levels ranging from 29 to 49% in the 2 nd set. More importantly, with time, bound residues showed a relatively important decline, from maximums, in the 1 st set (a decline to 11-15%) while it showed relative persistence in the 2 nd set (no decline in one soil and a decline to 31 to 44%). In contrast, data on bound residues, in the only anaerobic soil system (from the 1 st set), formed at a relatively low concentr ation as it reached a maximum of only 8% of the applied in 14 days and showed no a pparent decline up to th e end of the one year study. Furthermore, in the only anaerobic aquatic system (from the 2 nd set), bound residue

formed and reached a maximum of 20% of th e applied at 110 days and showed a sharp decline to 6% at the end of this 370 days study (Figure B-1, Appendix B ). Bound residues were characterized only by fr actionation/quantification of radioactivity from the bound residues that is present in fulvic and humic aci ds and the humin fractions in soils/sediments. Examination of the degradation profile for Pr opamocarb-HCl in all of the systems, suggests

that the formation of the bound residues are direc tly related to parent biodegradation in both level and timing. In each soil or aquatic system , the bound residues increase with the increase in the rate of parent degradation and reach its maximums as parent mineralizes completely to

CO 2

.

• Both sets of studies track ed only the parent and CO 2 , the major mineralization product of the chemical. Observed degradation products were quantified as % of a pplied radioactivity but were only identified in one study. In this st udy, formed degradation products were compared to the standards of possible degradates shown in Figure B-2, Appendix B . None of the observed degradates were found to be any of these investigated standards.

It is noted however; that inte rpretation of data, in terms of expected environmental exposure, may not be affected by non-identif ication of degradates because all degradates formed at low

concentration and most declined with time. Ho wever, the non-identifica tion of the significant bound residue, if proved to be toxic, is impor tant. The residue, that partitions and bound to sediment and soil particle, is of concern especial ly if it is un-extracted parent and/or a toxic unidentified degradate(s). Availa ble data appear not to support the first possibility due to the apparent efficiency of parent extraction and due to the fact that formation of the bound residue increases in parallel to the decr ease in parent by degradation. Ho wever, the second possibility of the bound residue being a toxic degradates(s) need to be further investigated.

• For chemical identification, the 1 st set of studies relied on 1 or 2 dimensional thin layer chromatography (1-2 D TLC) without using anot her confirmatory method. In contrast, the

152 nd set of studies did use HPLC for this purpose. It is howev er, important to note that both sets were able to only iden tify parent compound. Measurement of radioactivity by LSC was the procedure used for quantification in the two sets of submitted studies.

• There are apparent difference between the two sets of aerobic soil studies in the observed quantities of evolved CO 2 and calculated half-lives. In the 1 st set, evolved CO 2 ranged from 80 to 87% and half-lives from 10 to 27 days (90 th percentile t1⁄2= 27 days). Half-lives in the

aerobic soils from this 1 st set appear to be directly related to mineralization of the chemical and in some cases degradation of the bound residue. In contrast, evolved CO 2 from soils in

the 2 nd set ranged from 31 to 49% and ha lf-lives from 14 to 70 days (90 th percentile t1⁄2= 45 days). Half-lives determined in this 2 nd set are longer and appear to be directly related to

mineralization of the chemical to CO 2 (which was comparably less ) in addition to the fact that the significant un identified bound residue was considered as a fraction of no concern (i.e. a chemical sink). The differences in calculated half-lives, between the two sets of data, may

be related to differences in ch aracteristics of the soils. However close examination of texture, pH, O.C%, clay%, and CEC reveal s no direct relation to calculate d half-lives. No other soil information was provided such as soil taxonomy, in cluding soil series in order to obtain more

information about the soils used in the studi es. In the absence of additional soil data, differences may be related to differences in bi ological viability of the soils (this was not monitored or confirmed by data in all studies) and/or other soil characteristics that were not measured such as clay mineralogy.

• For the anaerobic soil system, only one study was submitted, as part of the 1 st set, and the degradation profile in this soil suggests that Propamocar b-HCl is highly persistent (extrapolated t1⁄2= 459 days). Mineralization of the chemical appears to be relatively low (Maximum evolved CO 2 = 8%). In addition, the formati on of bound residue was relatively low (Maximum= 8%).

• For the anaerobic aquatic systems, only one study was submitted, as part of the 2 nd set, and the degradation profile in this system suggest s that Propamocarb-HCl is relatively persistent (t1⁄2= 92 days). Mineralization of the chemical appears to be relatively high (Maximum

evolved CO 2 = 68%) while formation of bound residue was relatively low (Maximum= 20%) and show a sharp decline to only 6% after 365 days presumably by mineralization to CO 2 (Figure B-1, Appendix B ). In this anaerobic aquatic study, the applied radioactivity (parent application) partitioned within two w eeks from the water to the sediment (Figure B-3, Appendix B ). By TLC/HPLC, most of this radio activity was the parent compound indicating that applied parent is the one involved in the observed partitioning. Following this portioning, parent appears to mineralize directly into CO 2 with only a small part becomes as bound residue. The high extent of parent minera lization in this anaerob ic aquatic system is not expected when compared to the anaerobic soil system. Examination of data on the aerobicity in this an aerobic aquatic study suggests that the system was sub-oxic and not completely anaerobic (Figure B-4, Appendix B ). Therefore data obtained from this study may not reflect the expected behavior of Propa mocarb-HCl in an anaerobic aquatic system in

the natural environment.

16In conclusion, laboratory biotic fate studies suggest that Pr opamocarb-HCl is relatively nonpersistent in some soils and exhibits higher pe rsistence in others. Propamocarb-HCl degradation in the soil system can be mainly related to microbialy mediated mineralization to CO 2. Propamocarb-HCl is expected to be highly pers istent in anaerobic soil systems while its persistence in aerobic and anaerobic aquatic syst ems is uncertain due to lack of an aerobic aquatic metabolism study and the existence of only sub-oxic conditions in the submitted anaerobic aquatic study.

Mobility data suggest that Propamocarb-HCl is highly mobile in some soils while it is moderately mobile in others ( Table B-2, Appendix B ). Adsorption-Desorption data were

obtained for seven soils varied in texture, pH, organic car bon% (O.C%), clay%, and cation exchange capacity (CEC). Organic carbon based adsorption coefficient (K

oc ) ranged from 41 to 359 mL/g in five of the soils and ranged from 802 to 1,317 mL/g in the other two. No apparent relationship was observed with the soil system OC% and as a result different mobility interpretation was obtained depending on whether the interpretation is based on K

oc or K d coefficients. Therefore, K d is the preferred parameter for describing partitioning for this

chemical. Values for K d ranged from 0.67 to 1.29 mL/g in three soils, 5.2 to 6.72 mL/g in another three, and was 13.83 mL/g for the last one. In addition, a positive relationship appears to

exist between K d and both soil clay content and its CEC in only five of the soils. All of the examined soils were acidic (pH range from 5.2 to 6.5), therefore the positive relationship might be partly related to the fact th at Propamocarb-HCl is an organic week acid (pKa =9.1). In acidic

conditions this week acid acts as a base capable of accepting H + ions and be positively charged. Presence of the positive charge causes more ad sorption of the chemical into the negatively charged clays. This may have caused the obs erved increase in adsorption and related K d values.

In conclusion, Propamocarb-HCl is expected to show high mobility in hi ghly permeable soils if rainfall or irrigation leads to leaching before it is affected by microbial activity that causes its degradation into CO 2 and immobile bound residues. In most other soils, the chemical is expected to be of moderate mobility. When leaching to lower anaerobic soil horizons soon after application occurs, propamocarb- HCl is expected to persist in these anaerobic horizons and eventually reach ground water where it also ex pected to persist. Ground water contamination with propamocarb-HCl is therefor e expected in case of high rainfall after application in vulnerable sandy soils affected by high ground water table.

Table 6 contains a summary of the fate and transport properties of propamocarb-HCl

Table 6 Summary of acceptable fate and tran sport properties for propamocarb-HCl

Parameter Value for parent (Estimated Value for Total Parent + Bound Residue) 1 Source

Soil adsorption

coefficient K d and

K

oc (mL/g) Adsorption K d = 0.671

, 0.849

, 5.2

, 1.29

, 6.27

, 13.83, and 4.65 Adsorption K

oc = 140, 41, 359, 57, 180, 1,317, and 802 MRID: 412781-30
and

MRID: 458943-21

17Value for parent (Estimated Value for

Parameter Total Parent + Bound Residue) 1 Source

Aerobic metabolism half-life in soil (days) Loamy sand soil: 14 (22); Loamy

sand soil: 27 (48); Loamy sand soil: 10 (58); Sandy

Loam soil: 23 (60);

Silt loam soil 16 (59); Clay loamy

sand soil: 15 (58); and Sandy Loam soil: 70 (140)

90 th percentile value= 36 (83) MRIDs: 412781-25/26/27

And

MRID: 458943-19

Anaerobic

metabolism half-life in soil (days) Loamy sand soil 459 (No need for recalculation of half-life

because the maximum bound residue reached only 8% of the applied radioactivity) MRID: 412781-29Aerobic Aquatic halflife (days) No data

Anaerobic Aquatic half-life (days) 92 (No need for recalculation of half-life

because bound residue showed a significant decline to nearly 6% of the applied radioactivity) MRID: 445385-04

1 This value is a rough es timate only, half lives may incr ease or decrease based on the c hosen procedure for calculating

half-lives

In the field, three terrestrial field dissipation st udies were conducted the first one was from the 1 st
set) and was conducted on turf plots in CA and NY (MRID 424212-02). The second and third

studies were from the 2 nd set and were conducted on bare so il plots in IL and NC (MRID 440016-01) and on turf plots in CA and GA (M RID 458943-22). Propamocarb-HCl formulations were applied three to four times at a single application rates ranging from 4.6 to 9.2 kg/ha. The application rates used in turf pl ots corresponds to the cu rrent turf application rate of 9.5 x 4 kg/ha however, the rate used on bare soil plots is much higher than the current vegetables single rate of 1.0 to 1.7 kg/ha and seasonal rate of 3.8 to 6.7 kg/ha. Terrestrial field diss ipation data obtained

from these sites are summarized in Table7

.

Table 7 Terrestrial field dissipation st udies data for Propamocarb-HCl

Study (MRID) Crop Location (Study Duration; Days) Study Results

Study 1 (1 st set) (424212-02) 1 Turf NY (21+127=148) Dissipation Half-life (top 8 cm) : 10 days; noting that no data were submitted for dissipation of the chemical in various turf layers (Grass, thatch, and soil) Leaching : parent detected up to the maximum depth monitored (90 cm) @ day 2 with a maximum of nearly 10% Therefore, the extent of parent leaching may have been below 91 cm

CA (21+111=132) Dissipation Half-life (top 8 cm) : 15 days Leaching : parent was not detected below 46 cm at any day after last application

Study 2 (2 nd set) (440016-01) 2 Bare plots IL (21+548=569) Dissipation Half-life (top 15 cm) : Biphasic with 7 days half-life for the fast phase and 165 days for the slow phase Leaching : Parent was not detected below 30 cm at any after last application

NC Dissipation Half-life (top 15 cm) : Biphasic with 23 days half-life for the

18Location (Study Study (MRID) Crop Duration; Days) Study Results

(21+546= 567) fast phase and 187 days for the slow phase Leaching : Parent was not detected below 30 cm at any day after last application

Study 3 (2 nd set)

458943-22 Bare plots CA (21+123=144) Dissipation Half-life (top 15 cm) : 22 days Leaching : Parent was not detected below 30 cm at any day after last application

GA (21+123=144) Dissipation Half-life (top 15 cm) : 18 days, observed bi-phasic with <5 day half-life for the 1 st degradation phase Leaching : Parent was not detected below 30 cm at any day after last application

Turf CA (21+123=144) Grass: Dissipation DT 50 = 18 days; Thatch: Dissipation DT 50 = 23 days;

Soil: Dissipation DT 50 = 18 days) Leaching: Parent was not detected below 45 cm at any day after last application

GA (21+123=144) Grass: Dissipation DT 50 = 18 days ; Thatch: Dissipation DT 50 = 18 days; Soil: Dissipation DT 50 = 13 days Leaching : Parent was not detected below 15 cm at any day after last application

Data in Table 7 suggest that Propamocarb- HCl dissipate in four fiel d soils with half-lives ranging from 7 to 23 days in bare ground plots. Si milar range of half-lives were also observed in four turf plots (Range= 10 to 23 days). Half-liv es for Propamocarb-HCl were also in the same range on the turf grass (18 days), associated that ch layer (18-23 days), and the soil layer below (13-18 days). In some soils the degradation pr ofile was biphasic and st ated half-lives above represent the fast phase (22 to 42 days) which was followed by a slow degradation phase in which the chemical degraded with half-lives ranging from 165 to 187 days. Leaching was observed to occur within the top 30 cm in bare ground soils and with in 15-46 cm in three of the turf plots. Leaching of residues to 90 cm and po ssibly even deeper at levels above the detection limit was confirmed at only one site: NY turf site (Maximum sampling depth 90 cm).

