OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

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

March , 2014 PC Code: 123301 MEMORANDUM DP Barcode: 352367

SUBJECT: Preliminary Ecological Risk Assessment for Registration Review of Fosetyl

Aluminum

FROM: Kristina Garber, Senior Biologist ERB2/EFED (7507P)

THROUGH: Brian Anderson, MEM, Branch Chief ERB2/EFED (7507P)

TO: Kelly Ballard , Chemical Review Manager Neil Anderson, Branch Chief RMIB1 / PR D (750 8 P)

This memorandum transmits the preliminary ecological risk assessment for the registration review of the fungicide fosetyl

- a luminum (referred to as fosetyl

- Al) . Based on currently registered uses and labeled rates, this preliminary assessment identifies potential risks to non

target organisms . This assessment is focused on species that are not Federally listed as threatended or endangered (referred t o as “listed”) ; however, some general discussion of taxa of listed species for which “ no effect ” determniations are expected is included in this assessment. For taxa where there may be risk, specific determinations for listed species are considered uncerta in at this time. Currently labeled rates of fosestyl

- Al pose a potential for adverse effects

, i.e ., risk, to non

- target terrestrial animals, including insects, birds, reptiles, terrestrial

- phase amphibians and mammals. In addition, applications may impact sensitive species of dicot yledenous plants (dicots) in terrestrial habitats. These risks may be reduced through label changes, including decreases in maximum single applications, decreases in the number of applications allowed per year, removal of aerial a pplications , use of spray drift buffers and specification of coarse droplet spectrum to reduce spray drift. In addition, section 2.1.4 addresses ambiguous label language that could be revised to reduce conservative assumptions used in assessing potential r isks

.

# Ecological Risk Assessment for the Registration Review of FOSETYL

- A l

IUPAC name: aluminium tris (ethylphosphonate) CAS Number 39148

- 24

- 8 USEPA PC CODE 123301

Prepared by : Kristina Garber

, Senior Biologist Amy Blankinship, Senior Biologist

Reviewed by: R. David Jones , Ph.D., Senior Agronomist Donna Judkins, Ph.D., Biologist Jean Holmes, DVM, MPH, Risk Assessment Process Leader Thomas Steeger, Ph.D., Senior Science Advisor (Review Panel) Rochelle Bohaty, Ph.D., Chemist (Review Panel) Michael Wagman, M.S., Biologist (Review Panel)

Approved by: Brian Anderson

, MEM, Branch Chief , Environmental Risk Branch II

Environmental Fate and Effects Division Office of Pesticide Programs U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, D.C. 20460

March 20, 2014 3+

-

## Table of Contents

1. Executive Summary

................................ ................................ ................................ ...... 4 2. Problem Formulation

................................ ................................ ................................ .... 6 2.1. Use C haracterization

................................ ................................ ......................... 6 2.1.4. Uncertainties Surrounding Label Language

................................ ....... 15 2.2. Exposure Assessment

................................ ................................ ...................... 17 2.3. Effects Assessment

................................ ................................ ......................... 19 2.4. Ris k Assessment

................................ ................................ ............................. 23 3. Exposure Analysis

................................ ................................ ................................ ...... 26 3.1. Direct Deposition onto Food Items (located on treated field)

........................ 26 3.2. Spray Drift Transport

................................ ................................ ...................... 27 4. Effects Analysis

................................ ................................ ................................ .......... 29 4.1. Toxicity of Fosetyl

- Al

................................ ................................ ..................... 30 4.1.1. Terrestrial Organisms

................................ ................................ .......... 30 4.1. 2. Aquatic Organisms

................................ ................................ .............. 36 4.2. Endocrine Disruptor Screening Program

................................ ........................ 37 5. Risk Characterization

................................ ................................ ................................ .. 38 5.1. Terrestrial Organisms

................................ ................................ ...................... 38 5.2.1. Birds, Amphibians and Reptiles

................................ ........................... 38 5.2.2. Mammals

................................ ................................ ............................... 42 5.2.3. Terrestrial invertebrates

................................ ................................ ........ 49 5.2.4. Plants

................................ ................................ ................................ ..... 50 5.2. Aquatic Organisms

................................ ................................ .......................... 51 5.3. Listed Species

................................ ................................ ................................ . 52 5.4. Risk Co nclusions

................................ ................................ ............................ 52 Appendix A. Detailed description of available effects data for fosetyl

- Al

............................. 54 Appendix B. MRID Bibliography for Environmental Fate and Toxicity Studies

................. 70

### 1. Executive Summary

The purpose of this assessment is to evaluate the potential risks to non

- target organisms from registered uses of fosetyl

- aluminum (fosetyl

- Al) . This assessment is focused on non

- listed species and does not consider risks to individual f ederally listed endangered and threatened (listed) species.

Fosetyl

- Al is used to control several fungal pathogens and can be applied either as a preventative measure ( i.e
., prophylactically) or to treat existing fungal infections of plants. Fosetyl

- Al acts as a systemic fungicide that can move throughout the treated plant (as ethylphosphonate ). It is applied as a r oot treatment (soil application, root dip), trunk spray and as a foliar treat ment to crops by ground or air spray

. It is also soil

- incorporated or some ornamental uses

. Maximum single applications range from 2

- 70 lbs a.i./A; however for most uses, the maximum single rate is 4 lb s a.i./A. Multiple applications are a llowed for most uses
at reapplication intervals that vary from weeks to months

. Fosetyl

- Al is a salt and is not e x pected to persist in the environmental as a complex. D issociat ion is expected to occur rapidly releasing aluminum ( Al 3+ 

### ) and three ethanophosphonate ions. Fate data indicate ethanophos phonate degrades rapidly in soil through microbially mediated processes to degradates (aluminum, phosphonic acid and ethanol) that are not considered residues of concern in this assessment

. Fosetyl

- Al an d ethanophosphonate are not expected to volatilize or bioaccumulate. Fosetyl

- Al, as ethanophosphonate , appears to be more persistent in plants following uptake. The primary transport mechanism away from treated areas is spray drift. Although fosetyl

- Al is soluble and mobile, transport via runoff and leaching are not expected to be primary dissipation
routes in the environment due to the rapid disscoation and subsequent degradation of the dissocisation products in soil.

Fosetyl

- Al is practically non

- toxic to b irds and mammals on an acute exposure basis. In a chronic toxicity study with birds, no effects were observed in any of the dietary treatment levels tested, resulting in a NOAEC of 1414 mg/kg

- diet. Available chronic toxicity data for mammals indicate effects to body weights of offspring at 12,000 mg/kg

- diet, resulting in a no observed adverse effect concentration (NOAEC) of 6,000 mg/kg

- diet. Although fosetyl

- Al is practically non

- toxic to honey bees ( Apis mellifera ) on an acute exposure basis, t oxicity data for other species of insects ( e.g. , predatory mites and sweet

- potato whiteflies) suggest that other insect species may be more sensitive to fosetyl

- Al and that they may be impacted at currently registered application rates ( i.e.

, as low as 1.8 lb a.i./A). Available data for terrestrial plants indicate that dicotyledenuous ( dicots ) species are more sensitive than monocotyledenous ( monocots ) species and that the most sensitive tested dicot expressed a 25% decrease in growth when ex posed to fosetyl

- Al at a treatment rate equivalent to 7.6 lbs a.i./A

. Only two incident reports are available for fosetyl

- Al, both of which involve damage
to spinach crops (dicot species)

. For aquatic animals, fosetyl

- Al is slightly toxic to fish and moderately toxic to invertebrates on an acute exposure basis . No chronic toxicity data are available for fish. C hronic toxicity

### data for fre shwater invertebrates include decreased survival of adult daphnids at 84 mg a.i./L, resuting in a NOAEC of 16 mg a.i ./L. The most sensitive aquatic plant species had a no effect level of 0.32 mg a.i./L and a 50% decrease in growth at 0.780 mg a.i./L.

Currently labeled rates of fosestyl

- Al pose a potential risk to no n - target terrestrial animals , including insects, birds, reptiles, terrestrial

- phase amphibians and mammals as well as sensitive species of terrestrial dicot plants

. The risk conclusions are summarized as follows:

• For terrestrial invertebrates, most applications of fosetyl

- Al may decrease the

re produ ction of sensitive species. L ess sensitive species, such as honey bees

, are only expected to be impacted at higher application rates (i.e., ≥5.6 lb a.i./A) . Potential risks apply to insects located on fields where fosetyl

- Al is sprayed and to areas su bject to spray drift. Risks to sensitive terrestrial invertebrates are estimated to extend as far out as 266 feet from the edge of the field for aerial applications and 26 feet for ground applications.

• For birds (and terrestrial

- phase amphibians and reptil es , for which birds are considered surrogates ) , fosetyl

- Al pose s a potential acute and chronic risk for most
uses, except those o n asparagus, bananas , hops (S ection 3 use) and stone fruits.

• For mammals, fosetyl

- Al exposures pose a n acute risk for most use s, with the exception of almonds, asparagus, bananas, citrus, cranberry, kiwis, peaches, plums, prunes, stone fruits and walnuts. All uses of fosetyl

- Al pose a potential chronic risk to mammals

.

• Although fosetyl

- Al is practically non

- toxic to birds and mam mals on an acute oral exposure basis, and the chronic toxicity endpoints suggest low toxicity, risk is identified for many uses due to potential high exposures from high application rates.

• Effect determinations for listed species of birds, terrestrial

- phase amphibians, reptiles, mammals and terrestrial insects are uncertain.

• Although applications of 7.6 lb a.i./A and greater may result in a >25% effect to growth of dicots

, risks are expected to be negligible to non

- listed dicot species since risk is only estimated to extend only 7 feet from the edge of the field. Effects are not expected to monocots.

• Effect determinations for listed species of dicot s (in terrestrial and wetland habitats) are uncertain. Risks to these species may extend beyond 7 feet from the edge of the field.

• Direct adverse e ffects are not expected for aquatic animals and plants exposed to fosetyl

- Al following spray drift and runoff.

• No Effect determinations can be made for listed species of fish, aquatic

- phase amphibians (that do not have terrestrial

- phases), aquatic invertebrates, aquatic plants and terrestrial monocots (in terrestrial and wetland habitats) that

o do not rely upon birds, terrestrial

- phase amphibians, reptiles, mam mals and terrestrial insects (for food or shelter), and

o do not have obligate relationships with dicot plants (in terrestrial and wetland habitats).

### 2. Problem Formulation

This problem formulation is based on the preliminary problem formulation for the registration review of fosetyl

- Al (D P 342370; October 30, 2007). Modifications have been made to accomidate newly available data and methods currently approved for use in ecological risk assessments. The purpose of this assessment is to evaluate the potenti al risks of the registred uses of fosetyl

- Al on non

- target organisms. This assessment is focused on species that are not federally listed as threatended or endangered (referred to as “listed”) ; however, some general discussion of taxa for which “ no effect ” determniations are expected is included in this assessment. For taxa where there may be risk for non

- listed species, specific determinations for listed species are considered uncertain at this time.

2.1. Use Characterization

2.1.1. Target Pests and Mode of Action

Fosetyl

- Al is used to control several fungal pathogens, including crown and root rot ( Phytophtora spp. )

, leaf spot ( Alternaria spp. )

, anthracnose ( Colletotrichum spp. )

, downy mildew ( Plasmopara spp

. and Peronospora spp ) . This chemical can be applied eithe r as a preventative measure

, i.e ., prophylactically, or to treat existing fungal infections of plants. Fosetyl

- Al acts as a systemic fungicide that can move downward (as ethylphosphonate ) throughout the treated plant (from the leaves to the roots). As a fungicide, i t is thought that increases production of phytoalexin (antimicrobial) chemicals in the plant, and it may also cause direct inhibition of the target fungi (Guest and Bompeix, 1990 1 

### ; Oku, 1994 2 

### ). It has also been suggested that fosetyl

- Al is broken

- down to phosphonic acid , which inhibits mycelial growth of fungal pathogen s (Oku, 1994). It appears to trigger a defensive reaction in the affected plant that sequesters the fungus and prevents sprea d (Harte, Holdren, Schneider, & Shirley, 1991 3 

### ).

2.1.2. Registered U ses

At this time, there are 10 S ection 3 registrations for formulated products containing fosetyl

Al; all of which contain fosetyl

- Al as the sole active ingredient. These registrations are

ma intained by five different registrants. Table 1 summarizes the formulated products currently registered for fosetyl

- Al. In addition, there are three registrations for technical fosetyl

- Al ( 264

- 466, 11678

- 69 and 83504

- 1), which will not be discussed further in this
assessment. Table 2 lists the nine special local needs registrations ( S ection 24c) that are currently allowed, all of which apply to the Alliette ® 

### WDG S ection 3 label.

1 Guest, D.I. & Bompeix, G. (1990). The complex mode of action of phosphonates. Australasian Plant Path

., 19, 113

- 115
2 Oku, Hachiro. (1994). Plant Pathogenesis and Disease Control

. Boca Raton, FL: CRC Press, Inc . p. 134

- 136.
3 Harte, J., Holdren , C., S chneider, R., Shirley, C (1991). Toxic A to Z: a guide to everyday pollution hazards

, 1 st ed. Berkely and Los Angeles, California: University of California Press. pp. 322.

### Table 1 . Current Section 3 Registrations of Fosetyl

- Al

Product Name Registrant EPA Registration # (latest label date) % Active Ingredient Form Use(s)

Aliette ® Fungicide Bayer CropScience 264

- 467 (12/18/95) 80 wettable powder/ water soluble packet turf

Aliette ® Injectable Fungicide Bayer CropScience 264

- 504 (02/22/94) 9.5 ready

- to

- use solution avocado trees

Aliette ® WDG

Fungicide Bayer CropScience 264

- 516 (08/08/08) 80 water dispersible granule avocado, citrus, macadamia nuts, pome fruit, almonds, stone fruit, blueberry, caneberry, cranberry, grapes, strawberry, asparagus, brassica crops, cucurbit crops, leafy vegetables, onions, tomato, banana, ginseng, hops, pineapple, tobacco Aliette ® WDG Brand Fungicide Bayer Environmental Science 432

- 890 (10/15/07) 80 water dispersible granule turf and ornamentals

Chipco Aliette ® WSP

Brand Fungicide Bayer Environmental Science 432

- 894 (07/01/94) (formally 264

- 542) 80 soluble concentrate/ wettable powder turf and ornamentals

Aliette ® HG Brand Fungicide Bayer Environmental Science 432

- 897 (12/02/08) 80 emulsifiable
concentrate turf and ornamentals

Terronate ® WDG Winfield 9779

- 353 (06/05/98) 80 water dispersible granule avocado, citrus, pome fruit, stone fruit, caneberry, almonds, strawberry, asparagus, brassica crops, cucurbit crops, leafy vegetables, onions, tomato, ginseng, hops, pineapple

Linebacker ® WDG Fungicide Tessenderlo Kerley 61842

- 9 (05/15/07) 80 water dispersible granule citrus, pome fruit, stone fruit, caneberry, almonds, strawberry, asparagus, brassica crops, cucurbit crops, leafy vegetables, onions, tomato, ginseng, hops, pineapple, macadamia nuts, bananas, avocado, turf, ornamentals
Autograph ® Tessenderlo Kerley 61842

- 10 (08/07/07) 70 emulsifiable
concentrate turf and ornamentals

Legion ® 80 WDG Makhteshim

- Agan of N. America, Inc 66222

- 161 (06/12/08) 80 water dispersible granule citrus, pome fruit, stone fruit, caneberry, almonds, strawberry, brassica crops, cucurbit crops, leafy vegetables, onions, tomato, ginseng, hops, pineapple, macadamia nuts, bananas, avocado, tobacco, cranberry, gra pes, turf, ornamentals

### Table 2 . Current Section 24c Registrations of Fosetyl

- Al * EPA Registration # Use(s) CA95000300 avocado CA97000800 strawberry CA97001300 almonds, walnuts, peaches, plums, prunes, kiwi FL0400300 citrus ID03000100 peas ID96001300 hops OR03000100 peas OR04001800 hops
WA02003000 peas * All registrations involve the use of Aliette® WDG.



### Table 3 summarizes the registered uses of fosetyl

- Al, by crop. Uses of fosetyl

- Al apply to residential and agricultural areas. Registered application methods for fosetyl

- Al include: foliar spray (ground and aerial methods), soil drench, chemigation, root dip, tre e trunk spray or paint, tree injections, and seed treatment.

It should be noted that the labels specify the maximum amount of fosetyl

- Al that may be used per season or per year (varies by crop) as well as the maximum single application rates by crop. The maximum number of applications allowed per season or per crop is determined by dividing the maximum total application by the maximum single application rate. It is possible that applicators may make more applications per year or per season at lower rates. For those crops that specify applications by season ( e.g., strawberries, tomoatoes) and where those crops may be grown multiple times per year ( e.g., California), the maximum number of applcitions per year may be greater.

### Table 3 . Current Register ed Uses of Fosetyl

- Al

Crop Application rate lbs a.i./A Number of Applications (per

season or year) Application Method Minimum Application Interval

(days) Registration Number(s)*

almonds 4 4 aerial; ground 60; 30

- 60 (CA only) 264

- 516; 264

- 516; 9779

- 353; 61842

- 9;66222

- 161; CA970013
almonds (non

- bearing) NS to 4 1 NS to 4 (max of 16 lb a.i./A/year) 1 trunk spray/paint NS 264

- 516
asparagus (in ca only) 4 1 aerial; ground

-- 264

- 516; 9779

- 353; 61842

- 9

avocado 0.0625 lb a.i./tree NS drench NS 264

- 516

avocado (non

- bearing and bearing) NS (non

bearing) or 4

(bearing) 2 NS; bearing indicates max of 16 lb a.i./A/year trunk spray/paint NS 264

- 516

avocado 9.5 mL a.i./tree 2 injection NS 264

- 504

banana 4.8 4 aerial; ground 90 264

- 516; 61842

- 9; 66222

- 161

banana 4.8 NS (max 4.8 lb a.i./A/year) injection NS 264

- 516

brassica (broccoli, broccoli raab, brussels sprouts, cabbage, chinese broccoli, chinese cabbage, chinese cabbage, chinese mustard cabbage, cauliflower, cavalo broccolio, collards, kale, kohlrabi, minzuna, mustard greens, mustard spinach, rape greens) 4 7 Aerial; Ground 7

- 21 264

- 516; 9779

- 353; 61842

- 9; 66222

- 161

citrus (bearing and non

- bearing) 4 4 Aerial; Ground; Chemigation NS to 30

- 45 264

- 516; 9779

- 353; 61842

- 9; 66222

- 161; FL040003
citrus (non

- bearing) 2.4/100 gallons 3 NS Root Dip NS 264

- 516

citrus (bearing and non

- bearing) NS 4 4; max of 16 lb a.i./A/year Trunk Spray/Paint NS 264

- 516Crop Application rate lbs a.i./A Number of Applications (per

season or year) Application Method Minimum Application Interval

(days) Registration Number(s)*

cranberry, blueberry, caneberry (blackberry, loganberry, raspberry, cultivars and/or hybrids of these) 4 4 Aerial; Ground 30

– cranberry; 14

- 21 blueberry; caneberry

– 45 E of Rockies, 21 W. of Rockies 264

- 516; 9779

- 353; 61842

- 9; 66222

- 161

cucurbits (chinese waxgourd, citron melon, cucumber, gherkin, gourd, momordica spp, muskmelon, pumpkin, summer and winter squash, watermelon) 4 7 Aerial; Ground 7

- 14 264

- 516; 9779

- 353; 61842

- 9; 66222

- 161

ginseng 4 9 Ground 7 264

- 516; 9779

- 353; 66222

- 161 grapes (east of rockies only) 4 7 Aerial; Ground 21 264

- 516; 66222

- 161 hops (section 3) 2 4 Ground 21

- 60 264

- 516; 9779

- 353; 61842

- 9; 66222

- 161
hops (section 24 (c) id and or only) 4 4 Ground; Aerial 21

- 60 ID960013; OR040018 kiwis, peaches, plums, prunes (ca only) 4 4 Aerial; Ground 30

- 60 CA970013
leafy vegetables (amaranth, arugula, cardoon, celery, celtuce , chervil, chrysanthemum edible, corn salad, cress, dandelion, dock, endive, fennel, lettuce, orach, parsley, purslane, radicchio, rhubarb, spinach, swiss chard) 4 7 aerial; ground 7

- 21 264

- 516; 9779

- 353; 61842

- 9; 66222

- 161

macadamia nuts 6 4 aerial; ground 21 264

- 516; 61842

- 9; 66222

- 161 onion (dry) 2.4 7 aerial; ground 7

- 14 264

- 516; 9779

- 353; 61842

- 9; 66222

- 161

ornamentals and/or conifer nurseries 16 NS A erial ; ground 7 (foliar) 30 432

- 890 & 894; 61842

- 9 & 10; 66222

- 161 ornamentals 69.7 8 NS ground (drench) 30 432

- 890 & 894; 61842

- 9; 66222

- 161 ornamentals (bacterial blight suppression) 12.8/12.9 9 NS ground 7 (foliar) 7 432

- 890 & 894; 61842

- 10; 66222

- 161

ornamentals (bedding plants) 12.8/12.9 9 NS ground 7 (foliar) 14

- 30 432

- 890 & 894; 61842

- 9 & 10; 66222

- 161 ornamentals (downy mildew control in roses, fire blight suppression) 8.0/9.6 10 NS ground 7 (foliar) 7 432

