2 

# Preliminary Problem Formulation for the Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments in Support of the Registration Review of Starlicide

(3-chloro-p-toluidine hydrochloride) (CAS 7745-89-3)

P repared by: Christine Hartless, Wildlife Biologist R. David Jones, Senior Fate Scientist Christina DeMariano, Biologist U. S. Environmental Protection Agency Office of Pesticide Programs E

nvironmental Fate and Effects Division E

nvironmental Risk Branch I I 1200 Pennsylvania Ave., NW Mail Code 7507P Washington, DC 20460 R eviewed by: Brian Anderson, Branch Chief

September 1, 2011 

## NH 2



## Cl3 

### Table of Contents

1. Purpose ................................................................................................................... .................... 4 2. Nature of Regulatory Action ............................................................................................... ....... 4
3. Conclusions from Previous Risk Assessments .......................................................................... 4
4. Stressor Source and Distribution ........................................................................................... ..... 6
4.1. Mechanism of Action ..................................................................................................... ..... 6 4.2. Overview of Pesticide Usage ............................................................................................. . 6 4.3. Environmental Fate and Transport ..................................................................................... 10 5. Receptors.................................................................................................................. ................ 13 5.1. Effects to Aquatic Organisms ........................................................................................... 14 5.2. Effects to Terrestrial Organisms ....................................................................................... 14 5.3. Degradate toxicity ...................................................................................................... ....... 14 5.4. Ecological Incidents ..................................................................................................... ...... 15

6. Ecosystems Potentially at Risk .............................................................................................. 1 5 7. Assessment Endpoints ...................................................................................................... ....... 15 8. Conceptual Model ........................................................................................................... .......... 15 8.1. Risk Hypothesis .......................................................................................................... ....... 16 8.2. Conceptual Diagram ....................................................................................................... ... 16 9. Analysis Plan .............................................................................................................. .............. 19
9.1. Stressors of Concern .................................................................................................... ..... 19 9.2. Measures of Exposure .................................................................................................... ... 19
9.3. Measures of Effect ...................................................................................................... ...... 21 9.4. Integration of Exposure and Effects ................................................................................. 22 9.5. Endangered Species Assessments ..................................................................................... 22 9.6. Drinking Water Assessment ............................................................................................. 2 3

10. Endocrine Disruptor Screening Program ........................................................................... 23 11. Preliminary Identifica tion of Data Gaps ................................................................................ 2 4

11.1. Fate ................................................................................................................... ............... 24
11.2. Effects ................................................................................................................ ............. 27
12. References ............................................................................................................... ............... 31 Attachment 1: Non-guideline Study DCI Justifications ............................................................... 344 

## 1. Purpose

The purpose of this problem formulation is to pr ovide an understanding of the environmental fate and ecological effects of the registered us es of starlicide (3 -chloro-p-toluidine hydrochloride). Starlicide is an avicide used to control rave ns, starlings, crows, pigeons, cowbirds, grackles, blackbirds, magpies, and cert ain gull species. It is slow-acting and highly toxic to target species, with death occurring 1- 3 days after ingestion. Use sites vary by species but include livestock and poultry feedlots, bui ldings and fenced non-crop areas, Federal and State wildlife refuges and protected areas, gull col onies in coastal areas, and bird staging areas and roosting sites.

This document will provide a plan for analyzing data relevant to starlicide and for conducting environmental fate and ecologica l risk, endangered species, and dr inking water assessments for its registered uses. Additionally, this problem formulation is intended to identify data gaps, uncertainties, and potential assumptions used to address those uncertainties, relative to characterizing the ecological risk associated wi th the registered uses of starlicide.



## 2. Nature of Regulatory Action

The Food Quality Protection Act of 1996 mandate d the Environmental Protection Agency (EPA) to implement a new program for a ssessing the risks of pesticides, i.e ., registration review ( http://www.epa.gov/oppsrr d1/registration_review/ ). All pesticides distributed or sold in the United States generally must be registered by EPA. The decision to register a pesticide is based on the consideration of scientific data and other factors showing th at it will not cause unreasonable risks to human health, workers, or the environment when used as directed on product labeling. The registration re view program is intended to en sure that, as the ability to assess risk evolves and as policie s and practices change, all regist ered pesticides continue to meet the statutory standard of no unreasonabl e adverse effects to human health and the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the new registration review program, the Ag ency periodically reeval uates pesticides to ensure that as change occurs, products in the marketplace can be used safely.

As part of the implementation of the new Regist ration Review program purs uant to Section 3(g) of the Federal Insecticide, Fungi cide and Rodenticide Act (FIFRA), the Agency is beginning its evaluation to determine whether st arlicide continues to meet the FIFRA standard for registration. This problem formulation for the environmental fate and ecological risk assessment chapter in support of the registration review is intended for the initial dock et opening the public phase of the review process.



## 3. Conclusions from Previous Risk Assessments

The Agency has conducted previous ecological risk assessments on starlicide that serve as a basis for this problem formulation. Thes e are briefly summarized below.5 The starlicide RED was completed in 1995. Environm ental risk conclusions included non-target birds and mammals that may be at risk from eat ing starlicide treated bait (primary exposure), or, as scavengers and predators, from consuming animals who have eaten treated baits (secondary exposure). The risk to primary non-target bird po pulations was considered high for all uses of starlicide, as was the risk to endangered small mammals in ar eas treated with the highest application rates. In addition, st arlicide also posed acute risks to aquatic invertebrates. Based on the environmental and human health risk conc lusions, the Agency required risk reduction measures to mitigate mixer/loader and ecological risk. These included lowering the application rates on all broadcast app lications, which were as high as 0.5 lb a.i./acre, to 0.1 lb a.i./acre, requiring pre-baiting to ensure ra pid bait acceptance by target specie s, and restricting the use of treated baits to at least 50 ft. from bodies of water. In addi tion, because of its potential high risk to non-target mammals and birds, the only re maining starlicide end-use product which was classified for general use, was changed to restri cted use. The Agency also required a respirator for mixers/loaders of packages containing one p ound or more of starlicide concentrate, because of its presumed high acute inhalation toxicity. No ecological toxicity or fa te data were requested as a result of the RED.

The RED mitigations that addr essed ecological risk concerns have been implemented on a majority of the labels. All labels are classified as restricted use and ha ve application rates of ≤ 0.1 lbs a.i./acre/application. The majority of the labels clearly require treated baits to be used at least 50 ft. from bodies of water a nd require pre-baiting. Those labels that do not have these statements are listed below:

 EPA Reg. No. 67517-8 (Starlicide Complete)

o Does not include a statement required pl acing baits at least 50 ft. from water bodies.

o Language on label regarding prebaiting is: “Prebaiting with non-toxic pellets may be necessary to achieve desired results.”

 EPA Reg. No. 56228-29 (Compound DRC-1339 Concentr ate – livestock, nest and fodder depredations)

o Language on label regarding proximity to water: “DO NOT apply baits within 50 feet of permanent manmade or natural bodi es of water, unless baited sites are under constant observation while baits are exposed.”

 EPA SLN No. TX060016 (Compound DRC-1339 Concentrate – egg depredation of federal and/or state-designated T&E species – TX) Parent label is EPA Reg. No. 56228- 29.

o Does not include a statement required pl acing baits at least 50 ft. from water bodies.

o Parent label language is: “DO NOT appl y baits within 50 feet of permanent manmade or natural bodies of water, unless baited sites are under constant observation while baits are exposed.”

Since the RED was completed, EFED has conducted several risk assessments for new uses of starlicide through Sec tion 3s, Section 24Cs, and Section 18s. Ri sk concerns were similar to those outlined in the RED; a complete list of a ll currently stamped labels is presented in Section 4.2.6 

## 4. Stressor Source and Distribution

4.1. Mechanism of Action

Starlicide is an aniline avicide. The primary mode of action of DRC- 1339, following its ingestion by susceptible bird species appears to be that it ca uses irreversible necrosis of the kidney and the affected bird is subsequently unable to excret e uric acid. DRC-1339 itself is rapidly metabolized, excreted, and is apparently not accumulated in body tissues. Death usually occurs from uremia 1 to 3 days after most of the D RC-1339 has left the body (Knittle et al . 1990). In less sensitive bird species and in mammal species, central nervous system depressi on and the attendant cardiac or pulmonary arrest is the caus e of death (Schaefer 1984).