Finally, three environmental chemistry methods (ECM) were submitted for determination of Propamocarb-HCl residues in water, su rface water, and soil (MRIDs 458943-15, 458943-16, and 458943-17, respectively. Each of these methods included an inde pendent laboratory validation (ILV). For water, th e method was found to be valid for quantitative analysis of propamocarb wit an LOD= 0.02 μg/L and LOQ= 0.05 μg/L. For surface water, the method was found to be valid for quantitative analysis of propamocarb wit an LOD= 0.1 μg/L and LOQ= 0.5 μg/L. For soil, the method was found to be vali d for quantitative analys is of Propamocarb-HCl with an LOD= 0.004 mg/Kg and LOQ= 0.02 mg/Kg.

19

## 4. Ecological Effects

4.1 Aquatic and Terrestrial Effects

As described in the Agency’s Overview Docume nt (U.S EPA, 2004), the most sensitive endpoint for each taxonomic group will be used to calcula te risk quotients (RQs). Assessment endpoints include direct toxic effects on the survival, repr oduction, and growth of terrestrial and aquatic

life as well as indirect effects such as reduction in prey base and/or modification of habitat.

Acute and chronic toxicity data from studies submitted by pesticide registrants along with the available open literature are used to evaluate the potential direct effects of Propamocarb-HCl to the aquatic and terrestrial recepto rs identified in this section. Th is includes toxicity data on the technical grade active ingredient, degradates, an d when available, formulated products. The open literature studies are identified through EPA’s ECOTOX database ( http://cfpub.epa.gov/ecotox/ ), which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The eval uation of both sources of data can also provide insight in to the direct and indirect eff ects of Propamocarb-HCl on biotic communities from loss of species that are sensitive to the chemical and from changes in structure

and functional characteristics of the affected communities.

Other sources of information included the use of acute probit dose response relationship to establish the probability of an individual eff ect and reviews of the Ecological Incident Information System (EIIS), the American Bi rd Conservancy’s Avian Incident Monitoring System (AIMS) and EFED’s Aggregated Incident database are conducted to further refine the characterization of potential ec ological effects with exposure to Propamocarb-HCl. A summary

of the available eco-toxic ity information (below Table 8 ) and the incident information (Section 4.2) for Propamocarb-HCl are provided below.

Table 8 provides a summary of the taxonomic groups a nd the surrogate species tested to help understand potential acute and chronic ecological effects of Propamocarb-HCl. In addition, the table provides a preliminary overview of the potential acute toxicity of Propamocarb-HCl by providing the acute toxic ity classifications. The endpoints listed in Table 8 represent the most sensitive endpoints for a given taxa as multiple st udies were received in some cases to fulfill the same data requirement.

Table 8 Test Species Evaluated for Assessing Potentia l Acute and Chronic Ec ological Effects of Propamocarb-HCl

Taxonomic Group Surrogate Species Acute Toxicity (LC 50 , EC 50 , LD 50, EC 25 )

-- Chronic Toxicity (NOAEC, LOAEC, NOAEL, LOAEL) MRID Acute Toxicity

Classification

Birds 1 Mallard duck ( Anas platyrhynchos ) LC 50 = >4160 ppm 42567903 Slightly toxic

20Taxonomic Group Acute Toxicity (LC 50 , EC 50 , LD 50, EC 25 )

Surrogate Species -- Acute Toxicity MRID Chronic Toxicity Classification (NOAEC, LOAEC, NOAEL, LOAEL)

-- LOAEL = 990 ppm (adult female body weight) NOAEL = 250 ppm --

46145213 --

Northern bobwhite quail

( Colinus virginianus ) LD 50 = >2000 mg a.i/kg

bw

LC 50 = >4160 ppm

-- LOAEL = 4992 ppm a.i,(hatchling weight) NOAEL = 500 ppm a.i 46145210

42567902

-- 46145212 Practically nontoxic

Slightly toxic

--

Mammals Laboratory rat ( Rattus norvegicus ) LD 50 = >2000 mg/kg bw

-- NOAEL = 1250 ppm LOAEL = 8000 ppm (decreased body weight) 443049-07

-- 44730103,

44730102 Practically nontoxic

--

Insects Honey bee ( Apis mellifera ) LD 50 (contact) = > 100 ug/a.i/bee 44324501 Practically nontoxic

Freshwater Fish 2 Rainbow trout ( Oncorhynchus mykiss ) 96-hour LC 50 = >99 mg

a.i/L 42083103 Slightly toxic

Bluegill sunfish ( Lepomis macrochirus ) 96-hour LC 50 = >92 mg

a.i/L 42083102 Slightly toxic

Fathead minnow ( Pimephales promelas ) NOAEC = > 6.3, LOAEC = 13 (reduced dry weight) mg a.i/L 42083105

--

Freshwater

invertebrates Water Flea ( Daphnia

magna ) 48-hour EC 50 = >103.4 mg

a.i/L 45894303 Practically nontoxic

Estuarine/marine

fish Sheepshead minnow ( Cyprinodon variegatus ) 96-hour LC 50 = >96.8 mg

a.i/L

-- No Data submitted 41834603

No data Slightly toxic

--

Estuarine/marine

invertebrates Mysid shrimp ( Americamyis bahia ) 96-hour LC 50 = 50.5 mg

a.i/L

-- No Data submitted 45894306

-- No data

submitted Slightly toxic

--

Eastern oyster ( Crassotrea virginica ) 96-hour EC 50 = 39.2 mg

a.i/L 42083104 Slightly toxic

Terrestrial plants Multiple species Seedling Emergence:

Monocot and dicot EC 25 for all endpoints = >8.0

lbs a.i/A

Vegetative Vigor 4 : Monocot and dicot EC 25 for all endpoints = >8.0

lbs a.i/A 45894310

45894311 --

Aquatic plants Vascular Plant: Tier I EC 50 (biomass) = 45894313

--

21Taxonomic Group Acute Toxicity (LC 50 , EC 50 , LD 50, EC 25 )

Surrogate Species -- Acute Toxicity MRID Chronic Toxicity Classification (NOAEC, LOAEC, NOAEL, LOAEL) Duckweed ( Lemna gibba ) 476.1 mg a.i/L

-- NOAEC (biomass) = 269.1 mg a.i/L

Green Algae ( Selenastrum capricoruntum ) Tier I: EC 50 (cell density) = > 14 mg a.i/L

-- NOAEC (cell density) = 71 mg a.i/L 44187802 --

--

1 Birds represent surrogates for terrestrial-phase amphibians and reptiles

2 Freshwater fish represent surrog ates for aquatic-phase amphibians

Terrestrial Species

Propamocarb-HCl is classified as practically non-t oxic to birds on an acute oral basis and slightly toxic to birds on an acute dietary basis. A lthough not an eco-toxicol ogical requirement, a mammalian acute oral study with the rat showed that Propamocarb-HCl is practically non-toxic

on an acute oral basis. An acute contact toxicity study to the honey bee showed that propamocarb-HCl is practically non -toxic to terrestrial insects.

Non-definitive endpoints were observed in th e avian acute oral st udy with bobwhite quail (MRID 46145210) and both acute dietary studies with the bobwhite quail and mallard duck (MRIDs 42567902 and 42567903, respectively). These endpoints are listed as greater than values (e.g. >2,000 mg/kg-bw) because the highest dose tested did not re sult in at least 50% mortality. A definitive RQ value cannot be calculated from thes e non-definitive endpoints, risk cannot be estimated using RQs for these taxa . In looking at previous assessments for propamocarb-HCl, the maximum EEC listed in ri sk assessments (EEC on short grass from application to lettuce was 1184 ppm) was below the highest dose tested in both acute oral (highest dose tested was 2,000 ppm) and acute dietary (highest dose tested was 4,160 ppm) studies. However, in the acute oral toxicity study with the no rthern bobwhite quail, there were mortalities observed in 2 birds at the highest dose tested (2,000 mg/kg bw) within 7 hours of administration. Furthermore, treatm ent related clinical signs of toxi city were observed in birds at and above the 500 ppm dose level that include d fluid feces, quick breathing, drooping of the upper or lower eyelid, hunched posture, abnormal posture of the head, uncoordinated movements, tremors, spasms, and slow breathing. This study was originally classified as supplemental due to the fact that the study was not conducted with technical grade active ingredient (TGAI), as the purity for Propamocarb- HCl in this study was 69.1%. Of note is that

two mortalities and several treatmen t-related sublethal effects occurred at the highest dose of this formulated product. Additionally, the high percenta ge of inert ingredient s associated with the active ingredient may be affecting th e bioavailability of the test subs tance to the test organism. It

is therefore recommended that a new acute oral toxicity study on the bobwhite quail with

22technical grade propamocarb-HCl be submitted in order to achieve a definitive LD 50 while investigating the toxicity of TGAI Propamocar b-HCl. An acute oral toxicity study on a passerine species is also being requested in order to evaluate Propamocarb-HCl’s toxic effects on passerines.

In two dietary toxicity studies (one with malla rd duck and one with northern bobwhite quail), Propamocarb-HCl was shown to have an LC 50 of >4,160 ppm for both studies (the highest doses tested for the studies). Both studies were found to be supplemental as they were not conducted with TGAI propamocarb-HCl. In the study with th e mallard, there was a st atistically significant reduction in body weight gain and feed consum ption was observed at the highest treatment

concentration. While this concentration is 5 times higher than the hi ghest EEC reported in previous risk assessments, it is unclear if non-ta rget species would be affected given that a definitive endpoint was not achieved, yet sublethal effects were still note d. Furthermore, this study was conducted with a formulated product, a nd therefore a dietary st udy on the mallard with TGAI may show increased toxicity and the establishment of a definitive LC 50 . The high percentage of inert ingredients associated w ith the active ingredient may be affecting the bioavailability of the test substance to the test organism. A new dietary study with TGAI Propamocarb-HCl on the mallard is therefore recommended.

In the dietary study with the bobwhite quail, the treatment concentrations were 163, 325, 650, 1,300, 2,600, and 5,200 ppm a.i for nominal concentrations . There were two birds (one from the 650 ppm dose level and one from the 1,300 ppm dose level) that died duri ng the study. It was reported that the bird from the 1,300 ppm group app eared to show signs of pecking by the other birds. There were no reductions in bodyweight increase or feed consumption in any of the treatment groups during the test. In the initial review of the study, the study reviewer stated that the mortality that occurred from the bird in the 1,300 ppm group (that showed signs of being pecked) was not treatment related. The initial st udy reviewer did not addr ess the other mortality in the 650 ppm group. The high percentage of in ert ingredients associated with the active ingredient may be affecting the bioavailability of the test substance to th e test organism. As a non-definitive endpoint was reached that preclud es the ability to estimate risk and two mortalities occurred, a new dietary study with TGAI Propamocarb-HCl on the bobwhite quail is being recommended.

