U NITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHING T ON D.C., 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVEN T I ON



### PCCode:031801,079009,079021
DP Barcode: 425805

March 3

, 2015

MEMORANDUM

, SUBJECT: Revised Environmen tal Fate and Eco logical Risk Assessment for the Registration Review of Soap Salts



### TO: Eric Miederhoff, Chemical Review Manager Patricia Parrott, Branch Chief Risk Management and Implementation Branch 3 Pesticide Re-evaluation Division (7508P)



### FROM: Stephen Carey, Biologist ·

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William P

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Environmental Risk Branch VI
Environmental Fate and Effects Division (7507P)

The Environmental Fa te and Effects Di vision (EFED) has completed the revised screening le vel registration review assessment of the environmental fate and ecological risks for the soap salts

case

. This assessment addresses three active ingredients, the ammonium, potassium

, and sodium salts of fatty acids and updates the March 5, 2013 assessment, "Environmental Fate and Ecological Risk Assessment for the Registration Review of Soap Salts " (Docket ID EP A- H Q-OPP-2008- 0519-0019) based on public comments received.

12 

# Revised Environmental Fate and Ecological Risk Assessment for the Registration Review of Soap Salts

Potassium Salts of Fatt y Acids (PC Code 079021); Ammonium Salts of Fatty Acids (PC Code 031801); and Sodium Salts of Fatty Acids (PC Code 079009)

Prepared by: Stephen Carey, Biologist, ERB VI William P. Eckel, Ph.D, Senior Science Advisor, ERB VI U. S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division Environmental Risk Branch IV

1200 Pennsylvania Ave., NW Mail Code 7507P Washington DC 20460 Reviewed by: Brian Kiernan, Biologist, ERB VI Reuben Baris, ERB VI Mark Corbin, Branch Chief, ERB VI

Date: March 3, 20153 

## I. Executive Summary

This risk assessment addresses the potential risk s of the pesticide active ingredients potassium, ammonium, and sodium salts of fatty acids (“soap salts”) to the environment. It updates the Preliminary Risk Assessment (PRA) dated 2/ 28/13 based on public comments. Soap salts products are registered as algaecides, herbicides , insecticides/acaricides, and animal repellents. They are intended for residential, agricultural, or commercial use.

Soap salts are approved by USDA for use in organic agriculture (7 CFR 205, subpart G), including the uses as algaecides, demossers, herbic ides, insecticides, and an imal repellents.

Based on comments received during the Public co mment period for the February 2013 draft risk assessment, the maximum broadcast application rate is now assumed not to exceed 27 lb a.i./A. Labeled application rates for pota ssium and ammonium salts of fatty acids may be as high as 205 lb a.i./A and 104 lb a.i./A, respect ively, if they were to be applie d on a per acre basis However, based on additional use information from the regist rants, the agency now recognizes that these higher rates are for use only applie d as spot treatments that cover only a fraction of an acre. To be effective, soap salts generally must be app lied to thoroughly wet the target pest (insect or plant) since they have a physical, not toxic mode of action. This limits the effect of soap salts on listed species to the immedi ate area of application.

Sodium (and some ammonium) salts of fatty acids act as repellents on forage and grain crops, on vegetables and field crops, in orchards, and on nur sery stock, ornamentals, flowers, lawns, turf, vines, shrubs and trees. Sodium salts are also formulated as a soap bar enclosed in a one-ounce mesh bag hung or staked above the ground, and are typically placed by homeowners in gardens, averaging 5 bags per garden. The per-acr e application rate is thus undefined.

These soap salts affect the olfactory nerves of deer and rabbits, repel ling these animals away from the target area; however, ammonium salts can also be formulated as an herbicide to control annual weeds. FDA classifies the ammonium and sodium salts as generally recognized as safe (GRAS) for packaging only. Based on the use patte rn, it is assumed that exposure of non-target organisms to these products is minimal.

Potassium and ammonium salts are typically ap plied by ground equipment (hand-held, hose-end, foliar, pump, power, and backpack sprayers). To date, no information has been provided to USEPA on the geographic extent of soap salt use, but given the wide ranging use patterns, this assessment assumes that soap salts could be used practically anywhere in the United States.

Potassium salts of fatty acids mainly disrupt the exoskeleton in insects, causing insects to die; and also disrupt the photosynthetic process in plants, killing the plan t. They are used to control a variety of taxa including insects, mosses, algae, lichens, liverworts and other weeds. Use sites include many food and feed crops, ornamental fl ower beds, house plants , trees, shrubs, walks and driveways, and on dogs and cats. Some pota ssium salts of fatty acids are used as multipurpose food additives. The Food and Drug Administration (FDA) al so classifies the potassium salts as GRAS (generally rec ognized as safe) to humans.

In general, the soap salts do not have a toxic m ode of action, and work by direct contact with the target pest, be it plant or insect. Thus, advers e direct effects are believed to be limited to4 organisms that are present on the site of applic ation, and at the time of application. Off-site effects are assumed to be unlikely because direct, intensive exposure is requi red for an effect to occur. Calculations are provided in the assessm ent to show that possible effects on non-target species extend to about 30 feet from the edge of the application area. Given the size of field margins, potential effects do not meaningfully extend off of cultivated areas.

Risk Conclusions

We conclude, based on low toxicity and limited potential for exposur e, that soap salts as a group will not cause adverse effects to organi sms that are not directly exposed.

Soap salts are non-toxic to birds and mammals, so no adverse effects are expected. This conclusion is extended to their surrogates, reptiles and terrestria l-phase amphibians.

There is very limited potential for off-site exposur e in water, and we e xpect that the soluble residues to which aquatic animals and plants might be exposed are not toxic enough to cause adverse effects.

Adverse effects to terrestrial inve rtebrates and terrestrial plants are possible, based on pesticidal claims and limited data. Soap salts require thorou gh wetting of the target pest to be effective, so any adverse effect to non-target or ganisms is believed to be limite d to the site of application and its immediate environs.

Uncertainties and Risk Characterization

The product labels do not specify or limit the ma ximum number of applic ations per year or define a recommended minimum inte rval between applications. Th e impact of this uncertainty was evaluated by estimating the increase in pote ntial exposure due to multiple applications. Using a screening level model (GENEEC2), the exposure increased only 3% after 50 applications were made per year. This indicates that this label uncertain ty does not substantially change the risk profile described above.

An uncertainty addressed in this assessment is the relationship between the chain lengths of the fatty acids in the available toxicity data relative to the products used in the field. Generally, but not always, ammonium salts tend to be shorter-ch ain acids (C9 and lower), while potassium salts are longer-chain (C16 to C18). Also, the acute and chronic toxi cological endpoints used in the assessment for the active ingredients were es timated based on the purity reported in their ecological studies using the formul ated products as the test material. While the percentage of soap salts was specified, the composition of the chain lengths was not. Information submitted during the public comment period tended to c onfirm the identification of ammonium and potassium salts in the toxicity da ta, as being associated with s hort-chain and long-chain mixtures, respectively. It was not possibl e to obtain the actual endpoints for individual fatty acids from technical grade studies because the active ingred ients are formed only after being mixed through an integrated process. Data for related produc ts of known composition (the soluble fatty acid, nonanoic or pelargonic acid) was used to characteri ze the toxicity of the so ap salts. Lastly, the composition of registered soap salt products, specif ically the range of fatt y acid chain lengths, is variable.5 The composition of the product is significant due to long-chain so ap salts precipitation caused by metal ions (Ca, Mg, Fe, etc.) in the environm ent. Longer chain length products should pose minimal risks to aquatic organisms due to th is precipitation. Shorter- chain products may be soluble enough to cause exposure, but are not toxic enough to cause effects (i.e., acute toxicity data for nearly pure nonanoic (pelargonic) acid, which is representative of the shorter chainlength fatty acids, indicates that it does not reach levels of concern with a Tier I exposure assessment). Thus, the Agency believes there is no likely direct effect to aquatic organisms, because fatty acids that are high in toxicity are not sufficiently so luble in water for toxic effects to be expressed, and those fatty ac ids that are sufficiently soluble for effects to be expressed are low in toxicity.

For terrestrial plants, the vegetative vigor and s eedling emergence data show that soap salts are more toxic to plants when the foliage is expos ed to spray drift, than by exposure through the roots as a result of surface water runoff. A co mmenter indicated that herbicidal soaps are effective only when they thoroughly contact the fo liage, and are not effective by root uptake. Since the main route of exposure to non-target terrestrial plants is by spray drift, not by runoff, the LOC exceedance for potential risk to plants inhabiting dry and semi-aquatic areas exposed to runoff can be discounted, because the risk quotient is low compared to the level of concern (1.5 vs. 1.0) and it does not account for degradation of the fatty acids. Spray drift exposure analysis indicates that when ground-based application methods are used, e xposure falls to the 5% effect level (1.0 lb/A) for the most sensiti ve plants less than 30 feet off-s ite. This indicates that effects to terrestrial plants do not occur far from the site of application, and are essentially limited to the site of application incl uding field margins.

Terrestrial arthropods or inverteb rates could be impacted since potas sium salts are registered as insecticides and acaricides. Honey bee toxicity data were available, and used as a surrogate for terrestrial invertebrates. The data for ammoni um and potassium formula tions indicate that the highest observed mortality in bees (30%) was at a dose of 262 micrograms per bee, applied to the thorax. This is equivalent to an exposure of 2047 mg/kg body weight. The highest broadcast application rate is 27 lb/A, equivalent to 2538 mg /kg exposure to arthropods. Thus, the 27 lb/A rate is slightly higher than the dose causing 30% mortality. At 30 feet o ffsite, the exposure from spray drift is 1.0 lb/A or 94 mg/kg to arth ropods, which corresponds to about 10 to 15% mortality in the laboratory tests. Thus, mortality effects to invertebrates are not expected at great distances from the application site, especially as label use instructions direct the user to thoroughly wet leaves, top and bottom, which is not likely as a resu lt of spray drift.

Public comments on the February 2013 preliminar y risk assessment suggested that not allterrestrial invertebrates are susceptible to potassium salts. Susceptible invertebrates are softbodied ones such as aphids, whiteflies, and meal y bugs, including larval stages of hard-bodied adults. Based on the honey bee da ta, it appears that a dult invertebrates are less susceptible.

Toxicity was negligible in the avian and ma mmalian studies. Adverse effects are therefore unlikely to birds, mammals, and the surrogate taxa they represent (reptiles and terrestrial-phase amphibians).6 Exposure Characterization Summary

The fatty acid salts used in commercial pesticid e products range in chai n length from about C8 (octanoic acid) to C18 (octadecanoic acid). The physical properties of these acids vary directly with the chain length. The chief physical property that a ffects exposure in this case is solubility in water. In the open environment, in the presen ce of divalent metal cations such as calcium (II), magnesium (II) and others, the l onger fatty acids, approximately C12 and up, are too insoluble to reach toxic concentrations. The shorter fatty acids, approximately C11 and down, are soluble enough in the presence of metal i ons to cause exposure in the water column, but they are not toxic enough to cause adverse effects.

Effects Characterization Summary

Aquatic Organisms

Results of the acute toxicity studies tested with soap salts formulated pro ducts indicate potassium salts are moderately toxic to freshwater fish, wh ile ammonium salts are slightly toxic. Neither salt caused any effects to estuarin e/marine fish up to the solubility limit. Ammonium salts are slightly toxic to freshwater invertebrates whil e potassium salts are hi ghly toxic to the taxa. Effects of time to first brood release, reproduc tion, and growth were seen in freshwater invertebrates from chronic exposur e as low as 23 mg a.i./L for ammonium salts and 0.5 mg a.i./L for potassium salts. Acute studies with estuarine/ marine invertebrates indicate the moderately toxic potassium salts are more t oxic than the slightly toxic am monium salts. While no chronic data were available for estuarine invertebrates, potassium salts may be more toxic to estuarine/marine invertebrates th an ammonium salts. An acute to chronic ratio was applied to estuarine invertebrates. For al gaecide uses, aquatic nonvascular plants, algae, and diatoms exhibited equal inhibition of biom ass when exposed to both salts.

No toxicity data were availa ble for sodium salts. Sodium salts are registered as a low volume/minor use, typically hanging bags around a home garden, which results in low potential for runoff and spray drift; significant concentratio ns are not expected to reach the receptors. Previously, the Agency waived all aquatic toxicity data for sodium salts. This use pattern is not expected to result in meaningful exposure.

Terrestrial Organisms

Soap salts are practica lly non-toxic to birds and mammals on an acute exposure basis. No chronic toxicity data for birds and mammals were available since so ap salts undergo rapid degradation in less than a day. Thirty percent mortality of honey bees was observed for a dose approximately corresponding to the maximum broa dcast rate for the ammonium and potassium salts.

As expected with an herbicide, effects on growth were observed in terrestrial plant studies. The vegetative vigor life stage is generally more se nsitive than the seedli ng emergence life stage. Sensitivity varies by species, with dicots generally more sensitive to soap salts than monocots.

No terrestrial toxicity data we re available for sodium salts.7 Federally Threated and Endangered (Listed) Species

Given that the agencies are continuing to de velop and work toward implementation of the Interim Approaches to assess the potential risk s of pesticides to listed species and their designated critical habitat, this preliminary ri sk assessment for soap salts does not contain a complete ESA analysis that includes effects de terminations for specific listed species or designated critical habitat. Although EPA has not yet complete d effects determinations for specific species or habitats, for this prelim inary assessment EPA conducted a screening-level assessment for all taxa of non-ta rget wildlife and plants that assumes for the sake of the assessment that listed species and designated criti cal habitats may be present in the vicinity of the application of soap salts. This screening level assessment will allow EPA to focus its future evaluations on the types of speci es where the potential for effect s exists once the scientific methods being developed by the agencies have b een fully vetted. This screening-level risk assessment for soap salts indicates potential risks of dir ect effects to listed plants and terrestrial invertebrate, based on pesticidal cl aims, on some of the registered us e sites. Listed taxa may also be affected through indirect effects because of the potential for directeffects on listed and nonlisted species upon which such species may rely. Potential direct effects on listed plants and terrestrial invertebrates from th e use of soap salts may be a ssociated with modification of Primary Constituent Elements (PCEs) of designated critical habitats, where such designations have been made. Once the agencies have fu lly developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these met hods will be applied to subsequent analyses for soap salts as part of completing this registration review.8 

### Contents

I. Executive Summary ............................................................................................................. . 3 II. Problem Formulation ........................................................................................................... 9
II.1. Nature of the Regulatory Action ............................................................................................... .............. 9 II.1.1 History of Soap Salts Regulation .............................................................................................. ............... 9 II.2 Stressor Source and Distribution .............................................................................................. ............ 10 II.2.1 Nature of Chem ical Stressor ................................................................................................... ........... 10 II.2.2. Overview of Pesticide Usage ................................................................................................... .......... 14 II.3 Ecosystems Potentially at Risk ................................................................................................ .............. 15 II.3.1 Receptors .................................................................................................................... ...................... 15 II.3.2. Assessment En dpoints .......................................................................................................... ............. 16 II.4. Conceptual Model .............................................................................................................. ..................... 16 II.4.1. Risk Hypothesis ............................................................................................................... .................. 16 II.4.2. Conceptual Diagram ............................................................................................................ .............. 17 II.5. Analysis Plan Options ......................................................................................................... ................... 18 II.5.1 Measures of Exposure .......................................................................................................... ............. 18 II.5.2. Measures of Effect ............................................................................................................ ................. 19 II.5.3. Integration of Expos ure and Effects ........................................................................................... ....... 21 III. Analysis ...................................................................................................................... ...... 23
III.1. Environmental Chem istry of Fa tty Acids ................................................................................ ................ 23 III.2. Aquatic Expo sure Mode ling .................................................................................................... ............. 25 III.3. Ecological Effects Characterization .......................................................................................... ........... 29 III.3.1. Aquatic Effects Characteri zation ............................................................................................. ......... 30 III.3.2. Terrestrial Effects Characteri zation .......................................................................................... ......... 33 IV. Risk Characterization ..................................................................................................... 36
IV.1. Risk Esti mation ............................................................................................................... ........................ 36 IV.1.1 Risk Quotient Calculations for Aquatic Organisms ......................................................................... 36 IV.1.2 Risk Quotient Calculati ons for Aquatic Plants ................................................................................ . 40 IV.1.3. Risk Quotient Calculations for Terrestrial Animals ......................................................................... 4 1 IV.1.4. Risk Quotient Calculations for Te rrestrial Plants in Terrestrial and Semi-aquatic Environments .... 42 IV.2. Risk Des cription .............................................................................................................. ........................ 44 IV.2.1 Exposure to Aquatic Organisms ................................................................................................ ....... 45 IV.2.2. Exposure to Terre strial Wildlife ............................................................................................. .......... 49 V. Federally Threatened and Endangered (Listed) Species Concerns ............................... 52
V.1. Action Area ................................................................................................................... .......................... 53 V.2. Taxonomic Groups Potentially at Risk .......................................................................................... ....... 53 V.2.1. Probit Dose-Resp onse Analysis ................................................................................................ ....... 549 

## II. Problem Formulation

The purpose of this problem formulation is to pr ovide the foundation for the environmental fate and ecological effects for the registration review risk assessment for soap salts (Ammonium (PC Code: 031801), Potassium (PC Code: 079021) and Sodium (PC Code: 079009) Salts of Fatty Acids). Soap salts are used as insecticides, acaricides, herbicides, and algaecides on many food and non-food crops and are also used as a deer and rabbit repellent (ammonium and sodium salts only).



### II.1. Nature of the Regulatory Action

Under the Federal Insecticide, F ungicide, and Rodenticide Act (FIFRA), all pesticides sold or distributed in the United States generally must be registered by the Environmental Protection Agency (EPA). In determining whether a pesticid e can be registered in the U.S., EPA evaluates its safety to non-target species based on a wide range of environm ental and health effects studies. In 1996, FIFRA was amended by the Food Qua lity Protection Act (FQPA), and EPA was mandated to implement a new program for the peri odic review of pesticides, i.e., registration review ( http://www.epa.gov/oppsrrd1/ registration_review/ ). The registration review program is intended to ensure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health and the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through th e registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely.

As part of the implementation of the Registratio n Review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticid e Act (FIFRA), the Agency is evaluating soap salts to determine whether they continue to meet the FIFRA standard for registration. In order to meet the requirements of FIFRA and the ESA, this assessment follows EPA guidance on conducting ecological risk assessments (USEPA 1998) and the Office of Pesticide Program’s Overview Document, which contains guidance fo r assessing pesticide ri sks to non-target and listed species (USEPA, 2004). This assessment was prepared to support evaluation of the registration review of soap salts.



### II.1.1 History of Soap Salts Regulation

Soap salts were first register ed as pesticides in 1947. In 1982, the Food and Drug Administration (FDA) classified soap salts as Generally R ecognized as Safe (G RAS). A national-level ecological assessment was completed as part of the reregistration eligibility decision (RED) for soap salts in 1992 with twenty-four registered so ap salts products. The ec ological risk assessment included in the soap salts RED was based on ba sic laboratory fate and acute toxicity data submitted by the registrants in support of registration for soap salts. The primary environmental concern identified in the 1992 RED was associated with risks to freshwater invertebrates. The risks to freshwater invertebrate s were not estimated using the ri sk quotient method at that time; however, the Agency assumed that the uses woul d not result in serious impact to freshwater invertebrates because soap salts are not appl ied directly to water and undergo very rapid microbial degradation in soil, from which sign ificant concentrations should not reach water10 bodies. Soap salts were reported as practically non-toxic to wate rfowl and upland game birds and slightly toxic to both cold wate r and warm water fish species.

No public literature data or inci dent reports were incorporated in the RED, nor were any risk quotients or modeled exposure conc entrations used to determine if the Agency’s levels of concerns (LOCs) were exceeded or not. Risk s were neither identified nor dismissed. No mitigation measures or potential risks to endang ered species were assessed. The only data the Agency required at that time was a honeybee acute c ontact test to evaluate the toxicity of soap salts to pollinators.

Currently, there are 44 active Se ction 3 products containing pota ssium salts of fatty acids, 8 active products containing ammonium salts of fatty acids, and one active product of sodium salts of fatty acids. Fewer than ten of these are la beled for broadcast application; the soap salts products are primarily used for spot treatments.

There are no pending registration actions, includi ng emergency exemptions (Section 18) for soap salts. There are no currently active Special Local N eed (Section 24c) registrations for soap salts. Twenty-two potassium salt products were subjec ted to reregistration, and these products have been reregistered or cancelled. Two ammonium salt products were subjected to reregistration and have been reregistered.



### II.2 Stressor Source and Distribution

II.2.1 Nature of Chemical Stressor

The soap salts case (case 4083) is comprised of three active ingredients (PC Codes 031801, 079009 and 079021) that are the primary chemical st ressors to be considered for registration review. These three active ingredients are: 1) potassium salts of fatty acids ([C 12 -C 18 saturated and C 18 unsaturated]) including potassi um laurate, potassium myrist ate, potassium oleate and potassium ricinoleate combined as a single act ive ingredient under the PC Code formerly assigned to potassium laurate, PC Code: 079021 ; 2) ammonium salts of fatty acids ([C 8 -C 18 saturated and C 18 unsaturated]) including ammonium ol eate, PC Code: 031801; and 3) sodium salts of fatty acids including sodium oleate, PC Code 079009. Soap salts belong to the soap chemical family of pesticides. There are at le ast 100 chemicals of this family, and they are generally used as insecticides , herbicides, and adjuvants.

Potassium salts of fatty acids disrupt the membra ne and cellular function in insects, causing cell to dehydrate and die; and also di srupt the photosynthetic process in plants, killing the plant. Ammonium salts of fatty acids a ffect the olfactory nerves of deer, rabbits, and other mammals, which repel these animals away from the target area, and also can be formulated as an herbicide to control common annual weeds. Sodium salts of fatty acids are formulated solely as a mammal repellent.

Potassium and ammonium salts are typically ap plied by ground equipment (hand-held, hose-end, foliar, pump, power, and backpack sprayers). A mesh bag of sodium salts also can be hung on a branch or staked in the ground. Soap salts may be applied to a wide variety of use sites including both agricultural and non-agricultural sites. The intended use for these compounds is also varied with both herbicidal and insecticidal modes of action. To da te, no information has been provided11 on the extent of soap salt use, and given the wide ranging use patterns, it is anticipated that soap salts could be used practically anywhere in the United States. Of course, the non-pesticidal use of soap salts is wide spread across the U.S.

Potassium salts of fatty acids are us ed as herbicides (and algaecides) ( Table II.1 ), insecticides (and acaricides) ( Table II.2 ). They are used to control a va riety of insects, mosses, algae, lichens, liverworts and other weeds, in or on ma ny food and feed crops, lawn/turf, ornamental flower beds, house plants, trees, shrubs, greenhouses, automobiles, tires, walks and driveways, as a wood protection treatment, and on dogs, puppies and cats to control flea infestation.

Table II.1. Overview on Herbicide U ses of Potassium Salts of Fatty Acids Crop Grouping Representative Use Terrestrial food and feed Agricultural crops/soils and vegetables Terrestrial food Vegetables
Terrestrial non-food / greenhouse Agricultural crops/soils

Greenhouse food Greenhouses-indoor use
Greenhouse non-food Greenhouses-indoor use

Terrestrial non-food Automobiles, taxis, limousines, recreational vehicles, tires, commercial/industrial outdoor premises/equipments, golf course turf, nonagricultural outdoor building/structures, recreational areas and lawns, commercial/industrial lawns

Terrestrial non-food/outdoor residential Nursery stock, fencerows/hedgerows, mulch, nonagricultural rights of way/fencerows/hedgerows, ornamental/shade trees, ornamental herbaceous plants, ornamental lawns/turf, ornamental non-flowering plants, ornamental woody shrubs/vines, paths/patios, and paved areas of private driveways/sidewalks

Outdoor residential Household/domestic dwellings outdoor premises, ornamental/shade trees, ornamental lawns/turf, residential lawns, as a wood protection treatment to outdoor buildings/products, paths/patios, and paved areas of private roads and sidewalks Indoor non-food Non-feed/non-food containers-full and ships/boats Indoor residential Household/domestic dwellings12 Table II.2. Overview on Insecticide U ses of Potassium Salts of Fatty Acids Crop Grouping Representative Use

Terrestrial food and feed Canola/rape, peanuts, eggplant, tomato, cereal grains, seeds, apple, peas, bulb vegetables, wheat, field corn, sweet co rn, soybeans, sugar beet, white/irish potato, fiber crops, cole crops, flavoring/spice crops, root and tuber vegetables, deciduous fruit trees, beans, vegetables and fruits, citrus, hops, nut crop/nut trees, pome fruits, pineapple, grapes, small fruits, fruiting vegetables, leafy vegetables, legume vegetables, and cotton.

Terrestrial food Apple, banana, beans, blackberry, blueberry, broccoli, brussel sprouts, cabbage, cauliflower, citrus, coffee, cole crops, collards, cucumber, cucurbit vegetables, currant, eggplant, grape, kale, loganberry, melons, olive, pear, peas, pepper, pomegranate, potato, pumpkins, raspberry, squash (summer), squash (winter), squash (zucchini), strawberry, toma to, vegetables, and stone fruits.
Terrestrial feed Alfalfa

Terrestrial food/greenhouse Almond, apple, apricot, asparagus, artichoke, avocado, banana, beans, beets, blackberry, brassica (head and stem) vegetables, broccoli, brussel sprouts, cabbage, canola/rape, celery, cherry, c itrus, cole crops, corn, cranberry, cucumber, cucurbit vegetables , deciduous fruit trees, eggplant, fig, flavoring and spice crops, fruiting vegetables, grapefruit, grape, herbs, hops, kale, kiwi fruits, leafy vegetables, legume vegetables, lemon, lettuce, lime, loganberry, macadamia nut, melons, nect arine, okra, orange, peach, peanuts, pear, peas, pecan, pepper, pineapple, plum, pome fruits , potato, radish, raspberry, root crop vegetables, small fruits, soybeans, spin ach, squash, strawberry, stone fruits, subtropical fruits, tangerines, tomato, tree nuts, vegetables and fruits, watercress, and walnut
Terrestrial non-food / greenhouse Ornamental/shade trees, ornamental herbaceous plants, ornamental nonflowering plants, and ornamental woody shrubs/vines Greenhouse food Greenhouses-indoor use, alfalfa, cotton, fruits, seeds, and wheat

Greenhouse non-food Christmas tree plantations, ornamental/shade trees, ornamental herbaceous plants, ornamental non-flowering plants, and ornamental woody shrubs/vines

Terrestrial non-food Citrus, pome fruits, pomegranate, stone fruits, tree nuts, tobacco, commercial/industrial outdoor premises/equipments, golf course turf, recreational areas, rose, wide area/genera l outdoor treatment for public health use, Christmas tree plantations, ornament al lawns/turf, eating establishments, ornamental/shade trees, ornamental woody shrubs/vines
Terrestrial non-food/outdoor residential Ornamental/shade trees and ornamental lawns/turf

Outdoor residential Fruits, household/domestic dwellings out door premises, ornamental/shade trees, ornamental herbaceous plants, ornamental lawns/turf, orname ntal non-flowering plants, ornamental woody shrubs/vines, and residential lawns
Indoor food Beehives/bee colony (diseased/nuisance)

Indoor non-food Commercial/industrial indoor premises/equi pments, ornamental/shade trees, ornamental herbaceous plants, ornament al non-flowering pl ants, ornamental woody shrubs/vines, and wide area/general indoor treatment Indoor medical Hospital/medical institutions premises

Indoor residential Household/domestic dwellings, ornamental/shade trees, ornamental herbaceous plants, ornamental non-flowering plants, ornamental woody shrubs/vines, adult dogs, puppies and cats.

Indoor residential/non-food Ornamental/shade trees, ornamental herbaceous plants, ornamental woody shrubs/vines, and ornamental non-flowering plants13 Ammonium salts of fatty acids ( Table II.3 ) formulated as a rabbit and deer repellent are used

on vegetables and fruits, nursery stock, ornamentals, flowers, vine s, shrubs and trees. It can

also be formulated as a herbicid e to control common annual weeds ( Table II.4 ) actively growing on agricultural fields , residential gardens and pa ved areas, empty greenhouses, household dwellings, outdoor buildings, trees, pl ants, lawns/turf, woody shrubs/vines, and as a wood protection treatment to out door buildings/products . It is recommended not to apply any

of the products of ammonium salts of fatty aci ds through any type of irrigation system. In addition, ammonium salt products are not compatible with soluble metallic salts such as zinc,

manganese, and iron sulfates. This is presumably because these metal ions cause the fatty acids to precipitate, causing them to be ineffective. Table II.3. Overview on Repellent Uses of Ammonium Salts of Fatty Acids Crop Grouping Representative Use Terrestrial food and feed crop Apples, peanuts, and soybeans Terrestrial food crop Carrots (including tops), pears, and vegetables

Outdoor residential Fruits, ornamental/shade trees, ornamental herbaceous plants, and ornamental woody shrubs/vines

Terrestrial non-food Nursery stock, ornamental/shade trees, ornamental herbaceous plants, and ornamental woody shrubs/vines

Table II.4. Overview on Herbicide Uses of Ammonium Salts of Fatty Acids Crop Grouping Representative Use

Terrestrial food and feed crop Grapes, cereal grains, vegetables, orchards, field crops, mulch, grass forage/fodder/hay, and non-grass forage/fodder/hay Terrestrial food crop Ornamental lawns and turf, ornamental woody shrubs and vines, vegetables, and ornamental shade trees Greenhouse food crop Field crops and vegetables

Outdoor residential Household/domestic dwellings, outdoor premises, mulch, rights-of-way, fencerows, hedgerows, ornamental/shade trees, ornamental herbaceous plants, ornamental lawns/turf, ornamental woody shrubs/vines, paths/patios, paved areas (private roads/sidewalks), and wood protection treatment to buildings/products

Terrestrial non-food Empty greenhouses, outdoor building and structures, rights-of-way, fencerows, hedgerows, ornamental/shade trees, ornamental herbaceous plants, ornamental lawns/turf, ornamental woody shrubs/vines, mulch, paths/patios, paved areas (private driveways/sidewalks), and wood protection treatment to buildings/products

Greenhouse non-food Ornamental/shade trees, ornamental herbaceous plants, and ornamental woody shrubs/vines

Sodium salts of fatty acids ( Table II.5 ) are used as a deer repelle nt, which are staked or hung next to shrubs, vines, shad e trees, and ornamentals.14 Table II.5. Overview on Repellent Uses of Sodium Salts of Fatty Acid Crop Grouping Representative Use

Outdoor residential Ornamental herbaceous plants, ornamental non-flowering plants, ornamental woody shrubs and vines, and ornamental shade trees.