- 890; 61842

- 9; 432

- 894Crop Application rate lbs a.i./A Number of Applications (per

season or year) Application Method Minimum Application Interval

(days) Registration Number(s)*

peas (succulent) 0.15/100 lbs seed 1 seed treatment

-- ID030001; WA020030; OR030001 pineapple 12 6 aerial; ground 90 5 264

- 516; 979

- 353; 61842

- 9; 66222

- 161 pineapple 2 NS pre

- plant dip NS 264

- 516 pome fruits & stone fruits (apples, crabapple, loquat, mayhaw, pear, oriental pear, quince, apricot, avocado nectarine, peaches, cherry (sour & sweet), plum, chickasaw plum, damson plum, japanese plum, plumcot, prune) 4 4 aerial; ground 4

- 7 pome

60 stone 264

- 516; 9779

- 353; 61842

- 9; 66222

- 161; CA950003 (avocado only)

pome fruits 2.4/100 gallons 3 NS root dip NS 264

- 516

strawberries 4 6 aerial; ground 7

- 14 264

- 516; 9779

- 353; 61842

- 9 CA970008

strawberries 2/100 gallons 6 NS root dip NS 264

- 516

tobacco 3.2 5 aerial; ground 7

- 10 264

- 516; 66222

- 161
tomato 4 4 aerial; ground 7

- 14 264

- 516; 9779

- 353; 61842

- 9; 66222

- 161

turf 17.3

- 17.6 NS ground 7 (foliar) 14/21 432

- 890 & 897 & 894; 61842

- 9 & 10; 66222

- 161; 264

- 467 walnut 4 4 aerial; ground 30

- 60 CA970013 NS=not specified on label *: While every crop listed in the “Crop” column may not be a registered use for every EPA Reg istration numbers listed at least one crop is for every reg #. Application rates represent maximum application rate for a least one of the EPA Reg istration number listed. Other labels may have slightly different application
rates. 1 Almond trunk spray

- Rate is specified as 2

– 4 lb a.i./5 gals and solution is applied to tree. Label does not indicate maximum amount of solution to apply only to thoroughly wet the lesion. Label has general restriction of no more than 4 lb a.i./A per application or 16 lb a.i./A per year or four applications per year.
2 Avocado trunk spray

- Rate for both non

- bearing and bearing is specified as 2

– 4 lb a.i./5 gals and solution is applied to tree. Label does not indicate maximum amount of solution to apply only to thoroughly wet the lesion or from soil line up the trunk approximately two feet. For bearing, label has general restriction of no more than 4 lb a.i./A per application.
3 Citrus and Pome Fruit root dip

- Label states to make solution per the rate above and then dip entire root sys tem 30

- 60 minutes prior to planting in field.
4 Citrus trunk spray

- Rate for both non

- bearing and bearing is specified as 2

– 4 lb a.i./5 gals and solution is applied to tree. Label does not indicate maximum amount of solution to apply only to thoroughl y wet the lesion or from soil line up the trunk approximately two feet. Label has general restriction of no more than four applications or 16 lb a.i./A per year.
5 Pineapple foliar

- The label has conflicting information. It states do not apply more than six foliar applications, but it also states to make applications every 90 days therefore it is not possible to make six applications in one year or season.6 Strawberry root dip

- Label states to dip roots and crowns for 15

- 30 minutes and plant with 24 h ours of dipping.
7 Ornamentals

- Labels do not indicate if ground or aerial application, however, based on information provided by BEAD only conifer nurseries were assumed to use aerial application methods. All other ornamental and turf uses were assumed to be ground application. .
8 Ornamentals soil drench. This application rate was calculated to a lb a.i./A rate based on the registered label rate of 0.8 lb product for every 400 square feet.
9 Ornamentals

- From label 61842

- 10 only, all other labels 12. 8 lb a.i./A
10 Ornamentals

- From label 432

- 894 only, all other labels 8.0 lb a.i./A

### 2.1.1. Estimated Use in the United States

From 1992

- 2009, the U.S. Geological Survey (USGS) estimated annual use of fosetyl

- Al to range from 0.2

- 1.0 million pounds, with the majority of use being attributed to vegetable, fruit, orchard and grape production ( Figure 1 ). The Biological and Economic Analysis Division (BEAD) estimated that each year, an average of 584,000 pounds of fosetyl

- A1 is applied to crops in the US, with the majority (51%) applied to lettuce (300,000 lbs). Major agricultural uses of fosetyl

- Al also include citrus (62,000 lbs), spinach (50,000 lbs), hops (30,000 lbs), strawberries and tomatoes (20,000 lbs each). When considering the proportion of acres of a crop that are treated in the U.S., a substantial amount of acres of lettuce (30%) spinach (20%) and caneberries (20%) are estimated to be treated with fosetyl

- Al ( Table 4 ) 4 

### . Major agricultural use sites of fosetyl

- Al re located in Californi a, the Pacific Northwest, the Great Lakes states and Florida ( Figure 1 5 

### ). No data are available to characterize the spatial distribution and pounds applied for ornamental and residential uses of fosetyl

- Al.

4 From Screening Level Usage Analysis (SLUA)
5 http://water.usgs.gov/nawqa/pnsp/usage/maps/show_map.php?year=2009&map=FOSETYL&hilo=LFigure 1 USGS E stimated (high and low) A nnual A gricultural U se of Fosetyl

- Al F rom 1992

- 2009 ( http://water.usgs.gov/nawqa/pnsp/usage/maps/show_map.php?year=200 9&map=FOSETYL&hilo=L )

### Table 4. Average Annual Use of Fosetyl

- Al in the U.S.

Crop lbs a.i. applied per year Percent Crop Treated Average Max

Lettuce 300,000 30 40 Oranges 50,000 <2.5 5 Spinach 50,000 20 30 Hops 30,000 Not calculated 10

Caneberries 20,000 20 25

Strawberries 20,000 10 20

Tomatoes 20,000 <2.5 <2.5 Asparagus 10,000 10 15

Lemons 10,000 5 10 Peppers 9,000 5 5

Pistachios 9,000 <2.5 <2.5

Watermelons 9,000 <2.5 5

Onions 7,000 <2.5 <2.5 Cabbage 6,000 5 10

Peaches 4,000 <1 <2.5

Prunes 4,000 <1 <2.5

Avocados 3,000 <1 <2.5 Celery 3,000 5 10

Pears 3,000 <2.5 5

Sod 3,000 Not calculated 5

Almonds 2,000 <1 <2.5 Apples 2,000 <1 <2.5 Grapefruit 2,000 <1 <2.5 Grapes 2,000 <1 <2.5 Pumpkins 2,000 <1 <2.5 Squash 2,000 <1 <2.5

Broccoli 1,000 <1 <2.5

Cherries 1,000 <1 <2.5

Cauliflower <500 <1 <2.5



### 2.1.2. U nc ertainties S urrounding L abel L anguage

The information provided on the S ection 3 and 24(c) labels is used to parameterize the fate and

### 16 transport models that estimate exposure concentrations of fosetyl

- Al in terrestrial and aquatic habitats. Relevant parameters include: maximum single application rate, number of applications per year, interval between applications and application method. I n many cases, these parameter values can be obtained directly from the label; however, when the labels are not clear about these parameters, assumptions are made. Unless there is evidence to the contrary and conservative assumptions are made. This section discusses cases where fosetyl

- Al labels are unclear and explains the conservative assumptions that are made in this assessment to compensate for the lack of clearly defined parameters relevant to application of fosetyl

- Al.

1. The labels do not specify if fo liar applications are permitted via ground, aerial nethods or both. Because aerial application methods are expected to have greater spray drift exposure than ground methods, the conservative assumption is that applications are made via aerial methods. Bas ed on information compiled by BEAD 6 

### , aerial application is not expected to occur on ornamental s (except for conifer nurseries), turf and ginseng

. 2. The labels do not indicate specific nozzles or intended spray droplet sizes; therefore, the conservative siz e of “ very fine ” to “ fine ” was used to determine an effect area off

- field. 3. The current labels do not indicate the maximum number of applications allowed for turf and ornamentals. The most conservative number of applications per year is modeled (assuming turf or ornamentals are present 365 days/year) , given minimum application intervals. 4. The registered label Aliette ® 

### HG does not indicate maximum application rates for use on turf and ornamentals in landscaping (EPA Reg # 432

- 897). The use rates for this label are given in terms of using tablespoons of the fosetyl

- Al solution to one gallon of solution. This would suggest that the volumes used for this label are small and exposure would be limited; therefore, the other uses for turf and ornamental s are expected to result in greater exposure and potential risk to non

- target organisms. 5. The currently registered fosetyl

- Al label Linebacker ® 

### (EPA Reg # 61842

- 9) does not indicate the maximum number of gallons of product to apply per acre for use on coni fer nurseries. Other labels prohibit the application of more than 400 gallons per acre; therefore, for this assessment an assumption of 400 gallons per acre was used. 6. The currently registered label CHIPCOALIETTE ® 

### EXTRA and CHIPCOALIETTE ® 

### WF2 (EPA Reg # 264

- 467 and # 432

- 894 ), for which the fosetyl

- Al is packaged as water soluble packets, does not indicate the amount of material/solution contained in a packet. The labels (EPA Reg # 264

- 542 and 432

- 894) do not specifically state one pound per packet, but for the EPA Reg # 432

- 894 label it states to mix for example “2 to 4 pounds of product (2 to 4 WS packets)” or “3 pounds of product (3 WS packets)” suggesting that one packet contains one pound of product. Therefore, the assumption used in this
assessment was that one packet did equal one pound of product. 7. The application intervals for citrus are not well defined. According to the Alliette WDG label (registration # 264

- 516), f 

### osetyl

- Al can be applied to citrus (bearing and non

- bearing) by root dip, trunk s pray or paint, foliar, and chemigation. The labels state that any combination of the labeled application methods can be used ; however, applications are

6 United States Environmental Protection Agency (EPA). Office of Pesticide Programs (OPP), Biological, Economical and Analysis Division (BEAD). 20111. Becker, J., Chis m, W., and Yourman, L. Refinements to the Exposure Scenarios Used in the Registration Reivew Ecological Risk Assessment and Effects Determination of Fosetyl

- Al. May 31, 2011.

### 17 not to exceed four applications or 20 lb product per acre per year (16 lb a.i./A per year)

. Except for Alternaria Brown Spot suppression in Florida, in which case subsequent applications should be at 30 to 45

- day intervals

. The label is unclear about the application interval for all types of applications, however, for foliar applications, an interval of 30

- 45 days is recommended. Therefore, for this assessment, the minimum application interval of 30 days is used. There is some uncertainty associated with this interval, since some uses do not specify an interval. 8. The application interval for use on pineappl e is also not clearly defined on the label. The application interval for pineapples is stated as 90 days on the label with a post

- harvest interval of 90 day s , but the label also indicates not to apply more than six applications. The time interval for the six applications is not clearly stated . Based on the information compiled by BEAD, a newly planted crop is first harvested at 18 months. Six applications at three month intervals are consistent with the 18

- month crop cycle. Therefore, on an annual bas is, pineapple was modeled with four applications 90

- days apart. 9. Use of fosetyl

- Al on grapes is only permitted in locations that are east of the Rocky Mountains. In addition, application instructions (specifically related to intervals between applications ) differ for locations that are east or west of the Rocky Mountains. It would be useful if the labels would clarify which states are east and which are west of the Rocky Mountains (including definitions for the 48 contiguous states, as well as Hawaii and A laska).

2.2. Exposure Assessment

2.2.1. Environmental Fate and Transport

Fosetyl

- Al is a salt and is not ecpected to persist in the environmental as a complex. D issociat ion is expected to occur rapidly releasing aluminum ( Al 3+ 

### ) and three ethanophosphonate ions. Fate data indicate ethanophos phonate degrades rapidly in soil through microbially mediated processes. This degradation process is expected to form ethanol (C 2 

### H 5 

### OH) and phosphonic acid ( H 2 

### PO 3 - 

### , also known and phosphorous acid ) which dissociates rapidly to hydrogen phosphite (H 2 

### PO 3 - 

### ) and phosphite ( HPO 3 2

- 

### ). Aluminum is abundant in soil, and the aluminim from fosetyl

Al would add only trivial amounts of aluminum to what exists naturally . In the conditions found in most agricultur al soils, the aluminum from fosetyl

- Al would form hydration species ( e.g. Al(OH) 2+



### , [A l(OH) 3 

### ]) and would mostly precipitate. These species are indistinguishable from the natural aluminum minerals present.

Although fosetyl

- Al is soluble and mobile, transp ort via runoff and leaching are not expected to be major dissipation routes due to the rapid dissociation fosetyl

- Al and subsequent degredation of the dissociation product, ethanophosphate

, in soil (hal f life is less than 2 hours ). Fosetyl

- Al may reach non

- target areas via spray drift. Available data suggest that fosetyl

- Al is eff i caceous in plants for weeks after application 7 

### (trunk application via paint) , suggesting that fosetyl

- Al is
more per sistent in plants than in soil. Fosetyl

- Al is not expected to volatilize or bioaccumulate

. Table 5 summarizes the physical, chemical and fate properties of f osetyl

- Al. It should be noted

7 For example, see: Thomidis, T. 2002. Persistence of the sustemic activity of metalaxyl and fosetyl

- Al applied as a soil drench or foliar spray to control Phytophthora crown rot of peach. Phytopathol. Mediterr., 41, 28

- 32.

### 18 that aerobic aquatic and terrestrial field dissipation studies have not been submitted for fosetyl

Al.

Table 5 . Summary of Physic al, Chemical, and Fate Properties of Fosetyl

- Al Property Value Source (MRID) Comments
Molecular weight (g/mol) 354 none calculated based on
structure
Vapor Pressure not applicable 00098325 fosetyl

- al is a ionic solid
Henry’s Law Constant not calculated 00098325 fosetyl

- al is a ionic solid Water solubility ( mg/L at 20 ° C) 120,000 00098325 none Hydrolysis no significant degradation 00098370 none Photolysis (Air, Water and soil) no significant degradation 00098371 none

Aerobic Soil Metabolism (half

life in hours ) sandy loam soil: 0.24 clay loam soil: 1.5 loamy sand: 1.2 and 0.69 00106018 ethanol and co 2 were the only degredates identified

Anaerobic Aquatic Metabolism(half

- life in hours ) silty clay loam: 40 sandy loam: 14 00147361 ethanol and co 2 were identified as degredates. phospho nic acid was not monitored. K d

- ads (mL/g) 6.5 00106019 none

Octanol

- water partition coefficient (K ow ) Empirical: 0.0020 Estimated: 0.20 Episuite v. 4.1 * Values derived using fosetyl (ethanophosphate) * http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm



### 2.2.2. Residues of Concern

Fosetyl

- Al is considered to be the residue of concern for this risk assessment.

A luminum (AL 3+ 

### ) and ethanol are not considered residues of concern because applications of fosetyl

- Al are expected to contribute negligible amounts of mass relative to what is already present in the environment.

Phosph onic acid ( hydrogen phosphite and phosphite) is al so registered as a fungicide (PC code 076416) 8



### . Available acute toxicity data for birds, mammals, honey bees suggest that like fosetyl

Al, phosphonic acid is practically non

- toxic to terrestrial animals. Available acute toxicity data for aquatic animals su ggests that phosphonic acid is less toxic on an acute exposure basis compared to fosetyl

- Al. Therefore, phosphonic acid will not be considered in the residues of

concern

. Toxicity data available for the same test species exposed separately to phosphonic acid and fosetyl

- Al are compared in Table 6 . It should be noted that several of the available studies did not establish definitive LC50 and EC50 values, making direct compar isons of values for fosetyl

- Al and phosphonic acid difficult (i.e., for birds, rats and bees)

.

Table 6

. Comparison of Toxicity Data (acute) Available for Phosphonic Acid and Fosetyl

Al

8 http://www.epa.gov/opp00001/chem_search/reg_actions/registration/fs_PC

- 076416_1

- Oct

- 98.pdf

### 19 Test species Endpoint (units) Fosetyl

- Al value Phospho nic acid value F osetyl

- Al MRID Phosphorus acid MRID Rainbow trout LC 50 (μg a.i./L) 83,400 790,000 00128944 44873510 Daphnia EC 50 (μg a.i./L) 304,000 1,200,000 00128943 44873511 Green algae EC 50 (μg a.i./L) 4,500 (7

- d) 5,900 (3

- d) 4 1128604 47408717

Bobwhite quail LD 50 (mg a.i./kg

bw) >8,000 >2,000 00098360 44873508 and 46708207 LC 50 (mg a.i./kg

food) >20,000 >5,620 00098362 46708208

Mallard LC 50 (mg a.i./kg

food) >20,000 >5,000 00098363 44873509

Rat LD 50 (mg a.i./kg

bw) 5793 3300 00098330 44873501
Honey bee LD 50 (μg a.i./bee) >986 >25 47418003 44873512



### 2.2.3. Exposure E stimation

To estimate exposure concentrations, the ecological risk assessment considers application at the maximum rate to fields that have vulnerable soils. This assessment will focus on fosetyl

- Al only. For this assessment, the Terrestrial Residue Exposure ( T

- REX ) model (version 1.5.2) is used to assess risks to terrestrial vertebrates ( i.e.

, mammals, birds, terrestrial

- phase amphibians and reptiles) consumin g food directly from the treated field. The distance from the edge of the field (to a non

- target area that is downwind) where risks extend to terrestrial plants and insects is estimated using the AgDRIFT model (version 2.0). For aquatic organisms, the conc entration in water due to spray drift from foliar spray applications will be calculated using the AgDRIFT model. Since fosetyl

- Al is only expected to persist in soil for a matter of hours, runoff transport will not be quantified and thus estimated environm ental concentration ( EEC ) value s will not be calculated

.
2.3. Effects A ssessment

2.3.1. Ecosystems of C oncern

The ecosystems that are potentially at greatest risk are those in close proximity to fosetyl

- Al use sites . These include agricultural fields and residential areas ( i.e.

, with turf and ornamentals) and the surrounding areas that may receive fosetyl

- Al via spray drift. Organisms of concern include birds, mammals, reptiles, fish, and terrestrial and aquatic invertebrates, plants, and amphibians.

2.3.2. Ass essment and M easurement E ndpoints

Assessment endpoints are intended to relate to ecosystems at risk. If risks are expected for a given species/taxa based on the risk assessment, then risks might be expected to translate to higher levels of biological orga nization. Assessment endpoints are represented by measurement endpoints, which are t he most sensitive toxicity endpoints f r om a surrogate test species to estimate trea tment

- related direct effects following acute and chronic exposure. Measurement

e ndpoints are standardized so that acute toxicity is represented by levels that result in mortality to 50% of tested individuals ( i.e.

, LC 50 

### , LD 50 

### and EC 50 

### ) and chronic toxicity is represented as a

### 20 no observed adverse effect concentration or dose ( i.e.

, NOAEC or NOAEL). Tables 7 and 8 include the mos t sensitive toxicity endpoints available for fosetyl

- Al that will be used as measurement endpoints to assess risks to terrestrial and aquatic organisms (respectively). These values were used to derive risk qu otients.

### T ABLE 7

. Measurement E ndpoints for T errestrial O rganisms E xposed to F osetyl

- Al

Taxa represented Species Toxicity Value * Citation (MRID) Study Classification Comments

Birds, terrestrial

phase amphibians and reptiles ** Colinus virginianus (bobwhite quail) and Anas platyrhynchos (Mallard Duck) LC 50 >20,000 mg a.i. /kg

- food 00098362 and 00098363 Acceptable No observed mortalities at highest treatment level

. RQs not calculated using this endpoint.

Coturnix japonica (Japanese quail) LD 50 = 4976 mg a.i. /kg

- bw 00098361 Supplemental Confidence interval: 3678

- 6788 . Since LD 50 was calculated using moving average method, no slope was calculated. Average body weight of control birds at test initiation was 192 g. NOAEC = 1414
mg a.i. /kg

- food 47408710 Supplemental No observed effects at highest treatment level. LOAEC not established.

Terrestrial mammals Mus musculus

. (mouse) LD 50 = 3712 mg a.i./kg

- bw 00098330 Mean body weight = 20 g

Rattus norvegicus (laboratory rat) NOAEC =6000 mg a.i./kg

- food NOAEL = 300 mg a.i./kg

- bw 00247174 LOAEC = 12,000 mg/kg

- food based on decreased body weight in offspring

Terrestrial invertebrates Typhlodromus pyri (predatory mite) LOAEC = 1.8 lb a.i./A 48803208 Supplemental Based on 22% decrease in reproduction

Apis mellifera (honey bee) LD 50 = 14 lb a..i./A 47418003 Supplemental The oral LD 50 of 455 μg a.i./bee was converted to an application rate using the pollinator risk assessment method. Non

- target terrestrial and wetland plants

- dicots Solanum esculentum (t omato ) E C 25 = 7.6 lb a.i./A 47395701 Supplemental Decrease in shoot weight observed in vegetative vigor study.

Non

- target terrestrial and wetland plants

- dicots Avena sativa (o at )

, Allium
cepa ( onion ) E C 25 >66 lb a.i./A 47395701 Supplemental From vegetative vigor study.

* LC50 and LD50 values are used to evaluate acute exposures and NOAEC and NOAEL values are used for chronic exposures.