In two chronic reproduction studies with the northern bobwhite quail and mallard duck (MRIDs 46145212 and 46145213, respectively) Propamocarb- HCl yielded a NOAEC of 500 and 250 ppm, respectively. The bobwhite quail study show ed no treatment related mortalities and there was a treatment related statistically significant de crease in hatchling weig ht in the highest dose level tested. This study was found to be supplemental due to the use of a formulated product and not TGAI Propamocarb-HCl. In the mallard study, there was no treatment related to the observed mortalities. At the highest dose leve l (3800 ppm), treatment related sublethal effects included decreases in eggs laid per pen, eggs se t per pen, viable embryos per pen, live embryos per pen, number of hatchlings pe r pen, hatchlings per eggs set, hatchling survival per pen, and hatchling survival per eggs. Again, this study wa s found to be supplemental due to the use of a formulated product and not T GAI Propamocarb-HCl.

23In an acute oral study with the laboratory rat (MRID 443049- 07), Propamocarb-HCl was shown to be practically non-toxic to mammals with a LD 50 of >2,000 mg/kg bw (the highest dose tested). There were no sublethal effect s observed during the course of the study.

In a mammalian two-generation reproduction st udy with the laborat ory rat (MRIDs 44730103, 44730102), there were statistically significant reductions in mean body weights of the F 1 generation at the highest treatment level (8,000 pp m). Mean food consumption values were also significantly reduced at the highest dose level. The NOAEL was therefore determined to be 1250 pm. There were no effects at any treatmen t level other than the highest. The dietary exposure levels for this study were : 0 (control), 250, 1,250, and 8,000 ppm.

Aquatic Species

Propamocarb-HCl is classified as slightly toxic to freshwater fish and practically non-toxic to

freshwater invertebrates on an acute basis. In acute toxicity test s with rainbow tr out and bluegill sunfish (MRIDs 42083103 and 42083102, respectively) non-definitive endpoints were reached (LC 50 /EC 50 values of >99 mg a.i/L, >92 mg a.i/L, resp ectively, mean measured concentrations). In the both studies, there were no mortalities observed, nor were any sublethal effects reported. Previous risk assessments have reported that maximum EECs in surface water (from application to lettuce) reached 162 μg a.i/L which is several orders of ma gnitude less than the highest

concentration tested in both studies (100 mg a.i/L nominal c oncentration). As there is no incident data indicating a risk to freshwater fish. Therefore, the pr esumed risk to freshwater fish is considered low and additional toxicity data are not recommended.

In an acute toxicity study with Daphnia magna (MRID 45894303), there were no mortalities or sublethal effects observed and, the EC 50 (>103.4 mg a.i/L) was several orders of magnitude below to maximum EEC determined in previous assessments (162 μg a.i/L). There are no incident data indicating a risk to freshwater invertebrates fr om Propamocarb-HCl The presumed

risk to this taxa is low.

In a freshwater fish early life stage test with the fathead minnow (MRID 42083105), there were no treatment related effects on percent hatching success at all treatment levels. The treatment levels for this test were defined as 3.5, 6.3, 13, 25, and 51 mg a.i/L. Fish wet weight and length at concentrations 25 and 51 mg a.i/L were signifi cantly different from the control. Fish dry weight at 13, 25, and 51 mg a.i/L were significan tly reduced when compared to the control. This study was classified as supplemental due to the fact that a formulated product was used instead of TGAI Propamocarb-HCl.

A chronic freshwater inverteb rate toxicity study with Daphnia magna was previously submitted,

but found to be invalid for several reasons. In sufficient analytical sampling was conducted to provide accurate mean-measured concentrations and to verify the stability of Propamocarb-HCl in the test media for up to 72 hours between re newal periods. Furthermore, the study does not fulfill guideline requirements because it wa s not conducted with t echnical-grade active ingredient, and terminal length measurements were not obtained. The registrant submitted another chronic toxicity study in Daphnia (MRID 45727801), which is currently undergoing Agency review. This study remains a data requirement for Propamocarb-HCl until EPA has reviewed and approved a ch ronic toxicity study for Daphnia

.

24Propamocarb-HCl is shown to be practically non-toxi c to estuarine/marine fish and slightly toxic

to estuarine/marine invertebrates on an acute exposure basis. In an acute toxicity test with the sheepshead minnow (MRID 41834603), Propamocarb- HCl exposure resulted in no mortalities

or sublethal effects at the lone treatment level (100 mg a.i/L nominal concentration, 96.8 mg a.i/L mean measured concentration). Even though the study failed to reach a definitive LC 50, as the highest EEC reported in prev ious assessment (162 μg a.i/L for application on lettuce) is several orders of magnitude below the highest tr eatment level tested for this study (96.8 mg a.i/L mean measured) and there is no incident data indicating Propamocarb-HCl poses a threat to estuarine/marine fish, the presumed risk for this taxa despite the absence of a definitive endpoint is low. There were no sublethal effects in the acute toxicity test with the mysid shrimp. The acute toxicity study with the easte rn oyster (shell deposition) show ed a slightly more sensitive endpoint than that of the mysid study (LC 50 = 39.2 mg a.i/L for oysters and LC 50 = 50.5 mg a.i/L for mysids. Both studies were determined to be supplemental due to a formulated product being used instead of TGAI Propamocarb-HCl.

An early life stage toxicity test with the sheep shead minnow and a chronic life stage invertebrate toxicity test with the mysid shrimp are conditio nally required provided that several triggers of toxicity and exposure are met. For Propamocarb-HCl, the only triggers that are expected to be met is the persistence in water (half-life greater than 4 days ) and the likelihood to enter the estuarine/marine environment as Propamocarb-HCl has a very high solubility and a propensity to

leach off soil. Based on the fact that the chemical is stable to hydrolysis, it is expected that the half-life will be longer than 4 days in th e recommended aerobic aquatic metabolism study. Therefore, sheepshead minnow early life stage toxici ty test and a chronic life stage invertebrate toxicity test with the mysid shrimp are reques ted. If a new aerobic aquatic metabolism study

shows the half life to be less than 4 days, these two studies may be waived.

Available environmental fate studi es show degradation of Propamoc arb-HCl, in the soil system, can be mainly related to microbia lly mediated mineralization to CO 2. There is a fraction of propamocarb that is unidentified bound residue wher e the toxicity is not known. When the Tier 1 aquatic model GENEEC is run with the highest application rate (64 lbs a.i/A) from previous assessments under the assumption that degradates ar e as toxic as the parent, the resulting EEC is 3.22 ppm. When taking the most sensitive aquatic organism in toxicity tests (Eastern oyster)

EC 50 of 39.2 mg a.i/L, the resulting RQ is 0.08. Th is value is below the acute high risk to nonlisted species LOC, and risk that may be mitig ated through restricted use LOC, but above the endangered species LOC. The uncertainty that goes along with the toxicity of the bound residue is an issue that will need to be revisited pendin g future uses of Propamocarb-HCl. In the absence of sediment toxicity studies, the assumption is made that the bound residue is as toxic as the parent compound which lengthens half lives and increases aquatic EECs.

Terrestrial and Aquatic Plants

Tier I Seedling Emergence (MRID 45894310) an d Vegetative Vigor (MRID 45894311) studies were previously submitted and classified as acceptable. Propamocarb-HCl exposure did not result in a 25% reduction of endpoints in either study and therefore Tier II studies are not required. It was determined however that b ecause a NOAEC could not be established in all species for both the seedling emergence and vege tative vigor studies (and therefore an inability

25to estimate an EC 05 values in lieu of a NOAEC), the uti lity of the study will be impacted when characterizing risk to endangere d species. Despite this, the da ta requirements for Terrestrial Plant studies for Propamocarb-HCl are fulfilled.

An aquatic plant study with freshwater green algae ( Selenastrum capricornutum ) (MRID 45894312) was submitted and classified as supplemental. The study was deemed to be scientifically sound but because it was only c onducted for 72 hours and not 96 hours, current policy is to only consider those studies as screening studies onl y. Furthermore the test solutions were not measured during the study at every test level. Despite these deficiencies, this study is

suitable for use in risk assessment in that scientifically sound endpoi nt can be derived.

An aquatic plant study (MRID 45894313) with a freshwater vascular plant ( Lemna minor ) was submitted and classified as acceptable.



### 4.2 Incident Database Review

A preliminary review of the Ec ological Incident Information System (EIIS, Version, 2.1) which is maintained by the Agency’s Office of Pes ticide Programs indicated one reported ecological

incident. The incident occurred in Montana in July of 2002 on sugar beets with the primary symptom of stunting being reported. This in cident number is I013246-040 with the product

PREVICUR ® FLEX that was applied to a 500-acre crop and reportedly damaged 200 acres. The probable cause was determined to be adjuvant. Sugar beets is not included as a crop suitable for

treatment with PREVICUR FLEX ® but the sugar beet might have been included under an umbrella of tank mixtures, according to the re port submitted by Bayer Crop Sciences. A search of the Avian Monitoring Information System (AIM S), which is maintained by the American Bird Conservancy and the EFED Aggregated Incident Database, yielded no reported ecological incident associated with the use of Propamocarb-HCl.

Incident reports for non-target organisms typical ly provide information only on mortality events and plant damage incidents. Except for phytotoxic effects in terrestrial pl ants, sublethal effects for organisms such as reduced growth or im paired reproduction are ra rely reported. EPA’s changes in the registrant reporting requirement s for incidents in 1998 may account for a reduced number of reported incidents. Registrants are now only required to submit detailed information on “major,” fish, wildlife and plant incidents. Minor fish, wildlife, and plant incidents, as well as all other non-target incidents, are generally reported aggregately and are not included in EIIS. In addition, there have been changes in state m onitoring effect due to a lack of resources.



### 4.3 Ecosystems Potentially at Risk

The ecosystems at risk are often extensive in scop e, and as a result it may not be possible to identify specific ecosystems during the development of a baseline risk assessment. However, in general terms, terrestrial ecosystems potentially at risk could include the treated field and areas immediately adjacent to the treated field that may receive drift or runoff. Areas adjacent to the

treated field could include cultiv ated fields, fencerows and hedgero ws, meadows, fallow fields or grasslands, woodlands, riparian habita ts and other uncultivated areas.

26Aquatic ecosystems potentially at risk include wa ter bodies adjacent to or down-stream from, the treated field and might include impounded bodies such as ponds, lake s and reservoirs, or flowing waterways such as streams or rivers. For uses in coastal areas, aquatic habitat also includes marine ecosystems, including estuaries.



### 4.4 Assessment Endpoints

Assessment endpoints represent the ac tual environmental value that is to be protected, defined by an ecological entity (species, community, or othe r entity) and its attri bute or characteristics (EPA, 1998). For Propamocarb-HCl, the ecological entities may include the following: birds, mammals, freshwater fish and invertebrates, estuarine/marine fish and invertebrates, terrestrial plants, insects, and aquatic plants and algae. Th e attributes for each of these entities may include growth, reproduction, and survival.



### 4.5 Conceptual Model

For a pesticide to pose an ecological risk, it mu st reach ecological receptors in biologically significant concentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological recepto r. For an ecological pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecological receptors, an d a feasible route of exposure.

The conceptual model for Propamocarb-HCl pr ovides a written description and visual representation of the predicted relationships between propamocar b-HCl, potential routes of exposure, and the predicted effects for the asse ssment endpoint. According to EPA’s ecological risk assessment guidelines (U .S EPA, 1998) a conceptual model consist of two major components: a risk hypothesis and a conceptual diagram.

Risk Hypothesis

A risk hypothesis describes the predicted re lationship among the stre ssor, exposure, and assessment endpoint response along with the rationa le for their selection. For propamocarb-HCl, the following ecological risk hypothesis is be ing employed for this national-level risk

assessment:

Propamocarb-HCl, when used in accordance wi th registered labels , will likely lead to off-site movement of the compound via runoff, spray drift, and eroded soil leading to exposure of non-target plants and animals. Based on information on environmental fate, mode of action, direct toxicity, and potent ial indirect effect, EFED assumes that registered uses of Propamocarb-HCl have the potential to cause reduced survival, growth, and reproduction to non-target terre strial plants and/or aquatic animals and plants. Based on available data and previous risk assessments for propamocarb-HCl, acute risk to terrestrial organi sms is presumed to be low.

