1 OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON

, D.C. 20460

November 30, 2011

PC Code: 090112

MEMORANDUM DP Barcode: 373577

SUBJECT: Penthiopyrad (MTF-753): Section 3 New Chemical Environmental Fate and Ecological Risk Assessment

FROM: Christina Wendel, Biologist Greg Orrick, Environmental Scientist

Environmental Risk Branch II

Environmental Fate and Effects Division (7507P)

THROUGH: Brian Anderson, Branch Chief Jean Holmes, Risk Assessment Process Leader Kristina Garber, Se nior Biologist James Lin, Environmental Engineer

Environmental Risk Branch II

Environmental Fate and Effects Division (7507P)

TO: Tawanda Maignan, Risk Manager Reviewer Tony Kish, Risk Manager Fungicide Branch, RM Team 22 Registration Division (7505P)

The Environmental Fate and Effects Division (EFED) has completed its ecological risk assessment for the new fungicide penthiopyrad, wh ich includes proposed new uses on alfalfa,

brassica vegetables, bulb vegetables , canola, cereals (excluding rice and wild rice), cotton, cucurbits, fruiting vegetables, leafy vegetables , low growing berries (including cranberries), peanuts, pome fruits, root and tuber vegetabl es and leaves, stone fruits, succulent and dry legumes, sunflowers, tree nuts (including pistach ios and excluding pecans), turf (including sod farms and any landscaped areas) and landscape or namentals. Four end use formulations of penthiopyrad are proposed for regi stration in the United States. These include Fontelis (20% active ingredient (a.i.)), a suspension concentrat e (SC) for a range of agricultural uses; Vertisan (20% a.i.), an emulsifiable concentrate (EC) for a range of agricultural uses ; Treoris (8.9% a.i.), a suspension concentrate (SC) c ontaining 22.3% chlorothalonil and for a range of agricultural uses; and Velista (50% a.i.), water dispersibl e granules (WG) for us e on turf and landscape

ornamentals.

The results of this assessment indicate that th e proposed uses of penthiopyrad other than canola-Page 2 of 166- have the potential for direct a dverse effects on listed freshwater fish (a surrogate for aquaticphase amphibians). Also, acute effects on listed estuarine/marine fish and invertebrates (via spray drift from Fontelis formulation) cannot be precluded. The proposed use on cranberries results in potential direct adve rse acute effects on listed and non-listed freshwater fish (a surrogate for aquatic-phase amphibians); acute effects on listed freshwater invertebrates, estuarine/marine fish and invertebrates; chronic effects to freshwater fish and estuarine/marine

invertebrates 1 ; and acute effects on listed estuarine/marine fish and invertebrates (via spray drift from the Fontelis formulated product). All prop osed uses of penthiopyrad result in potential

direct adverse chronic effects on listed and non-liste d mammals. Due to effects seen at the single application rate for both terres trial monocot and dicot plant sp ecies in the seedling emergence and vegetative vigor toxicity tests and the absence of establishing an NOAEC or EC05, risk to terrestrial plants and animals with obligate relati onships with plants are assumed to exceed LOCs for listed species. Based on the submitted toxicity data for the formulations of penthiopyrad, exposure to penthiopyrad may adve rsely affect sensitive arthr opod species including honeybees. Toxic effects were observed in honeybees and beneficial insects at and below proposed application rates of penthiopyrad. Although at this time risk to th ese taxa cannot be quantified, it is possible that adverse effects to terrestrial invertebrates, in cluding pollinators and beneficial insects, may occur based on exposure to the F ontelis, Vertisan, and/or Treoris formulated products of penthiopyrad in a nd around the use areas of the proposed uses of penthiopyrad. Therefore, levels of concern were exceeded for a ll taxonomic groups for either direct or indirect

effects.

In order to result in no LOC exceedances for all list ed aquatic organisms, the application rate for the proposed use of highest exposure using the PE model (succulent legumes) would have to be reduced to one treatment per year at 0.29 lbs a.i. /A. The application rate for the proposed use

with the smallest LOC exceedance (sugarbeets) would have to be reduced to 2 treatments per year at 0.27 lbs a.i./A or the propos ed application rate of 0.39 lbs a.i./A could be limited to one treatment per year in order to result in no LO C exceedances. If the proposed use on succulent legumes is reduced to one treatment per year at 0.39 lbs a.i./A, then the chronic LOC is not exceeded for any size class of mammals that cons ume aquatic prey. The application rate for the proposed use on cranberries would have to be re duced to one treatment per year at 0.055 lbs

a.i./A in order to result in no LOC exceedances for listed aquatic organisms.

Based on the environmental fate and transport characteristics of pe nthiopyrad, the following surface water label advisory is recommended.

For surface water:

“This product may impact surface wate r quality due to runoff of rain water. This is especially true fo r poorly draining soils and soils with shallow ground water. This product is classified as having high potential for reaching surface water via runoff for several weeks after application. A level, well-maintained vegetative buffer strip between areas to which

1 Based on the refined cranberry model calculated EEC values, and derived acute and chronic RQs. The Tier I rice model calculated EEC value results in potential direct advers e acute and chronic effects to all aquatic organisms, as well as aquatic non-vascular plants.-Page 3 of 166- this product is applied a nd surface water features such as ponds, streams, and springs will reduce the potential loadi ng of this chemical from runoff water and sediment. Runoff of this pr oduct will be reduced by avoiding applications when rainfall is foreca sted to occur within 48 hours.”

All of the available ecological effect and environmental fate studies that were submitted to fulfill data requirements under 40 CFR Pt. 158 for aquatic and terrestrial food and non-food uses are

tabulated in Appendices H and I . Also tabulated are the stud y classifications and whether

additional data are needed for the risk assessmen t. The following paragraphs describe the notable gaps in the data set for penthiopyrad.

Data gaps and needs for penthiopyrad include:

 a passerine subacute dietary st udy using the penthiopyrad TGAI

 an oyster BCF study using the penthiopyrad TGAI;

 an estuarine/marine invertebrate (mysid) ch ronic toxicity study using the penthiopyrad TGAI;

 estuarine/marine aquatic invertebrates (mysid and oyster) acute toxicity studies using the Fontelis (DPX-LEM17 20SC) formulation;

 an estuarine/marine fish acute toxicity study using the Fontelis formulation;

 a Tier II seedling emergence study usi ng the Fontelis formulation; and

 a Tier II vegetative vigor study us ing the Fontelis formulation.

Additional data gaps for penthiopyrad that are considered low value to risk assessment include:

 an avian reproduction toxicity study with the bobwhite quail using the penthiopyrad TGAI; and

 an acute contact honeybee toxicity study using the penthiopyrad TGAI.



### Description of Importance of Data Gaps to Risk Assessment:

As a result of the new 40 CFR Part 158 data requ irements, avian acute oral data are now required for one passerine species in addition to either a waterfowl or upland game species for all new federal actions including Section 3 new chemical registrations. An avian oral toxicity study was submitted for a passerine species exposed to penthiopyrad; however, the submitted study was not

able to establish a lethal dose due to significant (treatment re lated) regurgitation. However, because regurgitation was observed at every leve l and this effect is assumed to be a toxic response to the chemical exposure, an effect dose (ED 50 ) was calculated using regurgitation as the effect, as a LD 50 (lethal dose) could not be determined from the doses tested. In addition, the available acute oral toxicity data for the bobwhite quail, when compared to estimated

environmental concentrations of penthiopyrad, indicate that LOCs are not exceeded for birds on an acute basis. Currently, EFED policy requires that the lack of accepta ble passerine data be listed as a data gap. In the absence of data, risk will be assumed for passerine birds at the current application rates. However, due to the treatm ent-related regurgitation of the test compound for passerine species, a subacute di etary toxicity study using th e passerine species is more appropriate to assess risk to non- target passerine bird species. Therefore, an acute dietary toxicity study with a passerin e species using the pe nthiopyrad technical is recommended to characterize risk to passerine sp ecies. Submission of a protoc ol for the passerine subacute-Page 4 of 166- dietary study is al so recommended.

The log K OW of penthiopyrad (4.62) results in chr onic risk LOC exceedances in KABAM for small mammals (shrews and moles) that consum e benthic invertebrates. LOCs were not exceeded for mammals (minks and otters) that do not consume benthic invertebrates because these mammals consume fish and penthiopyrad is readily metabolized in fish. Study-derived

metabolism rates in fish cannot be extrapolated to metabolism rate s in benthic invertebrates since the latter may uptake and depurate compounds slower or faster than fish. Therefore, there is concern for bioaccumulation of penthiopyrad in be nthic invertebrates. An oyster BCF study to

address this concern would be va luable to the risk assessment and can be used to evaluate

whether risk conclusions for small mammals can be revised. More spec ifically, uptake and depuration rates observed in an oyster BCF study are needed to represent metabolism/depuration in benthic invertebrates in exposure modeling with KABAM (metabolism is conservatively

assumed not to occur in KABAM in the absence of measured values). If a submitted oyster BCF study indicates that metabolism in benthic invertebrates is substa ntial, then risk conclusions could change ( i.e. , chronic risk LOCs may not be exceeded for any mammals that consume benthic invertebrates).

Estuarine/marine invertebrates are of particular concern as availa ble acute toxicity data for the penthiopyrad technical i ndicate that estuarine/marine invert ebrates are more sensitive than

freshwater invertebrates on an acute exposure basis. However, no chronic toxicity data is

available for estuarine/marine inve rtebrates. In the absence of data, an acute to chronic ratio (ACR) was derived using freshwater invertebra te toxicity data. Based on the estimated estuarine/marine invertebrate NOAEC using th e ACR, the Agency’s chronic risk LOC is exceeded for the proposed penthiopyrad use on cra nberries (using both the Tier I Rice model and additional provisional model refine ments). There is an exposure potential for estuarine/marine invertebrates to be exposed to penthiopyrad from the proposed use on cranberries, as cranberries in Massachusetts are grown along Cape Cod, near coas tal areas. As a result, there is concern for chronic risk to estuarine/marine invertebrates; th erefore, an estuarine/marine invertebrate lifecycle toxicity study with the mysid would alleviat e this concern. In the absence of additional data, chronic risk to estuarine/marine invertebra tes will be estimated using the ACR derived from freshwater toxicity data.

In addition, the Fontelis formulation was appr oximately 40 times more toxic to freshwater invertebrates than the penthi opyrad technical (TGAI), and no data on this formulation are

available for saltwater invertebra tes. Therefore, based on these results, the Fontelis formulation toxicity to estuarine/marine invertebrates is not known, and could potentia lly be more toxic than

the freshwater invertebrates as was the case with the TGAI. There is the potential for

estuarine/marine invertebrates to be exposed to the penthiopyrad Fontelis formulation (via spray drift); therefore to be able to fully characterize and describe the risk to estuarine/marine

invertebrates associated with a pplication of the Fontelis formul ation acceptable estuarine/marine invertebrate toxicity studies would be valuable to this as sessment. In the absence of

estuarine/marine invertebrate acute toxicity data, risk to estuar ine/marine invertebrates exposed to the Fontelis formulation via spray drift is presum ed to exceed LOCs due to elevated toxicity of this formulation observed in other species and LO C exceedances based on TGAI toxicity data.-Page 5 of 166- Although estuarine/marine fish appe ar to be less sensitive to the Fontelis formulation compared with freshwater fish, the available estuarine/ marine fish toxicity study was classified as supplemental and does not satisfy the data requirement for an acute estuarine/marine fish toxicity study with the penthiopyrad Font elis formulation. Although the test material was mixed using a top-down mixer there is still concern that the samples may not represent only soluble penthiopyrad concentrations, and is not considered suitable for use within the risk assessment. There is the potential for estuar ine/marine fish to be exposed to the penthiopyrad Fontelis formulation (via spray drift); therefore, to alle viate the uncertainty and to be able to fully

characterize and describe the risk to estuarine/ma rine fish associated w ith application of the Fontelis formulation, an acceptable estuarine/marine fish toxicity study is needed. In the absence

of estuarine/marine fish acute toxi city data, risk to estuarine/mari ne fish exposed to the Fontelis formulation via spray drift is presumed to exceed concern levels due to elev ated toxicity of this

formulation and due to LOC exceedances ba sed on the TGAI toxicity data.

Tier II seedling emergence and vegetative vigor studies would reduce the uncertainty regarding risk to listed species. Without a valid/definitive NOAEC value, risk to listed plant species would be assumed to an undefined area around the applicat ion site. However, there were less than 25%

effects observed at a level above the highest proposed a pplication rate, risks to non-listed plants

and indirect effects to listed an imals with no obligate relationships with plants can be discounted. However, risk to listed plants and animal s with obligate relationships with plants cannot be

discounted as direct risk to lis ted plants is assumed. Tier II seedling emergence and vegetative vigor toxicity studies with a defined, definitive NOAEC would a lleviate uncertainty for listed species. Therefore, EFED recommends request ing a Tier II seedling emergence study using ryegrass, wheat, and tomato, and a Tier II vegetative vigor study using wheat and soybean.

Available avian chronic toxicity data for the pe nthiopyrad technical indi cate that the control mortality in this study (12.5%; 3 females and 1 male out of 16 pairs) exceeded the limit for an acceptable study (OCSPP, form. OPTTS 850.2300). The effects that were seen in the necropsies

of the dead control birds also raise concerns relati ng to potential impact s on reproduction of the other control birds, resulting in an overall decreased eggs laid mean for the control birds. As a result, risk may potentially be underestimated. Submittal of an acceptable avian reproduction toxicity study using bobwhite quail for penthiopyrad technical, completed in accordance with OPPTS 850.2300 would eliminate the data gap, ho wever, the available information for the mallard duck is sufficient to complete estimation of risk to non-target birds (surrogate for terrestrial-phase amphibians and reptiles) on a ch ronic exposure basis, an d therefore, a new study

is not needed at this time. EFED recommends not requesting a new study, as an acceptable mallard avian reproduction study is available. Ho wever, the avian reprod uction guideline is not fulfilled and EFED recommends that the Agency re serve the right to request a new study if it is deemed necessary in the future.

The acute contact honeybee study with the pent hiopyrad technical (TGA I) does not satisfy the data requirement, as a negative control was not tested concurrently with the solvent control during this study. Submittal of an acceptabl e honeybee acute contac t toxicity study for penthiopyrad technical, completed in accordance with OPPTS 850.3020 would eliminate the data gap. However, as no effects were seen in th e treatment group or the solvent control, EFED believes that a new study would not likely be of high value to this assessment. Therefore, the-Page 6 of 166- acute contact honeybee study using the penthiopyrad technical (TGAI) guideline is not fulfilled and EFED recommends that the Agency reserve th e right to request a new study if it is deemed necessary in the future.-Page 7 of 166- 

## Environmental Fate and Ecological Risk Assessment for the Registration of the New Chemi cal Penthiopyrad (MTF-753)

Penthiopyrad

CAS 183675-82-3 PC Code 090112

Prepared by: Greg Orrick, Environmental Scientist Christina Wendel, Biologist U.S. Environmental Protection Agency Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch II 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington, DC 20460 Reviewed by: Kristina Garber, Senior Biologist James Lin, Environmental Engineer Jean Holmes, Risk Assessment Process Leader Brian Anderson, Branch Chief-Page 8 of 166- Table of Contents

1. Executive Summary ............................................................................................................. .............................. 10

1.1. Nature of Chem ical Stressor ................................................................................................... .................. 10

1.2. Exposure Charact eriza tion ..................................................................................................... ................... 10

1.3. Effects Charact eriza tion ...................................................................................................... ..................... 11

1.4. Potential Risks to N on-target Organisms........................................................................................ .......... 12

1.5. Data Gaps and Uncertainties ................................................................................................... ................. 14

2. Problem Formulation ................................................................................................. ....................................... 17

2.1. Nature of Regu latory Action ................................................................................................... ................. 17

2.2. Stressor Source an d Distribution .............................................................................................. ................ 18

2.2.1. Nature of the Chemical Stressor ................................................................................. ....................... 18

2.2.2. Overview of Pesticide Usage ................................................................................................... .......... 18 2.3. Receptors ........................................................................................................ ......................................... 19

2.3.1. Aquatic and Terrest rial Effects ............................................................................................... ........... 19

2.3.2. Ecosystems Poten tially at Risk ................................................................................................ .......... 19

2.4. Assessment En dpoints .......................................................................................................... .................... 20 2.5. Conceptual Model .................................................................................................. ................................... 20

2.5.1. Risk Hypotheses ............................................................................................................... ................. 20

2.5.2. Conceptual Diagram ............................................................................................................ .............. 20 2.6. Analysis Plan ....................................................................................................... ....................................... 21

2.6.1. Residues of Concern ........................................................................................................... ............... 21

2.6.2. Measures of Exposure .......................................................................................................... ............. 22

2.6.3. Measures of Effect ............................................................................................................ ................. 26

2.6.4. Integration of Expos ure and Effects ........................................................................................... ....... 27 3. Analysis ............................................................................................................ ................................................ 28

3.1. Use Character ization........................................................................................................... ...................... 28

3.2. Exposure Charact eriza tion ..................................................................................................... ................... 31

3.2.1. Environmental Fate and Tran sport Character ization ......................................................................... 31

3.2.1.1. Transport an d Mob ility

........................................................................................................ .... 32

3.2.1.2. Degrada tion ................................................................................................................... ........... 33

3.2.1.3. Bioaccumula tion ............................................................................................................... ....... 34

3.2.1.4. Field St udies ................................................................................................................. ........... 35

3.2.1.5. Environmental Degradates ...................................................................................................... . 36

3.2.2. Measures of A quatic Exposure .................................................................................................. ........ 38

3.2.2.1. Surface Water Exposure ........................................................................................................ .. 38

3.2.2.2. Ground Water Exposure ......................................................................................................... . 46

3.2.2.3. Aquatic Bioacc umulation ....................................................................................................... .. 47

3.2.3. Measures of Terrest rial Exposure .............................................................................................. ........ 49

3.2.3.1. Terrestrial Wildlife .......................................................................................................... ........ 49

3.3. Ecological Effects Characteri zation ........................................................................................... .............. 51

3.3.1. Aquatic Toxicity Characteriz ation ............................................................................................. ........ 52

3.3.2.1. Toxicity to Fres hwater Fish ................................................................................................... .. 54

3.3.2.2. Toxicity to Freshwat er Invertebrates ....................................................................................... 56

3.3.2.3. Toxicity to Estuarin e/Marine Fish ........................................................................................... 6 1

3.3.2.4. Toxicity to Estuarine/Ma rine Invertebrates ............................................................................. 62

3.3.2.5. Toxicity to Aq uatic Plants .................................................................................................... ... 63

3.3.2 Terrestrial Effects Characteri zation .......................................................................................... ......... 66

3.3.2.1. Toxicity to Birds ............................................................................................................. ......... 68

3.3.2.2. Toxicity to Mammals ........................................................................................................... .... 70

3.3.2.3. Toxicity to Terrestrial Inverteb rates and Benefici al Insects .................................................... 72

3.3.2.4. Toxicity to Terr estrial Pl ants ................................................................................................ ... 77

4. Risk Charact erization ......................................................................................................... ................................ 78

4.1 Risk Estim ation ............................................................................................................... ......................... 78-Page 9 of 166- 4.1.1. Aquatic Organisms ...................................................................................................... ............................. 78

4.1.1.1. Aquatic An imals ............................................................................................................... ....... 79

4.1.1.2. Aquatic Pl ants ................................................................................................................ .......... 82 4.1.2. Terrestrial Organisms .................................................................................................. ............................. 83

4.1.2.1. Birds ......................................................................................................................... ................ 83

4.1.2.2. Mammals ....................................................................................................................... .......... 84

4.1.2.3. Terrestrial In vertebra tes ..................................................................................................... ...... 85

4.1.2.4. Non-target Terrestrial and Semi-Aquatic Plants ...................................................................... 85

4.2. Risk Desc ription .............................................................................................................. ......................... 86

4.2.1. Risks to Aqua tic Animals ...................................................................................................... ............ 87

4.2.1. Risks to Aqua tic Plan ts ....................................................................................................... ............... 89

4.2.2. Risks to Terrestr ial Organisms ................................................................................................ .......... 90 4.2.2.1. Birds, Te rrestrial-Phase Amphi bians and Reptile s ..................................................................... ...... 90

4.2.2.2. Mammals .............................................................................................................. ............................ 92

4.2.2.3. Terrestria l Inverteb rates............................................................................................. ....................... 96

4.2.2.4. Terrestrial Plants ................................................................................................... ............................ 98

5. Federally Threatened and Endanger ed (Listed) Speci es Concerns ................................................................. ... 99

5.1. Action Ar ea ................................................................................................................... ........................... 99

5.2. Taxonomic Groups Pote ntially at Risk .......................................................................................... ......... 100

5.2.1. Probit Dose-Resp onse Analysis ................................................................................................. ..... 102

5.2.2. Listed Species Occurrence Associat ed with Penthiopyrad Use ....................................................... 104

6. References .................................................................................................................... .................................... 105

6.1. Submitted Product Chemistry and En vironmental Fate Studies ............................................................. 108

6.2. Submitted Ecotoxi city St udies ................................................................................................. ............... 111

6.3. Chlorothalonil Ecotoxicity Studies Disc ussed (Previously Submitted) .................................................. 122 Appendix A. STIR v.1.0 (Screening To ol for Inhalation Ri sk) Input/O utput ..................................................... ..... 124 Appendix B. Chemical Names, Structures, and Maximum Reported Amounts of Penthiopyrad and Its Degradates.