II.2.2. Overview of Pesticide Usage

The soap salt products may be applied at highly variable rates using br oadcast ground application equipment and spot treatment via backpack sp raying (BEAD LUIS repor t 05/12/13). Terrestrial spot treatment application rates are as high as 205 lbs/acre. The herbicidal products are generally applied as a spot treatment for weed control and as a broadcast spray or spot treatment for moss control, while the insecticidal products are applied br oadcast using ground sp ray equipment. The high application rates (>27 lb a.i. /A) for these products are practic al only for spot treatments and usually are not applied to an enti re acre but to thoroughly spray all plant (or tree) pa rts to achieve herbicidal or insecticidal cont rol. Furthermore, the herbicidal products with high rates for moss control are labeled for lawns/turf , exterior building, and paving su rfaces; not for agricultural field uses at rates which are about 10 times lower than used for moss control. In addition, some but not all labels are unclear on the number of applications allo wed and do not appear to limit the maximum number of applications per year or de fine a recommended minimum interval between applications; however, they some labels do includ e restrictions such as avoiding crop-specific injury from repeated applications, to avoid sp raying desirable plants, a buffer size or coarse nozzle settings to reduce sp ray drift to sensitive plants, or to not spray to water bodies or use in a manner that could cause surface water contamination.

Based on the variable application rates described above and the in ability to associate use sites (such as “agricultural crops” and “vegetables”) with application rates, EFED estimated the exposures of non-target terrestri al and aquatic animals and plants to potassium and ammonium salts to general “bins” of labeled appli cation rates (1, 10, 20, a nd 27 lb per acre); ( Table II.6 ). The dominant application types are broa dcast by ground boom and backpack spray.

Due to the difficulty in estimating exposure from backpack spraying, only broadcast applications will be modeled. Backpack spraying or spot trea tment at non-broadcast application rates of morethan 27 lb a.i./A will be characterized as to whether any meaningful exposure to nontargetspecies is likely. Aerial applications ar e not included in the asse ssment because they are unlikely to achieve the thorough foliar cove rage required for effective control.

In addition, only single applications will be modeled; the uncertainty is addressed quantitatively in section IV.2.1.1.

Sodium salts uses as registered through the Agency are not applied using aircraft, ground equipment, or spot treatment equipment. The end-us e product is unique in th at it is formulated as a soap bar enclosed in a mesh bag that is hung or staked in an individu al gardener’s backyard. This use pattern is not exp ected to result in meaningful exposure to wildlife.15 Indoor premises such as greenhouse, households , industrial, commerci al, and hospital are enclosed places where the pesticide does not reac h the environment are ther efore not expected to result in meaningful exposure to wildlife. Examples of use site groups are greenhouse food, greenhouse nonfood, indoor food, indoor nonfood, indoor medical, indoor reside ntial, and indoor residential/nonfood uses. While potassi um salts products can be used to control fleas on pets, it is not expected to produce concentrations as high as on agricultural fields to pose risk to the environment. Thus, indoor and pet uses ar e not included in this assessment.

In this assessment, the term insecticidal so ap refers only to thos e products whose active insecticidal ingredient is the soap itself.



### II.3 Ecosystems Potentially at Risk

The terrestrial ecosystems potentially at risk in clude the treated area, and areas immediately adjacent, that might receive residues of potassium and ammonium salts via drift or runoff. The ecosystems and communities at risk will tend to be those in close proximity to and downwind, downstream, or down gradient from registered us e sites. For Tier 1 assessment purposes, risk will be assessed to terrestrial species that are assumed to feed on and otherwise occupy the treated area. Exposure to animals off the treate d site is also possible, but exposure and risk estimates are likely to be lower than on the treated site.

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, aquatic habitat also includes marine ecosystems including estuaries. For Tier 1 assessment purposes, risk will be assessed to species in small ponds receiving runoff and drift from treated areas.

II.3.1 Receptors

Potassium and Ammonium Salts Terrestrial receptors likely to be exposed to potassium and ammonium salts include birds, mammals, reptiles and terre strial stages of amphib ians that may live and forage in treated fields and terrestrial plants adjacent to, or down slope from treated areas. Table II.6. Assumptions for Potassium and Ammonium Salts Application Information for Exposure Analysis

Crop Rate (lbs a.i./A) No. of Applications Minimum Interval (days)

All Uses –Broadcast & Ground Application 27 1 not applicable

All Uses –Broadcast & Ground Application 20 1 not applicable

All Uses – Broadcast & Ground Application 10 1 not applicable

All Uses – Broadcast & Ground Application 1 1 not applicable16 The aquatic receptors likely to be exposed to potassium and ammonium salts include fish, invertebrates, aquatic stages of amphibians and plants living in waterways adjacent to or downstream from treated areas.

Sodium Salts Based on the use pattern (suspended mesh bags), the low use rate (one ounce per bag), and the mode of action (mammal repellency ), meaningful exposur e of wildlife to the sodium salts is not anticipated.

II.3.2. Assessment Endpoints

Assessment endpoints include reduced survival of individuals, and re production and growth impairments within populations and/or adverse effects to communities. Species potentially exposed include terrestrial and aquatic plants a nd animals. Potential effects are determined through testing of surrogate representatives within those taxonomic groups, or from other related taxonomic groups.

In order to protect threatened and endangered species, all asse ssment endpoints are measured at the individual level. Measurement of endpoint s at the individual leve l also provides insight about risks at higher levels of biological organization ( e.g. populations and communities). For example, pesticide effects on individual survi vorship have important implications for both population growth increase and habitat carrying capacity.

Assessment endpoints and toxicity data used for the risk a ssessment are identified in Table II.7

. 

### II.4. Conceptual Model

In order for a chemical to pose an ecologica l risk, it must reach ecological receptors in biologically significant c oncentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological receptor. For an ecological exposure pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecological r eceptors, and a feasible route of exposure.

The conceptual model depicts the potential pathways for ecologica l risk associated with soap salts use. The conceptual mode l provides an overview of the e xpected exposure routes for animals and plants within the soap salts action area.

II.4.1. Risk Hypothesis

Risk hypotheses are specific assumptions about potential adverse effects (i.e. changes in assessment endpoints) and may be based on theory and logic, empirical data, mathematical models, or probability models (EPA, 1998). For this assessment, the risk is stressor-linked, where the stressor is the release of soap salts to the environment. The following risk hypothesis was developed for this registration review.

The use of soap salts as herb icides, insecticides, acaricides , algaecides, and repellents in outdoor and terrestrial crop and non-crop sites w ill likely cause exposure of terrestrial and aquatic animals and plants. Based on the mobility and persistence of soap salts, the mode of17 action, and the food-web of the ta rget aquatic and terrestrial eco systems, soap salts have the potential to cause reduced survival, and reprodu ctive and growth impairment for both terrestrial and aquatic animals and plant species.

II.4.2. Conceptual Diagram

The potential exposure pathways and effects of th e registered uses of potassium and ammonium salts on crops and non-crops are depicted in Figure 1 . Solid arrows depict the most likely routes of exposure and effects; dashed li nes depict potential r outes of exposure that are not considered likely for soap salts.

Application of Potassium and Ammonium Salts to Food and Feed Crops, Ornamental Flower Beds, House Plants, Trees, Lawn, Shrubs, Walks and Driveways, on Dogs, Puppies and Cat, and as a Rabbit and Deer Repellent Stressor

Direct Ground Deposition Volatilization/ Wind Suspension Leaching

Non-Target Plants: •Plant growth abnormalities •Lethality •Developmental/reproductive effects Source:

Transport Pathway

Terrestrial Animals: •Lethality •Reproductive/developmental

effects Aquatic Animals and Plants: •Effects to survival, growth, and

reproduction •Reductions in cell density/

biomass in aquatic plants

Altered Terrestrial Community Assemblages: Reduced food supply and edge habitat availability Altered Aquatic Community Assemblages: Effects to riparian habitat availability Effects to species abundance/diversity Changes in physical/chemical parameters Source:
Exposure Media

Exposure Point

Receptors

Direct Effects

Indirect Effects Terrestrial Food Residues (foliage, fruit, insects)

Direct Contact

& Ingestion

Terrestrial Vertebrates and

Invertebrates Direct Contact/ Root Uptake

Terrestrial

Upland Plants Surface Water Sediment Groundwater

Gill/Integument Uptake

Aquatic Invert & Vertebrates Upland Soil and Foliage Riparian/Wetland Foliage/Soil Spray Drift Runoff/ Erosion

Uptake/ Adsorption

Riparian/ Wetland Plants Aquatic Plants

Plant Population Reduced Population growth

Figure 1 - Conceptual Model Diagram: Potassium and Ammonium Salts Application to Terrestrial18 Habitats



### II.5. Analysis Plan Options

In order to address the risk hypot hesis in the soap salts regist ration review, the potential for adverse effects on non-target aquatic and terrestri al animals and plants will be analyzed in accordance with the Agency’s Overview Docu ment (Overview of the Ecological Risk Assessment Process in the Office of Pesticide Pr ograms, U.S. Environmental Protection Agency, January 2004).

During this step, measurements of effect and expo sure used to evaluate the risk hypothesis are delineated. The Analysis Plan provides a synopsis of measures that will be used to evaluate the risk hypothesis for soap salts. There are three categories of measures: exposure, effects, and risk.

II.5.1 Measures of Exposure

The measures of exposure are estimated usi ng standard EFED models. Aquatic exposure consists of aquatic estimated environmental c oncentrations (EECs) derived using a waterbody that is vulnerable and representati ve of static ponds and first or der waterways. Because only the shorter-chain fatty acids are soluble in environm ental water, aquatic expo sures will be modeled as nonanoic (pelargonic) acid, a repr esentative soluble fatty acid.

Terrestrial exposures are estimated using a model th at assumes direct appli cation to a variety of avian, mammalian and reptilian food items. Exposur e to terrestrial plants are estimated using a model that assumes potassium and ammonium sa lts drift or move with runoff to adjacent habitats.

The only potential exposure of the sodium salts mesh bags to the environment would be via direct ingestion of the mesh bags (e.g., there wo uld be minimal surface water runoff, spray drift, or residues expected on potential food items). Direct ingestion is considered to be highly unlikely.

Aquatic Animals and Plants

Tier I simulation model GENEEC2 was used to ge nerate estimated environmental concentrations (EECs) that may occur in surface water bodies adj acent to application sites. The predicted peak, 21-day, and 60-day concentrations are used to es timate risk to aquatic animals and plants inhabiting shallow-water aquatic communities that receive runoff during rainfall events and/or drift from adjacent use sites. More details on GENEEC2 may be found at the following website:

http://www.epa.gov/oppefed1/m odels/water/index.htm#geneec2

Aquatic Exposure Monitoring and Field Data

No monitoring data are available for soap salts. Even if monitoring data were available, it is unlikely that exposures from pesticidal and non-pesticidal uses c ould be distinguished.19 Terrestrial Animals

The potential exposure pathways for terrestrial pl ants and animals include spray drift deposition from ground spray applications, runoff/leaching fro m treated areas, direct consumption of mesh bags (considered unlikely) , resulting in residues on non-target species as well as residues on food items for non-target species. EFED uses the T-REX and TERRPLANT models to estimate exposure concentrations of potassium and ammoni um salts to non-target terrestrial animals and plants, respectively, following single broadcast ap plication rates of 1.0, 10, 20, and 27 lb a.i./A.

Because soap salts were found to be non-toxi c to birds and mammals, no TREX exposure assessment is presented. Possible risk to bird s and mammals, and thei r surrogates reptiles and terrestrial-phase amphibians, will be consider ed qualitatively in the risk characterization.

Terrestrial Plants

TerrPlant (v. 1.2.2) was developed to provide screening level estima tes of exposure to terrestrial plants from single pesticide applications. The m odel does not consider exposures to plants from multiple pesticide applications. Te rrPlant derives pesticide EECs in runoff and in spray drift. Based on public comments, adverse effects are consid ered more likely via the spray drift route. RQs are developed for non-listed and listed species of monocots and dicots inhabiting dry and semi-aquatic areas that are adja cent to treatment sites receivi ng runoff and/or drift from applications on sites treated with potassium and ammonium salts.

In addition, the AgDRIFT spray drift model (v. 2.01) will be used to assess exposures of terrestrial plants to potassium and ammonium salt s deposited on terrestrial habitats by spray drift. The model consider the amount deposited on a gi ven distance by spray drift to assess the distance (feet) from the edge of field a depositi on needs to fall below the terrestrial plant LOC.

Drinking water and inhalation risks are not quantitatively examined in this assessment, due to the non-toxicity of soap salt s to birds and mammals.

II.5.2. Measures of Effect

Measures of ecological effects are obtained fr om submitted guideline studies conducted with a limited number of surrogate species on soap salts. The test species ar e not intended to be representative of the most sensitive species but rather were selected based on their ability to thrive under laboratory conditions and their standard ized use for toxicity st udies of a variety of chemicals. Toxicity testing does not represent all species of birds, mammals, or aquatic animals. Only a few surrogate species for both freshwater fish and birds are us ed to represent all freshwater fish (2000+) and bird (680+) spec ies in the United States. For mammals, acute studies are usually limited to the laboratory rat. Estuarine/marine testing is usually limited to a crustacean, a mollusk, and a fish. In addition, neith er reptiles nor amphibian data are available. The risk assessment assumes that avian, terrestri al-phase amphibian and reptilian toxicities are similar. The same assumption is used for fish and aquatic-phase amphibians.20 As noted previously, the correspondence between th e products tested in th e toxicity studies, and particular currently registered products, is unc ertain. The uncertainty is mainly due to unspecified fatty acid chain le ngth compositions. Exposure modeling was therefore also conducted on a surrogate substance (C9 fatty aci d or nonanoic acid) that comprises the bulk of the fatty acid content in products expected to be soluble in environmental waters.

Where available, sublethal effects observed in ac ceptable studies will be evaluated qualitatively. Such effects may include behavioral changes (e.g., lethargy and changes in coloration). Quantitative assessments of risks, though, are lim ited to those endpoints that can be directly linked to the Agency’s assessment points of impaired survival, gr owth and reproduction.

The following table ( Table II.7 ) lists the measures of enviro nmental exposure and ecological effects used to assess the poten tial risks of potassium and amm onium salts of fatty acids to nontarget organisms. The methods used to assess the risk are consistent with those outlined in the document “Overview of the Ecological Risk As sessment Process in the Office of Pesticide Programs” (USEPA, 2004).21 Table II.7. Measures of Exposure and Measures of Effect Used in Assessing Potential Risks. Assessment Endpoint Surrogate Species and Measures of Ecological Effect 1 Measures of Exposure

Birds 2 Survival Lowest acute LD 50 (single oral dose test) and LC 50 (subacute dietary test) Upper-bound residues on food items and estimates on concentration of the mesh bag for consumption

(animal repellent use). Reproduction and Growth Lowest NOAEC (21-week reproduction test)

Mammals Survival Lowest acute LD 50 (single oral dose test)

Reproduction and Growth Lowest NOAEC (2-generation reproduction test)

Aquatic Animals (Fish

and invertebrates) 3 Survival Lowest tested LC 50 or EC 50 (acute toxicity test) Peak EECs 4

Reproduction and Growth Lowest NOAEC (early life-stage or full life-cycle tests) 21-day EECs for invertebrates and 60-day EECs for fish 4

Terrestrial plants 5 Survival and growth Lowest EC 25 (for non-listed plants) and corresponding NOAEC (for listed plants)

(endpoints derived for monocots and dicots from seedling emergence and vegetative vigor studies) Estimates of runoff and spray drift to non-target

areas

Insects 6 Survival (not quantitatively

assessed) Lowest honeybee LD 50 (acute contact test) Maximum application rate for honeybees

Aquatic plants (vascular and non-vascular) Survival and growth Lowest EC 50 (for non-listed plants) and corresponding NOAEC or EC 05 (for listed plants) Peak EECs 4

1 The most sensitive species tested within taxonomic gr oups is used for screening-level risk assessments.

2 Birds represent surrogates for terrestrial-phase amphibians and reptiles.

3 Freshwater fish represent surroga tes for aquatic-phase amphibians.

4 Aquatic EECs are based on modeling described in Section III

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

6 Risk to terrestrial invertebra tes from use is not evaluated, rather the poten tial hazard to honey bees (i.e. the available dat a) are qualitatively assessed.

II.5.3. Integration of Exposure and Effects

Risk characterization is the integration of e xposure and ecological effects to determine the potential ecological risk from the use of soap sa lts of fatty acids and the likelihood of direct and indirect effects to non-target animals and plants in aquatic and terrestria l habitats. The exposure and toxicity effects data are inte grated in order to evaluate the risks of adverse ecological effects on non-target species. For the as sessment of risks from exposure to potassium and ammonium salts, the risk quotient (RQ) method is used to compare exposure and measured toxicity values. EECs are divided by acute and chronic toxicity va lues. The resulting RQs are then compared to the Agency’s Levels of Concern (LOCs) (USEPA 2004) ( Table II.8) . The chance of an individual effect (mortality) can be calculated fo r the RQ using the Individual Effects Calculator (IEC). These criteria are used to indicate when soap salts’ uses, as directed on the label, have the potential to cause adverse dire ct or indirect effects to non- target animals and plants.22 Table II.8. Agency Risk Quotient (RQ) Metr ics and Levels of Concern (LOC) Per Risk Class

RISK CLASS RISK DESCRIPTION RQ LOC Aquatic Animals (fish and invertebrates)

Acute Potential for effects to non-listed animals from acute

exposures Peak EEC/LC 50 1 0.5

Acute Restricted Use Potential for effects to an imals from acute exposures Risks may be mitigated through restricted use classification Peak EEC/LC 50 1 0.1

Acute Listed Species Listed species may be potentially affected by acute

exposures Peak EEC/LC 50 1 0.05

Chronic Potential for effects to non-listed and listed animals from chronic exposures 60-day EEC/NOAEC (fish) 1 21-day EEC/NOAEC (invertebrates) Aquatic Plants Non-Listed Potential for effects to non-listed plants from exposures Peak EEC/LC 50 1 1 Listed Potential for effects to listed plants from exposures Peak EEC/NOAEC 1
Terrestrial Animals (mammals and birds)

Acute Potential for effects to non-listed animals from acute

exposures EEC 2 /LC 50 (Dietary) 0.5 EEC/LD 50 (Dose)

Acute Restricted Use Potential for effects to an imals from acute exposures Risks may be mitigated through restricted use classification EEC 2 /LC 50 (Dietary) 0.2 EEC/LD 50 (Dose)

Acute Listed Species Listed species may be potentially affected by acute

exposures EEC 2 /LC 50 (Dietary) 0.1 EEC/LD 50 (Dose)

Chronic Potential for effects to non-listed and listed animals from chronic exposures EEC/NOAEC 1

Terrestrial and Semi-Aquatic Plants

Non-Listed Potential for effects to non-target, non-listed plants from

exposures EEC/ EC 25 1

Listed Plant Potential for effects to non-target, listed plants from

exposures EEC/ NOAEC 1 EEC/ EC 05

1 LC 50 or EC 50

. 2 Based on upper bound on feed items23 

## III. Analysis

III.1. Environmental Chemistry of Fatty Acids

The sodium, potassium and ammonium salts of fatty acids across the range C8 to C18 are “soluble” in water, meaning at the maximum co mpletely miscible. The corresponding free acids are less soluble (C8, 789 mg/L a nd C18, 0.6 mg/L). Thus, formulating the Soap Salt products as sodium, potassium, or ammonium sa lts aids in the solubilization of the fatty acid moieties in

water.

The solubility of fatty acid salts of divalent metal cations (Ca 2+ , Mg 2+ , Zn 2+ ) is much lower than that of the sodium, potassium, and ammonium sa lts. This is why “ammonium salt products are not compatible with soluble metallic salts such as zinc, manganese, and iron sulfates.” The metal ions precipitate the fatty acids as insoluble, high molecular weight salts and make them biologically unavailable. In “hard” water, which is high in Ca a nd Mg, this is observed as “soap scum” on bathtubs and sinks. The metal ion c ontent of soil provides repeated opportunity for fatty acids to be precipitated out of run-off before reaching an exposure point.

Irani and Callis (1960) reported good correlation between solubility and the number of carbons in saturated fatty acid calcium salts according to the following equations:

-logK sp = -2.63 + 1.24C

K sp = [Ca 2+ ][fatty acid] 2

where Ksp is the solubility product constant of the salt and C is the number of carbon atoms in the chain. Taking 0.3 mmolar (12 mg/L) as [Ca] for soft water, and 3 mmolar (120 mg/L) as [Ca] for hard water, Table III.1 gives the solubility limit in mg/L of saturated fatty acid calcium salts, as [fatty acid] in soft and hard water, along with laboratory -measured solubility data given in EPISuite for unknown wate r hardness conditions.

___________________________________________________________________________ Table III.1. Solubility Limits of Calcium Fatty acid salts, as mg/L [fatty acid]

Carbon# MW acid logKsp Ksp(1) Soft water(2) Hard water(3) Acid solubility (4)

8 144.22 7.29 5.13E

‐ 08 1886 596 789

9 158.24 8.53 2.95E

‐ 09 496 157 284

10 172.27 9.77 1.699E

‐ 10 130 41 61.8

11 186.3 11.01 9.77E

‐ 12 34 11 52

12 200.32 12.25 5.623

‐ 13 8.7 2.7 4.8

13 214.35 13.49 3.24E

‐ 14 2.2 0.70 33

14 228.38 14.73 1.86

‐ 15 0.57 0.18 1.07

15 242.41 15.97 1.07E

‐ 16 0.14 0.046

16 256.43 17.21 6.17E

‐ 18 0.037 0.012 0.04

17 270.46 18.45 3.55E

‐ 19 0.0093 0.0029

18 284.49 19.69 2.04E

‐ 20 0.0023 0.00074 0.597 (1) solubility product constant. (2) fatty acid solubility in soft water. (3) fatty acid solubility in hard water. (4) labor atory-24 measured solubility literature values fro m EPISuite in water of unknown hardness.

The lowest toxicity endpoint for pot assium and ammonium soap salts ( Tables III.9 and III.10 ) is higher (0.39 mg/L for algae NOAEC) than the solubilities for C15 a nd above, indicating that fatty acids above C15 are too insoluble to reach toxicity thresholds. Thus the fatty acids contributing to the exposure are generally the more soluble C8 to C12 acids.

Data for dodecanoic acid (MRID 43465501) indicate that its calcium salt is not soluble enough to reach the measured LC 50 for fish (36 mg/L), and that the EC 50 for Daphnids (16.9 mg/L) is over the solubility limit (8.7 mg/L in soft wa ter and 2.7 mg/L in hard water). Above C12, the fatty acids may be too insoluble in environmental water to reach these acute toxicity thresholds.

The environmental fate models used by OPP to es timate fatty acid concentrations in water do not account for interaction with metal ions. Thus, it can be expected that fatty acid concentrations will be lower in waters with relatively high meta l ion content than the models predict. Also, in some agricultural situations, lime, which is rich in Ca, is added to raise the pH of the soil. The presence of added Ca in agricultural fields shoul d also serve to limit the solubility and mobility, and thus the environmental wate r concentration, of fatty acids.



### Environmental Fate Summary

A typical commercial soap is made by saponification of fats with a strong base to produce a salt of a fatty acid (C 12 –C 18 saturated). These fatty acids in so ap are an excellent energy source in soil and are among the most efficient energy so urces available to liv ing cells. Fatty acids constitute a significant portion of the normal daily diet of mammals (including humans), birds, and invertebrates since they are found in large amounts in the form of lipids in all living tissues (including seeds).

Hydrolysis of potassium salts of fatty acids did not occur over a period of 43 days (MRID 470307006). This is consistent with open literature data on fatty acids, wh ich indicates that the primary environmental degradation route of fatty acids is by micro-floral action (the cleavage of the carbon chain of fatty acids requires oxida tive chemistry) as opposed to hydrolysis.

Aqueous photolysis of two formulated products of fatty acids (Safer’s Weed and Grass Killer Concentrate and Safer’s Sapestai n) was tested (MRID 470307007). Th e active ingredient in this study was free fatty acids which showed no degrad ation during the 32 day course of the study. Due to the similarity of chemical structure, it is expected that hydrolysis of the ammonium salts of fatty acid would be similar to that of the potassium salts of fatty acids.

An aerobic soil metabolism study (MRID 470168026) submitted to the Agency indicated that the half-life of these fatty acids is less than one day. The study wa s conducted using soil collected below turf, and analytical results were reported ov er a three week period. Both sterilized and non-sterilized soils were treated a nd the results indicate that the na tural fatty acid content of the soil was lower than the fatty acid content of the tr eated soil. The results also indicated that the concentration of fatty acids in th e treated soils had declined to natural levels within 10 days of treatment and that the primary mechanism of degradation was via microbial processes. Extraction for individual degradates was not done because microbial metabolism of fatty acids25 has the effect of either co nverting the degradates to CO 2 , or converting the carbon content of the fatty acid to any of the thousands of naturally occurring organic substances produced by the soil micro flora (if used as a carbon source).

Finally, an adsorption/desorption study (M RID 470306008) was submitted for two fatty acids including Capric and Pelargonic fatty acids. The study suggests that leaching of Capric and Pelargonic fatty acids would be minimal, although no Kd or Koc estimates were provided nor could they be calculated using the data provided in the study.

In order to address the need fo r adsorption data (either Kd or Koc) for modeling purposes EFED estimated Koc values for a variety of fatty acids using EpiSuite. EpiSuite is modeling software that relies on a database of physical/chemical property data and a suite of environmental fate estimation models developed by EPA’s Office of Pollution Prevention & Toxics (OPPTS). Estimates of Koc were generated for nonanoic acid, because this fatty acid represents an average chain length for soap salt products that are soluble enough in environmental water to cause exposure. Estimates of Koc for nonanoic acid ranged from 53 mL/g (molecular connectivity index method) to 111 mL/g (Kow method). A valu e of 100 mL/g was taken to be representative of soap salt mixtures of length C8 to C11.

http://www.epa.gov/opptintr/e xposure/pubs/episuite.htm

In addition, EPA’s OPPTS maintains a database of physical/chemical property data under the High Production Volume (HPV) Challenge Program . The HPV program makes human health and environmental effects data available to the public and includes information on Tall Oil Fatty Acids and Related Substances. This database includes limited information on these fatty acids but does include several compounds specifically included in this assessment including potassium salts of fatty acids, fatty acids, ta ll oil, and sodium salts of fatty acids. The environmental fate data set for these fatty acids is limited but does include some information on log K ow and persistence as measured by biodegradation. In general, these data are consistent with the environmental fate data summarized above and s uggests that these fatty ac ids have the potential to bioaccumulate but are not likel y to be persistent. More information on the HPV program in general and the specific data for tall oils may be found at the following website:

http://www.epa.gov/hpvis/



### III.2. Aquatic Exposure Modeling

Because the longer-chain fatty acids present in soap salts are not expected to be soluble enough for toxicity to be expressed, the exposure mode ling needs to be based on the short-chain acids (generally C8 to C12). It was therefore assume d that only the portion of the product up to C12 contributes to the exposure. Ma ximum broadcast application ra tes (27 lb/acre) were used. Maximum spot treatment rates with higher applica tion rates than the broadcast application rates were not modeled. Because the maximum broadcas t rates include an inso luble portion, modeling the exposure as only soluble fatty acid overstates the actual exposure. For this range (C8 to C12), an overall solubility of 100 mg/L, limited by metal ion concentrations, was judged to be representative based on the data in Table III.1 . This is roughly equivale nt to the solubility of C10 acid in soft water (130 mg/L).26 Model input parameters ( Table III.2 ) were selected based on laboratory fate data in accordance with EFED’s input parameter guidance. More in formation on selection of input parameters for GENEEC2 may be found at the following website:

http://www.epa.gov/oppefed1/mode ls/water/input_guidance2_28_02.htm

Table III.2. GENEEC2 Input Para meters for Soap Salts for Aquati c Ecological Exposure Assessment for Broadcast Applications

Model Parameter Value Comments Source

Spray Drift by Scenario ground -6.6 % Default Assumption 1

Aerobic Soil Metabolism (t 1⁄2) 1 day MRID 470168026

Aerobic Aquatic Degradation (t 1⁄2) 2 days 2x aerobic soil metabolism value due to lack of data 1 Aqueous Photolysis (t 1⁄2) Stable MRID 470304007

Hydrolysis Stable MRID 470307006

K oc 100 Estimates are representative of mixtures dominated by nonanoic acid (C9) EpiSuite Estimates

Water Solubility 100 mg/l EpiSuite Estimates

1- From “ Guidance for Chemistry and Management Practice Input Parameters for Use in Modeling the Environmental Fate and Transport of Pesticides”

Modeling Results

Aquatic EECs calculations generated from GENEEC 2 for the registered uses of soap salts on outdoor sites based on maximum broadcast app lication rates have been updated for risk estimations in this screening-level assessment ( Table III.3 ). The highest br oadcast application rate for potassium and ammonium salts (27 lb a.i./A) coupled with the representative K oc for lower chain length products (100) yield the EECs in Table III.3 . Broadcast application rates for modeling purposes were selected in accordance with a range of broadcast application rates (i.e., 1, 10, 20 and 27 lb a.i./A) in order to assess th e relative magnitude of exposure across the spectrum of use sites and applica tion rates allowed. EECs for spot treatment applications are not available; however, exposure from spot treatment using backpack sprayers will be subsequently discussed for any potential risks to non-targ et wildlife and plants after the assessment on broadcast applications.27 Table III.3. Exposure Estimates ( ppm) for Soap Salts modeled as Nonanoic Acid

Application Rate lb a.i./A Peak 21-Day Avg 60-Day Avg

Ground Application

27 0.378 0.1 0.0378

20 0.28 0.076 0.028

10 0.14 0.038 0.014

1 0.014 0.0038 0.0014

Terrestrial Organisms

Exposure modeling for birds and mammals, and by extension, reptiles a nd terrestrial phase amphibians, was not conducted because soap salts are non-toxic to these taxa . The risks to these taxa is considered qualitatively in the Risk Characterization.

Terrestrial Plants

Modeling Results

EFED's exposure scenario for off-site plants is based on the broadcast application rates (spot treatment application rates are excluded), appl ication method (ground), a nd the water solubility of the pesticide. The amount of pesticide that runs off is a propor tion of the appli cation rate and is assumed to be 1%, 2%, or 5% for water so lubility values of <10 mg/L, 10-100 mg/L, and >100 mg/L, respectively. For soap salts, a runoff value of 2% is presumed, based on the solubility of 100 mg/L in water, representing C9 fatty acid. Drift from ground-spray applications are assumed to be 1% of the application rate . The EECs are tabulated below in Table III.4 . Further refinement of the exposures to plant from off- site drift using the AgDR IFT model are discussed in Section IV.2.2.4.

Table III.4. TERRPLANT EECs for Terrestrial Plants Located Adjacent to Potassium and Ammonium Salts Treated Sites.