Conceptual Diagram

27The conceptual site model is a generic graphic de piction of the risk hypothesis, and assumes that Propamocarb-HCl, having outdoor uses only, is ca pable of affecting aquatic and terrestrial animals provided that environmental concentrati ons are sufficiently elevated as a result ofproposed label uses. Based on an examination the physicochemical properties of PropamocarbHCl, the fate and disposition in the environment, and mode of a pplication, a conceptual model was developed that represents the possible relationships betw een the stressors, ecological receptors, and assessment endpoints. Through a preliminary iterative process of examining available data, the conceptual model (i.e., the representation of the ri sk hypothesis) may be refined to reflect the likely expos ure pathways and the organisms th at are the most relevant and applicable to this assessment. It includes the potential pestic ide or stressor (Propamocarb-HCl), the sources and/or transport pa thways, exposure media, exposure points, biological receptor types, and attributes changes. The conceptual model depicted in Figures 2 and 3. This model represents labeled uses for propamocarb- HCl including both urban outdoor uses of.

28Figure 3 A conceptual model for Propamocarb- HCl effects on aquatic organisms



### Stressor

Source

Receptors

Attribute Change Propamocarb HCl applied to use site

Spray drift

Fish/aquatic-phase amphibians

Invertebrates

Vertebrates

**Piscivorous

mammals and birds

Individual organisms

Reduced survival Reduced growth Reduced reproduction Food chain Reduction in algae Reduction in prey Habitat integrity Reduction in primary productivity

Reduced cover Community change Surface water/

Sediment Runoff

Aquatic Animals

Invertebrates

Vertebrates 

### Exposure

Media

Uptake/gills or integument

Ingestion Ingestion Soil Ground water

Uptake/gills or integument

Aquatic Plants

N on-vascular

Vascular Uptake/cell, roots, leaves Riparian plant

terrestrial

exposure pathways see

Figure 2

**Route of exposure includes only ingesti on of fish and aquatic invertebrates

29Figure 4 A conceptual model of Propamocarb-HC l effects on terrestrial organisms



### Stressor

Source

Receptors

Attribute Change Propamocarb HCl applied to use site

Direct Application Spray drift

Birds / Terrestrialphase amphibians / reptiles /

mammals Terrestrial

Insects

Individual organisms

Reduced survival Reduced growth Reduced reproduction Food chain Reduction in prey Habitat integrity Reduction in primary productivity

Reduced cover Community change Terrestrial/riparian plants grasses/forbs, fruit, seeds (trees, shrubs) Runoff

Mammals 

### Exposure

Media Soil

Ingestion Ingestion

Ingestion Ingestion Dermal uptake/Ingestion

Root uptake

Terrestrial food

web Ingestion

In order for a chemical to pose an ecologica l risk, it must reach ecological receptors in biologically significant c oncentrations. Exposure pathway is the means by which a pesticide

moves in the environment from a source to an ecological receptor. Fo r an ecological exposure pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecological recep tors, and a feasible route of exposure. In addition, the potential mechanisms of degrada tion/ transformation (i.e . which degradation/ transformation products may form in the environm ent, in which media, and how much) must be understood, especially if for the chemical, its metabolites/transfo rmation products are of greater toxicological concern than the parent com pound. The assessment of ecological exposure pathways, therefore, includes an examination of the source and pot ential migration pathways for constituents, and the determination of potential exposure routes.

In the case of Propamocarb-HCl, mammals are expos ed to the chemical but available data have shown that the chemical is not toxic, even beyond levels that are the resu lt of registered uses. EFED presumes the likelihood of risk to be lo w based on available data from mammalian studies as well as previous risk assessments for Propamo carb-HCl where it was determined that risk to

mammals was below levels of concern. In the case of birds, despite available data indicating Propamocarb-HCL is slightly to practically non -toxic to birds (depending on the exposure and

30test species), these studies were conducted with formulated product and so while previous risk assessments have concluded low risk to avian spec ies, there is still some uncertainty in this

statement until new studies with TGAI are conducted.



## 5. Analysis Plan

In order to address the risk hypot hesis, the potential for adverse effect on the environment is estimated. The use, environmental fate, a nd ecological effects of Propamocarb-HCl are characterized and integrated to assess the risks. This is accomplished using a risk quotient (ratio of exposure concentration to eff ect concentration) approach. A lthough risk is often defined as the likelihood and magnitude of adverse ecological effects, the risk-quotie nt based approach does not provide a quantitative estima te of likelihood and/or magnitude of an adverse effect. However, as outlined in the Overview Document (U.S EPA, 2004), the li kelihood of effects to individual organisms from partic ular uses of propamocarb-HCl is estimated using the probit-dose response slope and either the level of concern (dis cussed below) or actual calculated risk quotient

value.

This analysis plan will be revisited and ma y be revised depending on the information submitted by the public in response to the opening of the Registration Review docket for PropamocarbHCl.



### 5.1 Stressors of Concern

The stressor of concern for this assessment is the total toxic resi due of parent compound propamocarb-HCl and bound residue with the assu mption that the bound residue is of equal toxicity to the parent the bound residue is consider ed as part of the stressor because it forms in significant amounts in the aerobic soil.



### 5.2 Measures of Exposure

Exposure modeling is an important step in es timating risks of Propamocarb-HCl. All exposure modeling in aquatic and terrestrial environments will be based on maximum application rates, minimum application intervals and maximum number of applications for a given use. Measures of exposure are based on aquatic and terrestria l models that predict estimated environmental concentrations (EECs) of Propamocarb-HCl. The models that will be used to predict aquatic

EECs are the Pesticide Root Z one Model coupled with the Exposure Analysis Model System (PRZM/EXAMS). The model used to predict te rrestrial EECs on food items is T-REX. The

model to derive EECs relevant to terrestrial and wetla nd plants is TerrPlant. These models are parameterized using relevant reviewed registrant-submitted environmental fate data.

Exposure estimates for terrestrial an imals assumed to be in the target area or in an area exposed to spray drift are derived using the T-REX model (version 1.3.1, 12/07/2006). This model incorporates the Kenega nomogr aph, as modified by Fletcher et al. (1994), which is based on a large set of actual field residue data. The upper limit values from the nomograph represented the

95 th percentile of residue values from actual field measurements (Hoerger and Kenega, 1972).

The Fletcher et al. (1994) modifications to the Kenega nomograph are based on measured field

31residues from 249 published research papers, including information on 118 species of plants, 121 pesticides, and 17 chemical classes. EECs for te rrestrial plants inhabiti ng dry and wetland areas are derived using TerrPlant (ver sion 1.2.2, 12/26/2006). This model us es estimates of pesticides in runoff and in spray drift to calculate EECs. EECs are based upon solub ility, application rate and minimum incorporation depth.



### 5.3 Measures of Effect

Ecological effect data are used as measures of di rect and indirect effect s to biological receptors. Data were obtained from registrant-submitted st udies or from literature studies identified by ECOTOX. The ECOTOXicology data base (ECOTOX) was searched on May 1, 2008 in order to provide more ecological effects da ta to bridge existing data gaps. ECOTOX is a source for locating single chemical toxicity data and potenti ally chemical mixture toxicity data for aquatic life, terrestrial plants, and wildlife. ECOTOX was created and is maintained by the USEPA,

Office of Research and Devel opment, and the National Health and Environmental Effects Research Laboratory's Mid-Contin ent Ecology Division (ECOTOX, 2006).

Information on the potential effects of Propamocar b-HCl on non-target animal s is also collected from the Ecological Incident In formation System (EIIS; USEPA 2007 c ). The EIIS is a database containing adverse effect (typic ally mortality) reports on non-t arget organisms where such

effects have been associated with the use of pesticides. Where available, sublethal effects observed in both registrant-submitted and open literature studies will be evaluated qualitatively. Such effects have included behavioral changes ( e.g. , lethargy, changes in coloration and effects olfaction). Quantitative assessments of risks, th ough, are limited to those endpoints that can be directly linked to the Agency’s assessment endpoints of impaired survival, growth and reproduction.

The assessment of risk for direct effects to non-target organisms makes the assumption that toxicity of Propamocarb-HCl to birds is similar to terrestrial-phase amphibians and reptiles. The same assumption is made for fish and aquatic-phase amphibians.

The acute measures of effect used for animals in this screening-level assessment are the LD 50 , LC 50 and EC 50 ( Table 9 ). LD stands for "Lethal Dose", and LD 50 is the amount of a material, given all at once, that is estimated to cause the de ath of 50% of the test organisms. LC stands for

“Lethal Concentration” and LC 50 is the concentration of a chemical that is estimated to kill 50% of the test organisms. EC stands for “Effective Concentration” and the EC 50 is the concentration of a chemical that is estimated to produce a spec ific effect in 50% of the test organisms. Endpoints for chronic measures of exposure for listed and non-listed animals are the

NOAEL/NOAEC and NOEC. NOAEL stands for “No Observed-Adverse-Effect-Level” and refers to the highest tested dose of a substance that has b een reported to have no harmful (adverse) effects on test organisms. The NOAEC ( i.e. , “No-Observed-Adverse-EffectConcentration”) is the highest test concentratio n at which none of the observed effects were statistically different from the control. The NOEC is the No-O bserved-Effects-Concentration. For non-listed plants, only acute exposures are assessed ( i.e. , EC 25 for terrestrial plants and EC 50 for aquatic plants); for listed plants, either the NOAEC or EC 05 is used.

32Table 9 Measures of Ecological Effects and Exposure for Propamocarb-HCl

Assessment Endpoint Surrogate Species and Measures of Ecological

Effect 1 Measures of Exposure

Birds 2 Survival Bobwhite acute oral LD 50 Bobwhite and mallard subacute dietary LC 50

Maximum residues on food items (foliar) Reproduction and growth Bobwhite and mallard chronic reproduction NOAEC and

LOAEC

Mammals Survival Laboratory rat acute oral LD 50

Reproduction and growth Laboratory rat oral reproduction chronic NOAEC

and LOAEC

Freshwater fish 3 Survival Rainbow trout and bluegill

sunfish acute LC 50 Peak EEC 4

Reproduction and growth Fathead minnow chronic (early life-stage)

NOAEC and LOAEC 60-day average EEC 4

Freshwater

invertebrates Survival Water flea (and other freshwater invertebrates)

acute EC 50 Peak EEC 4

Reproduction and growth Water flea chronic (life cycle) LOAEC (no study usable for quantitative risk assessment) 21-day average EEC 4

Estuarine/marine fish Survival Sheepshead minnow acute

LC 50 Peak EEC 4

Reproduction and growth Sheepshead minnow chronic - early life-stage – (no study

submitted 60-day average EEC 4

Estuarine/marine

invertebrates Survival Eastern oyster acute EC 50 and mysid acute LC 50 Peak EEC 4

Reproduction and growth No study submitted 21-day average EEC 4

Terrestrial plants 5 Survival and growth Monocot and dicot seedling emergence and vegetative vigor EC 25, EC 05 , and

NOAEC values Estimates of runoff and spray drift to non-target areas

Insects Survival (not quantitatively assessed) Honeybee acute contact LD 50 Maximum application rate

Aquatic plants and algae Survival and growth Algal and vascular plant (i.e., duckweed) EC 50 and NOAEC values for growth rate and

biomass measurements Peak EEC

1 If species listed in this table represent most commonly encountered species from registrant-submitted studies, risk assessment guidance indicates most sensitive species tested within taxonomic group are to be used for baseline risk assessments.

2 Birds represent surrogates for amphibian s (terrestrial phase) and reptiles.

3 Freshwater fish may be surrogate s for amphibians (aquatic phase).

4 One in 10-year return frequency.

5 Four species of two families of monocots - one is corn, six species of at least four dicot families, of which one is soybeans.

LD 50 = Lethal dose to 50% of the test population; NOAEC = No observed adverse effect concentration; LOAEC = Lowest

33observed adverse effect concentration; LC 50 = Lethal concentration to 50% of the test population; EC 50 /EC 25 = Effect concentration to 50%/25% of the test population.