* * Birds represent surrogates for terrestrial

- phase amphibians and reptiles. Fish represent surrogates for aquatic

- phase amphibians.

### 22 TABLE 8

. Measurement E ndpoints for A quatic O rganisms E xposed to F osetyl

- Al Taxa represented Test Species (common name) Toxicity Value (μg a.i./L) * Citation (MRID) Study Classification Comments

freshwater and saltwater fish and aquatic

- phase amphibians ** Oncorhynchus mykiss (rainbow trout) 96

- hr LC 50 = 83,400 00128944 Acceptable Most sensitive endpoint used as screen. Value selected from available from freshwater and saltwater test species. Not available none none no chronic toxicity studies are available.

Freshwater and Estuarine/ Marine Invertebrates Crassostrea virginica (Eastern oyster) 96

- hr EC 50 =1,850 000147359 Acceptable none

NOAEC = 179 Calculated value None Based on ACR of 19 from toxicity data for Daphnia
magna applied to the acute grass shrimp LC 50 of 3,400 μg a.i./L.

. Acute endpoint = 304,000 μg a.i./L (MRID 00128943 ; Acceptable classification ). Chronic endpoint = 16,000 μg a.i./L (MRID 47395703; supplemental classification ). Aquatic Plants (unicellular and vascular) Skeletonema cosatum (marine diatom) 7

- d EC 50 = 780 41128605 Acceptable NOAEC = 320 μg a.i./L

*LC50 values are used to evaluate acute exposures and NOAEC values are used for chronic exposures.

* * Birds represent surrogates for terrestrial

- phase amphibians and reptiles. Fish represent surrogates for aquatic

- phase amphibians.

### 2.4. Risk Assessment

2.4.1. Conceptual M odel

Figures 2

- 4 depict the conceptual models of the fate and potential effects associated with spray applications, soil drench to ornamentals, and seed treatments of fosetyl

- Al

. These figures are modified from the preliminary problem formulation. One notable change is that the original conceptual models from the problem formulation indicated that runoff would be considered a relevant transport route. This assessment focuses on parent fosetyl

- Al alone . In the figures, dashed lines represent pathways of exposur e that are unlikely to occur because of physical or chemical properties. Based on the rapid degredation of fosetyl

- Al in soil, runoff and leaching are not expected to represent substantial transport pathway. In addition, fosetyl

- Al is not expected to vola tilize or bioaccumulate. Therefore, major non

- target organism exposure routes of concern for this assessment include ingestion of food items that have received direct deposition ( i.e.

, on the treated field) or spray drift to non

- target areas.

Figure 2

. Ecological Conceptual Model for Fosetyl

- Al from Ground and Aerial Foliar Application and Trunk Spray Stresso r Fosetyl

- Al applied as a ground/aerial foliar spray and trunk spray to an agriculture field

Source/ Transport Pathways Volatilization of degradates / Wind Suspension* Direct Deposition Spray Drift Runoff/ Erosion Leaching (Infiltration/ Percolation

Source/ Exposure Media Terrestrial Food Residues (foliage,

fruit, insects Upland Foliage/Soil Riparian/ Wetland Foliage/Soil Receiving Water Body/

Sediment Groundwater

Exposure Route Ingestion Direct contact/ Root Uptake Direct contact/ Root Uptake Gill/ Integument

Uptake

Receptors

Attribute Changes Terrestrial Invertebrates Birds, Mammals, Reptiles, Terrestrial Phase Amphibians Terrestrial Upland Plants, Inverts

Individual Animals

Reduced survival Reduced growth Reduced

reproduction Aquatic Invertebrates Aquatic Vertebrates Wetland/ Riparian

Plants

Individual Plants

Seedling emergence Vegetative vigor Individual vertebrates and invertebrates

Reduced

survival Reduced

growth Reduced

reproduction Plant population

Reduced

population growth Aquatic Plants Uptake/ Adsorption Ingestion up the Food Chain

Piscivourous Vertebrates Birds, Mammals

Individual Animals

Reduced

survival Reduced

growth Reduced

reproduction *Long

- range transport with dry/wet deposition onto soil, foliage, receiving water body resulting in same exposure pathway concerns identified for direct deposition, spra y drift, runoff/erosion, and leaching

### 24 Figure 3

. Ecological Conceptual Model for Fosetyl

- Al from Soil Drench to Ornamentals Stressor Fosetyl

- Al applied as a soil drench to ornamentals

Source/ Transport Pathways Direct Deposition Runoff/ Erosion Leaching (Infiltration/ Percolation

Source/ Exposure Media Terrestrial Food Residues (foliage,

fruit, insects Upland Foliage/Soil Riparian/ Wetland Foliage/Soil Receiving Water Body/

Sediment Groundwater

Exposure Route Ingestion Direct contact/ Root Uptake Direct contact/ Root Uptake Gill/ Integument

Uptake

Receptors

Attribute Changes Terrestrial Invertebrates Birds, Mammals, Reptiles, Terrestrial Phase Amphibians Terrestrial Upland Plants, Inverts

Individual Animals

Reduced survival Reduced growth Reduced

reproduction Aquatic Invertebrates Aquatic Vertebrates Wetland/ Riparian Plants

Individual Plants

Seedling emergence Vegetative vigor Individual vertebrates and invertebrates

Reduced

survival Reduced

growth Reduced

reproduction Plant population

Reduced

population growth Aquatic Plants Uptake/ Adsorption Ingestion up the Food Chain

Piscivourous Vertebrates Birds, Mammals

Individual Animals

Reduced

survival Reduced

growth Reduced

reproduction

-

### 25 Figure 4 Ecological Conceptual Model for Fosetyl

- Al from Seed Treatment to Peas

2.4.2. Risk H ypothesis

For fosetyl

- Al, the following ecological risk hypotheses are being employed for this risk

assessment:

Terrestrial Environment

• Exposure to fosetyl

- Al residues on seeds, insects, and foliage due to direct deposition or spray drift from labeled use of the pesticide will cause reduced survival, growth and reproduction to terrestrial vertebrates (birds, mammals, reptiles, terrestrial

- phase amphibians) and terrestrial invertebrates.

• 

### Exposure to fosetyl

- Al resid ues on foliage due to spray drift resulting from labeled use of the pesticide will result in reduced survival and biomass to upland plants and riparian/wetland plants in areas adjacent to a treated field. Stressor Fosetyl Al applied to pea seeds that are then planted

Source/ Transport Pathways Direct Deposition

Source/ Exposure Media Terrestrial Food
Residues (on seeds)

Exposure Route Ingestion

Receptors

Attribute Changes Terrestrial Vertebrates Birds, Mammals,

Reptiles, Terrestrial Phase Amphibians

Individual Animals Reduced survival Reduced growth Reduced Reproduction

-

### 26 Aquatic Environment

• Exposure to fosetyl

- Al resid ues in water due to spray drift resulting from labeled uses of fosetyl

- Al will cause reduced survival, growth and reproduction to aquatic invertebrates and fish in surface waters adjacent to a treated field.

• Exposure to fosetyl

- Al residues in water due to spray drift from labeled uses of fosetyl

- Al will cause reduced survival and biomass to aquatic vascular and non

- vascular plants in surface waters adjacent to a treated field.

3. Exposure Analysis

3.1. Direct Deposition onto F ood I tems (located on treated field)

The T

- REX model is used to generate upper

- bound concentrations of fosetyl

- Al on food items ( i.e. , grass, broadleaf plants, seeds and arthropods) located on the treated field. This is accomplished by modeling the single maximum foliar applications as allowed on registered labels. The resulting concentrations from single applications are depicted in Figure 5 . These values will be used to represent dietary

- based exposures and will be converte d to dose

- based exposures using food ingestion rates for mam mals and birds.

Figure 5. Estimated U pper - bound P esticide C oncentrations of F osetyl

- Al on D ifferent F ood I tems F ollowing One A pplications at V arious Application R ates Estimates generated by T

REX model.

Exposures resulting from multiple applications will also be modeled using the maximum number of applications allowed per year, sep a rated by the minimum allowed reapplication intervals ( Table 9 )

. Labels with uses on ornamentals, conifer nurseries and turf did not specify the maximum number of applicatio ns allowed per year. For modeling purposes, it was assumed that the maximum number of applications that are possible per year may occur, when considering the minimum application interval. 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

0 5 10 15 20 Short grass

Tall Grass
Broadleaf plants

seeds
arthropods



### application rate (lb a.i./A)estimated concentration (mg a.i./kg)

### Page 27 of 78 Table 9 . Use

- specific I nput P arameters for E stimating E xposure in T

- REX for F oliar A pplications of F osetyl

- Al Based on M aximum Labeled R ates and M inimum Retreatment I ntervals S ummarized in Table 3
Crop Application rate lbs a.i./A Number of Applications Application Interval (days) hops 2 4 21 onion (dry) 2.4 7 7
tobacco 3.2 5 7

asparagus 4 1 NA
stone fruits 4 4 60 almonds, citrus, cranberry, kiwis, peaches, plums, prunes, walnuts 4 4 30

caneberry, hops (24 c) 4 4 21 blueberry 4 4 14

tomato 4 4 7 pome fruits 4 4 4
strawberries 4 6 7

grapes 4 7 21 brassica, cucurbits, leafy vegetables 4 7 7 ginseng 4 9 7
banana 4.8 4 90
macadamia nuts 6 4 21 pineapple 12 6 90
ornamentals 12.9 NS (52) * 7
ornamentals and/or conifer nurseries 16 NS (12) * 30
turf 17.6 NS (26) * 14 *Value not specified on labels. Number of applications in parentheses was assumed to be the maximum number of applications per year based on the application interval.


### Fosetyl

- Al is systemic in plants and the data suggest that once taken up by the plant it is shielded from the relatively rapid de gradation via soil microbes. For instance, in a study examining the efficacy of fosetyl

- Al applied to peach trees via trunk paint, it appeared to protect plants from fungal spread up to 40 days after the application (but not 60 days later) (Thomidis 2002)

. Therefore, f or multiple applications of fosetyl

- Al, the default foliar dissipation half

- life of 35 days will be used for terrestrial assessments

. Available magnitude of the residue and metabolism studies submitted for fosetyl

- Al are insufficient to deriv e a chemical

- specific half

- life for various reasons, for instance, lack of day 0 measurements and insufficient mass balance.

3.2. Spray Drift Transport

The s pray deposition curves as calculated by AgDRIFT are provided in Figures 6, 7 and 8

. Note that these figures represent point estimates of spray drift depiction at distances from the edge of the field. Values are expressed as the percent of the applied rate so as to apply to various rates of fosetyl

- Al. When multiplied by the appropriate si ngle maximum application rate, these values can be used to determine the distance from the edge of the field where effects to non

- target organisms are no longer of concern.

### Page 28 of 78 Figure 6. Percent of A pplied P esticide at D ifferent D istances from the E dge of t he F ield T reated by A erial Application M ethods

Figure 7 . Percent of A pplied P esticide at D ifferent D istances F rom the E dge of the F ield T reated by G round Application methods 0% 10% 20% 30% 40% 50%

0 200 400 600 800 1000% of applied

Distance from edge of field (feet) ASAE very fine to fine

ASAE fine to medium

ASAE medium to

coarse

0% 10% 20% 30% 40% 50%

0 100 200 300 400 500% of applied

Distance from edge of field (feet) High boom, ASAE very fine to fine
High boom, ASAE fine to medium/coarse

Low boom, ASAE very fine to fine

Low boom, ASAE fine to medium/coarse

### Page 29 of 78 Figure 8 . Percent of A pplied P esticide at D ifferent D istances F rom the E dge of the F ield T reated by A irblast Equiptment

For the aquatic assessment, the aquatic deposition tool of AgDRIFT was used to estimate the pesticide concentrations in the standard farm pond following aerial and ground foliar spray applications made at t he maximum rates. For aerial applications, the maximum rate of 16 lb a.i./A (made to conifer nurseries) yielded an EEC of 92 μg a.i./L

. For ground applications, the maximum rate of 17.6 lb a.i./A (made to turf) yielded an EEC of 3.5 μg a.i./L

. For airblast applications (sparse setting), the maximum rate of 6 lb a.i./A (made to macadamia nut) yielded an EEC of 0.35 μg a.i./L

.

4. Effects Analysis

This section summarizes the availale toxicity data for fosetyl

- Al Additional details on the fosetyl

- Al studies are p rovided in Appendix A

. The endpoints used for deriving risk quotient ( RQ ) value s are depicted in Tables 7 and 8

. Toxicity data were obtained from registrant

submitted studies and the scientific literature.

In addition, the Ecological Incident Information System ( EIIS )

, the Avian Incident Monitoring System ( AIMS ) and aggregate incident databases were searched for reports. Two ecological incidents involving fosetyl

- Al have been reported, both of which relate to p lant damage observed 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0% 45.0% 50.0%

0 200 400 600 800 1000% of applied

Distance from edge of field (feet) Orchard

Vineyard

Sparse

### Page 30 of 78 on a treated crop, speci fically spinach ( Appendix A, Section A.1.4 )

.
4.1. Toxicity of Fosetyl

- Al

4.1.1. Terrestrial Organisms

B irds

On an acute oral and sub

- acute dietary exposure basis, fosetyl

- A l is practically non

- toxic to birds ( i.e.

, LD 50 

### >2000 mg/kg

- bw and LC 50 

### >5000 mg/kg

- diet ). In an acute oral toxicity study with the Japanese quail (MRID 00098361), the acute oral LD 50 

### of technical fosetyl

- Al was 4,976 (3678

- 6788) mg/kg

- bw. There is uncertainty in this endpoint due to the test design of this study ( i.e.

, close spacing of test doses, low number of birds per treatment, observation of mortality at all test doses) . In another acute oral toxicity study (MRID 00098360), the LD 50 

### was >8000 mg/kg

- bw for bobwhite quail dosed with technical fosetyl

- Al. At the highe st test concentration ( i.e.

, 8000 mg/kg

- bw), 30% mortality was observed. In a study with a formulated product containing fosetyl

- Al (79.4%), no significant mortalities to bobwhite quail were observed at the highest dose of 5082 mg a.i./kg

- bw (MRID 47408712 ). In sub

- acute dietary toxicity studies with fosetyl

Al , LC 50 

### values were >20,000 mg a.i./kg

- diet for bobwhite quail and mallard and n o significant mortalities were observed at the highest treatment groups ( i.e.

, 20,000 mg a.i./kg

- diet; MRIDs 00098362 and 00098363).

In a chronic reproduction study with the Japanese quail fed technical fosetyl

- Al , no statistically significant effects were observed on endpoints representing parental survival and reproduction, and offspring growth and survival at the highes t dose tested ( i.e.

, 1414 mg/kg

- diet; MRID 47408710). The NOAEC from this study is 1414 mg/kg

- diet; however, this value should be considered uncertain since no LOAEC was established in this study. Chronic toxicity data for birds is required for two test s pecies, which are typically the bobwhite quail and the mallard duck. Lack of toxicity data for two test species represents a data gap in this assessment, leading to uncertainty associated with the quantification of an endpoint to represent reproductive eff ects of fosetyl

- Al on birds.

Mammals

On an acute oral exposure basis, fosetyl

- al is practically non

- toxic to mammals ( i.e.

, LD 50 

### >2000 mg/kg

- bw). The acute oral LD 50 

### values for the rat, mouse, rabbi t and guinea pig are 5793, 3712, 2682 and 2789 mg/kg

- bw for fosetyl

- Al, respectively ( MRID 00098330 ). When considering the process for adjusting acute oral toxicity values from tested to assessed mammals, the mouse LD 50 

### would yield the most conservative LD 50 

### values (due to its small size relative to the other test species) ; therefore this value is considered the most sensitive for evaluating acute oral

- based dietary toxicity of fosetyl

- Al. Available acute toxicity data for formulated products containing fosetyl

- Al do not suggest an increased toxicity of the fo rmula tions

. In an acute oral study involving Aliette ® 

### WDG, LD 50 

### value was 2,860 mg/kg

- bw. All other available tests with formulations resulted in non

- definative LD 50 

### values (Aliette ® 

### WP, Aliette ® 

### Injectable, 10361A WG, and EXP ® 

### 10100G LD 50 

### values were >5,0 00 mg/kg

- bw and the LD 50 

### value of EXP ® 

### 11047A was >2,000 mg/kg

- bw

.

### Page 31 of 78 A multiple generation rat reproduction study (MRID 00247174) had a NOAE C of 6,000 mg/kg

diet ( NOAEL = 300 mg/kg

- bw/day), and a LOAEC of 12,000 mg/kg

- diet. The LOAE C is based on decreased litter and pup body weight (day 8) in both matings of each generation, F 1 

### and F 2


### .
Invertebrates

Toxicity data involving exposures of terrestrial invertebrates to fosetyl

- Al are available from registrant

- submitted studies and the scien tific literature. These studies have a variety of designs, endpoints, results, and uncertaint ies . Available toxicity information indicate that many species

, including the honey bee 9 

### are insensitive to fosetyl

- Al ; however, some species, such at the predator y mite ( Typhlodromus pyri ) and s weet

- potato whitefly (Bemisia tabaci) appear to be impacted by fosetyl

- Al at levels that are relevant to currently registered application rates ( i.e.

, as low as 1.8 lb a.i./A). The available insect data are summarized in Tab le 10 . Note that studies from open literature that did not provide sufficient information to allow for conversion of exposure values to lb s a.i./A were not included in this table.

9 In the standard acute contact study with the honey bee, Fosetyl

- Al is classified as practically non

- toxic (contact LD 50 >986 μg a.i./bee ; MRID 47418003).

### Page 32 of 78 Table 10

. Summary of E ffects D ata for L aboratory and F ield T ests I nvolving E xposures of I nsects to F osetyl

- Al Application rate (lb a.i./A) Effect observed? Effect assessed Exposure route Study type MRID/Citation Test Species (common name)

1.8 no mortality contact Lab 48803208 Typhlodromus pyri (predatory mite) 1.8 yes (22% decrease) reproduction contact Lab 48803208 Typhlodromus pyri (predatory mite) 2.6 no Population size contact Field 48803214 Predatory mites (primarily Typhlodromus pyri )

2.8 no Population size contact Field Palumbo et al

. 1993 10 Bemisia tabaci (Sweetpotato whitefly)

2.9 yes (25% reduction) Population size contact Field 48803214 Predatory mites (primarily Typhlodromus pyri ) 3.2 yes (42% decrease) Number of eggs contact Field Chu et al

. 1994a 11 Bemisia tabaci (Sweetpotato whitefly)

3.2 no Number of nymphs contact Field Chu et al

. 1994a Bemisia tabaci (Sweetpotato whitefly)

4 yes (75% decrease) Number of adults contact Field Stansly and Cawley 1994 12 Bemisia tabaci (Sweetpotato whitefly)

4 yes (90% decrease ) Number of eggs contact Field Stansly and Cawley 1994 Bemisia tabaci (Sweetpotato whitefly)

4 yes (83% decrease) Number of nymphs contact Field Stansly and Cawley 1994 Bemisia tabaci (Sweetpotato whitefly)

4 no Population size contact Field Chu et al

. 1994 b 13 Bemisia tabaci (Sweetpotato whitefly) 4 no Population size contact Field Schuster 1993 14 Bemisia tabaci (Sweetpotato whitefly) 4 no Population size contact Field Riley 199 4 15 Bemisia tabaci (Sweetpotato whitefly)

5.1 yes (25

- 40% reduction) Population size contact Lab 48803214 Predatory mites (primarily Typhlodromus pyri )

5.4 yes (61% increase) Mortality contact Lab 48803212 Typhlodromus pyri (predatory mite) 5.4 yes (77% decrease ) Reproduction contact Lab 48803212 Typhlodromus pyri (predatory mite) 6.3 no mortality contact Lab 48803208 Typhlodromus pyri (predatory mite) 6.3 yes (59% decrease) reproduction contact Lab 48803208 Typhlodromus pyri (predatory mite)

10 Palumbo, J.C, C.H. Mullis, and F.J. Reyes. 1993. Control of sweetpotato whitefly in cantaloupe with various pesti cides. Insecticide and Acaricide Test. Vol. 18. P 117. 35E.
11 Chu, C. C., Henneberry, T. J., and Akey, D. H. ( 1994). Insecticide Control of Sweetpotato Whitefly on Spring Cantaloupe, 199 2. Arthropod Manag.Tests 19: 78

- 79 (29E)
12 Stansly, P. A. and Cawl ey, B. M. (1994). Control of Immature Sweetpotato Whitefly (SPWF) on Staked Tomato, Spring, 1992. Arthropod Manag.Tests 19: 156

- 158 (121 & 122E)
13 Chu, C. C., Henneberry, T. J., and Akey, D. H. ( 1994). Insecticide Control of Sweetpotato Whitefly on Cotto n, 1992. Arthropod Manag.Tests 19: 221 (61F)
14 Schuster, D.J. 1993. Management of the Sweetpotato Whitefly and Geminivirus on Fresh Market Tomatoes in West

- Central Florida, Spring 1992. Insectic. Acaric. Tests18: 177

- 179
15 Riley, D. (1994). Insecticide Co ntrol of Sweetpotato Whitefly in South Texas. Subtrop.Plant Sci. 46: 45

- 49.