### 4.2. Overview of Pesticide Usage

Starlicide is labeled for use non- crop staging areas associated w ith roosts, peanut fields and pecan orchards, in and around feed and dairy lots , near target birds’ nests, industrial and commercial areas ( e.g., utility poles, rooftops, and electrical lines), with in fruit tree orchards, and in “decoy sunflower fields” ( i.e., sunflowers planted in an altern ative field to lure pest bird species from harvest). The Biological and Econo mic Analysis Division (B EAD) reported that no usage data were available for starlicide.

Table 1 lists all national end-us e product labels and Special Local Needs (SLN labels) with the associated application rates, met hods of application, maximum rates, and target species. This use information will form the basis of the starlicide exposure estimation for the registration review risk assessment. Starlicide is a restricted use pe sticide due to its potential high risk to non-target mammals and birds; its corrosiveness to eyes and skin; and presumed high acute inhalation toxicity.

Only one product is formulated as pre-mixed bait pellets (EPA Re g. No. 67517-8, Starlicide Complete). All other starlicide products are formulated as a c oncentrate with directions on the label for preparing the baits. The directions will vary depending on the type of baits ( e.g., rice, grains, dry dog food, cull French fries, fa t nuggets, hard-boiled eggs, meat chunks, and watermelon) that are specified on the label. For the majority of the baits, starlicide is applied by dissolving or suspending the avic ide in a solvent of water or oil and mixing the solution with bait. When the prepared bait appears coated, baits are dried before use.

As a result of the RED mitigation, all labels s hould require a pre-baiting period (specified as applying non-treated bait 1 to 3 da ys before treatment at same appl ication rate as treated bait). All labels except one (EPA Re g. No. 67517-8, Starlicide Complete ) include this requirement. Pretreatment observations must include: feeding habits, preferred feedi ng location, daily activity patterns, and population of target species as we ll as relative abundance and types of non-target species at baiting sites. Treated bait may not be placed in areas where there is danger of consumption by Endangered or Threatened species. After the daily patterns of target species have been assessed, appropriate bait ing locations can be selected.

The table below is designed to provide a summary of the use sites, applic ation rates, and target7 species. It does not provide all the detailed information that is available on each label ( e.g., types of bait for each label, mixing di rections, secondary target pests (only applicable when mixed in flocks of the primary target pests), carcass and residual bait collection, a nd specific listed species protections).

Table 1. Summary of Starlicide Labeled Uses as of March 23, 2011

Use site State and EPA Reg
No. Max. Single App. Rate

(lb a.i./ acre) Max. No. Apps. Max. annual rate

(lb a.i./acre) Application method of treated baits b Target pest

National labels Beef cattle, dairy cattle, swine, and poultry feedlots 56228-10 0.08 Not provided Not provided Manually place bait in stations, on the ground inside feedlots (with no animals present) or on the perimeter outside pen areas (if animals present) Brewer’s blackbird, Brown-headed cowbird, common grackle, red-winged blackbird, European starling

Nesting colonies and feeding
areas at airports, industrial sites, dumps, landfills,and noncrop areas. 56228-17 0.1 10 1.0 a Hand broadcast treated bait Herring gull, great black-backed gull, ring-billed gull, laughing gull (except locations where laughing gull is protected), western gull, California gull

Pigeons in and around
structuresand noncrop areas 56228-28 0.05 Not provided Not provided Hand broadcast treated bait on rooftops, bait containers, or bare ground (in fenced areas) Feral pigeons ( Columbia livia )8 Table 1. Summary of Starlicide Labeled Uses as of March 23, 2011

Use site State and EPA Reg
No. Max. Single App. Rate

(lb a.i./ acre) Max. No. Apps. Max. annual rate

(lb a.i./acre) Application method of treated baits b Target pest

Pasture and rangeland, refuges and other areas, within 25 ft of silage/ fodder bags 56228-29 0.083 Not provided Not provided Manual broadcast or placement in draw stations (fresh, unpoisoned carcass), dummy nests, or elevated wooden platforms Common raven, Chihuahuan raven, American crow, black-billed magpie, and fish

crow.

Non-crop staging

areas associated with roosts 56228-30 0.1 5 0.5 Feeding stations, mechanical broadcast, manual broadcast Boat-tailed grackle, brown-headed cowbird, common grackle, great-tailed grackle, red-winged blackbird, European starling
Livestock feedlots and poultry operations 67517-8 (sold as a prepared bait, 0.1% a.i.) 0.001 lb a.i./1000 linear feet Not provided 0.02 lb a.i/acre for lots >10
acres; 0.05 lb a.i./acre for lots < 10

acres Manual broadcast or feeding stations Starling, common grackle, brown headed cowbird, red-winged blackbird, Brewer’s blackbirds

Special Local Need labels Non-staging

areas associated with roost, feedlots,
non-crop areas, within fruit
trees ID - 050013 IN - 040001 IN - 080003 KY-020002 KY-020003 NM-030003 NV-020005 TN-080003 TN-080004 WV-010002 WV-040001 WY-070002 NE-100003 0.1 5 a 0.5 Manual or mechanical broadcast, livestock, bait containers, elevated platforms American/Common crow, European starlings, common
ravens, boat-tailedgrackles, brownheaded cowbirds, common grackles, great tailedgrackles, redwinged blackbirds rock doves and magpies9 Table 1. Summary of Starlicide Labeled Uses as of March 23, 2011

Use site State and EPA Reg
No. Max. Single App. Rate

(lb a.i./ acre) Max. No. Apps. Max. annual rate

(lb a.i./acre) Application method of treated baits b Target pest

Non-staging

areas associated with roost and pecan orchard MD-080005 MS-050008 OK-990001 TX-020003 WV-110001 0.09 5 a 0.5 Manual broadcast; bait station Common crow, fish

crow , American crows, fish crows, Chihuahua ravens,

common ravens

Nonharvesting areas of ripening commercial and “decoy” sunflower fields SD-980005 0.038 b Not reported Not reported Manual broadcast Red -winged blackbirds, yellowheaded black birds, Brewer's blackbirds,starlings, brownheaded cowbird and common grackles In and around feedlots and dairies ID-050014 0.08 5 a 0.4 Manual broadcast; feeding station Common ravens, American crows, black-billed magpies and pigeon Federal listed feedlots TX-090010 0.08 N/A Not reported Not reported Control target species

25 feet from listed areas; Dummy nest maybe constructed to house treated eggs NV-040004 0.083 1 a 0.083 Manual broadcast Common ravens and white necked

ravens

“Decoy sunflowers fields” ND-920001 0.04 12 a 0.5 Manual Broadcast Red -winged blackbirds, yellowheaded black birds, Brewer's blackbirds, European starlings, brown-headed cowbird and common grackles Staging

areas associated with roost TX-890001 0.04 5 a 0.2 Manual broadcast; bait station feral pigeons and roosting birds including starlings, common grackle, great-tailed grackle, brown headedcowbirds, and redwinged blackbirds10 Table 1. Summary of Starlicide Labeled Uses as of March 23, 2011

Use site State and EPA Reg
No. Max. Single App. Rate

(lb a.i./ acre) Max. No. Apps. Max. annual rate

(lb a.i./acre) Application method of treated baits b Target pest

Applied to stubble fields, open
grassy or bare grounds PA-050002 0.045 11 a 0.5 Manual broadcast, bait dispenser Common crows, fish crows

Bait stations at least 6 feet high OR-010024 0.1 Not reported Not reported Manual placement on platform Mag-pies

Near target species nest TX-060016 0.000043 lba.i. per hardboiled egg, maximum 18 eggs per bait site Not reported Not reported Manual placement Common grackle, great-tailedgrackles, boattailed grackle

a EFED calculated.
b Individual labels may allow a subset of these application methods



### 4.3. Environmental Fate and Transport

Based on submitted data, starlicide (3-chloro- p -toluidine) is expected to degrade rapidly in the presence of sunlight and be moderately mobile in the environment. Registrant-submitted data defining the physical, chemical, fate and transport characteristics associated with starlicide are summarized in Table 2 . The formation of degradates in an aerobic soil metabolism study suggests that this could also be a major route of dissipation, but the st udy is inadequate to quantify the rate of degradation. Starlicide is soluble in water (53.2 g/L) and has a relatively high Henry’s Law Constant, (1.47 x 10 -8 atm·m 3 ·mol -1 ), so it is not expected to volatilize significantly in the environment. It has an estimated pK a of 3.9 for protonation of the amine group; consequently, in soils at pH values >4.8, over 90 % of the starlicide will be in the free amine form, and in soils below pH 3, the ammonium i on form of starlicide will be the major species. No monitoring data are available for starlicid e in the environment and field studies to characterize starlicide’s fate and transport have not been conducte d. However, given starlicide’s use pattern is on baits for birds, it is likely that the major route of dissipation from the use site is consumption of the bait. Dissipation by the targ et species after cons umption has not been characterized.11 Table 2. General physico-chemical and envi ronmental fate properties of starlicide.