### 5.4 Integration of Exposure and Effects

Risk characterization is the integration of e xposure and ecological effects characterization to determine the potential ecological risk from the us e of pesticides and the likelihood of direct and indirect effects to non-target organisms in aquatic and terrestrial habitats. The exposure and toxicity effects data are integrated in order to evaluate the risks of a dverse ecological effects on non-target species. For the asse ssment of risks, the risk quotie nt (RQ) method is used to compare exposure and measured toxicity values. EECs are divided by acute and chronic toxicity values. The resulting RQs are then compared to the Agency’s Levels of Concerns (LOCs) (U.S EPA, 2004). These criteria will be used to indicate when Propamocarb-HCl’s uses, as directed o the label, have the potential to cause adverse direct or indirect effects to n on-target organisms. In addition, incident data from the E IIS will be considered as part of the risk characterization.



### 5.5 Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to Federally-listed th reatened and/or endangere d (listed) species from registered uses of Propamocarb-HCl. This asse ssment will be conducted in accordance with the Overview Document (USEPA 2004), provisi ons of the ESA, and the Services’ Endangered Species Consultation Handbook (USFWS/NMFS, 1998).

The assessment of effects associ ated with the registration of Propamocarb-HCl is based on an

action area. The action area is considered to be the area directly or indi rectly affected by the federal action, as indicated by the exceedance of Agency Levels of Concern (LOCs) used to

evaluate direct or indi rect effects. The Agency’s appro ach to defining the action area under the provisions of the Overview Document (USEPA 2004) considers the results of the risk assessment process to establish boundaries for that action area with the understanding that exposures below the Agency’s defined LOCs constitute a no-effect threshold. For the purposes of this assessment, attention will be focused on the footprint of the action ( i.e. , the area where Propamocarb-HCl application occurs), plus all areas where offsite transport may result in potential exposure that exceeds the Agency’s LOCs. Specific measures of ecological effect that define the action area for listed species include any direct and indirect eff ects and/ or potential modification of its critical habitat, including re duction in survival, grow th, and reproduction as

well as the full suite of sub-lethal effects availabl e in the effects literature . Therefore, the action area extends to a point where environmental expos ures are below any measured lethal or sublethal effect threshold for any biological entity at the whole organism, organ, tissue, and/or cellular level of organiza tion. In situations where it is not pos sible to determine the threshold for an observed effect, the action area is not spatially limited and is assumed to be the entire United

States.



### 5.6 Drinking Water Assessment

34A

a estimates of Propamocarb-HCl in surface Propamocarb-HCl in surface waters will

drinking water assessment will be conducted to support future human health dietary risk ssessments of Propamocarb-HCl. The drinki ng water assessment will incorporate model

wate r and ground water. Concentrations of

be es timated using PRZM/EXAMS (see description

be

concentrations found in ground water used as drinki ng water. The output of SCIn

sediment were found at the present time.

f

ided at: nation_cy.cause_detail_303d?p_cause_group_id=88 above).

EFED’s Tier I aquatic model SCI-GROW (Scr eening Concentration in Ground Water) will used to arrive at the Estimated Drinking Wa ter Concentration (EDWC) of propamocarb-HCl residues in ground water. SCI-GROW is a regressi on model used as a screening tool to estimate

esticide p GROW represents the concentrations that might be expected in shallow unconfined aquifers under sandy soils, which represents the ground water most vulnerable to pesticide contaminatio and likely to serve as a drinking water source.

The drinking water assessment will also in clude any available surface and ground water monitoring data with consideration of changes in use patterns that may have occurred. States are encouraged to submit monitoring data for review.



### 5.7 Monitoring Data

The USGS NAWQA 5 databases were searche d, and no monitoring data on the concentration of Propamocarb-HCl in surface water, groundwater, or



### 5 .8 Clean Water Act

Based on the EPA list of impaired water bodies, Pr opamocarb-HCl is not identified as a cause o impairment for any water bodies listed as impair ed under section 303(d) of the Clean Water Act, based on information prov

ttp://iaspub.epa.gov/tmdl_waters10/attains_ h

5

.

Also, no Total Maximum Daily Loads (TMDL) ha s been developed for Propamocarb-HCl, based on information provided at: http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?p_pollutant_group_id

= 885 &p_pollutant_group_name=PESTICIDES

.

More information on impaired wate r bodies and TMDLs can be found at: http://www.epa.gov/owow/tmdl/

.

he Agency invites submission of water quality da T ta for this pesticide. To the extent possible, ndard Operating

ta in OPP’s t and Management Process . This procedure can be found at: data should conform to the quality standards in Appendix A of the OPP Sta ater Body and Other Water Quality Da Procedure: Inclusion of Impaired W

egistration Review Risk A ssessmen R http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1-sop.pdf

5 http://infotrek.er.usgs.gov/nawqa _queries/swmaster/index.jsp (visited June, 24, 2011)

35Data should conform to the referenced quality st andards in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.



### 5.9 Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and FFDCA, EPA reviews num erous s tudies to asse ss potential adverse

s include acute, sub-chronic and toxicity, developmental, productive, and general or systemic toxicity. These studies include endpoints which may be

nd

Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required

a l

A

and

ropamocarbCl is not among the group of 58 pe sticide active ingredie nts on the initial list to be screened

with

of outcomes from exposure to chemicals. Collectivel y, these studie chronic toxicity, including asse ssments of carcinogenicity, ne uro

re susceptible to endocrine influence

, including effects on endocrine target organ histopathology, organ weights, estrous cyclicity, sexual maturati on, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests a chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its re-registration decision, EPA reviewed th ese data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA sec tion 408(p), Propamocarb-HCl is subject to the endocrine screening part of the Endocrine Disruptor Screenin g Program (EDSP).

EPA has developed the EDSP to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effect s as the

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormona systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EP will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects caused by the substance, establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pest icide active ingredients and 9 inert ingredients. P

H under the EDSP. On November 17, 2010, a notice fr om the Federal Register was released the planned second list of chemicals to have th e Tier I Screening Level performed and includes 134 chemicals. Propamocarb-HCl is not among this list of chemicals. Accordingly, as part of registration review, EPA will issue future EDSP or ders/data call-ins, requiring the submission EDSP screening assays for Propamocarb-HCl. Fo r further information on the status of the EDSP, the policies and procedures, the list of 67 ch emicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.

36

### 5.10 Uncertainty and Preliminary Identification of Data Gaps

Environmental Fate & Transport

Review of submitted studies reveals that bound resi dues had formed in significant quantities in

certain aerobic soils and its iden tity and toxicity is unknown. In deciding on the stressor, all

residues are to be cons idered when it is of toxicological concern. The observed significant bound residue in some of the soils was only quantif ied by radioactivity but was not identified. Therefore, uncertainty exists, on determining the stressor of concern, until the bound residue toxicity is established. For modeling currently reported half-lives can only be used on the assumption that the stressor is parent al one and the significant bound residue is of no toxicological concern. In case th e bound residue was found to be oftoxicological concern, halflives are to be recalculated for the stressor which will be parent plus bound residue.

Also, uncertainty exists in the expected fate of the chemical in aerobic aquatic systems as no studies were submitted. Furthermore, uncertainty al so exists in the expected behavior of the chemical in anaerobic aquatic systems b ecause the only submitted study included one pond system in which the anaerobic conditions were not maintained. Lastly, submitted mobility data points out to high probability for leaching in some soils and uncertainty exists on the type(s) of soils in which such leaching may occur. Add itional adsorption/desorption data are necessary along with higher levels of soil ch aracterization (such as mineral ogy) in order to understand the reason for the observed differences in the mobility data. This will help in identifying the type of soils were leaching to ground water may occur. This might also explain differences in the observed leaching profiles in previously submitted field dissipation studies. Table 10 below lists

the status of environmental fate da ta requirements for Propamocarb-HCl.

The list of studies that were submitted is included previously in Tables 4, 5, 6, and 7 located in Section 3.3 (Environmental Fate and Transport) and in Appendix B . Based on examination of the available data and its quality in addition to identified uncertainties, EFED recommends the following:

- Submittal of a new aerobic aquatic study (Guideline number 835.4300) for two system from areas, in the USA, where the chemical is expected to be used;

- Submittal of a new anaerobic aquatic study (Guideline number 835.4400) for one system from an area, in the USA, where the chemical is expected to be used w ith special attention to monitoring and maintaining the anaerobic c ondition of the system as per guideline.

- Submittal of one adsorption/desorption study (Guideline number 835.1230) for two soil from areas, in the USA, where the chemical is expected to be used. In choosing the two soils, the purpose of this reco mmendation is to be considered ; that is to “understand the reason for the observed differences in the mobility data” and to identify the type of soil

37Table 10. Environmental fate Data Requirements for Propamocarb-HCl

Guideline

Number Data Requirement Additional Data Needed

for Risk Assessment? MRID #’s Study

Classification

835.2120 Hydrolysis NO 000712-97 S

835.2240 Photo-degradation in water NO 000712-96 A

835.2410 Photo-degradation on soil NO 045893-18

418346-08 S

A

835.4100 Aerobic soil metabolism NO 412781-25

412781-26

412781-27

458943-19 A

A

A

S

835.4200 Anaerobic soil metabolism NO 412781-29 A

835.4300 Aerobic Aquatic Metabolism Yes: Submittal of new study None submitted N/A

835.4400 Anaerobic Aquatic Metabolism Yes: Submittal of new study 445385-04 (A) A

835.1230

835.1240 Leaching and adsorption/ desorption Yes: Submittal of new study* 412781-30

458943-21

412781-32

000714-72

458943-20

412781-31 S S (Upgradable)

A

S

S

U

835.6100 Terrestrial Field Dissipation NO 424212-02

440016-01

458943-22 S

A

S

Fish Bio-concentration NO 412781-14

458943-23 A

U

Special Environmental Chemistry Methods and Independent Laboratory

Validations NO 458943-15

458943-16

458943-17 A

A

A

A= Acceptable; S= Supplemental; U=Unacceptable

* New study is needed in order to understand the reason for the obs erved differences in previously submitted mobility data and identify the soils were leaching to ground water may occur

Ecological Effects

The majority of the studies (both terrestrial and aquatic) submitted for Propamocarb-HCl were conducted using a formulated product rather than TGAI Propamocarb-HCl. While all but one of these studies was scientifically sound, there is uncertainty in that a higher percent active ingredient formulation may cause increased toxicity than what was seen in previously submitted studies. Specifically the studies that fail to achieve an LD/LC/EC 50 are highly uncertain as these studies were conducted using a product with a per cent active ingredient in the range of 60 – 70%

38a.i. While the majority of these studies observe d no mortalities or sublet hal effects, uncertainty

still exists in all taxa that the formulated product was used when TGAI should have been. The list of studies that were submitted is included previously in Tables 7 located in a previous section (Section 4.1). Based on ex amination of the available data and its quality, EFED recommends the following:

- Submittal of a new acute oral toxicity st udy on the bobwhite quail with TGAI (OCSPP 850.2100)

- Submittal of two new acute dietary studies (one with the northern bobwhite quail and one with the mallard duck) conducted with TGAI (OCSPP 850.2200)

- Submittal of an avian acute oral toxicity study with a passerine species conducted with

TGAI

- Submittal of a chronic freshwater invertebrate life cycle toxicity study with the water flea ( Daphnia magna ) as the previously submitted study was classified as INVALID and this study remains a requirement (OCSPP 850.1300)

- Submittal of an early life stage toxicity test for sheepshead minnow and a chronic life stage invertebrate toxicity test w ith the mysid shrimp. If a ne w aerobic aquatic metabolism study

shows the half life to be less than 4 days, these two studies may be waived.

Table 11 lists the status of the ecological eff ects data requirements for Propamocarb-HCl.

Table 11 Ecological Effects Data Requi rements for Propamocarb-HCl

Guideline Data Requirement Test Species MRID Preliminary Study

Classification More Data

Needed for

Risk

Assessment?