### Page 33 of 78 Application rate (lb a.i./A) Effect observed? Effect assessed Exposure route Study type MRID/Citation Test Species (common name)

8 no Mortality and reproduction contact Lab 48803215 Coccinella septempuncatata (ladybird beetle)

8.3* n o mortality Oral Lab 47418002 Apis mellifera (honey bee)

8.6 no Mortality and parasitism contact Lab 48803202 Aphidius rhopalosiphi (parasitoid wasp)

8.6 yes (81% increase) Mortality contact Lab 48803204 Typhlodromus pyri (predatory mite)

8.6 yes (almost 100% decrease) Reproduction contact Lab 48803204 Typhlodromus pyri (predatory mite)

8.6 no Mortality and reproduction contact Lab 48803205 Coccinella septempuncatata (ladybird beetle)

8.6 no Mortality and reproduction contact Lab 48803211 Aleochara bilineata (rove beetle)

8.7 no Mortality and parasitism contact Lab 48803210 Aphidius matricariae (predatory wasp)

11 no mortality contact Lab 48803201 Poecilus cupreus (carabid beetle)

13 no Mortality and parasitism contact Lab 48803202 Aphidius rhopalosiphi (parasitoid wasp)

13 yes (89% increase) Mortality contact Lab 48803204 Typhlodromus pyri (predatory mite)

13 yes (almost 100% decrease) Reproduction contact Lab 48803204 Typhlodromus pyri (predatory mite)

13 yes (66% increase) Mortality contact Lab 48803205 Coccinella septempuncatata (ladybird beetle) 13 no mortality contact Lab 48803208 Typhlodromus pyri (predatory mite) 13 yes (58% decrease) reproduction contact Lab 48803208 Typhlodromus pyri (predatory mite) 13 no Mortality contact Lab 48803211 Aleochara bilineata (rove beetle) 13 yes (15% decrease) Reproduction contact Lab 48803211 Aleochara bilineata (rove beetle) 13 yes (87% increase) Mortality contact Lab 48803212 Typhlodromus pyri (predatory mite)

13 no Mortality and reproduction contact Lab 48803215 Coccinella septempuncatata (ladybird beetle)

15* yes (47% increase) Mortality Oral Lab 47418003 Apis mellifera (honey bee) 17 no mortality contact Lab 48803201 Poecilus cupreus (carabid beetle) 18* yes (77% increase) mortality Oral Lab 47418003 Apis mellifera (honey bee)

23 no Mortality and reproduction contact Lab 48803215 Coccinella septempuncatata (ladybird beetle)

### Page 34 of 78 Application rate (lb a.i./A) Effect observed? Effect assessed Exposure route Study type MRID/Citation Test Species (common name)

36 yes (43% decrease) Mortality/Repro duction (amount of capped brood) oral Field 47408716 Apis mellifera (honey bee)

39 yes (17% decrease) Reproduction contact Lab 48803216 Aleochara bilineata (rove beetle)

40 no Mortality and reproduction contact Lab 48803215 Coccinella septempuncatata (ladybird beetle)

46 yes (22% decrease) Reproduction contact Lab 48803216 Aleochara bilineata (rove beetle)

57 no Mortality and parasitism contact Lab 48803207 Aphidius rhopalosiphi (parasitoid wasp)

57 no Mortality and reproduction contact Lab 48803213 Typhlodromus pyri (predatory mite)

57 no Mortality and reproduction contact Lab 48803215 Coccinella septempuncatata (ladybird beetle)

71 yes (50% decrease) Mortality/Repro duction (amount of capped brood) oral Field 47408716 Apis mellifera (honey bee)

71 yes (14% increase) Mortality contact Lab Cabrera et al. 2004 16 Statiolaelaps scimitus (Soil

- Dwelling Predatory Mite) 89 yes (65% increase) Mortality contact Lab 48803203 Pardosa amentata (wolf spider) 89 no Mortality contact Lab 48803206 Poecilus cupreus (carabid beetle) 115* no mortality c ontact Lab 47418002 Apis mellifera (honey bee) 365* no mortality c ontact Lab 47418003 Apis mellifera (honey bee) *Converted from ug a.i./bee using methods descr ibed in USEPA, PMRA, CADPR 2012

16 Cabrera A.R., Cloyd, R.A., and Zaborski, E.R. 2004. Effects of Greenhouse Pesticides on the Soil

- Dwelling Predatory Mite Statiolaelaps scimitus (Acari: Mesostigmata: Laelapida e) Under Laboratory Conditions. The Journal of Toxicological Sciences 19:25

- 35.

### Page 35 of 78 P

lants

Toxicity data involving exposures of terrestrial plants to fosetyl

- Al are available from registrant

submitted studies, open literature as well as reported incidents. These studies have a variety of designs, endpoints, results and uncertaint ies . The available data are summarized in Table 1 1

, with detailed descriptions provided in Appendix A

. As described below, separate endpoints are used in this assessment to assess potential effects of fosetyl

- Al on non

- listed species of dicots and monocots.

Table 1 1 . Effects to P lants O bserved in S tudies I nvolving F oliar A pplications of F osetyl

- Al Species (scientific

name) Applicatio n rate (lb a.i./A) Magnitude of Effect Description of effect Source (ECOTOX #, MRID #, Incident #)

C antaloupe ( Cucumis melo var. cantalupensis) 3.2 none number of melons E97787; Chu et al

. 1994a

cantaloupe 4 none melon size and number E97955; Riley 1994 cantaloupe 4 49% decrease sugar in melons E97955; Riley 1994
Cotton (Gossypium sp.) 4 none Lint yield E97788; Chu et al

. 1994b
Cabbage ( Brassica oleracea) 4 none Cabbage head size E97955; Riley et al

. 1994

cabbage 4 none Leaf damage E97955; Riley et al

. 1994 Tomato ( Solanum lycopersicum) 4 none Visible phytotoxicity E98097;Schuster 1993

tomato 4 none Fruit size and number E98097; Schuster 1993

tomato 4.2 none Shoot dry weight ( NOAEC in this study ) MRID 47395701

tomato 7.6* 25% decrease shoot dry weight (EC 25 ) MRID 47395701

tomato 8.4 30% decrease shoot dry weight ( LOAEC in this study ) MRID 47395701
cabbage 34 Not quantified chlorosis MRID 47395701
Cucumber ( Cucumis sativus) 66 9% decrease Shoot dry weight MRID 47395701

Oat ( Avena sativa) 66 Not quantified chlorosis MRID 47395701
cabbage 66 none Shoot dry weight MRID 47395701

oat 66 none Shoot dry weight MRID 47395701
Onion ( Allium cepa) 66 none Shoot dry weight MRID 47395701
Soybean ( Glycine max ) 66 none Shoot dry weight MRID 47395701

tomato 67 Not quantified chlorosis MRID 47395701 *This value represents the endpoint used for deriving RQs for dicots.

### Page 36 of 78 D icots: T he EC 25 

### value for tomato, i.e.

, 7.6 lb a.i./A ( MRID 47395701 ) is used quantitatively in this risk assessment to calculate RQs for non

- listed terrestrial and semi

- aquatic dicot plants and to determine indirect effects to listed species of animals which depend upon terrestrial or semi

aquatic plants ( e.g. , for food o r shelter). Of all of the available toxicity data inv olving exposures of terrestrial dicots to fosetyl

- Al, this endpoint is the most certain because it was conducted under standard test procedures, with known application rates and quantified response variables. All other tested dicot species experienced effects less than 25% even at higher application rates.

Monocots : T he EC 25 

### value used to assess risks to non

- listed monocots is >66 lb a.i./A. This is based on the results of the vegetative vigor study with fosetyl

- Al, where monocots were tested at a limit concentration of 66 lb a.i./A and the percent dry weight inhibition compared to the controls was <25% ( i.e. , 0 and

- 8%, for the onion and oat, respectively).

Two incident reports exist in EFED’s EIIS database , both of which apply to effects to spinach, following applications to this crop

. Both of the incidents were considered registered uses at the time of the incident. The first incident report was of plant damage follow ing an application of Aliette ® 

### WDG (Incident # I010772

- 031). The application rate is uncertain. The second incident involved leaf burn following an application of 3 lb a.i./A of Aliette ® 

### 80WDG (Incident # I016232

- 005). The cer tain ty categories regarding t he likelihood that the use of fosetyl

- Al caused the two incidents are both possible. Neither of the incidents involved reported additional chemicals besides fosetyl

- Al. In addition, registrants have reported one minor plant incident for fosetyl

- Al.

4.1.2. Aq uatic Organisms

Fish

Information is available fr om eight acute toxicity studies of fosetyl

- Al with freshwater fish, and one study for an estuarine / marine fish. Fosetyl

- Al is classified as slightly toxic to practically

non

- toxic to freshwater and estuarine / marine fish on an acute basis. The most sensitive endpoints for all fish (LC 50 

### = 83,400 μg a.i./L for rainbow trout; MRID 00128944) will be used to derive RQs for freshwater and saltwater species.

Invertebrates

On an acute exposure basis, foset yl

- A l is practically non

- toxic to freshwater invertebrates and slightly toxic to estuarine

- marine invertebrates. For acute exposure, EC 50 

### values for freshwater and saltwater invertebrates are 304,000 μ g a.i./L and 1,850 μg a.i./L, respectively

. A chronic N OAEC of 16,000 μg a.i./L is available for waterfleas ( D aphnia m agna ) exposed to fosetyl

- Al; however, no chronic toxicity data are available for saltwater invertebrates. For this risk assessment, RQs w ere derived using the most sensitive acute toxicity endp oint ( i.e. , 1,850 μg a.i./L for sal t water invertebrates) and a chronic endpoint of 179 μg a.i./L will be used based on
an acute

- to

- chronic ratio of 19 from the available data for D. magna

.
Plants

### Page 37 of 78 The most sensitive non

- vascular aquatic plant is the marine diatom Skeletonema costatum , with a reported the 7

- d EC 50 

### value of 780 μg a.i./L (MRID 41128605). The corresponding NOAEC from that study , which is used to characterize effects of fosetyl

- Al on listed aquatic plants is 320 μg a.i./L. the EC 50 

### v alues for the other species range from 4,200 to 7,200 μg a.i./L (MRIDs 41128601, 41128602, 41128604, 47408718, and 47408719 , see Appendix A for more details ). Available data do not indicate an increase in toxicity of formulations compared to technical fose tyl

- Al.

The aquatic vascular plant, Lemna gibba , study using technical grade fosetyl

- Al, reported a 7

- d EC 50 

### value of 80,000 μg a

. i

. /L and a NOAEC of 2 0

, 4 00 μg a

. i

. /L based on the most sensitive endpoint of reduced frond count (MRID 41128603).

4.2. Endocri ne Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxici ty, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturati on, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of the Preliminary Problem Formulation for Registration Review (DP Barcode 34 2370 ), EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FF DCA section 408(p), fosetyl

- Al is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether 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 other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations . Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse end ocrine

- related effects caused by the substance, and 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, EP A issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list

### Page 38 of 78 of chemicals identified for EDSP screening was published on June 14, 2013 17 

### and includes some pest icides scheduled for registration review and chemicals found in water

. Neither of these lists should be construed as a list of known or likely endocrine disruptors.

Fosetyl

- Al is on the second list

. This l ist represents the next set of chemicals for whic h EPA intends to issue test orders/da ta call

- ins in the near future. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit o ur website. 18



### 5. Risk Characterization

For this preliminary assessment of fosetyl

- Al, the deterministic RQ method was used to provide a metric of potential risks. The RQ is a comparison of exposure estimates to toxicity endpoints ( i.e. , RQ = EEC/toxicity endpoint) . The resulting RQs are compared to the Agency’s risk levels of concern (LOC), which are the Agency’s interpretive policy such that when acute or chronic risk LOCs are exceeded, the need for regulatory action may be considered. These criteria ar e used to indicate when the use of a pesticide, as directed on the label, has the potential to cause adverse effects to non

- target organisms. For acute and chronic risks to animals, the LOCs are 0.5 and 1.0, respectively

, and for plants, the LOC is 1.0. Fo r each taxa, RQs are generated and risks are discussed. This discussion includes consideration of additional data and lines of evidence.

5.1. Terrestrial Organisms

5 .2.1. Birds, Amphibians and Reptiles

RQs were calculated ( using T

- REX) to represent risks to birds following consumption of dietary items directly sprayed with fosetyl

- Al. As noted previously, birds are considered surrogates for terrestrial

- phase amphibians and reptiles. Therefore, conclusions related to risks to birds also applied to risks to terrestrial

- phase amphibians and reptiles.

Although fosetyl

- Al is practically non

- toxic to birds on an acute oral exposure basis (LD 50 

### = 4976 mg/kg bw), and the chronic toxicity endpoint (NOAEC = 1414 mg/kg

- diet) suggests low toxicity, risk is identified fo r uses due to potential high exposures from high application rates.

Figures 9

- 1 1 include acute, dose

- based RQs for small

- , medium

- and large

- sized birds. Exposure estimates represent multiple applications of fosetyl

- Al (see Table 9 ). As indicated in thes e figures, most uses of fosetyl

- Al pose a n acute risk to non

- listed birds, with the exception of uses

on asparagus, bananas and stone fruits. The S ection 3 hops use of fosetyl

- A l does not pose a n acute risk; however, the S ection 24 c use, which involves a higher rate, does pose a n acute risk. It should be noted that in Figures 9 and 10 , RQs for uses on ornamentals, conifer nurseries and turf exceed the upper bound of the y

- axis ( i.e., 2).

17 See http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.
18 http://www.epa.gov/endo/

### Page 39 of 78 Figure 1 2 includes chronic RQs. For fosetyl

- Al use on a sparagus, bananas , hops ( S ection 3 only) and stone fruits, chronic effects are not expected. For all other uses, RQs exceed the chronic risk LOC, indicating that fosetyl

- Al may impact the reproduction of birds , terrestrial

- phase amphibian and reptiles . There is unce rtainty associated with these risk conclusions that can be attributed to the toxicity endpoint used to derive chronic RQs. First, data are only available for one species

, i.e ., Japanese quail ; however, two species are required according to 40 CFR Part 158

. Typically, these species are represented by the mallard duck and the bobwhite quail. Second , no effects were observed at the highest test level, resulting in no LOAEC value and a lack of confidence in how well the NOAEC endpoint tr u ely represented a thre shold for where effects would not occur.

There is some uncertainty associated with the magnitude of exposure resulting from applications to ornamentals, conifer nurseries and turf (labels do not define the maximum number of applications so the maximum nu mber of applications were calculated based on label

- defined intervals); however, a single application at the maximum labeled rate to these uses is sufficient to
pose both a cute and chronic risk to birds. Single applications of less than or equal to 6 lbs a .i./A do not pose either an a cute or chronic risk to birds above concern levels

.

Figure 9 . Acute D ose - based RQs for S mall

- sized B irds (20 g) E xposed to F osetyl

- A l T hrough C onsumption of P lants and A rthropods L ocated on T reated F ields 0 0.2 0.4 0.6 0.8

1 1.2 1.4 1.6 1.8

2

Short Grass Tall Grass Broadleaf plants Fruits/pods Arthropods Seeds Fosetyl

- Al uses (* indicates that number of applications was assumed) LOC (0.5)acute, dose-based RQs for small birds

### Page 40 of 78 Figure 10

. Acute D ose - based RQs for M edium

- sized B irds ( 100 g) E xposed to F osetyl

- A l T hrough C onsumption of P lants and A rthropods L ocated on T reated fields. 0 0.2 0.4 0.6 0.8

1 1.2 1.4 1.6 1.8

2

Short Grass Tall Grass Broadleaf plants Fruits/pods Arthropods Seeds Fosetyl

- Al uses (* indicates that number of applications was assumed) LOC (0.5)Acute, dose-based RQs for medium birds

### Page 41 of 78 Figure 1 1 . Acute dose

- based RQs for large

- sized birds ( 1000 g) exposed to fosetyl

- A l through consumption of plants and arthropods located on treated fields. 0 0.2 0.4 0.6 0.8

1 1.2 1.4 1.6 1.8

2

Short Grass Tall Grass Broadleaf plants Fruits/pods Arthropods Seeds Fosetyl

- Al uses (* indicates that number of applications was assumed) LOC (0.5)acute, dose-basedRQs for large birds

### Page 42 of 78 Figure 1 2

. Chronic D ietary

- based RQs for A ll S izes of B irds E xposed to fosetyl

- A l T hrough C onsumption of P lants and A rthropods L ocated on T reated F ields

5 .2.2. Mammals

RQs were calculated (using T

- REX) to represent acute and chronic risks to mammals following consumption of dietary items directly sprayed with fosetyl

- Al. Figures 1 3

- 1 5 include acute, dose

- based RQs for small

- , medium

- and large

- sized mammals. Exposure est imates represent multiple applications of fosetyl

- Al (see Table 9 ).

F osetyl

- Al uses pose a n acute risk to non

- listed mammals above concern levels , with the exception of uses on a lmonds , asparagus, bananas, citrus, cranberry, k iwis, p eaches, p lums,
p runes, stone fruits and walnuts. The S ection 3 hops use of fosetyl

- A l does not pose a n acute risk; however, the S ection 24c use on hops , which involves a higher rate, does pose a risk above concern levels . It should be noted that in Figures 1 3

- 1 5 , RQs for uses on ornamentals, conifer nurseries and turf exceed the upper bound of the y

- axis ( i.e., 2). Figure s 1 6

- 1 8 includes chronic RQs for mammals and indicate that a ll uses of fosetyl

- Al result in at least one RQ value that exceeds the chronic risk LOC of 1.0. Single applications <2.9 lb a.i./A would result in RQ value s below the acute and chronic risk LOCs for mammals, thereby resulting in no risk concerns for

non

- listed species.

Although fosetyl

- Al is practically non

- toxic to mammals on an acute oral exposure basis 0 1 2 3 4 5 6 7 8 9 10

Short Grass Tall Grass Broadleaf plants Fruits/pods/seeds Arthropods Fosetyl

- Al uses (* indicates that number of applications was assumed) LOC (1.0)Chronic,dietary-based RQs for birds

### Page 43 of 78 (LD 50 

### =3712 mg/kg bw), and the chronic toxicity endpoint (NOAEC = 6000 mg/kg

- diet) suggests low toxicity, risk exceeds concern levels for uses due to potential high exposures from high application rates. It should be noted that exposure estimates are conservative, representing high end exposures on food residues. For many uses, acute exposures are only of concern for mammals consuming short grass. For animals that consume other dietary items, most uses of fosetyl

- Al do not pose an acute risk. For chronic exposures, many EECs exceed the NOAEC for mammals consuming various food items, resulting in RQs that exceed the LOC. EECs also exceed the LOAEC, where growth effects were observed in offspring.

Figure 1 3 . Acute D ose - based RQs for S mall

- sized M ammals (15 g) E xposed to F osetyl

- A l T hrough C onsumption of P lants and A rthropods L ocated on T reated F ields 0 0.2 0.4 0.6 0.8

1 1.2 1.4 1.6 1.8

2

Short Grass Tall Grass Broadleaf plants Fruits/pods Arthropods Seeds Fosetyl

- Al uses (* indicates that number of applications was assumed) LOC (0.5)Acute, dose-based RQs for small mammals

### Page 44 of 78 Figure 1 4 . Acute D ose - based RQs for M edium

- sized M ammals (35 g) E xposed to F osetyl

- A l T hrough C onsumption of P lant s and A rthropods L ocated on T reated F ields 0 0.2 0.4 0.6 0.8

1 1.2 1.4 1.6 1.8

2

Short Grass Tall Grass Broadleaf plants Fruits/pods Arthropods Seeds Fosetyl

- Al uses (* indicates that number of applications was assumed) LOC (0.5)Acute, dose-based RQs for medium mammals

### Page 45 of 78 Figure 1 5 . Acute D ose - based RQs for L arge - sized M ammals (1000 g) E xposed to F osetyl

- A l T hrough C onsumption of P lants and A rthropods L ocated on T reated F ields 0 0.2 0.4 0.6 0.8

1 1.2 1.4 1.6 1.8

2

Short Grass Tall Grass Broadleaf plants Fruits/pods Arthropods Seeds Fosetyl

- Al uses (* indicates that number of applications was assumed) LOC (0.5)acute, dose-basedRQs for large mammals

### Page 46 of 78 Figure 1 6

. Chronic D ose - based RQs for S mall

- sized M ammals (15 g) E xposed to F osetyl

- A l T hrough C onsumption of P lants and A rthropods L ocated on T reated F ields 0 1 2 3 4 5 6 7 8 9 10

Short Grass Tall Grass Broadleaf plants Fruits/pods Arthropods Seeds Fosetyl

- Al uses (* indicates that number of applications was assumed) LOC (1.0)Chronic, dose-based RQs for medium mammals

### Page 47 of 78 Figure 17

. Chronic D ose - based RQs for Medium

- sized Mammals (35 g) E xposed to F osetyl

A l T hrough C onsumption of P lants and A rthropods L ocated on T reated F ields 0 1 2 3 4 5 6 7 8 9 10

Short Grass Tall Grass Broadleaf plants Fruits/pods Arthropods Seeds Fosetyl

- Al uses (* indicates that number of applications was assumed) LOC (1.0)Chronic, dose-based RQs for medium mammals

### Page 48 of 78 Figure 18

. Chronic D ose - based RQs for Large

- sized Mammals (1000 g) E xposed to F osetyl

A l T hrough C onsumption of P lants and A rthropods L ocated on T reated F ields 0 1 2 3 4 5 6 7 8 9 10

Short Grass Tall Grass Broadleaf plants Fruits/pods Arthropods Seeds Fosetyl

- Al uses (* indicates that number of applications was assumed) LOC (1.0)Chronic, dose-basedRQs for large mammals

### Page 49 of 78 5 .2.3. Terrestrial invertebrates

Exposure values for terr estrial invertebrates are expressed as application rates ( i.e., lb a.i./A). Therefore, for assessing risks to invertebrates on treated fields, maximum single application rates will be used ( Table 3 ). Since all spray application rates exceed the measurement endpoint for

non

- Apis terrestrial invertebrates ( i.e.