Broadcast Application Rate (lb a.i./A) Application Method TERRPLANT EECs (lbs a.i./A) Total Loading to Areas Adjacent to Treated

Areas 1 Total Loading to Semi-Aquatic Areas Adjacent to Treated Areas 2 Drift to Adjacent

Areas 3

27
Ground Unincorp. Spray 0.81 5.67 0.27

20 0.6 4.2 0.2

10 0.3 2.1 0.128 Table III.4. TERRPLANT EECs for Terrestrial Plants Located Adjacent to Potassium and Ammonium Salts Treated Sites.

Broadcast Application Rate (lb a.i./A) Application Method TERRPLANT EECs (lbs a.i./A) Total Loading to Areas Adjacent to Treated

Areas 1 Total Loading to Semi-Aquatic Areas Adjacent to Treated Areas 2 Drift to Adjacent

Areas 3

1.00 0.03 0.21 0.01

1 EEC = Sheet Runoff + Drift (1% for ground)

2 EEC = Channelized Runoff + Drift (1% for ground)

3 EEC for ground (appl. rate x 1% drift)29 

### III.3. Ecological Effects Characterization

In screening-level ecological risk assessments, effects characterization describes the types of effects a pesticide can have on aquatic and terrest rial organisms. This ch aracterization is based on the registrant-submitted toxicity data for birds, mammals, fish, invertebrates, and plants for the soap salts registration review . Effect data were available fo r potassium and ammonium salts; however, none were available for sodium salts . With sodium salts registered as a low volume/minor use and the only potential exposure to the environment is via direct ingestion of the bar (e.g. there would be no runof f, spray drift, or residues exp ected on potential food items), toxicity data were waived.

As described in the Agency’s Overview Docu ment (USEPA 2004), the mo st sensitive endpoint for each taxon is used for risk estimation. For th is assessment, evaluated taxa include freshwater fish, freshwater invertebrates, aquatic plants, birds (also su rrogate for terrestrial-phase amphibians and reptiles), terrestr ial invertebrates, and terres trial plants. Mammalian endpoints were not available for risk estimation as the Ag ency’s Health Effects Di vision (HED) has waived all mammalian endpoints due to available data for related products of known composition that show lack of effects at high rates to mammals.

Toxicity endpoints are established based on data generated from guideline studies submitted by the registrant, and from open lite rature studies that meet the criteria for inclusion into the ECOTOX database maintained by EPA/Office of Research and Development (ORD) (U.S. EPA, 2004). Open literature data searched for this screening assessment were obtained from ECOTOX information obtained in Ju ne 2008. In order to be incl uded in the ECOTOX database, papers must meet the following minimum criteria:

(1) the toxic effects are related to single chemical exposure; (2) the toxic effects are on an aquatic or terrestrial plant or animal species; (3) there is a biological effect on live, whole organisms; (4) a concurrent environmental chemical con centration/dose or ap plication rate is reported; and (5) there is an explicit duration of exposure.

Data that pass the ECOTOX screen are evaluate d along with the registrant-submitted data, and may be incorporated qualitatively or quantitatively into this assessmen t. In general, effects data in the open literature that indicates effects at lower concentrations than the registrant-submitted data are considered. The degree to which open lit erature data are quantita tively or qualitatively characterized is dependent on whether the inform ation is relevant to the assessment endpoints (survival, reproduction, and growth) identified in Section II.5 . For example, endpoints such as behavior modifications are likely to be qualitatively evaluated, because quantitative relationships between modifications and reduction in specie s survival, reproduction, an d/or growth are not available. To date, none of the open literature that passed the EC OTOX screen resulted in effects at lower concentrations than the registrant subm itted studies and thus are not used in this risk

assessment.

Ecological effects studies are ty pically performed using the tec hnical grade active ingredient (TGAI); however, because the soap salts are formed through an integrated manufacturing30 process, there is no technical product. To resolve these issues, the Agency requested studies with the formulated products.

In addition to registrant-submitted and open litera ture toxicity information, other sources of information, including use of the acute probit dose -response relationship to establish the probability of an individual effect and reviews of the Ecological Incident Information System (EIIS), are conducted to further refine the ch aracterization of potenti al ecological effects associated with exposure to soap salts. A su mmary of the available aquatic and terrestrial ecotoxicity information and use of the probit do se-response relationship for salts are provided in Sections III and V , respectively.

A review of the Ecological In cident Information System (EIIS) maintained by the Agency’s Office of Pesticide Programs (OPP) indicates a tota l of 2 reported ecological incidents associated with the use of potassium salt formulated products. The reported incidents involved phytotoxicity damage to cherry trees (terrestrial pl ants) that occurred in two counties of Washington State in 1989 and 1999. Both incidents were associated with registered uses of soap salts and classified as “probable” that the incidents were associated with soap salts exposure. In addition, there are 29 aggregate plant incidents reported for potassium salt formulated products between 1997 and 2012 that were report ed by the pesticide registrants.

Similarly, a search of the Avian In cident Monitoring System (AIMS; http://www.abcbirds.org/abcprograms /policy/toxins/aims/aims/index.cfm ) was conducted on October 10, 2012. AIMS is a database administer ed by the American Bird Conservancy that contains publicly available dataon reported avian incidents invol ving pesticides. No incidents involving soap salts were found.

III.3.1. Aquatic Effects Characterization

The most sensitive acute and chronic effects meas urement endpoints associated with soap salts exposure to freshwater and estuarine/ marine species are summarized in Table III.5 for potassium and in Table III.6 for ammonium

. Selected effects endpoints for the risk assessment are from acceptable and supplemental studies for so ap salts and are described in Appendix C.

Laboratory studies examining the effects of salts of fatty acids to aquatic organisms indicated that the potassium salt is generally more toxi c than the ammonium salt. Based on the most sensitive toxicity data, the potassium salt is acutely classified as moderately toxic to freshwater fish and estuarine/marine inverteb rates; highly toxic to freshwater invertebrates; and no effects were seen in estuarine/marine fi sh at doses up to 4.4 mg a.i./L. The data presented in Table III.9 are mostly for chain lengths of C14 to C18. Thes e fatty acids are too inso luble in environmental water (18 mg/L and lower) to reach the toxicity endpoints shown.

Ammonium soap salts (Table III.6) are classified as slightly toxic to freshwater fish and both freshwater and estuarine/marine invertebrates; and practically nontoxic to estuarine/marine fish on an acute basis. Most of the data in Table III.10 are for formulations containing 93% nonanoic acid, which is soluble enough in hard water (157 mg /L) to cause exposure in the water column. The results of acute toxicity studies with nonanoic acid itself indicate that the LC 50 in bluegill sunfish is greater than 105 mg/L (MRID 43065301), the LC 50 in rainbow trout is 91 mg/L (MRID 43065302), and the EC 50 in daphnia magna is 96 mg/L (MRID 43065303). These31 results indicate that a fatty acid of defined comp osition (99.2% C9 and isome r) is less toxic than would be indicated by the toxicity data for pot assium and ammonium salts of unknown fatty acid composition.

In addition, freshwater fish also act as surrogates for aquatic-pha se amphibians in the absence of data; therefore, acute toxicity data with freshw ater fish indicates potassium and ammonium salts are moderately and slightly toxic to aquatic- phase amphibians, respectively. With chronic toxicity data limited to the daphnid life cycle stud ies, reproductive and grow th effects in the time release of first brood, offspring per adult, a nd length were observed; however, daphnids’ life cycle was more sensitive to potassium sa lts than ammonium. Ac ute-to-Chronic Ratio calculations were used to estimate the NOAEC for chronic effects to freshwater fish, estuarine/marine fish, and estuarine/marine inve rtebrates, using data from the daphnid and mysid studies.

No aquatic organism toxicity data are availa ble for sodium salts; however, the sodium salts product is formulated as mesh bags which are h ung on branches or stakes, which results in low potential for runoff and spray drift to aquatic organisms/plants. In addressing the lack of toxicity data, the required exposure for adverse effects on aquatic organisms/plants exposed to sodium salts are discussed further in Section IV.2

.32 Table III.5. Most Sensitive Acute and Chro nic Toxicity Data fo r Aquatic Organisms Exposed to Potassium Salts of Fatty Acids. 1 Exposure Scenario Species Affected Endpoint Toxicity Measurement MRID (Classification)

Freshwater Fish Acute Rainbow trout ( Onchorhynchus mykiss ) Mortality 96-hr LC 50 = 9.19 mg a.i./L 40053304 Chronic No data available Estimated NOAEC = 8.06 mg a.i./L ACR 2

Freshwater Invertebrates Acute Water flea ( Daphnia spp.) Immobility 48 hr EC 50 = 0.57 mg a.i./L 40053305 Chronic Reproduction and Growth NOAEC = 0.5 mg a.i./L (offspring/adult and length) 48664201

Estuarine/Marine Fish Acute Sheepshead minnow ( Cyprinodon variegates) Mortality 96-hr LC 50 >4.4 mg a.i./L 48469802 Chronic No studies available Estimated NOAEC >3.9 mg a.i./L ACR 2

Estuarine/Marine Invertebrates Acute Mysid shrimp ( Americamysis bahia ) Mortality 96-hr LC 50 = 1.2 mg a.i./L 48608707 Chronic No data available Estimated NOAEC = 1.05 mg a.i./L ACR 2

Aquatic Plants 7-day

exposure Duckweed ( Lemna gibba ) Frond count 7-day EC 50 : >5.0 mg a.i./L NOAEC = 5.0 mg a.i./L 48608702

96-hour

exposure Green algae ( P. subcapitata ) Cell density 96-hr EC 50 : 0.59 mg a.i./L NOAEC = 0.39 mg a.i./L 48608701

1 Tested as formulated product; mostly long-chain (C14-C18 fatty acids). Actual toxicity limited by solubility product constant as shown in Table III.1.
2 Estimated value based on Acute to Chronic Ratio (ACR) method using daphnid data; ACR = 1.14. Trout NOAEC = (LC50 of 9.19 mg/L ÷ 1.14) = 8.06 mg/L; Minnow NOAEC = (LC50 of >4.4 mg/L ÷ 1.14) = >3.9 mg/L; Mysid NOAEC = (EC50 of 1.2 mg/L ÷ 1.14) = 1.05 mg/L33 Table III.6. Most Sensitive Acute and Chro nic Toxicity Data fo r Aquatic Organisms Exposed to Ammonium Salts of Fatty Acids. 1 Exposure Scenario Species Affected Endpoint Toxicity Measurement MRID

Freshwater Fish Acute Rainbow trout ( Onchorhynchus mykiss ) Mortality 96-hr LC 50 = 12 mg a.i./L 42806405 Chronic No studies available Estimated NOAEC = 10.3 mg a.i./L ACR 2

Freshwater Invertebrates Acute Water flea ( Daphnia spp.) Immobility 48 hr EC 50 = 27 mg a.i./L 42806406 Chronic Reproduction and Growth NOAEC = 23 mg a.i./L (time to first brood release) 48402203

Estuarine/Marine Fish Acute Sheepshead minnow ( Cyprinodon variegates) None 96-hr LC 50 >105 mg a.i./L 48402202 Chronic No studies available Estimated NOAEC = >90 mg a.i./L ACR 2

Estuarine/Marine Invertebrates Acute Mysid shrimp ( Americamysis bahia ) Mortality 96-hr LC 50 = 67 mg a.i./L 48402201 Chronic No data available Estimated NOAEC = 57 mg a.i./L ACR 2

Aquatic Plants 7-day

exposure Duckweed ( Lemna gibba ) Frond count 7-day EC 50 = 200 mg a.i./L NOAEC = 15 mg a.i./L 48402206

96-hour

exposure Green algae ( P. subcapitata ) Cell density 96-hr EC 50 : 6.6 mg a.i./L NOAEC = 2.9 mg a.i./L 48402207

1 Data are for soluble, short-chain (93% C9) fatty acids.

2 Estimated value based on Acute to Chronic Ratio (ACR) method using daphnid data; ACR = 1.17. Trout NOAEC = (LC50 of 12 mg/L ÷ 1.17) = 10.3 mg/L; Minnow NOAEC = (LC50 of >105 mg/L ÷ 1.17) = >90 mg/L; Mysid NOAEC = (EC50 of 66.5 mg/L ÷ 1.17) = 57 mg/L

III.3.2. Terrestrial Effects Characterization

The most sensitive acute and chronic effects measurement endpoints associated with salts exposure to terrestrial sp ecies are summarized in Table III.7 for potassium and in Table III.8 for ammonium

. Selected effects endpoints for the ri sk assessment are from acceptable and supplemental studies for salts and are described below.

Overall, soap salts are practically nontoxic to bi rds on an acute basis. After adjusting for purity, potassium and ammonium salts caused no mortality or sub-lethal effects up to and including 2,450 mg a.i./kg bw and 5620 mg a.i./kg diet to upland game birds and waterfowl via oral and dietary routes, respectively. In addition, while limited, the 1981 studies with these species also indicated no effect to birds in the diet as hi gh as 10,000 mg TEP/kg diet. No acute avian toxicity data is available for sodium salts. In addition, birds also act as surrogates for reptiles and terrestrial-phase amphibians in the absence of da ta; therefore, acute toxicity data with birds indicates potassium and ammonium salts are practic ally nontoxic to reptiles and terrestrial-phase amphibians. Avian reproduction data for soap salts were not available so th e chronic toxicity to birds, reptiles, and terrestrial-phase amphibian s is unknown; however, the Agency is not asking34 for reproduction data since it is an ticipated that the ecological eff ects to birds are minimal with the soap salts undergoing rapid degr adation in less than a day and th e lack of effects at high rates in the acute studies.

The Office of Pesticide Programs’ Health E ffects Division (HED) has waived all generic mammalian toxicity data requirements for soap salts due to the lack of e ffects at high doses in the available studies of other fatty acid salts, the nature of the chemicals (fatty acids) and their ubiquity in nature, and the lim ited potential for human exposur e via the oral route from established uses. With no systemic toxicity observed, HED did not sele ct endpoints for human health risk assessment. Thus, for the ecological risk assessmen t, the ecological effects to mammals are anticipated to be minimal.

Results of the acute contact test s with honeybees indicate that fo rmulated products of soap salts are practically non-toxic to honeybees

.
Summaries of the toxicity studi es are given in Appendix C.

Table III.7. Most Sensitive Acute and Ch ronic Toxicity Data for Terrestrial Animals Exposed to Potassium Salts of Fatty Acids. Exposure Scenario Species Exposure Duration Toxicity Reference Value MRID

Mammals Acute (Dose-based) No mammalian endpoints sel ected from HED due to lack of effects at high doses in available studies of other acid salts, the ecological effects to mammals are anticipated to be minimal. Chronic(Dietarybased) Birds
Acute (Dose-based) Bobwhite quail Colinus virginianus 14-day single oral dose LD 50 > 2450 mg a.i./kg bw 44980310

Passerine bird No data available
Acute(Dietarybased) Bobwhite quail Colinus virginianus 8-day dietary LC 50 : >5620 mg a.i./kg-diet 40066204

Chronic(Dietarybased) No studies available, surrogate data from other salts are used.

Terrestrial Plants Seedling

emergence Ryegrass (monocot)

14 days EC 25 = >62.34 lbs a.i./A NOAEC = 31.17 lbs a.i./A 48608704

Radish (dicot) EC 25 = 53.9 lbs a.i./A NOAEC = 3.865 lbs a.i./A Vegetative Vigor Corn (monocot) EC 25 = 5.91 lbs a.i./A NOAEC = 4.239 lbs a.i./A 48402302

Oilseed rape (dicot) EC 25 = 18.5 lbs a.i./A EC 05 = 4.38 lbs a.i./A Beneficial Insects Contact Honey bee 48-hours LD 50 >100 μg a.i./bee 4280600135 Table III.8. Most Sensitive Acute and Ch ronic Toxicity Data for Terrestrial Animals and Plants Exposed to Ammonium Salts of Fatty Acids. Exposure Scenario Species Exposure Duration Toxicity Reference Value MRID

Mammals Acute (Dose-based) No mammalian endpoints sel ected from HED due to lack of effects at high doses in available studies of other acid salts, the ecological effects to mammals are anticipated to be minimal. Chronic(Dietarybased) Birds
Acute (Dose-based) No data available, surrogate data from other salts are used.

Acute(Dietarybased) Japanese quail (Cortunix japonica) 8-day dietary LC 50 : >5000 mg/kg diet or 1100 mg a.i./kg diet 46206301

Chronic(Dietarybased) No data available, surrogate data from other salts are used.

Terrestrial Plants Seedling

emergence All 4 monocots and 6 dicots 14 days EC 25 >100 lbs a.i./A NOAEC = 100 lbs a.i./A 48402204

Vegetative Vigor Corn (monocot) EC 25 = 6.2 lbs a.i./A NOAEC = 1.5 lbs a.i./A 48402205

Tomato (dicot) EC 25 = 2.2 lbs a.i./A EC 05 = 1.1 lbs a.i./A Beneficial Insects Contact Honey bee 48-hours LD 50 >100 μg/bee 4476640136 

## IV. Risk Characterization

IV.1. Risk Estimation

Toxicity data and exposure estimates are used to evaluate the potential for adverse ecological effects on non-target species. Th is assessment for soap salts re lies on the deterministic RQ method to provide a metric of potential risks, for te rrestrial plants, fish and aquatic invertebrates. The RQ provides a comparison of exposur e estimates to toxicity endpoints ( i.e. , the estimated exposure concentrations are divided by acute and ch ronic toxicity values). The resulting RQs are compared to the Agency’s LOCs, as shown in Table II.8 . LOCs are used by the Agency to indicate when the use of a pestic ide, as directed by the label, has the potential to cause adverse effects to non-target organisms. Due to a lack of toxicity, RQs are not calculated for mammals or birds. These risks will be considered qualitatively.

IV.1.1 Risk Quotient Calcul ations for Aquatic Organisms

There is a potential for exposure of the active ingredients to aquatic organisms. Toxicity information on the percentage of the active ingredie nt in the formulations is used to estimate the risks to aquatic organisms as a result of surface runoff and sp ray drift from broadcast ground applications. RQs for spot treatment a pplications were not calculated. The LD 50 and EC 50 is used to estimate acute risk for adverse effects on surviv al to fish and invertebrates, respectively, and the NOAEC is used to estimate chronic risk fo r adverse effects on reproduction and growth to both fish and invertebrates. A single broadcast ground application is modeled. Applications from spot treatments were not modeled.

Freshwater Fish and Invertebrates

Tables IV.1 and IV.2 list acute and chronic RQs calculated for freshwater fish (also surrogates for aquatic-phase amphibians) and invertebrates exposed to potassium and ammonium salts, respectively, based on the EECs generated from GENEEC modeling. Exposures for potassium salts (long-chain fatty acids) may be limited by preci pitation with metal cations in natural water, thus the exposures in Table IV.1 may not be realized.

Results of the assessment on freshwater organisms indicate no acute LOC exceedances for freshwater fish exposed to soap salts ( Table IV.1 – potassium; Table IV.2 - ammonium); the highest acute RQ was 0.04. No chr onic toxicity data were availabl e for freshwater fish. The acute to chronic ratio method was used to estimate the ch ronic toxicity value for freshwater fish using data from rainbow trout and da phnid studies. Chronic RQs (highest RQ = <0.01) for freshwater fish exposed to soap salts were below the chr onic LOC at the maximum broadcast applications rate. The data gap is discussed further in Section IV.2

.
The acute RQs for freshwater invertebrates exposed to potassium salts exceeded the acute listed species and restricted use LOCs when applying at and greater than the application rate of 20 lb a.i./A using ground equipment (acute RQ = 0.49) and exceeded the acute liste d species, restricted use, and acute non-listed species LOCs when applyi ng at and greater than 27 lb a.i./A (acute RQ = 0.66). However, the potassium salts (predom inantly longer-chain fatty acids) may not be soluble enough for these effects to be seen in the open environment. When compared to toxicity37 data for 99.2% nonanoic acid (MRIDs 43065302 and -03) , however, the acute risk quotients are below Agency levels of concern. The acute fr eshwater fish RQ is 0.378/91 (EEC/toxicity) = 0.004, and the Daphnia acute RQ is 0.378/96= 0.004. Chronic RQs (highest RQ = 0.2) for freshwater invertebrates exposed to potassium salts are below the Agency’s LOC of 1 for chronic risk when applied at and great er than 27 lb a.i./A when us ing broadcast ground equipment.

The acute and chronic RQs for freshwater invertebrates exposed to ammonium salts are below the Agency’s LOCs; the highest RQ was 0.01. The potential risks to fres hwater organisms are discussed further in Section IV.2

.38 Table IV.1. Risk Quotients for Freshwater Or ganisms for Potassium Salts of Fatty Acids

Use (# apps/ lb a.i./A) Peak EEC 21D EEC 60D EEC Solubility Limit (C12- C18) Freshwater Fish (LC 50 = 9.19 mg a.i./L;

NOAEC = No data, ACR = 8.06 mg a.i./L) Freshwater Invertebrate (EC 50 = 0.57 mg a.i./L; NOAEC = 0.5 mg a.i./L)

(mg a.i./L) Acute Chronic Acute* Chronic
1 ground app @ 27 0.378 0.1 0.0378

2.7 – 0.00074 0.04 <0.01 0.66*** 0.2

1 ground app @ 20 0.28 0.076 0.028 0.03 <0.01 0.49** 0.15

1 ground app @ 10 0.14 0.038 0.014 0.02 <0.01 0.25** 0.08

1 ground app @ 1.0 0.014 0.0038 0.0014 0.0015 <0.01 0.02 0.01

* Depending on fatty acid mixture, soap salt may not be soluble enough for this effect to be observed. ** Exceeds the restricted use LOC of 0.1 and the listed species LOC of 0.05; and *** Exceeds the nonlisted species, restricted use, and listed species LOCs of 0.5, 0.1, and 0.05, respectively.

Table IV.2. Risk Quotients for Freshwater Orga nisms for Ammonium Salts of Fatty Acids

Use (# apps/ lb a.i./A) Peak EEC 21D EEC 60D EEC Freshwater Fish (LC 50 = 12 mg a.i./L; NOAEC = No data,

ACR = 10.3 mg a.i./L) Freshwater Invertebrate (EC 50 = 27 mg a.i./L ; NOAEC = 23 mg a.i./L)

(mg a.i./L) Acute Chronic Acute Chronic
1 ground app @ 27 0.378 0.1 0.0378 0.03 <0.01 0.01 <0.01
1 ground app @ 20 0.28 0.076 0.028 0.02 <0.01 0.01 <0.01
1 ground app @ 10 0.14 0.038 0.014 0.01 <0.01 <0.01 <0.01
1 ground app @ 1.0 0.014 0.0038 0.0014 0.001 <0.01 <0.01 <0.01

Estuarine/Marine Fish and Invertebrates

Tables IV.3 and IV.4 list acute and chronic RQs calculated for estuarine/marine fish and invertebrates exposed to potassium and amm onium salts based on the EECs generated from GENEEC modeling.

The acute RQs for estuarine/marine fish exposed to potassium salts were not calculated since no effects were observed at the ma ximum dose tested in the toxic ity studies with sheepshead minnows. This may be due to precipitation of the fatty acids by metal ions in the salt water.

Exposed to potassium salts, the acute RQ of 0.1 fo r estuarine/marine invertebrates exceeded the restricted use and acute listed species LOCs of 0.1 and 0.05, re spectively, when applying at and greater than 10 lb a.i./A. At 27 lb a.i./A, the highest broadcast a pplication rate, the acute RQ was39 as high as 0.3. None of the chronic RQs exceeded the chronic LOC of 1.0 for estuarine/marine invertebrates exposed to potassium salts; the hi ghest chronic RQ was 0.09. Exposures may not reach the levels indicated, due to precipitation by metal ions.

Acute and chronic RQs for uses of ammonium salts were below the Agency’s LOCs for estuarine/marine organisms exposed to the salt as a result of broad cast ground applications; therefore, RQs based on other uses with lower a pplication rates of ammoni um salts are also less than the LOC.

No chronic toxicity data were available for es tuarine/marine organisms. The acute to chronic ratio method was used to estimate the chronic t oxicity value for estuarine/marine fish and invertebrates using data from sheepshead mi nnow, daphnid, and mysid studies. None of the ACR-derived NOAECs values resulted in chro nic LOC exceedances for estuarine/marine organisms exposed to soap salts. Th e data gap is discussed further in Section IV.2

.
The potential risks to estuarine/marine organisms are discussed further in Section IV.2

.

Table IV.3. Risk Quotients for Estuarine/Marine Organisms for Potassium Salts of Fatty Acids

Use (# apps/ lb a.i./A) Peak EEC 21D EEC 60D EEC Estuarine/marine Fish (LC 50 >4.4 mg a.i./L; NOAEC = no data, ACR >3.9 mg a.i./L) Estuarine/marine Invertebrates (EC 50 = 1.2 mg a.i./L; NOAEC = no data, ACR = 1.05 mg a.i./L)
(mg a.i./L) Acute Chronic Acute* Chronic
1 ground app @ 27 0.378 0.1 0.0378

RQs not calculated due to no effects at the solubility limit RQs were

not derived due to a

nondefinitive NOAEC

using ACR method 0.3** 0.09
1 ground app @ 20 0.28 0.076 0.028 0.2** 0.07 1 ground app @ 10 0.14 0.038 0.014 0.1** 0.04

1 ground app @ 1.0 0.014 0.0038 0.0014 0.01 <0.01

* Depending on fatty acid mixture, soap salt may not be soluble enough for this effect to be observed; ** Exceeds the nonlisted species LOC of 0.5 and the listed species LOC of 0.05.40 Table IV.4. Risk Quotients for Estuarine/marine Organisms for Ammonium Salts of Fatty Acids

Use (# apps/ lb

a.i./A) Peak EEC 21D EEC 60D EEC Estuary Fish (LC 50 >105 mg a.i./L; NOAEC = no data, ACR >90 mg a.i./L) Estuary Invertebrate (EC 50 = 67 mg a.i./L; NOAEC = no data, ACR = 57 mg a.i./L)
(mg a.i./L) Acute Chronic Acute Chronic

1 ground app @ 27 0.378 0.1 0.038 RQs not calculated due to no effects at the

maximum dose RQs were not derived due to

a nondefinitive NOAEC using ACR method <0.01 <0.01

IV.1.2 Risk Quotient Calculations for Aquatic Plants

There is a potential for exposure of the active ingredients to aquatic vascular and nonvascular plant species, toxicity informati on on the percentage of the active ingredient in the TEP are used to estimate the risks to aquatic plants as a re sult of surface runoff and spray drift from broadcast ground applications. The EC 50 is used to estimate risk for adverse effects on growth to non-listed aquatic plants and the NOAEC (or EC 05 when a NOAEC is not available) is used to estimate risk for adverse effects on growth to listed aquatic plants.

Non-listed and Listed Aquatic Plants

According to peak GENEEC EEC and the rang e of application rates for broadcast ground application and toxicity values of the salts, the nonlisted and list ed RQs for aquatic plants (both vascular and nonvascular species) are below Agency’s plant LOC of 1.0 ( Table IV.5 ). RQs were not derived for non-listed aquatic vascular plants because only non-definitive EC 50 s are available and the risks to these species are discussed further in the Risk Description section.

RQs for uses of ammonium salts at the maximu m label rate of 27 lb a.i./A fall below the Agency’s plant LOCs for aquatic plants (both vascular and nonvascula r) exposed to ammonium salts via broadcast ground applications ( Table IV.6 ); therefore, RQs based on other uses with lower application rates of ammonium salts are also less than the LOC.

The potential risks to aquatic pl ants are discussed further in Section IV.2

.

Table IV.5. Risk Quotients for Aquatic Plan ts for Potassium Salts of Fatty Acids*

Use (# apps/lb a.i./A) Peak EEC Vascular Aquatic Plant (EC 50 >5.0 mg a.i./L NOAEC = 5.0 mg a.i./L) Non-Vascular Aquatic Plant (EC 50 = 0.59 mg a.i./L; NOAEC = 0.39 mg a.i./L)
(mg a.i./L) Non-Listed Listed Non-Listed Listed
1 ground app @ 27 0.378 RQs not calculated 0.07 0.64 0.96
1 ground app @ 20 0.28 0.06 0.44 0.7241 1 ground app @ 10 0.14 due to no effects at the solubility limit 0.03 0.2 0.4
1 ground app @ 1.0

0.014 0.003 0.02 0.04

*Depending on fatty acid mixture, soap salt may not be soluble enough for this effect to be observed.

Table IV.6. Tier II Risk Quotients for Aquati c Plants for Ammonium Salts of Fatty Acids

Use (# apps/lb a.i./A) Peak EEC Vascular Aquatic Plant (EC 50 = 200 mg a.i./L NOAEC = 15 mg a.i./L) Non-Vascular Aquatic Plant (EC 50 = 6.6 mg a.i./L; NOAEC = 2.9 mg a.i./L)
(mg a.i./L) Non-Listed Listed Non-Listed Listed
1 ground app @ 27 0.378 <0.1 <0.1 <0.1 < 0.1

IV.1.3. Risk Quotient Calculatio ns for Terrestrial Animals

For this screening-level risk assessment with birds and mammals, acute and chronic RQs are derived based on ecological toxicity data for fo rmulations of soap salts (e.g. potassium and ammonium salts of fatty acids), and then directly compared to the dietary-based EECs generated from T-REX. For dose-based RQs, the EECs and t oxicity values are firs t adjusted based on food intake and body weight differen ces of the terrestrial animals prior to the assessment. The LD 50 and LC 50 are used to estimate acute risk for adve rse effects on survival to both birds and mammals; the NOAEC is used to estimate chroni c risk for adverse effects on reproduction and growth to both birds and mammals.

Birds

There is a potential for acute exposure to birds via the oral and dietary routes, but acute RQs were not calculated because toxicity inform ation on the potassium and ammonium salt TEPs were not established (potassium: acute oral LD 50s >2450 mg a.i./kg-bw (q uail); acute dietary LC 50 s were >2450 mg a.i./kg-diet to >10,000 mg TEP/kg-diet ( quail and duck); ammonium: acute dietary LC 50 >5,000 mg/kg diet).

No chronic reproduction data were available to assess the toxicity of the active ingredients to birds; thus, chronic RQs were not calculated. Back calculating for the chronic toxicity value using highest T-REX EEC and LOC of 1.0 for chronic risk to bird s calculates a toxicity value (NOAEC) of >6480 mg/kg-diet based on the ma ximum application rate for broadcast ground applications, respectively, is needed for the RQ to not exceed the LOC. The potential risk for acute and chronic exposure to birds is disc ussed in the Risk Description section.

Terrestrial-phase Amphibians and Reptiles

EFED currently uses surrogate data (birds) for te rrestrial amphibians and reptiles when data are not available. Risks are discussed in the Risk Description section.42 Mammals

Acute and chronic RQs were not calculated becaus e no mammalian toxicity data are available for the soap salts. The poten tial risk for acute and ch ronic exposure to mammals is discussed in the Risk Description section.

