2 

## I. Executive Summary

This risk assessment phase of registration review addresses the potential risks of the pesticide active ingredients potassium, ammonium, and sodi um salts of fatty acids to the environment. Soap salts products are registered as acaricides, algaecides, herbicides, in secticides, and animal repellents. They are intended for residential, agri cultural, or commercial use. Application rates for potassium and ammonium salts of fatty acids ma y be applied at rates as high as 205 lb a.i./A and 103.8 lb a.i./A, respectively, and as low as 1 lb a.i./A and less for both salts. Sodium salts are formulated as a soap bar enclosed in one-oun ce mesh bag hung or staked above the ground, and because how the sodium salt was formulated, th e application rate is undefined. There are no technical products; there are only formulated products containing the active ingredients because soap salts are formed through an in tegrated manufacturing process.

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, puppies and cats. Some potassium salts of fatty acids are used as multi-purpose food additives. The Food and Drug Ad ministration (FDA) classifies the potassium salts as GRAS (generally recognized as safe) to humans. Ammonium and sodium salts of fatty acids mainly act as a repellent on forage and grain crops, on vegetables and field crops, in orchards, and on nursery stock, or namentals, flowers, lawns, tu rf, vines, shrubs and trees, affecting the olfactory nerves of deer and rabbits, repelling thes e animals away from the target area; however, ammonium salts can be formulated as a herbicide to control annual weeds. FDA also classifies the ammonium and sodi um salts as GRAS for packaging only.

Potassium and ammonium salts are typically ap plied by ground equipment (hand-held, hose-end, foliar, pump, power, and knapsack sprayer) alth ough some aerial applications are allowed. Sodium salts are typically placed by homeowners in gardens, averaging 5 bags per garden. To date, no information has been provided to USEPA on the extent of soap salt use, and given the wide ranging use patterns, soap salts could be used practically anywhere in the United States. Soap salts in their non- pesticidal uses are wi dely used in the U.S.

Potential Risks to Non-target Organisms

The results of this screening-level risk assessmen t on the registered uses of soap salts indicate there are LOC exceedances for non-target organisms and plants from potassium salt uses at and greater than 10 lb a.i./A with aerial applications and at and greater than 63 lb a.i./A with ground applications and from ammonium salts uses at and greater than 63 lb a. i./A with only aerial applications. There are no LOC exceedances for ammonium salts with ground applications. Due to the number of assumptions in corporated into this assessment and the uncertainty with the available information, discussed below, it is uncer tain whether the LOC ex ceedances constitute a potential affect for Listed species.

There is no LOC exceedance for the sodium salts, b ecause the only use is as an animal repellent in one-ounce mesh bags. This use pattern is not expected to result in m eaningful exposure to wildlife. Therefore, the sodium salt uses are concluded to have No Effect on Listed species.3 Ecologically, there is high uncertainty in the assu mptions that triggered th e direct adverse effects of soap salts ( e.g. potassium and ammonium salts of fatty acids) to aquatic species. The available toxicity data are for soap salt mixtures of unknown composition as to fatty acid chain length. Likewise, there is uncertainty as to which fatty acids will result in exposure, and whether those acids are appreciably toxic to wildlife. Thus , the LOC exceedances were evaluated further on whether soap salts would be toxic enough to ca use effects to the receptors if exposed. The defined-chain-length fatty acid da ta suggest the adverse effects to these non-target organisms are highly uncertain.

At least one other organization (H ERA, 2003) has concluded that co mmercial uses of soap salts pose minimal risks to wildlife.

The product labels are unclear on th e number of applications allo wed and do not appear to limit the maximum number of applications per year or define a recommended minimum interval between applications; however, it appears that additional risks would not be expected with multiple applications. The expos ure concentrations calculated in GENEEC2 increased only 3% after 50 applications were made weekly or per year, which suggests the risk conclusions would remain unchanged even with multiple applications.

Also, the acute and chronic to xicological endpoints used in the assessment for the active ingredients were estimated based on the purity re ported in their ecotoxicity studies using the formulated products as the test material. While the percentage of soap salts was specified, the composition as to chain lengths was not. It wa s not possible to get the actual endpoints for individual fatty acids from technical grade stud ies because the active ingr edients are formed only after being mixed through an integrated process. Data for related products of known composition (the soluble fatty acid, nonanoic or pelargonic acid) was used to characterize the toxicity of the soap salts. Lastly, the composition of registered so ap salt products, specifi cally the range of fatty acid chain lengths, is variable. Due to long-chai n soap salts precipitati on caused by metal ions (Ca, Mg, Fe, etc.) in the environment, longer chain length products should not pose risks to aquatic organisms because exposure is not exp ected. Shorter-chain products may be soluble enough to cause exposure, although it is uncertain if these exposures will result in toxicity.

The Agency believes there is no direct effect to aquatic organisms, for fatty acid salts of chain length C14 and higher, because such fatty acids are not sufficiently soluble in environmental water for toxic effects to be expressed. For shor ter chain-length fatty acids (C9 – C11) there is uncertainty, because the available toxicity data is not clear as to what chain-length mixtures were tested. However, acute toxicity data for n early pure nonanoic (pelargonic) acid, which is representative of the shorter chain-length fatty ac ids, indicate that it does not reach levels of concern with a Tier I exposure assessment.

The exposure to terrestrial plants is uncertain beca use aerial or broadcast spraying as directed are applied at rates much lower than 10 lb a.i./A and spray drift e xposure from spot treatments at high rates are not expected to produce the same amount of exposure as with broadcast spraying. The terrestrial plant risk assessmen t predicts that soap salts is more toxic to plants when exposed to the foliage via spray drift than through the roots as a result of surface wate r runoff; therefore, the exposure route of greatest concern to non-target terrestrial plants is by spray drift. Using default model inputs, the LOC exceedances for terrestrial plants exposed to spray drift extend up4 to >997 feet from the edge for aerial applica tions at the maximum a pplication rate; however, only extend up to 7 feet from the edge if ground app lications rather than ae rial use was utilized. Modeling also suggests that usi ng coarser droplet spectra woul d reduce the distance, whereas very fine droplet spectra would increase the dist ance. Also, if the products are applied via spot treatments instead of broadcast applications it is expected th at distances of concern off the treated field would be reduced as well.

Toxicity was negligible in th e avian and mammalian studies.

Minimal risk is likely for thes e taxonomic groups assessed (birds , reptiles, terrestrial-phase amphibians, mammals, bees, and estuarine/marine fish) exposed to soap salts as a group. Therefore, the registered uses of soap salts ar e concluded to have No Effect on Listed birds, reptiles, terrestrial-phase amphibians, mamm als, bees, and estuarine/marine fish).

It is unclear if registered soap salt products applied at high ap plication rates are broadcast across the landscape or represent spot treatments. Fo r assessment purposes, EFED has assumed that the high rates are broadcast. In making this assump tion, EFED believes that exposure estimates for aquatic resources are possibly ove rly conservative for those uses that may be spot treated because the underlying assumption in the models is that 100% of the fiel d is treated with the pesticide. In order to better characterize the im portance of this assumption on the overall risk conclusions EFED has provided an estimate of th e threshold of spot treatment for each taxa where the LOC would no longer be exceeded. As an example EFED estimated that for the highest application rate (i.e. 205 lbs a.i./acre) for freshwater fish if a site were only spot treated at less than 16% of the entire fiel d the LOC would not be exceeded and no effect would be likely for this use. If the % of actual area treated is higher than the estimated threshold, EFED believe that the potential for a direct eff ect to that taxa exists. However, EFED does not have information to allow for an estimate of what is a reasonabl e assumption of a maximum percentage of a field that may be spot treated that can be used to dete rmine what % of area is a typical spot treatment. Also, the existing labels do not specify whether any of the registered uses can only be spot treated. Additional data are needed on how much % of an area a typical spot treatment is before EFED can make a definitive call on whether effects are likely from these uses. Until a determination for listed species can be made, the risks of soap salts to aquatic organisms from spot treatments at high app lication rates are uncertain.

Overall, for algaecide, herbicide, acaricide, insecticide, and animal repellent uses at estimated maximum application rates, exposure levels, com position of registered soap salt products, and available effects data, soap salts used as directed indicate uncertain direct effects for those taxa identified above from the registered uses ( Table I.1 – Potassium/Ammonium Salts and Table I.2 – Sodium Salts). Such findings suggest concern fo r indirect effects to listed animal and plant species with both narrow (i.e., spec ies that are obligates or have very specific habitat or feeding requirements) and general dependencies (i.e., cover type requirements) as a resource or important habitat component.5 Table I.1. Preliminary Conclusion s for Potential Direct Effects to Fe derally Listed Ta xa Associated with the Registered Uses of Potassium and Ammonium Salts, Based on Best Available Data. Listed Plant Taxon Potential Direct Effects Terrestrial and semi-aquatic plants – monocots and dicots Uncertain – LOC exceedances we re observed for broadcast applications; uncertain if LOC exceedances exists for spot treatments at high application rates Aquatic plants

Listed Animal Taxon Potential Direct Effects Acute Notes Chronic Notes

Terrestrial invert ebrates Uncertain While soap salts are used as insecticides, bee

toxicity data indicate low

toxicity N/A No tools available to measure chronic

effects. Listed invertebrates might be affected if they are present on the treated site at the time of application.

Mammals No effect No toxic effects at highest dose tested No effect Undergo rapid degradation in less than a day, unlikely for wildlife to consume 100% of diet in treated spots, and fatty acid is an important diet for wildlife, chronic effects are not likely Birds No effect No toxic effects at highest dose tested No effect

Reptiles No effect Based on birds as surrogate No effect

Terrestrial-phase Amphibians No effects No effect

Freshwater fish

Uncertain LOC exceedances were observed for broadcast applications; uncertain if LOC

exceedances exists for spot
treatments at high application
rates No effects No LOC exceedances Aquatic-phase Amphibians No effects

Freshwater invertebrates Uncertain It is uncertain whether aquatic

organisms areexposed to moretoxic (long-chain) fatty acids due to solubilitylimitations; moresoluble (shortchain) fatty acids do

not appear to be sufficiently toxic to cause adverse effects. Estuarine/marine fish No effects No LOC exceedances Estuarine/marine invertebrates No effects6 Table I.2. Preliminary Conclusion s for Potential Direct Effects to Fe derally Listed Ta xa Associated with the Registered Uses of Sodium Sa lts, Based on Best Available Data.
Listed Plant Taxon Potential Direct Effects Terrestrial and semi-aquatic plants – monocots and dicots No Effect
Aquatic plants No Effect

Listed Animal Taxon Potential Direct Effects Acute Notes Chronic Notes

Terrestrial invertebrates No Effect The one active product registration is a

low volume,

minor use product intended for homeowner use only, typically hanging bags, which results in low potential for runoff and spray drift; significant concentrations are not expected

to reach the receptors. This use pattern is not expected to

result in meaningful
exposure. N/A No tools available to measure chronic effects Mammals No Effect No Effect The one active product registration

is a low volume, minor use product intended for homeowner use only, typically hanging bags, which results in low potential for runoff

and spray drift;

significant concentrations are

not expected to reach the receptors. This use pattern is

not expected to result in meaningful
exposure. Birds No Effect No Effect Reptiles No Effect No Effect Amphibians No Effect No Effect

Freshwater fish

No Effect No Effects Freshwater invertebrates

Estuarine/marine fish

Estuarine/marine invertebrates

Additional Considerations for Listed Species

Based on this screening-level assessment, there ar e potential risks of di rect effects to listed aquatic organisms, terrestrial invertebrates, a nd plants (terrestrial a nd aquatic nonvascular) and non-listed aquatic invertebrates (freshwater and es tuarine/marine) and plants (terrestrial and aquatic nonvascular) from the use of soap salts on so me of its registered use sites, especially with those high application rates. List ed species of aquatic organisms, terrestrial invertebrates, and plants (terrestrial and aquatic nonvascular) may also be aff ected through indirect effects because of the potential direct effects on listed and non-listed sp ecies. Potential direct effects on listed aquatic organisms, terrestrial invertebrates, a nd plants (terrestrial a nd aquatic nonvascular) and non-listed aquatic invertebrates (freshwater and es tuarine/marine) and plants (terrestrial and aquatic nonvascular) from the use of soap salts may be associated with modification of primary constituent elements of designate d critical habitats, where such designations have been made. However, at this current stage of the Registration Review process, it is premature to make effects determinations for listed species until further refinements are conducted. In order to make effects determinations for indivi dual species, useful refinements ma y include analyses of 1) more detailed, species-specific eco logical and biological data; 2) more detailed and accurate information on soap salts use patterns; and 3) su b-county level spatial proximity data for the cooccurrence of potential e ffects areas and listed species and a ny designated critical habitat. Examples of such refinements are described below.7 EFED is currently developing tools that are expe cted to further refine the assessment and are designed to support effects determinations for individual federally list ed species and their designated critical habitats (whe re applicable). Scientific in formation obtained from the U.S. Fish & Wildlife Service (USFWS), the National Marine Fisheries Service (NMFS), and other reliable sources is being co llated by EFED to address all currently listed species. The information will be stored in an Office of Pesticide Programs Pesticide Registration Information SysteM (PRISM) knowledgebase. The listed species knowledgebase will consist of an information repository that houses biological and behavioral info rmation relevant to individual species ( e.g. , habitat, diet, and life history, including specific temporal and spatial associations) and a document repository that contains supporting documents ( e.g ., USFWS recovery plans) and electronic information ( e.g ., GIS data files). For terrestria l taxa, the biological information relevant to risk quotient (RQ) calculations ( e.g ., diet and body weight) will be used to parameterize exposure estimates to derive speci es-specific RQs using a method consistent with currently used methods in the T-REX and T-HERPS models.