, 1.8 lb a.i./A), there is a potential risk to non

- Apis terrestrial invertebrates. AgDRIFT model estimates of how far risks from spray drift ex posure exten d from the edge of the field are provided in Table 1 2 . These estimates were made using very fine to fine droplet spectrum since labels do not specify a specific nozzle that would result in a less conservative droplet spectrum.

Table 1 2 . Distan ces from edge of field where risks extend for terrestrial invertebrates.

Use Application rate (lb a.i./A) Application method Distance from the edge of the treated field to where the concetration is expected to be equal

to concentration of concern (i.e.,

e ndpoint ) (feet) almond, brassica, citrus, berry, cucurbit, ginsing, grape, stonefruit, leafy vegetable, tomato, walnut 4 aerial 7

almond, brassica, citrus, berry, cucurbit, ginsing, grape, stonefruit, leafy vegetable, tomato, walnut 4 ground 7

banana 4.8 aerial 23 banana 4.8 ground 7 hops 2 aerial 0 hops 2 ground 3 ornamental and/or conifer nurser y 16 ground 26 ornamental and/or conifer nurser y 16 aerial 266 ornamental (bacterial blight suppression and bedding plants) 12.9 ground 20

ornamental (downy mildew control in roses, fire blight suppression) 9.6 ground 16
pineapple 12 aerial 180 pineapple 12 ground 20
turf 17.6 ground 26
macadamia nut 6 aerial 52
macadamia nut 6 ground 10 onion (dry) 2.4 aerial 0 onion (dry) 2.4 ground 3
tobacco 3.2 aerial 0
tobacco 3.2 ground 7



### This analysis indicates that most applications of fosetyl

- Al may decrease the reproduction of sensitive species of non

- Apis terrestrial invertebrates. E ffects to predatory mites and sweet

- potato whiteflies , which serve as surrogates for non

- Apis terrestrial invertebrates in this risk assessment

### Page 50 of 78 were observed at ≤4 lb a.i./A, which represents the single maximum application rate for the majority of fosetyl

- Al uses

. Potential risks apply to non

- Apis insects located on fiel ds where fosetyl

- Al is sprayed as well as to areas receiving spray drift. Risks to sensitive non

- Apis terrestrial invertebrates are estimated to extend as far out as 266 feet from the edge of the field for aerial applications (to ornamentals or conifer nur series) and 26 feet for ground applications (to ornamentals, conifer nurseries or turf)

. Less sensitive species, such as honey bees, are only expected to be impacted at higher application rates ( Table 10 )

. For honey bees, t he acute oral 96

- h LD 50 

### for tec hnical fosetyl

- Al was 455 μg a.i./bee. Using the exposure methodology for foliar sprays as presented in the pollinator white paper 19 

### , where an application rate of 1 lb a.i./A generates a dietary dose of 32 μg a.i./bee, the greatest LD 50 

### value of 455 μg a.i. /bee is equivalent to 14 lb a.i./A. Since the LOC for acute exposures to bees is 0.4, application rates ≥5.6 would pose a potential risk to honey bees.

5.2.4. Plants

As noted in the problem formulation, the measurement endpoint ( E C 25 

### ) for non

- listed plants is 7.6 lb a.i./A, based on potential effects to vegetative vigor. The most comparable exposure route for this type of endpoint is through spray drift. Since the LOC for plants is 1.0, any application rate below 7.6 would not be expec ted to generate spray drift exposures that would pose a risk to plants. The distances from the edge of the field where risks from spray drift extend were calculated for all single applications ≥7.6 lb a.i./A using the AgDRIFT model. This analysis was condu cted for all ground and aerial spray applications (ground drench and tree trunk applications were excluded). AgDRIFT model estimates of how far risks from spray drift exposure exten d from the edge of the field are provided in Table 1 3 . These estimates were made using very fine to fine droplet spectrum since labels do not specify a specific nozzle that would result in a less conservative droplet spectrum.

Table 1 3 . Distances where risks extend for plants.

Use Application rate (lb a.i./A) Application metho d Distance (in feet) from edge of field to : 7.6 lb a.i./A * 3.0 lb a.i./A ** Ornamentals and/or Conifer Nurseries 16 Ground 7 20

Ornamentals and/or Conifer Nurseries 16 Aerial 3 13 0
Ornamentals (Bacterial Blight Suppression and bedding plants) 12.9 Ground 3 14
Ornamentals (downy mildew control in roses, fire blight suppression) 9.6 Ground 3 7

Pineapple 12 Aerial 0 80 Pineapple 12 Ground 3 12
Turf 17.6 Ground 7 23 *Equivalent to EC 25 for dicots **Application rate of incident report for possible effects of fosetyl

- Al on spinach.

19 USEPA, PMRA, and CADPR (2012) White paper in support of the proposed risk assessment process for bees. United States Environmental Protection Agency, Office of Pesticide Programs, Washin gton DC. Pest Management Regulatory Agency, Health Canada, Ottawa. California Department of Pesticide Regulation, Sacramento, CA.

### Page 51 of 78 These results indicate that ≥ 25% degrease in growth of non

- target dicotyledenous plants may occur following uses on ornamentals, conifer nurseries, pineapple and turf; however, those effects are only expe c ted to extend up to 7 feet from the edge of the field. The potential risks are

c onsidered negligible because the spatial extent of the effect area is small since it only applies to the downwind side of the field.

There is some uncertainty associated with the toxicity endpoint of 7.6 lb a.i./A because available data indicate that effects to plants may occur at application rates <7.6 lb a.i./A. As noted in section 4.1.1, an incident report is available where an appli cation of 3.0 lb a.i./A fosetyl

- Al possibly resulted in leaf burn to spinach

. In addition, a 49% decrease in the sugar content of melons was noted in canalope. T he distance from the edge of the field to the level where leaf burn was reported in the inciden t ( i.e., to a deposition of 3.0 lb a.i./A fosetyl

- Al) could potentially potentially extend as far as 23 feet for ground applications and 130 feet for aerial applications ( Table 1 3 ).

5.2. Aquatic Organisms

RQs were generated using the most conservative EEC de rived from AgDRIFT ( i.e., 92 μg a.i./L ) and the most conservative acute and chronic endpoints for animals and plants ( Table 1 4 ). No acute RQs for animals exceed the LOC for non

- listed species ( i.e.

, 0.5). In addition, the aquatic plant and chronic invertebrate RQs do not exceed the LOC of 1.0.

Table 1 4 . RQs for acute and chronic exposures to aquatic organisms.

Exposure duration Taxa EEC (μg a.i./L) Endpoint (μg a.i./L) RQ

acute fish

92 83400 0.001 1
invertebrates 1850 0.0 49 plants 780 0.1 2
chronic invertebrates 179 0. 51



### When considering the probability of individual mortality to fish and invertebrates, the Individual Effect Chance (IEC) model (v.1.1) can be used along with the acute RQ values and slopes associated with the endpoints. It should be noted that these estimates of probability are assumed to be conservative due to the conservative nature of the EECs used to derive the RQs. For fish, based on a slope of 19 and an RQ of 0.001 1, the chance of individual mortality is 1 in 10 16 

### . For invertebrates, based on a slope of 4.5 (default) and an RQ of 0.050, the chance of individual mortality is 1 in 4.2 x 10 8 

### . Given that the chance of mortality is less than one in a million, the lik elihood that any of the fosetyl

- Al uses will cause mortality to individual aquatic animals as a result of spray drift is considered low.

Although an RQ was not calculated for determining chronic risk to fish (due to a lack of toxicity data), effects to g rowth and reproduction are not expected because: 1) the exposure estimate for spray drift is expected to be conservative (since it represents a conservative modeling scenario due to lack of consideration of degredation and the highest application rate allo wed for fosetyl

Al) and 2) the chronic toxicity of fosetyl

- Al would have to be a factor of >907 lower than the acute toxicity. It is considered unlikely that fosetyl

- Al would be orders of magnitude more toxic

### Page 52 of 78 to fish on a chronic exposure basis than the ac ute toxicity value because this pattern has not been observed in other taxa ( i.e.

, birds, mammals and aquatic invertebrates). In addition, an ACR of >907 is unlikely given the available toxicity data in the EFED toxicity database (for aquatic organisms), w here the median and 90 th 

### percentile ACRs were 8.3 and 79.5, respectively (Raimondo et al

. 2007 20 

### ). Therefore, the likelihood that spray drift from use of fosetyl

- Al will result effects on survival, growth and reproduction of non

- listed aquatic organisms via long

- term exposure is considered low

. Although RQs for plants were based on EC 50 

### values , NOAECs can be used to characterize low thresholds of effect. The lowest available NOAEC for aquatic plants is 320 μg a.i./L ( MRID 41128605) for the marine diatom

. The high

- end estimate of exposure, i.e., 92 μg a.i./L, is a factor of 3.5 lower than the NOAEC. This indicates that adverse effects to plants are unlikely.

5.3. Listed Species

This analysis indicates that direct effects to fish, aquatic invertebrates, aquat ic plants and monocot plants (in terrestrial and wetland habitats) are unlikely . Also, fosetyl

- Al poses both acute and chronic risk to birds, terrestrial

- phase amphibians, reptiles, mammals, terrestrial insects and sensitive species of dicot plants (in ter restrial and wetland habitats).

Indirect effects may occur to listed animals and plants that rely upon birds, terrestrial

- phase amphibians, reptiles, mammals, and terrestrial insects for food or shelter. Also, indirect effects may occur to listed species that have obligate relationships with dicot plant species in terrestrial or wetland habitats.

No Effect determinations can be made for listed species of fish, aquatic

- phase amphibians (that do not have terrestrial

- phases), aquatic invertebrates, aquati c plants and monocot plants (in terrestrial and wetland habitats) that do not rely upon birds, terrestrial

- phase amphibians, reptiles, mammals and terrestrial insects (for food or shelter), and do not have obligate relationships with dicot plants (in terrestrial and wetland habitats). For all other species, the effect d eterminations are uncertain.

5.4. Risk Conclusions

Currently labeled rates of fosestyl

- Al pose a potential risk to non

- target terrestrial animals, including insects, birds, reptiles, terrestrial

- phase amphibians and mammals as well as sensitive species of ter restrial dicot plants. The risk conclusions are summarized as follows:

• For terrestrial invertebrates, most applications of fosetyl

- Al may decrease the reproduction of sensitive species. Less sensitive species, such as honey bees, are only expected to be im pacted at higher application rates (i.e., ≥5.6 lb a.i./A). Potential risks apply to insects located on fields where fosetyl

- Al is sprayed and to areas subject to spray drift. Risks to sensitive terrestrial invertebrates are estimated to extend as far out a s 266

20 Raimondo, S., B.J. Montague and M.G. Barron. 2007. Determinants of variability in acute to chronic ratios for aquatic inve rtebrates and fish. Environ. Toxicol. Chem. 26:2019

- 2023.

### Page 53 of 78 feet from the edge of the field for aerial applications and 26 feet for ground applications.

• For birds (and terrestrial

- phase amphibians and reptiles, for which birds are considered surrogates), fosetyl

- Al poses a potential acute and chronic risk for most uses, except those on asparagus, bananas, hops (Section 3 use) and stone fruits.

• For mammals, fosetyl

- Al exposures pose an acute risk for most uses, with the exception of almonds, asparagus, bananas, citrus, cranberry, kiwis, peaches, plums, prunes, stone fruits and walnuts. All uses of fosetyl

- Al pose a potential chronic risk to mammals.

• Although fosetyl

- Al is practically non

- toxic to birds and mammals on an acute oral exposure basis, and the chronic toxicity endpoints suggest low toxicity, risk is identified for many uses due to potential high exposures from high application rates.

• Effect determinations for listed species of birds, terrestrial

- phase amphibians, reptiles, mammals and terrestrial insects are uncertain.

• Although applications of 7.6 lb a.i./A and greater may result in a >25% effect to growth of dicots, risks are expected to be negligible to non

- listed dicot species since risk is only estimated to extend only 7 feet from the edge of the field. Risks are not expected to
monocots.

• Effect d eterminations for listed species of dicots (in terrestrial and wetland habitats) are uncertain. Risks to these species may extend beyond 7 feet from the edge of the field.

• Direct adverse effects are not expected for aquatic animals and plants exposed to fo setyl

Al following spray drift and runoff.

• No Effect determinations can be made for listed species of fish, aquatic

- phase amphibians (that do not have terrestrial

- phases), aquatic invertebrates, aquatic plants and terrestrial monocots (in terrestrial and wetland habitats) that

o do not rely upon birds, terrestrial

- phase amphibians, reptiles, mammals and terrestrial insects (for food or shelter), and

o do not have obligate relationships with dicot plants (in terrestrial and wetland habitats).

In regards to the risk conclusions, the following risk hypotheses related to aquatic organisms are rejected:

• Exposure to fosetyl

- Al residues in water due to spray drift resulting from labeled uses of fosetyl

- Al will cause reduced survival, growth and reproduction to aqu atic invertebrates and fish in surface waters adjacent to a treated field.

• Exposure to fosetyl

- Al residues in water due to spray drift from labeled uses of fosetyl

- Al will cause reduced survival and biomass to aquatic vascular and non

- vascular plants in

su rface waters adjacent to a treated field.

The following risk hypotheses related to terrestrial organisms are not rejected:

• Exposure to fosetyl

- Al residues on seeds, insects, and foliage due to direct deposition or spray drift from labeled use of the pesti cide will cause reduced survival, growth and reproduction to terrestrial vertebrates (birds, mammals, reptiles, terrestrial

- phase amphibians) and terrestrial invertebrates.

• 

### Exposure to fosetyl

- Al residues on foliage due to spray drift resulting from labele d use of the pesticide will result in reduced survival and biomass to upland plants and riparian/wetland plants in areas adjacent to a treated field.

### Page 54 of 78 Appendix A

. Additional information related to effects data for fosetyl

- A l

A .1. Terrestrial Organisms

A .1.1. Birds

Table 1 Affect of Fosetyl

- Al on Birds

Chemical/Guideline No. / Study Type / Test Material Toxicological Effects (a) Source / Study Classification and Exposure Groups Fosetyl

- Al/71

- 1 Avian Single Dose Oral Toxicity

– Japanese Quail ( C. japonica ), young adult (mean body weight for concentrations ranged from 168 to 200 grams), intubation / Technical Fosetyl

- Al (LS 741

- 783) Purity not given LD 50 = 4976 mg/kg

- bw (95% CI 465

- 6386) NOAEL <4117 mg/kg

- bw (Some evidence of depressed food consumption, but no evidence to suggest body weight was affected)

Slope = 4.43 (0.259

- 8.61)

Classified as practically nontoxic MRID 00098361 Ross, et. al ., 1977 (Unpublished) / Supplemental 0 (0.5% sodium carboxymethylcellulose), 4117, 4852, 6288, 7056, 8929 mg/kg

- bw, 6 birds (3 males, 3 females) per group

Fosetyl

- Al/71

- 1 Avian Single Dose Oral Toxicity

– Bobwhite Quail ( Colinus virginianus ), young adult (mean body weight for concentrations ranged from 177 to 197 grams), intubation / Technical Fosetyl

- Al (LS 741

- 783) 95% fosetyl

- Al LD 50 >8000 mg/kg

- bw (7600 mg ai/kg

- bw) NOAEL = 5000 mg/kg

- bw ( Three mortalities in the highest treatment
grou p. 30% affected, binomial 95% CI for mortality at this concentration is 6.7 to 65%. Food consumption and body weight changes

within acceptable limits. One control bird had small cyst in body cavity at termination.)

Classified as practically nontoxic MRID 0009836 0 Roberts

, et. al

., 19 81 (Unpublished) / Acceptable 0 ( corn oil ), 500, 1000, 3000, 5000, 8000 mg/kg

- bw (475, 950, 2850, 4750, 7600 mg ai/kg

- bw)

, 10 birds ( 5 males, 5 females) per group

Fosetyl

- Al/850.2100 Avian Single Dose Oral Toxicity

– Bobwhite Quail ( Colinus virginianus ), 11

- month old (body weight ranged from 173 to 207 grams), intubation / Formulation EXP10369F (79.4% Fosetyl

- Al ) LD 50 >5082 mg a.i/kg

- bw NOAEL < 1270 mg ai/kg

- bw

(One mortality in 2541 and 5082 mg a.i. /kg

bw

. 10% affected, binomial 95% CI at these concentrations is 0.2 to 44.5%)

. No other mortality, clinical signs of toxicity, or post

mortem findings were observed in any bird during the study. In addition, no treatment

related effect on male body weight or male o r female food consumption was observed. However, statistically

- significant reductions in female body weights were observed at all dose levels on Day 7 , albeit not dose

responsive. In addition, although not statistically significant, a 22

- 27% reduction in weight gain compared to the control was observed in the females from Day 0 to 14)

Classified as practically nontoxic MRID 47408712 Gillham, 1999 (Unpublished) / Acceptable 0 (water), 1270, 2541, 5082 mg ai/kg

- bw, 10 birds (5 males, 5 females) per group

### Page 55 of 78 Table 1 Affect of Fosetyl

- Al on Birds

Chemical/Guideline No. / Study Type / Test Material Toxicological Effects (a) Source / Study Classification and Exposure Groups Fosetyl

- Al/71

- 2 Avian Dietary Toxicity

– Northern Bobwhite ( Colinus virginianus ), 10

- day old chicks / Technical Fosetyl

- Al 9 7. 5% fosetyl

- Al 8

- d LC 50 (b) > 18,330 mg ai/kg

- diet NOAEC = 13,748 mg ai/kg

- diet (one mortality in control and highest test concentration (nominal 20,000 ppm), no effects on food consumption or body weight observed)

Classified as practically nontoxic MRID 00098362 Roberts et al. , 1982 (Unpublished) / Acceptable 0, 2353, 3361, 4802, 6860, 9800, 14,000 and 20,000 mg/kg

- diet [0, 2 506 , 3 773

, 5002 , 6 718

, 10,238

, 13, 748 and 1 8,330 mg ai/kg

- diet measured]; 10 birds per group;

Fosetyl

- Al/71

- 2 Avian Dietary Toxicity

– Mallard duck ( Anas platyrhynchos ) , 1 2

- day old chicks / Technical Fosetyl

- Al 9 7. 5% fosetyl

- Al 8

- d LC 50 (b) > 1 8,330 mg ai/kg

- diet NOAEC = 13,748 mg ai/kg

- diet ( no mortalit ies in control or any test concentration s , no effects on food consumption or body weight observed)

Classified as practically nontoxic MRID 0009836 3 Roberts et al. , 198 1 (Unpublished) / Acceptable 0, 2353, 3361, 4802, 6860, 9800, 14,000 and 20,000 mg/kg

- diet [0, 2 506 , 3 773

, 5002 , 6 718

, 10,238

, 13, 748 and 1 8,330 mg ai/kg

- diet measured]; 10 birds per group;

FOSETYL

- AL/850.2300 Avian Reproduction Toxicity

– Japanese quail ( Coturnix coturnix japonica)

, 10

- wk old / (body wt 131

- 243 g)/ Technical Fosetyl

- Al 99.6% fosetyl

- Al NOAEC (c) at least 1414 mg ai/kg

- diet, highest concentration tested

( No treatment

- related effects were observed on any adult or offspring parameter at any treatment level ) (6 week exposure) MRID 47408710 Gallagher, et.al

., 1999 (Unpublished) / Supplemental 0, 166, 459, 1414 mg ai/kg

- diet;

(a) Effect levels are expressed in terms of the chemical.: mg/kg

- bw is milligrams of the test material per kilogram of body weight; mg ai/kg

- bw is milligrams of fosetyl

- Al per kilogram of body weight; mg ai/kg

- diet is milligrams of fosetyl

- Al per kilogram of diet.. (b) 5

- day exposure and 3

- day post

- exposure



### A .1.2. Mammals

### Page 56 of 78 Table 2 Affec t of Fosetyl

- Al on Mammals

Chemical/Guideline No. / Study Type / Test Material Toxicological Effects Source / Study Classification and Exposure Groups

FOSETYL

- AL/ 81

- 1 Acute Oral

– Rat (Charles River), body weight 120

- 160 g/ Technical Fosetyl

- Al 98.4% fosetyl

- Al LD 50 = 5,793 mg fosetyl

- Al/kg

- bw (95% CI 4827

- 6758) LD 50 = 5,400 mg acid/kg

- bw

weight loss statistically significant at Day 5 for 2,800 mg/kg

- bw group (no mortality), but not by Day 15 MRID 00 247160 (Unpublished) Pasquet, et al . 1977/ (5 females, 5 males /treatment; 0 (10% aqueous soln w/10% gum arabic), 2800, 4200, 6300, 9400 mg acid /kg