Beneficial Insects

Honey bee toxicity data was available, and th is was used as a surrogate for terrestrial invertebrates. The data, for ammonium and pot assium formulations, indicate that the highest observed mortality in bees (30%) was at a dose of 262 micrograms per bee, applied to the thorax. This is equivalent to an exposure of 2047 mg/ kg body weight. The highest broadcast application rate is 27 lb/A, equivalent to 2538 mg/kg exposur e to arthropods. Thus , the 27 lb/A rate is slightly higher than the dose causing 30% mortal ity. At 30 feet offsite, the exposure from spray drift is 1.0 lb/A or 94 mg/kg to arthropods, whic h corresponds to about 10 to 15% mortality in the laboratory tests. Thus, mortality effects to invertebrates are not expected at great distances from the application site, especially as label us e instructions direct th e user to thoroughly wet leaves, top and bottom, which is not likely as a result of spray drift.

IV.1.4. Risk Quotient Calculations for Terrestrial Plants in Terrestrial and Semi-aquatic Environments

For this risk assessment with terrestrial monocots and dicots, Non-listed and listed plant species RQs are derived based on ecological toxicity data for the active i ngredients and then compared to the TERRPLANT EECs for plants in non-target area receiving surface runoff combined with spray drift adjacent to the target area. De tails of the TERRPLANT model and EECs are presented in Table II.11

.
There is a potential for exposure of the active ingredients to terrestri al plants; toxicity information on the formulations are used to estimate the risks to non-target ( non-listed ) terrestrial plants inhabiting dry or semi-aquatic areas adjacen t to a treated field as a result of surface runoff and/or spray drift. The EC 25 was used to estimate risk for adverse effects on growth to non-listed plant species while the NOAEC (or EC 05 when a NOAEC is not available) was used to estimate risk for adverse effects on growth to listed plant species. Note: TerrPlant does not consider exposures to plants from multiple pesticide a pplications; thus, results are based on single pesticide applications

.

Non-listed and Listed Terrestrial Plants

For terrestrial plants, the vegetative vigor and s eedling emergence data show that soap salts are more toxic to plants when the foliage is expos ed to spray drift, than by exposure through the roots as a result of surface water runoff. A co mmenter indicated that herbicidal soaps are effective only when they thoroughly contact the fo liage, and are not effective by root uptake. Since the main route of exposure to non-target terrestrial plants is by spray drift, not by runoff, the LOC exceedance for potential risk to plants inhabiting dry and semi-aquatic areas exposed to runoff can be discounted, because the risk quotient is low compared to the level of concern (1.543 vs. 1.0) and it does not account for degradation of the fatty acids. Spray drift exposure analysis (Tier 1 AgDrift, High boom, fine to medium-coarse spray, 90 th percentile) indicates that when ground-based application methods are used, exposure falls to the 5% effect level (1.0 lb/A) for the most sensitive plants less than 30 feet off-site. This indicates that effects to terrestrial plants do not occur far from the site of application.

Tables IV.8 and IV.9 present RQs for the formulated pr oducts of potassium and ammonium salts, respectively, to terrestrial pl ants via ground spray applications.

RQs (1.09-1.47) for listed dicots inhabiting semi-aquatic areas adjacent to a treated site exceed the plant LOC of 1.0 when exposed to a combin ation of surface water runoff and spray drift resulting from broadcast ground applications of pot assium salts at a rate of 20 lb a.i./A and higher. However, listed dicots inhabiting dry areas adjacent a treated field are not impacted significantly; highest RQ was 0.21. There are no LOC exceedances for non-listed dicots exposed to potassium salts at any rate; highest RQ was 0.11.

There are no exceedances for nonlisted or listed monocots inhabiting dry and semi-aquatic areas adjacent to a treated field exposed to potassium soap salts through a combination of surface water runoff and spray drift as well as spray drift alone.

There are no exceedances for nonlisted or listedmonocots or dicots inhabiting dry and semiaquatic areas adjacent to a treated field exposed to ammonium soap salts through a combination of surface water runoff and spray drif t as well as spray drift alone.

The potential risks to terrestrial plants are discussed further in the Risk Description section.

Table IV.8. Terrestrial Plant Risk Quotient Summary for Potassium 1, 2, 3, 4

Scenario Non-listed RQs Listed RQs

Terrestrial Adjacent area Semi-aquatic Adjacent area Drift Terrestrial Adjacent area Semi-aquatic Adjacent area Drift

One Ground Spray at Maximum Labeled Rate for Potassium Salt at 27 lb a.i./A

Monocot <0.1 <0.1 <0 .1 <0.1 0.18 <0.1 Dicot <0.1 0.11 <0.1 0.21 1.47 <0.1 One Ground Spray of Potassium Salt at 20 lb a.i./A
Monocot <0.1 <0.1 <0 .1 <0.1 0.13 <0.1 Dicot <0.1 <0.1 <0.1 0.16 1.09 <0.1 One Ground Spray of Potassium Salt at 10 lb a.i./A
Monocot <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 Dicot <0.1 <0.1 <0.1 <0.1 0.54 <0.1

1 RQs for ground spray applications in this table we re calculated using the maximum application rates for potassium (205 lb a.i./A) salt uses and the general “bin” rates created in the problem formulation.

2 Non-listed potassium salt toxicity thresholds (EC 25 ) were 62.34, 53.9, 5.91, and 18.5 lb a.i./A for seedling emergence monocot, seedling emergence dicot, vegetative vigor monocot, and vegetative vigor dicot.

3 Listed potassium salt toxicity thresholds (NOAEC) were 31.17, 3.865, 4.239, and 4.38 lb a.i./A for seedling emergence monocot, seedling emergence dicot, vegetative vigor monocot, and vegetative vigor dicot.
4 Values in bold are LOC exceedances.44 Table IV.9. Terrestrial Plant Risk Qu otient Summary for Ammonium Salts 1, 2, 3, 4

Scenario Non-listed RQs Listed RQs
Terrestrial Adjacent area Semi-aquatic Adjacent area Drift Terrestrial Adjacent area Semi-aquatic Adjacent area Drift

One Ground Spray at Maximum Labeled Rate for Ammonium Salt at 27 lb a.i./A

Monocot <0.1 <0.1 <0 .1 <0.1 <0.1 0.18 Dicot <0.1 <0.1 0.12 <0.1 <0.1 0.25 One Ground Spray of Ammonium Salt at 20 lb a.i./A
Monocot <0.1 <0.1 <0 .1 <0.1 <0.1 0.13 Dicot <0.1 <0.1 <0.1 <0.1 <0.1 0.18 One Ground Spray of Ammonium Salt at 10 lb a.i./A
Monocot <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 Dicot <0.1 <0.1 0.23 <0.1 <0.1 <0.1

1 RQs for ground spray applications in this table we re calculated using the maximum application rates for ammonium (103.8 lb a.i./A) salt uses and the general “bin” rates created in the problem formulation.

2 Non-listed ammonium salt toxicity thresholds (EC 25 ) were >100, >100, 6.2, and 2.2 lb a.i./A for seedling emergence monocot, seedling emergence dicot, vegetative vigor monocot, and vegetative vigor dicot.

3 Listed ammonium salt toxicity thresholds (NOAEC) were 100, 100, 1.5, and 1.1 lb a.i./A for seedling emergence monocot, seedling emergence dicot, vegetative vigor monocot, and vegetative vigor dicot.
4 Values in bold are LOC exceedances.



### IV.2. Risk Description

The risk hypothesis states that the use of the potassium, ammoni um, and sodium salts of fatty acids as an insecticide, acaric ide, herbicide, algaecide and mammal repellant for terrestrial crop sites has the potential to adve rsely affect survival, reproductio n, and/or growth of non-target aquatic and terrestrial animals a nd plants, including Federally-lis ted endangered and threatened species. Results are based on a single broadcast ground application. Aerial or spot treatment applications were not modeled.

Based on the LOC exceedances from available eco toxicity data and predicted environmental exposures of the registered uses of potassium salts, the exceedances are for potential acute effects to aquatic invertebrates (freshwater and estuarine/marine species) and terrestrial plants (semi-aquatic areas only) starting at the appli cation rate of 10 lb a.i./A and higher for invertebrates and that the exceedance starts at 20 lb a.i./A and higher fo r terrestrial plants.

No LOC were triggered for ammonium salts uses.

For sodium salts in mesh bags, no LOC exceedances occurred.

LOCs were not exceeded for beneficial insects, es tuarine/marine fish, and aquatic vascular plants exposed to potassium or ammonium salts.45 The following sections discuss the potential risk s of the soap salts to these taxonomic groups; however, because of the additi onal data provided during the public comment period and the numerous uncertainties raised when interpre ting the potential risks from spot treatment applications labeled at those high application rates, only broadcast applications will be analyzed. While not analyzed quantitatively, spot treatment applications are subsequently discussed as to whether any meaningful exposures to the receptors are likely as well.

IV.2.1 Exposure to Aquatic Organisms

Due to the high variability in the application rates and the inability to categorize uses by application rates, GENEEC2, a tier I model was us ed to conservatively estimate surface water EECs as a result of broadcast ap plications of potassium and ammonium salts using maximum and a range of broadcast applica tion rates coupled with the repr esentative solubility. A single broadcast ground application was modeled. Envir onmental fate data were limited and largely based on EpiSuite estimates. The modeling wa s meant to represent no nanoic acid, a soluble fatty acid that is a major constitu ent of many ammonium salt products.

For sodium salts in mesh bags, it is unlikely aq uatic organisms would be exposed to biologically significant concentrations of sodi um salts in the environment as a result of surface water runoff and offsite spray drift; thus, aquatic organism s are excluded as aquatic receptors in this assessment and the adverse affects to aquatic organisms are anticipated to be minimal.

IV.2.1.1 Risks to Aquatic Organisms

Potassium and Ammonium Salts of Fatty Acids The screening-level risk assessment on aquati c organisms exposed to both potassium and ammonium salts applied at the highe st broadcast application rate of 27 lb a.i./A indicates none of the taxa except for aquatic invertebrates inhabiti ng freshwater and estuarine/marine water bodies adjacent to a treated field with potassium salts exceeds the Agency’s LOCs for potential adverse effects.

For both freshwater and estuarin e/marine invertebrates exposed to potassium salts, the LOC exceedances start at 10 lb a.i./A and higher wi th these acute RQs ranging 0.1 – 0.66. The highest RQ for freshwater and estuarine/marine invert ebrates was 13.2x and 6x, respectively, above the listed species LOC of 0.05. However, because the fatty acids represented by these data have limited solubility in environmental water, it is unlikely that adverse effects will be observed.

The Agency believes there is no likely direct effect to aquatic organisms, for fatty acid salts of chain length C 14 and higher, because such fatty ac ids are not sufficiently soluble in environmental water for toxic effects to be e xpressed. For shorter ch ain-length fatty acids (C 9 – C 11 ) there is uncertainty, because the available toxici ty data is not clear as to what chain-length mixtures were tested. However, acute toxicity data for nearly pure nonanoic (pelargonic) acid, which is representative of the shorter chain-le ngth fatty acids, indicate that it does not reach levels of concern with a Tier I exposure assessment. Over all, the Agency antic ipates it is unlikely that soap salts as a group will cause di rect effects to listed aquatic species.

For ammonium salts, there were no LOC exceedances for any of the aquatic taxa (acute RQs <0.01-0.03).46 For estuarine/marine fish exposed to both salts, acute and chronic RQs were not derived in the Risk Estimation section of this assessment. Because no mortality to sheepshead minnows was observed at the maximum dose of 105 mg a.i./L a nd at the solubility lim it of 4.4 mg a.i./L for ammonium and potassium salts formulations, resp ectively, the acute risks to estuarine/marine fish are anticipated to be mini mal. The chronic RQs were not derived for estuarine/marine fish due to a non-definitive NOAEC calculated fr om the ACR method using minnow and daphnid data. A comparison of the non-definitive NOAEC at the solubility limit (>3.9 mg/L potassium salts; >105 mg/L ammonium salts (P/A)) with the highest GENEEC 60-day EEC (0.038 mg/L) indicates the estuarine/marine fish N OAEC is 103x/>1000x (P/A) greater than the environmentally relevant concentrations; thus, the chronic risks to estuarine/marine fish adjacent a treated field exposed to broadcast ground applic ations of soap salts are anticipated to be minimal as well.

RQs were not derived for aquatic vascular plan ts, in the Risk Estimation section of this assessment because none of the non-target vascular plants were inhibited 50% or more in the duckweed studies (i.e., >5.0 mg a.i./L). Ho wever, for non-vascular plants, no LOC was exceeded. Thus, the risks to aquatic plants adja cent a treated field exposed to broadcast ground applications of soap salts ar e expected to be minimal.

An uncertainty to this chronic risk assessment st ill exists because the chronic RQs were based on these ACR-estimated toxicity values in absence of data; yet, soap salts would need to be 212x to 271x (Potassium/Ammonium) more toxic to freshwater fish, 103x to >1000x (Potassium/Ammonium) more toxic to estuarine/marine fish, and 10.5x to 570x (Potassium/Ammonium) more toxic to estuarine/ma rine invertebrates from a single application to be risks of concern. However, the labels ar e unclear on the number of applications allowed and do not appear to limit the maximum number of applications per year or define a recommended minimum interval between applicati ons. Repeat applications may be needed in order to control pest infestati ons, potentially resulting in higher longer-term (chronic) average exposure concentrations. In making the assumpti on, the concentrations were analyzed as to whether additional applications at three, ten, or more applications coupl ed with the shortest reapplication interval of 7 days could result in higher exposure to aquatic organisms that may exceed the chronic LOC. Table IV.10 presents the aquatic EECs calculations generated from GENEEC2 for multiple ground applications of so ap salts. Model defaults were used. The maximum soap salt application rate at 205 lb a.i. /A (used for spot treatments only) was used. As LUIS reported no aerial uses at those high application rates, the aerial applications were excluded from the assumption. Resu lts indicate the concentrations increased 3% when applied 10 or 50 times, respectively, and if 50 applications ma de weekly translates to a small increase in concentrations, higher long-term e xposures to aquatic organisms fr om repeated applications are unlikely. Thus, based on the available informa tion, addressing the data gap of reproduction studies with aquatic organisms would be unlikel y to change the risk conclusions for aquatic organisms from chronic exposure to soap salts; the agency is not asking for chronic toxicity data to address the uncertainty because it is not likely that chronic exposure with repeated applications would increase enough in the long term to affect aquatic organisms.47 Table IV.10. Exposure Estimates ( ppm) for Soap Salts modeled as Nonanoic Acid

Application Rate (lb a.i./A) and no.

of applications Peak 21-Day Avg 60-Day Avg

Ground Application

205 x 1 2.9 0.79 0.28

205 x 3 3.0 0.84 0.3

205 x 10 3.0 0.84 0.3

205 x 25 3.0 0.84 0.3

205 x 50 3.0 0.84 0.3

IV.2.1.1.1. Aquatic Organisms Exposed to Soap Salts As a Result of Spot Treatment Applications

There is uncertainty with the a quatic risk assessment for some s pot treatment uses, particularly those with the highest applica tion rates (205 lb/acre). EFED has modified the aquatic risk assessment for spot treatment uses using an assumption that the high rates are broadcast ( Table IV.11 ). EFED believes that exposure estimates for aquatic resources are overly conservative for spot treatments because the underlying assumption in the aquatic models is that 100% of the field is treated with the pesticid e. In order to better characteri ze the importance of the 100% area treated assumption on the ove rall risk conclusions, an estimate of the area threshold of spot treatment for each taxon where the LOC w ould no longer be exceeded is given.

As an example, it is estimated that for the highest application rate (i.e. 2 05 lbs a.i./acre) the spot area treated would need to ex ceed 16% of the total area for the LOC to be exceeded for freshwater fish. However, EFED does not have information on typical spot treatment area percentages. Also, the labels that do specify spot treatment a nd the total area the container can cover (square feet) can be compared with Table IV.11 to determine whether effects are possible from these uses.

Again, the Agency believes there is no direct effect to aquatic organisms, for fatty acid salts of chain length C 14 and higher, because such fatty ac ids are not sufficiently soluble in environmental water for toxic effects to be e xpressed. For shorter ch ain-length fatty acids (C 9 – C 11 ), levels of concern are not exceeded with a Ti er I exposure assessment. It is unlikely that soap salts used as a spot treatment using backpa ck sprayers will cause direct effects to listed aquatic species.48 Table IV.11 Area Percentage of App lication Needed to Exceed the LOC Taxa Application
rates (lb a.i./A) RQs assuming 100% area treated (highest to lowest)* LOC Area Percentage of application needed to exceed LOC 1

Potassium Salts

Freshwater fish (acute effects) 205 0.3

Acute = 0.05 16%
116 0.2 25%
63 0.1 50% 10 0.02 No exceedance
Freshwater invertebrates (acute effects) 205 5

Acute = 0.05 1%
116 3 2%
63 2 3%
10 0.3 17% 1 0.03 No exceedance
Estuarine/marine fish (acute effects) None No effects; RQ not calculated Acute = 0.05 No exceedance

Estuarine/marine invertebrates (acute effects) 205 2

Acute = 0.05 3%
116 1 5%
63 1 5%
10 0.1 50% 1 0.01 No exceedance

Freshwater fish (chronic effects) 205 0.04 Chronic = 1.0 No exceedance

Estuarine/marine fish (chronic effects) None Non-definitive endpoint; RQ not calculated Chronic = 1.0 No exceedance

Freshwater invertebrate (chronic effects) 205 2 Chronic = 1.0 50%
116 1 100% 63 0.5 No exceedance
Estuarine/marine invertebrates (chronic effects) 205 0.8 Chronic = 1.0 No exceedance

Aquatic vascular plants (non-listed and listed effects) None No 50% inhibition; RQ not calculated Non-listed plants = 1.0 No exceedance

0.6 Listed plants = 1.0 No exceedance
Aquatic nonvascular plants (non-listed and listed effects) 205 5

Non-listed plants = 1.0 20%
116 3 33%
63 2 50%
10 0.3 No exceedance
205 7

Listed plants = 1.0 14%
116 4 25%
63 2 50%
10 0.4 No exceedance
*Bold values indicate LOC exceedance

1 The threshold percentage is assessed to determine how much percent of exposure that RQ needs to exceed the LOC. For example, the highest acute RQ for freshwater invertebra tes inhabiting a pond adjacent a field applied at 205 lb a.i./A is 5 which is 100 times higher th an the listed species LOC of 0.05; to asse ss the % of exposure needed at which the LOC exceedance occurred, results indicate 1% is needed for the RQ to exceed the LOC. A “no effect” or “may affect” determination was not made si nce it is unknown what % of an actua l area is typical spot treatment.49 IV.2.2. Exposure to Terrestrial Wildlife

In the conceptual model, dietary ingestion of potassium and ammonium salts residues on vegetative matter and insects on tr eated areas as depicted in Figure 1 are predicted as the most likely sources of exposure to terrestrial animal s. Spray drift, runoff and wind erosion of soil particles with resulting residue s on upland and/or wetland foliage and soil are the most likely sources of potassium and ammonium salts exposu re to non-target terrestrial plants, including Federally-listed endangered and threatened species.

Direct ingestion of sodium salts mesh bags on tr eated areas would be predicted as the most likely source of exposure to wildlife beca use it is unlikely that signifi cant concentrati ons of sodium salts would be found on vegetative matter and insects. However, the repellent is not meant to be ingested, but works by producing an odor that wild life do not like. Thus, based on the use pattern (suspended mesh bags), the low use rate (one ounce per bag), and the mode of action (mammal repellency), meaningful expos ure of wildlife to the sodium salts is not anticipated.

IV.2.2.1 Risks to Birds

Available avian acute toxicity data indicates that the soap salts are practically nontoxic to upland game birds and waterfowls on an acute basis via either or both oral a nd dietary routes. Acute RQs were not derived for birds in the Risk Estim ation section of this assessment due to the nondefinitive endpoints observed in the acute oral an d dietary avian studies. Furthermore, numerous ecological studies observed no mortality or sub-leth al effects in birds at doses as high as 5,000 - 10,000 mg/kg diet, so the potential for acute risk to birds from exposure to potassium and ammonium salts is expected to be low.

Chronic RQs were not calculated because sub-lethal effects data were not available. The Agency is not asking for toxicity data to evaluate the reproductive risks to birds due to the salts undergoing rapid degradation via metabolism in less than a day and the lack of effects at high rates in the acut e avian studies.

In addition, fatty acids are a ma jor component in wildlife diets. 1 Fatty acids or animal fats are also consumed in humans. 2 In addition, potassium salts is recognized by the FDA as a “Generally Recognized As Safe” (GRAS) food additive. 3 It is anticipated that significant exposure of birds to so ap salts is unlikely.

IV.2.2.2 Risks to Mammals

Acute and chronic RQs were not derived for mamma ls in the Risk Estimation section of this assessment because no mammalian toxicity data were available for the soap salts. Since HED did not select any endpoints for the human health asse ssment due to no systemic toxicity observed at high rates, EFED presumes the ecological effect s to mammals are expected to be minimal.

1 http://npic.orst.edu/factsheets/psfagen.pdf

2 http://www.heart.org/HEARTORG/GettingHealth y/FatsAndOils/Fats101/PolyunsaturatedFats_UCM_301461_Article.jsp

3 Food Additives Permitted for Direct addition to Food for Human Consumption. Code of Federal Regulations, Part 172.863, title 21, 1998.50 IV.2.2.3 Potential Effects to Terrestrial Invertebrates

The available terrestrial insect toxicity data, based on tests wi th honeybees, indicate that the formulated products containing soap salts are practically non-toxi c to bees on an acute contact basis. The highest LD 50 value for potassium and ammonium salts was >100 μg a.i./bee.

However, other terrestrial arthr opods or invertebrates could be impacted since potassium salts are registered as an insecticide and acaricide. Ammonium and sodium salts are not registered for use as an insecticide. With no t oxicity data available for terrest rial invertebrates, honey bees were used as a surrogate. In making this assumpti on for terrestrial invertebrates, the weight of a bee (0.128 g) was used to convert μg a.i./bee to a μg a.i./g (ppm) concentration and then compare this toxic level to concentrations expected on terre strial invertebrates that are sprayed on directly.

Thirty percent mortality was observed at 262 ug/bee in the contact thorax test (MRID 42806407). So, the LD30 is equal to 262/0.128 = 2047 mg /kg. This is slightly below exposure (2538 ppm) at 27 lb/A. Mortality slightly ex ceeding 30% at maximu m broadcast rate is expected, providing that indivi duals are thoroughly wetted.

While honeybees were relatively insensitive to the insecticidal soap, it is reported that potassium salts are relatively selective in its toxicity to invertebrates based on the insect species and stage of development. Soft-bodied insects such as aphids, whiteflies, and mealy bugs are more susceptible to soaps. The least affected are flyi ng adult insects with heavier cuticle, such as ladybird beetles; however, hard-bodied insects in the immature, flightless stage of development can be vulnerable to the e ffects of potassium salts. 4 Thus, not all terrestr ial invertebrates were susceptible to soap salts but t hose that are soft-bodied includi ng hard-bodied ones during larval development would be sensitive when exposed directly to potassium salt applications.

Lastly, formulated as a contact insecticide, it is unlikely the adverse effect of the use patterns would be maintained beyond the target applicati on area since potassium sa lts are effective only against those susceptible terrestr ial invertebrates that come into direct contact; yet, without additional information on listed terre strial invertebrates, it is uncer tain whether all, some, or none of the listed invertebrate s would be adversely affected when e xposed directly to potassium salts.

IV.2.2.4 Risk to Terrestrial Plants

The risk to non-target plants exposed to soap salts is unlikely because 1) TERRPLANT does not account for the rapid degradation of soap salts before or during surface water runoff following application; 2) As discussed above in the aquatic assessment, envi ronmental fate and effect data indicate that soap salts products in water are either too insoluble to reach toxic concentrations or soluble enough but not toxic enough to cause adverse effects; 3) Terrestrial plant toxicity studies on seedling emergence and vegetative vigor result ed in adverse effects to the vigor of young plants when exposed to soap salts formulated products; this data support the assumption that vegetative vigor is a more sensitive life-stage than seedling emergence, when plants are adversely affected as a result of unwanted spray drift rather than surface water runoff to areas where non-target terrestrial plan ts inhabits; and 4) There were no LOC exceedances for plants exposed to unwanted spray drift alone. Thus, it is unlikely for soap salts products to maintain its

4 http://greenmethods.com/site/weblog/2009/05/understanding-insecticidal-soaps-and-detergents51 toxicity in periodically wet area s where terrestrial plants resides after the pesticide runoff or drift away from the adjacent treated field.

Based on the available data, monocots are less sens itive to soap salts than dicots. The RQs for runoff to semi-aquatic areas result in the highest RQs. This scenario represents a 10 acre area running off into a one acre area. The highest RQ for runoff to semi-aquatic areas was a 1.47, which barely exceeded the Agency’s LOC of 1 fo r potential risk to plants. On the other hand, none of the RQs for plants inhabiting dry areas exposed to a combination of runoff and drift and for plants inhabiting areas exposed to spray drif t alone exceeded the Agency’s LOCs. Since the main route of exposure to non-targ et terrestrial plants is by spray drift, not by runoff, the LOC exceedance for potential risk to plants inhabiting semi-aquatic areas is discounted.

For ammonium salts, none of the RQs exceeded the plant LOC of 1.0; risk to non-target plants exposed as a result of receiving surface water runo ff and/or spray drift is expected to be low.

Exposure to plants is based on the highest single application rate; multiple applications are not considered. The current assumption is that plants will be mainly affected by the first application. Although there is uncertainty in this assumption, there would also be uncertainty in trying to model multiple applications. Data the Agency recei ves for terrestrial plants is based on a single application, followed by a 14 to 21 day observation period. To estimate the effect of a second application would require a simplistic assumption of additive effect, when in fact the effect may be much more complex.

The most sensitive plant in the Vegetative Vigor test ( Table III.22 ) is tomato for an ammonium salt formulation. The EC 25 is 2.2 lb/A and the EC 05 is 1.1 lb/A. (Radish VV has NOAEC of 0.094, but EC 25 is higher, 5.8 lb/A.) On-site RQs are therefore 27/2.2 = 12.3 and 27/1.1 = 24.5, which are both above the LOC of 1.0. A spray dr ift analysis (AgDrift, Tier 1 hi-boom, finemedium/coarse spray, 90 th percentile) gives a negligible buffer (13 feet) for a 1.1 lb/A threshold.

Thus, spray drift-caused effects to terrestrial plants are expected to be limited to plants on the treated field.

IV.2.2.5 Terrestrial Plants Exposed to Soap Salts As a Result of Spot Treatment Applications

Similar to the aquatic risk assessment, EFED has modified the terrestrial plant risk assessment for spot treatment uses using an assump tion that the high rates are broadcast ( Table IV.15 ). As discussed above ( Table IV.11 ) and in Table IV.15 below , if a site were only spot treated at less than 42% of the entire field at the maximum 205 lb a.i./A rate, the LOC would not be exceeded and no adverse effect determinati on for listed terrestrial plants w ould be likely for this use.52 Table IV.15 Percentage of Exposure from Spray Drift Needed to Exceed the LOC Taxa Application
rates (lb a.i./A) RQs (highest to lowest)* LOC Percentage of exposure needed to exceed LOC 1

Potassium Salts Terrestrial plants (non-listed effects) 205 1.7 Non-listed = 1.0 59% 116 0.98 No exceedance 63 0.5 No exceedance Terrestrial plants (listed effects) 205 2.4
Listed = 1.0 42%
116 1.4 71%
63 0.7 No exceedance Ammonium Salts Terrestrial plants (non-listed effects) 205 2.4 Non-listed = 1.0 42%
116 1.4 71% 63 0.2 No exceedance Terrestrial plants (listed effects) 205 4.7 Listed = 1.0 21%
116 2.9 34% 63 0.5 No exceedance
*Bold values indicate LOC exceedance

1 The threshold percentage is assessed to determine how mu ch percent of exposure th at RQ needs to exceed the LOC. For example, the highest listed RQ for terrestrial plants inhabiting an area adjacent to a field applied at 205 lb a.i./A potassium salts is 2.4 which is 2.4 times higher than the listed species LOC of 1.0; to assess the % of exposure needed at which the LOC exc eedance occurred, results indicate 42% is ne eded for the RQ to exceed the LOC. A “no effect” or “may affect” determination was not made since it is unknown what % of an actual area is typical spot

treatment.


### V. Federally Threatened and En dangered (Listed) Species Concerns

In November 2013, the EPA, along with the U. S. Fish & Wildlife Service (USFWS), the National Marine Fisheries Service (NMFS) (collectively, the Servi ces), and the U.S. Department of Agriculture (USDA) released a summary of th eir joint Interim Approaches for assessing risks to listed species from pesticides. The Inte rim Approaches were developed jointly by the agencies in response to the National Academy of Sciences’ (NAS) recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the Endangered Species Act (ESA) and FIFRA.

The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presen ted the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Co mmittee (PPDC) and State-FIFRA Issues Research and Evaluation Group ( SFIREG) meetings, and held a stakeholder workshop in April 2014, allowing additional opportunities for stakeholde rs to comment on the Interim Approaches. As part of a phased, iterative process for deve loping the Interim Approaches, the agencies will also consider public comments on the Interim Appr oaches in connection with the development of upcoming Registration Review deci sions. The details of the jo int Interim Approaches are53 contained in the white paper “Interim Approaches for Natio nal-Level Pesticide Endangered Species Act Assessments Based on the Recommenda tions of the National Academy of Sciences April 2013 Report,” dated November 1, 2013.

Given that the agencies are continuing to de velop and work toward implementation of the Interim Approaches to assess the potential risk s of pesticides to listed species and their designated critical habitat, this preliminary ri sk assessment for soap salts does not contain a complete ESA analysis that includes effects de terminations for specific listed species or designated critical habitat. Although EPA has not yet complete d effects determinations for specific species or habitats, for this prelim inary assessment EPA conducted a screening-level assessment for all taxa of non-ta rget wildlife and plants that assumes for the sake of the assessment that listed species and designated criti cal habitats may be present in the vicinity of the application of soap salts. This screening level assessment will allow EPA to focus its future evaluations on the types of speci es where the potential for effect s exists once the scientific methods being developed by the agencies have b een fully vetted. This screening-level risk assessment for soap salts indicates potential risks of dir ect effects to listed plants and terrestrial invertebrate, based on pesticidal cl aims, on some of the registered us e sites. Listed taxa may also be affected through indirect effects because of the potential for directeffects on listed and nonlisted species upon which such species may rely. Potential direct effects on listed plants and terrestrial invertebrates from th e use of soap salts may be a ssociated with modification of Primary Constituent Elements (PCEs) of designated critical habitats, where such designations have been made. Once the agencies have fu lly developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these met hods will be applied to subsequent analyses for soap salts as part of completing this registration review.