71-1 (850.2100) Avian Oral LD 50 Mallard duck

Bobwhite quail

Passerine species No study

submitted

46145210

No study

submitted N/R

Supplemental

N/R No

Yes 1

Yes 1

71-2 (850.2200) Avian Dietary LC 50 Mallard duck

Bobwhite quail 45894212

46145211 Supplemental

Supplemental Yes 2

Yes 2

71-4 (850.2300) Avian Reproduction Mallard duck

Bobwhite quail 46145213

46145212 Supplemental

Supplemental No

72-1 (850.1075) Freshwater Fish LC 50 Rainbow trout

Bluegill sunfish 45894302

45894301 Supplemental

Supplemental No

72-2 (850.1010) Freshwater

Invertebrate Acute

LC 50 Water flea 45894303 Supplemental No

72-3(a) Estuarine/Marine Sheeps head 45894304 Supplemental No

39Guideline Data Requirement Test Species MRID More Data Preliminary Needed for Study Risk Classification Assessment? (850.1075) Fish LC 50 minnow

72-3(b) (850.1025 or

850.1055) Estuarine/Marine

Mollusk Shell Deposition EC 50 Eastern oyster 45894305 Supplemental No

72-3(c) (850.1035 or

850.1045) Estuarine/Marine

Invertebrate EC 50 Mysid shrimp 45894306 Supplemental No

72-4(a) (850.1400) Freshwater Fish Early Life Stage Fathead minnow 45894307 Supplemental No

72-4(b) (850.1300) Freshwater

Invertebrate Life Cycle Water flea 45894308

45727801 Invalid

In-review Yes 3

In-review 5

72-4(c)

850.1350 Estuarine/marine

Invertebrate Life Cycle Mysid Shrimp No study

submitted N/A Yes 4

72-4(d) (850.1400) Estuarine/Marine Fish Early Life Stage Sheepshead

minnow No study

submitted N/A Yes 4

123-1(a) (850.4100) Seedling Emergence (Tier I) Multiple species 4589 4310 Acceptable No

123-1(b) (850.4150) Vegetative Vigor (Tier I) Multiple species 4589 4311 Acceptable No

122-2(a) (850.4400) Aquatic vascular plants (Tiers I and II) Duckweed 4589431 3 Acceptable No Freshwater algae 45894312 Supplemental No

141-1 (850.3020) Honey bee acute contact toxicity Honey bee 44324501 Acceptable No

1 Data are required for one passerine species and either one waterfowl or one upland game bird species. At this time, only an acute oral test for a game bird species has been submitted and this study, conducted with formulated product, may be showing less toxicity than a study conducted with TGAI propamocarb-HCl would.

2 Data required based on the current study being conducted with formulated Propamocarb-HCl and the study showing sublethal effects.

3 Data required based on previous submission of an invalid study.

4 This data may be waived if the results of a new aerobic aquatic metabolism study indicate that the half life is less than 4 days.

5 This study is currently in review and the status of this study being a data requirement may change pending the

review.

40

## Bibliography

(1) General References

U.S. Environmental Protection Agency. 1998. Guidelines for Ecological Risk Assessment. Risk Assessment Forum, Office of Resear ch and Development, Washington, D.C. EPA/630/R-95/002F. April 1998.

U.S. Environmental Protection Agency. 2000. Risk Characterization Handbook. Science Policy Council, U.S. Environmental Prot ection Agency, Washington, D.C. 20460. EPA

100-B-00-002. December 2000.

U.S. Environmental Protection Agency. 2004. Overview of the Ecological Risk Assessment

Process in the Office of Pes ticide Programs, U.S. Environmental Protection Agency. Endangered and Threatened Species Effect s Determinations. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington, D.C. January 23, 2004.

U.S. Environmental Protection Agency. 2005. Generic Format and Guidance for the Level I Screening Ecological Risk Assessments Conducte d in the Environmental Fate and Effects Division. Office of Pesticide Programs, Washington, D.C. January 24, 2005.

U. S. Environmental Protection Agency. 2007. Ecological Incident Information System. http://www.epa.gov/espp/consultation/ecorisk-overview.pdf

U. S. Environmental Protection Agency. 1995. Re-registration eligibility decision: propamocarb hydrochloride, case 3124.

ETN (Extension Toxicology Network). 1997. Propamocarb. Pesticide Information Profile. Cornell University. ( http://pmep.cce.cornell.edu/profiles/extoxnet/metirampropoxur/propamocarb-ext.html )

FRAC (Fungicide Resistance Action Committee). 2010a. FRAC Code List © : Fungicides sorted by mode of action (inc luding FRAC Code numbering). http://www.frac.info/frac/publicat ion/anhang/FRAC_Code_List_2010.pdf )

FRAC (Fungicide Resistance Action Committee). 2010b. List of plant pathogenic organisms

resistant to disease control agents. Revised January 2010. http://www.frac.info/frac/publ ication/anhang/List_of_resis tant_plant_pathogens_Jan%202010.pd

f )

Kline and Co. (2000-2007). Professional Turf and Ornament al Markets for Pesticides and

Fertilizers.

EPA Proprietary Data. GfK Kynetec. 1998-2008.

41EFED, 2000. Section 3 for propamocarb hydrochloride to control late blight (Phytophthora infestans) on potatoes (DP Barcode 0259522).

BEAD, 2011. Chemical Profile for Registration Review: Propamocarb-HCl (119302), April

2011



### (2) Environmental Fate and Transport References

MRID 00071297 Riemann, J.; Repenthin, W. (1976) Determination of Rates of Hydrolysis of Propamocarb Base at pH 5, 7 and 9: Report No. APC 26/76. (Tra nslation; unpublished study received Feb 24, 1981 under 2139-121; prepared by Schering, AG, West Germany, submitted by Nor-Am Agricultural Products, Inc., Naperville, Ill.; CDL: 244469-D). (Same but clear readable copy was submitted

under MRID 2402168-04 ).

MRID 00071296 Klehr, M. (1980) Photolysis Experiments with Propamocarb-HCl (SN 66 752) in Heat Sterilized Aqueous Solutions. (Unpublished study receiv ed Feb 24, 1981 under 2139-121; prepared by Schering, AG, West Germany, submitted by Nor-Am Agricultural Products, Inc., Naperville, Ill.; CDL:244469-C)

MRID 45894318 Yeomans, P. (2001) (Carbon 14)-Propamocarb Hydrochloride: Photodegradation on a Soil Surface: Final Report: Lab Project Number: 1669/8: 1669/8-D2149. Unpublished study prepared by Covance Laboratories Ltd. 62 p.

MRID 41834608 Tschampel, M. (1990) W78 Propamocarb: The P hotodegradation of Propamocarb Hydrochloride on soil surfaces (Schering Code ZK 66 752) on Soil Surfaces. Laboratory Project ID: APC 87/90. Study No. 90/030. Unpublished Study Perf ormed by Schering AG, Berlin, Federal Republic of Germany and Submitted by No r-Am Chemical Company, Wilmington, DE.

MRID 41278125 Bruhl, R.; Celorio, J.; Wi. (1978) Degradation of SN 66 752 in a Loamy Sand: Report No. PA 66 752.71/6. (Unpublished study received Feb 2 4, 1981 under 2139-121; prepared by Schering AG, West Germany, submitted by Nor-Am Agricu ltural Products, Inc., Naperville, Ill.; CDL:244472-F).

MRID 41278126 Bruhl, R.; Wi. (1979) Degradation of Propamocar b Hydrochloride in a Ca lifornian Loamy Sand: Report No. R + S 29/79--PA 66 752.71/6. (Unpublished study received Feb 24, 1981 under 2139-121; prepared by Schering AG, West Germany, submitted by Nor-Am Agricultural Products, Inc., Naperville, Ill.; CDL: 244472-E).

MRID 41278127

42Bruhl, R. and J. Celorio (1980a) W15 Propamocarb : Degradation of Propamocarb Hydrochloride in a Loamy Sand. Laboratory Project ID : R+S71/80 PA66752 71/6. Unpublished Study Performed by Schering AG, Berlin, Federal Republic of Germany, and Submitted by Nor-AM Chemical Company, Wilmington, DE.

MRID 45894319 Schnoder, F. (2002) (Carbon 14)Propamocarb Hydroc hloride: Aerobic Route and Rate of Soil Degradation: Final Report: Lab Projec t Number: 1760-1669-007: 1669-007. Unpublished study prepared by Covance Laboratories GmbH. 110 p.

MRID 41278129 Bruhl, R. (1979) W20 Propamocarb HCL: Degr adation of SN 66 752 in a Loamy Sand under Anaerobic Conditions: Lab Project Number: PA /66/752/71/6. Unpublished study prepared by Schering AG. 11 p.

MRID 44538504 Judge, D.N. (1998) W144-1 Propamocarb: Th e Degradation of [1 -14C]Propamocarb under Laboratory Anaerobic Aquatic Co nditions. Laboratory Project ID: AV97E517. Unpublished Study Performed by AgrEvo USA Company, Pike sville, NC and Submitted by AgrEvo USA Company, Wilmington, DE.

MRID 00071465 Bruhl, R.; Celorio, J.; Wi. (1980) Anaerobic De gradation of Propamocarb Hydrochloride in River Sediment: R + S 60/80--PA 66 752.71/6. (Unpublished study received Feb 24, 1981 under 2139-121; prepared by Schering AG, West Germany, submitted by Nor-Am Agricultural Products, Inc., Naperville, Ill.; CDL: 244472-H)

MRID 41278130 Bruhl, R. (1988) W59 Propamocar b Hydrochloride: Adsorption to and Desorption from Soil: Lab Project Number: UPSR/ 19/88. Unpublished study prepared by Schering AG. 41 p.

MRID 45894321 Willems, H. (1998) Adsorption/Desorption of Propamocarb Hydrochloride on Soil: Lab Project Number: 220769. Unpublished study prep ared by NOTOX B.V. 41 p.

MRID 41278132 Bruhl, R.; Wi. (1978) Mobility of Propamocar b Hydrochloride in Four Soils: PA 66 752.71/6. (Unpublished study received Feb 24, 1981 under 2139-121; prepared by Schering AG, West Germany, submitted by Nor-Am Agricultural Produc ts, Inc., Naperville, Ill.; CDL:244473-D).

MRID 00071472 Bruhl, R.; Celorio, J.; Wi. (1979) Mobility of SN 66 752 in Two Soils after Aging: R + S 28/79-

-PA 66 752.71/6. (Unpublished study received Feb 24, 1981 under 2139-121; prepared by Schering AG, West Germany, submitted by Nor-Am Agricultural Products, Inc., Naperville, Ill.; CDL:244473-E).

43MRID 45894320 Willems, H. (1998) Aged Leaching of Propamo carb Hydrochloride: Lab Project Number: 220758. Unpublished study prepared by NOTOX B.V. 38 p.

MRID 41278131 Feyerabend, M. (1988) W69 Pr opamocarb: The Mobility of N-(3-dimethylamino-?1-14C|- Propyl)-Propamocarb-Hydrochloride in Four Soils Determined by Soil TLC: Lab Project Number: UPSR/88/88. Unpublished study prepared by Schering AG. 30 p.

MRID 42421202 Wred-Rucker, A. (1992) W115 Propamocarb Hc1: Dissipation of Propamocarb X HC1 in Soil Following Application of Banol – USA 1990. Report No. UPSR 57/91. Study No. PF-R 89093. Unpublished Study Performed by Schering AG, Berlin, Germany and Submitted by Nor-Am Chemical Company, Goldsboro, NC.

MRID 44001601 Cole, M. (1995) Dissipation of Propamocarb.HCl in Soil Following Application of Banol to Bare Plot, USA, 1993: Lab Project Number: AV- 93R-01: A54951: W132. Unpublished study prepared by AgrEvo USA Co. 161 p.

MRID 45894322 Willard, T. (2002) Terrestrial Field Soil Dissip ation of Propamocarb Hydrochloride in Turf: Final Study Report: Lab Project Number: AA010716: 01-0027: ENC-1/02. Unpublished study prepared by American Agricu ltural Services, Inc. 406 p.

MRID 45894316 Melkebeke, T. (2000) Validation of an Analytical Method for th e Determination of Propamocarb Residues in Surface Water: Lab Project Number: 289676. Unpublished study prepared by NOTOX.27 p.

MRID 45894317 Melkebeke, T. (1997)Validation of an Analy tical Method for Residues of Propamocarb in Soil:Lab Project Number: 174904. Unpublished study prepared by NOTOX.19p.