.............................................................................................................................. ..................................................... 126 Appendix C. Aquatic Mo del Input/Out put Data. ................................................................................. ..................... 130 Appendix D. Example T-REX Output for Penthiopyrad. ........................................................................... .............. 135 Appendix E. Penthiopyrad De gradate Toxic ity Summary. ......................................................................... .............. 136 Appendix F. Comparison of Treoris Formulation and the Chlorothalonil Activ e Ingredient (TGAI) Toxicity. ...... 140 Appendix G. Provisional Tier I Cranberry Mode l Equatio ns. .................................................................... .............. 141 Appendix H. Submitted Ec ological Effects Studies fo r Penthiopyrad and Analysis of Data Gaps. ......................... 144 Appendix I. Submitted Environmental Fate Studies for Penthiopyrad. ........................................................... ......... 16410 

## 1. Executive Summary

1.1. Nature of Chemical Stressor

Penthiopyrad ( i.e. , MTF-753, DPX-LEM17, or (RS)-N-[2 -(1,3-dimethylbutyl)-3-thienyl]-1- methyl-3-(trifluoromethyl)-pyrazole-4-car boxamide; CAS# 183675-82-3), is a pyrazole carboxamide in the succinate dehydrogenase in hibitor (SDHI) class of fungicides. The compound is nonvolatile, lipophilic, moderately mobile in soil, and is not expected to bioaccumulate in fish. Penthiopyrad is proposed fo r use on a wide range of agricultural crops as well as turf and landscape ornamentals.

Four end-use formulations of penthiopyrad are proposed for registration in the United States. These include Fontelis (20% active ingredient (a .i.)), a suspension concentrate (SC) for a range of agricultural uses; Vertisan (20% a.i.), an emulsifiable concentrate (EC) for a range of agricultural uses; Tr eoris (8.9% a.i.), a suspension c oncentrate (SC) co-formulated with chlorothalonil (22.3% a.i.) for a range of agricultural uses; and Velista (50% a.i.), a water dispersible granule (WG) for use on tu rf and landscape ornamentals.

The proposed maximum single and annual applica tion rates for penthiop yrad are 0.95 and 2.9 pounds of active ingredient per acre (lbs a.i./A), respectively, on turf (Velista). Fontelis, Vertisan and Treoris each have proposed maxi mum single and annual application rates of 0.39 and 0.94 lbs a.i./A, respectively for selected agricultural uses.

1.2. Exposure Characterization

Penthiopyrad is a racemic mixture of enantiomers that undergo slight en antiomeric selectivity (mostly to the S-isomer) in studied soils. The compound is non-volatile, lipophilic, and moderately mobile in soil. Penthiopyrad is not expected to bioaccumulate in fish; however, the compound may bioaccumulate in benthic invertebrates. Indirect photolysis in soil is the fastest route of penthiopyrad degradati on (half-life of 6.4 days); howe ver, the compound persists in many compartments of the environment, dissipat ing in shaded and aquatic areas by slow aerobic biodegradation (half-life of 60-406 days) a nd slow leaching (Freundlich organic carbonnormalized partition coefficient (K FOC ) range of 560-900 L/kg OC ). Penthiopyrad does not undergo hydrolysis or photolysis in water bod ies. The compound persists in anaerobic conditions. Depending on the soil type, the co mpound may slowly move to ground water via leaching and may move to surface water bodies via spray drift, runoff of dissolved or sorbed residues, and transport of dissolved residues in ba se flow from shallow ground water. Terrestrial field dissipation study results ar e relatively consistent with those of the laboratory studies, showing that the chemical dissipates by degrad ation and slow leaching, with dissipation halflives ranging from 2.2 to 44 days (laboratory study half-lives ranged from 6.2 to >365 days).

Major identified environmental degradates of penthiopyrad are PAM, PCA, DM-PCA, and carbon dioxide (chemical names a nd structures are provided in Appendix B ). Additional minor degradates were increasing in concentration at study termination and may have become major degradates if the studies were continued. PAM, PCA, and DM-P CA are cleavage products that retain the pyrazole ring of the parent compound. These three major degradates were persistent11 and highly mobile in studies of penthiopyrad. Compounds with trifluorom ethyl groups, such as penthiopyrad, may slowly form hydrofl uorocarbons in the environment.

Aquatic exposure estimates reflect environments where indirect photolysis does not occur. Where indirect photolysis occurs, exposure estim ates and associated RQs may be 38-43% lower than reported in this assessment.

1.3. Effects Characterization

Penthiopyrad is classified as moderately to hi ghly toxic to freshwater fish and freshwater invertebrates and moderately toxic to estuarine/marine fish and es tuarine/marine invertebrates on an acute exposure basis. Mort ality and sublethal e ffects were observed in most of the acute aquatic animal studies for penthiopyrad. Observed sublethal effects included loss of equilibrium, lying on the bottom of the test chamber, lethargy, surfacing, hype rventilation, haemorrhage, and reduced activity. The available acute t oxicity data for the Treoris (DPX-QFA61 SC) formulation, which contains 8.91% penthiopyra d and 22.3% chlorothalonil, show that it is approximately 28 to 137 times more toxic than the penthiopyrad active ingredient alone to freshwater fish, freshwater invertebra tes, and aquatic non-vascular plants ( Appendix F ). Although the Treoris formulation is more toxic than technica l grade penthiopyrad, further

examination of the available data indicate that chlorothalonil, not penthi opyrad, likely accounts for the toxicity of this formulation. In addition, the available toxicity datafor the Fontelis (DPXLEM17 20SC) formulation which contains 20% pe nthiopyrad show that it is approximately 42 times more toxic than the penthiopyrad techni cal grade active ingredient to freshwater

invertebrates. Chronic effects to freshwater fi sh were based on treatmen t-related effects on the larval survival and growth (total length and weight ). Chronic effects to freshwater invertebrates ( Daphnia ) were based on treatment-related reductions in first-generation survival (immobility), reproduction (mean number of live offspring per su rviving adult), and term inal length. Benthic sediment toxicity testing with spiked sedime nt indicates that the compound does partition to sediment. Exposure of benthic invertebrates resu lted in a 34% reduction in emergence rate. All available aquatic toxicity data show that metabolites of penthi opyrad are less toxic to aquatic animals and plants than the parent penthiopyrad.

Penthiopyrad is classified as practically non-toxic to avian species on an acute oral and subacute dietary-exposure basis; however, treatment-re lated regurgitation was observed in zebra finch dosed with technical penthiopyrad. The lowest no observed adverse effect [dietary] concentration (NOAEC) in an avian reproducti on study (1520 mg a.i./kg diet) wa s based on a reduction in the number of eggs laid and eggs set by mallard ducks . Penthiopyrad is classi fied as practically nontoxic to mammals on an acute oral exposure basi s. A two-generation reproduction study of rats

resulted in a no observed adve rse effect level (NOAEL) of 38 mg a.i./kg-bw/day based on reduced body weight gain in first generation (F 1 ) adult males, increased li ver weight in parental (P) and F1 adult females and increased relative adrenal weight with in creased incidence of cortical hypertrophy in F1 females. Some sublethal effects were observed in the acute terrestrial animal studies for penthiopyrad, including body wei ght gain in the subacute dietary study with the bobwhite quail.

Based on the available data, direct adverse effects to terrestrial invertebrates are considered low for penthiopyrad technical, but not for the formul ations. It is possible that adverse effects to12 terrestrial invertebrates, including pollinators and beneficial insects, may occur based on exposure to the Fontelis, Vertis an, and/or Treoris formulated products in and around the use areas of the proposed uses of penthiopyrad. Howeve r, at this time, risk to these taxa cannot be quantified.

Results of the Tier I seedling emergence and vegetative vigor studies with the Fontelis

formulation indicate that there were significant effects that were less than 25% in magnitude

relative to controls obse rved at a level above the highest pr oposed application rate, risks to nonlisted plants and indirect effects to listed anim als with no obligate relatio nships with plants are below concern levels. Risk to listed plants a nd animals with obligate re lationships with plants are above concern levels. Ryeg rass, wheat (monocots), tomato, and soybean (dicots) exhibited treatment related, statistically significant, reducti ons at the limit concentration relative to the negative control. Although Tier II studies are not triggered becuase no effects were greater than 25%, Tier II studies would reduc e the uncertainty re garding Endangered Sp ecies assessments. Without a valid/definitive NOAEC value, risk to listed plant species would be assumed to an undefined area around the appli cation site. The results of these tests indicate that some terrestrial plants may be sensitive to penthiopyrad exposure.

1.4. Potential Risks to Non-target Organisms

The results of this assessment indicate that the proposed uses of pe nthiopyrad (except use on canola) result in LOC exceedances for listed freshwater fish (a surrogate for aquatic-phase amphibians). The potential for acute effects on liste d estuarine/marine fish and invertebrates (via spray drift from the Fontelis formulation) canno t be precluded. The pr oposed use on cranberries results in additional LOC exceedances, including exceedances for acute effects on listed and non-listed freshwater fish (a surrogate for aqua tic-phase amphibians); acute effects on listed freshwater invertebrates, estuarine/marine fish and invertebrates; chronic effects to freshwater

fish and estuarine/marine invertebrates 2 ; and acute effects on listed estuarine/marine fish and invertebrates (via spray drift from the Fontelis formulation) . All proposed uses of penthiopyrad result in LOC exceedances for chronic effects on listed and non-listed mammals. In addition, due to effects seen at the singl e application rate for both terr estrial monocot and dicot plant species in the seedling emergence and vegetative vigor toxicity tests, risk to terrestrial plants and animals with obligate relationships with plan ts are presumably above concern levels.

Although concern levels were not exceeded for risk to aquatic plants, birds, terrestrial-phase amphibians, and reptiles, indirect effects to these taxa are po ssible, given the potential for

adverse acute effects to freshwat er fish, aquatic-phase amphibian s, estuarine/marine fish and invertebrates (via spray drift of the Fontelis formulation, which cannot be precluded), chronic

effects to terrestrial mammals and adverse effects to terrestrial plants. Potential effects include, but are not limited to, reduction in food resources, decrease in cover, change in water quality parameters, and loss of breeding/nesting habitat. Id entified potential direct and indirect risks to listed species that may result from the proposed us es of penthiopyrad (except use on cranberries)

are summarized in Table 1.1. The potential direct and indirect risk to listed species that may

2 Based on the refined cranberry model calculated EEC values, and derived acute and chronic RQs. The Tier I rice model calculated EEC value results in potential direct advers e acute and chronic effects to all aquatic organisms, as well as aquatic non-vascular plants.13 result from the proposed cranberry use is summarized in Table 1.1a. In addition, it is possible

that adverse effects to terrestria l invertebrates, including pollinato rs and beneficial insects, may occur based on exposure to the Fontelis, Vertisa n, and/or Treoris formul ated products in and around the use areas of the proposed uses of penthi opyrad. However, at this time, risk to these taxa cannot be quantified. Ther efore, no taxonomic groups could be excluded from being at risk

from either direct or indirect effects at this time.

Table 1.1. Potential Effects to Federally List ed Taxa Associated with Direct or Indirect Effects from the Proposed Uses of Penthiopyrad (all uses except cranberries).

Listed Taxon Direct

Effects Uses of Concern Indirect

Effects Uses of Concern

Terrestrial and semiaquatic plants -

monocots Yes All uses Yes 2 All uses

Terrestrial and semiaquatic plants - dicots Yes All uses Yes 2 All uses

Birds No None Yes 1,2,3 All uses Terrestrial-phase amphibians No None Yes 1,2,3 All uses

Reptiles No None Yes 1,2,3 All uses

Mammals Yes All uses Yes 1,3 All uses

Terrestrial invertebrates Yes a All uses Yes 1 All uses Aquatic vascular and non-vascular plants No None Yes 3 All uses

Freshwater fish Yes All uses except canola Yes 1,3 All uses Aquatic-phase

amphibians Yes All uses except canola Yes 1,3 All uses

Freshwater

invertebrates No None Yes 1,3 All uses

Mollusks No None Yes 1,3 All uses

Marine/estuarine fish Yes b All uses Yes 1,3 All uses

Marine/estuarine

invertebrates Yes b All uses Yes 1,3 All uses

Sediment-dwelling organisms No None Yes 3 All uses

a RQs were not calculated due to lack of a standard quantification methodology for non-listed species. Therefore, the

‘LOC exceedance’ was based on lines of evidence includi ng application rate, toxicity data (both pollinators and beneficial insects), and the mode of action of penthiopyrad.

b Risk cannot be precluded via spray drift of the Fontelis formulation to water bodies with lack of data for the

Fontelis formulation for estuarine/marine fish and invertebrates.

Potential indirect effects on a taxon attributable to:

1 direct effects on plants (t errestrial and semi-aquatic)

2 direct chronic effects on mammals

3 direct acute effects on freshwater fish and aquatic-phase amphibians14 Table 1.1a. Potential Effects to Federally List ed Taxa Associated with Direct or Indirect Effects from the Proposed Uses of Penthiopyrad on Cranberries*.

Listed Taxon Direct

Effects Uses of Concern Indirect

Effects Uses of Concern

Terrestrial and semiaquatic plants -

monocots Yes All uses Yes 2 All uses

Terrestrial and semiaquatic plants - dicots Yes All uses Yes 2 All uses

Birds No None Yes 1,2,3 All uses Terrestrial-phase amphibians No None Yes 1,2,3 All uses

Reptiles No None Yes 1,2,3 All uses

Mammals Yes All uses Yes 1,3 All uses

Terrestrial invertebrates Yes a All uses Yes 1 All uses Aquatic vascular and non-vascular plants No None Yes 3 All uses

Freshwater fish Yes Cranberry Yes 1,3 All uses Aquatic-phase

amphibians Yes Cranberry Yes 1,3 All uses

Freshwater

invertebrates Yes Cranberry Yes 1,3 All uses

Mollusks Yes Cranberry Yes 1,3 All uses

Marine/estuarine fish Yes b Cranberry Yes 1,3 All uses

Marine/estuarine

invertebrates Yes b Cranberry Yes 1,3 All uses

Sediment-dwelling organisms No None Yes 3 All uses

* Based on the refined cranberry model calculated EEC values, and derived acute and chronic RQs. The Tier I rice model calculated EEC value results in potential direct advers e acute and chronic effects to all aquatic organisms, as well as aquatic non-vascular plants.

a RQs were not calculated due to lack of a standard quantification methodology for non-listed species. Therefore, the

‘LOC exceedance’ was based on lines of evidence includi ng application rate, toxicity data (both pollinators and beneficial insects), and the mode of action of penthiopyrad.

b Risk cannot be precluded via spray drift of the Fontelis formulation to water bodies with lack of data for the

Fontelis formulation for estuarine/marine fish and invertebrates.

Potential indirect effects on a taxon attributable to:

1 direct effects on plants (t errestrial and semi-aquatic)

2 direct chronic effects on mammals

3 direct acute effects on freshwater fish and invertebrates, aquatic-phase amphibians, estuarine/marine fish and invertebrates; and direct chronic effect s on freshwater fish and estuarine/marine invertebrates (based on the refined cranberry model calculated EEC values, and derived acute and chronic RQs).

1.5. Data Gaps and Uncertainties

As a result of the new 40 CFR Part 158 3 data requirements, avian acute oral data are now required for one passerine species in addition to either a waterfowl or upland game species for all new federal actions including Section 3 new chemi cal registrations. An av ian oral toxicity study was submitted for a passerine species exposed to penthiopyrad; however, the submitted study

was not able to establish a lethal dose due to treatment-related regurgi tation. In addition, the

3 CFR 2011. http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&sid=55aa15659b5f49d286f1a93853dc7a2d&tpl=/ecfrbrowse/Title40/40cfr158_main_02.tpl15 available acute oral toxicity data for the bobwhite quail, when compared to estimated

environmental concentrations of penthiopyrad, indicate that LOCs are not exceeded for birds on an acute exposure basis. Because an apparent treatment-related regurgitation occurred in the submitted passerine study, a subacute dietary toxi city study using the passerine species and the penthiopyrad TGAI is more approp riate to assess risk to non-tar get passerine bird species.

In addition, other data needs and/ or data gaps needed to obtai n a complete risk picture for penthiopyrad include:

 a passerine subacute dietary st udy using the penthiopyrad TGAI

 an oyster BCF study using the penthiopyrad TGAI;

 an estuarine/marine invertebrate (mysid) ch ronic toxicity study using the penthiopyrad TGAI;

 estuarine/marine invertebrates (mysid and oyster) acute toxicity studies using the Fontelis formulation;

 an estuarine/marine fish acute toxicity study using the Fontelis (DPX-LEM17 20SC) formulation;

 a Tier II seedling emergence study usi ng the Fontelis formulation; and

 a Tier II vegetative vigor study us ing the Fontelis formulation.

The log K OW of penthiopyrad (4.62) results in chr onic risk LOC exceedances in KABAM for small mammals (shrews and moles) that consum e benthic invertebrates. LOCs were not exceeded for mammals (minks and otters) that do not consume benthic invertebrates because these mammals consume fish and penthiopyrad is readily metabolized in fish. Study-derived

metabolism rates in fish cannot be extrapolated to metabolism rate s in benthic invertebrates since the latter may uptake and depurate compounds slower or faster than fish. Therefore, there is concern for bioaccumulation of penthiopyrad in be nthic invertebrates. An oyster BCF study to

address this concern would be va luable to the risk assessment and can be used to evaluate

whether risk conclusions for small mammals can be updated. More spec ifically, uptake and depuration rates observed in an oyster BCF study are needed to represent metabolism/depuration in benthic invertebrates in exposure modeling with KABAM (metabolism is conservatively

assumed not to occur in KABAM in the absence of measured values). If a submitted oyster BCF study indicates that metabolism in benthic invertebrates is substa ntial, then risk conclusions could change ( i.e. , chronic risk LOCs may not be exceeded for any mammals that consume benthic invertebrates).

Estuarine/marine invertebrates are of particular concern as availa ble acute toxicity data for the penthiopyrad technical i ndicate that estuarine/marine invert ebrates are more sensitive than

freshwater invertebrates on an acute exposure basis. However, no chronic toxicity data is

available for estuarine/marine inve rtebrates. In the absence of data, an acute to chronic ratio (ACR) was derived using freshwater invertebra te toxicity data. Based on the estimated estuarine/marine invertebrate NOAEC using th e ACR, the Agency’s chronic risk LOC is exceeded for the proposed penthiopyrad use on cra nberries (using both the Tier I Rice model and additional provisional model refine ments). There is an exposure potential for estuarine/marine invertebrates to be exposed to penthiopyrad from the proposed use on cranberries, as cranberries in Massachusetts are grown along Cape Cod, near coas tal areas. As a result, there is concern for chronic risk to estuarine/marine invertebrates; th erefore, an estuarine/marine invertebrate life-16 cycle toxicity study with the mysid would alleviat e this concern. In the absence of additional data, chronic risk to estuarine/marine invertebra tes will be estimated using the ACR derived from freshwater toxicity data.

In addition, the Fontelis formulation was appr oximately 40 times more toxic to freshwater invertebrates than the penthi opyrad technical (TGAI), and no data on this formulation are

available for saltwater invertebra tes. Therefore, based on these results, the Fontelis formulation toxicity to estuarine/marine invertebrates is not known, and could potentia lly be more toxic than

the freshwater invertebrates as was the case with the TGAI. There is the potential for

estuarine/marine invertebrates to be exposed to the penthiopyrad Fontelis formulation (via spray drift); therefore to be able to fully characterize and describe the risk to estuarine/marine

invertebrates associated with a pplication of the Fontelis formul ation acceptable estuarine/marine invertebrate toxicity studies would be valuable to this as sessment. In the absence of

estuarine/marine invertebrate acute toxicity data, risk to estuar ine/marine invertebrates exposed to the Fontelis formulation via spray drift is presumed to exceed LOCs due to elevated toxicity of this formulation observed in other species and LOC exceedances based on TGAI toxicity data.

Although estuarine/marine fish appe ar to be less sensitive to the Fontelis formulation compared with freshwater fish, the available estuarine/ marine fish toxicity study was classified as supplemental and does not satisfy the data requirement for an acute estuarine/marine fish toxicity study with the penthiopyrad Font elis formulation. Although the test material was mixed using a top-down mixer there is still concern if the samples repres ent only soluble penthiopyrad concentrations, and is not consid ered suitable for use within the risk assessment. There is the potential for estuarine/marine fi sh to be exposed to the penthi opyrad Fontelis formulation (via spray drift). To alleviate the uncertainty and to be able to fully characteri ze and describe the risk

to estuarine/marine fish associ ated with application of the F ontelis formulation, an acceptable estuarine/marine fish toxicity study is needed. In the absence of estuarine/marine fish acute toxicity data, risk to es tuarine/marine fish exposed to the F ontelis formulation via spray drift is presumed to exceed concern levels due to elevated t oxicity of this formulation and due to to LOC exceedances based on the TGAI toxicity data.