V.1. Action Area

For listed species assessment pur poses, the action area is consider ed to be the area affected directly or indirectly by the registered use and not merely the immediate area where the pesticide is applied. At the initial base line, the risk assessment cons iders broadly described taxonomic groups and conservatively assumes that listed sp ecies within those broad groups are co-located with the pesticide treatment area. This means that listed terrestrial plants and wildlife are assumed to be located on or adjacent to the treat ed site and listed aquatic organisms are assumed to be located in a surface water body adjacent to th e treated site. The assessment also assumes that the listed species are located within an assumed area, which ha s the relatively highest potential exposure to the pesticide, and that ex posures are likely to decrease with distance from the treatment area. Section III of this risk assessment presents the registered pesticide use sites that are used to establish initial co-l ocation of species with treatment areas.

The federal action addressed herein is the re gistration review of pot assium, ammonium, and sodium salts of fatty acids on agricultural, resi dential, and commercial use sites. Based on the wide-ranging registered uses , it is expected that the action area is nationwide.

V.2. Taxonomic Groups Po tentially at Risk54 If the assumptions associated with the baseline action area result in RQs that are below the listed species LOCs, a "no effect" determination conclusi on is made with respect to listed species in that taxon, and no further refinement of the actio n area is necessary. Furthermore, RQs below the listed species LOCs for a given taxonomic gr oup indicate no concern fo r indirect effects on listed species that depend upon the taxonomic group for which the RQ was calculated. However, in situations where the screening assumptions le ad to RQs in excess of the listed species LOCs for a given taxonomic group, a potential for a "m ay affect" conclusion exists and may be associated with direct effect s on listed species belonging to th at taxonomic group or may extend to indirect effects upon listed species that de pend upon that taxonomic gro up as a resource. In such cases, additional information on the biology of listed species, th e locations of these species, and the locations of use sites are considered to determine the extent to which screening assumptions regarding an action ar ea applies to a particular list ed organism. These subsequent refinement steps will consider how this informa tion would impact the action area for a particular listed organism and potentially include areas of exposure that are downwind and downstream of the pesticide use site.

Assessment endpoints, exposure pathways, and the conceptual models addressing the registered uses, and the associated expos ure and effects analyses condu cted for the soap salts (e.g. potassium, ammonium, and sodium salts of fa tty acids) screening-le vel ecological risk assessment are in Sections II to III . The assessment endpoints used in the ecological risk assessment include those defined operationally as reduced survival, growth and reproductive impairment for both aquatic and terrestrial animal species and survival and growth of aquatic and terrestrial plant species from both direct acu te and chronic exposures. These assessment endpoints are intended to address the standard set forth in the Endangered Species Act requiring federal agencies to ensure that any action th ey authorize does not appreciably reduce the likelihood of both the survival and recovery of a listed species in th e wild by reducing the reproduction, numbers, or distribu tion of the species. Risk esti mates (RQs), integrating exposure and effects, are calculated for broad based taxonomic groups in the screening-level risk assessment presented in Section IV.

Both acute listed species and ch ronic risk LOCs are evaluated in the screening-level ecological risk assessment to identify direct and indirect effects to taxa of listed species. This section identifies direct effect concerns, by taxon, that are triggered by exceeding endangered LOCs in the risk assessment, with an evaluation of th e potential probability of individual effects for exposures that may occur at th e established listed species LOC. Data on exposure and effects collected under field and laborat ory conditions are evaluated to make determinations on the predictive utility of the direct effect screening assessment findings to listed species

V.2.1. Probit Dose-Response Analysis

The Agency uses the probit dose-response rela tionship as a tool fo r providing additional information on the potential for acute direct effects to aquatic and terrestrial animals (USEPA, 2004). As part of this evaluation, the acute RQ for listed species is pres ented in terms of the chance of an individual event ( i.e. , mortality or immobilization) should exposure at the EEC actually occur for a species with sensitivity to soap salts on par w ith the acute toxicity endpoint selected for RQ calculation. To accomplish this in terpretation, the Agency uses the slope of the55 dose-response relationship availabl e from the toxicity study used to establish the acute toxicity measures of effect for each taxonomic group except plants and terrestrial invertebrates that is relevant to this assessment. The individual eff ects probability associated with the acute RQ is based on the mean estimate of the slope a nd an assumption of a probit dose-response relationship. In addition to a single effects probab ility estimate based on the mean, upper and lower estimates of the effects proba bility are also provided to account for variance in the slope, if available. Based on the available acute toxici ty for soap salts, a summary of the probit doseresponse analysis is provided in Table V.3 . If no dose response information is available to estimate a slope for this analysis, a default sl ope assumption of 4.5 (with lower and upper bounds of 2 to 9) (Urban and Cook, 1986) is used.

Except for terrestrial invertebrates, no risk con cerns were identified for soap salts; thus, the probability of an acute direct effect to listed sp ecies derived based on the highest calculated acute RQ was not calculated. While LOC exceedances we re seen in terrestrial invertebrates, an uncertainty exists since a honeybee study was used as a surrogate that triggered the exceedances. It was not proper to find the probabi lity of an acute direct effect to Listed terrestrial invertebrates when risks were identified and no significant mortality was observed in honeybees as high as 100 μg/bee.

Individual effect probabilitie s are calculated based on an Ex cel spreadsheet tool IECV1.1 (Individual Effect Chance Model Version 1.1) deve loped by the U.S. EPA, OPP, Environmental Fate and Effects Division (June 22, 2004). The m odel allows for such calculations by entering the mean slope estimate (and the 95% confidence bounds of that estimate) as the slope parameter for the spreadsheet. The desired threshold for the pr obability of an individual effect is entered as the listed species LOC or the derived acute RQ.

Table V.3. Summary of Soap Salts Probit Dose Response Analysis for Listed Species

Taxa (study type) Acute Effect Slope (95% C.I.) Chance of Individual Effect at Listed Species LOC (95% C.I.) Chance of Individual Effect at Derived Acute RQ (95% C.I.)

Bird oral dose No mortality observed Not calculated; no mortality observed Not calculated; no mortality observed
Bird dietary No mortality observed Not calculated; no mortality observed Not calculated; no mortality observed
Mammal oral dose No mortality observed Not calculated; no mortality observed Not calculated; no mortality observed

Freshwater fish Mortality Slope = 3.9

(3 – 5) 1 in 5.13E+06 (1 in 2.1E+4 to 1 in 2.58E+10) Not calculated; no LOC exceedances

Estuarine/marine fish No mortality observed Not calculated; no mortality observed Not calculated; no mortality observed

Freshwater Invertebrates Immobilization Slope = 3.2

(2 – 4) 1 in 6.38E+04 (1 in 216 to 1 in 1.03E+7) Not calculated; environmental fate and effects data suggest soap salts in water is not toxic to aquatic invertebrates. Estuarine/marine Invertebrates Mortality Default Slope = 4.5 (2 – 9) 1 in 4.18E+08 (1 in 216 to 1 in 1.75E+31)

As shown in Table V.3 , the probability for acute direct effects ( i.e. , mortality) to individual listed fish (based on the most sensitive species, ra inbow trout) at the Listed species LOC is 1 in56 5,130,000 following one application at 205 lb a.i./A. This reflects a slope of 3.9. The chance of an individual effect for freshwater and estuarin e/marine invertebrates, based on the daphnid and mysid, respectively, are 1 in 63,800 and 1 in 418,000,000.

V.2.2. Listed Species Occurrence Associated with Soap Salts Use

The goal of the co-location analysis is de termine whether sites of pesticide use are geographically associated with known locations of listed species [following the convention of the Services, the word ‘species’ in this assessment may apply to a ‘species’, ‘subspecies’, or an Evolutionary Significant Unit (ESU)]. At the screening level, this analysis is accomplished using the LOCATES database (version 2.10.3). The database uses location information for listed species at the county level and compares it to agricultural census data (from 2002) for crop production at the same county level of resolution . The product is a lis ting of Federally-listed species that are located in c ounties known to produce the crops upon which the pesticide will be used.

Additional data is needed on the potentially affected species associated with the registered uses of soap salts; thus, until the un certainties have been addressed, this analysis has not been conducted for this assessment. For the purposes of listed species effects determination, exposure is assumed to occur.

VI. References

Irani, R.R. and C.F. Callis (1960). Metal comp lexing by phosphorous compounds II. Solubility of calcium salts of linear carboxyl ic acids. J. Phys. Chem. 64:1741

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Ag ency. Endangered and Threatened Species Effects Determinations. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington, D. C. January 23, 2004. Online at: http://www.epa.gov/oppfead1/endanger /consultation/ecorisk-overview.pdf

USEPA. 2006b. User’s Guide: Te rrPlant Version 1.2.2 (Terrestrial Residue Exposure model). United States Environmental Protection Agency. Environmental Fate and Effects Division. Office of Pesticide Programs. U.S. Environmental protection Agency. Washington, D.C. December 26, 2006.

Urban, D.J. and N.J. Cook, 1986. Hazard Evalua tion Division Standard Evaluation Procedure Ecological Risk Assessment . EPA 540/9-85-001. U.S. Environmental Protection Agency, Office of Pesticide Programs, Washington D.C.

VI.1. Submitted Studies

Guideline: OPPTS 850.2100 Avian Single Dose Oral Toxicity

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM57 No studies available

POTASSIUM MRID: 44980310 W.M.M. Stadens-peek and Drs. M.A. Leopold. 1996. Acute Oral toxicity Study in Bobwhite Quail. Unpublished study performed by NOTOX,‘s-Hertogenbosch, Netherlands. Laboratory Study No. 185052. Sponsored by Neudorff GmbH KG, Emmerthal, Germany. Study completed December 20, 1996.

MRID: 40066202 Hinken C. & Jaber, M. 1987. Aphid-Mite Attack Concentr ate: An Acute Oral Toxicity Study with the Bobwhite. Unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Study No.: 227-103A. Sponsored by Reuter Laboratories, Manassas Park, Virginia. Study completed January 16, 1987.

MRID: 40053301 Grimes, J. & Jaber, M. 1987. Aphid-Mite Attack Concentr ate: An Acute Oral Toxicity Study with the Bobwhite. Unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Study No.: 227-103. Sponsored by Reuter Laboratories, Manassas Park , Virginia. Study comple ted December 29, 1986.

MRID: 30861 Hunsaker, D. 1979. Acute Oral Toxicity Study of Safer’s Insecticidal Soap on Mallard Ducks. Unpublished studyperformed by San Diego State University, San Diego, CA. Laboratory study no.: Not reported. Sponsored by SaferAgro Chem Ltd, Victoria, British Columbia. Study completed May 24, 1979.

SODIUM
No studies available

Guideline: OPPTS 850.2300 Avian Dietary Toxicity

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM MRID: 46206301 Bien, E. 2003. Avian Dietary Toxicity Test of NEU 1170 H in the Japanese Quail. Unpublished study performed by Harlan Bioservice for Science GmbH, Walsrode, Germany. Laboratory Study No.: 10-16-0146-03. Sponsored by Neudorff GmbH KG, Emmerthal, Germany. Study completed October 30, 2003.

POTASSIUM MRID: 00157472 Beavers, J.B. 1986. Safer Herbicide H 2 : A Dietary LC50 Study with the Bobwhite. Unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Study No.: 208-104. Sponsored by Safer Agro-Chem Ltd., British Columbia, Canada. Study completed January 31, 1986.

MRID: 00105040 Beavers, J.B. and R. Fink. 1981. Untitled. Final Report on the Toxicity of Safer’s Insecticidal Soap #1 to Mallard Duck ( Anas platyrhynchos ). Unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Study No.: WI-447A. Sponsored by Applied Biological Sciences Laboratory, Glendale, California. Study completed May 5, 1981.

MRID: 40385601 Johnson, M. & Jaber, M. 1987. Herbicide H 2 : A Dietary LC50 Study with the Mallard. Unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Study No.: 508-106. Sponsored by Safer Ltd., Victoria, British Columbia, Canada. Study completed August 7, 1987.

MRID: 44980311 Leopold, M.A. 1997. 5-day Dietary Toxicity Study in Bobwhite Quail. Unpublished study performed by NOTOX, ‘s-Hertogenbosch, Netherlands. Laboratory Study Number 185085. Sponsored by W. Neudorff GmbH KG, Emmerthal, Germany. Study completed February 28, 1997.58 MRID: 44980312Leopold, M.A. 1997. 5-day Dietary Toxicity Study in Mallard Duck. Unpublished study performed by NOTOX, ‘sHertogenbosch, Netherlands. Laboratory Study Number 185118. Sponsored by W. Neudorff GmbH KG, Emmerthal, Germany. Study completed March 3, 1997.

MRID: 00096640 Beavers, J.B. and R. Fink. 1981. Untitled. Final Report on th e Toxicity of Safer’s Insecticidal Soap #1 to Bobwhite Quail ( Colinus virginianus ). Unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Study No.: 157-107. Sponsored by Applied Biological Sciences Laboratory, Glendale, California. Study completed April 22, 1981.

MRID: 40066203 Grimes, J., Hinken, C., Jaber, M. 1987. Aphid-Mite Attack Concentrate: A Dietary LC50 Study with the Bobwhite. Unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Study No.: 227-101B. Sponsored by Reuter Laboratories, Manassas Park, Virginia. Study completed January 23, 1987.

MRID: 40053302 Grimes, J. & Jaber, M. 1986. Aphid-Mite Attack Conc entrate: A Dietary Toxicity Study with the Bobwhite. Unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Study No.: 227-101A. Sponsored by Reuter Laboratories, Manassas Park , Virginia. Study comple ted December 12, 1986.

MRID: 40053303 Grimes, J. & Jaber, M. 1986. Aphid-Mite Attack Conc entrate: A Dietary Toxicity Study with the Mallard. Unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Study No.: 227-102. Sponsored by Reuter Laboratories, Manassas Park, Virginia. Study completed November 7, 1986.

MRID: 30862 Condrashoff, S.F. 1979. Avian Dietary LC50 Toxicity of Safer’s Insecticidal So ap on the Mallard Duck. Unpublished study performed by Professional Ecological Services, Victoria, British Columbia. Laboratory Study No.: Not reported. Sponsored by Safer Agro-Chem Ltd, Vi ctoria, British Columbia. Study completed October, 1979.

MRID: 30863 Condrashoff, S.F. 1979. Avian Dietary LC50 Toxicity of Safer’s Insecticidal Soap on the Bobwhite Quail. Unpublished study performed by Professional Ecological Services, Victoria, British Columbia. Laboratory Study No.: Not reported. Sponsored by Safer Agro-Chem Ltd, Victoria, British Columbia. Study completed November, 1979.

SODIUM No study available

Guideline OPPTS 850.2300 Avian Reproduction

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM No study available

POTASSIUM No study available

SODIUM No study available

Guideline OPPTS 850.1075 Freshwat er Fish Acute Toxicity

------------------ ------------------ ----------------- --------------- --------------- ------------59 AMMONIUM MRID: 42806405 Ward, T.J., P.L. Kowalski, and R.L. Boari. 1993. Acute Toxicity of Hinder to the Rainbow Trout, Oncorhynchus mykiss. Unpublished study performed by T.R. Wilbury Laboratories, Inc., Marblehead, Massachusetts. Laboratory Study No.: 211-UN. Sponsored by Uniroyal Chemical Company, Inc., Bethany, Connecticut. Study completed on May 28, 1993.

POTASSIUM MRID: 00096636 Berlin, C. 1981. Static Acute Toxicity – Fish Bioassay with Rainbow Trout. Unpublished study performed by Applied Biological Sciences Laboratory, Glendale, California. Laboratory Study Number 17382. Sponsored by Safer Agro, British Columbia, Canada. Study completed June 12, 1981.

MRID: 00090936 Janssen, R. 1979. Acute Toxicity Study of Safer’s Insecticidal Soap on the Rainbow Trout (Salmo gairdneri). Unpublished study performed by E.V.S. Consultants Ltd, Victoria, British Columbia. Laboratory Study Number 791/79-23. Sponsored by Safer Agro-Chem Ltd., Richmond, British Columbia, Canada. Study completed April, 1979.

MRID: 44980314 Grunert, B. 1996. Acute Toxicity Study in Bluegill Sunfish. Unpublished study performed by NOTOX, ‘sHertogenbosch, Netherlands. Laboratory study number 185142. Sponsored by W. Neudorff GmbH KG, Emmerthal, Germany. Study completed August 1, 1996.

MRID: 44980313 Nedvidek, W. 1996. Acute Toxicity Study in Rainbow Trout with Neudosan Neu. Unpublished study performed by BioChem GmbH, Karlsruhe, Germany. Laboratory study no.: 96 50 41 213 A. Sponsored by W. Neudorff GmbH KG, Emmerthal, Germany. Study completed July 30, 1996.

MRID: 40053304 Obenchain, F. 1986. Salmo gairdneri– Acute Toxicity Tests on Aphid-Mite Attack. Unpublished study performed by EA Engineering, Science, and Technology, Inc., Sparks, Maryland. Laboratory study no.: 12-19-133. Sponsored by Reuter Laboratories, Inc., Manassas Park, Virginia. Study completed December 1986.

MRID: 40053304 Obenchain, F. 1986. Lepomis macrochirus – Acute Toxicity Tests on Aphid-Mite Attack. Unpublished study performed by EA Engineering, Science, and Technology, Inc., Sparks, Maryland. Laboratory study no.: 12-19-133. Sponsored by Reuter Laboratories, Inc., Manassas Park, Virginia. Study completed December 1986.

MRID: 909737 Reid, B. 1979. Acute Toxicity of Safer’s Insecticidal Soap on Goldfish. Unpublished study performed by E.V.S. Consultants Ltd., North Vancouver, British Columbia. Labo ratory study no.: 791. Sponsored by Safer Agro-Chem Ltd., Victoria, British Columbia. Study completed November, 1979.

SODIUM No study available

Guideline OPPTS 850.1075 Estuarine/ma rine Fish Acute Toxicity

------------------ ------------------ ----------------- --------------- --------------- ------------ AMMONIUM MRID: 48402202 Fournier, A.E. 2011. H01 Concentr ate Herbicidal Soap - Acute Toxi city to Sheepshead Minnow ( Cyprinodon variegates ) Under Static-Renewal Conditions, Following OPPT S Draft Guideline 850.1075. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No: 13989.6106. Sponsored by W.60 Neudorff GmbH KG, Great Falls, Virginia. Study completed February 15, 2011.

POTASSIUM MRID: 48469802 Fournier, A.E. 2011. Neudorff’s Insecticidal Soap Concentrate - Acute Toxic ity to Sheepshead Minnow ( Cyprinodon variegates ) Under Flow Through Conditions, Following OPPTS Draft Guideline 850.1075. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No: 13989.6115. Sponsored by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed April 26, 2011.

MRID: 48636502 Sayers, L.E. 2011. Safer Brand O-Insecticidal Soap Concentrate – Acute Toxicity to Sheepshead Minnow ( Cyprinodon variegates ) Under Flow-Through Conditions, Following OPPTS Draft Guideline 850.1075. Laboratory Study No.: 13999.6107. Sponsored by Soap Salts Rere gistration Task Force, Washington, DC. Study completed October 4, 2011.

SODIUM No study available

Guideline OPPTS 850.1010 Freshwater In vertebrate Acute Toxicity

------------------ ------------------ --------------- --------------- --------------- ------------ AMMONIUM MRID: 42806406 Ward, T.J., Kowalski, P.L., and R.L. Boeri. 1993. Acute Toxicity of Hinder to the Daphnid, Daphnia magna

. Unpublished study performed by T.R. Wilbury Laboratories, Inc., Marblehead, Massachusetts. Laboratory study no: 210-UN. Sponsored by Uniroyal Chemical Company, Inc., Bethany Connecticut. Study completed May 28, 1993 and amended June 2, 1993.

MRID: 44760402 Kleiner, R. 1998. Acute Immobilization Test Daphnia – Daphnia magna according to OECD Guideline 202-1 (1984) NEU 1170 H (22%). Unpublished study performed by BioChem Agrar, Labor fur biologische und chemische Analytik, Cunnersdorf, Germany. Laboratory study no.: 98 10 78 039. Sponsored by Neudorff GmbH KG, Emmerthal, Germany. Study completed July 8, 1998 and amended September 24, 1998. Addendum No. 1 was completed September 22, 1998.

POTASSIUM MRID: 44980315 Grunert, B. 1996. Acute Daphnia Immobilization Test with Neudosan Neu. Unpublished study performed by BIOCHEM, Karlsruhe, Germany. Laboratory study number 96 50 41 213 B. Sponsored by Neudorff GmbH KG, Emmerthal, Germany. Study completed August 1, 1996 and amended August 22, 1997.

MRID: 40053305 Harrison, E. 1986. Aphid-Mite Attack Concentrate 48- hour Static Acute Bioassay: Daphnid pulex. Unpublished study performed by James R. Reed and Associates, Inc., Newport News, Virginia. Laboratory study number 86- 3368. Sponsored by Reuter Laboratories, Inc., Manassas Park, Virginia. Study completed November 15, 1986.

MRID: 30865 (96638) Condrashoft, S.F.. 1979. Acute Toxicity LC50 of Safer’s Insecticidal Soap on Daphnid pulex. Unpublished study performed by Professional Ecological Services, Victoria, British Columbia. Laboratory study number not reported. Sponsored by Safer’s Agro-Chem Ltd., Victoria, British Columbia. Study completed July, 1979.

SODIUM No study available

Guideline OPPTS 850.1025 Estuarin e/Marine Mollusk Acute T oxicity (Shell Deposition)61 ------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM No study available

POTASSIUM No study available

SODIUM No study available

Guideline OPPTS 850.1035 Estuarine/Marine Invertebrate Acute Toxicity

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM MRID: 48402201
A. E. Fournier. 2011. H01 Concentrate Herb icidal Soap -Acute Toxicity to Mysid ( Americamysis bahia ) Under Static-Renewal Conditions, Following OPPTS Guidelin e 850.1035. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No. 13989.6105. Study sponsored by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed February 15, 2011.

POTASSIUM MRID: 48469801
A. E. Fournier. 2011. Neudorff’s Insecticidal Soap Concentrate -Acute Toxicity to Mysid ( Americamysis bahia ) Under Flow Through Conditions, Following OPPTS Guideline 850.1035. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No. 13989.6114. Study sponsored by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed April 22, 2011.

MRID: 48608707 Sayers, L.E. 2011. Safer Brand O-Insecticidal Soap Concentrate -Acute Toxicity to Mysid ( Americamysis bahia ), Under Flow Through Conditions, Following OPPTS Guideline 850.1035. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No. 13999.6106. Study sponsored by Smithers Viscient, Wareham, Massachusetts. Study completed September 20, 2011.

SODIUM No study available

Guideline OPPTS 850.1300 Freshwater Aqua tic Invertebrate Life Cycle

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM MRID: 48402203 Fournier, A.E. 2011. H01 C oncentrate Herbicidal Soap – Full Life-C ycle Toxicity Test with Water Fleas ( Daphnia magna) Under Static-Renewal Conditioning, Following OPPTS Draft Guideline 850.1300. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No.: 13989.6107. Sponsored by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed February 24, 2011.

POTASSIUM MRID: 48668601 Fournier, A.E. 2011. Neudorff’s Insec ticidal Soap Concentrate – Full Life-Cycle Toxicity Test with Water Fleas ( Daphnia magna) Under Flow-Through Conditions, Following O PPTS Draft Guideline 850.1300. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No.: 13989.6116. Sponsored by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed November 23, 2011.

MRID: 48664201 Sayers, L.E. 2011. Safer Brand O-Insecticidal Soap Concen trate – Full Life-Cycle Toxicity Test with Water Fleas62 ( Daphnia magna) Under Flow-Through Conditions, Following O PPTS Draft Guideline 850.1300. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No.: 13999.6108. Sponsored by Soap Salts Reregistration Task Force, Washington, DC. Study completed November 18, 2011.

SODIUM No study available

Guideline OPPTS 850.1350 Estuarine/Mari ne Invertebrate Life Cycle

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM No study available

POTASSIUM No study available

SODIUM No study available

Guideline OPPTS 850.1400 Freshwater and Estuar ine/marine Fish Early-Life Stage

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM No study available

POTASSIUM No study available

SODIUM No study available

Guideline OPPTS 850.3020 Honeybee Acute Contact Toxicity

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM MRID: 44766401 Nengel, S. 1998. Assessment of Side Effects of NEU 1170 H to the Honey Bee, Apis mellifera L. in the Laboratory Following EPPO Guideline No. 170. Unpublished study performed by Arbeitsgemeinschaft, GAB Biotechnologie GmbH & IFU Umweltanalytik GmbH, Niefern-Oschelbronn, Germany. Laboratory Study No.: 97253/01-BLEU. Sponsored by Neudorff GmbH KG, Emmerthal, Germany. Study completed June 22, 1998.

MRID: 42806407 Ward, T.J., Kowalski, P.L., and Boari, R.L. 1993 . Acute Toxicity of Hinder to the Honey Bee, Apis mellifera

. Unpublished study performed by T.R. Wilbury Laboratorie s, Inc., Marblehead, Massachusetts. Laboratory Study No.: 209-UN. Sponsored by Uniroyal Chemical Company, Inc. , Bethany, Connecticut. Study completed May 28, 1993.

POTASSIUM MRID: 42806001 Hoxter, K.A., Bernard, W.L., and Smith, G.J. 1993. Ring er/Safer 50% Insecticidal Soap Concentrate Technical grade: An Acute Contact toxicity Study with the Honey Bee. Unpublished study performed by Wildlife International Ltd., Easton, Maryland. Laboratory Study No.: 333-101D. Sponsored by Ringer Corporation, Eden Prairie, Minnesota. Study completed on May 12, 1993.

SODIUM No study available63 Guideline OPPTS 850.4100 Seedling Emergence

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM MRID: 48402204 Martin, J.A. 2011. H01 Concentrate Herbicidal Soap – Seedling Emergence Test Following U.S. EPA OPPTS Draft Guideline 850.4225. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study Number 13989.6101. Sponsored by W. Neudorff Gm bH KG, Great Falls, Virginia. Study completed February 18, 2011.

POTASSIUM MRID: 48608704 Martin, J.A. 2011. Safer Brand O-Insecticidal Soap C oncentrate – Seedling Emergen ce Test Following U.S. EPA OPPTS Draft Guidelines 850.4100 and 850.4225. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study Number 13999.6102. Sponsored by Soap Salts Reregistration Task Force, Washington, DC. Study completed September 13, 2011.

MRID: 48402301 Martin, J.A. 2011. Neudorff’s Insecticidal Soap Conc entrate – Seedling Emergence Test Following U.S. EPA OPPTS Draft Guideline 850.4225. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study Number 13989.6110. Sponsored by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed February 18, 2011.

SODIUM No study available

Guideline OPPTS 850.4150 Vegetative Vigor

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM MRID: 48402205 Martin, J.A. 2011. H01 Concentrate Herbicidal Soap – Vegetative Vigor Test Following U.S. EPA OPPTS Draft Guideline 850.4250 (Tier II). Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study Number 13989.6102. Sponsored by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed February 15, 2011.

POTASSIUM MRID: 48608703 Martin, J.A. 2011. Safer Brand O-Insecticidal Soap C oncentrate – Vegetative Vigor Test Following U.S. EPA OPPTS Draft Guideline 850.4250 (Tier II). Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No. 13999.6103. Sponsored by Soap Salts Reregistration Task Force, Washington, DC. Study completed September 14, 2011.

MRID: 48402302 Martin, J.A. 2011. Neudorff’s Insecticidal Soap Concen trate – Vegetative Vigor Test Following U.S. EPA OPPTS Draft Guideline 850.4225 (Tier II). Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No.: 13989.6111. Sponsored by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed February 15, 2011.

SODIUM
No studies available

Guideline OPPTS 850.4400 Aquatic Vascular Plant Toxicity

------------------ ------------------ ----------------- ------------------ --------------64 AMMONIUM MRID: 48402206 Softcheck, K.A. 2011. H01 Concentrate Herbicidal Soap – 7-day toxicity Test with Duckweed ( Lemna gibba) following OPPTS Draft Guideline 85 0.4400. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No.13989.6103. Sponsored by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed on February 17, 2011.

POTASSIUM MRID: 48608702 Softcheck, K.A. 2011. Safer Brand O-Insecticidal Soap Concentrate – 7-day Toxic ity Test with Duckweed ( Lemna gibba ) following OPPTS Draft Guideline 850.4400. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No. 13999.6104. Sponsored by Soap Salts Reregistration Task Force, Washington, DC. Study completed September 16, 2011.

MRID: 48469803 Softcheck, K.A. 2011. Neudorff’s Insecticidal Soap Concentrate – 7-day Toxicity Test with Duckweed ( Lemna gibba ) following OPPTS Draft Guideline 850.4400. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No. 13989.6112. Sponso red by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed April 15, 2011.

SODIUM No study available

Guideline OPPTS 850.5400 Al gal Plant Toxicity

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM MRID: 48402207 Softcheck, K.A. 2011. H01 Concentrate Herbicidal Soap – 96-hour Toxicity Test with the Freshwater Green Alga, Pseudokirchneriella subcapitata , Following OPPTS Draft Guideline 850.4400. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No. 13989.6104. Sponsored by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed February 22, 2011.

POTASSIUM MRID: 48608701 Softcheck, K.A. 2011. Safer Brand O-Insecticidal Soap Concentrate – 96-hr Toxicity Test with the Freshwater Diatom, Navicula pelliculosa. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Study No. 13999.6111. Sponsored by Soap Salts Reregistration Task Force, Washington, DC. Study completed September 16, 2011.

MRID: 48636501 Softcheck, K.A. 2010. Safer Brand O-Insecticidal Soap Con centrate – 96-hr Toxicity Testwith the Freshwater BlueGreen Alga, Anabaena flos aquae , Following OPPTS Draft Guideline 850.5400. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No. 13999.6110. Sponsored by Soap Salts Reregistration Task Force, Washington, DC. Study completed September 30, 2011.

MRID: 48608706 Softcheck, K.A. 2010. Safer Brand O-Insecticidal Soap Concentrate – 96-hr Toxicity Test with the Freshwater Green Alga, Pseudokirchneriella subcapitata , Following OPPTS Draft Guideline 850.5400. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No. 13999.6105. Sponsored by Soap Salts Reregistration Task Force, Washington, DC. Study completed September 15, 2011.

MRID: 48402303 Softcheck, K.A. 2010. Neudorff’s Insec ticidal Soap Concentrate – 96-hr Toxicity Test w ith the Freshwater Green Alga, Pseudokirchneriella subcapitata , Following OPPTS Draft Guideline 850.5400. Unpublished study performed65 by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No. 13989.6113. Sponsored by W. Neudorff GmbH KG, Great Falls, Virginia. Study completed February 24, 2011.