Refinements may also include more detailed analyses of the registered uses and their use patterns that result in LOC exceedances for federally list ed species in the screening-level assessment. The analyses may include more information on wh ere, when, and how soap salts are used to control plant growth and insect infestation. Actual usage data (w hen available) and national landcover datasets that indicate potential use sites ( e.g ., national land cover dataset (NLCD), crop data layer (CDL)) may be used to support a more refined analysis of where soap salts are reasonably expected to be used. Similarly, refinements for the timing of applications and how soap salts are used may be based on the analys is of additional usage data, beyond what were available at the time of the screening-level a ssessment, and a more in-depth exploration of agronomic practices.

In addition, a committee of the National Rese arch Council (NRC) has been tasked with providing advice on ecological risk assessment tools and scientif ic approaches under ESA and FIFRA (Project Identification Number DELS-BES T-11-01). The committee has been asked to review the use of “best available data”; me thods for evaluating subl ethal, indirect, and cumulative effects; the state of the science regarding assessment of mixtures and pesticide inert ingredients; the development, a pplication, and interpretation of re sults from predictive models; uncertainty factors; and what constitutes aut horitative geospatial and temporal information for the assessment of individual specie s and habitat effects. The Agency anticipates that this NRC report, tentatively expected in Spring 2013, will provide recommendations to ensure the scientific soundness and maximize the utility of risk assessment refinements for listed species.

The refinements based on individu al species data; additional, de tailed usage information, when available; and further recommendations from th e NRC report are expected to help to more accurately identify potential area s of effect and to better inform effects and habitat determinations for listed species and any designated critical habitats. For example, if soap salts are used when a particular species of concern is not present ( e.g ., it is migratory) or is not colocated in space, then risk of pot ential direct effects to the species may often be precluded. If LOCs are still exceeded for aquatic organisms, terr estrial invertebrates, and plants (terrestrial and aquatic nonvascular) after conduc ting the refined analyses, furt her analyses of the potential spatial and temporal co-occurrence of listed sp ecies of concern (and an y designated critical habitat) may be conducted. The extent of possible refinement in the analyses of spatial/temporal8 co-occurrence will largely depend on the scale and quality of the available sub-county level use site ( e.g ., NLCD, CDL) and species location data

.

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

The available toxicity data for soap salts ar e for mixtures of unknown composition as to chain length. The following discussion id entifies tested products as pota ssium or ammonium salts, but the correspondence to currently re gistered products is not clear.

Results of the acute toxicity studies tested with soap salt s formulation products indicate potassium salts are moderately toxic to freshwater fish, while ammonium salts are slightly toxic. Neither salt caused any effects to estuarine/mari ne fish up to the solubility limit. Ammonium salts are slightly toxic to freshwater invertebra tes while potassium salts are highly toxic to the taxa. Effects of time to first brood release, repr oduction, 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 estuarin e/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 estuary invertebrate s, potassium salts may be more toxic to estuarine/marine invertebrates th an ammonium salts. An acute to chronic ratio was applied to estuary invertebrates. For algaecide uses, a quatic nonvascular plants , algae and diatoms, exhibited equal inhibitions of biom ass when exposed to both salts.

No toxicity data were ava ilable for sodium salts. The one active sodium salts product registration is a low volume, minor use produc t intended for homeowner use only, typically hanging bags, which results in low potential for r unoff and spray drift; significant concentrations are not expected to reach the receptors. Previousl y, the Agency waived all aquatic toxicity data for sodium salts. This use pattern is not e xpected 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. No effects were seen in bees when exposed to the soap salts9 formulation products.

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.

As with aquatic organisms, no toxicity data were available for sodium salts.10 

### Contents
I. Executive Summary ............................................................................................................. . 2 II. Problem Formulation ......................................................................................................... 1 1 II.1. Nature of the Regulatory Action ............................................................................................... ............ 11 II.1.1 History of Soap Salts Regulation .............................................................................................. ............. 11 II.2 Stressor Source and Distribution .............................................................................................. ............ 12 II.2.1 Nature of Chem ical Stressor ................................................................................................... ........... 12 II.2.2. Overview of Pesticide Usage ................................................................................................... .......... 15 II.3 Ecosystems Potentially at Risk ................................................................................................ .............. 17 II.3.1 Receptors .................................................................................................................... ...................... 17 II.3.2. Assessment En dpoints .......................................................................................................... ............. 17 II.4. Conceptual Model .............................................................................................................. ..................... 18 II.4.1. Risk Hypothesis ............................................................................................................... .................. 18 II.4.2. Conceptual Diagram ............................................................................................................ .............. 18 II.5. Analysis Plan Options ......................................................................................................... ................... 19 II.5.1 Measures of Exposure .......................................................................................................... ............. 20 II.5.2. Measures of Effect ............................................................................................................ ................. 23 II.5.3. Integration of Expos ure and Effects ........................................................................................... ....... 24 III. Analysis ...................................................................................................................... ...... 25 III.1. Environmental Chem istry of Fa tty Acids ................................................................................ ................ 25 III.2. Aquatic Expo sure Mode ling .................................................................................................... ............. 30 III.3. Ecological Effects Characterization .......................................................................................... ........... 37 III.3.1. Aquatic Effects Characteri zation ............................................................................................. ......... 38 III.3.2. Terrestrial Effects Characteri zation .......................................................................................... ......... 54 IV. Risk Characterization ..................................................................................................... 72 IV.1. Risk Esti mation ............................................................................................................... ........................ 72 IV.1.1 Risk Quotient Calculations for Aquatic Organisms ......................................................................... 72 IV.1.2 Risk Quotient Calculati ons for Aquatic Plants ................................................................................ . 75 IV.1.3. Risk Quotient Calculations for Terrestrial Animals ......................................................................... 7 7 IV.1.4. Risk Quotient Calculations for Te rrestrial Plants in Terrestrial and Semi-aquatic Environments .... 78 IV.2. Risk Des cription .............................................................................................................. ........................ 80 IV.2.1 Exposure to Aquatic Organisms ................................................................................................ ....... 81 IV.2.2. Exposure to Terre strial Wildlife ............................................................................................. .......... 85 V. Federally Threatened and Endangered (Listed) Species Concerns ............................... 92 V.1. Action Area ................................................................................................................... .......................... 93 V.2. Taxonomic Groups Potentially at Risk .......................................................................................... ....... 93 V.2.1. Probit Dose-Resp onse Analysis ................................................................................................ ....... 96 V.2.2. Listed Species Occurrence Asso ciated with Soap Salts Use ............................................................ 9711 

## 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 revi ew risk assessment for soap salts (Ammonium (PCCode: 031801), Potassium (PCCode: 079021) and Sodium (PCCode: 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 continues to meet the FIFRA standard for registration. In addition to non-target species animals and plants, potential effects to listed species ( e.g., species on the Federal list of endangered and threatened wildlife and plants) and th eir designated critical habitat are also considered under the Endangered Sp ecies Act (ESA) in order to ensure that the continued registration of soap sa lts is not likely to jeopardize the continued existence of listed species or adversely modify their critical habitat. In order to meet the requirements of FIFRA and the ESA, this assessment follows EPA guida nce on conducting ecological risk assessments (USEPA 1998) and Office of Pesticide Program’s Overview Document, wh ich contains guidance for assessing pesticide risks to non-target and listed species (USEPA, 2004). This assessment was prepared to support evaluation of th e registration review of soap salts.


### II.1.1 History of Soap Salts Regulation

Soap salts were first registered in 1947. In 1982, the Food and Drug Administration (FDA) classified soap salts as Generally Recognized as Safe (GRAS). A national-level ecological assessment was completed as part of the reregistra tion eligibility decision (RED) for soap salts in 1992 with twenty-four registered soap salts prod ucts. The ecological risk assessment included in the soap salts RED was based on basic laboratory fate and acute toxicity data submitted by the registrant in support of registra tion for soap salts. The primary environmental concern identified in the 1992 RED was associated with risks to fres hwater invertebrates. The risks to freshwater12 invertebrates were not estimated using the risk quotient method at that time; however, the Agency assumed that the uses w ould not result in serious impact to freshwater invertebrates because soap salts are not applied directly to water and undergo very rapi d microbial degradation in soil, from which significant concentrations should not reach waterbodies. Soap salts were reported as practically non-toxic to waterfowl and upland game bird s and slightly toxic to both coldwater and warmwater 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 41 active produc ts containing potassium salts of fatty acids, 7 active products containing ammonium salts of fatty acids and one active product of sodium salts of fatty acids. There are no pending registration actions, includi ng emergency exemptions (Section 18) for soap salts. There is one active Special Local Need (Sec tion 24c) for potassium salts of fatty acids in California. Twenty-two potassium salt products were subjected 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

Soap salts (case 4083) comprised of thr ee active ingredients (PC Codes 031801, 079009 and 079021) that are the primary chemical stressors 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 potassium laurate, potass ium myristate, potassium oleate and potassium ricinoleate combined as a singl e active 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 oleate, 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 least 100 chemicals of this family and are generally used as insecticides or/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 fr om the target area and can be fo rmulated as an herbicide to control common annual weeds. Sodium salts of fa tty 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 knapsack sprayer) alth ough some aerial applications are allowed. 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 includi ng both agricultural and non-agricultural sites.13 The intended use for these compounds is also vari ed with both herbicidal and insecticidal modes of action. To date, no information has been provid ed on the extent of soap salt use, and given the wide ranging use patterns, it is anticipated that so ap salts could be used practically anywhere in the United States. Of course, the non-pesticidal use of soap salts is widespread 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-in use Greenhouse non-food Greenhouses-in 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 dwellings

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, brussels 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 Alfalfa14 Table II.2. Overview on Insecticide U ses of Potassium Salts of Fatty Acids Crop Grouping Representative Use

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-in use, al falfa, 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 plants

Ammonium salts of fatty acids ( Table II.3 ) formulated as a rabbit and deer repellent are used on vegetables and fruits, nursery stoc k, ornamentals, flowers, vines, sh rubs and trees. It can also be formulated as a herbicide 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, plants, lawns/turf, woody shrubs/vines, and as a wood protection treatment to outdoor buildings/products. It is recommended not to apply any of the products of ammonium salts of fatty acids th rough any type of irrigation syst em. In addition, ammonium salt products are not compatible with soluble meta llic salts such as zinc, manganese, and iron sulfates. This is presumably because these me tal 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 vegetables15 Table II.3. Overview on Repellent Uses of Ammonium Salts of Fatty Acids Crop Grouping Representative Use

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.

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

Together, the soap salt products may be applied at highly variable rates using ground application equipment and less frequently, by aerial applications at lower rates. Terrestrial application rates are as high as 205 lbs/acre and as low as 1 lb/ acre and below. Both potassium and ammonium salts uses have rates greater th an 100 lbs/acre. The herbicidal pr oducts are generally applied as a spot treatment for weed control and as a broadc ast spray or spot treatment for moss control, while the insecticidal products are applied broadcast using gr ound spray equipments. The high application rates for these produc ts are practical only for spot treatments and usually are not applied to an entire acre but to throughly spray all pl ant (or tree) parts to achieve herbicidal or insecticidal control. Furthermor e, the herbicidal products with high rates for moss control are labeled for lawns/turf, exterior building, and pa ving surfaces; not for agricultural field uses at rates ~10x lower than used for moss control. In addition, the labels are un clear 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 applications ; however, do come with label restrictions such as avoiding cr op-specific injury from repeated applications, to avoid spraying16 desirable plants, a buffer size or coarse nozzle setti ngs to reduce spray drift to sensitive plants, or to not spray to water bodies or use in a manne r that could cause surface water contamination.

Based on the high variability in the application rates and the inability to categorize uses by application rates, EFED estimated the exposure concentrations of potassium and ammonium salts to non-target terrestrial and aquatic animals and pl ants using a range of labeled application rates (i.e., 1, 10, 63, 116 lb a.i./A), in addition to the updated BEAD LUIS report (May 12, 2012) on revising the maximum application rates to 205 an d 103.8 lb a.i./A for potassium and ammonium salts, respectively. At this time EFED is unabl e to associate specific use sites with specific application rates ( e.g. the application rate of 116 lbs/acre is associated with many general use sites including “agricultural crops” and “vegetable s”). Therefore, EFED will model aquatic and terrestrial exposures by creating ge neral application rate “bins” ( Table II.6 ), in addition to the revised maximum application rates of the salts in order to assess the relative magnitude of exposure and risk across the sp ectrum of use sites and applic ation rates allowed. Although the dominant application type app ears to be broadcast by ground boo m and backpack spray, aerial applications (realistically applied at low applications rate s) cannot be precluded and thus both aerial and ground applications will be assessed.

In addition, only single applicati ons will be modeled; however, mu ltiple applications used at high application rates will be considered whether the total amount of salts applied more than 205 lbs a.i./acre per year would results in additional risks since multiple applications could result in higher longer-term (chronic) averag e exposure concentrations.

Sodium salts uses as registered through the Ag ency are not sprayed br oadcast using aircraft, ground equipments, or for spot treatment. The produc t is unique in that it is formulated as a soap bar enclosed in a mesh bag hung or staked in an individual gardener’s ba ckyard. Due to how the sodium salt product is formulated for individual gardeners, the applicati on rate is not defined. This use pattern is not exp ected to result in meaningful exposure to wildlife.