Parameter Value Reference

Selected Physical/Chemical Parameters

Structure

Molecular Weight 179.24 g·mol (salt) 143.70 g·mol (cation only) calculated

Water Solubility 53.2 g·L -1 at 30 o C MRID 41609301

Vapor pressure 1.06 x 10 -4 torr at 25 o C MRID 41609301

Density 0.44 kg·L -1 MRID 41609301

Henry's Law Constant 1.47 x 10 -8 atm·m 3 ·mol -1 calculated

Octanol/Water Partition Coefficient (K ow ) 0.022 estimated*

pK a 3.9 MRID 41609301

Hydrolysis t 1/2 p H 5
p H 7 pH 9 no evidence of degradation no evidence of degradation no evidence of degradation MRID 41760501

Aqueous Photolysis t 1⁄2 0.67 days MRID 42838801

Batch Equilibrium (K d ) 69 L·kg -1 – Menlo Park loam 3.7 L·kg -1 - EPA 14 silty clay

7.0 L·kg -1 – EPA 12 clay 3.7 L·kg -1 – ‘Ward’s’ sandy loam 8.8 L·kg -1 - ‘Ward’s’ clay loam MRID 43284502

Bioconcentration Factor Fish: 150 in viscera

33 in filet 88 in whole body MRID 43069801

* K ow estimated as the ratio of the solubilities in n-octanol and water at 30 oC. n-octanol solubility: 1.2 g·L -1 (MRID 41609301).

There is no evidence that starli cide degrades in water through hydrolysis at environmentally significant pH's in a single study at 3 pHs run over thirty days , but starlicide does degrade rapidly by photolysis in water. In a 30 hour test at pH 7, starlici de degraded with a half-life of NH 2

Cl12 1.25d in the test system, which would be equi valent 0.67 d in fall sunlight conditions. One degradate, 3-hydroxy-p-toluidine (HPT), was identif ied in the irradiated solution. HPT increased 46.8% after 18 hours of irradiation ( Table 3 ). A submitted aerobic soil metabolism study on a Kenyon loam provide some information on degrad ates formed by metabolism in soil but was inadequate for use in estimating degradation rates due to poor extrac tion. The degradate, Nacetyl-3-chloro-p-toluidine (ACPTH) , was found at 10.2% of the initial concentration of parent in the test system at 24 h afte r the initiation of the test.

Table 3. The maximum amount of degradates formed in laboratory fate studies by starlicide and the time when the maximum occurred. Degradate Aqueous Photolysis Aerobic Soil Metabolism BCF

CO 2 12.8% @ 99 d 3-hydroxy-p-toluidine 67% @ 14d

N-acetyl-3-chloro-p-toluidine 10.2% @ 1d max @ 28 d

An acceptable batch equilibrium study has not been conducted for starlicide. Soil-water partition coefficient (K d 's) were estimated using a kinetics st udy at a single concentration, were 69, 3.7, 7.0, 3.7, and 8.8 for the loam soil, two sandy loams, a silty clay, and a clay sediment, respectively (MRID 43284502).

Starlicide residues accumulated only slightly in bluegill sunfish exposed to starlicide hydrochloride at 0.1 mg/L for 28 days under flow-through conditions. Average calculated bioconcentration factors were 33x, 150x, and 88x for edible tissues (muscle), inedible tissues (carcass and viscera), and whole fish, respectiv ely. One major degradate, N-acetyl-3-chloro- 4- methylaniline, was identified from fish (all tissue substrates) collected after 28 days of exposure. Depuration was relatively slow; after 28 days of depuration, 54.3% of the accumulated residues were eliminated from the edible tissues, 64.1% from the non-edible tissues, and 63.4% from the NH 2

HO

NH

Cl13 whole fish (MRID 43069801)



## 5. Receptors

Consistent with the process described in th e Overview Document (USEPA 2004), the risk assessment for starlicide will rely on a surrogate species approach. Toxicological data generated from surrogate test species, which are intended to be representative of broad taxonomic groups, are used to extrapolate to potential effects on a variety of species (receptors) included under these taxonomic groupings.

Acute and chronic toxicity data from studies submitted by pesticide registrants along with the available open literature are used to evaluate the potential direct and indirect effects of starlicide on aquatic and terrestrial receptors. These include toxicity data on the technical grade active ingredient, degradates, and, when available, formulated products ( e.g . “Six-Pack” studies). The open literature studies are iden tified using EPA’s ECOTOX databa se which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestri al plants, and wildlife. The evaluation of both sources of data can also provi de insight into the dir ect and indirect effects of starlicide on biotic communities from loss of species that are sensitiv e to the chemical and from changes in structure and functional char acteristics of the affected communities.

Table 4 provides a summary of the taxonomic groups and the surrogate species tested to characterize the potential acute and ch ronic ecological effects of star licide. In addition, the table provides a preliminary overview of the potential acute toxicity of star licide by providing the acute toxicity classifications.

Table 4. Test Species Evaluated for Assessing Potential Ecological Effects of Starlicide and the Associated Acute Toxicity Classification.

Taxonomic Group Tested Species Acute Toxicity Endpoint Acute Study MRID and Toxicity Classification Chronic NOAEC

Birds 1 Bobwhite quail LD 50 = 2.94 mg a.i./kg-bwt (2.33, 4.56) Slope = 4.92 (2.18, 7.67) 417605-03 (acceptable) Very highly toxic No data
Bobwhite quail LC 50 = 14.08 mg a.i./kg-diet (8.67, 20.88) Slope = 2.78 (1.47, 4.08) 426718-02 (acceptable) Very highly toxic

Mammals Laboratory rat ( Rattus norvegicus ) LD 50 = 350 mg a.i./kg-bwt (male) LD 50 = 302 mg a.i./kg-btw (female) 41632101 (Acceptable 3 ) Moderately toxic No data

Insects No data No data

Freshwater fish 2 Rainbow trout LC 50 = 9.7 mg a.i./L (4.9, 14) Slope NA 41767502 (acceptable) moderately toxic No data

Freshwater invertebrates Daphnia magna EC 50 = 0.07 mg a.i./L (0.06, 0.09) Slope = 5.4 (3.0, 7.8) 41783701 (acceptable) Very highly toxic No data

Estuarine/marine No data No data14 Table 4. Test Species Evaluated for Assessing Potential Ecological Effects of Starlicide and the Associated Acute Toxicity Classification.

Taxonomic Group Tested Species Acute Toxicity Endpoint Acute Study MRID and Toxicity Classification Chronic NOAEC

fish Estuarine/marine

invertebrates No data No data
Terrestrial plants No data Aquatic plants and algae No data

1 Birds represent surrogates for terrestrial-phase amphibians and reptiles.
2 Freshwater fish may be surrogates for aquatic-phase amphibians.
3 Study classification made by Health Effects Division (HED). 

### 5.1. Effects to Aquatic Organisms

Technical grade starlicide is classified as mode rately toxic to freshwater fish, aquatic-phase amphibians and is very highly toxic to freshwat er aquatic invertebrates on an acute exposure basis. Data were not submitted to the Agency to allow for the estimation of acute toxicity to estuarine/marine fish and invertebrates, chronic to xicity to freshwater and estuarine/marine fish and invertebrates, or toxicity to vasc ular and non-vascular aquatic plants.