- bw)

FOSETYL

- AL/ 81

- 1 Acute Oral

– Rabbit (Fauve de Bourgogne), body weight 1.9

- 2.9 kg/ Technical Fosetyl

- Al 98.4% fosetyl

- Al LD 50 = 2,682 m g fosetyl

- Al/kg

- bw (95% CI not calculable) LD 50 = 2,500 mg acid/kg

- bw

No statistically significant weight loss for 2,000 mg/kg

- bw group (highest concentration w/no mortality) ; 4/4 dead at 3000 mg/kg

- bw, 0/4 dead at 2000 mg/kg

- bw MRID 00 247160 (Unpublished) Pasquet, et al . 1977/ (2 females, 2 males /treatment; 0 (10% aqueous soln w/10% gum arabic), 1350, 2000, 3000, 4500, 6700 mg acid /kg

bw)

FOSETYL

- AL/ 81

- 1 Acute Oral

– Mouse (Specific Pathogen Free), body weight 19

- 22 g/ Technical F osetyl

- Al 98.4% fosetyl

- Al LD 50 = 3,712 mg fosetyl

- Al/kg

- bw (95% CI 3132

- 4409) LD 50 = 3,460 mg acid/kg

- bw

weight loss statistically significant at Day 10 for 1350 mg/kg

- bw group (highest concentration w/no mortality), but not by Day 15 MRID 00 247160 (Unpublished) Pasquet, et al . 1977/ (5 females, 5 males /treatment; 0 (10% aqueous soln w/10% gum arabic), 1350, 2000, 3000, 4500, 6700 mg acid /kg

bw)

FOSETYL

- AL/ 81

- 1 Acute Oral

– Guinea pig (Dunkin/Hartley), body weight 230

- 285 g/ Technical Fo setyl

- Al 98.4% fosetyl

- Al LD 50 =2,789 mg fosetyl

- Al/kg

- bw (95% CI not calculable) LD 50 =2600 mg acid/kg

- bw

No statistically significant weight loss for 2,000 mg/kg

- bw group (highest concentration w/no mortality) MRID 00 247160 (Unpublished) Pasquet, et al . 1977/ (5 females, 5 males /treatment; 0 (10% aqueous soln w/10% gum 56 rabic ), 1350, 2000, 3000, 4500 mg acid /kg

- bw)

FOSETYL

- AL/ 81

- 1 Acute Oral

– Rat ( Sprague

- Dawley ), body weight 186

- 310 g/ Formulation Aliette WDG 80 % fosetyl

- Al LD 50 =2860 mg/kg

- bw (95% CI 2410

- 3380) MRID 41641802 (Unpublished) Kuhn . 19 90 / (5 females, 5 males /treatment ; 0 , 500, 2000, 2500, 3000, 4000, 5050 mg/kg

- bw)

FOSETYL

- AL/ 81

- 1 Acute Oral

– Rat

Formulation Aliette WP 80 % fosetyl

- Al LD 50 > 5, 0 00 mg/kg

- bw

(One female died at limit concentration of 5000 mg/kg

- bw. Observations of hypomotility, females coats appeared dirty, muscular hypotonia in females, congestion in lungs, and grayish deposit adhering to mucosa of glandular zone of stomach) MRID 00 2471 86 (Unpublished) Pasquet, et al . 19 81 / ( 10 females, 10 males /treatment; 0 , 5000 mg/kg

- bw)

### Page 57 of 78 Table 2 Affec t of Fosetyl

- Al on Mammals

Chemical/Guideline No. / Study Type / Test Material Toxicological Effects Source / Study Classification and Exposure Groups
FOSETYL

- AL/81

- 2 Acute Dermal toxicity

– Rabbit

Technical Fosetyl

- Al 97% fosetyl

- Al LD50 > 2000 mg/kg MRID 00247160 (Unpublished) Pasquet, et al . 1977

FOSETYL

- AL/81

- 5 Primary Skin Irritation

– Rabbit Technical Fosetyl

- Al 97% Fosetyl

- Al Non

- irritant MRID 00247160 (Unpublished) Pasquet, et al . 1977

FOSETYL

- AL/81

- 4 Primary Eye Irritation

– Rabbit Technical Fosetyl

- Al 97% Fosetyl

- Al O c cular Irritant Category I MRID 00247160 (Unpub lished) Pasquet, et al . 1977

FOSETYL

- AL/81

- 3 Acute Inhalation Toxicity

– Rat Technical Fosetyl

- Al 98% fosetyl

- Al LD50 > 1.73 mg/L MRID 00247160 (Unpublished) Pasquet, et al . 1977

FOSETYL

- AL/83

- 4 Reproduction 3

– generation

– rat Technical Fosetyl

- Al NOAEL = 300 mg/kg/day (6000 ppm) LOAEL = 600 mg/kg/day (12000 ppm)

Decreased litter and pup weight (Day 8) in both matings of each generation (F1&F2) MRID 00247174 (Unpublished) Spicer, et. al ., 1981/ 0, 6000, 12000, 24000 ppm

FOSETYL

- AL/82

- 1 90

- day Feeding

– Rat Technical Fosetyl

- Al 98% fosetyl

- Al NOAEL = 5,000 ppm

- diet LOAEL = 25,000 ppm

- diet

Slight increase in extramedullary hematopoiesis in the spleen when compared to control animals. MRID 00098336 (Unpublished) Coquet, et. al ., 1977/ Supplemental/ 1,000, 5,000, and 25, 000 ppm

- diet



### A .1.3. Invertebrates

A .1.3.1. Insects (class Insecta)

Beetles (order coleoptera)

Toxicity data are available for six species of beetles exposed to fosetyl

- Al. In registrant

submitted and open literature studies, mortality was not increased in exposed ladybird beetles ( Coccinella septempuncatata ) (MRID 48803215); mealybug ladybird ( Cryptolaemus montrouzieri) ( Mani and Krishnamoorthy (1990)); carabid beetles ( Poecilus cupreus ) (MRIDs 48803201 and 48803206), and rove beetles ( Aleochara bilineata ). Exposures via contact to sprayed surfaces were at or above single maximum application rates of fosetyl

- Al (based on current labels). Development time was not impacted in two ladybeetle species ( Cycloneda

s anguinea and Harmonia axyridis ; Michaud 2001). Reproduction was not impacted in the ladybird beetle (MRIDs 48803205 and 48803215); however, it was reduced by 15

- 17% when exposed to surfaces treated with 13

- 39 lb a.i./A (MRIDs 48803211 and 48803216).

### Page 58 of 78 Bees and wasps (order hymenoptera)

No adverse effects (including mortality and parasitism) were observed in three species of wasps, including Aphidius rhopalosiphi (MRIDs 48803202 and 48803207), Aphidius matricariae (MRID 48803210) and Anagyrus dactylopii (Ma ni and Krishnamoorthy 1990).

Two contact toxicity honey bee ( Apis mellifera ) studies involving technical grade fosetyl

- Al yielded 48

- h LD 50 

### values of >100 μg/bee (MRID 40676301) and >986 μg a.i./bee (MRID 47418003). In a contact study involving a 79.4% f osetyl

- Al formulation, the LD 50 

### value was >310 μg a.i./bee (MRID 47418002). Using the exposure methodology presented in the pollinator white paper 21 

### , where an application rate of 1 lb a.i./A generates a contact dose of 2.7 μg a.i./bee, the greatest LD 50 

### val ue ( i.e. , >986 μg a.i./bee) is equivalent to >365 lb a.i./A. Oral toxicity studies involving technical and formulated (79.4% a.i.) fosetyl

- Al yielded 48

- h LD 50 

### values of 709 and >349 μg a.i./bee, respectively (MRIDs 47418003 and 47418002). The 96

- h LD 50 

### fo r the technical formulation was 455 μg a.i./bee. Using the exposure methodology for foliar sprays as presented in the pollinator white paper, where an application rate of 1 lb a.i./A generates a dietary dose of 32 μg a.i./bee, the greatest LD 50 

### value of 45 5 μg a.i./bee is equivalent to 14 lb a.i./A. In a semi

- field (tunnel) study examining effects on honey bee colonies following soil drench applications of formulated products containing fosetyl

- Al at 36 and 71 lb a.i./A, a decrease in brood (larval and capp ed stages) and survival of adults was observed in both treatment groups compared to the control (MRID 47408716).

Bugs (order Hemiptera)

Several studies from the open literature examined the efficacy of fosetyl

- Al to the sweetpotato whitefly ( Bemisia tab aci ) in which fosetyl

- Al was applied to various crops. Many of the studies were conducted at a foliar application rate of 4.0 lb a.i./A Aliette ® 

### 80 WP, WG or a n unidentified formulation to several crops in the field grown under typical culturing condition s ( e.g. , cotton, cabbage, tomato, and cantaloupe (2.8 and 4.0)) and no adverse effects on populations of the sweetpotato whitefly were observed (Chu 1994b; Riley 1994; Schuster 1993; and Palumbo 1993). However, there were two studies in which fosetyl

- Al, (Aliette ® 

### 80 WDG or WP), foliarly applied to either tomato at 4.0 lb a.i./A or cantaloupe at 3.2 lb a.i./A under typical field conditions, did result in significant decreases in the number of adults, nymphs and/or eggs when compared to the control (Chu 1994a; Stansly and Cawly 1994). A review of these studies did not reveal an obvious reason for the differences in results

.

A .1.3.2. Arachnids (class arachnida)

Spiders (order araneae)

One species of spider ( Pardosa amentata, wolf spider) was tested for effects of fosetyl

- Al. Although 65% mortality was observed in spiders exposed via direct spray and contact, the

21 USEPA, PMRA, and CADPR (2012) White paper in support of the proposed risk assessment process for bees. United States Environmental Protection Agency, Office of Pesticide Programs, Washington DC. Pest Management Regulatory Agency, Health Canada, Ottawa. California Department of Pesticide Regulation, Sacramento, CA.

### Page 59 of 78 exposure rate of 89 lb a.i./A was much higher than the single maximum application rates allowed on the label.

Predatory mite (order mesostigmata)

In a study involving a soil

- dwelling predatory mite ( Stratiolaelaps scimitus ), mortality was increased by 14.0%, but reproduction (number and viability of eggs) was not adversely affected. It should be noted that the application rate was much higher than allowed on labels (71.4 lb a.i./A), which makes these results difficult to interpret relative to actual use rates (Ca brera et al. 2004).

Predatory mite (order acarina)

In available lab studies involving exposures of predatory mites ( Typhlodromus pyri) to fosetyl

Al, mortality increased (67%) when exposed to 5.4 lb a.i./Aand greater (MRIDs 48803204 and 48803212). Reproduction was also negatively impacted (22%) in groups of mites exposed to 1.8 lb a.i./A and higher (MRIDs 48803204, 48803208, and 48803212). Impacts to predatory mites from fosetyl

- Al applied at similar rates we re also observed in a field study. After three applications made at 2.9 lb a.i./A, the number of mites on treated apple leaves were lower than control (by 25%); however, mite populations appeared to rebound after three weeks. A 25

- 40% decrease in mite nu mbers was observed in a field study following 2 and 3 applications of 5.1 lb a.i./A fosetyl

- Al. Following three applications of 2.6 lb a.i./A, mite numbers were not different from the control (MRID 48803214).

A .1.4. Plants

Toxicity data involving exposu res of terrestrial plants to fosetyl

- Al are available from registrant submitted studies, the scientific literature as well as reported incidents. These studies are described below.

Registrant

- submitted studies

Registrant

- submitted studies are available t o characterize the toxicity of fosetyl

- Al to terrestrial plants. These submissions include 1) a Tier I vegetative vigor study with 6 crop species exposed to Aliette ® 

### 80 WG; 2) a Tier I vegetative vigor study with tomato exposed to Aliette ® 

### 8 0 WG; 3) a Tier I vegetative vigor study with 8 species exposed to a formulated product containing fosetyl

Al and another fungicide (propamocarb

- HCl); and 4) a Tier I seedling emergence study with 8 species exposed to a formulated product containing fosetyl

- Al + propamoc arb

- HCl. These studies are described below.

Tier I studies are essentially limit tests that are designed to indicate whether the maximum application rate of a pesticide will cause >25% effects to plants, which would necessitate a Tier II study. Tier II st udies are designed to establish EC 25 

### values for plants. Tier I studies are not used to establish risk assessment endpoints ( i.e.

, NOAEC and EC 25 

### values), but are described in this assessment in order to characterize potential effects of fosetyl

- Al on plant s.

### Page 60 of 78 In a tier I study involving a formulated product applied at 66 lb a.i./A fosetyl

- Al (Aliette ® 

### 80 WG), <25% effects were observed in shoot dry weights relative to controls for the following test species: cucumber (9% decrease),oat (0% decrease), onion (0 % decrease) and soybean (0% decrease). A 37% inhibition in shoot c hlorosis was observed in cucumber and oat (MRID 47395701). This study was classified supplemental because shoot length was not measured. Tier II tests were conducted for cabbage and tomato exposed to Aliette ® 

### 80 WG. For cabbage, the EC 25 

### was not established; however, chlorosis was observed in plants exposed to 34 lb a.i./A. For tomato, the EC 25 

### value was 7.6, lb a.i./A. At the NOAEC of 4.2 lb a.i./A, a 18% decrease in shoot dry weight was ob served. At the LOAEC of 8.4 lb a.i./A, a 30% decrease in shoot dry weight was observed. Chlorosis was also observed in tomato plants exposed to 67 lb a.i./A (MRID 47395701). This study was classified supplemental because shoot length was not measured.

In a tier I vegetative vigor study involving a formulated product containing fosetyl

- Al (29.9%; 0.75 lb a.i./A) and propamocarb

- HCl (57.8%; 1.44 lb a.i./A), statistically significant effects were observed in dry weights of onion (17% difference), shatterca ne (25%), soybean (12%) and oilseed rape (19%) exposed to the formulation, relative to controls. No effects were observed in corn, oat, sunflower and cucumber (MRID 47370503). This study was classified supplemental for a Tier I vegetative vigor study becau se it was not conducted under Good Laboratory Practices (GLP) and no explanation was provided of how the test methods related to GLP. The results of this study indicate that fosetyl

- Al could cause effects to plants at 0.75 lb a.i./A; however, there is subs tantial uncertainty associated with these results for several reasons. First, the study involved two active ingredients and it is unknown whether the toxicity can be attributed to fosetyl

- Al alone or the mixture of the two ingredients. In a Tier I vegetati ve vigor study involving a formulated product containing propamocarb

- HCl as the only active ingredient, 8.0 lb a.i./A resulted in <25% effects to 10 test species. This suggests that propamocarb

- HCl alone is not causing effects to plants (at 0.75 lb a.i./A) . The results for four species ( i.e.

, cucumber, oat, onion and soybean) tested separately with formulated products containing fosetyl

- Al, propamocarb

HCl and a combination of fosetyl

- Al and propamocarb

- HCl do not suggest that fosetyl

- Al alone is causing th e effects ( Table A1 ). All that being said, there are no formulated products registered in the U

. S

. at this time with fosetyl

- Al and propamocarb

- HCl. Therefore, the results are of little utility for this risk assessment.

Table A 1 

### . Decrease (%) in shoot dry weight of treatment relative to controls observed in Tier I studies.

Test species Fosetyl

- Al (66 lb a.i./A) (MRID 47395701) Propamocarb

- HCl (8 lb a.i./A) (MRID 45894311) Fosetyl

- Al (0.75 lb a.i./A) +Propamocarb (1.44 lb a.i./A) (MRID 47371503) cucumber 9 0 2 Oat 0 7.5 0 Onion 0 0 17 soybean 0 14 12

Scientific literature

### Page 61 of 78 The scientific literature includes several studies where effects of fosetyl

- Al on terrestrial plants were examined. These studies include exposures involving direct spray to crops, root dips and soil drench applications. This section focuses on studies inv olving foliar applications to plants, which are most representative of potential exposures of non

- target plants to fosetyl

- Al (through spray drift). In general, these studies were not intended to determine the impact of fosetyl

- Al on plants but rather to e xamine the efficacy of various pesticides on crop pests; however, these data are still useful for the observations of potential effects of fosetyl

- Al to plants.

In a field study examining the effects of various pesticides on sweet potato whitefly, Aliette ® 

### 80 WP was applied to cabbage and to cantaloupe at a rate of 4.0 lb a.i./A fosetyl

- Al. Relative to the controls , no effects to cabbage head weight or leaf damage were observed. No effects were observed in number or weight of harvested cantaloupes; however , the % sugars of the fruit were significantly decreased (by 49%) in the treated plants relative to controls (Riley 1994). Data are available from another field study involving applications of Aliette ® 

### 80 WP to cantaloupe. In this study, 6 applications w ere made at a rate of 3.2 lb a.i./A of fosetyl

- Al. The number of marketable melons harvested per acre was not significantly different compared to the untreated plots (Chu et al . 1994a).

In a field study involving cotton, 9 foliar applications of Aliette ® 

### 80 WP were made at a rate of 4.0 lb s a.i./A of fosetyl

- Al. The yield of cotton lint harvested per acre was not significantly different compared to the untreated plots (Chu et al . 1994b).

In another field study, 13 applications of Aliette ® 

### were made to t omatoes at a rate of 4.0 lb a.i./A of fosetyl

- Al. The number and size of tomatoes harvested per 10 plants was not significantly different compared to the untreated plots. No visible phytotoxicity was observed in treated plants (Schuster 1993).

Reported i ncidents

Two incident reports exist in EFED’s EIIS database. Both incidents occurred from registered applications in spinach crops. The first incident occurred on 9/1/00 in San Benito County, CA and involved a registered use of fosetyl

- Al (Aliette ® 

### WDG) at an application of 3 ounce s /A 22 

### applied as a pre

- broadcast spray to spinach that resulted in plant damage to 10 of the 20 acres treated (Incident # I010772

- 031). The type of plant damage observed was not reported. The second incident was in Montgomery County, CA on 4/25/05 in which plant damage described as leaf burn occurred across all 5.5 acres of spinach sprayed with Aliette ® 

### 80WDG at a rate of 3 lb s /A, assumed to be a.i. (Incident # I016232

- 005). The cer tain ty categories regarding the likelihood tha t the use of fosetyl

- Al caused the two incidents are both possible. Both of the incidents were considered registered uses at the time of the incident and are still registered uses. Neither of the incidents involved reported additional chemicals besides f osetyl

- Al. In addition,

22 The 3 oz/A (0.19 lb/A, based on mass) application rate in the I010772

- 031 incident is substantially lower than the registered applic ation rate for this use (4 lb a.i./A). Therefore, it is not known if this is due to a reporting error, or if this was the actual application rate; as such, there is uncertainty in this incident regarding application rate.

### Page 6 2 of 78 registrants have reported one minor plant incident for fosetyl

- Al. Unless additional information on this aggregated incident becomes available, it will be assumed to be representative of registered uses of fosetyl

- Al in the risk assessment.

There is uncertainty in the incident data for terrestrial plants that are available. Both of the incidents were for direct application to spinach at an application rate lower than what was tested in the vegetative vigor toxicity study. For t he incident I016232

- 005, the symptom was reported as leaf burn. For this incident, the registrant claimed that “speckling of leaves is warned of on the label and the crop is growing through the speckling”. However, the overall magnitude of the impaired g rowth ( e.g. , loss of biomass or stunted height) is not reported. Currently registered labels for fosetyl

- Al contain a warning regarding the addition of certain additives in regards to potential phytotoxicity. In particular, the labels state that the use of foliar fertilizer, copper products and adjuvants which enhance pesticide penetration may not be compatible with formulations of fosetyl

- Al and may cause phytotoxicity. As no further details were provided regarding the three incident reports regarding t ank mixes, it is not known if a compound that is warned of on the label was present during application. Therefore, the assumption was made that the se other compo unds were not present , and the toxicity was attributed to fosetyl

- Al.