Indoor premises such as greenhouse, households, industrial, commercial, and hospital that are enclosed places where the pesticide does not reac h the environment are not expected to result in Table II.6. Summary of Potassium and Ammonium Salts Application Information

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

Potassium Salts Maximum Rate – Aerial & Ground Applications 205 1 not applicable

All Potassium Salts Uses – Aerial & Ground Applications 116 1 not applicable

Ammonium Salts Maximum Rate – Aerial & Ground Applications 103.8 1 not applicable

All Uses – Aerial & Ground Application 63 1 not applicable

All Uses – Aerial & Ground Application 10 1 not applicable

All Uses – Aerial & Ground Application 1 1 not applicable

All Uses = Potassium and Ammonium Salts Uses17 meaningful exposure to wildlif e. Examples of use site gr oups are greenhouse food, greenhouse nonfood, indoor food, indoor nonfood, indoor medi cal, indoor residential, 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. Soap products that contai n other kinds of insecticides are excluded in this assessment.


### II.3 Ecosystems Potentially at Risk

The terrestrial ecosystems potentially at risk include the treated area and areas immediately adjacent to the treated area 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 these and other registered use 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 treated 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, aquati c 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.

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 determined18 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. Measuring endpoints at the individual level also prov ides insight about risks at higher levels of bi ological organization ( e.g. populations and communities). For example, pesticide effects on individual survivorship have important implicat ions 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.8

. 

### 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 an herbicide, insectic ide, acaricide, algaecide, and repellent in terrestrial crop and non-crop sites will likely invo lve situations where terrestrial and aquatic animals and plants will be exposed to the chemic als. Based on the mobility and persistence of soap salts, the mode of action, and the food-web of the target aquatic and terrestrial ecosystems, soap salts have the potential to cause reduced survival, and re productive 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.19 Figure 1 - Conceptual Model Diagram: Potassium and Ammonium Salts Application to Terrestrial 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) and also will be done in accordan ce with Section 7 of the Endangered Species Act. 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 growth20 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 salts. There ar e three categories of m easures: exposure, effects, and risk.

Using the screening ecological risk assessment for soap salts, EFED will evaluate the risk hypothesis of whether soap salts may potentially impact, either directly or indirectly, listed species or critical habitat. If the use of soap sa lts does not support a “not likely to adverse affect” determination, then further refinements will be made. This will involve determining whether use of soap salts “may affect” a particular listed speci es, and if so, whether it is “likely to adversely affect” the species, or in the case of critical habi tat, whether use of the pesticide may destroy or adversely modify any principle constituent elemen ts (PCE) for the critical habitat, and if so, whether the expected impacts are “likely to adversel y affect” the critical hab itat. The first step in the process is to improve the exposure estimate s based on refining the geographic proximity of soap salts’ use and the listed species and/or cri tical habitat. If there is no geographic proximity, this information would support a determination th at soap salts use will have no effect on the species or critical habitat. If the Agency dete rmines that a geographic proximity exists, both potential direct effects and any potential indirect effects of soap salts use will be examined. This process is consistent with the Agency’s Overview Document. The Agency will consult as necessary with the U.S. Fish and Wildlife Service and National Marine Fisheries Service (Services), consistent with the Services’ regulations.

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 assume potassium and ammonium salts dr ift or move with runoff to adjacent habitats, if data are available.

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:21 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.

Terrestrial Animals

The potential exposure pathways for terrestria l plants and animals include deposition from ground and aerial spray applicatio ns, runoff/leaching from treated areas, spray drift, direct consumption of mesh bags (considered unlikely), and wind erosion of soil particles resulting in residues on non-target species as well as residues on food items for non-target species. As part of the terrestrial assessment, 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 applic ation rates of 1.0, 10, 63, 103.8,116, 205 lb a.i./A.

T-REX estimation of pesticide concentrations in wildlife food items focuses on quantifying possible dietary ingestion of resi dues on vegetative matter and insect s. No field residue data or field study information is available for soap salts ; therefore, the residue estimates were based on a nomogram that relates food item re sidues to pesticide application rate. The residue EECs were generated from a spreadsheet-bas ed model (T-REX version 1.5, an update from the version 1.3.1 that was used in the preliminary problem formul ation) that calculates the decay of a chemical applied to foliar surfaces for singl e or multiple applications on an one-acre field, and is based on the methods of Hoerger and Kenaga (1972) as modified by Fletcher et al. (1994). Uncertainties in the terrestrial EECs are primarily associated wi th a lack of data on in terception and subsequent dissipation from foliar surfaces. The EECs on terrestr ial food items were compared directly with dietary toxicity data or convert ed to an oral dose, as is the case for small mammals. For mammals, the residue concentration is converted to daily oral dose based on the fraction of body weight consumed daily as estimated through mammalian allometric re lationships. The risk assessment for potassium and ammonium salts uses upper bound predicted residues as the measure of exposure. Note: T-REX does not differentiate between aerial and ground applications, the method of application is not c onsidered; thus, all aerial and ground applications are considered equivalent. In addition, T-REX assumes 100% of a one-acre agricultural field would be treated using broad cast application equipments.

Brief Description of T-REX Modeling for Birds and Mammals

Formulas presented below in Table II.7 are used to calculate dose- based and dietary based risk quotients:22 Table II.7. Formulas Used to Calculate Do se-Based and Dietary- Based Risk Quotients Duration Dose or Dietary RQ Surrogate Organism Equation

Acute Dose-based Birds and mammals Acute Daily Exposure (mg/kg-bw) / adjusted LD 50 (mg/kg-bw) 1,2Dietarybased Birds Kenaga EEC (mg/kg-food item) / LC 50 (mg/kg-diet)

Chronic Dietarybased Birds and mammals EEC (mg/kg-food item) / NOAEC (mg/kg-diet)

Dose-based Mammals only EEC (mg/kg-bw) / Adjusted NOAEL (mg/kg-bw) 2

1 Adj. Bird LD 50 = Bird LD 50 (AW/TW) (a-1)

2 Adj. Mammal LD 50 or NOAEL = Mammal LD 50 or NOAEL (TW/AW) 0.25

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 drift. RQs are developed for non-listed and listed species of monocots and dicots i nhabiting dry and semiaquatic areas that are adjacent to treatment sites receiving runoff and/or drift from applications on sites treated with pota ssium 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.

Although not used in risk assessment, the S creening T ool for I nhalation R isk (STIR v.1.0) and S creening I mbibition P rogram (SIP v.1.0) typically are m odeled for an upper bound estimate of exposure on inhalation via spray dr ift and/or vapor and on drinki ng water to determine whether they are a potential pathway of c oncern for terrestrial species that warrants for additional studies to further analyze the risks to terrestrial species from exposure to either inhalation or drinking water that are not addressed in the risk assessment. In order to model STIR and SIP, ecological toxicity studies on acute oral a nd inhalation and chronic reproduc tion with rat and on acute oral and chronic reproduction with bird s, in additional to the physioch emical data on vapor pressure, molecular weight, and solubility for the salts are considered necessary to complete the analyses. However, because the generic mammalian toxicity data requirements have been waived by the Agency’s Health Effect Division (HED) for the soap salts due to the lack of effects at high doses in the available studies with other fatty acids, th e 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; numerous avian toxicity studies show no mortality or sub-lethal effects at high doses as high as 5,000-10,000 mg/kg diet; and the composition of soap salts vary depending on which salt is being assessed, EFED has not atte mpted to model STIR and SIP due to the nature of the salts and presumes that e xposure to inhalation or drinking water were determined not to be a potential pathway of concern for terrestrial species on an acute and chronic exposure basis.23 The analysis of the routes in STIR and SIP do not consider that aggrega tion with other exposure pathways such as dietary, dermal, or drinking wa ter may contribute to a total exposure that has a potential for effects to non-target animals. However, the Agency does consider the relative importance of other routes of expos ure in situations where data i ndicate that pesticide exposures through other routes may be potentially significan t contributors to wildlife risk (USEPA, 2004). Detailed information about STIR v.1.0 and SIP v.1.0, as well as the tool, can be found on the EPA’s website at: http://www.epa.gov/pest icides/science/models_pg.htm#terrestrial and http://www.epa.gov/pesticides/science/models_pg.htm#terrestrial , respectively.

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. As stated above, toxicity testing doe s not represent all species of birds, mammals, or aquatic animals. Only a few surrogate species for both freshwater fish and birds are used to represent all freshwater fish (2000+) and bird (6 80+) species 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 addi tion, neither reptiles nor amphibian data are available. The risk assessment assumes that avian, terrestrial-phase amphibian and reptilian toxicities are similar. The same assumption is used for fish and aquatic-phase amphibians.

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 ch ain length compositions.

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.8 ) lists the measures of enviro nmental exposure and ecological effects used to assess the potenti al risks of potassium, ammonium and sodium salts of fatty acids to non-target organisms. The method s used to assess the risk are c onsistent with those outlined in the document “Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs” (USEPA, 2004).24 Table II.8. 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. 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 characterization to determine the potential ecological risk from the us e of soap salts of fatty acids and the likelihood of direct and indirect effects to non-target animals and plants in aquatic and terrestrial habitats. The exposure and toxicity effects data are integrated in order to evaluate the risks of adverse ecological effects on non-target sp ecies. For the assessment of risks from exposure to potassium and ammonium salts, the risk quotient (RQ) met hod is used to compare exposure and measured toxicity values. EECs are divide d by acute and chronic toxicity values. The resulting RQs are then compared to the Agency’s Leve ls of Concern (LOCs) (USEPA 2004) ( Table II.9) . These criteria are used to indicate when salts’ uses, as directed on the label, ha ve the potential to cause adverse direct or indirect effect s to non-target animals and plants . In addition, incident data from the EIIS and open literature from ECOTOX will be considered as part of the risk characterization.25 Table II.9. 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 items



## 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 lower than that of the sodium, potassium, ammonium salts. Th is is why “ammonium salt products are not26 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 Fa tty acid salts, as mg/L [fatty acid]

Carbon# MW acid logKsp Ksp(1) Soft water(2) Hard water(3) Acid sol (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 so ft water. (3) fatty acid solubility in hard water. (4) laboratory-measured solubility literature values from 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 not27 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.

Figure 2 presents a plot of the ECOSAR estimations of the toxicities of normal fatty acids from n-C8 to n-C18, along with the sol ubilities in soft and hard water. For the shorter chain lengths, solubilities are high enough for the toxicity endpo ints to be reached, but at higher chain lengths, the acids are too insoluble for t oxic levels to be reached.

The exception to this conclusion appears to be fo r the mysid shrimp, however it is a salt water organism, and fatty acid solubilities in salt water will be even less than shown in Figure 2

. Compared to “hard” fresh water (calcium con centration 120 mg/L), calci um concentrations in seawater are even higher (400 mg/L) with hi gh concentrations of fatty-acid precipitating magnesium as well (1,350 mg/L) [CRC Ha ndbook of Chemistry and Physics, 69 th ed., 1988-89, p. F-146]. Thus, the higher fatty acids above about n-C13 will not be sufficiently soluble in salt water to be toxic.28 Figure 2. Comparison of Calcium-limited Sol ubilities of Fatty acids and their Estimated toxicity of Aquatic Organisms



### 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 soap 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). Potassium salts of fatty acids are naturally occurring.

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 oxidativ e chemistry) as opposed to hydrolysis. Aqueous photolysis of two formulated products of fatty aci ds (Safer’s Weed and Grass Killer Concentrate and Safer’s Sapestain) was te sted (MRID 470307007). The active in gredient in this study was free fatty acids which showed no degradation duri ng 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. 0.000001

0.00001

0.0001

0.001

0.01

0.1

1 10 100 1000 10000Enpointorsolubility,mg/L

Fatty Acid chain length 

### Fatty Acids: QSAR

‐ estimated Toxicity Endpoints and Solubility in Soft and Hard Water

Fish96

‐ hrLC50

Fish14

‐ dayLC50
Daphnid48

‐ hrLC50
GreenAlgae96

‐ hrEC50

Fish30

‐ dayChV
DaphnidChV
GreenAlgaeChV
Fish(SW)96

‐ hrLC50
MysidShrimp96

‐ hrLC50
Fish(SW)ChV
MysidShrimpChV

soft water solubility

hard water solubility29 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 acids has the effect of either converti ng the degradates to CO, and ester (if used as an energy source) or converting the carbon content of the fatty acid to any of the thousands of naturally occurring organic substances produced by the soil mi cro 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 fa tty acids. Both of these fatty acids are naturally occurring. As with the aerobic soil metabolism study, soil was co llected from beneath a turf site and treated with both compounds. Leaching was evaluated by extracting with distilled water, CHCL 3 , and CH 3 OH using a sepratory funnel. Leachate was extracted using H 2 SO 4 , hexane and distilled water. Extracts were analysis using a gas chroma tograph in duplicate with 3 runs per replicate. The study suggests that leaching of Capric and Pelargonic fatty acids would be minimal, although no Kd or Koc estimates were provided no r 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 and log Kow 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 devel oped by EPA’s Office of Pollution Prevention & Toxics (OPPTS). Estimates of Koc were genera ted 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. Esti mates of Koc for nonanoic acid ranged from 53 mL/g (molecular connectivity index method) to 111 mL/g (Kow method). A value 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/30 

### 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. Maximum applicatio n rates were used. Because the maximum rates include an insoluble portion, modeling the expos ure as only soluble fa tty 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 equivalent to the solubility of C10 acid in soft water (130 mg/L).

Model input parameters ( Table III.2 ) were selected based on laboratory fate data in accordance with EFED’s input parameter guidance. Ti er I modeling was conduc ted based on a single application at the maximum application rate. The screening risk assessment has been revised to include the maximum label application rates of 205 and 103.8 lb a.i. /A for potassium and ammonium salts, respectively, based on the updated BEAD LUIS report to the previously discussed ‘bin’ rates of 1.0, 10, 63 and 116 lb a.i./A in the preliminary problem formulation (based on assumptions about the volume of pes ticide that may be sprayed per unit area) as described in Section II.2 . More information 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

Model Parameter Value Comments Source

Spray Drift by Scenario aerial –13% 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 Estimate is 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 app lication rates have been updated for risk estimations in this screening-level assessment ( Table III.3 ). The highest applicati on rates for potassium and31 ammonium salts (205 and 103.8 lbs/ acre, respectively) coupled with the representative K oc for lower chain length products (100) yield the EECs in Table III.3 . Application rates for modeling purposes were selected in accordance with a range of application rates (i.e., 1, 10, 63, 116 lb a.i./A) and the maximum labeled application rates for potassium and ammonium salts (205 and 103.8 lb a.i./A, respectively) in order to assess the relative ma gnitude of exposure across the spectrum of use sites and application rates allowed.