### 5.2. Effects to Terrestrial Organisms

Starlicide is very highly toxic to birds on an acute oral and sub acute dietary exposure basis and is moderately toxic to mammals on an acute oral exposure basis. Data were not submitted to the Agency to allow for the estimation of acute toxicity to terrestrial invertebrates, chronic toxicity to birds and mammals, or toxic ity to terrestrial plants.

Previous assessments utilized acute avian (m ourning dove and red-winge d blackbird) toxicity data from USDA/APHIS/Denver Wildlife Rese arch Center (DWRC) (MRID 412672-01). Recent review of the starlicide studies for mourning dove (LD 50 = 3.1 mg a.i./kg-bwt) and red-winged blackbird (LD 50 = 2.4 mg a.i./kg-bwt) classified both studies invalid since no control birds were included.


### 5.3. Degradate toxicity

Three major degradates have been identified in th e environmental fate stud ies: carbon dioxide in the aerobic soil metabolism study, 3-hydroxy-p-to luidine in the aqueous photolysis study, Nacetyl-3-chloro-p-toluidine in the aerobic soil metabolism study and the fish bioaccumulation study. The toxicity of the degradates, 3-hydroxy-p- toluidine and N-acetyl-3-chloro-p-toluidine, relative to the parent is not known. For the purpo ses of registration review environmental risk assessment, these degradates will be considered to be equally toxic to the parent. Based on structural analysis, an assumption of equal toxicity of parent and degradates appears reasonable. If information becomes available which indicates th at these degradates are not similarly toxic to the parent, the risk assessment will be altered accordingly.15 

### 5.4. Ecological Incidents

A review of the Ecological Incident Informa tion System (EIIS, version 2.1), the ‘Aggregate Incident Reports’ (AIR v. 1.0) database, and th e Avian Monitoring Information System (AIMS) for ecological incidents involving starlicide was completed on May 27, 2011. Two incidents were reported in EIIS, one incident was reporte d in AIMS, and no incide nts were reported in AIR; the degree of certainty ra nged between possible and probabl e. Mortalities of between 100 and 300 birds were reported for each incident; tw o incidents involved starlings and one involved cowbirds. These incidents will be discussed in further detail in the risk assessment. If information is available, further characteriza tion may include application rates and methods, intended targeted species, and legality of use. 

## 6. Ecosystems Potentially at Risk

The ecosystems potentially at risk are often extensive in scope; therefore, it may not be possible to identify specific ecosystems during the deve lopment of a nation-wide ecological risk assessment. However, in general terms, terrest rial ecosystems potentially at risk could include the treated field and immediately adjacent areas th at may receive drift or runoff. Areas adjacent to the treated field could incl ude cultivated fields, fencerow s and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats, and other un cultivated areas.

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



## 7. Assessment Endpoints

Assessment endpoints represent the ac tual environmental value that is to be protected, defined by an ecological entity (species, community, or other entity) and its attribute or characteristics (EPA 1998). For starlicide, the ecological entities include the following: birds, reptiles, terrestrialphase amphibians, mammals, freshwater fis h, freshwater aquatic- phase amphibians and invertebrates, estuarine/marine fish and invertebra tes, terrestrial plants, insects, aquatic plants, and algae. The attributes for each of these entiti es include growth, reproduction, and survival.



## 8. Conceptual Model

For a pesticide to pose an ecological risk, it mu st reach ecological receptors in biologically significant concentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological recepto r. For an ecological pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecological receptors, an d a feasible route of exposure.16 The conceptual model for starlicide provides a wr itten description and visual representation of the predicted relationships betw een starlicide, potential routes of exposure, and the predicted effects for the assessment endpoint. A conceptual model consists of two major components: risk hypothesis and a conceptual diagram (USEPA 1998).

As discussed previously, severa l ecological risk assessments ha ve been conducted by EFED for starlicide, including a na tional level risk assessment supporti ng the reregistration eligibility decision (USEPA 1995).



### 8.1. Risk Hypothesis

A risk hypothesis describes the predicted re lationship among the stre ssor, exposure, and assessment endpoint response along with the rationa le for their selection. For starlicide, the following ecological risk hypothesi s is being employed for this national-level ecological risk
assessment:

Starlicide, when used in accordance with current labels, can result in off-site movement of the compound via runoff leadi ng to exposure of non-target plants and animals. Consumption of treated bait and contaminat ed carcasses may serve as a major source of starlicide expos ure to wildlife. Exposure in these environmental compartments will result in adverse effects upon the survival, growth, and reproduction of non-target te rrestrial and aquatic organisms. These non-target organisms include federally-lis ted threatened and endangered species.



### 8.2. Conceptual Diagram

The conceptual model assumes that starlicide wi ll be available to non-ta rget organisms and, as toxic food bait, will adversely aff ect terrestrial species. The move ment away from the site of application in turn represents exposure pathways for a broad range of biological receptors of concern (non-target animals) and the potential attribute changes, i.e. , effects such as reduced survival, growth and reproduction, in the receptors due to starlicide exposure. Figure 1 illustrates the anticipated exposure pathways and transport r outes to ecological receptors and identifies the predicted attribute changes from this exposure. The major sources of exposure of non-target terrestrial animals are expected to be ingestion of the formulat ed food bait and consumption of vertebrate body tissues or inverteb rates that have eaten the food ba it. Exposure via these routes is expected primarily for birds and mammals, though it is likely that other te rrestrial animals such as reptiles and terrestrial amphi bians are at risk if they cons ume invertebrates or tissues of vertebrates that have eaten bait. Starlicide may also be consumed by target and non-target animals through ingestion of fecal material (coprophagy).

Terrestrial species may ingest starlicide by drinking contaminated water. St arlicide is applied on bait, and it binds only moderately to surfaces. He nce it is possible that it may partition into drinking water source ( e.g. puddles) compared to that which is available for direct consumption on the bait itself; therefore, this route of expos ure will be assessed. Since starlicide is not sprayed17 directly onto plants, and because so little is expected to leach fr om the bait and then be available for plant uptake, consumption of starlicide on pl ants is not being cons idered as a route of exposure. Aquatic species may ingest some ba it and may be exposed to starlicide via uptake through gills/integument. Dermal and inhalation r outes of exposure occur for some pesticides ( e.g ., foliar sprays). However, these are not exp ected to be important routes of exposure for grain-based, avicide food bait becau se starlicide is not volatile a nd is not expected to absorb appreciably through the skin.18Figure 1. Conceptual Model Diagram of Starlicide Exposure and Effects in Nontarget Species.Dotted lines indicate exposure pathwaysthat have a low likelihood of contributing to ecological risk.StressorTransportPathwaysRunoff into Water Bodies orStanding WaterConsumption byTerrestrialVertebratesDeposition on Ground: Intentional (Broadcast or HandApplication) or Incidental (Bait Station)ExposureMediaWater Body/ StandingWaterSedimentReceptorsUptake and/or Consumptionby Aquatic Vertebrates andInvertebrates and AquaticPlantsIngestion ofWater byTerrestrialVertebratesExposed Intact Bait atApplication SiteConsumption of Tissues(as prey or carcass) byPredators/ScavengersAttribute Changes(Direct Effect)Individual organisms:Reduced Reproduction andSurvival of Aquatic OrganismsIndividual Organisms:Reduced Reproduction and Survival of TerrestrialNon-Target OrganismsStarlicideLoaded BaitStationUptake byTerrestrialPlantsConsumption and/orUptake by SoilMacroinvertebratesAttribute Changes(Indirect Effect)Habitat Integrity:Altered plant communitiesFood Chain:ReducedpreybaseUpland/Riparian Soil(dislodging from grain andsorbing on to soil particles)19 

## 9. Analysis Plan

In order to address the risk hypot hesis, the potential for adverse effects on the environment is estimated. The use, environmental fate, and ecologi cal effects of starlicide are characterized and integrated to assess the risks. This is accomp lished using a risk quotient (ratio of exposure concentration to effects concentr ation) approach. Although risk is often defined as the likelihood and magnitude of adverse ecological effects, the risk quotient-based approach does not provide a quantitative estimate of likelihood and/or magnitude of an adverse effect. However, as outlined in the Overview Document (USEPA 2004), the likelihood of effects to individual organisms from particular uses of starlicide is estimated using the probit dose-respon se slope and either the level of concern (discussed below) or actual calculated risk quotient value.