MRID: 48608705 Softcheck, K.A. 2011. Safer Brand O-Insecticidal Soap Co ncentrate – 96-hr Toxicity Te st with the Marine Diatom, Skeletonema costatum, Following OPPTS Draft Guideline 850.5400. Unpublished study performed by Smithers Viscient, Wareham, Massachusetts. Laboratory Study No.: 13999.6109. Sponsored by Soap Salts Reregistration Task Force, Washington, DC. Study completed September 15, 2011.

SODIUM No study available66 

### Appendix A. GENEEC2 Inputs and Outputs

RUN No. 1 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 205.000(205.000) 1 1 100.0 100.0 AERL_B( 13.0) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MILLIGRAMS/LITER (PPM)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 3.17 2.52 .89 .32 .21

RUN No. 2 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 116.000(116.000) 1 1 100.0 100.0 AERL_B( 13.0) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MILLIGRAMS/LITER (PPM)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 1.79 1.43 .50 .18 .12

RUN No. 3 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 103.800(103.800) 1 1 100.0 100.0 AERL_B( 13.0) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

--------------------------------------------------------------------67 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MILLIGRAMS/LITER (PPM)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 1.60 1.28 .45 .16 .11

RUN No. 4 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 63.000( 63.000) 1 1 100.0 100.0 AERL_B( 13.0) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 973.47 775.90 273.81 97.62 65.08

RUN No. 5 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 10.000( 10.000) 1 1 100.0 100.0 AERL_B( 13.0) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 154.52 123.16 43.46 15.49 10.33

RUN No. 6 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 1.000( 1.000) 1 1 100.0 100.0 AERL_B( 13.0) .0 .068 FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 15.45 12.32 4.35 1.55 1.03

RUN No. 7 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 205.000(205.000) 1 1 100.0 100.0 GRHIFI( 6.6) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MILLIGRAMS/LITER (PPM)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 2.85 2.24 .79 .28 .19

RUN No. 8 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 116.000(116.000) 1 1 100.0 100.0 GRHIFI( 6.6) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MILLIGRAMS/LITER (PPM)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 1.61 1.27 .45 .16 .11

RUN No. 9 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP69 ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 103.800(103.800) 1 1 100.0 100.0 GRHIFI( 6.6) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MILLIGRAMS/LITER (PPM)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 1.44 1.13 .40 .14 .09

RUN No. 10 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 63.000( 63.000) 1 1 100.0 100.0 GRHIFI( 6.6) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 876.40 687.46 241.76 86.18 57.46

RUN No. 11 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 10.000( 10.000) 1 1 100.0 100.0 GRHIFI( 6.6) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY70 GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 139.11 109.12 38.37 13.68 9.12

RUN No. 12 FOR soap salts ON any * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 1.000( 1.000) 1 1 100.0 100.0 GRHIFI( 6.6) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 13.91 10.91 3.84 1.37 .91

EECs after 3, 10, 25, and 50 applications at the maximum rate

RUN No. 3 FOR soap salts ON * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 205.000(206.614) 3 7 100.0 100.0 GRHIFI( 6.6) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MILLIGRAMS/LITER (PPM)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY
GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 3.01 2.38 .84 .30 .20

RUN No. 10 FOR soap salts ON * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 205.000(206.614) 10 7 100.0 100.0 GRHIFI( 6.6) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

--------------------------------------------------------------------71 METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MILLIGRAMS/LITER (PPM)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY
GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 3.02 2.39 .84 .30 .20

RUN No. 25 FOR soap salts ON * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 205.000(206.614) 25 7 100.0 100.0 GRHIFI( 6.6) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MILLIGRAMS/LITER (PPM)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY
GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 3.02 2.39 .84 .30 .20

RUN No. 50 FOR soap salts ON * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 205.000(206.614) 50 7 100.0 100.0 GRHIFI( 6.6) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 1.00 2 N/A .00- .00 2.00 2.00

GENERIC EECs (IN MILLIGRAMS/LITER (PPM)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY
GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 3.02 2.39 .84 .30 .2072Appendix B. Incident ReportsEIIS Pesticide Summary Report: Species InformationPotassium salts of fatty acids (079021)Incident #SpeciesScientific NameMagnitudeResponseRt. ExposurePLANTSCherryI008521-001cherryPrunus sp.6 acresplant damageTreated directlyI008521-002cherryPrunus sp.all .5 acresplant damageTreated directlyIncident #DateCountyStateCertaintyLegal.Formul.Appl. MethodTotal MagnitudePLANTSCherryI008521-0026/18/1998YAKIMAWA3RUN/RBroadcast3.5 ACRESI008521-0013/9/1999YAKIMAWA3RUN/RBroadcast6 ACRES73 

### APPENDIX C. Toxici ty Study Summaries

Freshwater Fish, Acute Effects

Fish toxicity studies using the typical end-use products were submitted to establish the acute toxicity of salts to fish. Results of the acute studies with the ammoni um and potassium salts formulated products to freshwat er fish indicate the trout LC 50 value of 12 mg a.i./L and 9.19 m a.i./L, respectively, ( Table C.1 ) are used to evaluate potential acute effects of the salts to freshwater fish.

AMMONIUM SALTS OF FATTY ACIDS

A 96h static-renewal acute exposure study (M RID 42806405; Supplemental) with rainbow tr o ( Onchorhynchus mykiss ) is available for a 13.1% ammonium salts of fatty acids formulation. Twenty trout per level were e xposed to nominal concentrations of 0 (control), 3, 5, 8, 13 and 2 Table C.1. Freshwater Fish Acute Toxicity with Soap Salts (Ammonium and Potassium). Species % a.i. 96-hour LC 50 (mg a.i./L) Toxicity Category MRID No. Author/Year Study Classificati o AMMONIUM SALTS OF FATTY ACIDS
Rainbow trout ( Oncorhynchus mykiss ) 13.1 12 A Slightly toxic 42806405 Ward et al. (1993) Supplement a

POTASSIUM SALTS OF FATTY ACIDS

Rainbow trout ( Oncorhynchus mykiss ) 51 131.3 B Practically nontoxic 00090936 Janssen. (1979) Supplement a

49 17 C Slightly toxic 44980313 Nedvidek. (1996) Acceptabl e

25 9.19 D Moderately toxic 40053304 Obenchain. (1986) Supplement a

Not reported 18.1 mg formulation/L E N/A 4 00096636 Berlin. (1981) Supplement a Bluegill sunfish ( Lepomis macrochirus ) 25 23 F Slightly toxic 40053304 Obenchain. (1986) Supplement a

A Trout 95% Confidence Interval (C.I.) = 11-1 4 mg a.i./L; slope = N/A (moving average)

B Trout 95% C.I. = 85-151 mg a.i./L; slope = N/A (binomial)

C Trout 95% C.I. = 7.67-28.64 mg a.i./L; slope = N/A (binomial)

D Trout 95% C.I. = 7.28-11.5 mg a.i./L; slope (95% C.I) = 3.88 (2.53-5.22)

E Trout 95% C.I. = 16.8-19.3 mg formulation/L; slope (95% C.I.) = 18.15 (9.42-26.88)

F Sunfish 95% C.I. = 19.2-27.5 mg a.i./L; slope (95% C.I.) = 4.97 (3.27-6.66)

1 No chemical analyses were performed on the test concen trations at the beginning and end of the test as well as before and after each renewal.

2 Each concentration was less than 60% of the next higher concentration, there were not enough concentrations at which between 0% and 100% of the fish died in 96 hours.

3 Aeration was applied within 24 hours of the test in order to maintain dissolved oxygen levels since levels fell below 40% saturation between 24- and 48-hours.

4 The purity of the active ingredient in the formulati on was not reported, it was not possible to determine the toxicity category for th e active ingredient when corrected for purity.

5 No chemical analyses of the test solutions for th e presence of the formulation or active ingredient.

6 Aeration was used.74 mg a.i./L (corrected for purity). 10, 40 and 100% mortalities occurred at the 8, 13 and 20 mg a.i./L concentrations. The LC 50 was determined to be 12 mg a.i./L (adjusted for purity). Dark coloration and lethargy were observed in the 13 and 20 mg a.i./L concentrations, the EC 50 could not be calculated; the visual-observed NOAEC is 8 mg a.i./L.

POTASSIUM SALTS OF FATTY ACIDS

A 96h static acute exposure study (MRID 90936; Supplementa l) with rainbow trout ( Onchorhynchus mykiss ) is available for a 51% potassium sa lts of fatty acids formulation. Ten trout per level were exposed to nominal con centrations of 0 (cont rol), 24, 43, 77, 135 and 240 mg a.i./L (corrected for purity). No mortality oc curred in the control or in concentrations up to 43 mg a.i./L. 100% mortality occurred in the 135 mg a.i./L and 240 mg a.i./L, the two highest concentrations tested. While the formul ated product was used, the 96-hour LC 50 and NOAEC for the active ingredient was determined to be 131 and 87 mg a.i./L, respectively.

A 96h static acute exposure study (MRID 96636; Supplementa l) with rainbow trout ( Onchorhynchus mykiss ) is available for a potassium salts of fatty acids formulation. Twenty trout per level were exposed to nominal concen trations of 0 (control) , 10, 15, 17, 20 and 22 mg formulation/L. The purity of the active ingredie nt was not reported; th e reviewer could not correct the concentrations fo r purity. 10, 30, 70 and 100% mortalities occurred at the 15, 17, 20 and 22 mg formulation/L concentrations. The LC 50 was determined to be 18 mg formulation/L. Data on sub-lethal effects were not available to evaluate whether there were other effects than mortality. The statistical output calculated an NOAEC of 17 mg/L for mortality; however, the reviewer felt that the observed mortality at th is level (30%) was biologically significant and therefore, visually determined the NOAEC to be 15 mg formulation/L based on the single mortality at this level.

A 96h static acute exposure study (MRID 40053304; Supplemental) with bluegill sunfish (Lepomis macrochirus) is available for a 25% potassium salts of fatty acids formulation. Twenty sunfish per level were exposed to nominal c oncentrations of 0 (c ontrol), 10, 18, 32, 56 and 100 mg a.i./L. 5, 30, 70, 100 and 100% mortalities o ccurred at the 10, 18, 32, 56 and 100 mg a.i./L test levels. While the formulat ed product was used, the 96-hour LC 50 for the active ingredient based on 25% of product by volume was dete rmined to be 23 mg a.i./L.

A 96h static acute exposure study (MRID 40053304; Supplementa l) with rainbow trout (Onchorhynchus mykiss) is available for a 25% potassium salts of fatty acids formulation. Twenty trout per level were exposed to nominal concentrations of 0 (control), 3.7, 7.5, 15.2, 32 and 65 mg a.i./L. 10, 30, 80, 100 and 100% mort alities occurred at the 3.7, 7.5, 15.2, 32 and 65 mg a.i./L test levels. While the fo rmulated product was used, the 96-hour LC 50 for the active ingredient based on 25% of product by volume wa s determined to be 9.19 mg a.i./L.

A 96h static acute exposure study (MRID 44980313; Acceptable) with rainbow trout (Onchorhynchus mykiss) is available for a 49% potassium salts of fatty acids formulation. Twenty trout per level were e xposed to initial-measured conc entrations of 0 (control), 4.48, 7.67, 28.64, 41.42, 260.1 and 404.9 mg a.i./L (adjusted for purity). 90, 100, 100 and 100% mortalities occurred at the 28.64, 41.42, 260.1 and 404.9 mg a.i./L test levels. The LC 50 was determined to be 17 mg a.i./L. The NOAEC, based on subletha l effects of lying at the bottom, floating vertically and swimming slowly, is 4.48 mg a.i./L based on ini tial-measured concentrations.75 

### Freshwater Fish, Chronic Effects

AMMONIUM and POTASSIUM SALTS OF FATTY ACIDS

No chronic ecological effects studies of ammoni um and potassium salts using freshwater fish were submitted.



### Freshwater Invertebrates, Acute Effects

Toxicity studies using the typica l end-use products were submitted to establish the acute toxicity of salts to freshwater invertebrates. Results of the acute studies w ith the ammonium and potassium salts formulated products to freshwater inverteb rates indicate the EC 50 value of 27.1 mg a.i./L and 0.57 mg a.i./L, respectively, ( Table C.2 ) is used to evaluate potential acute effects of the salts to freshwater invertebrates.

Table C.2. Freshwater Invertebrate Acute Toxicity with Soap Salts (Ammonium and Potassium). Species % a.i. 48-hour EC 50 (mg

a.i./L) Toxicity Category MRID No. Author/Year Study Classification

AMMONIUM SALTS OF FATTY ACIDS

Water flea (Daphnia magna) 13.1 27.1 A Slightly toxic 42806406
Ward et al . (1993) Supplemental 1

22 30.9 B Slightly toxic 44760402 Kleiner (1998) Acceptable

POTASSIUM SALTS OF FATTY ACIDS

Water flea (Daphnia pulex) 51 106 C Practically non-toxic 00096638
Condrashoft. (1979) Supplemental 2

Water flea (Daphnia magna) 25 0.57 D Highly toxic 40053305 Harrison. (1986) Acceptable

Water flea (Daphnia magna) 49 17.3 E Slightly toxic 44980315 Grunert. (1996) Supplemental 1

A D. magna 95% Confidence Interval = 20-33 mg a.i./L; slope = N/A (binomial)

B D. magna 95% Confidence Interval = 24-40.9 mg a.i./L; slope = N/A (moving average)

C D. pulex 95% Confidence Interval = N/A; slope = N/A

D D. magna 95% Confidence Interval = 0.44-0.75 mg a.i./L; slope and its 95% C.I. = 3.18 (2.13-4.23)

E D. magna 95% Confidence Interval = 14.1-21.3 mg a.i./L; slope and its 95% C.I. = 4.46 (2.9-6.0)

1 No chemical analyses were performed on the test conc entrations for the presence of the active ingredient or formulation especially when mort ality/immobility were observed.

2 The test solutions were aerated after the test material was added; the dissolved oxygen data was not reported to verify the need to aerate the test solutions.76 AMMONIUM SALTS OF FATTY ACIDS

A 48h static-renewal acute exposure study (M RID 42806406; Supplemental) with daphnids ( Daphnia magna ) is available for a 13.1% ammonium salts of fatty acids formulation. Twenty daphnids per level were exposed to nominal c oncentrations of 0 (control), 12, 20, 33, 52, 79 and 131 mg a.i./L (corrected for purity). 90, 100, 100 and 100% mortalities occurred at the 33, 52, 79 and 131 mg a.i./L concentrations. The immobility EC 50 was determined to be 27.1 mg a.i./L; the NOAEC was 20 mg a.i./L (adjusted for purity ). 100% lethargy was observed in the 33 mg a.i./L concentration; in higher concentrati ons, complete immobility/mortality precluded the observations of sublethal effects, the EC 50 could not be calculated ; the visual-observed NOAEC for sub-lethal effects is 20 mg a.i./L.

A 48h static-renewal acute exposure study (MRID 44760402; Acceptable) with daphnid ( Daphnia magna ) is available for a 22% ammonium salts of fatty acids formulation. Twenty daphnids per level were exposed to initial-meas ured concentrations of 0 (control), 0.5, 0.9, 1.4, 4.7, 6.6, 22.6, 34.4, 82.3 and 203.7 mg a.i./L (correct ed for purity). 5, 10, 55, 100 and 100% immobility occurred at the 6.6, 22.6, 34.4, 82.3 and 203.7 mg a.i./L concentrations. The EC 50 and NOAEC for immobility was determined to be 30.9 and 22.6 mg a.i./L, respectively (adjusted for purity). The sub-lethal effects were not repor ted since immobility was considered a sub-lethal effect by the study authors.

POTASSIUM SALTS OF FATTY ACIDS

A 48h static acute exposu re study (MRID 96638; Supplemental) with daphnids ( Daphnia pulex ) is available for a 50.5% potassium salts of fatty acids formulation. Th irty daphnids per level were exposed to nominal concentrations of 0 (control), 50, 100, 150 and 200 mg a.i./L. 33.3, 40, 73.3 and 100% mortality occurred in the first te st and 20, 40, 66.7 and 100% mortality occurred in the second test. The study author base d its conclusion on dead daphnids; no data on immobilized daphnids were available and were not included in the count; it is possible the actual EC 50 value could be lower if immobilized daphnids had been included in the count. The reviewer calculated the LC 50 for the first and second tests separately and was 84.7 and 97.6 mg a.i./L, respectively; however, the study author reported a LC 50 of 106 mg a.i./L by combining the data of the tests together. The immobility EC 50 is not available since data on immobilization were not available.

A 48h static acute exposure study (MRI D 40053305; Acceptable) with daphnids ( Daphnia pulex ) is available for a 25% potassium salts of fatty acids formulation. Twenty daphnids per level were exposed to nominal concentrations of 0 (control), 0.25, 0.5, 1.25, 2.5 and 3.75 mg a.i./L. 5, 55, 85, 95 and 100% effect occurred at the 0.25, 0.5, 1.25, 2.5 and 3.75 mg a.i./L concentrations. It appears that the study author based its conclusion on dead daphni ds rather than the total of daphnids dead and immobilized ; it is possibl e the actual EC 50 value could be lower if immobilized daphnids had been included in the count. The LC 50 based on mortality was determined to be 0.57 mg a.i./L. The NOAEC was not determined since >5% effects were observed in all levels. The immobility EC 50 is not available since data on immobilization were not available.

A 48h static acute exposu re study (MRID 44980315; Supplemental) with daphnids ( Daphnia

magna ) is available for a 49% potassium salts of fatty acids formulation. Twenty daphnids per77 level were exposed to nominal concen trations of 0 (control), 0.38, 0.76, 1.53, 3.06, 6.13, 12.25, 24.5, 49 and 98 mg a.i./L (corrected for purity ). 35, 65, 100 and 100% immobility occurred at the 12.25, 24.5, 49 and 98 mg a.i./L concentrations. The EC 50 and NOAEC for immobility was determined to be 17.2 and 6.13 mg a.i./L, respectively (adjusted for purity).



### Freshwater Invertebrates, Chronic Effects

Laboratory toxicity studies usi ng the typical end-use products we re submitted to establish the chronic toxicity of salts to fres hwater invertebrates. Results of the reproduction studies with the ammonium and potassium salts formulated product s to freshwater invert ebrates indicate the NOAEC value of 23 mg a.i./L and 0.5 mg a.i./L, respectively, ( Table C.3 ) is used to evaluate potential reproductive e ffects of the salts to freshwater fish.

Table C.3. Freshwater Invertebrate Chronic Toxicity with Soap Salts (Ammonium and Potassium). Species % a.i. 21-day NOAEC (mg a.i./L) Endpoint affected MRID No. Author/Year Study Classification

AMMONIUM SALTS OF FATTY ACIDS

Water flea (Daphnia magna) 21.85 23 Time to first brood release, offspring per adult, length and dry weight 48402203 Fournier. (2011) Acceptable

POTASSIUM SALTS OF FATTY ACIDS

Water flea (Daphnia magna) 50.1 0.5 Offspring per adult, length and parental survival 48664201 Sayers. (2011) Acceptable

Water flea (Daphnia magna) 46.8 0.52 Time to first brood release, offspring per adult and length 48668601 Fournier. (2011) Acceptable

AMMONIUM SALTS OF FATTY ACIDS

A 21d freshwater invertebrate life-cycle study (MRID 48402203; Acceptable) with daphnids ( Daphnia magna ) is available for a 21.85% ammonium sa lts of fatty acids formulation. Meanmeasured test concentrations were 0 (contro l), 4.8, 12, 23, 48 and 100 mg a.i./L. Survival averaged 70 to 100% for all levels. The mean day of first brood re lease averaged 8.3, 8.9, 9.1, 8.6, 10.2 and 18.1 days for the control and 4.8, 12, 23, 48 and 100 mg a.i./L levels, respectively. There was a significant (p <0.05) treatment-related delay in first brood rel ease at the two highest treatment levels. The cumulative number of offs pring release per female averaged 128 for the control, compared to 132, 113, 155, 148 and 14 for the test levels. The difference was statistically significant compared to the control (p < 0.05) at the 100 mg a.i./L level. At study termination, surviving daphnia from the cont rol and test levels measured 4.6, 4.67, 4.66, 4.71, 4.72 and 4.02 mm in length and 0.66, 0.76, 0.77, 0.74, 0.8 and 0.55 mg in dry weight with the difference statistically-re duced compared to the control at th e 100 mg a.i./L level. Offspring per78 adult female, length and weight were affected; ho wever, the time of the first brood releases was most affected, the NOAEC is 23 mg a.i./L.

POTASSIUM SALTS OF FATTY ACIDS

A 21d freshwater invertebrate life-cycle study (MRID 48664201; Acceptable) with daphnids ( Daphnia magna) is available for a 50.1% potassium salts of fatty acid formulation. Meanmeasured test concentrations were 0 (cont rol), 0.16, 0.31, 0.63, 1.3 and 2.5 mg a.i./L, 46-80% of nominal levels. Survival averaged 15 to 100% fo r all levels, with a st atistically-significant difference at 1.9 mg a.i./L, the highest test level, when compared to control. The day of first brood release was recorded on Day 7 or 8 for the control group and all treatment levels except the highest level where no offspring were produc ed. The day of the first brood release recorded was consistent with the control performance. The cumulative numb er of offspring released perfemale average 149 for the negative control, compared to 182, 182, 178, 65 and 0 for the meanmeasured 0.087, 0.14, 0.5, 0.9 and 1.9 mg a.i./L levels, respectively. The difference was statistically-significant compared to the contro l (p<0.05) at the 0.9 and 1.9 mg a.i./L levels. Surviving daphnia from the control group and treatment levels measured 4.8, 4.9, 4.9, 5.0, 4.1 and 2.7 mm in length and 0.99, 0.98, 1.05, 1.3, 1.04 and 0.59 mg in weight; the difference in length was statistically-reduced (p<0.05) compared to the control at the 0.9 and 1.9 mg a.i./L levels. No treatment-related reduc tions were observed for dry wei ght. Time of first brood release and parental survival were affected; however, offs pring per adult and length were most affected, the NOAEC is 0.5 mg a.i./L.

A 21d freshwater invertebrate life-cycle study (MRID 48668601; Acceptable) with daphnids ( Daphnia magna) is available for a 46.8% potassium salts of fatty acid formulation. Meanmeasured test concentrations were 0 (c ontrol), 0.091, 0.21, 0.33, 0.52 and 1.4 mg a.i./L, 52-85% of nominal levels. Survival averaged 90 – 98% for all levels, with no statistically-significant differences from the control. The day of first br ood release was recorded on Day 8 for the control group and levels up to the 0.52 mg a.i./L treatment level. The day of the first brood release recorded for the 1.4 mg a.i./L tr eatment level was on Day 10. The revi ewer interpreted this to be a treatment-related delay in first brood release at the highest test level. The cumulative number of offspring released per female averaged 115 for the control, compared to 136, 153, 170, 174 and 85 for the mean-measured 0.091, 0.21, 0.33, 0.52 and 1.4 mg a.i./L levels, respectively. The difference was statistically-signifi cant compared to the control (p<0.05) at the highest test level. Surviving daphnia from the control and trea tment levels measured 4.43, 4.46, 4.53, 4.63, 4.7 and 4.06 mm in length and 0.93, 1.00, 0.99, 1.02, 1.08 and 0.96 mg in dry weight. The difference in length was statistically-reduced (p<0.05) compared to the control at th e 1.4 mg a.i./L level. Time to first brood releases, offspring per adult a nd length were equally affected, the NOAEC is 0.52 mg a.i./L.



### Estuarine/Marine Fish, Acute Effects

Estuarine/marine fish toxicity studies using the typical end-use products were submitted to establish the acute toxicity of salts to fish. Re sults of the acute studies with the ammonium and potassium salts formulated products to es tuarine/marine fish indicate the minnow LC 50 value of >105 mg a.i./L and >4.4 mg a.i./L, respectively, ( Table C.4 ) is used to evaluate potential acute effects of the salts to freshwater fish.79 AMMONIUM SALTS OF FATTY ACIDS

A 96h static-renewal acute exposure study (M RID 48402202; Acceptable) with sheepshead minnow ( Cyprinodon variegatus ) is available for a 21.9% ammonium salts of fatty acids formulation. Twenty minnows per level were exposed to Time Weighted Average (TWA) concentrations of 0 (control), 6.3, 13, 25, 50 and 100 mg a.i./L. There were no mortality in the control and levels up to 50 mg a.i./L; 5% mortalit y occurred at the 100 mg a.i./L test level, the highest level tested. The TWA LC 50 is determined to be >105 mg a.i./L. The 5% mortality was not statistically-significant, the TWA NOAEC is 105 mg a.i./L. No sub-lethal effects were observed in the control or a ny of the treatment levels.

POTASSIUM SALTS OF FATTY ACIDS

A 96h flow-through acute exposure study (MRI D 48469802; Acceptable) with sheepshead minnow ( Cyprinodon variegatus ) is available for a 46.8% pota ssium salts of fatty acids formulation. Twenty minnows per level were ex posed to mean-measured concentrations of 0 (control), <LOD, 0.017, 0.35, 1.0 and 2.1 mg a.i./L, 0 to 42% of nominal levels due to rapid degradation in seawater. No mo rtality or sub-lethal effects occurred in the control or in treatment levels up to the sol ubility limit. While the formulated product was used, the 96-hour LC 50 and NOAEC for the active ingredient is de termined to be >2.1 and 2.1 mg a.i./L, respectively.

A 96h flow-through acute exposure study (MRI D 48636502; Acceptable) with sheepshead minnow ( Cyprinodon variegatus ) is available for a 50.8% pota ssium salts of fatty acids formulation. Twenty minnows per level were ex posed to mean-measured concentrations of 0 (control), <LOD, 0.12, 0.76, 2.9 and 4.4 mg a.i./L, 9.4 to 85% of nominal levels due to rapid degradation in seawater. No mo rtality or sub-lethal effects occurred in the control or in treatment levels up to the sol ubility limit. The 96-hour LC 50 and NOAEC for the active ingredient is determined to be >4.4 and 4.4 mg a.i./L, respectively. Table C.4. Estuarine/Marine Fish Acute T oxicity with Soap Salts (Ammonium and Potassium). Species % a.i. 96-hour LC 50 (mg

a.i./L) Toxicity Category MRID No. Author/Year Study Classification

AMMONIUM SALTS OF FATTY ACIDS
Sheepshead minnow (Cyprinodon variegates) 21.9 >105 Practically nontoxic 48402202 Fournier. (2011) Acceptable

POTASSIUM SALTS OF FATTY ACIDS

Sheepshead minnow (Cyprinodon variegates) 46.8 >2.1 No effects up to 2.1

mg/L 48469802 Fournier. (2011) Acceptable

50.8 >4.4 No effects up to 4.4

mg/L 48636502 Sayers. (2011) Acceptable80 

### Estuarine/Marine Fish, Chronic Effects

AMMONIUM and POTASSIUM SALTS OF FATTY ACIDS

No chronic ecological effects studies of ammoni um and potassium salts using estuarine/marine fish were submitted.



### Estuarine/Marine Invertebrates, Acute Effects

Toxicity studies using the typica l end-use products were submitted to establish the acute toxicity of salts to estuarine/marine invertebrates. Resu lts of the acute studies with the ammonium and potassium salts formulated products to estuarine/ marine invertebrates indicate the mysid shrimp LC 50 value of 66.5 mg a.i./L and 1.2 mg a.i./L, respectively, ( Table C.5 ) is used to evaluate potential acute effects of the salts to estuarine/ marine invertebrates. No data on Eastern oysters were available, this is a data ga p and the value is discussed further in the risk description section.

Table C.5. Estuarine/Marine Invertebrate Acut e Toxicity with Soap Salts (Ammonium and Potassium). Species % a.i. 96-hour LC 50 /EC 50 (mg a.i./L) Toxicity Category MRID No. Author/Year Study Classification

AMMONIUM SALTS OF FATTY ACIDS
Mysid shrimp (Americamysis bahia) 21.85 66.5 A Slightly toxic 48402201 Fournier. (2011) Acceptable

Eastern oyster ( Crassostrea

virginica ) -- -- -- No data --

POTASSIUM SALTS OF FATTY ACIDS

Mysid shrimp (Americamysis bahia) 46.8 >2.2 No effects up to 2.2 mg a.i./L 48469801 Fournier. (2011) Acceptable

50.8 1.2 B Moderately toxic 48608707 Sayers. (2011) Acceptable

Eastern oyster ( Crassostrea

virginica ) -- -- -- No data --

A Mysid 95% Confidence Interval = 54.1-85.7 mg a.i./L; slope = N/A (moving average)

B Mysid 95% Confidence Interval = 0.9 – 1.6 mg a.i./L; slope = N/A (binominal)

AMMONIMUM SALTS OF FATTY ACIDS

A 96h static-renewal acute exposure study (MRI D 48402201; Acceptable) with mysid shrimp ( Americamysis bahia ) is available for a 21.85% ammonium salts of fatty acids formulation.81 Twenty mysids per level were exposed to time-w eighted average concentr ations of 0 (control), 3.3, 8, 20, 45 and 125 mg a.i./L. All mysids in the control group and TWA-measured 8.0 mg a.i./L were normal throughout the test. At test termination, 10, 5, and 5% mortality was observed in the lowest test level (3.3 mg a.i./L), 20 and 45 mg a.i./L. Complete mortality was observed in the highest test level. The LC 50 is determined to be 66.5 mg a.i./L; the NOAEC via Fisher’s Exact Test is 45 mg a.i./L. Data on the sublet hal effects observations were not available for analysis.

No acute ecological effects studies of ammonium salts using mollusks were submitted.

POTASSIUM SALTS OF FATTY ACIDS

A 96h flow-through acute exposure study (MRID 48469801; Acceptable) with juvenile mysids ( Americamysis bahia ) is available for a 46.8% potassium salts of fatty acids formulation. Twenty mysids per level were exposed to m ean-measured concentrations of 0 (control), 0.081, <0.034, 0.31, 1.1 and 2.2 mg a.i./L. Two and three my sids died in the control group and the lowest test level, respectivel y, and two died at the third high est test level, considering the naturally occurring variability in mortality, the re viewer agrees the mysids that died were not treatment-related. Mysids were normal in all other test levels. The LC 50 is >2.2 mg a.i./L. The NOAEC is 2.2 mg a.i./L, the highe st test level tested. The EC 50 is not available since data on sublethal effects were not available.