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

Aerial Application

205 3.2 0.89 0.32

116 1.8 0.50 0.18

103.8 1.60 0.45 0.16

63 0.97 0.27 0.098

10 0.16 0.043 0.016

1 0.016 0.0043 0.0016 Ground Application

205 2.9 0.79 0.28

116 1.6 0.45 0.16

103.8 1.44 0.40 0.14

63 0.88 0.24 0.086

10 0.14 0.038 0.014

1 0.014 0.0038 0.0014

Terrestrial Organisms

Modeling Results

The predicted upper bound re sidues of potassium and ammonium salts that may be expected to occur on selected avian or mammalian food items immediately following application (at the maximum label rates for the salts and general ‘bin’ application rates) are presented in Table III.4 (dietary-based EECs for birds and mammals), Table III.5 (dose-based EECs for various sizes of birds), and Table III.6 (dose-based EECs for vari ous sizes of mammals).32 Table III.4. Terrestrial Dietary-Base d EECs (Birds and Mammals) Following Potassium and Ammonium Salts Spray Application.

Uses Maximum Labeled and General ‘Bin’ Application Rates Food Items Upper Bound Dietary-Based EEC 1 (mg a.i./kg)

Max potassium use 205 lb a.i./A x 1 application Short Grass Tall Grass Broadleaf Plants Fruits, Pods, Seeds Arthropods 49200 22550 27675 3075 19270

All potassium uses 116 lb a.i./A x 1 application Short Grass Tall Grass Broadleaf Plants Fruits, Pods, Seeds Arthropods 27840 12760 15660 1740 10904

Max ammonium

use 103.8 lb a.i./A x 1 application Short Grass Tall Grass Broadleaf Plants Fruits, Pods, Seeds Arthropods 24912 11418 14013 1557 9757

All registered uses 63 lb a.i./A x 1 application Short Grass Tall Grass Broadleaf Plants Fruits, Pods, Seeds Arthropods 15120 6930 8505 945 5922

All registered uses 10 lb a.i./A x 1 application Short Grass Tall Grass Broadleaf Plants Fruits, Pods, Seeds Arthropods 2400 1100 1350 150 940

All registered uses 1.00 lb a.i./A x 1 application Short Grass Tall Grass Broadleaf Plants Fruits, Pods, Seeds Arthropods 240 110 135 15 94

1 Used to determine the potential risk to non-tar get wildlife and plants and the need to consider regulatory action. All registered uses = Potassium and Ammonium Salts uses33 Table III.5. Terrestrial Dose-Based EECs (B irds) Following Potassium and Ammonium Salts Spray Application.

Uses Maximum Labeled and General ‘Bin’ Application Rates Food items Avian Classes and Body Weights small mid large 20 g 100 g 1000 g
Upper Bound Dose-based EEC (mg a.i./kg bw) 1

Max potassium use 205 lb a.i./A x 1 application Short Grass 56033.87 31952.89 14305.73 Tall Grass 25682.19 14645.07 6556.79 Broadleaf Plants 31519.05 17973.50 8046.97 Fruits, Pods 3502.12 1997.06 894.11 Arthropods 21946.60 12514.88 5603.08 Seeds 778.25 443.79 198.69

All potassium uses 116 lb a.i./A x 1 application Short Grass 31706.97 18080.66 8094.95 Tall Grass 14532.36 8286.97 3710.19 Broadleaf Plants 17835.17 10170.37 4553.41 Fruits, Pods 1981.69 1130.04 505.93 Arthropods 12418.56 7081.59 3170.52 Seeds 440.37 251.12 112.43

Max ammonium use 103.8 lb a.i./A x 1 application Short Grass 28372.27 16179.07 7243.59 Tall Grass 13003.96 7415.41 3319.98 Broadleaf Plants 15959.40 9100.73 4074.52 Fruits, Pods 1773.27 1011.19 452.72 Arthropods 11112.47 6336.80 2837.07 Seeds 394.06 224.71 100.61

All registered uses 63 lb a.i./A x 1 application Short Grass 17220.17 9819.67 4396.40 Tall Grass 7892.58 4500.68 2015.01 Broadleaf Plants 9686.34 5523.56 2472.97 Fruits, Pods 1076.26 613.73 274.77 Arthropods 6744.57 3846.04 1721.92 Seeds 239.17 136.38 61.06

All registered uses 10 lb a.i./A x 1 application Short Grass 2733.36 1558.68 697.84 Tall Grass 1252.79 714.39 319.84 Broadleaf Plants 1537.51 876.76 392.54 Fruits, Pods 170.83 97.42 43.62 Arthropods 1070.57 610.48 273.32 Seeds 37.96 21.65 9.69

All registered uses 1.00 lb a.i./A x 1 application Short Grass 273.34 155.87 69.78 Tall Grass 125.28 71.44 31.98 Broadleaf Plants 153.75 87.68 39.25 Fruits, Pods 17.08 9.74 4.36 Arthropods 107.06 61.05 27.33 Seeds 3.80 2.16 0.97

1 Used to determine the potential risk to non-target w ildlife and the need to consider regulatory action. All registered uses = Potassium and Ammonium Salts uses34 Table III.6. Terrestrial Dose-Based EEC s (Mammals) Following Potassium and Ammonium Salts Spray Application.

Uses Maximum Labeled and General ‘Bin’ Application Rates Food items Mammalian Classes and Body Weights small mid large 20 g 100 g 1000 g Upper Bound Dose-based EEC (mg a.i./kg bw) 1

Max potassium use 205 lb a.i./A x 1 application Short Grass 46908.43 32420.00 7516.69 Tall Grass 21499.70 14859.17 3445.15 Broadleaf Plants 26385.99 18236.25 4228.14 Fruits, Pods 2931.78 2026.25 469.79 Arthropods 18372.47 12697.83 2944.04 Seeds 651.51 450.28 104.40

All potassium uses 116 lb a.i./A x 1 application Short Grass 26543.31 18344.98 4253.35 Tall Grass 12165.68 8408.11 1949.45 Broadleaf Plants 14930.61 10319.05 2392.51 Fruits, Pods 1658.96 1146.56 265.83 Arthropods 10396.13 7185.12 1665.89 Seeds 368.66 254.79 59.07

Max ammonium use 103.8 lb a.i./A x 1 application Short Grass 23751.68 16415.59 3806.01 Tall Grass 10886.19 7523.81 1744.42 Broadleaf Plants 13360.32 9233.77 2140.88 Fruits, Pods 1484.48 1025.97 237.88 Arthropods 9302.74 6429.44 1490.69 Seeds 329.88 227.99 52.86

All registered uses 63 lb a.i./A x 1 application Short Grass 14415.76 9963.22 2310.01 Tall Grass 6607.22 4566.48 1058.75 Broadleaf Plants 8108.87 5604.31 1299.38 Fruits, Pods 900.99 622.70 144.38 Arthropods 5646.17 3902.26 904.75 Seeds 200.22 138.38 32.08

All registered uses 10 lb a.i./A x 1 application Short Grass 2288.22 1581.46 366.67 Tall Grass 1048.77 724.84 168.06 Broadleaf Plants 1287.12 889.57 206.25 Fruits, Pods 143.01 98.84 22.92 Arthropods 896.22 619.41 143.61 Seeds 31.78 21.96 5.09

All registered uses 1.00 lb a.i./A x 1 application Short Grass 228.82 158.15 36.67 Tall Grass 104.88 72.48 16.81 Broadleaf Plants 128.71 88.96 20.63 Fruits, Pods 14.30 9.88 2.29 Arthropods 89.62 61.94 14.36 Seeds 3.18 2.20 0.51

1 Used to determine the potential risk to non-target w ildlife and the need to consider regulatory action. All registered uses = Potassium and Ammonium Salts uses

Terrestrial Plants

Modeling Results

EFED's exposure scenario for off-site plants is based on the application rate, application method35 (ground or air), and the water solubility of the pestic ide. The amount of pesticide that runs off is a proportion of the application ra te and is assumed to be 1%, 2% , or 5% for water solubility 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 its solubility of 100 mg/L in water. Drift from ground-spray and aerial applications are assumed to be 1% and 5%, respectively, of th e application rate. The previous EECs in the preliminary problem formul ation were incorrect because a runoff value of 5% was used in the calculations and has been revised. The revised EECs are tabulated below in Table III.8

.36 Table III.8. EECs for Terrestrial Plants Loca ted Adjacent to Potassium and Ammonium Salts Treated Sites.

Application Rate (lb a.i./A) Application Method 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

205 Ground Unincorp. Spray 6.2 43.1 2.1

Aerial Spray 14.4 51.3 10.3

116 Ground Unincorp. Spray 3.5 24.4 1.2

Aerial Spray 8.1 29.0 5.8

103.8 Ground Unincorp. Spray 3.1 21.8 1.0

Aerial Spray 7.3 26.0 5.2

63 Ground Unincorp. Spray 1.9 13.2 0.6

Aerial Spray 4.4 15.6 3.2

10 Ground Unincorp. Spray 0.3 2.1 0.1

Aerial Spray 0.7 2.5 0.5

1.00 Ground Unincorp. Spray 0.03 0.21 0.01

Aerial Spray 0.07 0.25 0.05

1 EEC = Sheet Runoff + Drift (1 % for ground; 5% for aerial)
2 EEC = Channelized Runoff + Drif t (1% for ground; 5% for aerial)
3 EEC for ground (appl. rate x 1% drif t); for aerial (appl. rate x 5% drift)37 

### 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 active ingredients selected fo r this ecological risk assessment phase of soap salts registration review. Effect data were av ailable for potassium and amm onium salts; however, none were available for sodium salts. Because the one act ive sodium salts product registration is a low volume, minor use product intended for homeowner use only and the only potential exposure to the environment is via direct ingestion of the ba r (e.g. there would be no runoff, spray drift, or residues expected on poten tial food items), toxicity data were waived.

This assessment evaluates the potential for salts to directly or indirectly affect listed species or modify designated critical habitat. As previously discussed in Section II.5 , assessment endpoints include direct t oxic effects on the survival, reproduc tion, and growth of listed entities, as well as indirect effects, such as reduction of the prey base or modification of habitat. In addition, potential modification of cr itical habitat is assessed by ev aluating effects to the critical elements principle constituent elements (PCEs) , which are components of the critical habitat areas that provide essential life cy cle needs of listed entities.

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 enda ngered species assessment. 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 literature data are quantitatively or qualitatively ch aracterized is dependent on whethe r the information is relevant to the assessment endpoints (survival, reproduction, and growth) identified in Section II.5 . For38 example, endpoints such as behavior modificatio ns are likely to be qualitatively evaluated, because quantitative relationshi ps between modifications and reduction in species survival, reproduction, and/or growth are not available. To date, none of th e open literature that passed the ECOTOX screen obtained effects at lower concentr ations than the submitted studies and thus are not used in this risk assessment.

Ecological effect studies are ty pically performed using the tec hnical grade active ingredient (TGAI); however, because the sa lts are formed through an inte grated manufacturing process, there is no technical product. To resolve these issues, the Agency requested studies with the formulated products. However, an uncertainty on the toxicity values of the active ingredients used in the assessment exists because the part icular fatty acid chain length composition of the tested products is unknown.

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 salts. A summary of the available aquatic a nd terrestrial ecotoxicity information and use of the probit dose-res ponse 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 w ith registered uses of salts and classified as “probable” that the incidents we re associated with salts exposure. In addition, there are 29 aggregate plant inci dents reported for potassium sa lt formulated products between 1997 and 2012 that were reported 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 data on 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 measurement endpoints associated with salts exposure to freshwater and estuarine/ marine species are summarized in Table III.9 for potassium and in Table III.10 for ammonium

. Selected effects endpoin ts for the risk assessment are from acceptable and supplemental studies for salts and are described below.

Laboratory studies examining the effects of salts of fatty acids to aquatic organisms indicated potassium salt is generally more toxic than amm onium salt. Based on the most sensitive toxicity data, potassium is acutely classified as moderately toxic to freshwater fi sh and estuarine/marine invertebrates; highly toxic to freshwater invertebrates; and no effects were seen in estuarine/marine fish at doses up to 4.4 mg a.i./L . Ammonium is classified as slightly toxic to39 freshwater fish and both freshwat er and estuarine/marine invert ebrates; and pr actically nontoxic to estuarine/marine fish on an acu te basis. In addition, freshwater fish also act as surrogates for aquatic-phase amphibians in the ab sence of data; therefor e, acute toxicity da ta with freshwater fish indicates potassium and ammonium salts are moderately and slightly toxic to aquatic-phase amphibians, respectively. With ch ronic toxicity data limited to the daphnid life cycle studies, reproductive and growth effects in the time release of first brood, offspring per adult, and length were observed; however, daphnids’ life cycle wa s more sensitive to potassium than ammonium. Acute-to-Chronic Ratio calculati ons were used to estimate th e NOAEC for chronic effects to freshwater fish, estuarine/marine fish, and estuar ine/marine invertebrates, using data from the daphnid and mysid studies.