This analysis plan will be revisited and may be revise d depending upon the information submitted by the public in response to the openi ng of the Registration Review docket for starlicide.



### 9.1. Stressors of Concern

The parent compound, starlici de (3-chloro-p-toluidine hydrochloride), is the t oxicant that will be assessed. Degradates (3-hydroxy-p-toluidine an d N-acetyl-3-chloro-p-toluidine) may be considered, but their toxicity is unknown. Toxi city of degradates will be assumed to be equivalent to parent compound in the ab sence of data to suggest otherwise.

Evaluation of pesticide mixtures is beyond the sc ope of this assessment because of the myriad factors that cannot be qu antified based on the available data. Those factors incl ude identification of other possible co-contaminant s and their concentrations, di fferences in the pattern and duration of exposure among contamin ants, and the differential eff ects of other physical/chemical characteristics of the receiving waters ( e.g. organic matter present in sediment and suspended water). Evaluation of factors that could influence additivity/synergism is beyond the scope of this assessment and the capabilities of th e available data to allow for an evaluation. However, it is acknowledged that not consider ing mixtures could over- or under-estimate risks depending on the type of interaction and fact ors discussed above. The asse ssment will, however, analyze the toxicity of formulated produc ts (including formulations i nvolving more than one active ingredient) and will determine whether formulated products are more toxic than the technical grade active ingredient data used for asse ssing both direct an d indirect risks.


### 9.2. Measures of Exposure

In order to estimate risks of starlicide exposur es in aquatic and terres trial environments, all exposure modeling and resulting risk conclusion s will be based on maximum application rates and methods cited in Table 1 and will be estimated for each use of starlicide. Measures of exposure are based on aquatic a nd terrestrial models that pr edict estimated environmental concentrations (EECs) of starli cide. The model used to predic t Tier 1 aquatic EECs is GENEEC. If Tier 1 EECs result in LOC exceedances, a Ti er 2 assessment will be performed using PRZM20 and EXAMS. In addition, primary exposure to bait and secondary e xposure to starlicide poisoned carcasses will be considered for measures of exposure to terrestrial organisms. This assessment only considered exposure a nd toxicity to parent starlicide.

9.2.1 Estimating Aquatic Exposure

The exposure assessment for this use is being co nducted at the first tier using the GENEEC model, version 2.0, dated August 1, 2001. GENEEC is a metamodel of the Tier 2 models PRZM and EXAMS and as such mimics the output of th ese models. However, GENEEC is hard-wired to a single, high exposure scenario which is intend ed to be protective of aquatic environments for all crops on a national basis. While applic ation to control nuisa nce birds is not per se to an agricultural crop, the similarities are sufficient that EECs generated by GENEEC would still be expected to be protective of app lications of starlicide on a nationa l basis. Rather than the timeseries of concentration that is the output at Tier 2, GENEEC pr oduces point estimates of 1-in-10 year peaks and means of specified duration ( e.g. 4 day mean, 21-day mean) based on a more limited set of input data. If risks are above leve ls of concern at Tier 1 using GENEEC, more refined modeling at Tier 2 can be conducted whic h considers crop specific location information and additional fate data such as vapor pressure.

While the specific scenario built into GENEEC is a 10 ha field draining into a 1 ha pond, 2 meters deep, with no outlet, this scenario is intend ed to serve as a surrogate for a wide variety of small vulnerable water bodies that occur near the top of watersheds. These include prairie potholes, swamps, bogs, and other wetlands, playa lakes, and zero and fi rst-order streams. Larger water bodies such as second-order and highe r streams and rivers, a nd lakes reservoirs, are expected to be less vulnerable (lower EECs) th an the standard pond built into GENEEC as they large dilution ratios, and they are unlikely to have 100% of the watershed committed to one use pattern. The 1-in-10 year peak is used for estima ting acute exposures of di rect effects to aquatic organisms. The 1-in-10-year 60-day mean is us ed for assessing chronic exposure to fish and aquatic-phase amphibians. The 1-in-10-year 21-d ay mean is used for assessing chronic exposure to aquatic invertebrates.

9.2.2 Estimating Primary Terrestrial Exposure

EFED’s exposure assessment for avicide differs fr om that for most other pesticides. For an avicide, the bait itself is the pot ential food item of concern. Thus, the amount of active ingredient in the formulated bait is used as an EEC. This information is used to estimate the amount of grain bait that birds and mammals of various sizes need to consume to obtain a dose expected to be lethal to 50% of the i ndividuals in the population ( i.e., LD 50 dose). Estimates of foodingestion rates (g dry matter per day) are dete rmined from established allometric equations presented in the Wildlife Exposure Factors Handbook (USEPA 1993). The concentration of starlicide in grain bait is also used to estimate initial dietary exposure (mg a.i. per kg in bait) which in turn is used to calculate avian and mammalian dietary RQs.

9.2.3 Estimating Secondary Terrestrial Exposure

Secondary exposure analysis (from carcass) requires consideration of residues in tissues of target21 and non-target organisms that are commonly cons umed by predators and scavengers. Moreover, it is important to know how long the residue persists in body tissues. Estimated residue concentrations in carcasses may be estimated in several ways depending on available data. If residue concentrations for target or non-target animals fed starlicide are available, these data can be used to estimate starlicide body burden. A se cond approach is to es timate the quantity of starlicide a primary consumer must ingest to r each mortality; this inta ke amount will then be converted to a body burden estimate. The method(s ) used in the registration review assessment will be determined upon evaluati on of all available data.



### 9.3. Measures of Effect

Ecological effect data are used as measures of di rect and indirect effect s to biological receptors. Data were obtained from registrant-submitted st udies or from literature studies identified by ECOTOX. The ECOTOXicology databa se (ECOTOX) will be searched in order to provide more ecological effects data to bridge existing data gaps. ECOTOX is a source for locating single chemical toxicity data and potential chemical mi xture toxicity data for aquatic life, terrestrial plants, and wildlife. ECOTOX wa s created and is maintained by the USEPA, Office of Research and Development, and the National Health and Environmental Effects Research Laboratory's Mid-Continent Ecology Division. In addition, available toxicity da ta from federal laboratories will be evaluated and used as applicable.

Information on the potential effects of starlicide on non-target animals is al so collected from the Ecological Incident Information System. The EI IS is a database cont aining adverse effect (typically mortality) reports on non-target organism s where such effects have been associated with the use of pesticides.

Where available, sublethal effects observed in both registrant-submitted and open literature studies will be evaluated qualitatively. Such effects have included behavioral changes ( e.g. , lethargy, changes in coloration a nd effects olfaction). Quantita tive assessments of risks, though, are limited to those endpoints that can be direc tly linked to the Agency’s assessment endpoints of impaired survival, growth and reproduction.

The assessment of risk for direct effects to non-target organisms makes the assumption that toxicity of starlicide to birds is similar to te rrestrial-phase amphibians and reptiles. The same assumption is made for fish a nd aquatic-phase amphibians.

The acute measures of effect used for animals in this screening-level assessment are the LD 50 , LC 50 and EC 50 . LD stands for "Lethal Dose", and LD 50 is the amount of a material, given all at once, that is estimated to cause the death of 50% of the test orga nisms. LC stands for “Lethal Concentration” and LC 50 is the concentration of a chemical that is estimated to kill 50% of the test organisms. EC stands for “Effective Concentration” and the EC 50 is the concentration of a chemical that is estimated to produce a specific e ffect in 50% of the test organisms. Endpoints for chronic measures of exposure for listed and non-listed animals are the NOAEL/NOAEC and NOEC. NOAEL stands for “No Observed-Adverse-E ffect-Level” and refers to the highest tested dose of a substance that has been reported to have no harmful (adverse) effects on test22 organisms. The NOAEC ( i.e. , “No-Observed-Adverse-Effect-Concen tration”) is the highest test concentration at which none of the observed effects were statistically different from the control. The NOEC is the No-Observed-Effects-Concen tration. For non-liste d plants, only acute exposures are assessed ( i.e. , EC 25 for terrestrial plants and EC 50 for aquatic plants); for listed plants, either the NOAEC or EC 05 is used.