A .2. Aquatic Organism s

A .2.1. Fish

Table 3 Affect of Fosetyl

- Al on Freshwater and Estuarine or Marine Fish

Chemical/Guideline No. / Study Type / Test Material Toxicological Effects Source / Study Classification and Exposure Groups

FOSETYL

- AL /72

- 1 Acute Toxicity to Freshwater Fish

– Rainbow trout ( Salmo gairdneri ), juvenile (ave length 75 mm), 16 ± 1 o C, 7.9 pH, static test /

Technical Fosetyl

- Al 95% fosetyl

- Al 96

- h LC 50 = 4 15.8 ppm (total) ( 395.0 ppm ai (total)) (95% CI 309

- 530 ppm ai (total)) 96

- h NOAEC = 100 ppm (95 ppm ai) Slope = 5.0 (2.54

- 7.46)

A white gelatinous precipitate was observed on floor of aquaria (concentrations not reported); centrifugation or filtering not reported. 1 ppm Tween 80 used as solvent. Classified as practically non

- toxic MRID 00098364 Fra s er & Pell, 1977 (Unpublished) / Supplemental 0, 100, 200, 300, 500, and 1000 ppm nominal (95, 190, 285, 475, 950 ppm ai nominal) , 10 fish per treatment

FOSETYL

- AL /72

- 1 Acute Toxicity to Freshwater Fish

– Rainbow trout ( Salmo gairdneri ), juvenile ( mean length 23.3 mm , mean wet weight 0.17 ), 12 o C, stati c test / Technical Fosetyl

- Al 98.39% fosetyl

- Al 96

- h LC 50 = 83.4 ppm ai (95% CI 67.9

- 97.0 ppm ai) 96

- h N OAEC = 69.4 ppm ai

Slope = 19.3 (4.85

- 33.7)

Classified as slightly toxic MRID 00128944 Conzelmann. , 19 83 (Unpublished) / Acceptable 0, 61.4, 69.4, 84.2, 102, 103, 116 ppm measured (60.4, 68.3, 82.8, 100, 101, 114 ppm ai measured) , 10 fish per
treatment

### Page 63 of 78 Table 3 Affect of Fosetyl

- Al on Freshwater and Estuarine or Marine Fish

Chemical/Guideline No. / Study Type / Test Material Toxicological Effects Source / Study Classification and Exposure Groups
FOSETYL

- AL / 850.1075 Acute Toxicity to Freshwater Fish

– Rainbow trout ( Oncorhynchus mykiss ), juvenile ( mean length 38

mm , mean wet weight 0.86 ), 13

- 15 o C , 7.2

- 8.1 pH, 132

- 168 mg/L as CaCO3

, stati c renewal test / Technical Fosetyl

- Al 97.8% foset yl

- Al 96

- h LC 50 > 120 ppm ai 96

- h NOAEC = 120 ppm ai

Conducted as limit test Classified as practically non

- toxic MRID 47408705 Bell & Albuquerque , 19 99 (Unpublished) / Supplementa l 120 ppm ai measured

, 2 0 fish per
treatment

FOSETYL

- AL / 850.1075 Acute Toxicity to Freshwater Fish

– Rainbow trout ( Oncorhynchus mykiss ), juvenile ( mean length 38

mm , mean wet weight 0.86 ), 13

- 14 o C , 7.2

- 8.1 pH, 132

- 168 mg/L as CaCO3

, stati c renewal test / FormulationEXP 10369F 79.49 % fosetyl

- Al 96

- h LC 50 > 98.1 ppm ai 96

- h NOAEC = 98.1 ppm ai

Conducted as limit test Classified as no more than slightly toxic based on measured test concentrations MRID 47408708 Bell , 19 99 (Unpublished) / Supplementa l 98.1 ppm ai measured

, 2 0 fish per
treatment

FOSETYL

- AL/72

- 1 Acute Toxicity to Freshwater Fish

– Harlequin Fish ( Rasbora heteromorpha ), mean wet weight 0.6 grams (range 0.43

– 1.0 g)), 25±1 o C, hardness 25 mg/L as CaCO 3 , flow

- through /

Technical fosetyl

- Al Purity not given 96

- h LC 50 = 170.7 ppm (total) (95% CI 75

- 250 ppm) 96

- h NOAEC = 75 ppm (total)

No slope, poor fit Test material described as suspendable with difficulty in water ; centrifugation or filtering of test solution not reported . Tween 80 used as solvent.

Classified as practically non

- toxic MRID 00098365 Fraser & Pell, 1977 (Unpublished) / Unacceptable/ 0, 50, 75, 150, 250, 500
ppm nominal, 10 fish per treatment

. Loading

- 6 g/L; no reporting of DO, or pH.

FOSETYL

- AL /72

- 1 Acute Toxicity to Freshwater Fish

– Bluegill Sunfish ( Lepomis macrochirus ), juvenile ( mean length 37 mm , mean wet weight 0.52, 0.35 g/L ), 20.6 (20

- 21) o C, 7. 0 pH, hardness 116 mg/L as CaCO 3 , static test / Technical Fosetyl

- Al 98% fosetyl

- A l 96

- h LC 50 = 141 ppm ai (95% CI 100

- 200) 96

- h NOAEC = 100 ppm ai

No slope, poor fit

Classified as practically non

- toxic MRID 00119526 Spare et.al

. , 19 82 (Unpublished) / Acceptable 0, 100, 200, 300, 400, 500 ppm ai nominal, 10 fish per treatment

### Page 64 of 78 Table 3 Affect of Fosetyl

- Al on Freshwater and Estuarine or Marine Fish

Chemical/Guideline No. / Study Type / Test Material Toxicological Effects Source / Study Classification and Exposure Groups
FOSETYL

- AL /72

- 1 Acute Toxicity to Freshwater Fish

– Bluegill Sunfish ( Lepomis macrochirus ), juvenile ( mean length 47 mm , mean wet weight 1.12 g ), 21 o C, 6.8

- 7. 7 pH, hardness 100 mg/L as CaCO 3 , static renewal test / Technical Fosetyl

- Al 97% fosetyl

- Al 96

- h LC 50 >58 ppm ai (total) 96

- h NOAEC = 58 ppm ai (total)

Test conducted as limit test. Test solution contained very fine particulate

matter; centrifugation or filtering of solutions not reported.

Classified as no more than slightly

toxic based on mean measured MRID 47408706 Wetton , 19 97 (Unpublished) / Supplementa l 58 ppm ai measured

, 2 0 fish per
treatment

FOSETYL

- AL/72

- 3 Acute Toxicity to Estuarine and Marine Organisms

– Sheepshead minnow ( Cyprinodan variegatus ), juvenile (mean length 27 mm, me an wet weight 0.43 grams), 22 ± 1 o C, 4.6

- 7.9 pH, 32‰ salinity, daily renewal test) / Technical Fosetyl

- Al 98.2% fosetyl

- Al 96

- hr LC50 = 124 ppm (total) (122 ppm ai (total)) (95% CI 48

- 157 ppm ai) NOAEC = 49 ppm (total)

No slope, poor fit

Cloudy test solutions with a precipitate
at co ncentrations 45 ppm and greater; centrifugation or filtering of solutions

not reported. Solutions clear and

colorless at 3 9 ppm and below.

Class ified as practically non

- toxic MRID 00147360 Sousa, 1985 (Unpublished)/ Acce ptable 20, 24, 39, 45, 49, 115 and 160 ppm measured (19.6, 23.6, 38.3, 44.2, 113, 157 ppm ai measured). 10 fish per concentration

FOSETYL

- AL/ NA/ 28

- day Juvenile Growth Test with Rainbow Trout ( Oncorhynchus mykiss )

– juvenile mean length 6.1 c m, mean wet weight 3.53 grams), 14

- 15 o C, 4.6

- 7.9 pH 6.6

- 8.0 , daily renewal test /

Technical Fosetyl

- Al 97.0% fosetyl

- Al NOAEC = 8.2 ppm (8.0 ppm ai) (based on observation that test solutions at this conc. were clear and colorless)

No effect on survival or growth observed at any concentration tested. However, c loudy test solutions with a precipitate at co ncentrations 15 ppm (15 ppm ai) and greater; centrifugation

or filtering of solutions not reported. Solutions clear and colorless at 8.2
ppm (8.0 ppm ai)

.

Non

- guideline study MRID 47408709 Wetton 1998 (Unpublished)/ Supplemental 8.2, 15, 28, 53, 95 ppm measured (8.0, 15, 27, 51 and 92 ppm ai measured). 16 fish per concentration

### Page 65 of 78 Table 3 Affect of Fosetyl

- Al on Freshwater and Estuarine or Marine Fish

Chemical/Guideline No. / Study Type / Test Material Toxicological Effects Source / Study Classification and Exposure Groups
PHOSPHOROUS ACID/850.1075/ Acute Toxicity to Freshwater Fish

– Bluegill Sunfish (Lepomis macrochirus), juvenile (mean length 30 mm, mean wet weight 0.62 g), 22 ± 1 o C, 6.8

- 7.76 pH, 44.7

- 46 mg/L as CaCO3 hardness, flow

- through test / Potassium salts of phospho rous acid 29% phosphorous acid 96

- h LC 50 > 130 ppm (38.6 mg phosphorous acid)

96

- h NOAEC = 130 ppm

Test conducted as limit test Classified as practically non

- toxic MRID 47408707 Latham, 1999 (Unpublished)/Supplemental

130 ppm, 30 fish per concentration

Total = indicates that both dissolved and undissolved test material may be present in reported concentration



### A .2.2. Invertebrates

Table 4 Affect of Fosetyl

- Al on Freshwater and Estuarine or Marine Invertebrates

Guideline No. / Study Type / Test Material Toxicological Effects Source / Study Classification and Exposure Groups

FOSETYL

- AL /72

- 2 Acute Freshwater Invertebrate toxicity test

– Waterflea ( Daphnia magna ), <24

- h old, static test, 22

- 23 o C, 4.8

- 7.0 pH, hardness 130 mg/L as CaCO 3 , Technical Fosetyl

- Al 94.78% fosetyl

- Al 48

- h EC 50 = 304 ppm ai (total) (95% CI 178

- 465 ppm ai) 48

- h NOAEC = 178 ppm ai (total) No slope, poor fit Flocculant observed in test concentrations. Reported collecting samples without disturbing flocculant

but no mention of centrifugation or filtering of solution.

Classified as practically non

- toxic MRID 00128943 Spare, 1983 (Unpublished) / Acceptable 0, 63.7, 100, 178, 277 and 465 ppm ai measured

20 daphnia per test concentration

FOSETYL

- AL/72

- 2 Acute Freshwater Invertebrate toxicity test

– Waterflea ( Daphnia pulex ), mature (at least 5 days old), static test, 11±1 o C, 7.4 pH,

Technical Fosetyl

- Al 95% fosetyl

- Al 48

- h EC 50 = 161 ppm (1 53 ppm ai) (95% CI 138

- 170 ppm ai) 48

- h NOAEC < 50 ppm (48 ppm ai)

Classified as practically non

- toxic MRID 00098366 Cole, 1976 (Unpublished) /Unacceptable 0, 50, 75, 112, 169, 253, 360, 570 ppm nominal (48, 71, 106, 161, 240, 342, 542 ppm ai nominal)

Loading 1 daphnia/mL should be 1 <24

- hr old daphnia/20mL; aeration added; temp 11°C instead of 17

- 21°C; no reporting of DO or pH.

60 daphnia per test concentration

### Page 66 of 78 Table 4 Affect of Fosetyl

- Al on Freshwater and Estuarine or Marine Invertebrates

Guideline No. / Study Type / Test Material Toxicological Effects Source / Study Classification and Exposure Groups
FOSETYL

- AL/850.1010 Acute Freshwater Invertebrate toxicity test

– Waterflea ( Daphnia magna ), < 24

- hr old, static test, 21

- 22 o C, 4.9

- 7.7 pH,

Formulation EXP10369F 79.4% fosetyl

- Al 48

- h EC 50 = 2 9 ppm ai (total) (95% CI 17

- 84 ppm ai) 48

- h NOAEC = 4.6 ppm ai (total) Slope = 1.82 (95% CI 0.67

- 2.97)

Precipitate in test solutions at concentrations of 25 ppm ai and higher ;

centrifugation or filtering of solutions not reported.

Classified as slightly toxic MRID 47395702 Bell, 1999 (Unpublished) /Supplemental 0, 4.6, 8.1, 14, 25, 47, 82 and 146 ppm ai measured

20 daphnia per test concentration

FOSETYL

- AL/850.1010 Acute Freshwater Invertebrate toxicity test

– Waterflea ( Daphnia magna ), < 24

- hr old, static test, 21 ° C, 5 .9

- 7.7 pH, 270 mg/L as CaCO 3 hardness

Technical Fosetyl

- Al 95.9% fosetyl

- Al 48

- h EC 50 > 5.0 ppm ai (total) 48

- h NOAEC = 5.0 ppm ai (total)

Study conducted as limit test, p recipitate in test solutions at limit concentration of 100 ppm nominal; centrifugation or

filtering of solution not reported.

Classified as moderately toxic based on measured concentration MRID 47 408704 Sewell , 199 6 (Unpublishe d) /Supplemental 0, 5.0 ppm ai measured

20 daphnia per test concentration

### Page 67 of 78 Table 4 Affect of Fosetyl

- Al on Freshwater and Estuarine or Marine Invertebrates

Guideline No. / Study Type / Test Material Toxicological Effects Source / Study Classification and Exposure Groups
FOSETYL

- AL /72

- 3 Acute Estuarine and Marine Organisms toxicity test

– Fiddler Crab ( Uca pugio ), mean weight of 1.91 g, mean carapace width of 23 mm, static test, 2 1

- 2 2 o C, 5.8

- 8.2 pH, 22

- 23 ‰ salinity

Technical Fosetyl

- Al 95% fosetyl

- Al 96

- h EC 50 = 114 ppm ai (95% CI 83.6

- 156 ppm ai) 96

- h NOAEC = 31.0 ppm ai

Slope = 4.63 (95% 2.33

- 6.92) Loss of equilibrium observed at 63 ppm ai and higher

Classified as practically non

- toxic MRID 00 098367 Rhoderick et. al

. , 19 81 (Unpublished) / Supplemental 0, 31, 63, 125, 250 and 500 ppm ai nominal

10 crabs per test concentration

FOSETYL

- AL /72

- 3 Acute Estuarine and Marine Organisms toxicity test

– Grass Shrimp ( Palaemonetes pugio ), ~1 month old, mean length of 19 mm, mean wet weight 0.17 g, static test, 2 1

- 2 2 o C, 8.0

- 8.2 pH, 22 ‰ salinity

Technical Fosetyl

- Al 95% fosetyl

- Al 96

- h EC 50 = 3.4 ppm ai (95% CI 2.1

- 5.4 ppm ai) 96

- h NOAEC = <1.0 ppm ai

Slope = 2.21 (95% CI 1.13

- 3.30)

Loss of equilibrium observed at 8.0 ppm ai and higher; 10% mortality at 1.0 ppm ai

Classified as moderately t oxic MRID 00 098368 Rhoderick et. al

. , 19 81 (Unpublished) / Acceptable 0, 1.0, 2.0, 4.0, 8.0, 15 ppm ai nominal

10 shrimp per test concentration

FOSETYL

- AL /72

- 3 Acute Estuarine and Marine Organisms toxicity test

– Eastern Oyster Embryo and Larvae ( Crassostrea virginica ), static test, 2 2±1 o C, 7.5

- 7.9 pH, 20 ‰ salinity

Technical Fosetyl

- Al 95% fosetyl

- Al 48

- h EC 50 = 1.85 ppm ai (95% CI 1.84

- 1.86 ppm ai) 48

- h NOAEC = 1.3 ppm ai

No slope, poor fit Classified as moderately t oxic MRID 00 147359 Bioassay department , 19 85 (Unpublished) / Acceptable 0, 0.66, 1.30, 2.02, 3.62, 6.52 and 10.1 ppm measured

FOSETYL

- AL/72

- 4 Aquatic Invertebrate Life

- cycle toxicity test

Waterflea ( Daphnia magna ), static renewal, 21°C, 6.9

- 7.8 (5.2

- 5.8 high conc) pH

Technical Fosetyl

- Al 95.9% fosetyl

- Al 21

- day NOAEC = 16 ppm ai (total) (based on survival)

Test solution appearance was not clearly stated, but t he analytical method indicated that many of the samples contained very fine particulate matter that was solubilized by digestion with

acid. Solutions not reported to be centrifuged/filtered prior to analysis. Growth not quantitatively measur ed. MRID 47395703 Sewell 1996 (unpublished)/ Supplemental / 0.96, 3.1, 9.6, 31 and 96 ppm ai (nominal) (0.5, 1.8, 4.2, 16, 84 ppm ai (measured))



### A .2.3. Plants

### Page 68 of 78 Table 5 Affec t of Fosetyl

- Al on Aquatic Plants

Chemical/Guideline No. / Study Type / Test Material EC 50 Endpoint Affected NOAEC Endpoint Affected Source / Study Classification and Exposure Groups

Nonvascular
FOSETYL

- AL/122

- 2 (Tier II) Algal toxicity test Freshwater Diatom Navicula pelliculosa

, freshwater, static 24±2 o C, 400±60 ftCandles/ Technical Fosetyl

- Al 98.5% fosetyl

- Al 7

- d EC 50 = 4.2 ppm ai (95% CI 2.1

- 8.3)

Slope = 2.12± 0.475 (SE) ( area under curve ) 7

- d NOAEC <1.58 ppm ai EC05 = 0.7 ppm ai (95% CI = 0.17

- 3.0)

(area under curve) MRID 41128601 Hughes 1989 / Acceptable 1.56, 2.72, 5.08, 9.13, 17.0, 27.8 ppm ai mean measured (0, 1.58, 2.76, 5.16, 9.27, 17.3, 28.2 ppm mean measured )

FOSETYL

- AL/122

- 2 (Tier II) Algal toxicity test blue

green algae Anabaena flos

aquae freshwater, static 24±2 o C, 2 00± 3 0 ftCandles/ Technical Fosetyl

- Al 98.5% fosetyl

- Al 7

- d EC 50 = 7.2 ppm ai (95% CI 6.1

- 8.6) Slope = 4.53±1.33 (SE) ( yield ) 7

- d NOAEC =4.9 ppm ai

( yield ) MRID 4 1128602 Hughes 1989 / Acceptable 0, 0.80, 1.16, 1.37, 3.97, 4.85, 8.26, 15.4 ppm ai mean measured ( 0.81, 1.18, 1.39, 4.03, 4.92, 8.39, 15.6 ppm mean measured )

FOSETYL

- AL/122

- 2 (Tier II) Algal toxicity test green algae Selenastrum capricornutum freshwater, static 24±2 o C, 4 00± 6 0 ftCandles/ Technical Fosetyl

- Al 98.5% fosetyl

- Al 7

- d EC 50 = 4.5 ppm ai (95% CI 4.1

- 4.9) Slope=5.25±0.343 (SE) ( area under curve ) 7

- d NOAEC =1.3 ppm ai

( area under curve ) MRID 4 1128604 Hughes 1989 / Acceptable 0, 1.31, 2.25, 4.22, 8.87, 12.3
ppm ai mean measured ( 1.33, 2.28, 4.28, 9.01, 12.5 ppm

mean measure d )

FOSETYL

- AL/122

- 2 (Tier II) Algal toxicity test marine diatom Skeletonema

costatum marine , static 2 0 ±2 o C, 4 00± 6 0 ftCandles/ Technical Fosetyl

- Al 98.5% fosetyl

- Al 7

- d EC 50 = 0.78 ppm ai (95% CI 0.3

- 2.0) Slope = 0.851±0.174

( yield ) 7

- d NOAEC =0.32 ppm ai

(yield ) MRID 4 1128605 Hughes 1989 / Acceptable 0, 0.32, 0.69, 1.00, 2.76, 4.54, 7.08 ppm ai mean measured ( 0.32, 0.70, 1.02, 2.80, 4.61, 7.19 ppm mean measured )

FOSETYL

- AL/850.5040 (Tier II) Algal toxicity test green algae Scenedesmus subspicatus freshwater, static 23

- 24 o C, 6580

- 7570 lux/ Technical Fosetyl

- Al 97.8% fosetyl

- Al 72

- hr EC 50 = 5.6 ppm ai

( area under the curve ) 72

- hr NOAEC =1. 4 ppm ai

( area under the curve ) MRID 4740871 9 Bell et. al

. 1999 / Supplemental 0, 0.63, 1.4, 2.9, 6.9, 16 and 35 ppm ai mean measured

### Page 69 of 78 Table 5 Affec t of Fosetyl

- Al on Aquatic Plants

Chemical/Guideline No. / Study Type / Test Material EC 50 Endpoint Affected NOAEC Endpoint Affected Source / Study Classification and Exposure Groups

FOSETYL

- AL/ 850.5040 (Tier II) Algal toxicity test green algae Scenedesmus subspicatus freshwater, static 22 o C, 5580

- 6950 lux/ Formulation EXP 10369F 79.4% fosetyl

- Al 72

- hr EC 50 =7.4 ppm ai

(cell density) 72

- hr NOAEC =1.7ppm ai

(cell density) MRID 47408718 Bell et. al

. 1999 / Supplemental 0, 1.7, 3.9, 7.8, 20, 38, 82 ppm ai mean measured

Vascular
FOSETYL

- AL/122

- 2 (Tier II) Algal toxicity test duckweed Lemna gibba freshwater , static 2 5 ±2 o C, 390

- 540 ftCandles/ Technical Fosetyl

- Al 98.5% fosetyl

- Al 14

- d EC 50 = 80ppm ai (95% CI 69

- 91) Slope =3.81±0.337

( frond count) 14

- d NOAEC =20.4 ppm ai

( frond count) MRID 4 1128603 Hughes 1989 / Acceptable 0, 12.0, 20.1, 40.4, 88.1, 160, 300 ppm ai mean measured ( 12.2, 20.4, 41.0, 89.4, 162, 305 ppm mean measured )

### Page 70 of 78 Appendix B

. MRID Bibliography for Environmental Fate and Toxicity Studies

71

- 1 Avian Single Dose Oral Toxicity

MRID Citation Reference

98360 Roberts, N.L.; Phillips, C.N.K. (1981) The Acute Oral Toxicity (LDI50^) of LS 74.783 to the Bobwhite Quail: RNP 189 WL/81148. Final rept. (Unpublished study received Apr 5, 1982 under 359

- 705; prepared by Huntingdon Research Centre, England, submitted by Rhone

Poulenc Chemical Co., Monmouth Junction, N.J.; CDL: 247184

- B)

98361 Ross, D.B.; Cameron, M.McD.; Roberts, N.L. (1977) The Acute Oral Toxicity (LDI50^) of LS 74.783 to the Japanese Quail: RNP76WL/ 77187. (Unpublished study received Apr 5, 1982 under 359