No aquatic organism toxicity data are availa ble for sodium salts; however, sodium salt mesh bags are hung on branches or stakes, which results in low potential for runoff and spray drift to aquatic organisms/plants. In a ddressing the lack of toxicity data, the required exposure for adverse effects on aquatic organisms/plants expos ed to sodium salts are discussed further in Section IV.2

. It is not clear from the available data ( Tables III.11 thru III.16 ) for potassium, and ammonium salts whether the tested substance represented a long-chain (C14 – C18) or short-chain (C8 – C12) mixture. For comparison, toxicity test ing was conducted on a product whose composition is known (96.7% pelargonic, or nonanoic acid, C9, and 2.5% 2-methyloctanoic acid, a C9 isomer). This fatty acid is representative of s horter-chain fatty acids that are appreciably soluble even in the presence of metal ions. The resu lts of acute toxicity st udies with nonanoic acid indicate that the LC 50 in bluegill sunfish is greater than 105 mg/L (MRID 430653-01), the LC 50 in rainbow trout is 91 mg/L (MRID 430653-02), and the EC 50 in daphnia magna is 96 mg/L (MRID 430653-03).

These results indicate that a fatty acid of defined composition (99.2% C9 and isomer) is less toxic than would be indicated by the toxicity data for pota ssium and ammonium salts of unknown fatty acid composition. This introduces an un certainty in the risk quotient calculations, since with the available data ( Tables III.11 thru III.16 ), we are not certain which substance or substances is represented.40 Table III.9. Most Sensitive Acute and Chro nic Toxicity Data fo r Aquatic Organisms Exposed to Potassium Salts of Fatty Acids. 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 1

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 1

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 1

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 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/L41 Table III.10. Most Sensitive Acute and Chro nic Toxicity Data for Aquatic Organisms Exposed to Ammonium Salts of Fatty Acids. 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 1

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 1

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 1

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 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



### 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 mg a.i./L, respectively, ( Table III.11 ) are used to evaluate potential acute effects of the salts to freshwater fish.42 AMMONIUM SALTS OF FATTY ACIDS

A 96h static-renewal acute exposure study (MRI D 42806405; Supplemental) with rainbow trout ( Onchorhynchus mykiss ) is available for a 13.1% ammonium salts of fatty acids formulation. Twenty trout per level were expos ed to nominal concentrations of 0 (control), 3, 5, 8, 13 and 20 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

Table III.11. 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 Classification AMMONIUM SALTS OF FATTY ACIDS Rainbow trout ( Oncorhynchus mykiss ) 13.1 12 A Slightly toxic 42806405 Ward et al. (1993) Supplemental 1

POTASSIUM SALTS OF FATTY ACIDS

Rainbow trout ( Oncorhynchus mykiss ) 51 131.3 B Practically nontoxic 00090936 Janssen. (1979) Supplemental 2

49 17 C Slightly toxic 44980313 Nedvidek. (1996) Acceptable

25 9.19 D Moderately toxic 40053304 Obenchain. (1986) Supplemental 3

Not reported 18.1 mg formulation/L E N/A 4 00096636 Berlin. (1981) Supplemental 5
Bluegill sunfish ( Lepomis macrochirus ) 25 23 F Slightly toxic 40053304 Obenchain. (1986) Supplemental 6

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.43 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.



### 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 and44 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 III.12 ) is used to evaluate potential acute effects of the salts to freshwater invertebrates.

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

Table III.12. 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.45 ( 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 per 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 invertebrates indicate the NOAEC value of 23 mg a.i./L and 0.5 mg a.i./L, respectively, ( Table III.13 ) is used to evaluate potential reproductive e ffects of the salts to freshwater fish.46 Table III.13. Freshwater Invertebrate Chroni c 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 per 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 per47female 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 III.14 ) is used to evaluate potential acute effects of the salts to freshwater fish.

Table III.14. Estuarine/Marine 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 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 46.8 >2.1 No effects 48469802 Acceptable48 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.



### 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 (Cyprinodon variegates) up to 2.1 mg/L Fournier. (2011)

50.8 >4.4 No effects up to 4.4

mg/L 48636502 Sayers. (2011) Acceptable49 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 III.15 ) 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 III.15. Estuarine/Marine Invertebrate Acute 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. 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 mysids50 ( 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 rapidly 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 III.16 ) 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.51 Table III.16. 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 Softcheck. (2011) Acceptable

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./L52 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). 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 significant53 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 the reviewer that the statistically 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). Measured 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.54 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.

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.17 for potassium and in Table III.18 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 salt s were not available, th e chronic toxicity to birds, reptiles, and terrestrial-phase amphibian s is unknown; however, the Agency is not asking for reproduction data since it is an ticipated that the ecological eff ects to birds are minimal with the salts undergoing rapid degradatio n in less than a day and the lack of effects at high rates in the acute studies.

HED has waived all generic mammalian toxicity da ta requirements for soap salts due to the lack of effects at high doses in the available studie s of other fatty acid sa lts, the nature of the chemicals (fatty acids) and their ubiquity in na ture, and the limited potential for human exposure via the oral route from established uses. With no systemic toxicity observed, HED did not select endpoints for human health risk assessment. T hus, for the ecological risk assessment, the ecological effects to mammals ar e anticipated to be minimal.

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

.55 Table III.17. Most Sensitive Acute and Chro nic 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 selected 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 (Dietary-based) 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 (Dietary-based) Bobwhite quail Colinus virginianus 8-day dietary LC 50 : >5620 mg a.i./kg-diet 40066204

Chronic (Dietary-based) 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 4280600156 Table III.18. Most Sensitive Acute and Chro nic 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 selected 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 (Dietary-based) Birds Acute (Dose-based) No data available, surrogate data from other salts are used.

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

Chronic (Dietary-based) 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 44766401



### 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 III.19 ). No acute oral data on passerine birds for potassium salts and on any bird species for ammonium salts were available, bridging data from other salts are used as a surrogate.57 Table III.19. 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 4858 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.59 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.



### Birds, Subacute Dietary60 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 III.20 ). No acute dietary data on a waterfowl for ammonium salts were available, bridging da ta from other salts are used as a surrogate.61 Table III.20. 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.62 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%.63 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 ) was64 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-lethal65 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, 50,66 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.67 

### Mammals, Acute Oral and Reproduction

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 Table III.21

.

Table III.21. Acute Contact and Oral Toxici ty 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. Acceptable68 Table III.21. Acute Contact and Oral Toxici ty 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.69 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 III.22 ) and potassium salt formulated products ( Tables III.23 and III.24 ) to non-target terrestrial plants which was tested at doses lower than the maxi mum labeled application rates of 103.8 and 205 lb a.i./A for ammonium and potassium salts re spectively. The recommendations for seedling emergence and vegetative vigor studies are for te sting of (1) six species of at least 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 least two monocotyledonous families, one of which is corn ( Zea mays ).

AMMONIUM SALTS OF FATTY ACIDS

For seedlings and young plants exposed to ammonium salt formulated products ( Table III.22 ), seedlings at 100 lb a.i./A were not affect ed while active-growing monocotyledonous and70 dicotyledonous species were mostly affected. The seedling emergence EC 25 s were >100 lbs 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 III.22. 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 III.23 and III.24 ). 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 potassium71 salt formulated products. The most sensitive monocotyledonous species was corn, based on dry 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 III.23. Summary of Tier II Seedling 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.
A Toxicity value should be interpreted with caution as the 95% confidence intervals appear unreliable.

Table III.24. Summary of Tier II Seedling 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.72 

## 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. The RQ provides a comparison of exposure estimates to toxicity endpoints ( i.e. , the estimated exposure concen trations are divided by acute and chronic toxicity valu es). The resulting RQs are compared to the Agency’s LOCs, as shown in Table II.12 . LOCs are used by the Agency to indicate when the use of a pes ticide, as directed by the label, has the poten tial to cause adverse effect s to non-target organisms.

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 ingred ient in the formulations are used to estimate the risks to aquatic organisms as a result of su rface runoff and spray drift from aerial or ground applications. The LD 50 and EC 50 is used to estimate acute risk for adverse effects on survival to fish and invertebrates, respectively, and the NOAEC is used to estimate chronic risk for adverse effects on reproduction and growth to both fish and invertebrates.

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 peak EECs generated from GENEEC modeling. A single application is modeled. Results of the assessment on freshw ater organisms indica te the acute RQs for freshwater fish exceeded the acute listed sp ecies LOC of 0.05 and restricted use LOC of 0.1 when applying at and greater than the application rate of 63 lb a.i. /A of potassium salts via air or ground. The acute RQs for freshwater invertebra tes exceeded the acute listed species and restricted use LOCs when applying at and greater than the application rate of 10 lb a.i./A using aerial or ground equipments and exceeded the acute non-listed speci es LOC of 0.5 when applying at and greater than 63 lb a.i./A.

For uses of ammonium salts, acute RQs were above the Agency’s acute LOCs for freshwater fish at and greater than 63 lb a.i./A and for freshwat er invertebrates at the maximum application rate via aerial or ground applications.

When compared to toxicity da ta for 99.2% nonanoic acid, however, the acute risk quotients are below Agency levels of concern. The acute fr eshwater fish RQ is 3.2/91 = 0.04, and the Daphnia acute RQ is 3.2/96= 0.03.

Chronic RQs for freshwater inve rtebrates exposed to potassium salts are above the Agency’s LOC for chronic risk when applie d aerially at and greater than 116 lb a.i./A and at and greater than 205 lb a.i./A when using broadcast ground equipment.

No chronic toxicity data were available for fr eshwater fish. The acute to chronic ratio method73 was used to estimate the chronic t oxicity value for freshwater fish using data from rainbow trout and daphnid studies. Chronic RQs fo r freshwater fish exposed to potassium and ammonium salts were below the chronic LOC at maximum applications rates. The data gap is discussed further in Section IV.2

. The potential risks to freshwater organisms are discussed further in Section IV.2

.

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

Use (Aerial or ground/ # apps/ lb a.i./A) Peak EEC 21D EEC 60D EEC 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 aerial app @ 205 3.2 0.89 0.32 0.35* 0.04 5.6** 1.8*** 1 ground app @ 205 2.9 0.79 0.28 0.32* 0.04 5.1** 1.6*** 1 aerial app @ 116 1.8 0.50 0.18 0.20* 0.02 3.2** 1.0*** 1 ground app @ 116 1.6 0.45 0.16 0.17* 0.02 2.8** 0.90

1 aerial app @ 63 0.97 0.27 0.098 0.11* 0.01 1.7** 0.54 1 ground app @ 63 0.88 0.24 0.086 0.10* 0.01 1.5** 0.48 1 aerial app @ 10 0.16 0.043 0.016 0.02 <0.01 0.28* 0.09 1 ground app @ 10 0.14 0.038 0.014 0.02 <0.01 0.25* 0.08 1 aerial app @ 1.0 0.016 0.0044 0.0016 0.0017 <0.01 0.03 0.01 1 ground app @ 1.0 0.014 0.0038 0.0014 0.0015 <0.01 0.02 0.01 * Exceeds the listed species LOC of 0.05; ** Exceeds th e nonlisted species LOC of 0.5 and the listed species LOC of 0.05; and *** Exceeds the chronic LO C of 1.0 for nonlisted and listed species.74 Table IV.2. Risk Quotients for Freshwater Orga nisms for Ammonium Salts of Fatty Acids
Use (Aerial or ground/ # 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 aerial app @ 103.8 1.6 0.45 0.16 0.13* 0.02 0.06* 0.02 1 ground app @ 103.8 1.4 0.40 0.14 0.12* 0.01 0.05* 0.02 1 aerial app @ 63 0.97 0.27 0.098 0.08* <0.01 0.04 0.01 1 ground app @ 63 0.88 0.24 0.086 0.07* <0.01 0.03 0.01 1 aerial app @ 10 0.16 0.043 0.016 0.01 <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 aerial app @ 1.0 0.016 0.0044 0.0016 0.001 <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 * Exceeds the listed species LOC of 0.05; ** Exceeds th e nonlisted species LOC of 0.5 and the listed species LOC of 0.05; and *** Exceeds the chronic LO C of 1.0 for nonlisted and listed species.

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 ammonium salts based on the peak 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. Exposed to potassium salts, the acute RQ for estuarine/marine invertebrates exceeded the acute listed species LOC of 0.05 when applying at and greater than 10 lb a.i./A by air or ground. None of the chronic RQs exceeded the chronic LOC of 1.0 for estuarine/marine invertebrates. At the maximum rate, the highest acute and chronic RQs are 2.7 and 0.8, respectively.

Acute and chronic RQs for uses of ammonium salts at the maximum label rate of 103.8 lb a.i./A were below the Agency’s acute LOCs for estu arine/marine organisms exposed to ammonium salts via aerial or ground applic ations; therefore, RQs based on ot her uses with lower application rates of ammonium 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 sheepsh ead minnow, daphnid, and mysid studies.

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

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

Use (Aerial or ground/ # 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 aerial app @ 205 3.2 0.89 0.32

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

nondefinitive NOAEC

using ACR method 2.7** 0.8 1 ground app @ 205 2.9 0.79 0.28 2.4** 0.8 1 aerial app @ 116 1.8 0.50 0.18 1.5** 0.5 1 ground app @ 116 1.6 0.45 0.16 1.3** 0.4

1 aerial app @ 63 0.97 0.27 0.098 0.8** 0.3 1 ground app @ 63 0.88 0.24 0.086 0.7** 0.2 1 aerial app @ 10 0.16 0.043 0.016 0.1* 0.04 1 ground app @ 10 0.14 0.038 0.014 0.1* 0.04 1 aerial app @ 1.0 0.016 0.0044 0.0016 0.01 0.04 1 ground app @ 1.0 0.014 0.0038 0.0014 0.01 0.04 * Exceeds the listed species LOC of 0.05; ** Exceeds th e nonlisted species LOC of 0.5 and the listed species LOC of 0.05; and *** Exceeds the chronic LO C of 1.0 for nonlisted and listed species.