### 9.4. Integration of Exposure and Effects

Risk characterization is the integration of e xposure and ecological effects characterization to determine the potential ecological risk from the use of starlicide on crops listed in Table 1 and the likelihood of direct and indi rect effects to non-target organi sms in aquatic and terrestrial habitats. The exposure and toxicity effects data ar e integrated in order to evaluate the risks of adverse ecological effects on non-targ et species. For the assessment of starlicide risks, the risk quotient (RQ) method is used to compare exposur e and measured toxicity values. EECs are divided by acute and chronic toxicity values. The resulting RQs are then compared to the Agency’s LOCs (USEPA 2004). Th ese criteria are used to indicat e when starlicide’s uses, as directed on the label, have the potential to cause adverse direct or indirect effects to non-target organisms. As noted previously, where data are l acking on the toxicity of starlicide, risk will be presumed.

9.4.1. Deterministic and Probab ilistic Assessment Methods

The quantitative assessment of risk will primarily depend on the deterministic point-estimate based approach described in the risk assessment. An effort will be made to further qualitatively describe risk using probabilistic tools that the Agency has developed. These tools have been reviewed by FIFRA Scientific Advisory Panels and have been deemed as appropriate means of refining assessments where deterministic approaches have identified risks.



### 9.5. Endangered Species Assessments

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

The assessment of effects associated with the registration of starlicide is based on an action area. The action area is considered to be the area directly or indirectly affected by the federal action, as indicated by the exceedance of Agency LOCs used to evaluate direct or indirect effects. The Agency’s approach to defining the action area un der the provisions of the Overview Document (USEPA 2004) considers the resu lts of the risk assessment pro cess to establish boundaries for that action area with the unders tanding that exposures below the Agency’s defined LOCs constitute a no-effect threshold. For the purposes of this assessment, attention will be focused on the footprint of the action ( i.e ., the area where starlicide applica tion occurs), plus all areas where offsite transport may result in potential exposur e that exceeds the Agency’s LOCs. Specific23 measures of ecological effect that define the action area for listed species include any direct and indirect effects and/or potential modification of its critical habitat, including reduction in survival, growth, and reproduction as well as the full suite of sub-le thal effects available in the effects literature. Therefore, the action area ex tends to a point where environmental exposures are below any measured lethal or sub-lethal eff ect threshold for any biological entity at the whole organism, organ, tissue, and/or cellular level of organization. In situations where it is not possible to determine the threshold for an observe d effect, the action area is not spatially limited and is assumed to be the entire United States.



### 9.6. Drinking Water Assessment

A drinking water assessment will not be performe d for starlicide because there are no food uses for this pesticide. Drinking water assessments ar e performed to support dietary risk assessments and dietary risk assessments are only required to support tolerances for use of food crops. Since there is no food use for starlicid e, no tolerance is required.



## 10. Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its reregistration decision, EPA reviewed th ese data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), starlicide is su bject to the endocrine screening part of the Endocrine Di sruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects caused by the substance, 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. Between24 October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pest icide active ingredients and 9 inert ingredients. Starlicide is not among the group of 58 pesticide active ingredient s on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issu e future EDSP orders/data callins, requiring the submission of EDSP screening assays for starli cide. For further information on the status of the EDSP, the policie s and procedures, the lis t of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.


## 11. Preliminary Identification of Data Gaps

11.1. Fate

The Agency is currently requesting the following fate and transport studies ( Table 5 ) to support registration review of starlicide:

 835.1230 – soil column leaching

 835.1240 – adsorption/desorption

 835.2410 – photodegradation on soil

 835.4100 – aerobic soil metabolism

 835.4300 – aerobic aquatic metabolism

 835.4400 – anaerobic aquatic metabolism

 835.6100 – terrestrial field dissipation

- environmental chemistry method : soil

 835.6200 – aquatic field dissipation

- environmental chemistry method : water

Either the soil column leaching or the adsorpti on desorption study is required to satisfy the mobility data requirement. The adsorption deso rption study is preferred, but the soil column leaching study can be used when the pesticide de grades too rapidly to be measured by a batch equilibrium study. The Agency currently has no environmental metabolism study which is sufficient to estimate degradation rates. In addition, data requirement have changed since reregistration of starlicide and anaerobic so il metabolism, aerobic aquatic metabolism, and anaerobic aquatic metabolism studies are now re quired for all compound with terrestrial outdoor use. Note that four soils are now required to support the aerobic soil metabolism data requirement. The anaerobic soil metabolism study is required for these us e patterns in the CFR Part 158 but this study will not produce data which w ill be used in the risk assessment so it is not being requested. If metabolism data are not submitted which can be used to quantify the degradation rate, the Agency will conservative estimation techniques based on the appearance of degradates, or by assuming the starlicide does not de grade. A terrestrial fi eld dissipation study is required to support outdoor uses. However, feedi ng or efficacy studies which track the rate of consumption of bait and show that the most of the bait is consumed by the target species can be submitted to support the field dissipation require ment. An Environmental Chemistry Method for25 Soil is required to support th e field dissipation study. An Envi ronmental Chemistry Method for Water is also needed as there are aquatic ri sks exceeding the level of concern in the RED.26 Table 5. Available environmen tal fate data for starlicide

158 Guideline (OPPTS) Description MRID Classification Guideline Fulfilled? Comments

835.1230 (163-1) Leaching 43284503 unacceptable No Study did not address degradates;

835.1240 (163-1) Adsorption/Desorption 43284502 supplemental No new study required

835.1410

(163-2) Laboratory Volatility not required Yes

835.2120

(161-1) Hydrolysis 41760501 acceptable Yes

835.2240

(161-2) Photodegradation in
water 42830601 42838801 acceptable Yes

835.2370 (161-4) Photodegradation in air not required Yes

835.2410 (161-3) Photodegradation on soil No no data; study required

835.4100

(162-1) Aerobic soil metabolism 43284501 supplemental No rate not quantified; replacement study required

835.4200 (162-2) Anaerobic soil metabolism required No not being requested – not needed for risk
assessment

835.4300

(162-4) Aerobic aquatic metabolism required No study required

835.4400

(162-3) Anaerobic Aquatic Metabolism required No study required

835.6100

(164-1) Terrestrial Field Dissipation required No study required

835.6200 (164-2) Aquatic Field Dissipation not required Yes

835-6300 (164-3) Forestry Field Dissipation not required Yes

850.1730 (165-4) Fish Bioconcentration Factor 43069801 acceptable Yes

NGS Drinking Water Treatment not required Yes

835.6100 Footnote 7 Environmental Chemistry Method in soil required No supports field dissipation; required

835.6200 Footnote 7 Environmental Chemistry Method in Water required No required as there are aquatic LOC exceedances in RED27 

### 11.2. Effects

Although many submissions have been made to pr ovide data on the eff ects of starlicide to aquatic and terrestrial organisms, data gaps still exist ( Tables 6-8 ). Since the RED was signed, the Agency has finalized its update to the data requirements in 40 CFR part 158. These updated data requirements were promulgated in 2007 and 2008.

11.2.1 Toxicity of Starlicide to Terrestrial Animals

Acute passerine toxicity (850.2100)

Previous assessments utilized acute avian (m ourning dove and red-winge d blackbird) toxicity data from USDA/APHIS/Denver Wildlife Rese arch Center (DWRC) (MRID 412672-01). Recent review of the starlicide studies for mourning dove (LD 50 = 3.1 mg a.i./kg-bwt) and red-winged blackbird (LD 50 = 2.4 mg a.i./kg-bwt) classified both studies invalid since no control birds were included. The revised Part 158 data requirements speci fy that acute avian or al toxicity data be submitted for either one waterfowl or one upland game species and one passerine species. The available acute oral toxicity data, when compar ed to estimated envir onmental concentrations, indicate that levels of concern are exceeded for birds on an acute basis. Because passerine species have higher metabolic rates due to their smaller sizes than either waterfowl or upland game bird species and because they may utilize di fferent metabolic pathways, they may be more or less sensitive to starlicide. In order to properly characterize risk to passerines, an avian oral toxicity test is required for passerine birds. A passerine study protocol must be submitted for review by the Agency prior to in itiation of the study. These data will be used to refine the screening-level risk assessment by determining wh ether there are differences in avian species sensitivity to starlicide between currently test ed passerine and upland game and/or waterfowl species that are beyond the simple allometric predictions curren tly employed in the absence of such passerine data. The current extrapolation method may be under- or over-estimating risks to passerines.