A 96h flow-through acute exposure study (M RID 48608707; Acceptable) with young adult mysids ( Americamysis bahia ) is available for a 50.8% potassium salts of fatty acids formulation. Twenty mysids per level were exposed to mean -measured concentrations of 0 (control), <0.059, 0.17, 0.9, 1.6 and 5.0 mg a.i./L. One mysid died at the lowest level and 100% mortality was observed in the two highest test le vels at test termination. The revi ewer felt that the mysid that died in the lowest level is considered naturally occurring variability and not an adverse response. The LC 50 is 1.2 mg a.i./L; the NOAEC is 0.9 mg a.i./L. The EC 50 on sublethal effects is not available since data were not available for analysis.

No acute ecological effects studies of potassium salts using mollusks were submitted.



### Estuarine/Marine Invertebrates, Chronic Effects

AMMONIUM and POTASSIUM SALTS OF FATTY ACIDS

No chronic ecological effects studies of ammoni um and potassium salts using estuarine/marine invertebrates were submitted.



### Effects to Aquatic Vascular and Non-vascular Plants

Potassium salts studies were submitted for a freshwater vascular plant (duckweed, Lemna gibba ) and four phytoplanktonic nonvascular plants: a green algae ( Pseudokirchneriella subcapitata ), a cyanobacteria ( Anabaena flos-aquae ), a freshwater diatom ( Navicula pelliculosa ) and a marine alga ( Skeletonema costatum ). Duckweed and P. subcapitata were the only plants tested for ammonium salts, the effects to the three other phytoplanktonic nonva scular plants listed above exposed to ammonium salts are unknown. In each of these studi es, because the salts rapidly82 degrade by metabolism, no salts were detected at the end of the studies. However, based on the Pesticide Reregistration Rejection Rate Analys is (USEPA 1994), under such a circumstance, analysis is based on the initial measured concentrations.

Aquatic plant toxicity studies us ing the typical end-use products were submitted to establish the toxicity of potassium and ammonium salts to vasc ular and non-vascular sp ecies. Results of the studies with the ammonium and potassium salts fo rmulated products to aquatic plants indicate nonvascular plants were mo re sensitive than vascular plants to salts. EC 50 values of 200 and 6.6 for ammonium salts and of >5.0 and 0.59 mg a.i./L for potassium salts ( Table C.6 ) were used to evaluate potential effects of the salts to non-listed aquatic vascular and non-vascular plants, respectively. Corresponding NOAEC values of 15 a nd 2.9 mg a.i./L for ammonium salts and of 0.3 and 0.39 mg a.i./L for potassium salts were used to evaluate potential e ffects of the salts to listed aquatic vascular and nonva scular plants, respectively.

Table C.6. Aquatic Plant Toxicity with Soap Salts (Ammonium and Potassium). Species % a.i. EC 50 (mg a.i./L) NOAEC (mg a.i./L) MRID No. Author/Year Study Classification

AMMONIUM SALTS OF FATTY ACIDS

Vascular Plants

Duckweed Lemna gibba 21.9 200 A 30 48402206 Softcheck. (2011) Acceptable

Non-Vascular Plants

Marine diatom Skeletonema costatum -- -- -- No data --
Freshwater blue-green algae Anabaena flos-aquae -- -- -- No data --

Freshwater diatom Navicula pelliculosa -- -- -- No data -- Freshwater green algae

Pseudokirchneriella subcapitata 21.9 6.6 B 2.9 48402207 Softcheck. (2011) Acceptable

POTASSIUM SALTS OF FATTY ACIDS

Vascular Plants

Duckweed Lemna gibba 46.8 >19 19 48469803 Softcheck. (2011) Acceptable

50.8 >5.0 5.0 48608702 Softcheck. (2011) Acceptable

Non-Vascular Plants

Marine diatom Skeletonema costatum 50.8 8.1 C 1.2 48608705 Softcheck. (2011) Acceptable

Freshwater blue-green algae Anabaena flos-aquae 50.8 5.4 D 2.6 48636501 Softcheck. (2011) Acceptable

Freshwater diatom Navicula pelliculosa 50.8 0.59 E 0.39 48608701 Acceptable83 Table C.6. Aquatic Plant Toxicity with Soap Salts (Ammonium and Potassium). Species % a.i. EC 50 (mg a.i./L) NOAEC (mg a.i./L) MRID No. Author/Year Study Classification Softcheck. (2011)

Freshwater green algae

Pseudokirchneriella subcapitata 50.8 0.86 F 0.63 48608706 Softcheck. (2011) Acceptable

46.8 2.9 G 1.2 48402303 Softcheck. (2011) Acceptable

A Duckweed 95% Confidence Interval (C.I.) = 170-240 mg a.i./L

B Freshwater green algae 95% C.I. = 5.3-8.2 mg a.i./L

C Marine diatom 95% C.I. = 6.4-10 mg a.i./L

D Blue-green algae 95% C.I. = 4.8-5.9 mg a.i./L

E Freshwater diatom 95% C.I. = 0.43-0.82 mg a.i./L

F Green algae 95% C.I. = 0.46-1.6 mg a.i./L

G Green algae 95% C.I. = 1.2-3.2 mg a.i./L

AMMONIUM SALTS OF FATTY ACIDS

In a 7-day static-renewal toxicity stu dy, the aquatic vascular plant duckweed ( Lemna gibba ) was exposed to a 21.9% ammonium salts of fatty acids formulation (MRID 48402206; Acceptable). Measured concentrations at Day 0 ranged from 110 to 120% of nomi nal and by Day 3 dropped below the level of quantitati on in the three lowest levels ; thus, the initial-measured concentrations of 0 (control), 4.3, 11, 30, 68, 170, 430 and 1100 mg a.i./L were used in the calculations. All endpoints were affected with frond density the most sensitive endpoint, with EC 50 and NOAEC values of 200 and 30 mg a.i./L, re spectively. The % growth inhibition of frond density in the treated culture as compared to the control ranged from -6 to 96%. Smaller frond size, less root formation, curled and ch lorotic fronds were observed in the ≥ 170 mg a.i./L treatment levels.

In a 96-hour static toxicity study, the green algae Pseudokirchneriella subcapitata was exposed to a 21.9% ammonium salts of fatty acids formulation (MRID 48402207; Acceptable). Measured concentrations at Day 0 ranged from 100 – 123% of nominal a nd by test termination dropped below the level of quantitation in all test levels; thus, the initial-measured concentrations of 0 (control), 1.6, 2.9, 5.3, 10 and 20 mg a.i./L were used in the calculations. Cell density was the most sensitive endpoint, with 96-hour EC 50 and NOAEC values of 6.6 and 2.9 mg a.i./L, respectively. The % growth inhibi tion of cell density in the treated culture as compared to the control ranged from -1 to 87%. No signs of inju ry occurred and the cells were observed to be normal throughout the test.

No ecological effects studies of ammonium salts using the three remaining phytoplanktonic nonvascular plants (freshwater and marine di atom and blue-green algae) were submitted.

POTASSIUM SALTS OF FATTY ACIDS

In a 7-day static-renewal toxicity stu dy, the aquatic vascular plant duckweed ( Lemna gibba ) was exposed to a 46.8% potassium salts of fatty acids formulation (MRID 48469803; Acceptable).84 Measured concentrations at Day 0 ranged from 90 to 100% of nominal and by Day 7 dropped below the level of quantitation in all test levels ; thus, the initial-measured concentrations of 0 (control), 1.2, 2.5, 4.5, 9.7 and 19 mg a.i./L were us ed in the calculations. None of the endpoints inhibited 50% or more, with EC 50 and NOAEC values all >19 and 19 mg a.i./L, respectively. The % growth inhibition of frond dens ity in the treated culture as compared to the control ranged from -2 to 6%. Fronds were observed to be normal in all test levels.

In a 7-day static-renewal toxicity stu dy, the aquatic vascular plant duckweed ( Lemna gibba ) was exposed to a 50.8% potassium salts of fatty acids formulation (MRID 48608702; Acceptable). Measured concentrations at Day 0 ranged fr om 98-100% of nominal and by Day 7 dropped below the level of quantitation in all test levels ; thus, the initial-measured concentrations of 0 (control), 0.3, 0.63, 1.2, 2.5 and 5.0 mg a.i./L were us ed in the calculation s. None of the frond density, biomass or growth rate were inhib ited 50% or more in the test, with an EC 50 value of >5.0 mg a.i./L for all endpoints. A statistically significance difference in frond density and dry frond weight was observed in all test levels when compared to the control group, making the NOAEC below the lowest test concentration tested (<0.3 mg a.i./L). However, a closer look at the statistical results indicated the control group outperforme d the data of all treatment groups when compared which explains why the NOAEC could not be determined with significant differences at all test levels, while results wi thin the treatment groups were not statistically significant among treatment levels when compare d. If a graph was plotte d with inhibition the highest in the middle and lowest at the lowest and highest test concen trations, a shallow bellshaped dose-response curve would be observed rather than a monotonically decreasing dose response curve. Therefore, it was determined by th e reviewer that the st atistically significance differences were not biologically significant and that none of the endpoints were affected. Fronds were observed to be norma l in all test levels.

In a 96-hour static toxicity study, the marine diatom Skeletonema costatum was exposed to a 50.8% potassium salts of fatty acids formul ation (MRID 48608705; Acceptable). Measured concentrations at Day 0 ranged from 76-99% of nominal and by test termination dropped below the level of quantitation in all test levels; thus, the initial-measured concen trations of 0 (control), 0.62, 1.2, 1.9, 4.4 and 8.8 mg a.i./L were used in the calculations. Biomass was the most sensitive endpoint, with 96-hour EC 50 and NOAEC values of 8.1 and 1.2 mg a.i./L, respectively. The % growth inhibition of bioma ss in the treated culture as comp ared to the control ranged from 3 to 53%. No signs of injury occurred and the cells were observed to be normal throughout the

test.

In a 96-hour static toxicity study, the freshwater blue-green algae Anabaena flos-aquae was exposed to a 50.8% potassium salts of fatty acids formulation (MRI D 48636501; Acceptable). Measured concentrations at Day 0 ranged from 100-104% of nominal an d by test termination dropped below the level of quantitation in all test levels; thus, the initial-measured concentrations of 0 (control), 0.63, 1.3, 2.6, 5.0 and 10 mg a.i./L were used in the calculations. Biomass was the most sensitive endpoint, with 96-hour EC 50 and NOAEC values of 5.4 and 2.6 mg a.i./L, respectively. The % growth inhi bition of biomass in the treated culture as compared to the control ranged from -4 to 93%. No signs of inju ry occurred and the cells were observed to be normal throughout the test.

In a 96-hour static toxicity study, the freshwater diatom Navicula pelliculosa was exposed to a 50.8% potassium salts of fatty acids formul ation (MRID 48608701; Acceptable). Measured85 concentrations at Day 0 ranged from 84-100% of nominal and by test termination dropped below the level of quantitation in all test levels; thus, the initial-measured concen trations of 0 (control), 0.084, 0.18, 0.39, 0.79 and 1.6 mg a.i./L were used in the calculations. Cell density was the most sensitive endpoint, with 96-hour EC 50 and NOAEC values of 0.59 and 0.39 mg a.i./L, respectively. The % growth inhibi tion of cell density in the treated culture as compared to the control ranged from -27 to 98%. No signs of inju ry occurred and the cells were observed to be normal throughout the test.

In a 96-hour static toxicity study, the freshwater green algae Pseudokirchneriella subcapitata was exposed to a 50.8% potassium salts of fatty acids formulation (MRID 48608706; Acceptable). Measured concentrations at Da y 0 ranged from 93.8-100% of nominal and by test termination dropped below the level of quantitati on in all test levels except the highest concentration; thus, the initial-measured c oncentrations of 0 (c ontrol), 0.1, 0.26, 0.63, 1.5, 3.8 and 9.5 mg a.i./L were used in the calculations. Cell density was the most sensitive endpoint, with 96-hour EC 50 and NOAEC values of 0.86 and 0.63 mg a.i./L, respectively. The % growth inhibition of cell density in the tr eated culture as compared to th e control ranged from -4 to 98%. No signs of injury occurred and the cells we re observed to be normal throughout the test.

In a 96-hour static toxicity st udy, the freshwater green algae Pseudokirchneriella subcapitata was exposed to a 46.8% potassium salts of fatty acids formulation (MRID 48402303; Acceptable). Measured concentrations at Da y 0 ranged from 92.3-100% of nominal and by test termination dropped below the level of quantitation in the lowest test level while the remaining test levels were 1.5 – 5.8% of no minal; thus, the initial-measured concentrations of 0 (control), 0.6, 1.2, 2.4, 4.7 and 10 mg a.i./L were used in the calculations. Biomass wa s the most sensitive endpoint, with 96-hour EC 50 and NOAEC values of 2.0 and 0.6 mg a.i./L, respectively. The % growth inhibition of biomass in the treated cultur e as compared to the co ntrol ranged from 27 to 98%. No signs of injury occurr ed and the cells were observed to be normal throughout the test.



### Birds, Acute Oral

Acute avian oral toxicity studies using the typi cal end-use products were submitted to establish the acute toxicity of salts to birds via the oral route ( Table C.7 ). No acute oral data on passerine birds for potassium salts and on any bird specie s for ammonium salts were available, bridging data from other salts ar e used as a surrogate.86 Table C.7. Avian Acute Oral Toxicity wi th Soap Salts (Ammonium and Potassium). Species % a.i. Nominal
LD 50 (mg a.i./kg bw) Toxicity Category MRID No. Author/Year Study Classification

AMMONIUM SALTS OF FATTY ACIDS

Passerine bird n/a n/a n/a No data n/a

Northern bobwhite quail or mallard duck n/a n/a n/a No data n/a

POTASSIUM SALTS OF FATTY ACIDS

Passerine bird n/a n/a n/a No data n/a

Mallard duck ( Anas platyrhynchos ) 50 >2500 A Practically nontoxic 00030861
Hunsaker. 1979. Supplemental 1

50.5 >2000 A Practically nontoxic 00096639
Fink et al. 1981. Acceptable

Northern bobwhite quail (Colinus virginianus) Not reported >2250 mg formulation/ kg bw Could not be determined 40053301
Grimes & Jaber. 1987. Supplemental 2

25 >2000 A Practically nontoxic 40066202
Hiken & Jaber. 1987. Acceptable

60 >1350 No effects up to 1350 mg a.i./kg bw 0157471
Beavers. 1986. Supplemental 3

49 >2450 A Practically nontoxic 44980310 Stadens-peek & Leopold 1996. Acceptable

A The LD 50 was greater than the highest concen tration; therefore, it was not possibl e to calculate a probit slope and 95% confidence intervals.

1 Not enough of the birds tested at the 5000 mg/kg bw dose level were the proper age. There was no mention of the pretest condition of the duck s or the climatic conditions of the test chambe r if indoors or the atmospheric conditions if outdoors.

2 The purity of the active ingredient in the formulation was not reported; it was not possible to convert to mg active ingredient/kg bw.

3 The concentrations used (when adjusted for active ingredient) did not produce a precise LD50 and the highest concentration was below 2000 mg a.i./kg bw.

AMMONIUM SALTS OF FATTY ACIDS

No ecological effects studies of ammonium salts using an upland game bird or waterfowl and a passerine bird were submitted.

POTASSIUM SALTS OF FATTY ACIDS

The acute oral toxicity of a 50.5% potassium salts of fatty acids formulation (MRID 00030861; Supplemental) to juvenile and young mallard ducks ( Anas platyrhynchos ) was assessed over 4887 hours and held for an additional 5 days for post-observation. The formulation was administered in corn oil to a total of 31 duc ks comprising two groups of diffe ring ages per treatment level by gavage at nominal concentrations of 0 (cont rol) and 500 mg a.i./kg bw. No mortality was observed in the controls or at the limit dose. Following the completion of the study, an additional dose at 2500 mg a.i./kg bw using ducks from th e previous study were subsequently added to observe for any mortality at the higher dose. As a result, none of the juvenile or young ducks died at 500 or 2500 mg a.i./kg bw. Raw data were not available to verify the author’s conclusions on sublethal effects; however, th e author reported there were no externally observable effects on the behavior or physiology of ducks, including no decline in vigor or in food and water intake. The young ducks were able to reproduce, lay eggs, and engage in normal adult preening behavior. The 48-hours acute oral LD 50 is >2500 mg a.i/kg bw based on a lack of mortality and sub-lethal effects.

The acute oral toxicity of a 50.5% potassium salts of fatty acids formulation (MRID 00096639; Supplemental) to 6-month old mallard ducks ( Anas platyrhynchos ) was assessed over 14 days. The formulation was administered to ducks per treatment level by gavage at nominal concentrations of 0 (control), 201, 319, 505, 803 a nd 1268 mg a.i./kg bw (corrected for purity) and a second trail conducted at 2000 mg a.i./kg bw . No mortality was observed in the controls or in the treatment groups. Overa ll percent body weight change dur ing the 14-day exposure period averaged 1.9% in the control and 2.4, 1.0, 1.8, 4.5 and 6% in the nominal 201, 319, 505, 803 and 1268 mg a.i./kg bw treatment groups, respectively. In the 2 nd study with the nominal 2,000 mg a.i./kg bw treatment group, overall % body weight ch ange averaged 0% as compared to 3% in the vehicle control. The mean food consum ption in the control and nominal 201, 319, 505, 803 and 1268 mg a.i./kg bw treatment groups during 1-7 day period was 91 g in the control and 101, 81, 94, 112 and 100 g in the treatment groups, respectively, yielding inhibitions of -10, 11, -3, - 23 and -10%, respectively. During the 8-14 day pe riod, mean food consumption in the control was 96 g and 88, 104, 105, 106 and 103 g in the treatm ent groups, yielding inhibitions of 8, -8, - 9, -10 and -7%. In the 2 nd study with the nominal 2,000 mg a.i./kg bw treatment group, mean food consumption was inhibited 24% during the 1-7 day period and -12% during the 8-14 day period when compared to control. The 14-day acute oral LD 50 is >2000 mg a.i./kg bw based on a lack of mortality and sub-lethal effects.

The acute oral toxicity of a potassium sa lts of fatty acids formulation (MRID 40053301; Supplemental) to 26-week old bobwhite quails ( Colinus virginianus ) was assessed over 14 days. The formulation was administered to birds per treatment level by gavage at nominal concentrations of 0 (control) 292, 486, 810, 1350 and 2250 mg formulation/kg bw (% a.i. not reported, values not corrected for purity). No mort ality was observed in th e controls or in the treatment groups. Overall percent body weight ch ange for both males and females during the 14- day test period average 7% in the control a nd 6, 5, 5, 6 and 6% in the nominal 292, 486, 810, 1350 and 2250 mg formulation/kg bw treatment groups, respectively. The mean food consumption in the control and nominal 292, 486, 810, 1350 and 2250 mg formulation/kg bw treatment groups during the1-7 day period was 45 g in the control and 67, 55, 50, 43 and 35 g in the treatment groups, respectivel y, yielding inhibitions of -33, -22, -11, 4 and 22%, respectively. During the 8-14 day test period, mean food c onsumption in the control and nominal 292, 486, 810, 1350 and 2250 mg formulation/kg bw treatment groups was 45 g in the control and 51, 46, 47, 37 and 33 g in the treatment groups, respectivel y, yielding inhibitions of -13, -2, -4, 18 and 27%. The 14-day acute oral LD 50 is >2250 mg formulation/kg bw (not corrected for purity) based on a lack of mortality and sub-lethal effects.88 The acute oral toxicity of a 25% potassium salts of fatty acids formulation (MRID 40066202; Acceptable) to 31-week old bobwhite quails ( Colinus virginianus ) was assessed over 14 days. The formulation was administered to birds per treatment level by gavage at nominal concentrations of 0 (control), 500, 1000 and 2000 mg a.i./kg bw. No mortality was observed in the controls or in th e treatment groups. Overall percent body weight change for both males and females during the 14-day test period average 10% in the control and 8, 9 and 8% in the nominal 500, 1000 and 2000 mg a.i./kg bw treatment groups, respectively. The mean food consumption in the control and nominal 500, 1000 and 2000 mg a. i./kg bw treatment groups during the1-7 day period was 42 g in the control and 43, 37 and 45 g in the treatment groups, respectively, yielding inhibitions of -2, 12 and -7%, respectively. During the 8-14 day test period, mean food consumption in the control and nominal 500, 1000 and 2000 mg a.i./kg bw treatment groups was 33 g in the control and 38, 30 a nd 46 g in the treatment groups, re spectively, yielding inhibitions of -15, 9 and -40%. The 14-day acute oral LD 50 is >2000 mg a.i./kg bw based on a lack of mortality and sub-lethal effects.

The acute oral toxicity of a 60% potassium salts of fatty acids formulation (MRID 00157471; Supplemental) to 22-week old bobwhite quails ( Colinus virginianus ) was assessed over 14 days. The formulation was administered to birds per treatment level by gavage at nominal concentrations of 0 (control), 175, 292, 486, 810 a nd 1350 mg a.i./kg bw (corrected for purity). No mortality was observed in the controls or in the treatment groups. Overall percent body weight change for both males and females duri ng the 14-day test period average 7% in the control and 7, 8, 7, 9 and 5% in the no minal 175, 292, 486, 810 and 1350 mg a.i./kg bw treatment groups, respectively. Th e mean food consumption in the control and nominal 175, 292, 486, 810 and 1350 mg a.i./kg bw treatment groups during the1-7 day period was 58 g in the control and 59, 60, 52, 57 and 56 g in the treatment groups, respectively, yielding inhibitions of - 2, -3, 10, 2 and 3%, respectively. Du ring the 8-14 day test period, mean food consumption in the control and nominal 175, 292, 486, 810 and 1350 mg a. i./kg bw treatment groups was 48 g in the control and 47, 49, 43, 51 and 49 g in the treatment groups, respectively, yielding inhibitions of 2, 8, 10, -6 and -2%. The 14-day acute oral LD 50 is >1350 mg a.i./kg bw based on a lack of mortality and sub-lethal effects.

The acute oral toxicity of a 49% potassium salts of fatty acids formulation (MRID 44980310; Acceptable) to 21-week old bobwhite quail ( Colinus virginianus ) was assessed over 15 days. The formulation was administered to birds per the limit dose by gavage at a nominal concentration of 2450 mg a.i./kg bw (corrected for purity). No mort ality was observed in th e controls or in the limit dose. Overall percent body weight change for both males and females during the 15-day test period average 3% in the control and 4% in the nominal 2450 mg a.i./kg bw treatment group. The mean food consumption in the control and nominal 2450 mg a.i./kg bw treatment group during the1-8 day period was 15 g in the cont rol and 15 g in the treatment group, yielding an inhibition of 0%. During the 8-15 day test peri od, mean food consumption in the control and nominal 2450 mg a.i./kg bw treat ment group was 14 g in the control and 15 g in the treatment group, yielding an increase of 7%. The 15-day acute oral LD 50 is >2450 mg a.i./kg bw based on a lack of mortality and sub-lethal effects.

No ecological effects studies of potassium salts using a passerine bird were submitted.89 

### Birds, Subacute Dietary

Subacute avian dietary toxicity studies using the typical end- use products were submitted to establish the acute toxicity of salts to birds via the dietary route ( Table C.8 ). No acute dietary data on a waterfowl for ammonium salts were available, bridging da ta from other salts are used as a surrogate.90 Table C.8. Avian Acute Dietary Toxicity with Soap Salts (Ammonium and Potassium). Species % a.i. Nominal LC 50 (mg a.i./kg diet) Toxicity Category MRID No. Author/Year Study Classification

AMMONIUM SALTS OF FATTY ACIDS

Mallard duck ( Anas platyrhynchos ) n/a n/a n/a No data n/a

Japanese quail (Coturnix japonica) 22 >1,100 No effects up to 1,100 mg a.i./kg diet 46206301
Bien. 2003. Acceptable

POTASSIUM SALTS OF FATTY ACIDS

Mallard duck ( Anas platyrhynchos ) Not report

ed >10,000 mg formulation/kg diet Could not be determined 00105040
Beavers & Fink. 1981. Supplemental 1

60 >3,372 No effects up to 3,372 mg a.i./kg diet 40385601
Johnson & Jaber. 1987. Acceptable

49 >2,450 No effects up to 2,450 mg a.i./kg diet 44980312 Leopold. 1997. Acceptable

25 >1,405 No effects up to 1,405 mg a.i./kg diet 40053303
Grimes & Jaber. 1986. Supplemental

25 >5620 Practically nontoxic 40066204
Grimes & Jaber. 1987. Acceptable

50 >2,642 No effects up to 2,642 mg a.i./kg diet 00030862
Condrashoff. 1979. Supplemental

Northern bobwhite quail

(Colinus virginianus) 60 >3372 No effects up to 3372 mg a.i./kg diet 00157472
Beavers. 1986. Acceptable

25 >1,405 No effects up to 1,405 mg a.i./kg diet 40053302
Grimes & Jaber. 1986. Supplemental

Not report

ed >10,000 mg formulation/kg diet Could not be determined 00096640
Beavers & Fink. 1981. Supplemental 1

25 >5620 Practically nontoxic 40066203
Grimes et al. 1987. Acceptable

50 >2,642 No effects up to 2,642 mg a.i./kg diet 00030863
Condrashoff. 1979. Supplemental

49 >2450 A No effects up to 2,450 mg a.i./kg diet 44980311 Leopold. 1997. Acceptable

A The LD 50 was greater than the highest concen tration; therefore, it was not possibl e to calculate a probit slope and 95% confidence intervals.

1 The % of the active ingredient in the formulation was not reported; thus, it was not possible to correct the toxicity value to the active ingredient.91 AMMONIUM SALTS OF FATTY ACIDS

In an 8-day acute dietary toxicity study, the 8-day old Japanese quail ( Coturnix japonica ) was exposed to a 22% ammonium salts of fatty acids formulation (MRID 46206301; Acceptable). The formulation was administered to the birds in th e diet at nominal concen trations of 0 (control) and 1,100 mg a.i./L (corrected for purity). No mortalities were observed. Percent body weight change during the 5-day exposure period averag ed 40.7% in the control and 38.3% in the 1,100 mg a.i./kg diet treatment group yielding an inhibition of 5.8%. Pe rcent body weight gain during the 3-day observation period (d ays 6-8) averaged 15.9% in the control and 18.6% in the treatment group yielding an incr ease of 17%. The overall % body we ight gain was 50.2% in the control and 49.8% in the treatment group. The mean food consumption in the control and treatment group during the exposure period (days 0-5) was 134 and 123 g, respectively, yielding an inhibition of 8.2% and mean food consumpti on in the control and treatment group during the observation period was 178 and 169 g, respectivel y, yielding an inhibition of 5.1%. The 8-day LC 50 is >1,100 mg a.i./kg diet (corrected for purity) based on a lack of mortality and sub-lethal effects.

POTASSIUM SALTS OF FATTY ACIDS

In an 8-day acute dietary toxicity study, the 14-day old mallard duck ( Anas platyrhynchos ) was exposed to a potassium salts of fatty acids formulation (MRID 00105040; Supplemental). The formulation was administered to the birds in the diet at nominal concentrations of 0 (vehicle control), 562, 1000, 1780, 3160 and 5620 mg formulati on/kg diet and a sec ond trail conducted at 10,000 mg formulation/kg diet (% a.i. not repor ted, values not corrected for purity). No mortalities or behavioral abnormalities were obs erved. Percent body weight change during the 5- day exposure period averaged 46% in th e control and 47.1, 46.7, 48.1, 49.4 and 43.2% in the nominal 562, 1000, 1780, 3160 and 5620 mg/kg diet treatment groups, respectively, yielding inhibitions of -2.3, -1.5, -4.5, -7.3 and 6%. In the 2 nd study with the nominal 10,000 mg/kg treatment group, % body weight gain averaged 47 .4% as compared to the 44.8% gain in the vehicle control, yielding an inhibition of -5.8% . The mean food consump tion in the control and nominal 562, 1000, 1780, 3160 and 5620 mg/kg diet treatment groups during the exposure period (days 0-5) was 3965 g in the c ontrol and 4370, 3740, 4279, 3696 and 3882 g in the treatment groups, respectively, yielding inhibitio ns of -10.2, 5.7, -7.9, 6.8 and 2.1%, respectively. In the 2 nd study with the nominal 10,000 mg/kg diet treatment group, mean food consumption was 3814 g as compared to 3827 g in the vehicle control, yielding an inhibition of 0.3% The 8- day LC 50 is >10,000 mg formulation/kg diet (not corrected for pur ity) based on a lack of mortality and sub-lethal effects.

In an 8-day acute dietary toxicity study, the 10-day old mallard duck ( Anas platyrhynchos ) was exposed to a 60% potassium salts of fatty acids formulation (MRID 40385601; Acceptable). The formulation was administered to the birds in the diet at nominal concentrations of 0 (vehicle control), 337.2, 600, 1068, 1896 and 3372 mg a.i./kg diet (corrected for purity). No mortality or behavioral abnormalities were observed. Percent body weight change during the exposure period averaged 43.2% in the co ntrol and 42.1, 42.9, 40.9, 43.3 and 40.5% in the nominal 337.2, 600, 1068, 1896 and 3372 mg a.i./kg diet treatment groups , respectively, yielding inhibitions of 2.5, 0.7, 5.3, -0.2 and 6.3%. Percent body we ight gain during the observ ation period averaged 22.7% in the control and 22.7, 20.3, 20.0, 22.1 and 22.6% in the 337.2, 600, 1068, 1896 and 3372 mg a.i./kg diet treatment groups, respectively, yi elding increases of 0, -10.6, -11.9, -2.6 and -0.4%.92 The overall % body weight gain was 55.1% in the control and 55.2, 54.5, 52.8, 55.8 and 54.0% in the 337.2, 600, 1068, 1896 and 3372 mg a.i./kg di et groups, respectively. The mean food consumption in the control and nominal 337.2, 600, 1068, 1896 and 3372 mg a.i./kg diet treatment groups during the exposure period was 64 g in the control and 61, 56, 62, 60 and 53 g, respectively, yielding inhibitions of 5, 12, 3, 6 and 17%. Mean food consum ption in the control and treatment groups during the observation pe riod was 66.2 g in the control and 67, 61, 61, 71 and 65 g, respectively, yielding inhibitions of -2, 8, 8, -8 and 2%. The 8-day LC 50 is >3,372 mg a.i./kg diet (corrected for purity) based on a lack of mortality and sub-lethal effects.