Tier II seedling emergence and vegetative vigor studies would reduce the uncertainty regarding risk to listed species. Without a valid/definitive NOAEC value, risk to listed plant species would be assumed to an undefined area around the applicat ion site. However, there were less than 25%

effects observed at a level above the highest proposed a pplication rate, risks to non-listed plants

and indirect effects to listed animals with no obligate relations hips with plants do not exceed LOCs. However, risk to listed plants and animals with obligat e relationships with plants do exceed listed species LOCs. Tier II seedling emergence and vegetative vigor toxicity studies with ryegrass, wheat, tomato, and soybean with a defined, definitive NOAEC would alleviate uncertainty for listed species.

In addition, other data gaps for penthiopyrad that are of low value to risk assessment include:

 an avian reproduction toxicity study with the bobwhite quail using the penthiopyrad TGAI; and

 an acute contact honeybee toxicity study using the penthiopyrad TGAI.17 Available avian chronic toxicity data for the pe nthiopyrad technical indi cate that the control mortality in this study (12.5%; 3 females and 1 male out of 16 pairs) exceeded the limit for an acceptable study (OCSPP, form. OPTTS 850.2300). The effects that were seen in the necropsies

of the dead control birds also raise concerns relati ng to potential impact s on reproduction of the other control birds, resulting in an overall decreased eggs laid mean for the control birds. As a result, risk may potentially be underestimated. Submittal of an acceptable avian reproduction toxicity study using bobwhite quail for penthiopy rad technical, completed in accordance with OPPTS 850.2300 would eliminate the data gap, ho wever, the available information for the mallard duck is sufficient to complete estimation of risk to non-target birds (surrogate for terrestrial-phase amphibians and reptiles) on a ch ronic exposure basis, an d therefore, a new study

is not needed at this time.

The acute contact honeybee study with the pent hiopyrad technical (TGA I) does not satisfy the data requirement, as a negative control was not tested concurrently with the solvent control during this study. Submittal of an acceptabl e honeybee acute contac t toxicity study for penthiopyrad technical, completed in accordance with OPPTS 850.3020 would eliminate the data gap, however, the observed toxicity appears to be low for the technical grade material, and a new study would not likely be of high value to this assessment.



## 2. Problem Formulation

The purpose of this problem formulation is to pr ovide the foundation for the environmental fate and ecological risk assessment for the registra tion of the new chemical penthiopyrad. This problem formulation sets the objectives for the ri sk assessment, establishes a risk hypothesis and conceptual model depicting ris k, and provides a plan for analyz ing the data and characterizing the risk associated with the proposed uses of penthiopyrad (USEPA, 1998a).

2.1. Nature of Regulatory Action

This assessment was prepared to support the new chemical registration of penthiopyrad. As a new fungicide being proposed for use in the Un ited States, the U.S. Environmental Protection Agency (EPA or the Agency) is required under the Federal Insect icide, Fungicide, and Rodenticide Act (FIFRA) to ensu re that penthiopyrad does not have the potential to cause

unreasonable adverse effects to th e environment. In addition to non-target animals and plants, potential effects to listed species ( i.e. , species on the federal list of endangered and threatened wildlife and plants) are also c onsidered under the Endangered Species Act (ESA) in order to ensure that the registration of penthiopyrad is no t likely to jeopardize the continued existence of such listed species or adversely modify their critical habitat. In order to meet the requirements of FIFRA and the ESA, this assessment follows EPA guidance on conducting ecological risk assessments (USEPA, 1998a) and Office of Pest icide Program’s Overview Document, which contains guidance for assessing pesticide risk s to non-target and lis ted organisms (USEPA, 2004).

The end result of the EPA pesticide registration process ( i.e. , the FIFRA regulatory action) is an approved product label. The labe l is a legal document that sti pulates how and where a given pesticide may be used. Product labels (also know n as end-use labels) de scribe the formulation18 type ( e.g. , liquid or granular), acceptable methods of application, approved use sites, and any restrictions on how applications may be conducte d. Therefore, the use, or potential use, described by the pesticide’s labels is c onsidered “the action” being assessed.

2.2. Stressor Source and Distribution

2.2.1. Nature of the Chemical Stressor

Penthiopyrad is a broad-spectrum fungicide with preventative, curative, and some systemic activity intended to control foliar and soil-borne plant diseases caused by many Ascomycete and Basidiomycete fungi (MRID 47735219, 48081904). Th e compound is a pyrazole carboxamide in the succinate dehydrogenase inhibitor (SDHI) class of fungicides and stops spore germination, inhibits mycelium growth, and has antispor ulant activity (MRID 48081904). SDHI compounds bind to the protein succinate:ubi quinone reductase in complex II of the electron transport chain, which inhibits two critical resp iratory pathways, the citric acid cycle and mitochondrial electron transport (MRID 48081904). To clarify penthiopyr ad’s partial systemic activity, the compound is systemic in xylem, flowing throughout plants following root uptake (MRID 47735219); however, penthiopyrad only undergoes translaminar distribution from treated to untreated leaf surfaces following foliar application, with no systemic movement in phloem (MRID 47735219).

Mitsui Chemicals, Inc. and E. I. du Pont de Nemours and Company ar e applying to register penthiopyrad in the United States as a tech nical grade active ingredient (TGAI) and in formulated end-use products, respectively. Four end-use products currently proposed for registration in the United States include the following:

1. Fontelis: 20% penthiopyrad; agricultural uses proposed

2. Vertisan: 20% penthiopyrad; agricultural uses proposed

3. Treoris: 8.9% penthiopyrad and 22.3% chlo rothalonil; agricultural uses proposed

4. Velista: 50% penthiopyrad; use on turf and landscape ornamentals proposed

These end-use products include proposed uses on alfalfa, brassica vegetables, bulb vegetables, canola, cereals (excluding rice and wild rice), cotton, cucurbits , fruiting vegetables, leafy vegetables, low growing berries (including cranberries), peanuts, pome fruits, root and tuber vegetables and leaves, stone fruits, succulent and dry legumes, sunflowers, tree nuts (including pistachios and excluding pecans), turf (inclu ding sod farms and any landscaped areas) and landscape ornamentals. All of th e penthiopyrad end-use products may be foliarly applied. They may be applied via ground or aerial applica tion methods, with the exceptions of rhubarb, landscape ornamentals, and turf, which may be applied only by ground methods. Also, selected agricultural uses may be applied vi a chemigation or seedling methods.

2.2.2. Overview of Pesticide Usage

Usage data are not available for penthiopyrad beca use it is a new active ingredient proposed for use in the United States, the Unite d Kingdom, Canada, and Australia.19 2.3. Receptors

2.3.1. Aquatic and Terrestrial Effects

Table 2.1 provides examples of taxonomic groups and th e surrogate species tested to evaluate the potential ecological effects of pesticides to these non-target taxonomic groups. Within each of these very broad taxonomic groups, a measure of effect from either ac ute or chronic exposure

is selected from the available test data. Toxico logical data generated from surrogate test species, which are intended to be repres entative of broad taxonomic gr oups, are used to extrapolate potential effects on a variety of species (recep tors) included under th ese taxonomic groupings.

Table 2.1. Example Taxonomic Groups a nd Surrogate Test Species Evaluated for Assessing Potential Ecologica l Effects of Penthiopyrad.
Taxonomic Group Example( s) of Surrogate Species Birds, terrestrial-phase amphibians, and reptiles 1 Mallard duck ( Anas platyrhynchos ) Bobwhite quail ( Colinus virginianus ) Zebra finch ( Poephila guttata ) Mammals Wistar rat ( Ratus norvegicus ) Insects Honey bee ( Apis mellifera L. ) Freshwater fish, and aquatic-phase amphibitans 2 Bluegill sunfish ( Lepomis macrochirus ) Rainbow trout ( Oncorhynchus mykiss ) Fathead minnow ( Pimephales promelas ) Freshwater invertebrates Water flea ( Daphnia magna ) Midge ( Chironomus riparius ) Estuarine/marine fish Sheepshead minnow ( Cyprinodon variegatus ) Estuarine/marine invertebrates Mysid ( Americamysis bahia ) Eastern oyster ( Crassostrea virginica ) Terrestrial plants Monocots – corn ( Zea mays ) 3
Dicots – soybean ( Glycine max ) Aquatic plants and algae Duckweed ( Lemna gibba ) Freshwater algae ( Pseudokirchneriella subcapita )

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

2 Freshwater fish may be surrogates for aquatic-phase amphibians.

3 Four species of two families of monocots; six species of at least four dicot families.

2.3.2. Ecosystems Potentially at Risk

The ecosystems at risk are often extensive in scop e; therefore, it may not be possible to identify specific ecosystems at the screening level. In ge neral terms, terrestrial ecosystems potentially at

risk could include the treated site and areas imme diately adjacent to the treated site that may

receive drift or runoff. These ar eas could include the site itself, other cultivated fields, fencerows and hedgerows, meadows, fallow fields or grassl ands, woodlands, riparian habitats, and other

uncultivated areas.

Aquatic ecosystems potentially at risk include wa ter bodies adjacent to, or down stream from, the treated area and might include impounded water bodies (lentic environments) such as ponds, lakes and reservoirs, or flowing waterways (lotic environments) such as streams or rivers. For uses in coastal areas, aquatic habitat also in cludes marine ecosystems, including estuaries.20 2.4. Assessment Endpoints

Assessment endpoints represent the ac tual environmental value that is to be protected, defined by an ecological entity (species, community, or othe r entity) and its attri bute or characteristics (USEPA, 1998a). The ecological entities include the following: birds, amphibians, reptiles, mammals, freshwater fish and invertebrates, estuar ine/marine fish and invertebrates, terrestrial plants, insects, and aquatic vasc ular and non-vascular plants. Th e attributes for each of these entities may include growth, surv ival, and reproduction. (See Table 2.2 in Section 2.6.2 , the Analysis Plan, for further discussion).

2.5. Conceptual Model

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

The conceptual model is intended to provide a wr itten description and visual representation of the predicted relationships between penthiopyrad, potential routes of exposure, and the predicted effects for the assessment endpoints. The concep tual model consists of two major components: risk hypotheses and a conceptual diagram (USEPA, 1998a).

2.5.1. Risk Hypotheses

For penthiopyrad, the following eco logical risk hypothesis is bei ng employed for this baselinelevel risk assessment:

Based on the application methods, mode of action, and the sensitivity of non-target aquatic and terrestrial species, the proposed agricultural and non-agr icultural uses of penthiopyrad have the potential to reduce survival, reproduction, and/or growth in terrestrial and aquatic animals and plants via both direct an d indirect adverse effects.

2.5.2. Conceptual Diagram

Application methods for penthi opyrad include foliar broad cast (via ground, aerial, and chemigation equipment), seedling and transplant seedling treatment, and in-furrow methods. Ecological receptors that may pot entially be exposed to penthiopyrad include terrestrial and semi-aquatic wildlife ( i.e. , mammals, birds, terres trial-phase amphibians, te rrestrial invertebrates, and reptiles) and plants. In addition, aquatic receptors, ( i.e. , freshwater and estuarine/marine fish and invertebrates, aquatic-phase amphibians, a nd plants) may also be exposed as a result of potential movement of penthiopyra d to aquatic environments via sp ray drift, runoff, and/or base flow from ground water leachate originating at the si te of application (no di rect applications to water bodies are proposed). The potential exposur e pathways and effects of the proposed new registration of penthiopy rad are depicted in Figure 2.1

.21 Stressor Penthiopyrad applied as a broadcast spray to agricultural and nonagricultural areas

Source/ Transport Pathways Direct Deposition Spray

Drift Runoff/

Erosion Leaching (Infiltration/

Percolation

Source/ Exposure

Media Terrestrial Food Residues (foliage,

fruit, insects Upland Foliage/Soil Riparian/

Wetland Foliage/Soil Receiving Water Body/

Sediment Groundwater

Exposure

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

Uptake

Receptors

Attribute Changes Terrestrial Vertebrates Birds, Mammals, Reptiles, Terrestrial Phase Amphibians Terrestrial Upland

Plants

Individual Animals

Reduced survival Reduced growth

Reduced

reproduction Aquatic

Invertebrates Aquatic

Vertebrates Wetland/ Riparian

Plants

Individual Plants

Seedling emergence Vegetative vigor Individual

vertebrates and

invertebrates

Reduced

survival

Reduced

growth

Reduced

reproduction Plant population

Reduced

population growth Aquatic

Plants Uptake/ Adsorption

Figure 2.1. Conceptual Model Depicting Sou rces of Exposure, Receptors, and Potential Adverse Effects from the Proposed Uses of Penthiopyrad. 1

1 Inhalation is a potential route of exposure to terrestrial organisms ( i.e., birds, and mammals); however

inhalation is not considered to be an expo sure route of concern as indicated by S creening T ool for

I nhalation R isk (STIR v.1.0, November 19, 2010) (see Appendix A )

.

2.6. Analysis Plan

2.6.1. Residues of Concern

The major degradates of penthiopyrad ( i.e., those degradates constitu ting greater than 10% of applied residues from environmental fate stud ies) include PAM, PCA, DM-PCA, and carbon dioxide (chemical names and structures are provided in Appendix B ). Available toxicity data for the major organic degradates indicate that they are orders of ma gnitude less toxic than penthiopyrad to freshwater fish, freshwater in vertebrates, and aquatic non-vascular plants. However, PAM is a residue of concern for mammal s (including humans) due to a lack of toxicity data and its prevalence in animal residue studies (USEPA, 2011).

The minor degradates 753-T-DO, 753-A-OH, and 753-F-DO, which have the same structural backbone as the parent, were >7% of the app lied and increasing in concentration at study termination in some studies and may have toxici ty similar to the parent compound to freshwater22 invertebrates and aquatic plants (toxicity e ndpoints for 753-A-OH and 753-T-DO were within an order of magnitude, although most were non- definitive). However, 753-A-OH and 753-T-DO were substantially less toxic than penthiopyrad to freshwater fish.

In conclusion, the residues of concern are penthiopyrad, 753-T-DO, 753-A-OH, and 753-F-DO for aquatic invertebrates and a quatic plants, penthiopyrad alone for fish, and penthiopyrad and PAM for terrestrial organisms.

Because 1) inclusion of 753- A-OH, 753-T-DO, and 753-F-DO in exposure modeling would not appreciably increase exposure estimates, and 2) major degradates of penthiopyrad are much less toxic to aquatic organisms than the parent compound, penthiopyrad alone was modeled to estimate exposure for aquatic organisms in this assessment.

2.6.2. Measures of Exposure

Measures of exposure are based on terrestrial and aquatic models that estimate environmental concentrations of the chemical being assessed us ing labeled application rates and methods. The measure of exposure for aquatic sp ecies in water bodies receiving runoff and/or spray drift is the estimated environmental concentration (EEC) e xpected once every ten years based on 30 years of simulations. The 1-in-10 year peak concentr ation is used for estimating acute effects to aquatic vertebrate and invertebrate species; the 1-in-10 year 21-day mean concentration is used for assessing aquatic invertebrate chronic exposure; and the 1-in-10 year 60-day mean concentration is used for assessing chronic expo sure for fish (and aquatic -phase amphibians).

Aquatic EECs were calculated with the Tier II aquatic exposure model PRZM/EXAMS (PE) and

with the Tier I Rice Model for use on cranberries . Tier I and II provisional flooded agriculture models (Tier I Cranberry Model and PFAM) were us ed to further characte rize potential exposure resulting from use on cranberries. EECs from exposure to the Fontelis and Vertisan end-use products via spray drift were calculated using th e spray drift model AgDRIFT. Exposure in ground water due to leaching was assessed with the Tier I screening ground water model SCIGROW. The bioaccumulation model KABAM was used to estimate potential bioaccumulation of penthiopyrad residues in a fr eshwater aquatic food web and s ubsequent risks these residues may pose to terrestrial organisms via cons umption of contaminated aquatic prey ( i.e. , aquatic invertebrates and fish). The terrestrial meas ure of exposure for animals is upper bound exposure concentrations on various dietary items that are estimated with T-REX. Exposure of naturallyoccurring terrestrial and semi-aqua tic (wetland) plant species is typically estimated using OPP’s TerrPlant (v1.2.2) model to provide estimates of exposure to terrestrial plants from single pesticide applications and is assumed to encompass areas outside the immediate use site. However, only Tier I terrestrial plant toxicity data are available, and treatment related effects

were observed at the limit concentration in bot h the seedling emergence and vegetative vigor studies. Although effects were not greater than 25% for any endpoint that was tested, Terrplant is not appropriate for use in the risk assessment. The registrant has provided a suite of Office of Chemical Safety and Pollution Prevention (OCSPP) guideline-comp liant environmental fate and product chemistry studies that provide data for these measures of exposure (OCSPP guidelines are also known as OPPTS guidelines).23 PE (PRZM/EXAMS)

The Tier II model Pesticide Root Zone Model (PRZM v3.12.2; May 12, 2005; Carousel et al.

, undated) linked with EXposure Analysis M odeling System (EXAMS v2.98.4.6; Apr. 25, 2005; Burns, 2004) via the model shell PRZM/EXAM S (PE v5.0, Nov. 15, 2006) was run to estimate baseline-level exposure of aqua tic environments to penthiopyrad. The PRZM model simulates pesticide movement and transformation on and ac ross the agricultural fiel d resulting from crop applications. The EXAMS model simulates pestic ide loading via runoff, erosion, and spray drift assuming a “standard” 1-ha pond, 2-m deep (20,000 m 3 ) with no outlet that borders a 10-ha treated field. Simulations are run for multiple (u sually 30) years, and the Agency estimates peak and running mean values that are expected onc e every ten years based on the daily values generated during the simulation. The PE, PRZM , and EXAMS models and users manuals are

available from the U.S. Environmental Protec tion Agency Water Models web-page (USEPA,

2011 a ).

Exposure estimates generated us ing the “standard” pond are inte nded to represent those that might occur in a wide variety of vulnerable wate r bodies that occur at the top of watersheds including prairie pot holes, playa lakes, wetla nds, vernal pools, man-made and natural ponds, and intermittent and first-order streams. As a group, there are factors that make these water bodies more or less vulnerable than the standard surroga te pond. Static water bodies that have larger ratios of pesticide-treated drainage area to wa ter body volume would be e xpected to have higher peak EECs than the standard pond. These water bodies will be either sma ller in size or have large drainage areas. Smaller water bodies ha ve limited storage capacity and thus may overflow and carry pesticide in the discha rge, whereas the sta ndard pond has no discharge. As watershed size increases, it becomes increasi ngly unlikely that the entire watershed is planted with a nonmajor single crop that is all treated simultaneously with the pesticide. Headwater streams can also have peak concentrations higher than the standard pond, but they likel y persist for only short periods of time and are then car ried and dissipated downstream.

Tier I Rice Model

The Tier I Rice Model (v1.0, May 8, 2007) was used to estimate screenin g-level exposure to penthiopyrad that may occur in water bodies receiving released bog water following use on

cranberries. This model was used to assess the proposed use on cranbe rries because exposure models specific to cranberries us es are not vetted and approved fo r use in risk assessment. The model produces a single exposure va lue that represents a dissolved concentration within a rice paddy. This single value is used to appr oximate both acute and chronic exposure.

The Tier I Rice Model relies on an equilibrium partitioning concept to provide conservative exposure estimates resulting from ap plication of pesticides to rice paddies. When a pesticide is applied to a rice paddy, the model assumes that it will instantaneously partition between a water phase and a sediment phase. The model doe s not account for pestic ide degradation, mass transfer between the aqueous phase and the sedi ment, volatilization, dilu tion, or other dissipation processes. The Tier I Rice Model was calibrated to generate estimates that are consistent with or

conservative for dissolved concentrations measured within rice paddies and in discharged paddy

water. The model was not evalua ted or calibrated for concentrations measured in sediment and24 does not account for residues bound to suspended sediment. Furthermore, the model was not

calibrated to evaluate ex posure in cranberry bogs. A descrip tion of and guidance for using the Tier I Rice Model may be found on the U.S. E nvironmental Protection Agency (EPA) Water Models web-page (USEPA, 2011 a ).

Tier I Flooded Agriculture Model (Tier I Cranberry Model)

In order to characterize exposure from the propo sed use on cranberries, a provisional Tier I Cranberry Model was used to estimate screen ing-level peak and mean concentrations of penthiopyrad that may occur in water bodies receiving released bog water following use on cranberries. This model is produced by making tw o provisional refinements to the Tier I Rice Model, including the addition of simple degrad ation processes in dry and flooded conditions and a water depth of twelve inches, rather than the wa ter depth of four inches used in the rice model.

The cranberry bog water depth of twelve inches is a maximum depth recommended by the Cape Cod Cranberry Growers Associati on (2001). Previous assessment s of mesotrione uses that employed the provisional Tier I Cranberry Model assumed a water depth of eighteen inches (DP barcode 339984, USEPA, 2004; DP barcode 325840, US EPA, 2006a), which is within the range of water depths traditionally used. However, modern water conservation pressures are causing cranberry growers to reduce the flood depth to fewer inches above th e vertical cranberry branches, which grow up to eight inches hi gh (Cape Cod Cranberry Growers Association, 2001; The Cranberry Institute, 2008). Th erefore, a twelve-inch deep fl ood is a reasonable refinement to model assumptions. The equations used in th e provisional Tier I Cran berry Model are briefly

described in Appendix F

.