Chronic avian toxicity (850.2300)

No avian reproduction studies have been submitte d. The RED did not identify a chronic concern for the use of starlicide since the expected expo sure time was expected to be short. Now two avian reproduction studies, one with a waterfowl and one with an upland game bird, are required to support all terrestrial use patterns. Because so me pesticides are stable in the environment or can be stored in plant tissues that may be us ed by birds as a food source, avian reproduction testing (guideline 850.2300) was conditionally require d for pesticides to which birds are exposed repeatedly or continuously during or preceding the breeding season. In addition, research has shown that even short-term exposures to pestic ides can lead to signi ficant adverse reproductive effects and that adverse effects on avian reproduc tion can occur at levels of exposure several magnitudes lower than those that can cause acu tely toxic effects. For example, several organophosphorus insecticides have been shown to significantly reduce egg production and lead to changes in eggshell quality within days of dietary exposure. These data will be used to identify potential chronic risks to non-target bird s from exposure to starlicide. The data will reduce uncertainties associated with the curren t risk assessment for birds and will improve the28 Agency’s understanding of the pot ential effects of starlicide on terrestrial species. If chronic effects data are not submitted, than chronic risk to birds from exposure to starlicide will be assumed.

Acute honeybee oral toxicity (non-guideline)

At this time, no data are availabl e to define the toxicity of star licide to honey bees on an acute exposure basis. Given that the la bels prescribe that the pesticid e be coated on baits (many of which would be attractive to ins ects); terrestrial invertebrates have the potential to be exposed to starlicide by contacting and consum ing the bait. It is expected th at the major exposure route for non-target insects would be thr ough consumption, not through c ontact. Therefore, EFED is requesting that the registrant submit an acu te oral exposure study with honey bees (nonguideline). A DCI justificat ion table is included as Attachment 1. Although this is not an EPA guideline study, guidelines are available. For exam ple, OECD has an acute oral toxicity study with honey bees (OECD 213). These data will be us ed to identify potential risks to non-target, terrestrial invertebrates, including pollinators, from acute exposure to starlicide. The data will reduce uncertainties associated with the current risk assessment for terrestrial insects and will improve the Agency’s understanding of the potential effects of starlic ide on terrestrial species. If acute oral effects data are not submitted, than risk to terrestrial insects from acute exposure to starlicide will be assumed.

Table 6. Available ecological effects data for terrestrial animals exposed to technical starlicide.

158 Guideline (OPPTS) Description MRID/ Accession Classification Guideline Fulfilled? Comments

850.2100

(71-1) Avian oral toxicity 41760502, 41760503 Acceptable Acceptable No Requesting acute oral for passerine species

850.2200

(71-2) Avian dietary toxicity 42671801 42671802 Acceptable Acceptable Yes

850.2300

(71-4) Avian reproduction No data No Requesting avian reproduction for both bobwhite quail and mallard duck

850.3020 (141-1) Honeybee acute contact toxicity No data No Requesting honeybee acute oral in lieu of this study

NGS Honeybee acute oral NA a Requesting honeybee acute oral in lieu of the 850.3020

a NA – Not applicable, non-OCSPP guideline study.29 11.2.1 Toxicity of Starlici de to Aquatic Animals

Acute saltwater fish (850.1075), acute mysid (850.1035), and oyster shell growth (850.1025)

Estuarine/marine fish and invert ebrate acute toxicity studies ar e now required using the TGAI to support all outdoor end-use product uses. No estuarin e/marine fish or invertebrate studies have been submitted to the Agency that could be used for risk assessment. Starlicide can be applied to areas that could be in close pr oximity to estuarine/marine envi ronments such as airports and industrial sites for which the targets are a vari ety of gull species. (EPA Reg. No. 56228-17). All of the estuarine aquatic toxicity studies would allow the Agency to refine the screening level risk assessment of the RED. The Agency would be able to assess the potential risks to marine/estuarine organisms in future risk as sessments, including the li kelihood that the use of starlicide can potentially impact endangered species in aquatic communities, either by direct effects on fish and/or invert ebrates or by indirect effect s by reducing food sources.

Freshwater invertebr ate lifecycle (850.1300)

One freshwater invertebra te life-cycle study is required to su pport all terrestrial use patterns. The potential chronic risk of starlic ide to freshwater invertebrates is indicated by the fact that starlicide is very highly toxic on an acute basis to freshwater invertebrates. These data are critical to insure the Agency can accurately calculate ch ronic risk to freshwater invertebrates. The acute toxicity of starlicide to freshwater invertebrates indicat es the potential chronic risk to animals in this taxon. Based on GENEEC runs from the RED, the 21-day EEC was 3.78 μg/L; therefore, if the chronic NOAEC fo r freshwater invertebrates was ≤ 3.78 μg/L, the chronic LOC (=1) would be exceeded. The LC 50 for daphnids is 70 μg/L; th erefore, the chronic NOAEC would only need to be one order of magnitude lower than the acute endpoint. This difference between acute and chronic toxicity endpoints is very reasonable and is frequently seen in pesticide data. Without this study, the Agency w ould have to presume chr onic risk to listed and non-listed freshwater invertebrates, but w ould not be able to quantify the risk.30 Table 7. Available ecological effects data for aquatic animals exposed to technical starlicide.

Guideline Description MRID/ Accession Classification Guideline Fulfilled? Comments

850.1075

(72-1) Freshwater fish – Acute toxicity 41767501 41676502 Acceptable Acceptable Yes

850.1075

(72-3) Saltwater fish – Acute toxicity No data No Requesting for one species

850.1010

(72-2) Freshwater invertebrates – Acute toxicity 41783701 Acceptable Yes

850.1025 850.1035

(72-3) Saltwater invertebrates – Acute toxicity 41783701 Invalid No Requesting for mysid and oyster shell growth

850.1300

(72-4) Freshwater invertebrate – life cycle test No data No Requesting for daphnid

850.1350

(72-4) Saltwater invertebrates – life cycle test No data No Data have not been submitted to fulfill this guideline. A data gap was not identified as these data are not necessary for risk assessment at this time.

850.1400

(72-4) Freshwater fish – early life stage test No data No Data have not been submitted to fulfill this guideline. A data gap was not identified as these data are not necessary for risk assessment at this time.

850.1400

(72-4) Saltwater fish – early life stage test No data No Data have not been submitted to fulfill this guideline. A data gap was not identified as these data are not necessary for risk assessment at this time.

850.1500

(72-5) Fish – life cycle test No data No Data have not been submitted to fulfill this guideline. A data gap was not identified as these data are not necessary for risk assessment at this time.

11.2.1 Toxicity of St arlicide to Plants

No toxicity data are currently available to assess the risk of starlicide to terrestrial or aquatic plants. Since starlicide has te rrestrial outdoor uses, Tier II s eedling emergence, aquatic, and aquatic non-vascular studies are required. Tier I and/or II vegetative vigor studies are not requested at this time since dr ift is not expected to be a si gnificant exposure route. For the required terrestrial and aquatic pl ant studies, the registrant may c hoose to submit Tier I studies to the Agency, and if these demonstrate that starlicide at the maximum expected exposure concentrations has no effect on growth and/or survival of plants, the Agency may consider the31 Tier II requirements to be met.

These phytotoxicity data are needed to evaluate the level of pe sticide exposure to non-target terrestrial and aquatic plants and to assess the im pact of pesticides on endangered and threatened plants. Without these data, the Agency would ha ve to presume risk to listed and non-listed plants, but would not be able to quantify the risk. Presumption of ri sk to non-listed terrestrial and aquatic plants would result in the presumption of risk on other taxa th rough the potential for indirect effects by changes in ha bitat and re duction in food sources.

Table 8. Available ecological effects data fo r terrestrial and aquatic plants exposed to starlicide and remaining data gaps.

Guideline Description MRID Classification Guideline Fulfilled? Comments

850.4100 (122-1) Terrestrial Plant toxicity: Tier I seedling
emergence No data No Data have not been submitted to fulfill this guideline. A data gap was not identified as these data are not necessary for risk assessment at this time.