MRID 45894315 R. de Vries (1997)Validation of an Analyt ical Method for Residues of Propamocarb in Water:Lab Project Number: 173598. U npublished study prepared by NOTOX.19p.

MRID 41278114 Gray, C.; Knowles, C. (1980) W34 Propamocarb HCL: Uptake of propamocarb hydrochloride by bluegills and channel catfish. Chemosphere (9):329-333.

MRID 45894323 Mazzonetto, F. (2001) Bioconcentrat ion of Proplant to Zebrafish ( Danio rerio ): Final Report: Lab Project Number: RF-0998.210.022.01. Unpublis hed study prepared by BIOAGRI Laboratories Ltda. 92 p.

44

### (3) Ecological Effects References

71-1 Avian Single Dose Oral Toxicity

MRID 46145210. Teunissen, M.S. 2002. Acute Oral Toxicity Study in Northern Bobwhite with Proplant (Propamocarb HC1722 g/L ). Unpublished study performed by NOTOX B.V., DD'sHertogenbosch, The Netherlands. Laboratory ID No. 327004. Study sponsored by Chimac - Agriphar s.a., (Ougree, Belgium. Study initia ted October 18, 2001 and completed January 15,

2002.

71-2 Avian Dietary Toxicity

MRID 45894212 . Miller, V. 2002. Proplant - Dietary Toxicity Test with the Mallard Duck ( Anas platyrhynchos ). Unpublished study performed by Springborn Smithers Laboratories, Snow Camp, NC and Wareharn, MA. Labor atory Project ID No. 13763.4102. Study sponsored by Chimac - Agriphar, Ougree, Belgium. Study in itiated October 30, 2001 and completed March 22, 2002.

MRID 46145211. Teunissen, M.S. 2001. 5-Day Dietary Toxicity Study in Bobwhite Quail with Proplant (Propamocarb HCI 722 g/L). Unpublis hed study performed by NOTOX B.V., DD'sHertogenbosch, The Netherlands. Laboratory ID No. 329783. Study sponsored by Chimac - Agriphar s.a., Ougree, Belgium. Study initiated July 1, 2001 and completed November 20, 2001.

71-4 Avian Reproduction

MRID 46145212 . Teunissen, M.S. 2002. Reproduction Study in Bobwhite Quail with PROPLANT (Propamocarb HCI 722 g/L ) (By Dietary Admixture). Unpublished study performed by NOTOX B.V., DD's-Hertogenbosc h, The Netherlands. Laboratory ID No. 295526. Study sponsored by Chimac – Agriphar s.a , Ougr ee, Belgium. Study initiated September 3. 2001 and completed April 18, 2002.

MRID 46145213 . Miller, V. 2002. Proplant - Reproductive Toxicity Test with Mallard Duck ( Anas platyrhynchos ). Unpublished study performed by Springborn Smithers Laboratories, Snow Camp, NC and Wareham, MA. Labor atory Project ID No. 13763.4100. Study sponsored by Chimac - Agriphar, Ougree, Belgium. Study initiated April 11, 2001 and completed June 27,

2002.

72-1 Acute Toxicity to Freshwater Fish

MRID 45894301 . Migchielsen, H.J. 2001. 96-Hour Acute Toxicity Study in Bluegill Sunfish with Proplant (Propamocarb HC1722 g/L) (Static). Unpublished study performed by NOTOX B.V., Hertogenbosch, The Netherlands. Labor atory Project Identification No. 329748. Study submitted by CHIIVIAC-AGRIPHAR S.A., Ougree, Belgium. Study initiated July 4, 2001 and completed December 19, 2001.

45MRID 45894302 . Bodgers, M. 1996. 96-Hour Acute Limit Study in Rainbow Trout with Proplant (Semi-static). Unpublished study performed by NOTOX B. V., Hertogenbosch, The Netherlands. Laboratory Project Identific ation No. 161303. Study submitted by ChimacAgriphar s.a., Ougree, Belgium. Study init iated June 26, 1996 and completed August 28, 1996.

72-2 Acute Toxicity to Freshwater Invertebrates

MRID 45894303 . Bodgers, M. 1996. Acute Limit Study in Daphnia magna with Proplant. Unpublished study performed by NOTOX B.V., Hertogenbosch, The Netherlands. Laboratory Project Identification No. 16 13 14. Study submitted by Chimac-Agriphar s.a., Ougree, Belgium. Study initiated June 26, 1996 and completed August 28, 1996.

72-3 Acute Toxicity to Estuarine/Marine Organisms

MRID 45894304 . Putt, A. 2001. Proplant (Propamocarb HC1722 g/L SL) - Acute Toxicity to Sheepshead Minnow ( Cyprinodon variegatus ) Under Static Conditions. Unpublished study performed by Springborn Laboratories. In c.,Wareham, MA. Laboratory Study No. 13763.6104. Study submitted by Chimac-Agriphar, Ougree, Belgium. Study initiated May 14, 2001 and completed August 15, 2001.

MRID 45894305 . Dionne, E. Proplant (Propamocarb HC1722 g/L SL,) - Acute Toxicity to Eastern Oysters ( Crassostrea virginica ) Under Flow- Through Conditions. Study Completion Date: August 16, 2001. Laboratory: Springborn Laboratories, Inc. 790 Main Street Wareharn, MA 02571-1075. Sponsored by: CHIMAC-AGR IPHAR Rue de Renory 26 B-4102 Ougree, Belgium. Laboratory Report ID: 13763.6102

MRID 45894306 . Putt, A.E. Proplant (Propamocarb HC1722 g/L SL) - Acute Toxicity to Mysids ( Americamysis bahia ) Under Static Conditions. St udy Completion Date: August 28, 2001. Laboratory: Springborn Laboratories, Inc. 790 Main Street Wareham, MA 0257 1 – 1075. Sponsored by: CHIMAC-AGRIPHAR, Rue de Re nory 26 B-4 102 Ougree, Belgium. Laboratory Report ID: 13763.6 10 1.

72-4 Fish Early Life Stage/ Aquatic Invertebrate Life Cycle Study

MRID 45894307 . Gries, T. 2002. Proplant: Early-Life Stage Toxicity Test with the Fathead Minnow ( Pimephales promelas ) under Flow-Through Conditions . Unpublished study performed by Springborn Laboratories (Europe) AG, Sees trasse 21, Postfach CH-9326 Horn, Switzerland. Laboratory Study No. 1038.004.122. Study sponsored/s ubmitted by Chimac-Agriphar S.A., Rue de Renory, 26 8-4102 Ougree, Belgium. Study initiated October 24, 2001 and completed February 26, 2002.

122-2 Aquatic plant growth

MRID 45894312 . Bogers, M. 1996. Fresh Water Algal Grow th Inhibition Test with Proplant. Unpublished study performed by NOTOX B.V., Hertogenbosch, The Netherlands. Laboratory Project Identification No. 165364. Study subm itted by CHIMAC-AGRIPHAR S.A. Ougree, Belgium. Study initiated December 13, 1995 and completed September 4, 1996.

46MRID 45894313 . Bogers, M. 2001. A 7-Day Aquatic Plant Toxicity Test with using Lemna

minor with Proplant (Propamocarb HC1722 g/L) Unpublished study performed by NOTOX B.V., Hertogenbosch, The Netherlands. Labor atory Project Identification No. 329254. Study submitted by CHIMAC-AGRIPHAR S.A. Ougree, Belgium. Study initiated June 18, 2001 and completed November 13, 2001.

MRID 44187802. Christ, M. T., and Ruff, D. F. Propamocarb hydrochlor ide: 68.2% w/w (738 g/L) Toxicity to Duckweed (Lemna gibba , G3) in a Static Renewal System. Study Completion Date: December 2, 1996. Laboratory: AgrEvo USA Company, AgrEvo Research Center, Environmental Biology Department, 703 NOR-AM Road, PO Box 538, Pikeville, NC 27863. Sponsored by AgrEvo USA Company, 2 711 Centerville Rd.,Wilmington, DE 19808

522AV.

123-1 Seed germination/s eedling emergence and vegetative vigor

MRID 45894310 . Ir. W.H.C. Geuijen. Terrestrial Plant Toxicity Test, Tier 1: Seedling Emergence, With Proplant (Propamocarb HCL 722 G/L). Study Completion Date: February 1, 2002. Laboratory: NOTOX B .V., Hambakenwe tering 7, 5231 DD's-Hertogenbosch, The Netherlands. Sponsored by: CHIMAC-AGRPH AR S .A. Rue de Renory, 26 B-4102 Ougree, Belgium. Laboratory Report ID: 327048.

MRID 45894311. Ir. W.H.C. Geuijen. Terrestrial Plant Toxicity Test, Tier 1: Vegetative Vigor, with Proplant (Propamocarb HCI 722 GIL). Study Completion Date: December 20, 2001. Laboratory: NOTOX B .V. Hambakenwetering 7, 5231 DD's-Hertogenbosch, The Netherlands. Sponsored by: CHIMAC-AGRIPHAR S .A. Ru e de Renory, 26 B -4 102 OUGREE, Belgium Laboratory Report ID: 327059.

MRID 44187801 . Christ, Mark T. and Ruff, David F. Tier II: Investigati ng into the Phytotoxic Effects on Seedling Emergence/Growth of Terrestrial Plants. Study Completion Date: December 19, 1996. Laboratory: AgroEvo Research Center Pikeville, North Carolina. Sponsored by AgrEvo USA Company Wi lmington, DE. Laboratory Report ID: 511AV

141-1 Honey bee acute contact

MRID 44324501. Nengel, Sabine. Assessment of Side Ef fects of Proplant to the Honey Bee, Apis mellifera L. in the Laboratory Following the E PPO Guideline No. 170. Study Completion Date: 01/09/97. Laboratory: GAB Biotechnologie BmgH & I FU. Sponsored by GAB Biotechnologie BmgH & IFU. Labor atory Report ID: 96047/01-BLEU.

4748 

### Appendix A: Issues Associated with Current Labels for Propamocarb-HCl

(1) Vegetable labels

Issues associated with labels for this use can be categorized into the following:

a. Field Vegetables Labels

• Registrants need to confirm and correct discre pancies in data presented on this use in Table 1 of the problem formulation document and provide missing data.

b. Greenhouse application, namely, 55260-10 Promess and 264-678 Previcur Flex

• Registrants need to confirm data presented and correct discrepancies in data presented on this use in the problem formulation document

• Maximums for each cropping season were set to be 11.6 lbs. a.i./A with 6,000 plants, 9.4 lbs. a.i./A with 10,000 plants, and 27.1 lbs. a.i./A with 14,000 plants. However, label instructions needs to be clarified by stating the interv als between all applications, specifying which treatment applies to which crops (or state that all treatments may apply to all crops), and by clarifying the rate in case of the two applicati ons for soil or soilless seed beds. Based on the

label instructions EFED calculated the first application to be 65.33 lb a.i./A and the second application to be 32.67 lbs a.i./A and both are higher than the maximum permitted seasonal

rate of 27.1 lbs. a.i./A. Therefore labe l instruction need to be modified.

(2) Turf and Ornamentals Labels

• Registrants need to confirm and correct discre pancies in data presented on this use in Table 2 of the problem formulation document and provide missing data.