Degradation of penthiopyrad may be dominated by indirect photol ysis on soil prior to flooding at harvest. However, the effect on potential aqua tic exposure from indirect photolysis on soil was not explored due to the high exposure estimates re sulting from the initia l model scenario of no photolysis on the bog prior to flooding. A Tier II modeling approach was used next to refine aquatic exposure estimates.

Tier II Flooded Agriculture Model (PFAM)

For characterization, the provision al, Tier II Pesticides in Fl ooded Applications Model (PFAM v0.7; pre-release) was run to refine aquatic exposure estima tes for the proposed use of penthiopyrad on cranberries. PFAM simulates pe sticide transformation on and dissipation from flooded agricultural sites, such as cranberry bogs, following pesticide use. Up to 11 applications and up to 11 manually controlled changes in bog water level can be modeled per year of simulation. Simulations were run using 30 years of location-specific rainfall data.

A Variable Volume Water Model (VVWM) post-p rocessor was used in conjunction with PFAM to produce aquatic exposure con centrations in a flowing wate r body that receives released cranberry bog water. Peak and maximum mean exposure estimates that are expected once every ten years in the modeled water body were genera ted based on daily values produced during the

simulation. PFAM and associated docu mentation are available on-line at: http://sites.google. com/site/pfamodel/

.25 SCI-GROW

The Tier I model Screening Concentration in Ground Water (SCI-G ROW v2.3, Jul. 29, 2003; USEPA, 2002b) was used to estimate screening- level exposure in aquatic environments from base flow of ground water containing penthiopy rad. SCI-GROW is a regression model that was developed by fitting a linear model to ground wate r concentrations with the Relative Index of Leaching Potential (RILP) as the independent variable. Ground water concentrations were taken from 90-day mean high concentrations from Pros pective Ground Water studi es. The RILP is a

function of aerobic soil metabolism and the soil-water partition coe fficient. The output of SCIGROW represents the concentration of pesticid e residue that might be expected in shallow unconfined aquifers under sandy soils, which is representative of the ground water most vulnerable to pesticide contamination and likely to result in contaminated base flow in nearby surficial water bodies. This single 90-day mean value is used to approximate both acute and chronic exposure. The SCI-GROW model and use r’s manual are available from the EPA Water Models web-page (USEPA, 2011 a ).

AgDRIFT

AgDRIFT (v2.01; May 24, 2001) was used to estimat e aquatic exposure resulting from direct spray drift of Fontelis and Vertisan formula tions into the “standard ” 1-hectare pond. Details concerning the specifics and uncertainties associ ated with the AgDRIF T model are available online at www.agdrift.com

.

KABAM

K OW (based) A quatic B ioA ccumulation M odel (KABAM v.1.0) was used to estimate potential bioaccumulation of penthiopyrad residues in a fres hwater aquatic food web and subsequent risks these residues pose to terrestrial organisms vi a consumption of contaminated aquatic prey ( i.e.

, aquatic invertebrates and fish). The bioaccumu lation portion of KABAM is based on an aquatic food web bioaccumulation model published by Arnot and Gobas (2004) that relies on a pesticide's octanol-water partition coefficient (K OW ) to estimate uptake and elimination constants through respiration and diet of aquatic organism s in different trophic levels. Pesticide tissue concentrations in aquatic orga nisms are calculated for differe nt trophic levels of a food web through diet and respiration.

In the risk component of KABAM, pesticide con centrations in aquatic organisms are used to estimate dose- and dietary-based exposures and a ssociated risk quotients for mammals and birds consuming aquatic organisms. The methods used in the risk component of KABAM are consistent with EFED's current modeling approach for assessing risks to terrestrial mammals and birds described in USEPA 2004a, as implemente d in the T-REX model (version 1.4.1; USEPA 2008a). The KABAM model and user’s manual ar e available from the EPA Water Models webpage (USEPA, 2011 a ).26 T-REX

T-REX is a spreadsheet-based model that calc ulates the residues on avian and mammalian food items along with the dissipation rate of a chemical applied to foliar surfaces (for single or multiple applications) in order to estimate acute and reproductive risk quotients. The median lethal dose to 50% of the animals tested (LD 50 ) per square foot (ft -2 ) values are also calculated for both broadcast and banded (granular and liq uid) applications using an adjusted LD 50 method. The results are presented by weight class for va rious sized birds and mammals for each type of application. Avian and mammalian risk quotient s are also calculated for seed treatment applications to various crop seeds. The T-REX model and user’s manual are available from the

EPA Terrestrial Models web-page (USEPA, 2011 b ).

2.6.3. Measures of Effect

Measures of effect are obtained from a suite of registrant-submitted OCSPP guideline-compliant

studies that were conducted with a limite d number of surrogate test species ( Table 2.1) . No additional ecotoxicity data on pe nthiopyrad were located, based on a July 2011 query of the open

literature in the ECOTOX database (USEPA, 2011b).

The acute measures of effect used in th is baseline-level assessment are the LD 50 , LC 50 (median Lethal Concentration) or EC 50 (median Effects Concentration). These are measures of acute toxicity which result in 50% of the respective effect in tested organi sms. The endpoints for chronic measures of exposure are the NOAEC an d the NOAEL. Toxicity studies were submitted for freshwater fish and invertebrates, estuarine/ marine fish and inverteb rates, aquatic plants, birds, mammals, bees, and other terrestrial invertebrates. The e ndpoints used for risk

characterization were derived fr om studies which underwent revi ew and were classified as “acceptable” (conducted under guideline conditions and considered to be scientifically valid) or “supplemental” (conditions deviated from guidelin es but the results are considered to be scientifically valid).

Table 2.2 lists the measures of environmental exposur e and ecological effects used to assess the potential risks of penthiopyrad to non-target organisms. The met hods used to assess the risk are

consistent with those outlined in the document “Overview of the Ecological Risk Assessment

Process in the Office of Pes ticide Programs” (USEPA, 2004).27 Table 2.2. Measures of Exposure and Effect Used in Assessing Potential Risks Associated with the Proposed Uses of Penthiopyrad.
Assessment Endpoint 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 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 (Freshwater fish and

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

Survival Lowest tested LC 50 or EC 50 (acute toxicity test using formulations) Spray drift EECs 5

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

Aquatic plants (vascular and non-vascular) Survival and growth Lowest EC 25 (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 baseline-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 the modeling described in Section 3.2.2.1

. 5 Spray drift EECs are based on the modeling described in Section 3.2.2.1

2.6.4. Integration of Exposure and Effects

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 risk assessme nt of penthiopyrad, the risk quotient (RQ) method is used to compare estimate d exposure and measured toxicity values. The RQ method involves dividing EECs by acute and chronic toxicity va lues. The resulting RQs are then compared to the Agency’s Leve ls of Concern (LOC) (USEPA, 2004) ( Table 2.3 ). These criteria are used to indicate when applications of penthiopyrad, as directed on the label, have the potential to cause adverse effects to li sted and non-listed non -target organisms.

Table 2.3. 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) 128 RISK CLASS RISK DESCRIPTION RQ LOC

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 2 /NOAEC 1

1 LC 50 or EC 50

. 2 Based on upper bound Kenega values for foliar exposure.



## 3. Analysis

3.1. Use Characterization

Penthiopyrad is proposed for foliar use on alfalfa, brassica vegetables, bulb vegetables, canola, cereals (excluding rice and wild rice), cotton, cucurbits, fruiting ve getables, leafy vegetables, low growing berries (including cranbe rries), peanuts, pome fruits, root and tuber vegetables and leaves, stone fruits, succulent and dry legumes, sunflowers, tree nuts (including pistachios and excluding pecans), turf (including sod farms and any landscaped areas) and landscape

ornamentals. Four end use formulations of penthiopyrad are proposed for registration in the United States. These include Fontelis (20% activ e ingredient (a.i.)), a suspension concentrate (SC) for a range of agricultural uses; Vertisan (20% a.i.), an emulsifiable concentrate (EC) for a range of agricultural uses; Treoris (8.9% a.i.), a suspension concentrate (SC) containing the fungicide chlorothal onil (22.3% ) and for a range of agricultural uses; and Velista (50% a.i.), a water dispersible granule (WG) product for use on turf and landscape ornamentals. Each

formulation is flowable. Table 3.1 lists the proposed maximum use patterns on the proposed

labels for these four end use formulations.

The proposed maximum single and annual applic ation rates for penthiopyrad are 0.95 and 2.9 pounds of active ingredient per ac re (lbs a.i./A), respectivel y, on turf (Velista), which characterizes the maximum use pattern of penthiopyr ad for this national-le vel, ecological risk assessment. Fontelis, Vertisan, and Treori s each have proposed maximum single and annual application rates of 0.39 and 0.94 lbs a.i./A, respectively for selected agricultural uses. All uses are limited to two sequential applications with additional applications allowed following use of a fungicide with a different mode of action, with the exceptions that use on peanuts is limited to three sequential applications before rotating to an alternative fungici de and uses on landscape plantings and trees do not require ro tation with altern ative fungicides.29Table 3.1. Proposed Use Patterns for Penthiopyrad End-use Products.ProductLabelActiveIngredient(%)UseMax. SingleApp. Rate(lbs a.i./A)Max. AnnualApp. Rate(lbs a.i./A)App.Interval(d)Application TypeAdditional Application DirectionsFontelisPenthiopyrad(20%)Alfalfa0.310.637Aerial, ground orchemigationMake no more than two sequentialapplications before switching to afungicide with a different mode of action.Bulb vegetables; lowgrowing berriesA;fruiting vegetables0.310.94Leafy vegetablesAerial, ground,chemigation, seedling,transplant seedling orin-furrowBrassica vegetables0.390.94Aerial, ground,chemigation or seedlingLegumes (succulent)Aerial, ground,chemigation, transplantseedling or in-furrowCucurbit vegetables0.210.875Aerial, ground orchemigationPeanuts0.310.9414Aerial, ground,chemigation, transplantseedling or in-furrowMake no more than three sequentialapplications before switching to afungicide with a different mode of action.Pome fruits; stonefruits; tree nutsB0.260.797Aerial, ground orchemigationMake no more than two sequentialapplications before switching to afungicide with a different mode of action.Root vegetables andleaves0.390.79VertisanPenthiopyrad(20%)Canola 0.26 0.537Aerial, ground orchemigationMake no more than two sequentialapplications before switching to afungicide with a different mode of action.Cereal grainsC0.31 0.63Cotton; rootvegetables and leaves0.31 0.94Aerial, ground,chemigation, transplantseedling or in-furrowLegume vegetablesD0.26 0.53Soybeans0.39 0.79SugarbeetsSunflowers30ProductLabelActiveIngredient(%)UseMax. SingleApp. Rate(lbs a.i./A)Max. AnnualApp. Rate(lbs a.i./A)App.Interval(d)Application TypeAdditional Application DirectionsTreorisPenthiopyrad(8.9%) andchlorothalonil(22.3%)Beans (dry)E0.260.527Aerial, ground orchemigationMake no more than two sequentialapplications before switching to afungicide with a different mode of action.Snap beans; brassicavegetables0.390.93Blueberries (lowbush)0.31Aerial or groundBulb vegetables;celery; fruitingvegetables; potatoes;yamsAerial, ground orchemigationCarrots; parsnips;soybeans0.390.78Cucurbits0.210.885Peanuts0.310.9314Make no more than three sequentialapplications before switching to afungicide with a different mode of action.Rhubarb7GroundMake no more than two sequentialapplications before switching to afungicide with a different mode of action.Cherries, peaches,plums; almonds,filberts, pistachios0.260.78Aerial or groundVelistaPenthiopyrad(50%)Turf0.952.914F(not stated)Make no more than two sequentialapplications before switching to afungicide with a different mode of action.Landscapeornamentals0.253.07GroundNot for use on bearing fruit and nut trees,in commercial nurseries and greenhouses,or on ornamentals grown for commercialuse or commercial seed production.A Low growing berry uses on the Fontelis label include cranberries.B Labeled tree nut uses include pistachios and exclude pecans.C Labeled cereal grain uses include varieties of barley, buckwheat, corn, millet, oats, rye,sorghum, teosinte, triticale andwheat and exclude rice and wild rice.D Labeled legume vegetable uses include dry shelled peas and beans other than soybeans.E Labeled bean uses include varieties of dry beans, excluding soybeans.F The application interval of 14 days separates two fall applications. A third application may be made in the spring.31 3.2. Exposure Characterization

3.2.1. Environmental Fate and Transport Characterization

Penthiopyrad [(RS)-N-[2-(1,3-dimethylbutyl)-3-thi enyl]-1-methyl-3-(trifluoromethyl)-pyrazole4-carboxamide; CAS# 183675-82-3] is a racemic mi xture of enantiomers that undergo slight enantiomeric selectivity (ranging fr om 2.6% to the R-isomer to 23% to the S-isomer) in studied soils (see Appendix B for chemical structure). The compound is nonvolatile, lipophilic, and moderately mobile in soil ( Table 3.2 ). Indirect photolysis in soil is the fastest route of penthiopyrad degradation (half- life of 6.4 days); however, th e compound persists in many compartments of the environment, dissipating in shaded and aquatic areas by slow aerobic biodegradation (half-life of 60-406 days) and slow leaching (K FOC range of 560-900 L/kg OC ). Penthiopyrad does not undergo hydrol ysis or photolysis in water bodies. The compound persists

in anaerobic conditions.

Depending on soil type, the compound may slowly move to ground water via leaching and may move to surface water bodies via sp ray drift, runoff of dissolved or sorbed residues, and transport

of dissolved residues in base flow from shallow ground water. Terrestrial field dissipation study results are relatively consistent with those of the laboratory studies, showing that the chemical dissipates by degradation and slow leaching, w ith dissipation half-lives ranging from 2.2 to 44 days (laboratory study half-lives ranged from 6.2 to >365 days).

Penthiopyrad has an octanol-w ater partition coefficient (K OW ) at pH 7 of 42,000; however, the bioconcentration data sugge st that the compound is not expected to bioaccumulate in fish, mainly due to metabolism. Penthiopyrad may bioc oncentrate in benthic invertebrates. Table 3.2 summarizes the submitted chemical and environmental fate data for penthiopyrad.

Table 3.2. Chemical Properties and Environm ental Fate Parameters of Penthiopyrad.

Parameter Value Source

Selected Physical/Chemical Parameters

Molecular mass (molecular formula) 359.42 g/mol (C 16 H 20 F 3 N 3 OS) (Calculated)

Vapor pressure 2.2 x 10 -8 torr (20 °C)

4.8 x 10 -8 torr (25 °C) MRID 47614820

MRID 47614817

Aqueous solubility (20  C) pH 4: 2.5 mg/L pH 5: 7.5 mg/L pH 7: 1.4 mg/L pH 10: 1.7 mg/L MRID 47614828,

47614829

Henry’s Law Constant (20°C, pH 7) 7.6 x10 -9 atm-m 3 /mol (Calculated)

Log octanol-to-water partition coefficient (log K OW ) (20°C) pH 4: 4.36 pH 7: 4.62 pH 10: 4.54 MRID 47614832

Dissociation constant (pKa) 10.0 MRID 47614840,

4761484132 Parameter Value Source

Persistence

Hydrolysis half-life (50  C) No substantial degradation (pH 4, 7, and 9) MRID 47614837

Aqueous photolysis half-life (25  C) No substantial degradation MRID 47614839

Soil photolysis half-life; dark-control adjusted half-life (23  C) 6.2 d; 6.4 d MRID 47614965

Aerobic soil metabolism half-life (20°C) 60, 81, 165, 406 d MRID 47614959

152 d MRID 47614961

128 d (25°C) MRID 47614963

Anaerobic soil metabolism half-life (20  C) No substantial degradation MRID 47614964

Anaerobic aquatic metabolism half-life (20  C) No substantial degradation MRID 47614976

Aerobic aquatic metabolism half-life (20  C) 220, 311 d MRID 47614975

Aerobic activated sludge biodegradation % No substantial degradation MRID 47614974

Mobility

Freundlich soil-water partition coefficients (K F ); Freundlich organic carbon-normalized partition coefficients (K FOC ) 7.3, 9.2, 14, 14, 15 L/kg; 560, 570, 730, 850, 900 L/kg OC MRID 47614967

Field Dissipation

Terrestrial field dissipation half-life; maximum leaching depth of parent 35 d (CA bare soil); 5-15 cm MRID 47615162

4.4 d (GA bare soil); 5-15 cm MRID 47615163

2.2 d (MO bare soil/soybeans); 0-5 cm MRID 47615164

11 d (WA bare soil/wheat); 0-5 cm MRID 47615165

7.9 d (Ontario bare soil); 0-5 cm MRID 47615166

21 d (Saskatchewan bare soil); 5-15 cm MRID 47615167

44 d (NY turf); 15-30 cm MRID 47615172

15 d (GA turf); 15-30 cm MRID 47615173

Fish Bioconcentration

Fish bioconcentration factors (steady-state) 78-100 L/kg (edible); 226-277 L/kg (inedible); 155-184 L/kg (whole fish); substantial metabolism and rapid depuration (half-life of <1 d) were

observed. MRID 47614995

3.2.1.1. Transport and Mobility

Penthiopyrad is not expected to significantly vo latilize from soil or water bodies due to a low vapor pressure (2.2 x 10 -8 torr at 20°C; MRID 47614820) an d Henry’s Law Constant (7.6 x10 -933 atm-m 3 /mol; calculated from MRID 47614820 and 47614828) . Penthiopyrad is moderately soluble in water (limit of 1.4-7.5 mg/L at 20°C) at environmentally relevant pH values (MRID 47614828, -29). The compound is lipophilic, with a K OW of 23,000-42,000 (log K OW of 4.36- 4.62; MRID 47614832). With a dissociati on constant (pKa) of 10 (MRID 47614840), penthiopyrad does not exhibit aci d/base behavior in the environment. The source of the variability in measured aque ous solubility limits and K OW values is not understood.

Penthiopyrad is moderately mobile in soil, with K FOC values ranging from 560-900 L/kg OC (mean

K FOC of 720 L/kg OC ; MRID 47614967). Sorption to soil corr elates with the organic carbon fraction in soil ( i.e. , the coefficient of variat ion across five soils for K FOC (22%) is less than that

for K F (29%). Depending on soil type, the co mpound may slowly move to ground water via leaching ( e.g. , in field studies, leaching ranged from <5 to >15 cm; MRID 47615162, -63, -64, - 65, -66, -67, -72, -73). Penthiopyra d may be sorbed to residues in or dissolved in runoff feeding surface water bodies. The compound may also reach surface water bodies via transport of

dissolved residues in base flow from shallow ground water.

3.2.1.2. Degradation

Indirect photolysis in soil is th e fastest route of penthiopyrad de gradation (half-life of 6.2 days; MRID 47614965); however, the compound persists in many compartments of the environment, degrading in shaded and aquatic areas by slow aerobic biodegradation (half-life of 60-406 days; MRID 47614959, -61, -63, -75). Penthiopyrad do es not undergo hydrolysis (MRID 47614837) or photolysis (MRID 47614839) in water bodies. Th e compound persists in anaerobic conditions (MRID 47614976) and is not readily biodegraded in aerobic activated sludge (MRID 47614974).

Penthiopyrad is assumed to undergo indirect photolysis in soil becau se it degraded in irradiated soil and was stable to direct photolysis in water. This means that the compound is not directly photolyzed by light. Instead, it is susceptible to degradation in the presence of light-absorbing organic molecules in soil, such as humic and fulvic acids ( i.e. , indirect photolysis). The total degradation half-life in soil was 6.2 days. Adjust ed for biodegradation in the dark controls, the photolysis-only half-life was 6.4 days. Major degradates included PAM (up to 48% of the applied radioactivity (%AR) at study terminatio n), PCA (up to 41%AR 13 days after treatment), and carbon dioxide (up to 26-52%AR at study termination; chemi cal names and structures are

listed in Appendix B ). In the study, unradiolabled test compound was mixed with pyrazole- and thienyl-radiolabeled test compound prior to treati ng the test samples, resulting in uncertainty in amounts of transformation products formed. The a pplicant indicated that the radiolabeled test compounds were applied at equivalent doses (MRID 48239607). Therefore, measured amounts of single-ring degradates reported in the study were multiplied by two by th e reviewers in order

to indicate the amounts that would have been m easured in a study of penthiopyrad with a single radiolabel ( e.g. , PAM at 24%AR was interpreted as at 48%AR). Also, measured amounts of carbon dioxide and unextracted residues were repo rted as ranges from 1x to 2x the measured value because the actual value in a single radiol abeled study would lie so mewhere in that range ( e.g. , carbon dioxide reported at 26%AR was interpreted as 26-52%AR).34 Penthiopyrad slowly degraded in six aerobic soil s with half-lives ranging from 60 to 406 days (MRID 47614959, -61, -63). The major degradates in these studies included DM-PCA (up to 28%AR at study termination) and carbon dioxi de (up to 26%AR at study termination). Extraction procedures were not c onsidered exhaustive; unextracted residues were up to 40%AR.