Table IV.4. Risk Quotients for Estuarine/marine Organisms for Ammonium Salts of Fatty Acids
Use (Aerial or ground/ # 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 aerial app @ 103.8 1.6 0.45 0.16 RQs not calculated due to no effects at the

maximum dose RQs were not derived due to

a nondefinitive NOAEC using ACR method 0.02 <0.01

1 ground app @ 103.8 1.44 0.4 0.14 0.02 <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 resu lt of surface runoff and spray drift from aerial and 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 Plants76 According to peak GENEEC EECs of various applic ation rates and toxicity values of the salts, assuming 100% of the acre is treate d using broadcast applications, the listed RQs for aquatic vascular plants is below Agency’s plant LOC of 1.0 when applying at the maximum label rate of 205 lb a.i./A for aerial and ground applications; and the listed RQs for aquatic non-vascular plants is above Agency’s LOC when applying via air or ground at and grea ter than 63 lb a.i./A ( Table IV.5 ). RQs were not derived for non-listed aquatic vascular plants because only nondefinitive EC 50 s are available and the risks to these speci es are discussed in the Risk Description section. There was an LOC exceedance for non-listed aquatic non-vascular plants exposed to potassium salts following aerial or ground applic ations at and greater than 63 lb a.i./A.

RQs for uses of ammonium salts at the maximu m label rate of 103.8 lb a.i./A fall below the Agency’s plant LOCs for aquatic plants (both vascular and nonvascula r) exposed to ammonium salts via aerial or 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 Pl ants for Potassium Salts of Fatty Acids
Use (Aerial or ground/ # apps/lb a.i./A) Mobility 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 aerial app @ 205 3.2

RQs not calculated due to no effects at the solubility limit 0.6 5* 8** 1 ground app @ 205 2.9 0.6 5* 7** 1 aerial app @ 116 1.8 0.4 3* 5** 1 ground app @ 116 1.6 0.3 3* 4**

1 aerial app @ 63 0.97 0.2 2* 3** 1 ground app @ 63 0.88 0.2 2* 2** 1 aerial app @ 10 0.16 0.03 0.3 0.4 1 ground app @ 10 0.14 0.03 0.2 0.4 1 aerial app @ 1.0 0.016 0.003 0.03 0.04 1 ground app @ 1.0 0.014 0.003 0.02 0.04 * Exceeds the nonlisted species LOC of 1.0 for plants; ** Exceeds the listed species LOC of 1.0 for plants.77 Table IV.6. Tier II Risk Quotients for Aquati c Plants for Ammonium Salts of Fatty Acids
Use (Aerial or ground/ # 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 aerial app @ 103.8 1.6 0.01 0.1 0.24 0.55 1 ground app @ 103.8 1.44 0.01 0.1 0.22 0.50

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 formulations of soap salts (e.g. potassium, ammonium and sodium salts of fa tty acids), and then directly compared to the dietary-based EECs generated from T-REX. For dose-based RQs, the EECs and toxicity values are first adjusted based on food intake and body weight diffe rences of the terrestrial animals prior to the assessment. The LD 50 and LC 50 are used to estimate acute risk for adverse effects on survival to both birds and mammals; the NOAEC is used to estimate chronic 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 >49,200 and >24,912 mg/kg-diet based on the maximum application potassium and ammonium salts rate, re spectively, is needed for the RQ to not exceed the LOC. The potential risk for acute and chronic exposure to birds is discussed 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.

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.78 Beneficial Insects

Potassium and ammonium salts are classified as practically nontoxic to honeybees on an acute exposure basis. Only non-defini tive endpoints are available and RQs were not calculated. More discussion on the ratio between the highest concen tration tested and the expected exposure is presented in the Risk Description section.

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

Tables IV.8 and IV.9 present RQs for the formulated pr oducts of potassium and ammonium salts, respectively, to terrestria l plants via ground and aerial spray applications. Of the registered uses, the RQs exceeded (RQ = 1.73 (potassium sa lts at 205 lb a.i./A) and RQs of 1.43 – 2.36 (ammonium salts at 63 and up to 103.8 lb a.i./A)) the LOC of 1.0 for risk to non-listed terrestrial plants and the RQs exceeded (RQs = 1.37 – 2.42 ( potassium salts at 116 and up to 205 lb a.i./A) and RQs of 2.1 – 4.72 (ammonium salts at 63 and up to 103.8 lb a.i./A) the LOC of 1.0 for risk to listed terrestrial plants located anyplace adjacent to treated areas as a result of offsite spray drift alone using aerial equipments. Howeve r, there was no LOC exceedance for non-listed terrestrial plants exposed to soap salts as a result of spray drift alone using ground equipments or from surface water runoff via aerial or ground applications.

RQs (1.14-13.26) for listed dicots exposed to potassium salts through a combination of surface water runoff and spray drift exceeded the plant LOC of 1.0 for plants inhabiting dry and semiaquatic areas adjacent to an use site treated w ith aerial applications; for those inhabiting semiaquatic areas adjacent to a site treated with gr ound applications at a rate of 63 lb a.i./A and higher; and for those inhabiti ng dry areas exposed to ground a pplications at the maximum potassium salt rate. For listed monocots inhabiting semi-aquatic areas adjacent to a treated site exposed to a combination of runoff and spray dr ift of potassium salts, the exceedances (RQs = 1.38 – 1.64) were observed at the maximum-labeled rate. No exceedances for listed monocots inhabiting dry areas. No exceedances for listed monocots and dicots inhabiting dry or semi-79 aquatic areas adjacent to a treated site exposed to ammonium salts as a combination of runoff and drift.

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

Maximum Labeled Rate for Potassium Salt Uses (205 lb a.i./A)
Ground spray
Monocot <0.1 <0.69 0.35 0.2 1.38 0.48 Dicot 0.11 0.8 0.11 1.59 11.14 0.47 Aerial spray
Monocot 0.23 0.82 1.73 0.46 1.64 2.42 Dicot 0.27 0.95 0.55 3.71 13.26 2.34 General Bin Rate for Potassium Salt Uses (116 lb a.i./A) Ground spray Monocot <0.1 0.39 0.2 0.11 0.78 0.27 Dicot <0.1 0.45 <0.1 0.9 6.3 0.26 Aerial spray Monocot 0.13 0.47 0.98 0.26 0.93 1.37 Dicot 0.15 0.54 0.31 2.10 7.50 1.32 General Bin Rate for Potassiu m Salt Uses (63 lb a.i./A) Ground spray Monocot <0.1 0.21 0.11 <0.1 0.42 0.15 Dicot <0.1 0.25 <0.1 0.49 3.42 0.14 Aerial spray Monocot <0.1 0.25 0.53 0.14 0.51 0.74 Dicot <0.1 0.29 0.17 1.14 4.08 0.72 General Bin Rate for Potassiu m Salt Uses (10 lb a.i./A) Ground spray 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 Aerial spray Monocot <0.1 <0.1 <0 .1 <0.1 <0.1 0.12 Dicot <0.1 <0.1 <0.1 0.18 0.65 0.11

1 RQs for ground and aerial spray applications in this table were calculated using the maximum application rates for potassium (205 lb a.i./A) salt uses and the general “bins” 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.

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

Maximum Labeled Rate for Ammonium Salt Uses (103.8 lb a.i./A) Ground spray80 Monocot <0.1 <0.22 0.17 <0.1 0.22 0.69 Dicot <0.1 <0.22 0.47 <0.1 0.22 0.94 Aerial spray Monocot <0.1 <0.26 0.84 <0.1 0.26 3.46 Dicot <0.1 <0.26 2.36 <0.1 0.26 4.72 General Bin Rate for Ammonium Salt Uses (63 lb a.i./A) Ground spray Monocot <0.1 <0.13 0.1 <0.1 0.13 0.42 Dicot <0.1 <0.13 0.29 <0.1 0.13 0.57 Aerial spray Monocot <0.1 <0.16 0.51 <0.1 0.16 2.10 Dicot <0.1 <0.16 1.43 <0.1 0.16 2.86 General Bin Rate for Ammonium Salt Uses (10 lb a.i./A) Ground spray Monocot <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 Dicot <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 Aerial spray Monocot <0.1 <0.1 <0 .1 <0.1 <0.1 0.33 Dicot <0.1 <0.1 0.23 <0.1 <0.1 0.45

1 RQs for ground and aerial spray applications in this table were calculated using the maximum application rates for ammonium (103.8 lb a.i./A) salt uses and the general “bins” 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.

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 fish (freshwater only), aquatic-phase amphibians, invertebrate s (both freshwater and estuarine/marine), and terrestrial and aquatic (nonvascular only) plants; and potential chronic effects to freshwater invertebrates starting mostly at the general ‘bin’ a pplication rate of 63 lb a.i./A and higher with the excepti on for invertebrates that the excee dance starts at 10 lb a.i./A.

Results of the risk estimation indicate that re gistered uses of ammoni um salts result in LOC exceedances for non-listed and listed terrestrial pl ants exposed to offsite spray drift via aerial sprays starting at the genera l ‘bin’ application rate of 63 lb a.i./A and higher.

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

LOCs were not exceeded for beneficial insects, es tuarine/marine fish, and aquatic vascular plants81 exposed to potassium or ammonium salts.

The following sections discuss the potential risk s of the soap salts to these taxonomic groups; however, because of the numerous uncertainties in this assessment, additional data is needed before EFED can make a definitive call on whet her effects to the Fede rally-listed endangered and threatened species recepto rs are likely if exposed.

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 general ‘bin’ application rate s coupled with the representative solubility. Environmental fate data were limited and largely based on EpiSu ite estimates. In addition, EECs from aerial applications are higher than ground applications due to the di fferences in the spray drift assumption (13% vs. 6.6%, respectively).

For sodium salts in mesh bags, it is unlikel y aquatic organisms would not be exposed to biologically significant concentratio ns of sodium salts in the environment as a result of surface water runoff and offsite spray drift; thus, aquatic organisms are excluded as aquatic receptors in this assessment and the adverse affects to aqua tic organisms are anticipated to be minimal.

IV.2.1.1 Risks to Aquatic Organisms

Potassium and Ammonium Salts of Fatty Acids For freshwater fish exposed to potassium salts app lied at and greater than the application rate of 63 lb a.i./A, the acute RQs of 0.1 – 0.35 were above the listed species LOC of 0.05 and the restricted use LOC of 0.1, with the highest RQ 7x above the listed species LOC. For both freshwater and estuarine/marine invertebrates, th e exceedances start at 10 lb a.i./A with these acute RQs ranging 0.1 – 5.6 and the highest RQ for freshwater and estuarine/marine invertebrates 100x and 54x, respectiv ely, above the listed species LO C. For ammonium salts, the exceedances (acute RQs 0.05-0.13 above LOC of 0.05) were seen only with freshwater organisms at and greater than 63 lb a.i./A, with the highest RQ 3x above the listed species LOC.

For estuarine/marine fish exposed to both salt s, acute 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 and at the solubility limit of 4.4 mg a.i./L for ammonium and potassium salts formulations, respectively.

There were chronic LOC exceedances observed onl y with freshwater invertebrates exposed to potassium salts applied at and greater than 116 lb a.i./A, with the highest RQ 2x above the chronic risk LOC. In contrast to freshwater invertebrates, no chronic LOC exceedances for freshwater fish and estuarine/marine invertebrate s based on the chronic toxicity values estimated from ACR calculations using trout, daphnid, a nd mysid data. Also, the chronic RQs were not derived for estuarine/marine fish using a non- definitive NOAEC that was calculated from the ACR method using minnow and daphnid data. A comparison of the non-definitive NOAEC at the solubility limit (>3.9 mg/L potassium sa lts; >105 ammonium salts) with the highest GENEEC 60-day EEC (0.32 mg/L) indicates th e estuarine/marine fish NOAEC is 12x to 328x82 greater than the environmentally relevant concen trations. An uncertainty to this chronic risk assessment still exists because the chronic RQs were based on these ACR-estimated toxicity values in absence of data; yet, potassium and ammonium salts need to be 25x to 50x more toxic to freshwater fish, 12x to 328x more toxic to es tuarine/marine fish, and 1.3x to 125x more toxic to estuarine/marine invertebrates, respectively, th an the ACR-estimated toxicity values to exceed the chronic LOC from a single appl ication. Because it is unlikely for soap salts to be more toxic than the ACR-estimated values to result in LOC exceedances, the submission of reproduction studies with aquatic organisms are not required to address the uncertainty.

To further characterize the potenti al for chronic risk, EFED eval uated the likelihood that chronic exposures will be higher than those derived assu ming one application. Current labels are 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 be tween applications. Thus if repeated applications were to oc cur it is unclear what the impact will be on longer-term (chronic) average exposure concentrations. To test th e impact, alternative modeling was conducted to analyze whether additional applica tions coupled with the shortest re application interval of 7 days could result in higher chronic exposure to aquati c organisms that may exceed the chronic LOC. Table IV.10 presents the aquatic EECs calculations generated from GENEEC2 for multiple ground applications of soap salts using the same default assumptions previously used. Due to uncertainty whether the high applica tion rate at 205 lb a.i./A is act ually broadcast or spot treated the aerial applications were excluded from this evaluation. The modeling indicates the concentrations, regardless the number of applicat ions, increased only by 3%; this suggests that higher long-term exposures to aquatic organisms fr om repeated applications are unlikely. Thus, it is not likely that chronic expos ure with repeated applications would increase enough in the long term to affect aquatic organisms.