• Registrants need to address othe r issues associated with labels for this use which include one or more of the following:

• Specifying which application rates apply to ornamentals in greenhouses and which ones apply to ornamentals in nurseries;

• Correcting errors in ca lculating amount of a.i from formulation;

• Specifying if the nurseries are limited to container-grown;

• Including the yearly rate/acre that takes in consideration the number of containers that can be placed on an acre;

• Specifying the turf categories;

• Modifying the label so that single rate for ornamental does not exceeds the yearly rate;

• Including the number of applications; and

• Including the appli cation intervals in case of mo re than one application.Appendix B: Fate Data for Propamocarb-HClTable B-11st and 2ndsets for propamocarb-HCl biotic fatestudies compared (Abbreviations are inboldorbold italicand meaning isincluded below the Table)Location(ID)MRID(Classification)Soil/sediment propertiesExtractionProcedureIdentification/Confirmation&QuantificationProceduresDegradation DataIdentified ResiduesUn-identified Residues (% of applied)TexturepHO.CClayCECParent Halflife (StudyLength)CO2Degradation ProductsBoundAerobic Soil Systems (Data from 1stset):Radiolabel position aminopropyl-114C; Used an exaggerated rate of 200 ppm and incubated @ 250CGermany(Soil 1)412781-25(A)LS6.62.4511MeOH+ SHXTLC(Soil 3)andTLC/1 & 2 DTLC(soils 1&2)& LSC(All Soils)DT50=14 d(360 d)873 minor degradates(Apparent Decline)Max. 20% @ 30 days(Declined to 12% @ 360 d)USA, CA(Soil 2)412781-26(A)LS5.21.145MeOH+ SHXDT50=27 d(14-30 d)(360 d)873 minor degradates(No apparent Decline)Max.38% @ 14 days(Declined to 11% @ 360 d)Germany(Soil 3)412781-27(A)LS6.62.37NRMeOHDT50=10 d(7-13 d)(46 d)806 minor degradates(No apparent Decline)Max. 23% @ 13 days(Declined to 15% @ 46 d)Aerobic Soil Systems (Data from 2ndset):Radiolabel position aminopropyl-214C; Used an exaggerated rate of 250 ppm in all soils with one of the soils repeated at 10 ppm andincubated @ 200C with one soil repeated @ 100CUK(Soil 4)458943-19(S;becausesoils were notclassified/compared toexpected usesites of thechemical)SL7.12.51115ACNTRLTLC/HPLC& LSCt 1⁄2=23 d(365 d)497 minor degradates6 Declined/1 No DeclineMax. 45% @ 58 days(Declined to 31% @ 365 d)Same soil 4 above with the lowapplication rateACNTRLt 1⁄2=14 d(120 d)362 minor degradates1 Declined/1 No DeclineMax. 46% @ 58 days(Declined to 43% @ 120 d)Same soil 4 above with the same rate@ 100CACNTRLt 1⁄2=47 d(120 d)323 minor degradates1 Declined/3 No DeclineMax. 48% @ 120 days(No Decline)UK(Soil 5)SiL6.74.52018ACNTRLt 1⁄2=16 d(120 d)482 minor degradates1 Declined/1 No DeclineMax. 49% @ 90 days(Declined to 44% @ 120 d)UK(Soil 6)CL8.02.73422ACNTRLt 1⁄2=15 d(120 d)482 minor degradates1 Declined/1 No DeclineMax. 48% @ 30 days(Declined to 43% @ 120 d)UK(Soil 7)SL5.51.31211ACNTRLt 1⁄2=70 d(120 d)312 minor degradates2 No DeclineMax. 29% @ 120 days(No decline, end of study)Anaerobic Soil Systems* (Data from 1stset):Radiolabel position aminopropyl-114C; Used an exaggerated rate of 200 ppm and incubated @ 250CGermany(Soil 1)412781-29(A)Same soil 1 used in the aerobic soilMeOH+ OthersTLC & LSCt 1⁄2=459d(180 d)83 minor degradates2 Declined/1 No DeclineMax. 8% @ 14 days(No apparent decline)Aerobic Aquatic Systems:No data were submitted in either the 1stor the 2ndsetAnaerobic Aquatic Systems** (Data from 2ndset):Radiolabel position aminopropyl-214C; Used rate of 7.7ppm and incubated @ 250CUSA, NC445385-04Water6.8NRNANAACNTRLTLC/HPLCt 1⁄2=92 d689 minor degradatesMax. 20% @ 110 days49Location(ID)MRID(Classification)Soil/sediment propertiesExtractionProcedureDegradation DataIdentification/Confirmation&Identified ResiduesUn-identified Residues (% of applied)QuantificationProceduresTexturepHO.CClayParent Halflife (StudyCECLength)CO2Degradation ProductsBound(Pond)(A)CLSediment(25% ofsandremovedbysieving)5.54.02912+SHX(SHXextractedup to 9%moreparent)“selectedsamples”& LSCTotalSystem(370 d)8 Declined/1 No Decline(Declined to 6% @ 120 d)MRID= MRID number;Texture: Textural class:LS= Loamy sand,CL= Clay loam,SiL= Silt loam,SCL= Sandy clay loam;O.C= %of organic carbon%,Clay= % of clay,CEC=Cation exchange capacity (meq/100 g);NR= Not reported;NA= Not applicable; d= Time in days;CO2=Maximum evolved CO2occurring mostly at end of study (% of appliedradioactivity);Study Previous Classification:A= Acceptable,S= supplemental;MeOH=Aqueous methanol based extraction;ACNTRL= Aqueous acetonitrile and HCl basedextraction;SHX=Shoxhlet extraction; MeOH+ Others=3 times methanol + 1 time acetone + 1 time toluene + 1 time 5 N NaCl;TLC=Thin layer chromatography (1D=onedimensional; 2D= 2 dimensional);HPLC= high performance liquid chromatography;LSC=LSC= Liquid scintillation, a method for determination radioactivity;DT50= observed orestimated time degradation of 50% degradation;t 1⁄2= calculated half-life by linear and/or non-linear methods*No data was submitted in the 2ndset; **No data from the 1stset because the anaerobic aquatic study submitted under Accession Number000714-65 was classifiedUnacceptable50Table B-2The 1stand 2ndsets for propamocarb-HCl mobility data compared (Abbreviations are inboldorbold italicand meaning isincluded below the Table)Soil PropertiesLocation (ID)MRID(Classification)Study TypeTexturepHO.CClayCECAgingNotesGerman: Soil 1412781-30(S)Ad-Des(1stData Set)S6.00.554UnagedAminopropyl-114Clabeled propamocarb-HCl wasused and was the only chemical determined by TLCanalysis. It was reported that parent was stable (Nodata). Quantification by LSCGerman: Soil 2LS6.02.148UK Soil: 3SL5.21.51313Germany: Soil 4458943-21(S, Upgradable)Ad-Des(2ndData Set)LS6.12.379UnagedAminopropyl-214Clabeled propamocarb-HCl wasused and found to be stable through the study duration(TLC analysis). Quantification by LSCUK: Soil 5SCL6.53.53234US: Soil 6SL5.71.11611US: Soil 7LS5.90.666Germany: Soil 8412781-32(A)*Un-aged ColumnLeaching(1stData Set)S6.60.542UnagedAminopropyl-114Clabeled propamocarb-HCl wasused and was the only chemical determined by TLCanalysis. Quantification by LSC. Columns eluted for6-days at a rate of 8-10 mL/hrGermany: Soil 9LS5.71.978US: Soil 10LS5.21.145Germany: Soil 11000714-72(S)Aged ColumnLeaching(1stData Set)SL5.91.16530 dAminopropyl-114Clabeled propamocarb-HCl wasused and was the only chemical determined by TLCanalysis. It is assumed thatreported % parent is basedon radioactivity remaining in the aged soils.Quantification by LSC. Soil extraction by MOH.Columns eluted for 45 days at a rate of 25 mL/dayGermany: Soil 12LS6.12.5213Germany: Soil 13458943-20(S)Aged ColumnLeaching(2ndData Set)SL7.32.061012 dAminopropyl-214Clabeled propamocarb-HCl wasused with a residue, after aging and loss of 19% CO2from soil 13 and 33% CO2from soil 14. The residueconsists of mostly parent 35% and bound residues of35% in soil 13. In soil 14, the residue consisted ofmostly parent 46% and bound residues of 27% (TLCanalysis). Quantification by LSC. Soil extraction byMOH & NaCl. Columns eluted for 2 days. In Soil 13,radioactivity related to parent ranged from to andbound residues ranged from to . In Soil 14,radioactivity related to parent ranged from 31 to 40%and bound residues ranged from 27 to 29%US: Soil 14SL6.61.210923 dMobility ResultsAdsorption-Desorption Results (Ad-Des) from the 1stData Set at a rate of 0.04 ppm (MRID 412781-30)German: Soil 1AdsorptionKd(mL/g) =0.671& AdsorptionKoc(mL/g)=140(calculated fromKdand O.C%)German: Soil 2AdsorptionKd(mL/g) =0.849& AdsorptionKoc(mL/g)=41(calculated fromKdand O.C%)UK: Soil 3AdsorptionKd(mL/g) =5.2& AdsorptionKoc(mL/g)=359(calculated fromKdand O.C%)51Adsorption-Desorption Results (Ad-Des) from the 2ndData Set at a rate of 0.19 to 22.165 ppm (MRID 458943-21)Germany: Soil 4AdsorptionKd(mL/g) =1.29& AdsorptionKoc(mL/g)=57(calculated fromKdand O.C%)UK: Soil 5AdsorptionKd(mL/g) =6.27& AdsorptionKoc(mL/g)=180(calculated fromKdand O.C%)US: Soil 6AdsorptionKd(mL/g) =13.83& AdsorptionKoc(mL/g)=1,317(calculated fromKdand O.C%)UK: Soil 7AdsorptionKd(mL/g) =4.65& AdsorptionKoc(mL/g)=802(calculated fromKdand O.C%)Un-aged Column Leaching Results from the 1stData Set at a rate of 21 ppm (MRID 412781-32)Germany: Soil 852 to 61% of parent found inthe leachate suggesting the chemical isVery mobilein this soilGermany: Soil 9Only <1% of parent found in the leachate and≈87% in the upper 20 cm of the 30 cm columnsuggesting the chemical is relativelyImmobileUS: Soil 10Only <1% of parent found in the leachate and≈77% in the upper 20 cm of the 30 cm columnsuggesting the chemical is relativelyImmobileAged Column Leaching Results from the 1stData Set 2ndData Set at a rate of 420 ppm (MRID 000714-72)US: Soil 1138 to 48% of parent found inthe leachate suggesting the chemical isVery mobilein this soilGermany: Soil 12Only 2% of parent found in the leachate suggesting the chemical isrelatively ImmobileAged Column Leaching Results from the 2ndData Set at a rate of 15.4 (MRID 458943-20)Germany: Soil 13Only 1% of parent found in the leachate; ranged from 28-44% in the upper 6 cm of the 30 cm column suggesting the chemical isrelatively ImmobileUS: Soil 14Only 1% of parent found in the leachate; ranged from37-45% in the upper 6 cm of the 30 cm column suggesting the chemical isrelatively ImmobileMRID= MRID number noting thatnumbers starting with zeros are Accession numbers;Texture: Textural class:S= Sand,LS= Loamy sand,SL= Sandy loam,SCL= Sandyclay loam;O.C= %of organic carbon%,Clay= % of clay,CEC= Cation exchange capacity (meq/100 g); d= Time in days;CO2=evolved CO2(% of applied radioactivity);Study Previous Classification:A= Acceptable,S= supplemental;TLC=Thin layer chromatography;LSC= Liquid scintillation, a methodfor determination radioactivity* One un-aged leaching study (MRID 412781-31) was classified as Unacceptable520.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%100.0%050100150200250300350400ParentBoundresidueCO2Un‐identifiedDegradates

% of A pp lied Radioactivit yTime (days)Figure B-1Degradation profile for propamocarb-HCl ina pond water/sediment system from NC53AE B132674Name:3-hydroxypropyl[3-(dimethylamino)propyl]carbamateAE B155306Name:Propyl [3-(dimethylamino)propyl] carbamatehydrochloride N-oxideAE B1532679Name:3-[(3-dimethylamino)propyl]-4-hydroxy-4methyl-2-oxazolidineAE B132677Name:Propyl [3-(dimethylamino)propyl] carbamateFigure B-2Standard possible degradation products for Propamocarb-HCl540204060801001200100200300WaterSedimentCO2

% of A pp lied Radioactivit yTime (days)Figure B-3Distribution of radioactivity between water, sediment and evolved CO2 in a pondwater/sediment system from NC555.012.90 50 100 150 200 250 300 350400pe+phwaterpe+pHSediment56Figure B-4Aerobicity of the pond water/sedimentsystem from NC as indicated by pe+pHSub-OxicConditionsOxic Conditions (Aerobic)AnaerobicConditionsditions57