Studies of two soils were terminated before the first DT 50 of the compound had passed, which results in uncertainty in the degradation kine tics of penthiopyrad and in the formation and degradation kinetics of pent hiopyrad’s transformation product s. For example, the compound 753-T-DO was 8.1%AR and increasing at study termin ation (161 days after treatment). It is

unclear whether 753-T-DO would have been a ma jor degradate if the study was continued.

In aerobic aquatic systems, penthiopyrad persis ted with degradation half-lives of 220 and 311 days (MRID 47614975). These half-lives were extrap olated because the studies were terminated at 185 days after treatment, wh ich was before the first DT 50 of the test compound had passed. The only major transformation product was PCA (up to 12%AR at 111 days after treatment; 9.3%AR at 185 days after treatment). Carbon dioxide was only formed at up to 8.8%AR.

In anaerobic soil and aquatic systems, pe nthiopyrad did not degrade (MRID 47614964, -76).

Penthiopyrad photolysis in soil a nd aerobic biodegradation in so il and water appears to follow two main pathways (see Figure B.1 of Appendix B ): 1) oxidation at the carbon atom adjacent to the sulfur atom of the thienyl ring, leading to 753-T-DO followed by further oxidation to 753-FDO, and 2) hydroxylation at the al kyl side chain, leading to OH- substituted products such as 753-A-OH (chemical names and st ructures are provided in Table B.1 of Appendix B ). The degradates 753-F-DO and 753-A-OH do not accumula te but undergo further oxidation, leading to PAM and to transient sister cleavage products . PAM is then transformed to PCA by amide hydrolysis. PCA undergoes N-deme thylation of the pyrazole ring to form DM-PCA. Ultimately, the pyrazole ring degradates are mineralized, as carbon dioxide is the ma jor degradation product of DM-PCA (MRID 47614966). The environmental fa te of the trifluorinated methyl group is

unknown.

3.2.1.3. Bioaccumulation

While penthiopyrad is lipophilic, with a K OW of 23,000-42,000 (log K OW of 4.36-4.62; MRID 47614832), it is not expected to bioa ccumulate in fish. Bioconcentr ation factor (BCF) values in

fish were ≤ 277 L/kg and the compound was readily metabo lized in fish to an assortment of minor metabolites (MRID 47614995). Penthiop yrad accounted for only 35-42% of total radioactivity in fish after 10- 14 days of accumulation. The com pound depurated with a half-life of 0.65-0.86 days; however, depurati on rates decreased over time si nce measured BCF values for whole fish remained 10-25 L/kg in both system s after 3-14 days of depuration. Respective depuration rate constants (k T of 0.81-1.07) were well above the sum of elimination constants estimated by KABAM (k 2 +k E +k G of 0.23), which supports the study finding that the compound was readily metabolized in fish ( KABAM neglects metabolism by default).

Steady-state fish BCF value ranges reported in th is assessment include study-reported values as well as calculated values that are 18% higher in order to correct for the potential loss of35 bioavailable residues due to sorption to total orga nic carbon (TOC) in the test systems. TOC was up to 52 mg C/L due to the cosolvent, dimet hylformamide (DMF), and, to a minor extent, organic carbon present in the untreated water (u p to 6 mg C/L). An equation from Arnot and Gobas (2004) describing the fraction of test co mpound dissolved in water (in Table A.2 of the KABAM User’s Guide) indicated that up to 15% of the test compound ma y have bound to TOC, resulting in fish BCF values that may have been underestimated by 15%.

Bioconcentration of penthiopyrad in benthic invertebrates is un certain and of concern. Studyderived metabolism rates in fish cannot be ex trapolated to metabolism rates in benthic

invertebrates since the latter often metabolize compounds slower than fish. KABAM modeling (that assumes that benthic invertebrates do not metabolize penthiopyrad) indicates that bioconcentration of penthiopyrad in benthic invertebrates re sults in chronic risk LOC exceedances for mammals that consume benthic invertebrates (see Section 4.2.2.2 ). LOCs were

not exceeded for mammals that do not consume be nthic invertebrates. Oyster BCF study data could be used to reduce uncertainty in the bioaccumulation of penthiopyrad in benthic

invertebrates.

3.2.1.4. Field Studies

Six terrestrial field dissipation studies were in itiated on bare soil under field conditions in the United States and Canada (CN) in 2006 usi ng penthiopyrad formulated as a suspension concentrate (200 g/L SC) containing 200 g a.i. /L (MRID 47615162, -63, -64, -65, -66, -67). Two additional cropped plots were prepar ed at sites in Wash ington and Missouri. The study authors expected a low degradation rate and that th e presence of a crop would accelerate chemical dissipation in the field; however, initial soil sample analysis showed a fast dissipation of penthiopyrad in cropped and bare soil. Therefor e, analysis of soil samples from cropped plots was terminated early, with crop samples not anal yzed. For the California, Georgia, Ontario (CN), and Saskatchewan (CN) sites, two broad cast applications of the test substance were applied to the test plots at the target rate of 400 g a.i./ha (0.357 lbs a.i./A) at an interval of 15 days. A single broadcast application of the test substance was applied to the test plots at the target rate of 200 g a.i./ha ( 0.178 lbs a.i./A) for Washington a nd 100 g a.i./ha (0.089 lbs a.i./A) for the Missouri site. Soil samples were taken up to a depth of 90 cm and composited by depth at intervals over approximately 18 months at the test sites.

Penthiopyrad degraded at all sites to form seve ral degradates. The majo r degradates were DMPCA, PAM, and PCA. Degradates 753-A-OH, 753-F-DO and 753-T-DO were also detected at lower levels. The recovery of applied penthi opyrad using Petri dishes on the soil surface was between 75 and 107%, being between 75 and 87% fo r most sites. Therefore, the detected amounts of degradates may have been slightly underestimated.

Penthiopyrad dissipated in bare soil fields with half-lives ranging from 2.2 to 35 days (half-lives were partially correlated with soil pH; r 2 = 0.74). By the study end, <5% unchanged parent

remained at all bare soil sites a nd <10 % was present at the cropped sites, indicating that there is little potential for further primary degradate forma tion after the end of the study. The majority of residues were measured in the top 30 cm of so il, with no residues detected below 70 cm depth36 and no penthiopyrad detected below 15 cm. The main degradation products formed during the early sampling period (Day 14, 15, and 21) were PCA, PAM, and 753-F-DO, which were the main photolytic products in the soil phot olysis study (MRID 47614965), suggesting that photochemical oxidation contributed to the ea rly dissipation of penthiopyrad. Both penthiopyrad and its degradates tended to rema in on the soil surface for up to 100 days, with little being incorporated into the lower depths, so that residues may be exposed to sunlight. Dissipation rates were relatively consistent with the laboratory data, if the range of dissipation rates reflected the range of inso lation received on the fields.

Terrestrial field dissipation studies were conducte d on turf-covered fields located in Georgia and New York in 2007 using penthiopyrad formulated as a suspension concentrate (SC) containing 200 g a.i./L. At the Georgia site, the test substance was applied as two broadcast applications at the target rate of 750 g a.i./ha e ach, with a 14-day inte rval, for a total of 1500 g a.i./ha. At the New York site, the test substance was applied as th ree broadcast applications at the target rate of 500 g a.i./ha (0.446 lbs a.i./A) each, with a 14-day interval, for a total of 1500 g a.i./ha (1.34 lbs a.i./A).

Turf, thatch, and soil samples were taken at in tervals over approximately195 days in Georgia and 208 days in New York following test substa nce application. At bot h sites, penthiopyrad partitioned from the turf into the thatch and so il layers. Residues of penthiopyrad in the soil were mostly confined to the uppermost thatch la yer, and <1% of the a pplied material was found in the 15-30 cm layer. There were no signifi cant detections in the lower soil depths, below 30 cm. There were no detectable residues of any of the degradation produc ts below 15 cm at any point, except for DM-PCA that was detected at 30-50 cm depth in Georgia and 50-70 cm depth in New York. Penthiopyrad degraded at both sites to form several degradates. The main degradate was DM-PCA. Also detected were the degradates PAM, PCA, 753-A-OH, 753-F-DO,

and 753-T-DO.

Penthiopyrad dissipated in the turf fields with half-lives of 15 days in Georgia and 44 days in New York. By comparison to the half-life in the Georgia turf field study, in 2006, penthiopyrad dissipated in the bare soil fiel d dissipation study conducted in Georgi a with a half-life of 4.4 days (MRID 47615163). This 10-fold difference in di ssipation may be explained by suppression of indirect photolysis of penthiopyrad on the field due to the presence of turf.

3.2.1.5. Environmental Degradates

Major identified environmental degradates of penthiopyrad are PAM, PCA, DM-PCA, and

carbon dioxide. Available chemical names and structures are listed in Table B.1 of Appendix B

as well as maximum and final amounts formed in the submitted studies. Figure B.1 of Appendix B illustrates the transformation pathway of penthiopyrad in the environment.

Penthiopyrad’s major organic degr adates are cleavage products th at retain the pyrazole ring of the parent compound. PAM is the only degradate that retains the amide group of penthiopyrad. The degradates PAM, PCA, and DM-PCA were pe rsistent in studies of penthiopyrad. PAM and DM-PCA increased in concentration throughout the studies in which they were major degradates37 (soil photolysis and aerobic soil metabolism studies, respectively); whereas PCA concentrations reached a plateau and began to slowly declin e in the soil photolysis and aerobic aquatic metabolism studies in which it was a major degr adate. A submitted study indicates that DM-PCA degrades in aerobic soil with a mean half- life of 109 days (n=4; ra nge 36-168 days; MRID 47614966).

The major organic degradates of penthiopyr ad are highly mobile in soil. Mean K FOC values for PAM, PCA, and DM-PCA are 9.1, 8.1, and 7.0 L/kg OC (n=4; MRID 47614971, -69, and -66).

Table 3.3 lists the available environmental fate parameters of penthi opyrad’s degradates.

Table 3.3. Environmental Fate Parameters of Penthiopyrad Transformation Products.

Parameter Test Compound Value Source

Persistence

Aerobic soil metabolism half-life (20°C) DM-PCA 36, 110, 121, 168 d MRID 47614966

Mobility

Freundlich soil-water partition coefficients (K F ); Freundlich organic carbon-normalized coefficients (K FOC ) DM-PCA 0.033, 0.061, 0.094, 0.099 L/kg; 3, 4, 5, 16 L/kg OC MRID 47614966

PAM 0.1, 0.4, 0.4, 0.4 L/kg; 6.5, 8.7, 9.0, 12 L/kg OC MRID 47614971

753-A-OH 2.0, 2.1, 2.2, 3.0 L/kg; 45, 54, 63, 210 L/kg OC MRID 47614972

753-T-DO 5.0, 16, 23, 26 L/kg; 460, 460, 500, 510 L/kg OC MRID 47614973

The submitted environmental fate studies of pent hiopyrad did not directly show formation of hydrofluorocarbons or opening of the pyrazole ring to which the tr ifluorinated methyl group is attached. However, the pyrazole ring was indirec tly shown to have cleaved due to the formation of carbon dioxide with the pyrazo le-radiolabel. Formation of hydrofluorocarbons could not be observed because the test compound was not radiolab eled on or near the tr ifluorinated methyl group. Also, most of the study lengths were not su fficient to evaluate th e fate of the residues containing the pyrazole ring becaus e the parent compound was slow to degrade. This leads to uncertainty in the formation of hydrofluorocarbons.

Trifluoroacetic acid (CAS 76-05-1) may be a majo r transformation product of penthiopyrad. It is a degradation product shared by many pesticid es with a trifluorinated methyl group ( e.g. , saflufenacil, benfluralin, trifloxystrobin, fluometuron, a nd thiafluamide/flufenacet), hydrochlorofluorocarbons (HCFC), and hydrofluor ocarbons (HFC). Acco rding to the Hazardous Substances Data Bank, with a vapor pressure of 110 torr at 25°C, trif luoroacetic acid will volatilize and not persist if releas ed to the air or dry soil (USNIH, 2009). However, if formed in water bodies or wet soil, trifluor oacetic acid is a persistent anion (pKa of 0.52) that will not degrade by abiotic or microbial means. The compound has been detected in surface water, seawater, and precip itation (USNIH, 2009).38 The available aquatic toxicity data for trifluoroace tic acid show low toxicity for fish and aquatic invertebrates (LC/EC 50 >1200 mg/l) and a range of algal species (NOEC values are above 100 mg/L, with one exception ( Scenedesmus capricornutum ) at 0.12 mg/L; Europian Union, 2001). Also, continuous exposure (>5 months) to trif luoroacetic acid at 31-32 mg/L may cause adaptation in the physiology of stream bacter ial communities (Europian Union, 2001). Based on these data, there is low aquatic toxicity concer n for trifluoroacetic aci d and, therefore, risk concern is presumed low. Thus, the ecological risk from trifluoroacetic acid is not quantitatively

estimated in this assessment.

Trifluoroacetic acid may slowly decarboxylat e to the greenhouse gas fluoroform (HFC-23,

CHF 3 , CAS 75-46-7) with a half-life of approximately 80 years (Boutonnet et al. , 1999; Wine, 1994). Fluoroform (with a global warming potential of 12,000; USEPA, 2011 c ) persists in air with a lifetime of 222 years and will gradually di ffuse into the stratosphe re, in which its lifetime is 2,300 years (UNEP, 2010). However, data are not sufficient to indicate whether penthiopyrad residues will ultimately form fluoroform. If they do, formation of fl uoroform would not be observed in guideline-compliant la boratory studies, with a forma tion half-life of approximately 80 years, and it may be too early to observe a sign al in available monitoring data from pesticides with trifluoromethyl groups that were register ed in the last few decades. If penthiopyrad degrades to fluoroform, the amount produced is likely to be neglig ible with respect to industrial sources of the compound (UNEP, 2010). On a broa der level, it is unclea r how much total usage of pesticides with trifluoromethyl groups would be of concern with respect to other sources of fluoroform, if these pesticides ultimately degrade to fluoroform.

3.2.2. Measures of Aquatic Exposure

Exposure in surface water from the proposed penthi opyrad uses due to runoff, erosion, and spray

drift were assessed with the Ti er II screening model, PE, a nd, to assess the proposed use on cranberries, the Tier I Rice Mode l. Provisional Tier I and Ti er II (PFAM) flooded agriculture

models were also used to char acterize exposure from the propos ed use on cranberries. Exposure in ground water due to leaching was assessed with the Tier I screeni ng ground water model SCIGROW.

3.2.2.1. Surface Water Exposure

PE (PRZM/EXAMS)

The general chemical and environmental fa te data for penthiopyrad listed in Table 3.2 were used for generating model input parameters for PE (listed in Table 3.4 ). These inputs represent penthiopyrad alone, since additi on of degradates of concern would not appreciably change exposure estimates (see Section 2.6.1 ), and were determined in accordance with current divisional guidance (USEPA, 2009). The 90% confidence bounds on the mean half-life for aerobic soil metabolism (240 d) a nd for aerobic aquatic metabolism ( 287 d) were selected. Halflives from the submitted aerobic aquatic metabolism study conducted at 20°C were adjusted using a Q 10 of 2 to those that would occu r at 25°C, which PE requires.39 Table 3.4. PE Chemical Input Parameters for Penthiopyrad.

Input Parameter Value Comment Source (MRID)

Molecular Mass (g/mol) 359.4 Product chemistry data (Calculated)

Henry’s Law Constant (atm-m 3 /mol) 7.6 x 10 -9 Product chemistry data (Calculated)

Solubility in Water (mg/L) 1.4 Represents the value at pH 7. 47614828

Organic Carbon Partition Coefficient (K OC ) (L/kg OC ) 720 Represents the mean K fOC of five values. 47614967

Aerobic Soil Metabolism Half-life (days) 240 Represents the upper 90% confidence bound on

the mean of six half-lives. 47614959, -61,

-63

Aerobic Aquatic Metabolism Half-life (days) 287 Represents the upper 90% confidence bound on the mean of two half-lives adjusted to 25°C. 47614975

Anaerobic Aquatic Metabolism Half-life (days) 0 Represents no biodegradation under anaerobic

conditions. 47614976

Hydrolysis Half-life (days) 0 Represents no hydrolysis. 47614837

Aqueous Photolysis Half-life (days) 0 Represents no photolysis. 47614839

Laboratory and field studies indi cate that penthiopyrad may p hotolyze extensively on the field (with a half-life of 6.2 days over 29 days of natural sunlight; MR ID 47614965). Because soil photolysis is an important route of degradation in some environments, PE was also used to bracket potential aquatic exposure (for characteriza tion) using a soil photoly sis input in place of the aerobic soil metabolism input. A soil photolys is input of 19 days was used for the aerobic soil metabolism input because it is 3x the si ngle study value of 6.2 days (MRID 47614965). Use of the aerobic soil metabolism input of 240 days repr esents the case of no phot olysis on the field; use of the soil photolysis input of 19 days repres ents the case of photolysis on the field, at the rate observed in a laboratory st udy, prior to transportation into water bodies. The case that is most relevant for a given location depends on th e extent to which pent hiopyrad is indirectly photolyzed at the location based on 1) the am ount of shade available on the field, 2) the availability and composition of photo-oxidizers in the soil, and 3) the duration between applications and following runoff events.

The model input parameters used in PRZM to simulate penthiopyrad application and crop management practices are provided in Table 3.5 . Modeled use patterns represent the highest labeled single application rates, the maximum numbers of applicati ons per year in order to apply the maximum annual application rate, the shorte st re-application interv als, and the labeled application method of gr eatest spray drift for each use group listed in Table 3.1

.

Model scenarios and initial application dates were selected in order to represent the high-end of vulnerability. Specifically, each model scenario that is representative for a given use was modeled using a range of initial application dates limited to the 1 st and 15 th day of each month within the cropping period, based on labeled crop timing for applications, crop timing set by the model scenario, and crop-profile information provided by the United States Department of Agriculture (USDA, 2011). For example, use on sorghum was preliminarily modeled with the Kansas and Texas sorghum scenarios with init ial application dates ranging from June 1 st to August 15 th . The combination of scenario and intial ap plication date that re sulted in the highest40 estimated environmental concentrations (EEC) wa s selected for this assessment and listed in

Table 3.5 below. The North Dakota corn scenario was used as a surrogate scenario for sunflowers because a scenario speci fic to sunflowers is not availabl e, the majority of sunflowers are grown in North Dakota (USDA), 2011), and corn is most similar to sunflower with respect to the crops represented by available North Dakota scenarios.

Most proposed uses of penthiopyrad have a mini mum reapplication interv al of 7 days between two applications and most have the stipulation that no more than two sequential applications may be made before switching to a fungicide with a different mode of acti on. Therefore, a 14-day

interval was assumed between the second and thir d applications for most proposed uses with three applications allowed at th e maximum rate per year. Proposed uses with alternative label directions, including turf, peanuts, a nd cucurbits, were modeled accordingly.

Table 3.5. PRZM Scenario and Input Parame ters Describing the Maximum Proposed Penthiopyrad Use Patterns.

Use Scenario Date of

Initial App. App. Rate (lbs a.i./A) App.

per Year App.

Interval

(days) CAM Input IPSCND Input Application Efficiency/ Spray Drift

Turf A CA turf Mar. 1 s t 0.95 3 245, 14 B 2 3 0.99/0.01

Landscape ornamentals CA residential Apr. 1 s t 0.25 12 7 2 3 0.99/0.01

Brassica STX vegetable Feb. 21 s t 0.39, 0.15 C 3 7, 14 C 2 1 0.95/0.05

Succulent legumes MS soybean Sep. 15 t h 0.39, 0.15 C 3 7, 14 C 2 1 0.95/0.05

Peanuts NC peanuts Aug. 29 t h 0.31 3 14 2 1 0.95/0.05

Cucurbits STX melons Apr. 1 s t 0.21 4 5, 10 D 2 1 0.95/0.05

Alfalfa NC alfalfa Jul. 15 th 0.31 3 7, 14 C 2 1 0.95/0.05

Berries FL strawberries Jan. 15 t h 0.31 3 7, 14 C 2 1 0.95/0.05

Bulb vegetables STX vegetable Feb. 21 s t 0.31 3 7, 14 C 2 1 0.95/0.05

Fruiting vegetables FL peppers Nov. 1 s t 0.31 3 7, 14 C 2 1 0.95/0.05

Leafy vegetables CA lettuce Apr. 15 t h 0.31 3 7, 14 C 2 1 0.95/0.05

Pome fruits PA apple Jun. 1 s t 0.26 3 7, 14 C 2 3 0.95/0.05

Root vegetables FL carrots Nov. 1 s t 0.39 2 7 2 1 0.95/0.05

Stone fruit MI cherries Jun. 15 t h 0.26 3 7, 14 C 2 3 0.95/0.05

Tree nuts OR filberts Oct. 1 s t 0.26 3 7, 14 C 2 3 0.95/0.05

Dry beans IL beans Jul. 15 th 0.26 2 7 2 1 0.95/0.05

Potatoes and yams FL potato Mar. 1 s t 0.31 3 7, 14 C 2 1 0.95/0.05

Cotton MS cotton Aug. 1 s t 0.31 3 7, 14 C 2 1 0.95/0.05

Sugarbeets MN sugarbeets Aug. 1 s t 0.39 2 7 2 1 0.95/0.05

Sunflowers ND corn Jun. 15 t h 0.39 2 7 2 1 0.95/0.05

Canola ND canola Jun. 1 s t 0.26 2 7 2 1 0.95/0.05

Sorghum (cereals) KS sorghum Aug. 15 t h 0.31 2 7 2 1 0.95/0.05

Wheat (cereals) TX wheat Apr. 1 s t 0.31 2 7 2 1 0.95/0.0541 Use Scenario Date of

Initial App. App. Rate (lbs a.i./A) App.

per Year App.