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

There is uncertainty with the a quatic risk assessment for some uses particularly those with the highest application rates. From th e labels for selected uses (e.g. residential lawn, golf course turf, ornamental lawn/turf, recreational area lawn, and industrial/commercial lawn), it is unclear if the applications are broadcast across the landscap e or represent spot treatments. EFED has completed the aquatic risk assessment using an assumption that the high rates are broadcast ( Table IV.11 ). In making this assumption, EFED believes that exposure estimates for aquatic resources are possibly overly cons ervative for those uses that ma y be spot treated because the83 underlying assumption in the aquatic models is that 100% of the field is treated with the pesticide. In order to better characterize the im portance of this assumption on the overall risk conclusions EFED has provided an estimate of th e threshold of spot treatment for each taxa where the LOC would no longer be exceeded. As an example EFED estimated that for the highest application rate (i.e. 205 lbs a.i./acre) for freshwater fish if a site were only spot treated at less than 16% of the entire fiel d the LOC would not be exceeded and no effect would be likely for this use. If the % of actual area treated is higher than the estimated threshold, EFED believe that the potential for a direct eff ect to that taxa exists. However, EFED does not have information to allow for an estimate of what is a reasonabl e assumption of a maximum percentage of a field that may be spot treated that can be used to dete rmine what % of area is a typical spot treatment. Also, the existing labels do not specify whether any of the registered uses can only be spot treated. Additional data are needed on how much % of an area a typical spot treatment is before EFED can make a definitive call on whether effects are likely from these uses. Until a determination for listed species can be made, the risks of soap salts to aquatic organisms from spot treatments at high applicati on rates are uncertain. Only potassi um salts was assessed in the example.

Table IV.11 Percentage of Exposure 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
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 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 No exceedance

Estuarine/marine invertebrates (acute effects) 205 2 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 No exceedance

Freshwater invertebrate (chronic effects) 205 2 50% 116 1 100% 63 0.5 No exceedance Estuarine/marine invertebrates 205 0.8 No exceedance84 (chronic effects)

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

Non-listed = 1.0 Listed = 1.0 No exceedance

0.6 No exceedance Aquatic nonvascular plants (non-listed and listed effects) 205 5 20% 116 3 33% 63 2 50% 10 0.3 No exceedance 205 7 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 mu ch percent of exposure th at RQ needs to exceed the LOC. For example, the highest acute RQ for freshwater invertebrates inhabiting a pond adjacent a field applied at 205 lb a.i./A is 5 which is 100 times higher than the listed species LOC of 0.05; to assess 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 since it is unknow n what % of an actual area is typical spot treatment.

The Agency believes there is no direct effect to aquatic organisms, for fatty acid salts of chain length C14 and higher, because such fatty acids are not sufficiently soluble in environmental water for toxic effects to be expressed. For shor ter chain-length fatty acids (C9 – C11) there is uncertainty, because the available toxicity data is not clear as to what chain-length mixtures were tested. However, acute toxicity data for n early pure nonanoic (pelargonic) acid, which is representative of the shorter chain-length fatty ac ids, indicate that it does not reach levels of concern with a Tier I exposure assessment. Overall, the Agency is uncertain that soap salts as a group will cause direct effects to listed aquatic species.

RQs were not derived for aquatic vascular plants, 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 ). However, for Listed vascular plants, no LOC was exceeded. For algae and diatoms, the Non-lis ted and Listed plant LOC exceedances were triggered at and greater than 63 lb a.i./A. As discussed above and in Table IV.11 , if a site were only spot treated at less than 14% of the entire field at the maximum 205 lb a.i./A rate, the LOC would not be exceeded and no effect to listed aquatic nonvascular plants would be likely for this use. Additional data are needed on how much % of an area a typical spot treatment at the high application rates is before EFED can make a de finitive call on whether effects are likely from these uses.85 There is some uncertainty to the LOC exceedances for non-target aquatic plants inhabiting a pond adjacent the treated site sin ce characterization suggests that if treatment occurs to only a portion of the use site by spot treatment in many cases the percen tage of the site treated would need to be significant to yield sufficient loadi ng to an adjacent water body to produce a toxic concentration., EFED believes given the chemical nature of soap sa lts that it is unlikely for soap salts to maintain its activity beyond or farther th an the targeted area in a runoff event when the pesticide moves with water to a farm pond. This is supported by laboratory studies that stability was a problem because the salts rapidly degrade; no salts were detected at the end of the 96- hours studies. In addition, the stud ies also observed the salts to be algistatic to algae/diatoms. This suggests its algicidal activity as a contact pesticide only exists at the time of application and would not be maintained beyond the target ed area. Overall, as indicated in Table IV.11 , the Agency is uncertain whether soap salts as a gro up will cause a direct effects to Listed aquatic plants. Thus, an “uncertain” determinati on is made for listed aquatic plants.

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 th reatened species. Risks to terre strial species (i.e. birds, mammals and plants) exposed to potassium and ammonium salts are assessed based on modeled estimated environmental concentrations (EECs) and available toxicity data. Dose-based and dietary-based EECs for the ecological exposure to the acute and chronic toxicity values of potassium and ammonium salts are estimated using T-REX ( Tables III.4, III.5, and III.6 ) and surface water runoff and spray drift EECs are estimated using TerrPlant ( Table III.7 ).

Direct ingestion of sodium salts mesh bags on treated areas is pred icted as the most likely source of exposure to wildlife because it is unlikely th at significant concentrations 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. 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 exposure of wildlife to th e sodium salts is not anticipated.

IV.2.2.1 Risks to Birds

Available avian acute toxicity data indicates th at the salts are practic ally 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 and dietary avian studies. There is some uncertainty to the T-REX EECs calculated that re sulted in exceedances of the LOCs if the nondefinitive endpoints were used as definitive endpoints. T-REX EECs are more suitable for predicting maximum residue levels for low-to-mod erate use application ra tes no more than 10 lb a.i./A or less, not as high as 205 lb a.i./A that automatically trigger the exceedances at the maximum doses tested. Furthermore, numerous ecological studies observed no mortality or sublethal effects in birds at doses as high as 5,000 - 10,000 mg/kg diet, the potential for acute risk to86 birds from exposure to potassium and amm onium 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 majo r component in wildlife’s diet. 1 Fatty acids or animal fats are also consumed in humans. 2 In addition to human consumpti on, 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 soap salt is unlikely; thus, a “no e ffect” determination is made for listed birds.

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 effects to mammals are expected to be minimal. Thus, a “no effect” determination is made for listed mammals.

IV.2.2.3 Potential Effects to Terrestrial Invertebrates

The available terrestrial insect toxicity data, based on tests wi th honeybees, indicate that the formulation 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. Risk to beneficial insects in the direct treatment area exposed to soap salts is expected to be minimal

However, other terrestrial insect s or invertebrates could be imp acted since potassium salts are registered as an insecticide a nd acaricide. Ammonium and sodium salts are not registered for use as an insecticide. With no toxicity data availabl e for insects, honey bees we re used as a surrogate for insects. In making this assumption for terrestr ial arthropods, the weight of a bee was used to convert μg a.i./bee to a μg a.i./g (ppm) concen tration and then compare this toxic level to concentrations expected on terr estrial arthropods that are sprayed on directly. The maximum concentration expected on te rrestrial arthropods after one application at the maximum application rate is 19,270 ppm ( Table III.4 ). If the Agency’s LOC fo r terrestrial arthropods is 0.05, this toxic level has to be at or greater th an 385,400 ppm to not exceed the LOC. To convert bee endpoints to terrestrial arthropod e ndpoints, 96.04 μg a.i./bee (MRID 45060901) was selected for conversion as 20% b ee mortality, the highest mortality of all data, occurred at this high dose. Assuming the average fresh weight of a bee is 0.128 g, the LD 50 of bees can be multiplied by 7.8 (1 bee ÷ 0.128 g) to determine the arthropod endpoint in ppm. The resulting terrestrial arthropods endpoint is 749 μg a.i./g (ppm). With maxi mum exposure concentrations of the maximum application rates ranging 94 pp m - 19,270 ppm, the RQs of 0.13 - 26 exceeds the

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, 1998.87 terrestrial arthropod LOC of 0.05 at and greater than 1 lb a.i/A, with the highest RQ 520x above the LOC. Overall, there is stil l significant uncertainty with th e use patterns both in terms of labeled use rates and proximity of use sites to liste d species, as well as uncertainty with available toxicity data to state with confidence that there is a direct effect from soap salts to terrestrial invertebrates..

While the honeybee was relatively insensitive to in secticidal soap, it is reported potassium salts are relatively selective in toxicity based on the insect species and stage of development. Softbodied insects such as aphids, whiteflies, and mealy bugs are more susceptible to soaps. The least affected are flying adult insects with heavie r cuticle, such as ladybird beetles; however, insects in the immature, flightless stage of de velopment can be vulnerable to the effects of potassium salts. 4 Thus, not all terrestrial arthropods but those that are small and soft-bodied including hard-bodied ones during larval development would be se nsitive when exposed directly to potassium salt applications.

Lastly, formulated as a contact insecticide, it is unlikely the adverse affect of the use patterns would be maintained beyond the targ et area since potassium salts ar e effective only against those insects that come into direct contact; however, an “uncer tain” determination would be appropriate for listed terrestrial arthropods since it is uncertain whether lis ted arthropods inhabit the use sites at the time of treatment.

IV.2.2.4 Risk to Terrestrial Plants

The risk to non-target plants is uncertain because TERRPLANT does not account for the rapid degradation of soap salts before or during runo ff. Based on the available data, monocots are less sensitive to soap salts than dico ts, and generally vegetative vigor is a more sensitive life-stage than seedling emergence. The RQs for runoff to semi-aquatic areas result in the highest RQs. This scenario represents a 10 acr e area running off into a one acre area. While the potassium salts RQs for listed dicots range up to 13 (aerial app lication at the maximum application rate of potassium salts at 205 lb a.i./A), the highest listed monocot RQ is 1.6 for the same application; however, non-listed dicots and mono cots were not affected.

For ammonium salts, the highest RQ for the same scenario above is 0.26 (aer ial application at the maximum application rate of 103.8 lb a.i./A amm onium salts), which is below the plant LOC of 1.0. Risk to non-target plants exposed as a resu lt of receiving surface wate r runoff contaminated with ammonium salts 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.

RQs also exceed the non-listed and listed LOC for exposure to drift alone for both potassium

4 http://greenmethods.com/site/weblog/2009/05/understanding-insecticidal-soaps-and-detergents88 (ground and aerial application) a nd ammonium salts (aerial applic ation only), with the highest RQs no higher than 3 for potassium salts and 5 fo r ammonium salts. There is not currently a vetted way to refine the risk posed by runoff, but to some degree, the area of exposure is reduced with distance from the application site. The Te rrPlant assumptions for runoff, that sheet flow will result in a one to one area of exposure and th at channelized runoff will result in a ten to one ratio of areas exposed do not take distance from application into consider ation and assumes equal deposition across the non-target ar ea. These assumptions also c onsider only solubility, while other chemical attributes, such as K oc , likely affect the amount of soap salts deposited on the non-target areas.

Risk from drift alone can be refined using AgDRIFT. AgDRIFT was used to determine the distance from the edge of field where the RQ falls below the LOC for each of the species ( Tables IV.12-IV.14 ) for both aerial and ground applicati on for the highest application rates (205 lbs a.i./A potassium salts and 103.8 lb a.i. /A ammonium salts). M odel defaults for each scenario were used.

Table IV.12 Distance (feet) from the edge of field where the Potassium Salts RQ falls below the risk to terrestrial plant LOC fo r vegetative vigor and seedling emergence endpoints for aerial application, based on AgDRIFT EECs for the aerial application at 205 lbs a.i./A.

Plant Species Vegetative Vigor Seedling Emergence

EC 25 NOAEC Nonlisted (feet) Listed (feet) EC 25 NOAEC Nonlisted (feet) Listed (feet)

Corn 5.91 4.239 112 154 62.6 62.34 1 1

Oat >68.08 68.08 1 1 >62.34 62.34 1 1

Onion >68.08 68.08 1 1 >62.34 62.34 1 1

Ryegrass >68.08 68.08 1 1 >62.34 31.17 1 1

Bean 20.72 8.104 13 82 >62.34 31.17 1 1

Cucumber 23.05 16.208 10 23 >62.34 62.34 1 1

Oilseed
rape 18.50 4.38 (EC05) 20 151 >62.34 15.58 1 23

Radish 57.27 16.208 1 23 53.9 3.865 1 158

Soybean 30.55 16.208 3 23 >62.34 62.34 1 1

Tomato 21.73 16.208 13 23 >62.34 62.34 1 189 Table IV.13 Distance (feet) from the edge of field where the Potassium Salts RQ falls below the risk to terrestrial plant LOC fo r vegetative vigor and seedling emergence endpoints for ground application, based on AgDRIFT EECs for the ground application at 205 lbs a.i./A.

Plant Species Vegetative Vigor Seedling Emergence

EC 25 NOAEC Nonlisted (feet) Listed (feet) EC 25 NOAEC Nonlisted (feet) Listed (feet)

Corn 5.91 4.239 1 7 62.6 62.34 1 1

Oat >68.08 68.08 1 1 >62.34 62.34 1 1

Onion >68.08 68.08 1 1 >62.34 62.34 1 1

Ryegrass >68.08 68.08 1 1 >62.34 31.17 1 1

Bean 20.72 8.104 1 1 >62.34 31.17 1 1

Cucumber 23.05 16.208 1 1 >62.34 62.34 1 1

Oilseed
rape 18.50 4.38 (EC05) 1 7 >62.34 15.58 1 1

Radish 57.27 16.208 1 1 53.9 3.865 1 7

Soybean 30.55 16.208 1 1 >62.34 62.34 1 1

Tomato 21.73 16.208 1 1 >62.34 62.34 1 190 Table IV.14. Distance (feet) from the edge of field where the Ammonium Salts RQ falls below the risk to terrestrial plant LOC fo r vegetative vigor and seedling emergence endpoints for aerial application, based on AgDRIFT EECs for the aerial application at 103.8 lbs a.i./A.