In an 8-day acute dietary toxicity study, the 10-day old mallard duck ( Anas platyrhynchos ) was exposed to a 49% potassium salts of fatty acids formulation (MRID 44980312; Acceptable). The formulation was administered in the diet to 20 ducks at 2450 mg a.i./ kg diet (corrected for purity), 10 ducks were exposed to a diet without a vehicle and 10 ducks to a diet mixed with acetone. Twenty ducks were exposed to a control diet without a vehicle and twenty ducks to a diet mixed with acetone in case inhomogeneity occurred in the diets prepared without a vehicle. No mortality or behavioral abnormalities were observed. Percent body weight change during the exposure period averaged 42.6% in the control and 41.7% in the nominal 2450 mg a.i./kg diet treatment group, yielding an inhibition of 2.1%. For the groups mixed with acetone, the % body weight gain averaged 46.2% in the control and 46.3% in the limit dose level, resulting in an inhibition of -0.2%. The overall % body weight gain was 52.1% in the control a nd 51.7% in the treatment group without acetone; fo r the groups mixed with acetone, the gain was 53.9% in the control and 58.5% in the treatment group. The mean food consumption in the control and nominal 2450 mg a.i./kg diet tr eatment group during the exposure period was 35 g in the control and 38 g, yielding an inhibition of -8.6% and mean food consumption in the control and treatment groups during the observation period wa s 42 g in the control and 43 g, yielding an inhibition of -2.4%. The mean food consumption for the groups mixed with acetone during the exposure period was 40 g in the control and 37 g in the limit dose, yielding an inhibition of 7.5% and mean food consumption during the observation period was 43 g in the control and 47 g in the limit dose, yielding an inhibition of -9.3%. The 8-day LC 50 is >2450 mg a.i./kg diet (corrected for purity) based on a lack of mortality and sub-lethal effects.

In an 8-day acute dietary toxicity study, the 10-day old mallard duck ( Anas platyrhynchos ) was exposed to a 25% potassium salts of fatty acids formulation (MRID 40053303; Supplemental). The formulation was administered to the ducks in th e diet at nominal concen trations of 0 (vehicle control), 140.5, 250, 445, 790 and 1405 mg a.i./kg di et (corrected for purity). Percent body weight change during the exposure period av eraged 52% in the control and 53.6, 52.7, 51.5, 51.9 and 51.5% in the nominal 140.5, 250, 445, 790 and 1405 mg a.i./kg diet treatment groups, yielding inhibitions of -3.0, -1.3, 1.0, 0.2, 1.0%. Th e overall % body weight gain was 63.4% in the control and 65, 63.2, 63.5, 63.8 and 62.7% in the treatment groups, respectively. The mean food consumption in the c ontrol and nominal 140.5, 250, 445, 790 and 1405 mg a.i./kg diet treatment groups, respectively, during the expos ure period was 58.6 g in the control and 61, 56, 58, 61 and 54 g, respectively, yielding inhibiti ons of -4.0, 4.4, 1.0, -4.0 an d 7.8% and mean food consumption in the control and treatment groups during the observation period was 70 g in the control and 72, 65, 65, 75 and 73 g, respectively, yi elding inhibitions of -2.9, 7.1, 7.1, -7.1 and - 4.3%. The 8-day LC 50 is >1405 mg a.i./kg diet (corrected for purity) based on a lack of mortality and sub-lethal effects.

In an 8-day acute dietary toxicity study, the 10-day old mallard duck ( Anas platyrhynchos ) was93 exposed to a 25% potassium salts of fatty acids formulation (MRID 40066204; Acceptable). The formulation was administered to the birds in the diet at nominal concentrations of 0 (vehicle control), 562, 1000, 1780, 3160 and 5620 mg a.i./kg diet. No mortalit y or behavioral abnormalities were observed. Percent body weight ch ange during the exposure period averaged 45% in the control and 45, 45, 47, 47 a nd 44% in the nominal 562, 1000, 1780, 3160 and 5620 mg a.i./kg diet treatment groups , respectively, yielding inhibiti ons of -4, -2, 5, -4 and 4%. Percent body weight gain duri ng the observation period averaged 23% in the control and 23, 26, 22, 22 and 24% in the 562, 1000, 1780, 3160 and 5620 mg a.i./kg diet treatment groups, respectively, yielding increases of 4, 5, -3, 3 a nd -4%. The overall % body weight gain was 60% in the control and 57, 59, 60, 59 and 57% in the 562, 1000, 1780, 3160 and 5620 mg a.i./kg diet groups, respectively. The mean food consump tion in the control and nominal 562, 1000, 1780, 3160 and 5620 mg a.i./kg diet treatment groups during the exposure period was 69 g in the control and 63, 64, 62, 68 and 62 g, respectively, yielding inhibitions of 9, 7, 10, 1 and 10%. Mean food consumption in the control and treat ment groups during the observation period was 83 g in the control and 82, 87, 82, 79 and 78 g, resp ectively, yielding inhibitions of 1, -5, 1, 5 and 6%. The 8-day LC 50 is >5620 mg a.i./kg diet based on a lack of mortality and sub-lethal effects.

In a 5-day acute dietary toxicity study, the 14-day old mallard duck ( Anas platyrhynchos ) was exposed to a 50% potassium salts of fatty acids formulation (MRID 00030862; Supplemental). The formulation was administered to the ducks in th e diet at nominal concen trations of 0 (vehicle control) and 2,642 mg a.i./kg diet (corrected for purity). Percent body weight change during the exposure period averaged 42.7% in the control and 48.2% in the nominal 2642 mg a.i./kg diet treatment groups, yielding an inhibition of -13% . The overall % body weight gain could not be assessed since an observation peri od was not included in the test. The mean food consumption in the control and nominal 2642 mg a.i./kg diet treatment group during the exposure period was 724.9 g in the control and 781.6 g, yi elding an inhibition of -7.8% . The mean food consumption in the control and treatment gr oup during the observation period coul d not be assessed since an observation period was not include d in the test. The 8-day LC 50 is >2642 mg a.i./kg diet (corrected for purity) based on a lack of mortality and s ub-lethal effects.

In an 8-day acute dietary toxicity study, the 10-day old bobwhite quail ( Colinus virginianus ) was exposed to a 60% potassium salts of fatty acids formulation (MRID 00157472; Acceptable). The formulation was administered to the birds in the diet at nominal concentrations of 0 (vehicle control), 337, 600, 1068, 1896 and 3372 mg a.i./kg diet (corrected for purity). No mortality or behavioral abnormalities were observed. Percent body weight change during the exposure period averaged 40.4% in the co ntrol and 46.9, 45.2, 45.5, 44.8 and 45.2% in the nominal 337, 600, 1068, 1896 and 3372 mg a.i./kg diet treatment groups , respectively, yielding inhibitions of 2.4, 5.5, -0.6, 11.6 and 5.5%. Percent body weight gain during the observation period averaged 19.6% in the control and 20, 20.5, 23.3, 21.6 and 20.5% in the 337, 600, 1068, 1896 and 3372 mg a.i./kg diet treatment groups, respectivel y, yielding increases of 2.4, 4.9, -4.9, 9.8 and 4.9%. The overall % body weight gain was 52.1% in the control and 57.5, 56.4, 58.1, 56.8 and 56.4% in the 337, 600, 1068, 1896 and 3372 mg a.i./kg di et groups, respectively. The mean food consumption in the control and nominal 337, 600, 1068, 1896 and 3372 mg a.i./kg diet treatment groups during the exposure period was 9 g in the control and 13, 10, 11, 11 and 13 g, respectively, yielding inhibitions of -44, -11, - 22, -22 and -44%. Mean food consumption in the control and treatment groups during the obser vation period was 16 g in the control and 14, 10, 11, 10 and 13 g, respectively, yielding inhi bitions of 12.5, 37.5, 31.3, 37.5 and 18.8%. The 8-day LC 50 is >3,372 mg a.i./kg diet (corrected for purity) based on a lack of mortality and sub-lethal94 effects.

In an 8-day acute dietary toxicity study, the 10-day old bobwhite quail ( Colinus virginianus ) was exposed to a 25% potassium salts of fatty acids formulation (MRID 40053302; Supplemental). The formulation was administered to the birds in th e diet at nominal concen trations of 0 (vehicle control), 140.5, 250, 445, 790 and 1405 mg a.i./kg di et (corrected for purity). Percent body weight change during the exposure period av eraged 40.7% in the control and 37.9, 37, 37, 37.9 and 39.3% in the nominal 140.5, 250, 445, 790 and 1405 mg a.i./kg diet treatment groups, yielding inhibitions of -7.4, 0, 0, -7.4 and - 3.7%. Percent body weight gain during the observation period averaged 22.9% in the control and 21.6, 25, 20.6, 19.4 and 24.3% in the 140.5, 250, 445, 790 and 1405 mg a.i./kg diet treatmen t groups, respectively, yielding increases of 5.4, 2.7, -2.9, 2.7 and 5.4%. The overall % body we ight gain was 54.3% in the control and 51.4, 52.8, 50, 50 and 54.1% in the treatment groups, respectively. The mean food consumption in the control and nominal 140.5, 250, 445, 790 and 1405 mg a.i./kg diet treatment groups, respectively, during the expos ure period was 12 g in the control and 10, 11, 8, 13 and 9 g, respectively, yielding increases of -20, -9, -50, 7.7 and -33% and mean food consumption in the control and treatment groups during the obser vation period was 12 g in the control and 12, 18, 11, 20 and 12 g, respectively, yielding incr eases of 0, 33, -9, 40 and 0%. The 8-day LC 50 is >1,405 mg a.i./kg diet (corrected for purity) based on a lack of mortality and sub-lethal effects.

In an 8-day acute dietary toxicity study, the 14-day old bobwhite quail ( Colinus virginianus ) was exposed to a potassium salts of fatty acids formulation (MRID 00096640; Supplemental). The formulation was administered to the birds in the diet at nominal concentrations of 0 (vehicle control), 562, 1000, 1780, 3160 and 5620 mg formulati on/kg diet and a sec ond trail conducted at 10,000 mg formulation/kg diet (% a.i. not repor ted, values not corrected for purity). No mortalities or behavioral abnormalities were observed. Overall percent body weight change during the test averaged 43.2% in the control and 40.6, 39.4, 42.9, 38.7 and 36.1% in the nominal 562, 1000, 1780, 3160 and 5620 mg/kg diet treatment gr oups, respectively, yielding inhibitions of 13.5, 10.8, 5.4, 16.2 and 2.7%. In the 2 nd study with the nomi nal 10,000 mg/kg treatment group, overall % body weight gain averaged 44.9% as compared to the 47% gain in the vehicle control, yielding an increase of 2%. The mean food consumption in the control and nominal 562, 1000, 1780, 3160 and 5620 mg/kg diet treatment groups during the exposure period (days 0-5) was 396 g in the control and 357, 409, 361, 345 and 356 g in the treatment groups, respectively, yielding inhibitions of 10.1, -3.0, 9.1, 13.1 and 10.3%, respectively. In the 2 nd study with the nominal 10,000 mg/kg diet treatment group, mean food consumption was 406 g as compared to 376 g in the vehicle control, yielding an inhibition of -7.9% The 8-day LC 50 is >10,000 mg formulation/kg diet (not corrected for purity) base d on a lack of mortality and sub-lethal effects.

In an 8-day acute dietary toxicity study, the 10-day old bobwhite quail ( Colinus virginianus ) was exposed to a 25% potassium salts of fatty acids formulation (MRID 40066203; Acceptable). The formulation was administered to the birds in the diet at nominal concentrations of 0 (vehicle control), 140.5, 250, 445, 790 and 1405 mg a.i./kg di et (corrected for purity). Percent body weight change during the exposure period averaged 36.1% in th e control and 33.3, 36.4, 36.7, 36.4, 34.4% in the nominal 140.5, 250, 445, 790 and 1405 mg a.i./kg diet treatment groups, yielding inhibitions of 3.2, -6.5, 3.2, -6.5, and -3.2%. Percent body weight gain during the observation period averaged 21.3% in the control and 25, 21.4, 23.1, 21.4 and 22% in the 140.5, 250, 445, 790 and 1405 mg a.i./kg diet treatment gr oups, respectively, yiel ding increases of 1.5, 6.2, -1.0, 6.2 and 3.9%. The overall % body weight gain was 49.7% in the control and 50, 50,95 51.3, 50 and 48.8% in the treatment groups, respec tively. The mean food consumption in the control and nominal 140.5, 250, 445, 790 and 1405 mg a.i./kg diet treatm ent groups during the exposure period was 9.4 g in the control a nd 9, 10, 10, 10 and 11 g, respectively, yielding inhibitions of 4.3, -6.4, -6.4, -6.4 and -17% and mean food consumption in the control and treatment groups during the observation period was 15 g in the control and 12, 12, 16, 15 and 14 g, respectively, yielding inhibitions of 20, 20, -6.7, 0.0 and 6.7%. The 8-day LC 50 is >1405 mg a.i./kg diet (corrected for purity) based on a lack of mortality and sub-lethal effects.

In a 5-day acute dietary toxicity study, the 14-day old bobwhite quail ( Colinus virginianus ) was exposed to a 50% potassium salts of fatty acids formulation (MRID 00030863; Supplemental). The formulation was administered to the birds in th e diet at nominal concen trations of 0 (vehicle control) and 2,642 mg a.i./kg diet (corrected for purity). Percent body weight change during the exposure period averaged 37% in the control a nd 23% in the nominal 2642 mg a.i./kg diet treatment groups, yielding an inhibition of 25%. The overall % body weight gain could not be assessed since an observation peri od was not included in the test. The mean food consumption in the control and nominal 2642 mg a.i./kg diet treatment group during the exposure period was 317.2 g in the control and 263.3 g, yi elding an inhibition of 17%. The mean food consumption in the control and treatment group during the obser vation period could not be assessed since an observation period was not include d in the test. The 8-day LC 50 is >2642 mg a.i./kg diet (corrected for purity) based on a lack of mortality and s ub-lethal effects.

In an 8-day acute dietary toxicity study, the 14-day old bobwhite quail ( Colinus virginianus ) was exposed to a 50% potassium salts of fatty acids formulation (MRID 44980311; Acceptable). The formulation was administered to the birds in the diet at nominal concentrations of 0 (vehicle control) and 2,450 mg a.i./kg diet (corrected for purity). Percent body weight change during the exposure period averaged 33.8% in the control and 33% in the nominal 2450 mg a.i./kg diet treatment group, yielding an inhibition of 2.6%. Percent body weight gain during the observation period averaged 16.5% in the control and 20.8% in the limit dose, yielding an increase of 1.4%. The overall % body weight gain was 44.7% in the control and 46.9% in the limit dose. The mean food consumption in the contro l and nominal 2450 mg a.i./kg diet treatment group during the exposure period was 8 g in the control and 8 g in the treatment group, yielding an inhibition of 0%. The mean food consumption in the cont rol and treatment group during the observation period was 9 g in the control and 9 g in the tr eatment group, yielding an inhibition of 0%. The 8- day LC 50 is >2450 mg a.i./kg diet (corrected for pu rity) based on a lack of mortality and sublethal effects.



### Birds, Reproduction

AMMONIUM and POTASSIUM SALTS OF FATTY ACIDS

No chronic ecological effects studies of amm onium and potassium salts using birds were submitted. The Agency is not asking for the ecological studies due to the lack of effects at high rates in acute avian studies and the salts undergo rapid degradati on via metabolism in less than a day.



### Mammals, Acute Oral and Reproduction96 In most cases, rat or mouse toxicity values are obtained from the Agency's Health Effects Division (HED) for EFED’s ecological risk asse ssment to evaluate the potential risk to mammalians. In an August 29, 2012 memorandum (D399690), HED has reported the toxicology database for soap salts is adequate to suppor t reregistration eligibility. HED has waived all generic mammalian toxicity data requirements for so ap salts due to the l ack of effects at high doses in the available studies of other fatty acid salts, the nature of the chemicals (fatty acids) and their ubiquity in nature, and the limited potential for human e xposure via the oral route from established uses. With no systemic toxicity observed, HED did not sele ct endpoints for human health risk assessment and waived all mammalian toxicity data; thus, th e ecological effects to mammals are anticipated to be minimal.



### Beneficial Insects, Acute

Honeybee acute contact studies were submitted for soap salts because of its wide-ranging uses that will result in honeybee exposure ( Table III.21 ). The acute contact LD 50 , using the honey bee, Apis mellifera , is derived from a laboratory study de signed to estimate the quantity of toxicant required to cause 50% mortality in a test population of bees. Results of the acute contact studies with honeybees indicate the formulated produc ts of soap salts are practically non-toxic to bees on a contact exposure basis. The availabl e honeybee acute contact and oral studies are summarized in C.9

.

Table C.9. Acute Contact and Oral Toxicity of Ammonium and Potassium Salts to Honeybees

Species % a.i. Nominal
LD 50 /LC 50 * (μg a.i./bee) Toxicity Category MRID No. Study Classification

AMMONIUM SALTS OF FATTY ACIDS

Honey bee ( Apis mellifera ) 13.1 >262 (contact) Practically nontoxic 42806407 Ward et al

. 1993. Acceptable

22 >100 (contact) Practically nontoxic 44766401 Nengel. 1998. Acceptable

>108.94 (oral) Not categorized Supplemental †

POTASSIUM SALTS OF FATTY ACIDS

Honey bee 52.8 >13 (contact) Practically nontoxic 42806001 Hoxter and Bernard. 1993. Acceptable

19.9 >5 (contact) No significant effects up to 5

μg a.i./bee 43042801

Palmer and Beavers. 1993. Acceptable

40 >10 (contact) No significant effects up to 10 μg a.i./bee 43173604 Palmer and Beavers. 1993. Acceptable97 Table C.9. Acute Contact and Oral Toxicity of Ammonium and Potassium Salts to Honeybees

50.5 >100 (contact) Practically nontoxic 45060901
Schur. 1999. Acceptable

>96.04 (oral) Not categorized Supplemental †

† Acute oral - a non-guideline study * The LD 50 s/LC 50 s were greater than the highest concentration; therefore, it was not possible to calculate a probit slope and 95% confidence intervals.

AMMONIUM SALTS OF FATTY ACIDS

The acute contact toxicity of a 13.1% a mmonium salt formulated product (MRID 42806407; Acceptable) to honey bees ( Apis mellifera ) was tested in the labor atory. In the 48-hour acute contact test, bees were exposed to the formulatio n administered topically to the thorax, at an application rate of 0 (contr ol), 16.4, 32.8, 65.5, 131 and 262 μg a.i./bee. Lethargy was the only reported sub-lethal effect and was only observed in the two highest doses. At 48 hours, 10.4% of surviving bees in the 131 μg a.i. /bee treatment group were lethargi c. At 4 hours, one bee of the surviving 49 bees in the 262 μg a.i./bee treatment group was lethargic, and at 48 hours the number of lethargic bees in creased to 14%. Mortality was 2, 6, 6, 4 and 30% in the 16.4, 32.8, 65.5, 131 and 262 μg a.i./bee treatment groups, re spectively. The 48-hour acute contact LD 50 was >262 μg a.i./bee and the NOAEL was 65.5 μg a.i./bee, based on su b-lethal effects.

The acute contact and oral toxicity of a 22% ammonium salt formulated product (MRID 44766401; Acceptable (contact), Supplemental (oral) ) to honey bees were tested in the laboratory. In the 48- hour acute contact test, bees were exposed to the formulation administered topically to the thorax, at an application rate of 0 (control) , 6.25, 12.5, 25, 50 and 100 μg a.i./bee, while in the oral test, bees were exposed to the formulation by fe eding at an intake rate of 7.36, 13.56, 29.11, 59.21 and 108.94 μg a.i./bee. In the cont act test, no sub-lethal effects were observed in the control or in th e treatment groups. Mortality was 0% in the control and nominal 6.25, 12.5 and 25 μg a.i./bee treatment groups and 8 and 14% in the nominal 50 and 100 μg a.i./bee treatment groups, respectiv ely. The resulting contact NOAEL and LD 50 values were 50 and >100 μg a.i./bee, respectively. In the oral te st, no sub-lethal effect s were observed in the control or treatment groups. At the highest dose of 108.94 μg a.i./bee, only 4% of the bee died. The resulting oral NOAEC and LC 50 values were 108.94 and >108.94 μg a.i./bee, respectively.

POTASSIUM SALTS OF FATTY ACIDS

The acute contact toxicity of a 52.8% pot assium salt formulated product (MRID 42806001; Acceptable) to honey bees ( Apis mellifera ) was tested in the labor atory. In the 48-hour acute contact test, bees were exposed to the formulatio n administered topically to the thorax, at an application rate of 0 (nega tive and solvent controls), 0.8, 1.6, 3.3, 6.6 and 13 μg a.i./bee. Immobility was observed in one bee in the nomin al 0.8 μg a.i./bee treatment group and in two bees in each of the 1.6 and 13 μg a.i./bee treatm ent groups the first 2 hou rs following application of the formulation. No sub-lethal effects were observed. Mortality was 0% in the controls and nominal 0.8, 3.3 and 6.6 μg a.i./bee treatment groups and 4% in the nominal 1.6 ad 13 μg a.i./bee treatment groups, yielding 48-hour acute contact LD 50 and NOAEL values of >13 and 13 μg a.i./bee, respectively.98 The acute contact toxicity of a 19.9% pot assium salt formulated product (MRID 43042801; Acceptable) to honey bees ( Apis mellifera ) was tested in the labor atory. In the 48-hour acute contact test, bees were exposed to the formulatio n administered topically to the thorax, at an application rate of 0 (nega tive and solvent controls), 0.3, 0.6, 1.3, 2.5 and 5 μg a.i./bee. No mortality was observed in the nega tive control and solv ent control groups. Four bees appeared lethargic on day 0 in the negative control gr oup, all other control b ees appeared normal throughout the test. Mortality in the treatment groups ranged between 0 and 4%. On day 0, one bee was lethargic in the highest dose. All surviving bees were nor mal in appearance and behavior throughout the test. The 48-hour acute contact LD 50 and NOAEL values were >5 and 5 μg a.i./bee, respectively, based on lack of mortality and sub-lethal effects.

The acute contact toxicity of a 40% pota ssium salt formulated product (MRID 43173604; Acceptable) to honey bees ( Apis mellifera ) was tested in the labor atory. In the 48-hour acute contact test, bees were exposed to the formulatio n administered topically to the thorax, at an application rate of 0 (negativ e and solvent controls), 0.6, 1.2, 2.5, 5 and 10 μg a.i./bee. None of the bees died in the negative control group; howev er, 6% mortality was observed in the solvent control group. Mortality in th e treatment groups ranged betwee n 0 and 4%. The 48-hour acute
contact LD 50 and NOAEL values were >10 and 10 μg a.i./bee, respectively, based on lack of mortality and sub-lethal effects.

The acute contact and oral toxicity of a 50.5% potassium salt formulated product (MRID 45060901; Acceptable (contact), Supplemental (oral) ) to honey bees were tested in the laboratory. In the 48- hour acute contact test, bees were exposed to the formulation administered topically to the thorax, at an application rate of 0 (control) , 6.25, 12.5, 25, 50 and 100 μg a.i./bee, while in the oral test, bees were exposed to the formulation by f eeding at an intake rate of 6.15, 10.7, 24.32, 48.72 and 96.04 μg a.i./bee. In the contact te st, mortality was 0% in the control and nominal 6.25, 12.5, 25 and 50 μg a.i./bee treatmen t groups and 10% in the nominal 100 μg a.i./bee treatment group. The resulting contact NOAEL and LD 50 values were 50 and >100 μg a.i./bee, respectively. In the oral test, mortality was 8% in the control and 6, 18, 8, 14 and 20% in the nominal 6.15, 10.7, 24.32, 48.72 and 96.04 μg a.i./bee treatment groups, respectively. The resulting oral NOAEC and LC 50 values were 25 and >96.04 μg a.i./bee, respectively.



### Terrestrial Plants, Seedling Em ergence and Vegetative Vigor

Terrestrial plant studies are required for all terrestr ial outdoor pesticides. Ti er II terrestrial plant toxicity studies were con ducted to establish the toxi city of the ammonium ( Table C.10 ) and potassium salt formulated products ( Tables C.11 and C.12 ) to non-target terrestrial plants which was tested at doses lower than the maximum labe led application rates of 103.8 and 205 lb a.i./A for ammonium and potassium salts respectively. The recommendations for seedling emergence and vegetative vigor studies are for testing of (1) six species of at l east four dicotyledonous families, one species of which is soybean ( Glycine max ), and the second of which is a root crop, and (2) four species of at l east two monocotyledonous families, one of which is corn ( Zea mays ).

AMMONIUM SALTS OF FATTY ACIDS

For seedlings and young plants exposed to ammoni um salt formulated pr oducts (Table C.10), seedlings at 100 lb a.i./A were not affect ed while active-growing monocotyledonous and dicotyledonous species were mostly affected. The seedling emergence EC 25 s were >100 lbs99 a.i./A for all monocotyledonous and dicotyledonous species tested and would be used as a screening-level endpoint to assess risk to non-listed seedling, as well as it corresponding NOAEC of 100 lb a.i./A to asse ss risk to listed plants.

In the vigor studies, dry weight was most affected in corn, oa t, bean, oilseed rape and soybeans, while shoot length was most affected in cucumber , radish and tomato. No effects were seen in active-growing onion and ryegrass when exposed to ammonium salt formulated products. The most sensitive monocotyledonous species wa s corn, based on dry weight, with EC 25 and NOAEC values of 6.2 and 1.5 lb a.i./A and would be us ed to assess risk to non-listed and listed monocotyledonous plants, respectively. The most sensitive dicotyledonous species was tomato, based on shoot length, with EC 25 and EC 05 values of 2.2 and 1.1 lb a.i./A and would be used to assess risk to non-listed and listed dicotyledonous plants, respectively.

Table C.10. Summary of Tier II Seedling Emerg ence and Vegetative Vigor Results for an Ammonium Salt Formulated Product Vegetative Vigor* Seedling Emergence** Species Endpoint NOAEC/[EC05] EC 25 Endpoint NOAEC EC 25 Corn Dry weight 1.5 6.2 None 100 >100 Oat Dry weight 6.3 9.8 None 100 >100 Onion None 6.3 >6.3 None 100 >100 Ryegrass None 6.3 >6.3 None 100 >100 Bean Dry weight 6.3 27 None 100 >100 Cucumber Shoot length 1.3 6.6 None 100 >100 Oilseed Rape Dry weight 1.5 2.9 None 100 >100 Radish Shoot length 0.094 5.8 None 100 >100 Soybean Dry weight 1.5 4.4 None 100 >100 Tomato Shoot length 1.1 2.2 None 100 >100 * 21.85% a.i ammonium salts of fatty acids; MRID 48402205, Martin. 2011. Measured concentrations for tomato were <LOQ (<0.0015, control), 0.023, 0.094, 0.36, 1.5, and 6.3 lb a.i./A. For corn, oilseed rape, cucumber, onion, ryegrass, and radish, measured concentrations were <LOQ (<0.0015, control), 0.094, 0.36, 1.5, 6.3, and 22 lb a.i./A. For bean, oat, and soybean, measured concentrations were <LOQ (<0.0015, control), 0.36, 1.5, 6.3, 22, and 94 lb a.i./A. ** 21.85% a.i ammonium salts of fatty acids; MRID 48402204, Martin. 2011.

POTASSIUM SALTS OF FATTY ACIDS

Results indicate the plants at the 3-leaf stage (young plants) exposed to potassium salts were more sensitive to potassium salt fo rmulated products than seedlings ( Tables C.11 and C.12. Monocotyledonous and dicotyledon ous seedlings and active-growing monocotyledonous species were generally not inhibited 25% or more to potassium salt form ulated products at the maximum doses (62 or 68 lb a.i./A). The only relia ble dicotyledonous seedling was radish, the EC 25 and NOAEC values were 53.9 and 3.9 lb a.i./A base d on reduced height and would be used as screening-level endpoints to asse ss risk to non-listed and listed dicotyledonous seedlings, respectively. For monocotyledonous seedlings, the most sensitive species was ryegrass based on significant reductions in survival and emergence, the EC 25 and NOAEC values were >62.34 and 31.17 lb a.i./A and would be used to assess risk to non-listed and listed monocotyledonous seedlings, respectively.

Dry weight was the most sensitiv e endpoint in the vege tative vigor studies e xposed to potassium salt formulated products. The most sensitive monocotyledonous species was corn, based on dry100 weight, with EC 25 and NOAEC values of 5.91 and 4.24 lb a.i./A and would be used to assess risk to non-listed and listed monocotyledonous plants, respectively. The most sensitive dicotyledonous species was oilseed rape, based on dry weight, with EC 25 and EC 05 values of 18.5 and 4.38 lb a.i./A and would be used to assess ri sk to non-listed and list ed dicotyledonous plants, respectively.

Table C.11. Summary of Tier II S eedling Emergence and Vegetative Vigor Results for a Potassium Salt Formulated Product Vegetative Vigor* Seedling Emergence** Species Endpoint NOAEC/[EC05] EC 25 Endpoint NOAEC/[EC05] EC 25 Corn Dry weight 4.24 5.91 None 68.57 >68.57 Onion None 68.08 >68.08 None 68.57 >68.57 Ryegrass None 68.08 >68.08 None 68.57 >68.57
Oat None 68.08 >68.08 None 68.57 >68.57 Bean Dry weight 8.104 20.72 None 68.57 >68.57 Cucumber Dry weight 16.21 23.05 Emergence and Survival 16.83 23.8 A

Oilseed Rape Dry weight [4.38] 18.50 None 68.57 >68.57

Radish Dry weight 16.21 57.27 None 68.57 >68.57 Soybean Dry weight 16.21 30.55 Emergence and Survival [4.1] 43.79 A

Tomato Dry weight 16.21 21.73 None [0.0000021]*** >68.57 * 46.8% a.i potassium salts of fatty acids; MRID 48402302, Martin. 2011. ** 46.8% a.i potassium salts of fatty acids; MRID 48402301, Martin. 2011. *** Result is not reliable, as it is well below tested doses.

A Toxicity value should be interpreted with caution as the 95% confidence intervals appear unreliable.

Table C.12. Summary of Tier II S eedling Emergence and Vegetative Vigor Results for a Potassium Salt Formulated Product Vegetative Vigor* Seedling Emergence** Species Endpoint NOAEC/[EC05] EC 25 Endpoint NOAEC EC 25 Corn None 68.57 >68.57 None 62.34 >62.34 Onion None 68.57 >68.57 None 62.34 >62.34 Ryegrass Shoot length 31.79 NC Emergence and Survival 31.17 >62.34

Oat Dry weight 16.21 >68.57 None 62.34 >62.34 Bean Shoot length [39.3] 49.8 Height 31.17 >62.34 Cucumber Shoot length [2.3] A 47.7 None 62.34 >62.34 Oilseed Rape None [NC] NC Weight 15.58 >62.34 Radish None 68.57 >68.57 Height 3.9 53.9 Soybean None 68.57 >68.57 None 62.34 >62.34 Tomato Dry weight 31.79 32.6 None 62.34 >62.34 * 50.8% a.i potassium salts of fatty acids; MRID 48608703, Martin. 2006. ** 50.8% a.i potassium salts of fatty acids; MRID 48608704, Martin. 2011. NC – The ECx or/and 95% confiden ce intervals appear unreliable.

A Toxicity value should be interpreted with caution as the 95% confidence intervals appear unreliable.