Interval

(days) CAM Input IPSCND Input Application Efficiency/ Spray Drift

Corn (cereals) TX corn Jul. 15 th 0.31 2 7 2 1 0.95/0.05
A The use on turf includes sod farms and any landscape areas. B The second application occurs on Nov. 1 st , 245 days after the initial application. The third application follows on

Nov. 15 th , 14 days later (PE cannot split a set of multiple applications across years). C Two applications at 0.39 lbs a.i./A, 7 days apart, are fo llowed 14 days later by an application at 0.15 lbs a.i./A. D Two applications 5 days apart followed after 10 days by two additional applications 5 days apart.

Aquatic EECs from PE for the proposed penthiopyrad uses are presented in Table 3.6 . The model input/output files supporting these values are listed and provided in Appendix C . These exposure estimates are intended to be protective for this screening-level assessment. They represent the most vulnerable m odel scenario and timing for uses and use groups listed in Table

3.1 . Therefore, exposure estimates in United Stat es locations not modeled or from application timing not modeled may be less than those listed in Table 3.6 . Also, where use patterns were modeled to represent use groups, uses in the group that were not individua lly modeled may result in lower exposure than the use selected to repr esent the group. Modeled EECs represent aquatic exposure that may occur from a use or use within a group at a particular time and location in the

United States.

The 1-in-10-year peak values ranged from 13 μg /L (canola) to 45 μg/L (succulent legumes). Rolling mean values were similar to peak values due to the persistence of penthiopyrad. The 1- in-10-year 21-day pore water EEC for succulent legumes that is used to assess exposure to benthic invertebrates is 38 μg/L. Although pr oposed uses on turf and landscape ornamentals have higher application rates than other proposed uses, exposure estimates for uses on turf and

ornamentals were less than thos e for many proposed agricultural us es because aerial application to turf and ornamentals is not allowed, whereas aerial application is allowed for most proposed agricultural uses.

The persistence of penthiopyrad also resulted in carry-over of residues from year to year, leading

to an increase of maximum values over the firs t 15-20 years of the simulation until equilibrium in the standard pond was attained (see Figure 3.1 ). Therefore, exposure estimates are not true 1- in-10-year values. Because exposure estimates for the proposed uses of penthiopyrad did not widely vary, the EECs for the uses of highest (l egumes) and lowest (canola) exposure were used

for risk estimation in this screening-level assessment.42 Figure 3.1. EECs for Succulent Legumes from 1961 to 1990.

Table 3.6. PE 1-in-10-year Aquatic EEC s for Proposed Penthiopyrad Uses.

Use Scenario Max. App. Rate (lbs a.i./A/yr) Peak (μg/L) 21-day (μg/L) 60-day (μg/L)

Succulent legumes MS soybean 0.94 45 44 41
Fruiting vegetables FL peppers 0.94 45 43 40

Cucurbits STX melons 0.87 43 41 39

Cotton MS cotton 0.94 42 40 39
Potatoes and yams FL potato 0.93 42 40 39

Alfalfa NC alfalfa 0.63 40 38 37

Corn (cereals) TX corn 0.63 40 37 36

Brassica STX vegetable 0.94 38 36 34

Bulb vegetables STX vegetable 0.94 38 36 33

Root vegetables FL carrots 0.79 37 35 32

Leafy vegetables CA lettuce 0.94 35 34 33

Berries FL strawberries 0.94 34 33 33

Peanuts NC peanuts 0.94 34 32 30
Pome fruits PA apple 0.79 31 30 28

Wheat (cereals) TX wheat 0.63 29 28 26

Dry beans IL beans 0.52 27 26 26

Sorghum (cereals) KS sorghum 0.63 26 25 24

Turf CA turf 2.9 25 25 25

Sunflowers ND corn 0.79 24 23 23

Stone fruit MI cherries 0.79 23 23 23

Tree nuts OR filberts 0.79 23 22 22

Landscape ornamentals CA residential 3.0 21 20 20
Sugarbeets MN sugarbeets 0.79 21 20 20

Canola ND canola 0.53 13 13 12 0 10 20 30 40 50 60

1955 1960 1965 1970 1975 1980 1985 1990 1995EEC(μg/L)

Year 

## Succulent legume EECs

Peak

96 hr

21 Day

60 Day

90 Day

Yearly43 Exposure estimates for use on legumes on the in itial year of applic ation, prior to annual accumulation in the standard pond, were 17 μg/L (peak), 16 μg/L (21-day mean), and 13 μg/L (60-day mean). For canola, exposure estimates fro m the initial year of ap plication were 1.4 μg/L (peak), 1.2 μg/L (21-day mean), and 0.99 μg/L (60- day mean), which is s ubstantially less than accumulates in the model pond over multiple years.

If unabetted photolysis is assumed to occur on th e field (using a soil photolysis input of 19 days rather than the aerobic soil metabolism input of 240 days), 1-in-10-year exposure estimates for use on legumes are reduced by 40-43% to 27 μg/L (peak), 25 μg/L (21-day mean), and 24 μg/L (60-day mean). For canola, 1-in-10-year expos ure estimates are reduced by 38-40% to 8.1 μg/L (peak), 7.8 μg/L (21-day mean), and 7.4 μg/L (60-day mean).

Tier I Rice Model

The Tier I Rice Model has two inputs: the appl ication rate and the or ganic carbon partition coefficient (K OC ). The maximum proposed single applica tion rate of penthiopyr ad on cranberries (0.31 lbs a.i./A or 0.35 kg a.i./ha) was modeled as well as the annual appl ication rate limit (0.94 lbs a.i./A or 1.05 kg a.i./ha). The mean K FOC value for five soils (720 L/kg OC ) was input as well. The exposure estimates from the Tier I Rice Mode l for quantitative exposure assessment of the proposed use on cranberries were 176 μg/L (singl e use) and 529 μg/L (annual use). The single exposure estimates from the Tier I Rice Model are used for both acute and chronic exposure assessment. Additional provision al models were used to characterize exposure from the proposed use on cranberries because the screening exposure estimate from the Tier I Rice Model (529 μg/L) was an order of magnitude higher than screening exposure estimates from PE.

Tier I Cranberry Model (Provisional)

The proposed use of penthiopyrad on cranberries at the maximum proposed application rate (0.31 lbs a.i./A) may occur no more than three times per year, based on the annual application rate limit (0.94 lbs a.i./A). The minimum r eapplication interval is 7 days between two applications, with the stipulation that no more than two sequential appl ications may be made before switching to a fungicide wi th a different mode of action. Therefore, a 14-day interval was assumed between the second and third applications . There is no proposed pre-harvest interval.

Cranberry bogs are not typically flooded until the night before harvesting. Therefore, the proposed single application rate (0.31 lbs a. i./A) was aged on dry soil with the Provisional Cranberry Model for three durations: 21, 14, and 0 days. The resulting re sidues (in lbs a.i./A) were summed together for each residue and input into the flooded component of the model to estimate exposure in bog tailwater following harv est. Peak and annual mean exposure estimates were calculated beginning three days after flooding to account for the holding time during harvest. Chemical property input values were the same as those calcu lated for PE modeling. Model input parameters are listed in Table 3.7

.44 Table 3.7. Provisional Cranberry Model Input Parameters for Penthiopyrad. A

Input Parameter Value Comments Source

Application Rate (lbs a.i./A) 0.31 Maximum proposed single application

rate. Proposed label

Applications per Year 3 Maximum proposed number of applications per year at the maximum proposed single application rate. Proposed label

Application intervals (d) 0, 14, 21 Discussion of intervals between applications and prior to harvest is provided in text above. Proposed label

Organic Carbon Partition Coefficient (K OC ) (L/kg OC ) 720 Represents the mean K FOC value for

five soils. MRID 47614967

Aerobic Soil Metabolism Half-life (days) 240 Represents the upper 90% confidence

bound on the mean of six half-lives. MRID 47614959, 47614961,

47614963
Aerobic aquatic

metabolism half-life (days) 287 Represents the upper 90% confidence

bound on the mean of two half-lives adjusted to 25°C. MRID 47614975

A Source data are in Tables 3.1 and 3.4

.

Exposure estimates from the prov isional Tier I Cranberry Model for use on cranberries were 250 μg/L (peak), 245 μg/L (21-day mean), and 233 μg/L (60-day mean). These values were sufficiently high to trigger the need for additional refinement.

PFAM (Provisional)

Model input parameters for PFAM and its asso ciated VVWM post-processor are listed in Table

3.8 . Chemical-specific inputs represent the resi dues of concern, which include penthiopyrad alone (see Section 2.2.1 ), and were determined in accordance with current divisional guidance for PRZM and EXAMS (USEPA, 2009). The 90% confidence bounds on the mean half-life for aerobic soil metabolism (240 d) and for aerobic aquatic metabolism (406 d) were selected (PFAM automatically corrects the aerobic aqua tic metabolism half-life for temperature; therefore, the input valu e differs from the temperature-corre cted value used in other aquatic models). The heat of Henry ( i.e. , enthalpy of solvation; 55,0 00 J/mol) was calculated by multiplying the gas constant (8.314 J/mol·K) by the enthalpy of vaporization for penthiopyrad (6,600 K) estimated by HenryWin (v3.20).

Table 3.8. PFAM Input Parameters for Penthiopyrad.

Input Parameter Value Comments Source
Water column half-life (d) at

20 °C 406 Represents the upper 90% confidence

bound on the mean of two half-lives. MRID 47614975

Benthic Compartment half-life at 20 °C (d) 0 Represents no biodegradation under

anaerobic conditions. MRID 47614976

Unflooded half-life at 20 °C (d) 240 Represents the upper 90% confidence

bound on the mean of six half-lives. MRID 47614959, -61, -6345 Input Parameter Value Comments Source
Aqueous photolysis half-life at 40° Latitude (d) 0 Represents no photolysis in water. MRID 47614839

Hydrolysis half-life (d) 0 Represents no hydrolysis. MRID 47614837
Organic Carbon Partition Coefficient (K OC ) (L/kg OC ) 720 Represents the mean K FOC value for

five soils. MRID 47614967

Molecular weight (g/mol) 359.4 Product chemistry data (Calculated)
Vapor pressure at 20 °C (torr) 2.2 x 10 -8 Product chemistry data MRID 47614820
Water solubility at 20 °C (mg/L) 1.4 Product chemistry data MRID 47614828

Heat of Henry at 20 °C (J/mol) 55,000 Equals 8.314 × enthalpy of salvation (6,600 K) estimated by HenryWin

v3.20. (Calculated)

Application Date & Rate (kg a.i./ha) 9/9: 0.348

9/16: 0.348

9/30: 0.348 Maximum proposed single application

rate. Minimum intervals between applications and flooding. Proposed label

Meteorology data location (metfile code) La Crosse, WI (w14920) Meteorological file for a location near cranberry agriculture. CEAM, 2011

Fill level (m); Wier level (m) 10/1: 0.305; 0.458 10/2: 0; 0 Minimum flood depth and release depth; estimated wier heights (Estimated)

Crop zero height reference May 1 Estimated value (Estimated)
Days from zero to full height 120 Estimated value (Estimated)
Days from zero height to removal 153 Estimated value (Estimated)
Max. aerial coverage 0.2 Value from OR berries PE scenario (Estimated)

Area of application (m 2 ) 526,090 Represents 10x the area of the Index

Reservoir (Calculated)

Area of watershed (m 2 ) 1,728,000 Area of the Index Reservoir watershed USEPA, 2010 a

Watershed curve number 84 Value for fallow conditions in OR

berries and other PE scenarios (Estimated)

The application dates were chosen to repr esent the minimum intervals allowed between applications and between th e final application and harv est (flooding). The modeled meteorological data were collected from 1961 to 1990 in La Crosse, Wisconsin, which is the location closest to the majority of cranberry agriculture for which meteorological data were collected by the EPA Center for Exposure A ssessment Modeling (CEAM, 2011). A 12-inch flood was modeled on October 1, followed by dr aining the following day and throughout the year. The modeled flood date was selected as a pl ausible date of harvest. Alternative flood dates were explored and not used because they produced similar results. Crop stages were estimated. The maximum aerial coverage for berry crops used in the OR berries scenario for PE was used in

PFAM as well.

The VVWM was used to collect water and pest icide residues released from the modeled cranberry bog. The Index Reservoi r parameters of the model were used rather than those for EFED’s standard farm pond because the Index Reservoir has flow, whereas the standard pond does not, and cranberry bogs releas e into flowing water bodies. In order to maintain the 10:1 ratio of the treatment area to water body that is used for ecological aquatic exposure modeling, the treatment area (526,090 m 2 ) was set to 10x that of the Index Reservoir (52,090 m 2 ). The area

of the watershed that contains the Index Rese rvoir was kept at the standard value of 1,728,00046 m 2 . The curve number used for the watershed (84) was set to that for fallow conditions often used in PE scenarios, such as the OR berries scenario.

Exposure estimates from PFAM with its asso ciated VVWM post-processor were 298 μg/L (peak), 293 μg/L (21-day mean), and 289 μg/L ( 60-day mean). These values are 19-24% higher than EECs from the provisional Tier I Cranberr y Model and roughly 2x less than the EEC from

the Tier I Rice Model. Alt hough these values are high, no othe r models are available with which to estimate exposure from use on cranbe rries. Aquatic exposure estimates from the provisional Tier I and Tier II fl ooded agriculture models are unce rtain because the models have not been thoroughly vetted and evaluated with m onitoring data. Due to the uncertainty in the provisional models, th e results from both ( i.e. , the Tier I Cranberry Model and PFAM) were used to characterize aquatic exposure from use on cranberries.

Spray Drift of End-Use Products

The Tier I Aerial mode of AgDrift was used to estimate aquatic exposure resulting from direct spray drift of Fontelis and Vertisan form ulations into the “s tandard” 1-hectare pond ( i.e. , the “EPA-Defined Pond” in the “Aquatic Assessm ent” tool in the AgDRIFT Toolbox. The pond was assumed to be at the edge of the treatment area. The default drop si ze distribution of ASAE fine to medium was input as well as the two high est single application ra tes proposed for Fontelis and Vertisan (0.39 and 0.31 lbs a.i./A). The resulting EECs were 2.77 μg/L (from 0.39 lbs a.i./A) and 2.20 μg/L (from 0.31 lbs a.i./A).

3.2.2.2. Ground Water Exposure

Input parameters for the SCI-GROW model appear in Table 3.9 . These inputs were determined in accordance with current divisional guidan ce (USEPA, 2009). The median organic carbon partition coefficient (K OC = 730 L/kg OC ) and the median half-life ( 140 d) from six aerobic soils were selected (aerobic soil metabolism half-lives range 6.8-fold).

Table 3.9. SCI-GROW Input Parameters for Pe nthiopyrad. Source data are in Tables 3.1-

3.2.

Input Parameter Value Comments Source

Application Rate (lbs a.i./A) 0.95 Maximum proposed single application rate. Proposed label.

Applications per Year 3 Maximum proposed number of applications per year at the maximum proposed single application rate. Proposed label.

Organic Carbon Partition Coefficient (K OC ) (L/kg OC ) 730 Represents the median of five K fOC values. MRID 47614967

Aerobic Soil Metabolism Half-life (days) 140 Represents the median half-life in six soils. MRID 47614959, 47614961,

47614963

The modeled ground water EEC resulting from penthiopyrad use on turf was 0.49 μg/L. Because this value is substantially less than surface water EECs and the lowest endpoint for47 aquatic organisms, it was not used for risk es timation. The model inpu t/output file supporting this exposure estimate is provided in Appendix C

.

3.2.2.3. Aquatic Bioaccumulation

KABAM was used to estimate potential bioacc umulation of penthi opyrad residues in a freshwater aquatic food web and s ubsequent risks these residues pos e to terrestrial organisms via consumption of contaminated aquatic prey ( i.e. , aquatic invertebrates and fish).

Estimated BCF Values

In order to estimate BCF values for aquatic organisms accumulating penthiopyrad, KABAM was run using a log K OW of 4.62 (MRID 47614832) to represent th e partitioning of penthiopyrad to aquatic organisms. It was assumed that the sm all fish lipid content was 7.27% and the water temperature was 12.9 o C (reflecting a mean for two systems), which reflect values measured in the submitted fish BCF study (MRID 47614995). The body characteristics of organisms in the model trophic levels are depicted in Table 3.10 . The resulting BCF values for these trophic levels are depicted in Table 3.11 . Output files from KABAM are provided in Appendix C

.

Table 3.10. Characteristics of model aquatic organisms used to derive BCF values.

Trophic Level Wet Weight (kg) % lipids % Non-lipid organic matter % Water
phytoplankton N/A 2.0% 8.0% 90.0%
zooplankton 1.0E-07 3.0% 12.0% 85.0%

benthic invertebrates 1.0E-04 3.0% 21.0% 76.0%

filter feeders 1.0E-03 2.0% 13.0% 85.0%

small fish 1.0E-02 7.3% 23.0% 69.7%

medium fish 1.0E-01 4.0% 23.0% 73.0%
large fish 1.0E+00 4.0% 23.0% 73.0%

Table 3.11. Estimated BCF values for pe nthiopyrad in aquatic organisms.

Trophic Level Total BCF (μg/kg-ww)/(μg/L) Phytoplankton 2002
Zooplankton 1427

Benthic Invertebrates 1546

Filter Feeders 1016

Small Fish 3368

Medium Fish 2004

Large Fish 2004

Empirical BCF data

The highest fish BCF value for fish viscera in the submitted fish BCF study performed with rainbow trout ( Oncorhynchus mykiss ) was 277 (MRID 47614995). Substantial metabolism (confirmed by the presense of metabolites) and rapid depurati on were observed. Due to high48 total organic carbon (TOC) concentrations in the test systems, study-reported fish BCF values may be 15% lower than actual values (see Section 3.2.1.1 for discussion); therefore, fish BCF values used in this assessment ( e.g. , 277) include calculated values that are 18% higher than reported values in order to corr ect for the potential sorption of residues to TOC in the test systems and the resulting potential reduction of bioavailable residues dissolved in water.

Bioaccumulation modeling

KABAM was run in default mode (see user’s guide for full description), with a log K OW of 4.62,

a K OC of 720 L/kg OC (MRID 47614967) and surface water and pore water EECs of 45.0 and 38.1

μ g/L, respectively. These PE-generated surf ace and pore water EECs are based on the 1-in-10- year 4-day mean concentrations of penthiopy rad from use on succulent legumes. These EECs were selected because they represent the highe st 4-day mean EECs predicted for any use of penthiopyrad (penthiopyrad appeared to reach st eady state in the submitted fish BCF study in less than 4 days) and result in the highest pred icted accumulation of pent hiopyrad in tissues of aquatic organisms. The average water temperature (12.9 o C) of the test systems and the fish lipid content of 7.27% in the submitted fish BCF study we re used to simulate the water temperature of the abiotic compartment of KABAM and fish lipid content of small fish in KABAM, respectively. Metabo lism rate constants (k M ) of 0.58 or 0.84 were input for small, medium, and large fish in order to account for the rapid me tabolism observed in the submitted fish BCF study. The metabolism rate constant inputs were calcu lated with Equation H.4 of the KABAM User’s Manual [k M = k T - k 2 - k E - k G , i.e. , the metabolism rate constant (k M ) = the total elimination rate constant (k T ) – the respiratory elimination rate constant (k 2 ) – the excretion elimination rate constant (k E ) – the organism growth rate constant (k G )] using each of the two total elimination rate constants (k T ) from the submitted study and KABAM-calculated values for the elimination and growth rate constants (k 2 , k E , and k G ). The resulting exposure estimates of penthiopyrad in mammals and birds ingesting fish contaminated by the compound (based on the k M of 0.58) are provided in Table 3.12 . Output files from KABAM are provided in Appendix C . These values were used to derive RQs based on dose-based or dietary-based exposures of birds, terrestrial phase amphibians, reptiles, and mammals to pe nthiopyrad through consumption of contaminated aquatic prey (see Section 4.2.2 ).

Table 3.12. Concentrations of penthiopyrad residues in mammals and birds ingesting contaminated fish (estimated using KABAM).
Wildlife species Dose Based (mg/ kg-bw/d) Dietary Based (ppm)

Mammalian
fog/water shrew 42 71

rice rat/star-nosed mole 25 55

small mink 6.7 23
large mink 5.2 23

small river otter 4.4 23
large river otter 1.8 11

Avian
sandpipers 54 55

cranes 6.3 47

rails 32 5949 Wildlife species Dose Based (mg/ kg-bw/d) Dietary Based (ppm)

herons 7.4 47
small osprey 4.6 23
white pelican 1.2 11

3.2.3. Measures of Terrestrial Exposure

The application methods for the proposed penthi opyrad uses include aerial, ground, chemigation, transplant seedling, or in furro w applications, and are consider ed in the terrestrial exposure

assessment.