Plant Species Vegetative Vigor * Seedling Emergence

EC 25 NOAEC Nonlisted (feet) Listed (feet) EC 25 NOAEC Nonlisted (feet) Listed (feet)

Corn 6.2 1.5 16 141 >100 100 1 1

Oat 9.8 6.3 95 94 >100 100 1 1

Onion >6.3 6.3 1 1 >100 100 1 1

Ryegrass >6.3 6.3 1 1 >100 100 1 1

Bean 27 6.3 16 144 >100 100 1 1

Cucumber 6.6 1.3 (EC05) 16 164 >100 100 1 1

Oilseed
rape 2.9 1.5 72 141 >100 100 1 1

Radish 5.8 0.094 20 >997 >100 100 1 1

Soybean 4.4 1.5 203 623 >100 100 1 1

Tomato 2.2 1.1 (EC05) 10 49 >100 100 1 1
*Highest concentration for tomato was 6.3 lb a.i./A. For corn, oilseed rape, cucumber, onion, ryegrass, and radish

, highest concentration was 22 lb a.i./A. For bean, oat, and soybean , highest concentration was 94 lb a.i./A.

For potassium and ammonium salts, vegetative vigor is a much more sensitive life stage than seedling emergence, thus greater impacts on this life stage shoul d be expected to non-target plants as well. Aerial applica tions result in considerably more drift than ground sprays, and so impacts are expected farther from the field edge for aerial applicati ons. Application rate is a key variable in determining the distan ce effective drift is expected to travel, so ground applications of potassium salts at 205 lbs a.i./A wi ll have an impact at greater distance from the application area than ammonium salts at the 103.8 lbs a.i./A rate.

For non-listed species exposed to both potassium and ammonium sa lts, most are not expected to be at risk greater than 20 feet from the edge of the application area. Th e big exception is plants with similar sensitivity as corn, where effect s on vegetative vigor exposed to potassium salts could be expected 112 feet from the field edge at the maximum application rate tested for potassium salts (68 lbs a.i./A) from aerial a pplication. For non-liste d species exposed to ammonium salts at a rate of 94 lb a.i./A, the aerial applicatio n could also induce effects at 203 feet or less for species with se nsitivities similar to soybean.

The sensitivity of species in the submitted studies is not easily translated directly into specific sensitivity of listed plant species and the range of sensitivities needs to be broadly applied as potentially representative of the variations th at may be found in na tural population of listed plants. However, for the purposes of this risk as sessment, it is assumed that all listed species are91 as sensitive as the most sensitive monocot or dicot species in the available data.

Given this assumption, aerial applica tions of the 68 lbs a.i./A potassi um salts rate could affect the vegetative vigor of listed dicot plants 151 feet from the edge of the field and listed monocot plants out to 154 feet. The s eedling emergence of dicots coul d be affected out to 158 feet, although the seedling emergence of monocots is not likely to be a ffected. Ground applications at this rate could affect the vege tative vigor of listed dicots a nd monocots out to 7 feet. The seedling emergence of listed dicots may be affe cted out to 7 feet, although listed monocots are unlikely to be affected.

For ammonium salts at 94 lbs a.i./A, applied vi a aerial spray, the vegetative vigor of listed monocots may be affected 141 feet from the edge of the field while dicots as sensitive as radish could be affected >997 feet from the edge. The seedling emergence of listed dicots and monocots are not likely to be affected.

An uncertainty exists on the application methods for some uses particularly those with the high application rates in that it is unclear if aer ial applications are permitted in the labels. The terrestrial plant risk assessment i ndicates that soap salts is more toxic to plants when exposed to the foliage via spray drift than through the ro ots (using vegetative vigor data which is more sensitive as a surrogate for foliar sensitivity) as a re sult of surface water runoff. However, if it is assumed that no aerial applicati ons are allowed per current labe ls and only ground applications are allowed then the distance for spray drift is re duced to 7 feet. This assumption reduces the risk to non-target plants adjacent to a treated site exposed to soap salts as a result of spray drift and runoff from ground applications. Al so, model defaults including fi ne to medium droplet spectra were used to calculate the distan ces. If alternative assumptions are made with a coarser droplet spectra then that would further reduce risk from spray drift.

Similar to the aquatic risk assessment, the labels for selected uses at high application rates are unclear if the applications are broadcast across the landscape or represent spot treatments. EFED has completed the terrestrial plant risk assessment using an assumption 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 effect determin ation for listed terrestrial plants would be likely for this use. Additional data are needed on how much % of an area a typical spot treatment at the high application rates is before EFED can make a definitive call on whether effects are likely from these uses. Both potassium and ammonium salts were assessed.92 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.

Overall, an “uncertain” determination is made for listed terrestrial plants from the registered uses of soap salts given the high degree of un certainty associated with labeled uses.


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

Section 7 of the Endangered Species Act, 16 U. S.C. Section 1536(a)(2), requires all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and anadromous listed species, and/or the United States Fish and Wildlife Service (USFWS) for listed wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species or their designated critic al habitat. Each federal agen cy is required under the Act to ensure that any action they aut horize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. To jeopardize the continued existence of a listed species means "to engage in an action that reasonably would be expected, directly or indirect ly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in th e wild by reducing the reproduction, numbers, or distribution of the species" (50 C.F.R. § 402.02).

To facilitate compliance with the requirements of the Endangered Species Act (subsection (a)(2)), the Office of Pesticide Programs has es tablished procedures to evaluate whether a proposed registration action may directly or indi rectly appreciably reduc e the likelihood of both the survival and recovery of a listed species in the wild by re ducing the reproduction, numbers, or distribution of any listed sp ecies (USEPA, 2004). After the Agency’s screening level risk93 assessment is conducted, if any of the Agency’s listed species’ LOCs are exceeded for either direct or indirect effect s, an analysis is conducte d to determine if any lis ted or candidate species may co-occur in the area of the proposed pest icide use or areas downstream or downwind that could be contaminated from drift or runoff/erosi on. If listed or candidate species may be present in the proposed action area, further biological as sessment is undertaken. The extent to which listed species may be at risk is considered, whic h then determines the ne ed for the development of a more comprehensive consultation package, as required by the Endangered Species Act.

The federal action addressed herein is the re gistration review of pot assium, ammonium, and sodium salts of fatty acids on agricultural use sites it is expected th at its use could occur nationwide.

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.

V.2. Taxonomic Groups Po tentially at Risk

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 risk94 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. For soap salts ( Table V.1 -Potassium/Ammonium; and Table V.2 -Sodium), the ecological risk assessment along with a number of uncertainties suggest that the potential probab ility of a direct effect to a certain taxon cannot be determined un til the uncertainties are addressed.

Table V.1. Preliminary Conclusions for Potential Di rect Effects to Federally Listed Taxa Associated with the Registered Uses of Potassium and Ammonium Salts, Based on Best Available Data.

Listed Plant Taxon Potential Direct Effects

Terrestrial and semi-aquatic plants – monocots and dicots Uncertain – LOC exceedances we re observed for broadcast applications; uncertain if LOC exceedances exists for spot treatments at high application rates Aquatic plants

Listed Animal Taxon Potential Direct Effects

Acute Notes Chronic Notes

Terrestrial invert ebrates Uncertain While soap salts are used as insecticides, bee

toxicity data indicate low

toxicity N/A No tools available to measure chronic effects

Mammals No effect No toxic effects at highest dose tested No effect Undergo rapid degradation in less than a day, unlikely for wildlife to consume 100% of diet in treated spots, and fatty acid is an important diet for wildlife, chronic effects are not likely Birds No effect No toxic effects at highest dose tested No effect

Reptiles No effect Based on birds as surrogate No effect

Terrestrial-phase Amphibians No effects No effect

Freshwater fish Uncertain LOC exceedances No effects No LOC exceedances95 Table V.1. Preliminary Conclusions for Potential Di rect Effects to Federally Listed Taxa Associated with the Registered Uses of Potassium and Ammonium Salts, Based on Best Available Data.

Listed Plant Taxon Potential Direct Effects

Aquatic-phase Amphibians were observed for broadcast applications; uncertain if LOC

exceedances exists for spot
treatments at high application
rates No effects

Freshwater invertebrates Uncertain LOC exceedances were observed for broadcast applications; uncertain if LOC exceedances exists for spot treatments at high application
rates

Estuarine/marine fish No effects No LOC exceedances Estuarine/marine invertebrates No effects

Table V.2. Preliminary Conclusions for Potential Di rect Effects to Federally Listed Taxa Associated with the Registered Uses of Sodium Sa lts, Based on Best Available Data.

Listed Plant Taxon Potential Direct Effects

Terrestrial and semi-aquatic plants – monocots and dicots No Effect

Aquatic plants No Effect

Listed Animal Taxon Potential Direct Effects

Acute Notes Chronic Notes

Terrestrial invertebrates No Effect The one active product registration is a

low volume,

minor use product intended for homeowner use only, typically hanging bags, which results in N/A The one active product registration

is a low volume, minor use product intended for homeowner use only, typically hanging bags, which results in low potential for runoff

and spray drift; Mammals No Effect No Effect

Birds No Effect No Effect Reptiles No Effect No Effect Amphibians No Effect No Effect

Freshwater fish

No Effect No Effects Freshwater invertebrates

Estuarine/marine fish96 Table V.2. Preliminary Conclusions for Potential Di rect Effects to Federally Listed Taxa Associated with the Registered Uses of Sodium Sa lts, Based on Best Available Data.

Listed Plant Taxon Potential Direct Effects

Estuarine/marine invertebrates low potential for runoff and spray drift; significant concentrations are not expected

to reach the receptors. This use pattern is not expected to

result in meaningful
exposure. significant concentrations are

not expected to reach the receptors. This use pattern is

not expected to result in meaningful
exposure.

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 pot assium and/or ammonium salts on par with the acute toxicity endpoint selected for RQ calculation. To accomplish this interpretation, the Agency uses the slope of the dose-response relati onship available from the toxicity study used to establish the acute toxicity measures of eff ect for each taxonomic group except plants 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.

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. In addi tion, the probability of an individua l effect is also derived based on the highest calculated acute RQ following one application at 205 lb a.i./A for maximum exposure and at 63 lb a.i./A where most of the exceedances were triggered.97 Table V.3. Summary of Soap Salt 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.) 1,2,3
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) 1 in 26.5 (1 in 11.7 to 1 in 88.4) A

1 in 5.22E+7 (1 in 741 to 1 in 3.49E+6) B

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) 1 in 1 (1 in 1 to 1 in 1) C
1 in 1.4 (1 in 1.6 to 1 in 1.3) D

Estuarine/marine Invertebrates Mortality Default Slope = 4.5 (2 – 9) 1 in 4.18E+08 (1 in 216 to 1 in 1.75E+31) 1 in 1 (1 in 1.2 to 1 in 1) E
1 in 3 (1 in 2.36 to 1 in 5.22) F

1 Highest acute RQ for freshwater fish = A 0.35 (1 app. @ 205 lb a.i./A); B 0.1 (1 app. @ 63 lb a.i./A).
2 Highest acute RQ for freshwater invertebrates = C 5.6 (1 app. @ 205 lb a.i./A); D 1.5 (1 app. @ 63 lb a.i./A).
3 Highest acute RQ for estuar ine/marine invertebrate = E 2.7 (1 app. @ 205 lb a.i./A); F 0.8 (1 app. @ 63 lb a.i./A).

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, rainbow trout) and the hi ghest derived RQ value is 1 in 26.5 following one application at 205 lb a.i./A and is 1 in 52,200,000 following one application at 63 lb a.i./A. This reflects a slope of 3.9. The chance of an individual effect for freshwater and estuarine/marine invertebrates, based on the daphnid and mysid, respectively, are both 1 in 1.

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 uncertainties have been addressed, this analysis has not been conducted for this assessment.

VI. References98 HERA, 2003. Fatty Acid Salts (Soap) Envir onmental Risk Assessment Draft. Human & Environmental Risk Assessment on ingred ients of European household cleaning products. Sept. 2003, 61 pp. found at www.heraproject.com

. 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

------------------ ------------------ ----------------- ------------------ -------------- AMMONIUM 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, 1979.99 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.

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: 40053303100 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

------------------ ------------------ ----------------- --------------- --------------- ------------ 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, 1996.101 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. 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: 42806406102 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)

------------------ ------------------ ----------------- ------------------ -------------- 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 )103 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 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.: 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 available104 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 available
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, 2011.105 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

------------------ ------------------ ----------------- ------------------ -------------- 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 available106 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 performed 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 available107 

### 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)

--------------------------------------------------------------------108 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 .0109 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 INCORP110 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 DAY111 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)

--------------------------------------------------------------------112 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 .20113Appendix B. Incident Reports12EIIS Pesticide Summary Report: Species Information3Potassium salts of fatty acids (079021)4Incident #SpeciesScientific NameMagnitudeResponseRt. Exposure5PLANTS6Cherry7I008521-0018cherryPrunus sp.6 acresplant damageTreated directly9I008521-00210cherryPrunus sp.all .5 acresplant damageTreated directly1112Incident #DateCountyStateCertaintyLegal.Formul.Appl. MethodTotal Magnitude13PLANTS14Cherry15I008521-0026/18/1998YAKIMAWA3RUN/RBroadcast3.5 ACRES16I008521-0013/9/1999YAKIMAWA3RUN/RBroadcast6 ACRES1718