850.4100 (123-1) Terrestrial Plant toxicity: Tier 2 seedling emergence No data No Requesting Tier II study for ten species

850.4150 (122-1) Terrestrial Plant toxicity: Tier I vegetative vigor No data No Data have not been submitted to fulfill this guideline. A data gap was not identified as these data are not necessary for risk assessment at this time.

850.4150 (123-1) Terrestrial Plant toxicity: Tier 2 vegetative vigor No data No Data have not been submitted to fulfill this guideline. A data gap was not identified as these data are not necessary for risk assessment at this time.

850.5400 (123-2) Aquatic Plant Growth: algae No data No Requesting Tier II study for four species

850.4400

(123-2) Aquatic Plant Growth: vascular plants No data No Requesting Tier II study for Lemna gibba



## 12. References

Open Literature Citations

Knittle, C.E., E.W. Schafer Jr., and K.A. Fagerstone. 1990. Status of compound DRC-1339 registration. Proceedings of the Fourteenth Vertebrate Pest Conference 1990. pp 311- 313.32 Schafer, E.W., Jr. 1984. Potential primary and seconda ry hazards of avicides. Proc. Vertebr. Pest Conf. 11:217-222.

U.S. Environmental Protection Agency. 1993. Wildlife Exposure Factors Handbook . Office of Research and Development. December. EPA/600/R-93/187

U.S. Environmental Protection Agency

. 1995. Reregistration Eligibility Decision (RED): Starlicide (3-chloro-p-toluidine hydroch loride). September 1995. EPA-738-R-96-003.

U.S. Environmental Protection Agency. 1998. Guidelines for Ecological Risk Assessment

. United States Environmental Protection Agency (USEPA). Risk Assessment Forum. Office of Research and De velopment. Available at http://cfpub.epa.gov/ncea/cfm/recordispl ay.cfm?deid=12460 (Accessed June 19, 2009).

U.S. Environmental Protection Agency. 2004. Overview of the Ecolog ical Risk Assessment Process in the Office of Pesticide Programs . US EPA Office of Pesticide Programs, Environmental Fate a nd Effects Division.

U.S. Fish and Wildlife Service and National Mari ne Fisheries Service. 1998. Endangered Species Consultation Handbook. Procedures for Conducting Consultation and Conference Activities Under Section 7 of the Endangered Species Act. http://www.nmfs.noaa.gov/pr/ pdfs/laws/esa_section7_handbook.pdf

Data Submitted To Support Registration

41267201 Knittle, C. (1989) Summary of Curren tly Available Avian Single-dose Oral LD50 Data for the Chemical 3-Chloro-4-methyl benzenamine Hydrochloride. Unpublished study prepared by Denver Wildlife Research Center. 153 p.

41760502 Fletcher, D.; Pedersen, C. (1990) Compound 1339: 21-Day Acute Oral LD50 Study in Mallard Ducks: Lab Project Number : 89 DD 71. Unpublished study prepared by BioLife Associates, Ltd. 148 p.

41760503 Fletcher, D.; Pedersen, C. (1990) Comp ound 1339: 21-Day Acute Oral LD50 Study in Bobwhite Quail: Lab Project Number: 89 QD 135. Unpublished study prepared by BioLife Associates, Ltd. 176 p.

42671801 Pedersen, C.; Lesar, C. (1993) Compo und DRC-1339 98% Concentrate (Starlicide): 12-Day Acute Dietary LC50 Study in Mallar d Ducklings: Lab Project Number: 90 DC 151. Unpublished study prepared by Bio- Life Associates, Ltd. 220 p.

42671802 Pedersen, C.; Lesar, C. (1993) Compo und DRC-1339 98% Concentrate (Starlicide): 12-Day Acute Dietary LC 50 Study in Bobwhite Quail: Lab Project Number: 90 QC 155. Unpublished study prepared by Bio- Life Associates, Ltd. 214 p.33 41767501 Bowman, J. (1991) Acute Toxicity of DRC-1339 To Bluegill ( Lepomis macrochirus ): Lab Project Number: 38319: QA-141. Unpublishe d study prepared by Analytical BioChemistry Labs., Inc. 105 p.

41767502 Bowman, J. (1991) Acute Toxici ty of DRC-1339 to Rainbow Trout Oncorhynchus mykiss ): Lab Project Number: 38318: QA-140. Unpub lished study prepared by Analytical Bio-Chemistry Labs., Inc. 110 p.

41783701 Blasberg, J.; Herzog, D. (1991) Acute Toxicity of DRC 1339 to Daphnia magna : Lab Project Number: 38320: 139. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 98 p.

41609301. Ferder, T., and C. Fickerson. 1990. Product Chemistry Data: Purina Starlicide Technical Contains 97% (3-Chlor o-p-toluidine hydrochloride). Unpublished study prepared by Purina Mills Inc. 162 p.

41760501. Kimball, B., S. Greiner, and E. Mishalanie. 1990. Environmental Fate Study: Hydrolysis of 3-Chloro-p-t oluidine Hydrochloride: Lab Project Number: QA-144

. Unpublished study prepared by Denver W ildlife Research Center. 124 p.

42830601. Yao, D., T. Mill. 1993. Aquatic Photolysis Study of 3-Chloro-p-Toluidine Hydrochloride: Lab Proj ect Number: 3743-20: QA-268. Unpublished study prepared by SRI International Chemistry Lab. 64 p.

42838801. Yao, D., and T. Mill. 1993. Aquatic Photolysis Study of 3-Chloro-p-Toluidine Hydrochloride: Lab Proj ect Number: 3743-20: QA-268. Unpublished study prepared by SRI International Chemistry Lab. 64 p.

43284501. Spanggord, R., and G. Gordon. 1994. Aerobic Soil Metabolism Study of 3-Chloro-pToluidine Hydrochloride: Lab Project Number: 3743-N003-93: QA-270. Unpublished study prepared by SRI International. 73 p.

43284502. Irwin, K., and R. Podoll 1994. Sorption and Desorption Study of 3-Chloro-pToluidine Hydrochloride: Lab Project Number: 3743-N005-93: QA-271. Unpublished study prepared by SRI International. 75 p.

43284503. Irwin, K., and R. Podoll. 1994. Aged Leaching Study of 3-Chloro-p-Toluidine Hydrochloride: Lab Project Number: 3743-N004-93: QA-362. Unpublished study prepared by SRI International. 70 p.

43069801. Schocken, M. 1993. Starlicide (3-chloro-p-toluid ine hydrochloride, CPTH)-- Bioconcentration and Elimination of (carbon 14 ) Residues by Bluegill Sunfish (Lepomis macrochirus): Amended Final Repor t: Lab Project Number: 3743-50: 287.1192.6105.140: 93-7-4855. Unpublished study prepared by Springborn Labs, Inc. 112 p.34 

## Attachment 1: Non-guideline Study DCI Justifications

Guideline Number: non-guideline Study Title: Honey Bee Acute Oral Toxicity Test using the Technical Rationale for Requiring the Data Terrestrial invertebrate toxici ty data are required to quant itatively assess the potential impacts on this group of organisms. At this time, no data are avai lable to define the toxicity of starlicide to honey bees on an acute exposure basis. Given that the labels prescribe that the pesticide be coated on ba its (many of which would be attractive to insects); terrestrial invertebrates have th e potential to be expo sed to starlicide by contacting and consuming the bait. It is exp ected that the major exposure route for nontarget insects would be through consumption, not through contact.

US EPA does not have a guideline for the ac ute oral honey bee study; however, the OECD 213 guideline could be used fo r protocol development. Practical Utility of the Data How will the data be used? The honeybee study would allow the Agency to analyze pollinators and other non-target terrestrial ins ects. The effects data would be used to determine the likelihood that the risks can pot entially impact terrest rial invertebrate communities. The data will reduce uncertain ties associated with the current risk assessment for terrestrial invertebrates and will improve our understa nding of the potential effects of starlicide.

How could the data impact the Agency’s future decision-making? If future endangered species risk assessments are perf ormed without these data, the Agency would have to assume that starlicide "may affect " endangered terrestria l insects directly (and endangered species from other taxa indirectly), and use of starlicide might need to be restricted in areas where endangered species c ould be exposed. The l ack of these data will limit the flexibility the Agency and registrant s have in coming into compliance with the Endangered Species Act and could result in use restrictions for starlicide which are unnecessarily severe.