3.2.3.1. Terrestrial Wildlife

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals, emphasizing a dietary exposure route for uptake of pesticide active ingredie nts. Exposures for birds are considered as surrogates for terrestria l-phase amphibians as well as reptiles. For exposure to terrestrial organisms, such as bi rds and mammals, pestic ide residues on food items are estimated, based on the assumption that organi sms are exposed to pesticide residues in a given exposure use pattern.

The T-REX model (v1.4.1; 10/9/08) is used to calculate dietary and dose-based EECs of penthiopyrad residues on food items via spray applications for mamma ls and birds. Input values for deriving EECs in T-REX are located in Table 3.13 . Upper-bound Kenaga nomogram values are used to derive EECs for penthiopyrad expos ures to terrestrial mammals and birds. Table

3.14 summarizes the dietary- and dose-based EE Cs, based on the maximum single application rate of penthiopyrad is for the proposed turf us e which results in the highest EECs for all use scenarios. Remaining proposed uses on agricu ltural crops result in lower maximum single application rates; therefore, the EECs for bot h the maximum and minimum single application rate for the agricultural proposed uses of penthio pyrad were also calculat ed and are summarized

in Table 3.14 . A 1-year time period is simulated. Cons ideration is given to different types of feeding strategies for mammals, including herbiv ores, insectivores and granivores. For dosebased exposures, three weight cl asses of birds (20, 100, and 1000 g) and three weight classes of mammals (15, 35, and 1000 g) are considered. Uncerta inties in the terrestr ial EECs are primarily associated with a lack of data on interception and subsequent dissipation from foliar surfaces. Given that no data on interception and subsequent dissipation from foliar surfaces are available for penthiopyrad, a default foliar dissipation half -life of 35 days is used based on the work of Willis and McDowell (1987). Uncertainties can al so be attributed to using TREX to model potential systemic residues. Penthiopyrad is subject to xylem systemicity, and the movement within the plant is not necessarily known, resi dues could be greater or less depending on the location and movement of the compound within th e plant. An example output from the T-REX model is provided in Appendix D

.50 Table 3.13. T-REX Input Parameters for De riving Terrestrial EECs for Penthiopyrad Proposed Uses - Maximum single application rate 1

Proposed Use (Formulation; Application Method) Application Rate (lbs a.i./A) Number of Applications (Interval between applications)*

Non-agricultural (Turf) (Velista; flowable application) 0.95 2 (14 days)

Agricultural (maximum) (Fontelis, Vertisan, and Treoris; aerial, ground or chemigation) 0.39 2 (14 days)

Agricultural (minimum) (Fontelis, and Treoris; aerial, ground or chemigation) 0.21 2 (14 days)

1 Half-life used was the default 35 days, the body weight of chronic mammals was adjusted to 135g (body weight of test organisms during the study, MRID 47614906 and 47614907).

* No more than 2 sequential applications are allowed, before switching fungicides; annual maximum allows additional applications after switching fungicides. For the proposed turf use, the application interval separates two fall applications. A third application may be made in the spring. The only use that does not specify the number of sequential applications is the landscape ornamental use under the Velista label.

Table 3.14. T-REX Calculated EECs of Penthiopyrad Proposed Uses

Proposed Uses (Application Rate; lbs a.i./A) Food Type Dietary

Based (ppm) (mammals and birds) Dose Based (mg/kg-bw) (birds) Dose Based (mg/kg-bw) (mammals)

All Size

Classes Small (20 g) Medium (100 g) Large (1000 g) Small (15 g) Medium (35 g) Large (1000 g)

Non-Agricultural

use (Turf ; 0.95 lbs a.i./A) Short grass 401 456 260 117 382 264 61.2 Tall grass 184 209 119 53.4 175 121 28.1

Broadleaf plants/sm

insects 225 257 146 65.6 215 149 34.4

Fruits/pods/lg

insects 25.0 28.5 16.3 7.28 23.9 16.5 3.83

Seeds (granivore) N/A 6.34 3.62 1.62 5.31 3.67 0.85

Maximum Agriculture use (i.e., Brassica vegetables, legumes, soybeans, sugarbeets, sunflowers, carrots, parsnip, snap beans; 0.39 lbs a.i./A) Short grass 175 199 114 50.9 167 115 26.8 Tall grass 80.3 91.4 52.1 23.3 76.5 52.9 12.3

Broadleaf plants/sm

insects 98.5 112 64.0 28.6 93.9 64.9 15.1

Fruits/pods/lg

insects 10.9 12.5 7.11 3.18 10.4 7.21 1.67

Seeds (granivore) N/A 2.77 1.58 0.71 2.32 1.60 0.3751 Proposed Uses (Application Rate; lbs a.i./A) Food Type Dietary

Based (ppm) (mammals and birds) Dose Based (mg/kg-bw) (birds) Dose Based (mg/kg-bw) (mammals)

All Size

Classes Small (20 g) Medium (100 g) Large (1000 g) Small (15 g) Medium (35 g) Large (1000 g)

Minimum Agriculture use (cucurbits; 0.21 lbs a.i./A) Short grass 96.1 109 62.4 27.9 91.6 63.3 14.7 Tall grass 44.0 50.1 28.6 12.8 42.0 29.0 6.73

Broadleaf plants/sm

insects 54.0 61.5 35.1 15.7 51.5 35.6 8.25

Fruits/pods/lg

insects 6.00 6.84 3.90 1.75 5.72 3.96 0.92

Seeds (granivore) N/A 1.52 0.87 0.39 1.27 0.88 0.20

3.3. Ecological Effects Characterization

The ecological effects characterization is ba sed on registrant-submitted toxicity data for penthiopyrad (also referred to as MTF-753, technical grade ac tive ingredient (TGAI), or technical parent product); th ree of its formulated products , including Fontelis (DPX-LEM17 20SC; 20.4% penthiopyrad), Vertisan (DPX-L EM17 20EC; 20.6% penthiopyrad), and Treoris (DPX-QFA61 SC; 8.9% penthiopyrad and 22.3% chlorothalonil); and the metabolites of penthiopyrad (DM-PCA, PCA, PAM, 753-A-OH, and 753-T-DO). Appendix H lists these studies, their review cl assifications, and associated deficiencies.

In addition, the publicly-availab le version of the ECOTOX data base was searched on July 29, 2011 in order to provide more eco logical effects data (USEPA, 2011b) . The results of this query show that no additional ecotoxicity data are available for penthiopyrad or its degradates; therefore, all toxicity endpoints are ta ken from registrant-submitted studies.

A description of available aquati c and terrestrial toxicity data for penthiopyrad, its formulated products, and degradates is provided in Section 3.3.1 and 3.3.2, respectively.

Given that penthiopyrad is a new active ingredient with no previ ous registration in the U.S. or any other country, a query of the Agency’s O ffice of Pesticide Programs Ecological Incident Information System (EIIS) was not completed

, and it is assumed that no ecological incidents exist for penthiopyrad. The Treoris formulated product is co-formulated with chlorothalonil (PC code 081901) a currently registered active ingredient. A query of the EIIS database found 33 incidents with potential links to chlorothalonil use as of June 17, 2007 (no new incidents were identified as of September 13, 2011). Incidents recorded in the EIIS database are ranked according to level of certainty wi th which the incident can be linked with chemical exposure.52 For more detailed information on the incidents re lated to chlorothalonil, see the 2007 CRLF risk

assessment 4

.

3.3.1. Aquatic Toxicity Characterization

A summary of the most sensitive aquatic toxicity data for pent hiopyrad, including its formulated products, Fontelis, Vertisan, and Treoris, based on a current Agency review of all submitted data, is provided in Table 3.15 and discussed further in Sections 3.3.2.1 through 3.3.2.5 . No ecotoxicity data was submitted for either th e Velista (WDG) or WG formulations of penthiopyrad, which is an uncertainty as the Fo ntelis and Vertisan formulations will not be typical end-use products (TEP) for the Velista or WG formulations. For the formulations with associated ecotoxicity data, the Fontelis and Vert isan formulations were relatively similar in toxicity as the TGAI, with one exceptions; the Fontelis formulation was more toxic than the TGAI to daphnids. The Treoris formulated product , which is co-formulated with chlorothalonil,

is more toxic than the penthiopyrad TGAI. The available acute a quatic toxicity data for the Treoris formulated product is 28 to 137 times more toxic than the technical grade penthiopyrad to freshwater fish, invertebrate s, and aquatic non-vascular plants . However, it was determined that this difference in toxicity was due to the presence of the co-formulated chlorothalonil active ingredient, and is not a synergis tic effect of the combination of penthiopyrad plus chlorothalonil

co-formulation. When the availabl e toxicity data for the chloro thalonil active ingredient are compared to the toxicity results from the co-for mulation, the aquatic toxic ity endpoints for fish, invertebrates, and plants are simila r to those for chlorothalonil alone ( Appendix F ). Therefore, risk was assessed for the active ingredient and formulation products that contain penthiopyrad alone as the active ingredient, a nd not the co-formulation. Risk due to exposure to chlorothalonil was evaluated in a separate assessment (USEPA, 2010) 5 . The available aquatic toxicity data show that the DM-PCA, PCA, PAM, 753-A-OH, and 753-T-DO metabolites are less toxic to aquatic animals and plants th an the parent penthiopyrad ( Appendix E ). Therefore, acute toxicity endpoints for the parent penthiopyra d, including the Fontelis, and Ve rtisan formulations in terms of the penthiopyrad active ingredient are used in the risk assessment for freshwater aquatic animals and plants, where available.

It should be noted that several toxicity endpoints for aquatic te st species exceed the limit of penthiopyrad’s solubility in water (1.4 mg/L at pH of 7). This can be attributed to the use of a solvent (dimethylformamide (DMF)) in the test solu tions of several studies. Data were not used in the risk assessment if a precipitate was presen t in the study and test concentrations were not centrifuged or mixed. Therefore, although severa l toxicity endpoints are above penthiopyrad’s solubility, EFED has confidence in the toxicity values that are being used to estimate risk quotients because precipitates were not observed in those studies and test concentrations were

measured.

4 http://www.epa.gov/espp/litstatus/eff ects/redleg-frog/#chlorothalonil

.

5 US EPA. 2010. Ecological Assessment for the IR-4 Registration of Chlorothalonil (Bravo Weather Stik ® /Bravo ®
720, 54%; EPA Reg. 50534-188) and the Degradation Product, 4-Hydroxy-2,5,6-trichloro-1,3-dicyanobenzene (SDS-3701) for the New Uses On: Blub Vegetables, Bus hberris, and Low Growing Berries. (PC Code: 081901; DP Barcode: 370488) (Decision: 419169). Dated August 2, 2010.53 Table 3.15. Summary of the Most Sensitive Ac ute and Chronic Toxicity Data for Aquatic Organisms Exposed to Penthiopyrad
Aquatic Animals

Species Test

Substance Acute Toxicity Chronic Toxicity

96-hr LC 50 /EC 50 (μg a.i./L) (Toxicity Classification) 48-hr EC 50 (mg a.i./L) (Toxicity Classification) MRID NOAEC/

LOAEC (μg a.i./L) (Endpoints) MRID

Fathead

minnow ( Pimephales promelas ) TGAI

98.6% 290 μg a.i./L (Highly toxic) -- 47614988 100/188 μg a.i./L (Growth: total

length & dry weight) 47614994

Sheepshead

Minnow ( Cyprinodon variegates ) TGAI

98.6% 1381 μg a.i./L (Moderately toxic) -- 47615034 476.2/897 μg a.i./L* Calculated using an

ACR of

2.9 1

Waterflea ( Daphnia

magna ) TGAI

98.6% -- 2531 μg a.i./L (Moderately toxic) 47614996 471/818 μg a.i./L (Reproduction) 47615003

Waterflea ( Daphnia

magna ) Fontelis

20% a.i. -- 59.6 μg a.i./L (Very highly toxic) 47615226 10.61/20.75 μg a.i./L (Survival, Reproduction, length) 47615236

Eastern oyster ( Crassostrea virginica ) TGAI

98.6% 1200 μg a.i./L (Moderately toxic) -- 47615033 223/388 μg a.i./L* Calculated using

ACR of

5.37 2

Aquatic Plants

Species Test

Substance Endpoint (μg a.i./L) Effect (MRID)

Marine Diatom

Skeletonema

costatum TGAI

98.6% 96 hr EC 50 =1200 μg a.i./L NOAEC =417 μg a.i./L Cell density (47615006)

Duckweed Lemna gibba TGAI

98.6% 7-day EC 50 >1205 μg a.i./L NOAEC =1205 μg a.i./L No treatment related effects (47615015)
*Chronic toxicity data for estuarine/marine fish and invertebrates are not available, therefore, a NOAEC was derived using an acute to chronic ratio (ACR) based on freshwater fish and invertebrate data, respectively.

1 The calculated ACR was 2.9 (Freshwater fish LC 50 / Freshwater fish NOAEC = 290 μg a.i./L/100 μg a.i./L), and the resulting estimated chronic estuarine/ma rine fish NOAEC value was 476.2 μg a.i./L (1381 μg a.i./L/2.9).

2 The calculated ACR was 5.37 (Freshwater invertebrate EC 50 /Freshwater invertebrate NOAEC = 2531 μg a.i./L/471 μg a.i./L), and the resulting estimated chronic estuarine/ma rine invertebrates NOAEC value was 223 μg a.i./L (1200 μg a.i./L/5.37).54 3.3.2.1. Toxicity to Freshwater Fish

TGAI Penthiopyrad

As shown in Table 3.16 , four freshwater fish acute toxicity studies using the TGAI (98.6%) were submitted to evaluate the toxicity of penthiopy rad to fish in support of the new chemical registration. Three submitted acute toxicity studies with freshwat er fish were classified as acceptable, and showed both lethal and sublethal effects to the test species. Observed sublethal effects included loss of equilibrium, lying on the bottom of the test cham ber, lethargy, surfacing, haemorrhage, and reduced activity. These were observed in both organi sms that recoverd, and organisms that died. The reported 96-hr LC 50 values fall in the range of 290 to 572 μg a.i./L; therefore, penthiopyrad technical (M TF-753) is classified as highly toxic to freshwater fish on an acute exposure basis.

Table 3.16. Freshwater Fish Acute Toxici ty to Penthiopyrad Technical (TGAI).

Test Species/

Test Substance (Flow-through/Static) %

a.i. 96-hour LC 50 (95% C.I.) (μg a.i./L, mean-measured) Slope Toxicity Category MRID Study

Classification

Fathead Minnow ( Pimephales promelas ) Penthiopyrad technical (TGAI); (Static) 98.6 290 μg a.i./L (95% CI 203-414 μg a.i./L) Slope = NA Highly

toxic 47614988 Acceptable

Rainbow trout ( Oncorhynchus mykiss ) Penthiopyrad technical (TGAI); (Static) 98.6 386 μg a.i./L (95% CI 276-540 μg a.i./L) Slope = NA Highly

toxic 47614984 Acceptable

Common Carp ( Cyprinus carpio ) Penthiopyrad technical(TGAI); (Flowthrough) 98.6 572 μg a.i./L (95% CI 434-685 μg a.i./L) Slope = NA Highly

toxic 47614986 Supplemental

Slope = NA - Probit slope calculations we re not available; binomial method wa s used as there were less than two concentrations with partial mortality

A freshwater fish chronic early life stage to xicity test was submitted for fathead minnow ( Pimephales promelas ) with penthiopyrad technical (TGAI; 98.6%) ( Table 3.17 ). The test was conducted for 33 days under flow-through conditi ons. There was a significant difference in percent post-hatched (larval) survival (69% re duction), total length ( 9.2% reduction) and dry weight (10.8% reduction) in the highest test concentr ation (188 μg a.i./L) in comparison to control fish. Which correspond to NOAEC and LOAEC values of 100 μg a.i./L and 188 μg a.i./L, respectively. Observed sublethal effect s included being smaller in size, weak, curled, discoloured, and/or cu rved (crooked) spines; morphologically -deformed (i.e., swollen abdomen), surfacing, lying on the bottom, injured side, and/or a loss in equilibrium; however the effects did not increase in a dose-response manner, and were comparable to the control groups.55 Table 3.17. Freshwater Fish Chronic Toxici ty to Penthiopyrad Technical (TGAI).

Test Species (Flow-through/Static; Duration) %

a.i. NOAEC/LOAEC (μg a.i./L, mean-measured) Effect MRID Study

Classification

Fathead minnow ( Pimephales promelas ) (Flow-through; 33 days) 98.6 NOAEC = 100 μg a.i./L LOAEC = 188 μg a.i./L Growth (total length &

dry weight) 47614994 Acceptable

Formulated Products

There were three additional freshwater fish acu te static toxicity studies using the three formulated products Fontelis, Vert isan, and Treoris. The two addi tional freshwater fish toxicity studies using the formulated products Fontel is, and Treoris tested the rainbow trout ( Oncorhynchus mykiss ), and the study submitted using the formulation Vertisan tested the fathead minnow ( Pimephales promelas ), ( Table 3.18 ). Based on the results of these studies, a

96-hr LC 50 value of 356 μg a.i./L was re ported for Fontelis, a 96-hr LC 50 value of 309 μg a.i./L was reported for Vertisan and a 96-hr LC 50 value of 14 μg penthiopyrad a.i./L was reported for

Treoris. In addition to lethal effects, sublethal effects ( i.e. , loss of equilibrium, lethargy, lying on the bottom, hyperventilation, and su rfacing) were also observed. Pe nthiopyrad corrected toxicity endpoints for Fontelis and Vertisan formulati ons are similar in toxicity endpoints for the technical grade penthiopyrad and are classified as highly toxic to freshwater fish on an acute exposure basis. The Treoris formulation is considerably more toxic than technical grade penthiopyrad; the 96-hr LC 50 for Treoris formulation was 14.0 μg penthiopyrad a.i./L (MRID 47737323), which is 21 times more toxic than compared to the 96-hr LC 50 for the technical grade penthiopyrad (290 μg a.i./L; MRID 47614988). The t oxicity of the Treoris formulation in terms

of the chlorothalonil acitive i ngredient is less toxic (25.4 μg chlorothalonil a.i./L (MRID 47737323) as compared to 10.5 μg a.i./L for tech nical grade chlorothal onil (Davies and White 1985)). However, these results indicate that the in crease in toxicity of Treo ris as compared to the technical penthiopyrad and other penthiopyrad form ulations is due to th e high toxicity of the chlorothalonil, and is not cons idered to be a synergistic e ffect of the combination of penthiopyrad plus chlorothalonil. Therefore, based on these result s, the Treoris formulation is classified, in terms of the ac tive ingredient penthiopyrad, as very highly toxic to freshwater fish on an acute exposure basis.

Table 3.18. Freshwater Fish Acute Toxicity to the Fontelis, Vertisan, and Treoris

Formulations.

Test Species/

Test Substance (Flow-through/Static) %

a.i. 96-hour LC 50 (95% C.I.) (μg a.i./L, mean-measured) Slope Toxicity Category MRID Study

Classification

Rainbow trout ( Oncorhynchus mykiss )

Fontelis (Static) 20.72 356 μg a.i./L (95% CI 190-800 μg a.i./L) Slope = NA Highly

toxic 47615225 Acceptable

Fathead Minnow ( Pimephales promelas ) 20.8 309 μg a.i./L (95% CI 224-546 μg a.i./L) Highly

toxic 47615335 Acceptable56 Test Species/

Test Substance (Flow-through/Static) %

a.i. 96-hour LC 50 (95% C.I.) (μg a.i./L, mean-measured) Slope Toxicity Category MRID Study

Classification

Vertisan (Static) Slope = NA

Rainbow trout ( Oncorhynchus mykiss )

Treoris (Static) 8.91 a

22.8 b 14.0 μg a.i./L (95% CI 7.34-22.2 μg a.i./L) penthiopyrad Slope = NA

25.4 μg a.i./L (95% CI 11.6-51.1 μg a.i./L)

chlorothalonil

Slope = NA Very highly

toxic 47737323 Supplemental

Slope = NA - Probit slope calculations we re not available; binomial method wa s used as there were less than two concentrations with partial mortality

a Penthiopyrad active ingredient

b Chlorothalonil active ingredient

Degradates

Five penthiopyrad metabolite acute freshwater fi sh toxicity studies using the metabolites DMPCA, PCA, PAM, 753-A-OH, and 753-T-DO we re submitted and are summarized in Appendix

E . Based on the results of these tests, all test ed penthiopyrad metabolites were found to be less toxic than the parent TGAI. Th erefore, only the parent toxicity data will be considered to

characterize the acute risk to fish.

3.3.2.2. Toxicity to Freshwater Invertebrates

TGAI Penthiopyrad

Freshwater invertebrate acute t oxicity data for the waterflea ( Daphnia magna ) are available for penthiopyrad TGAI and are presented in Table 3.19 . The 48-hr EC 50 value for Daphnia exposure to the penthiopyrad TGAI is 2531 μg a. i./L, classifying penthiopyrad technical as moderately toxic to freshwater invertebrates on an acute exposure basis. Sublethal effects included lethargy, immobilization and reduced activity.57 Table 3.19. Freshwater Invertebrate Acute T oxicity to Penthiopyrad Technical (TGAI).