- 705; prepared by Huntingdon Research Centre, England, submitted by Rhone

Poulenc Chemical Co., Monm outh Junction, N.J.; CDL: 247184

- C)

71

- 2 Avian Dietary Toxicity

MRID Citation Reference

98362 Roberts, N.L.; Phillips, C.N.K.; Almond, R.H. (1982) The Subacute Dietary Toxicity (LC50) of LS 74.783 to the Bobwhite Quail: RNP 190 WL/81699. Fina l rept. (Unpublished study received Apr 5, 1982 under 359

- 705; prepared by Huntingdon Research Centre, England, submitted by Rhone

- Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247184

- D)

98363 Roberts, N.L.; Phillips, C.N.K.; Almond, R.H. (1981) The Subacute Dietary Toxicity (LCI50^) of LS 74.783 to the Mallard Duck: RNP 191 WL/81716. Final rept. (Unpublished study received Apr 5, 1982 under 359

- 705; prepared by Huntingdon Research Centre, Engla nd, submitted by Rhone

- Poulenc Chemical Co., Monmouth Junc

- tion, N.J.; CDL:247184

- E)

72

- 1 Acute Toxicity to Freshwater Fish

MRID Citation Reference

98364 Fraser, W.D.; Pell, I.B. (1977) The Acute Toxicity of LS.74.783 to the Rainbow Trout ( ?~Salmo gairdnerii~?): RNP78FT/7782. (Un

- published study received Apr 5, 1982 under 359

- 705; prepared by Huntingdon Research Centre, England, submitted by Rhone

- Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247184

- F)

98365 Fraser, W.D.; Pell, I.B. (1977) The Acute Toxicity of LS.74.783 to the Harlequin Fish (?~Rasbora heteromorpha~?): RNP78FT/77122. (Unpublished study received Apr 5, 1982 under 359

- 705; prepared by Huntingdon Research Centre, England, submitted by Rhone

- Poulenc Chemical Co., Monmou th Junction, N.J.; CDL:247184

- G)

119526 Spare, W.; Hutchinson, C. (1982) The Acute Toxicity of Fosetyl

- AL to the Bluegill Sunfish ...: Project No. 82

- E

- 380

- B. (Unpub

- lished study received Oct 28, 1982 under 359

- 705; prepared by Biospherics, Inc., submit ted by Rhone

- Poulenc, Inc., Monmouth Junction, NJ; CDL:248674

- A)

### Page 71 of 78 128944 Conzelmann, P.; Brady, S. (1983) Acute Toxicity Bioassay Testing Fosetyl

- AL on Rainbow Trout: GSRI Project No. 413

- B45

- 41. (Un

- published study received Jun 17, 1983 under 359

- 705; p repared by Gulf South Research Institute, submitted by Rhone Poulenc, Inc., Monmouth Junction, NJ; CDL:250499

- B)

72

- 2 Acute Toxicity to Freshwater Invertebrates

MRID Citation Reference

98366 Cole, J.H. (1976) The Acute Toxicity of LS 74

- 783 to~Daphnia~ ?~pulex~?: RNP77/76953. (Unpublished study received Apr 5, 1982 under 359

- 705; prepared by Huntingdon Research Centre, England, submitted by Rhone

- Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247184

- H)

127765 Spare, W.; Gottfried, G. (1 983) The Acute Toxicity of Fosetyl

- AL to Daphnia magna Straus: Biospherics Project No. 82

- E

- 380DM. (Unpublished study received Feb 4, 1983 under 359

- 705; prepared by Biospherics, Inc., submitted by Rhone

- Poulenc, Inc., Monmouth Junction, NJ; CDL:249478

- A)

128943 Spare, W.; Gottfried, G. (1983) The Acute Toxicity of Fosetyl

- AL to Daphnia magna Straus: Biospherics Project No. 82

- E

- 380DMR. (Unpublished study received Jun 17, 1983 under 359

- 705; prepared by Biospherics, Inc., submitted by Rhone

- Poulenc, Inc., Monmouth Junction, NJ; CDL:250499

- A)

72

- 3 Acute Toxicity to Estuarine/Marine Organisms

MRID Citation Reference

98367 Rhoderick , J.C.; Spare, W.C.; Hutchinson, C. (1981) The Acute Toxicity of Aluminum

- ethyl

phosphonate to the Fiddler Crab, Uca pugio: Project No. 381

- 1. (Unpublished study received Apr 5, 1982 under 359

- 705; prepared by Biospherics, Inc., sub

- mitted by Rhone

- Poulen c Chemical Co., Monmouth Junction, N.J.; CDL:247184

- I)

98368 Rhoderick, J.C.; Spare, W.C.; Hutchinson, C. (1981) The Acute Toxicity of Aluminum

- ethyl

phosphonate to Grass Shrimp, Palao

- monetes pugio: Project No. 381

- 2. (Unpublished study re

ceived Apr 5, 1982 under 359

- 705; prepared by Biospherics, Inc., submitted by Rhone

- Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247184

- J)

72

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

MRID Citation Reference

147359 Ward, G . (1985) Acute Toxicity of Fosetyl

- Al to Embryos and Larvae of the Eastern Oyster (Crassostrea virginica): ESE No. 85

- 314

- 0200

- 2130. Unpublished study prepared by Environmental Science and Engineering, Inc. 17 p.

147360 Suprenant , D. (1985) Acute Toxicity of Fosetyl

- Al to Sheepshead Minnow (Cyprinodon variegatus): Bionomics Report #BW

- 85

- 5

- 1777. Unpublished study prepared by Springborn Bionomics, Inc. 55 p.

### Page 72 of 78 81

- 1 Acute oral toxicity in rats

MRID Citation Reference

98330 Pasquet, J.; Mazuret, A.; Maratrat, ?; et al. (1977) LS 74

- 783 (Aluminium Ethyl Phosphite; 32 545 R.P., Aluminium Salt): Acute Toxicity in the Rat and Rabbit: R.P./R.D./C.N.G. No. 19 143

- E. (Translation; unpublished study received Apr 5, 1982 under 3 59

- 705; prepared by Rhone

Poulenc, France, submitted by Rhone

- Poulenc Chemical Co., Monmouth Junction, N.J.; CDL: 247160

- B)

98349 Pasquet, J.; Mazuret, A.; Maratrat, ? (1977) Phosphorous Acid (37 934 R.P.) and Disodium Phosphite (37 934 R.P., Disodium Sa lt): Acute Oral Toxicity in the Mouse and Rat: R.P./R.D./ C.N.G. No. 19 089

- E. (Translation; unpublished study received Apr 5, 1982 under 359

- 705; prepared by Rhone

- Poulenc, France, submitted by Rhone

- Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:2471 75

- A)

122781 Pasquet, J.; Mazuret, A.; Gaildrat, P.; et al. (1981) Fosetyl

- Al (32 545 R.P., Aluminium Salt); Aliette WP 80% (Wettable Powder Containing 80% Fosetyl

- Al); Acute Oral Toxicity in the Rat: Reference C.R. Vitry/C.N.G. No. 21 165

- E. (Translatio n; unpub

- lished study received Apr 5, 1982 under 359

- 706; prepared by Centre Nicolas Grillet, Fr., submitted by Rhone

- Poulenc, Inc., Monmouth Junction, NJ; CDL:247186

- B)

41039404 Siglin, J. (1988) Acute Oral Toxicity Study of Aliette Injectable in Rats

- - Limit Test (EPA): Final Rept.: Study No. 3147.7. Un

- published study prepared by Springborn Life Sciences, Inc. 20 p.

41641802 Kuhn, J. (1990) Aliette 80WDG: Acute Oral Toxicity Study in Rats: Lab Project Number: 6677

- 89. Unpublished study prepared by S tillmeadow, Inc. 25 p.

42273610 Rush, R. (1992) Acute Oral Toxicity Study in Rats with EXP 10100C: Final Report: Lab Project Number: 3147.117. Unpublished study prepared by Springborn Laboratories, Inc. 23 p.

42786703 Rush, R. (1992) Acute Oral Toxicit y Study in Rats with EXP 10361A W.G.: Final Report: Lab Project Number: 3147.143. Unpublished study prepared by Springborn Labs, Inc. 35 p.

43486401 Rieth, J. (1994) START WDG Cotton Fungicide: Response to PRS/RSB's Review of Acute Oral Toxicity and Skin Sensitization Studies (MRID Nos. 427867

- 03 and 427867

- 08). Unpublished study prepared by Rhone

- Poulenc Ag Co. 6 p.

83

- 4 2

- generation repro.

- ra t

MRID Citation Reference

98348 Palmer, A.K.; Bottomley , A.M.; Barton, S.J.; et al. (1981) Effect of LS 74

- 783 on Reproductive Function of Multiple Generations in the Rat: RNP/89/80745. (Unpublished study received Apr 5, 1982 under 359

- 705; prepared by Huntingdon Research Centre, England, submitted by Rhone

- Po ulenc Chemical Co., Monmouth Junc

- tion, N.J.; CDL:247174

- C)

114091 Palmer, A.; James, R. (1977) Effect of LS74

- 783 on Pregnancy of the Rat: (Ethylphosphite of Aluminum): RNP/33/76939. (Unpub

- lished study received Apr 5, 1982 under 359

- 705; prepared by Huntingdon Research Centre, Eng., submitted by Rhone

- Poulenc, Inc., Monmouth Junction, NJ; CDL:247174

- B)

123

- 2 Aquatic plant growth

### Page 73 of 78 MRID Citation Reference

41128601 Hughes, J. (1989) The Toxicity of Fosetyl

- Al to Navicula pelliculo

- sa: Proj . ID 1163

- 01

- 1100

- 3. Unpublished compilation prepared in cooperation with Malcolm Pirnie, Inc. and Biospherics Inc. 4 p.

41128602 Hughes, J. (1989) The Toxicity of Fosetyl

- Al to Anabaena flos

- aquae: Proj. ID 1163

- 01

- 1100

- 2. Unpublished compilation pre

- pared in cooperation with Malcolm Pirnie, Inc. and Biospherics Inc. 42 p.

41128603 Hughes, J. (1988) The Toxicity of Fosetyl

- Al to Lemna gibba G3: Proj. ID 1163

- 01

- 1100

- 5. Unpublished compilation prepared in cooperation with Malcolm Pirnie, Inc. and Bios pherics Inc. 40 p.

41128604 Hughes, J. (1989) The Toxicity of Fosetyl

- Al to Selenastrum capri

- cornutum: Proj. ID 1163

- 01

- 1100

- 1. Unpublished compilation pre

- pared in cooperation with Malcolm Pirnie, Inc. and Biospherics Inc. 41 p.

41128605 Hughes, J. (1989) The Toxicity of Fosetyl

- Al to Skeletonema costa

- tum: Proj. ID 1163

- 01

- 1100

- 4. Unpublished compilation prepared in cooperation with Malcolm Pirnie, Inc. and Rhone

Poulenc Ag Co. 30 p.

141

- 1 Honey bee acute contact

MRID Citation Reference

40676301 Hinken, C.; Dingledine, J.; Jaber, M. (1986) Fosetyl

- Al: An Acute Contact Toxicity Study with Honey Bees: Proj. No. 171

- 110. Un

- published study prepared by Wildlife International Ltd. 15
p.

161

- 1 Hydrolysis

MRID Citation Reference

98370 Buys, M.; Bertrand, A.; Giraud, J.P. (1981) Fosetyl

- al (Aluminium Tris

- O

- ethylphosphonate) Hydrolysis Study: Ref. AG/CRLD/An/AB/ MB/JPG/CB/613.81. (Unpublished study received Apr 5, 1982 under 359

- 705; prepared by Rhone

- Poulenc Agrochemie S.A., Fr ance, submitted by Rhone

- Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247185

- B)

98371 Bertrand, A. (1981) Fosetyl

- al: UV Absorption Characteristics: Ref. No. AG/CRLD/An/AB/DB/324/81. (Unpublished study received Apr 5, 1982 under 359

- 705; prepared by Rhone Poulenc Agrochimie, France, submitted by Rhone

- Poulenc Chemical Co., Monmouth Junc

- ti on, N.J.; CDL:247185

- C)

162

- 3 Anaerobic aquatic metab.

MRID Citation Reference

### Page 74 of 78 147361 Chabassol, Y. (1984) Anaerobic Aquatic Metabolism Study: Fosetyl

- Al: Ref. No. AG/CRLD/An/241.84. Unpublished study prepared by Rhone

- Poulenc Agrochimie. 57 p.

163

- 1 Leach/adsorp/desorption

MRID Citation Reference

98375 Buys, M.; Giraud, J.P. (1982) Fosetyl

- al (Aluminum Tris

- O

- ethyl

- phosphonate) Soil Leaching Studies: Ref. AG/CRLD/An/AB/MB/JPG/ CB/025.82. (Unpublished study received Apr 5, 1982 under 359

- 705; prepared by Rhone

- Poulenc Agrochimie, France, submitted by Rh one

- Poulenc Chemical Co., Monmouth Junction, N.J.; CDL: 247185

- G)

106019 Bertrand, A.; Buys, M. (1982) Fosetyl

- Al

-- Soil Sorption Studies: Ref. AG/CRLD/An/163.82. (Unpublished study received Jul 13, 1982 under 359

- 705; prepared by Rhone

- Poulenc Agrochimie S.A., Fr., submitted by Rhone

- Poulenc, Inc., Monmouth Junction, NJ; CDL:247820

- B)

835.1230 Sediment and soil absorption/desorption for parent and degradates

MRID Citation Reference

47408701 Buys, M. (1990) Fosetyl

- Al (Aluminum Tris

- O

- Ethylphosphonate): Soil Leaching Studies. Project Number: JPG/1, MB/1, MB/2. Unpublished study prepared by Rhone

- Poulenc Agrochemie. 49 p.

835.1240 Soil column leaching

MRID Citation Reference

474087 01 Buys, M. (1990) Fosetyl

- Al (Aluminum Tris

- O

- Ethylphosphonate): Soil Leaching Studies. Project Number: JPG/1, MB/1, MB/2. Unpublished study prepared by Rhone

- Poulenc Agrochemie. 49 p.

835.2110 Hydrolysis as a function of pH

MRID Citation Reference

47408702 Crowe, A. (2001) Fosetyl

- Aluminum: Hydrolysis Under Laboratory Conditions at pH 4, 7 and 9. Project Number: AES/042/012732, CO12596. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 30 p.

835.3300 Soil biodegradation

MRID Citation Reference

### Page 75 of 78 47408703 Mackie, J.; Philips, L. (1999) The Rate of Degradation of (Carbon 14)

- Fosetyl

- Al in Three Soils Under Aerobic Conditions at 20 Degrees Celsius . Project Number: 390519, 12546, R011664. Unpublished study prepared by Invere sk Research International. 85 p.

835.4100 Aerobic soil metabolism

MRID Citation Reference

47408703 Mackie, J.; Philips, L. (1999) The Rate of Degradation of (Carbon 14)

- Fosetyl

- Al in Three Soils Under Aerobic Conditions at 20 Degrees Celsius . Project Number: 390519, 12546, R011664. Unpublished study prepared by Inveresk Research International. 85 p.

850.1010 Aquatic invertebrate acute toxicity, test, freshwater daphnids

MRID Citation Reference

47395702 Bell, G. (1999) EXP10369F: Acute Toxicity to Daphnia Magna. Project Number: 646/994124. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 30 p.

47408704 Sewell, I. (1996) Fosettl

- Al: Acute Toxicity to Daphnia Magna. Project Number: 601401, R005424, 282/479. Unpublished s tudy prepared by Safepharm Laboratories, Ltd. 38 p.

850.1075 Fish acute toxicity test, freshwater and marine

MRID Citation Reference

47408705 Bell, G. (1999) Fosetyl

- Al: Acute Toxicity for Rainbow Trout (Oncorhynchus mykiss). Project Number: R014234, RNP/629/993803, 604528. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 29 p.

47408706 Wetton , P. (1997) Fosetyl

- Al: Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus). Project Number: 282/491, 446636, R011743. Unpublished study prepared by Safepharm Laboratories, Ltd. 41 p.

47408707 Latham, M. (1999) EXP10679A (Potassium Salts of Phosphoro us Acid): Determination of Acute Toxicity to Bluegill Sunfish (Lepomis Macrochirus). Project Number: AF0552/B, BL6508/B, R005931. Unpublished study prepared by Zeneca, Ltd. 17 p.

47408708 Bell, G. (1999) EXP 10369F: Acute Toxicity for Rainbow Trout (Oncor hynchus mykiss) . Project Number: RNP/632/993804, R011807, 604525. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 29 p.

850.1300 Daphnid chronic toxicity test

MRID Citation Reference

### Page 76 of 78 47395703 Sewell, I. (1996) Fosetyl

- Al: Daphnia Magna Reproduction Test. Project Number: 282/480. Unpublished study prepared by Safepharm Laboratories, Ltd. 80 p.

850.1400 Fish early

- life stage toxicity test

MRID Citation Reference

47408709 Wetton , P. (1997) Fosetyl

- Al: Fish, Juvenile Growth Test

- 28 Days. Project Number: 282/492, R011793, 602645. Unpublished study prepared by Safepharm Laboratories, Ltd. 78 p.

850.2100 Avian acute oral toxicity test

MRID Citation Reference

47408712 Gillham, A. (1999) EXP10369F: Acute Oral Toxicity (Lethal Dose 50) to Bobwhite Quail. Project Number: RNP/634/993102, R011797. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 43 p.

850.2300 Avian reproduction test

MRID Citation Referenc e

47408710 Gallagher, S.; Beavers, J.; Jaber, M. (1999) Fosetyl

- Aluminum: A Reproduction Study with the Japanese Quail (Coturnix coturnix japonica). Project Number: 171/138, R014231, 604145. Unpublished study prepared by Wildlife International, Ltd. 144 p.

850.3020 Honey bee acute contact toxicity

MRID Citation Reference

47418001 Schmitzer , S. (2000) Laboratory Testing for Toxicity (Acute Oral LD50) of EXP10679A (Potassium Salts of Phosphorous Acid) on Honey Bees (Apis mellifera L.) (Hymenoptera, Apidae): Final Report. Project Number: 8341036, B003052. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 25 p.

47418002 Schmitzer, S. (1999) Laboratory Testing for Toxicity (Acute Contact and Oral LD50) of EXP10369F on Honey Bees (Apis mellifera L.) (Hymenoptera, Apidae): Final Report. Project Number: 5961036 , 604490, R011801. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 29 p.

47418003 Schmitzer, S.; Stork, N. (1999) Laboratory Testing on the Acute Contact and Oral Toxicity of Fosetyl

- Al to Honey Bees (Apis mellifera L.) (Hymenoptera, Apidae): Final Report. Project Number: 6300036, 604366, R014232. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 29 p.

850.3040 Field testing for pollinators

### Page 77 of 78 MRID Citation Reference

47408716 Schur, A. (2000) Assessment of the Side Effects of Soil Application of EXP 10369F (Fosetyl

- Al 80% w/w) on the Honey Bee (Apis mellifera L.) under Semi

- Field Conditions: Final Report. Project Number: 20001108/01/BZEU, EXP/10369F. Unpublished study prepared by Arbeitsgemeinschaft GAB Biotechnologie. 46 p.

850.4100 Terrestrial plant toxicity, Tier 1 (seeding emergence)

MRID Citation Reference

47370502 Nguyen, D.; Gosch, H. (2005) Non

- Target Terrestrial Plants: An Evaluation of the Effects of Propamocarb

- fosetylate SL 840 in the Seedling Emergence Test (Tier 1). Project Number: SE05/01, EBPRX020. Unpublished study prepared by Bayer Cropscience Gmbh. 17 p.

850.4150 Terrestrial plant toxicity, Tier 1 (vegetative vigor)

MRID Citation Re ference

47370503 Nguyen, D.; Gosch, H. (2005) Non

- Target Terrestrial Plants: An Evaluation of the Effects of Propamocarb

- fosetylate SL 840 in the Vegetative Vigour Test (Tier 1). Project Number: VV05/01, EBPRX021. Unpublished study prepared by Bayer Cropscience Gmbh. 17 p.

850.4250 Vegetative vigor, Tier II

MRID Citation Reference

47395701 Teixeira, D. (2000) Aliette 80WG

- Determination of Effects on Vegetative Vigor of Six Plant Species. Project Number: 13726/6121. Unpublished study prepared by Springborn Laboratories, Inc. 101 p.

850.5400 Algal toxicity, Tiers 1 and II

MRID Citation Reference

47408717 Hutchings, M.; Latham, M.; Morris, D. (1999) EXP10679A (Potassium Salts of Phosphorous Acid): Toxicity to the Green Alga Selenastrum capricornutum. Project Number: BL6509/B, AF0552/C, R005933. Unpublished study prepared by Zeneca, Ltd. 23 p.

47408718 Bell , G. (1999) EXP 10369F: Algal Growth Inhibition Assay on Scenedesmus subspicatus. Project Number: RNP/633/994529, R011813. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 37 p.

47408719 Bell, G. (1999) Fosetyl

- Al: Algal Growth Inhibition Assa y on Scenedesmus subspicatus. Project Number: RNP/630/994528, R014235. Unpublished study prepared by Huntingdon Life

### Page 78 of 78 Sciences, Ltd. 41 p.

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