Test Species/

Test Substance (Flow-through/Static) % a.i. 48-hour EC 50 (95% C.I.) (μg a.i./L, mean-measured) Slope Toxicity Category MRID Study

Classification

Waterflea ( Daphnia magna ) Penthiopyrad technical (TGAI) (Static) 98.8 2531  g a.i./L (95% CI 2251-2829  g a.i./L) Slope = 10.3 (95% CI 6.06-14.5) Moderately

toxic 47614996 Acceptable

Slope = NA - Probit slope calculations we re not available; binomial method wa s used as there were less than two concentrations with partial mortality/immobility

A chronic 21-day full life cycle toxicity test was submitted for aquatic freshwater invertebrates using the penthiopyrad TGAI (M RID 47615003). The result of the study is summarized in

Table 3.20

. The chronic full life cycle toxicity test using the TGAI, indicated statisticallysignificant (p<0.05) reduction in the mean number of live young per reproductive day in the two highest test concentrations (818 and 1515 μg a.i./L); the co rresponding NOAEC and LOAEC are 471 μg a.i./L and 818 μg a.i./L, respectively (MRID 47615003).

Table 3.20. Freshwater Invertebrate Chroni c Toxicity to Pent hiopyrad Technical.
Test Species(Flow-through/Staticrenewal; Duration) %

a.i. NOAEC/LOAEC (μg a.i./L, mean-measured) Effect MRID Study

Classification

Waterflea ( Daphnia magna ) Penthiopyrad technical (TGAI) (Flow-through; 21 days) 98.6 NOAEC = 471 μg a.i./L LOAEC = 818 μg a.i./L Reproduction (time to first brood release, & the

number of live

offspring per reproductive day) 47615003 Acceptable

One additional spiked sediment toxicity study, which is summarized in Table 3.21 , wassubmitted by the registrant to assess the potential effects of penthiopyrad on the sedimentdwelling freshwater invertebrate midge ( Chironomus riparius ). The study, which followed the Organization of Economic Cooperation a nd Development (OECD) Guideline 218 6 methods for

sediment-water chironomid toxi city testing using spiked se diment, was classified as “Supplemental” because it is a non-guideline stu dy. The results of the study indicate that penthiopyrad remained predominantly associated with the sediment during the 28-day study. Only two test concentrations (the lowest and highest) were anal ytically-determined in sediment, overlying water, and pore water from surrogate vesse ls, they were the concen trations prepared at the nominal 3.1 (low) and 100 (high) mg a.i./kg levels, and were measured on days 0, 7, and 28. The 100 mg a.i./kg nominal sediment test concentr ation was analytically analyzed with resulting time-weighted average (TWA) concentrations of 72.5 mg a.i./kg in the sediment, and 3.3 mg a.i./L in the overlying water and 5.4 mg a.i./L in the pore water.

6 OECD. 2011. Test No. 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment. http://titania.sourceoecd.org/vl=65713224/cl=23/nw=1/rpsv/ij/oecdjournals/1607310x/v1n2/s19/p158 There was a treatment-related effect observe d on reduced survival (83% mortality; 68% reduction) and emergence rate (34% reduction) of adults at the highest nominal test concentration of 100 mg a. i./kg (measured as 5.4 mg a.i./L in the pore water) as compared to the negative control. However, since only the highest and lowest test concentr ations were measured, the pore water NOAEC value is not known. To estimate the NOAEC in terms of pore water concentrations a ratio analysis using the LOAEC for the nominal sediment test concentration and the LOAEC for the measured pore water concentr ation was completed. The resulting ratio was calculated to be 18.35 (the nominal sediment c oncentration LOAEC/ the measured pore water concentration LOAEC = 100/5.4), th is ratio was then compared to the NOAEC for the nominal

sediment concentration to estimate the NOAEC fo r the pore water concentration. Based on the ratio analysis, the estimated NOAEC for the pore water concentration was calculated to be 2.72 mg a.i./L (NOAEC for the nominal sediment con centration/ratio = 50/18.35). Therefore, based on these calculations the 28-day NOAEC and LOAE C were 2.72 and 5.4 mg a.i./L, respectively, based on pore water (estimated and measur ed, respectively) concentrations.

Given the propensity for penthiopyrad to remain in the sediment, the endpoint associated with the concentrations in the pore water is used to a ssess the potential toxicity of penthiopyrad TGAI to sediment-dwelling freshwater invertebrates.

Table 3.21. Toxicity of Sediment-Dwelling F reshwater Invertebrates to Penthiopyrad

TGAI
Test Species

Test Substance (Flow-through/Static; Duration) %

a.i. Endpoint (Measured/Nominal) Effect MRID Study

Classification

Chironomus riparius Penthiopyrad technical (TGAI) (Spiked sediment; Static; 28 days) 98.6 Sediment: NOAEC = 50 mg a.i./kg LOAEC = 100 mg a.i./kg (Nominal) LOAEC = 72.5 mg a.i./kg (Time-weighted average measured, TWA)

Pore Water : NOAEC = 2.72 mg a.i./L* LOAEC = 5.4 mg a.i./L (TWA)

Overlying Water : NOAEC = value could not be

determined LOAEC = 3.32 mg a.i./L (TWA) Mortality

& Emergence

rate 47615014 Supplemental (non-guideline study)

* Only the highest and lowest test concentrations were me asured, therefore, to estimate the NOAEC based on pore water concentrations a ratio using the nominal sediment concentration LOAEC and measured pore water LOAEC

was used.59 Formulated Products

There were three additional freshwater invertebrate acute static toxicity studies using the three formulation products Fontelis, Vertisan, a nd Treoris, the data are presented in Table 3.22

. The

available acute data for the Fontelis formulati on show that it is more toxic to freshwater invertebrates than technical grade pe nthiopyrad with a reported 48-hr EC 50 value of 59.6 μg a.i./L (MRID 47615226). In addition, the corresponding NOAE C for sublethal eff ects (lethargy) was 15.15 μg a.i./L. The available acute data for the Ve rtisan formulation show that it is slightly

more toxic to freshwater invertebrates th an technical grade penthiopyrad (48-hr EC 50 =2531 μg a.i./L) with a reported 48-hr EC 50 value of 1215 μg a.i./L (MRID 47615336). The corresponding NOAEC for sublethal effects ( i.e ., lethargy) was reported as < 488 μg a.i./L. The Treoris

formulation is more toxic than tec hnical grade penthiopyrad; the 48-hr EC 50 for Treoris was 18.5 μg penthiopyrad a.i./L (MRID 47737324), which is roughly 137 times more toxic than the 48-

hr EC 50 for the technical grade penthiopyrad (2531 μg a.i./L; MRID 47614996). The toxicity of

the Treoris formulation in terms of the chlorothal onil acitive ingredient is equally toxic (45 μg chlorothalonil a.i./L (MRID 47737324) as compar ed to 54 μg a.i./L for technical grade chlorothalonil (MRID 45710221). Thes e results indicate that the increased toxicity of this formulation compared to the technical penthi opyrad and other penthiopy rad formulations is likely due to chlorothalonil alone, an d is not considered to be a resu lt of a synergis tic effect of the combination of penthiopyrad plus chlorothal onil. Therefore, based on these results, the Treoris formulation is classified, in terms of the active ingredient penthiopyrad, as very highly

toxic to freshwater invertebrate s on an acute exposure basis.

Table 3.22. Freshwater Invertebrate Acute Toxicity to the Fontelis, the Vertisan and the

Treoris Formulations.

Test Species/

Test Substance (Flow-through/Static) % a.i. 48-hour EC 50 (95% C.I.) (μg a.i./L, mean-measured) Slope Toxicity Category MRID Study

Classification

Waterflea ( Daphnia magna )

Fontelis (Static) 20.72 59.6 μg a.i./L (95% CI 28.7-187.7 μg a.i./L) Slope = 2.19 (95% CI 0.646-3.74) Very highly

toxic 47615226 Acceptable

Waterflea ( Daphnia magna )

Vertisan (Static) 20.8 1215 μg a.i./L (95% CI 948-1920 μg a.i./L) Slope = NA Moderately

toxic 47615336 Acceptable

Waterflea ( Daphnia magna )

Treoris (Static) 8.91 a

22.8 b 18.5 μg a.i./L (95% CI 12-25.8μg a.i./L) penthiopyrad Slope = NA

45 μg a.i./L (95% CI 29.2-62.7 μg a.i./L)

chlorothalonil

Slope = NA Very highly

toxic 47737324 Acceptable60 Slope = NA - Probit slope calculations we re not available; binomial method wa s used as there were less than two concentrations with partial mortality/immobility

a Penthiopyrad active ingredient

b Chlorothalonil active ingredient.

A chronic 21-day full life cycle toxicity tests was submitted for aquatic freshwater invertebrates, using the Fontelis formulation (MRID 47615236). The result of the study is summarized in

Table 3.23

. The chronic full life cycle toxicity test using the Fontelis formulation indicated statistically-significant (p<0.05) re ductions in the mean adult surv ival, the mean number of live your produced per surviving female, and the mean adult length in the highest test concentraition (20.75 μg a.i./L); corresponding to a NOAEC and LOAEC of 10.61 μg a.i./L, and 20.75 μg a.i./L, respectively (MRID 47615236). The chroni c daphnid toxicity data for the Fontelis

formulation show that it is 44 times more toxic than the TGAI to freshwater invertebrates on a chronic exposure basis.

Table 3.23. Freshwater Invertebrate Chroni c Toxicity to the Fo ntelis Formulation.
Test Species(Flow-through/Staticrenewal; Duration) %

a.i. NOAEC/LOAEC (μg a.i./L, mean-measured) Effect MRID Study

Classification

Waterflea ( Daphnia magna )

Fontelis (Static-renewal; 21 days) 21.0 NOAEC = 10.61 μg a.i./L LOAEC = 20.75 μg a.i./L Adult mortality, clinical signs of toxicity, time to first brood,

number of live offspring per surviving adult, and length 47615236 Acceptable

Degradates

Acute freshwater invertebrate toxicity studies using the metabolites DM-PCA, PCA, PAM, 753- A-OH, and 753-T-DO were submitte d and are summarized in Appendix E . Based on the results of these tests, the penthiopyrad metabolites DM-PCA, PCA, and PAM were found to be less toxic than the parent penthiopyr ad active ingredient. However, the toxicity of two minor degradates, 753-A-OH and 753-T-DO, were found to be within an order of magnitude of the parent TGAI; although non-definitive , there is still a potential for effects resulting from exposure to these two metabolites. However, the inclus ion of the two minor degradates 753-A-OH, and 753-T-DO in exposure modeling would not appreciab ly increase exposure estimates. Since the major degradates of penthiopyrad were much less toxic to aquatic inverteb rates than the parent compound, penthiopyrad alone was m odeled to estimate exposure for aquatic organisms in this assessment. The parent toxicity data alone are used to characterize the acute risk to

invertebrates.61 3.3.2.3. Toxicity to Estuarine/Marine Fish

TGAI Penthiopyrad

One estuarine/marine fish acute toxicity study with the TGAI was required to evaluate the toxicity of penthiopyrad to fish in support of the new registration. Results from the submitted estuarine/marine fish acute toxicity tests are listed in Table 3.24 below. For the TGAI study, mortality was observed in the hi ghest test concentration (1447 μg a.i./L) and sublethal effects (including: surfacing, lethargy, lyi ng on the bottom of the test cham ber, and loss of equilibrium) were observed at the two highest test concen trations (996 and 1447 μg a.i./L); the 96-hr LC 50 value for sheepshead minnow ( Cyprinodon variegates ) is 1381 μg a.i./L. Therefore, penthiopyrad technical is classified as moderately toxic to estuarine/marine fish on an acute exposure basis.

Table 3.24. Estuarine/Marine Fish Acute Toxi city to Penthiopyrad Technical (TGAI).

Test Species (Static/Static-renewal) %

a.i. 96-hour LC 50 (95% C.I.) (μg a.i./L, mean-measured) Slope Toxicity Category MRID Study

Classification

Sheepshead Minnow ( Cyprinodon variegatus ) Penthiopyrad technical (TGAI) (Static-renewal) 98.6 1381 μg a.i./L (95% CI 996-infinity μg a.i./L) Slope = NA Moderately

toxic 47615034 Acceptable

Slope = NA - Probit slope calculations we re not available; binomial method wa s used as there were less than two concentrations with partial mortality

Chronic toxicity data for estuarine/marine fish are not available. It is po ssible to derive an acuteto-chronic ratio (ACR) for estuar ine/marine fish based on freshwat er fish data. An ACR of 2.9

was derived from the acute a nd chronic toxicity endpoints ( i.e ., 96-hr LC 50 = 290 μg a.i./L and NOAEC = 100 μg a.i./L) available for the fathead minnow. When this ACR is applied to the 96-

hr LC 50 for the sheepshead minnow (1381 μg a.i./L), the resulting estimated chronic estuarine/marine fish NOAEC is 476.2 μg a.i./L . The calculation of the ACR was completed between two different species of fish, which in creases the uncertainty as to what degree penthiopyrad may have chronic e ffects on estuarine/marine fish. But the calculation of an ACR still provides valuable information in helpi ng to discuss the possibl e chronic toxicity of penthiopyrad to estuar ine/marine fish.62 Formulated Products

In addition, one estuarine/marine fish acute t oxicity study with the Fontelis formulation was submitted ( Table 3.25 ). For the Fontelis formulation, mort ality was observed in the highest test concentration (3790 μg a.i./L) and sublethal effects (inc luding: surfacing, le thargy, lying on the bottom of the test chamber, and loss of loss of equilibrium) were observed at the two highest test concentrations (1830 and 3790 μg a.i./L); the formulation’s 96-hr LC 50 value for sheepshead minnow ( Cyprinodon variegates ) is 2634 μg a.i./L. A precipita te was observed in all but the lowest test concentrations, and the test materi al was not centrifuged prio r to being measured. Failure to centrifuge is an important flaw in the study design, and it raises the concern of potentially underestimating the to xicity of the Fontelis formul ation. Although the samples were mixed with a top-down mixer, this still raises a concern that th e samples may not represent only soluble penthiopyrad concentrations . Therefore, the Fontelis form ulation is also classified, in terms of the active ingredient penthiopyrad, as m oderately toxic to estuarine/marine fish on an acute exposure basis.

Table 3.25. Estuarine/Marine Fish Acute Toxicity to the Fontelis Formulation.

Test Species (Static/Static-renewal) %

a.i. 96-hour LC 50 (95% C.I.) (μg a.i./L, mean-measured) Slope Toxicity Category MRID Study

Classification

Sheepshead Minnow ( Cyprinodon variegatus )

Fontelis (Static) 21.0 2634 μg a.i./L (95% C.I.: 1830-3790 μg a.i./L) Slope = NA Moderately

toxic 47615232 Supplemental

Slope = NA - Probit slope calculations we re not available; binomial method wa s used as there were less than two concentrations with partial mortality

3.3.2.4. Toxicity to Estuarin e/Marine Invertebrates

Penthiopyrad TGAI

Estuarine/marine invertebrate acute toxicity data for penthiopyrad technical is summarized in

Table 3.26 . The 96-hr LC 50 value for mysid shrimp ( Americamysis bahia ) exposure to the TGAI is > 1700 μg a.i./L, classifying penthiopyrad techni cal as moderately toxic to estuarine/marine invertebrates on an acute exposure basis (MRID 47615032). In a 96-hr flow-through shell deposition study with estuarine/marine mollusks, the EC 50 value for the Eastern oyster ( Crassostrea virginica ) based on mean shell deposition was 1200 μg a.i./L, the highest exposure concentration tested. A precipita te was observed in the diluter mixing cups for the two highest treatment concentrations for the duration of the test. The test samples were appropriately centrifuged prior to measurement to account for the total soluble concentra tions of penthiopyrad. Based on the available data, it appears that penthi opyrad technical is modera tely toxic to oysters on an acute exposure basis.63 Table 3.26. Estuarine/Marine In vertebrates Acute Toxicity to Penthiopyrad Technical.

Test Species

Test Substance (Flow-through/Static) %

a.i. 96-hour LC/EC 50 (95% C.I.) (μg a.i./L, mean-measured) Slope Toxicity Category MRID Study

Classification

Mysid ( Americamysis bahia ) Penthiopyrad technical (TGAI) (Flow-through) 98.6 LC 50 > 1700 μg a.i./L Slope = NA Moderately

toxic 47615032 Acceptable

Eastern oyster ( Crassostrea virginica ) Penthiopyrad technical (TGAI) (Flow-through) 98.6 Shell deposition EC 50 = 1200 μg a.i./L (95% CI 940-1400 μg a.i./L) Slope = 3.59 ± 1.33 Moderately

toxic 47615033 Acceptable

Chronic toxicity data for estuarine/marine invertebra tes are not available. It is possible to derive an acute-to-chronic ratio (ACR) for estuarine/ marine invertebrates based on freshwater

invertebrate data. An ACR of 5.37 was derived from the acute and chronic toxicity endpoints ( i.e ., 48-hr EC 50 = 2531 μg a.i./L and NOAEC = 471 μg a.i./L) available for Daphnia magna

. When this ACR is applied to the 96-hr EC 50 for the eastern oyster (1200 μg a.i./L), the resulting

estimated chronic estuarine/mari ne invertebrates NOAEC is 223 μg a.i./L. When this ACR is applied to the 96-hr EC 50 for the mysid shrimp (>1700 μg a.i./L), the resulting estimated chronic

estuarine/marine invertebrate s NOAEC is >316 μg a.i./L. Th e calculation of the ACR was completed between two different species of invert ebrates, which increases the uncertainty as to what degree penthiopyrad may have chronic effects on estuarine/marine invertebrates. But the calculation of an ACR still prov ides valuable information in helping to discuss the possible chronic toxicity of penthiopyrad to estuarine/marine invertebrates.

3.3.2.5. Toxicity to Aquatic Plants

Acute aquatic plant toxicity studies were subm itted for non-vascular and vascular plants using the penthiopyrad TGAI, the Fontelis, and Treoris formulations. The results of these studies are

summarized in Table 3.27

.

Penthiopyrad TGAI

Non-Vascular Aquatic Plants Non-vascular aquatic plant data were submitted for freshwater green algae ( Pseudokirchneriella subcapitata ), freshwater blue-green (cyanobacteria) algae ( Anabaena flos-aquae ), freshwater diatom ( Navicula pellicosa ), and marine diatom ( Skeletonema costatum ) for the penthiopyrad

technical. The results of the acu te non-vascular plant data, whic h are discussed in further detail below, indicate the following sensitivity to pent hiopyrad technical of the species tested: marine diatom > freshwater green algae > freshwater bl ue-green algae > freshw ater diatom. For the freshwater green algae ( P

. subcapitata ), the 96-hr EC 50 and NOAEC values were 1600 μg a.i./L and 938 μg a.i./L, respectively, based on cell density (MRID 47615005). However, the most64 sensitive endpoint for aqua tic non-vascular plants is the marine diatom ( S.costatum ) with a the

96-hr EC 50 and NOAEC values of 1200 μg a.i./L and 417 μg a.i./L, respectively, based on decreased cell density (MRID 47615006). For the freshwater blue-green algae (Anabaena flosaquae ) and the freshwater diatom ( Navicula pellicosa ) the 96-hr EC 50 and NOAEC values were >1660 μg a.i./L and 1660 μg a.i./L, and > 1470 μg a.i./L and 1470 μg a.i./L, respectively, no effects were observed in the highest test concentration (MRIDs 47615007 and 47615008). The

results of these studies are summarized in Table 3.27

.

Vascular Aquatic Plants Acute vascular aquatic plant data for pent hiopyrad technical was submitted for duckweed ( Lemna gibba ). The 7-day EC 50 and NOAEC values for technical penthiopyrad were >1205 μg a.i./L and 1205 μg a.i./L, respectively, based on no detectable effect s on frond number, growth

rate and biomass. Re sults are summarized in Table 3.27

.

Formulated Products

Non-Vascular Aquatic Plants

There were two additional non-va scular plant (green algae P. subcapitata ) toxicity studies using two formulated products Fontelis , and Treoris. The available acute data for the Fontelis

formulation show that it is as equally toxic to freshwater green algae as the penthiopyrad technical with a reported 96-hr EC 50 value of 1400 μg a.i./L based on cell density and a NOAEC value of 250 μg a.i./L, based on decreased ce ll density, biomass and growth rate (MRID 47615230). The available acute data for the Treoris formulation show that it is more toxic to freshwater green algae than penthiopyr ad technical with a reported 72-hr EC 50 and NOAEC values of 51 μg penthiopyrad a.i./L and 35.6 μg penthiopyrad a.i./L, respectively, based on decreased cell density (MRID 47737325), which is two orders of magnitude (31 times) more toxic than compared to the 96-hr EC 50 for the TGAI (EC 50 =1600 μg a.i./L MRID 47615005). The toxicity of the Treoris formulation in terms of the chlorothalonil activ e ingredient is equally toxic (170 μg chlorothalonil a.i./L (MRID 47737325) as compared to 190 μg a.i./L for technical grade chlorothalonil (MRID 42432801). These results indicate that the incr ease in toxicity of this formulation compared to the technical pent hiopyrad and other penthi opyrad formulations is likely due to the toxicity of the chlorothalonil acti ve ingredient alone, and is not considered to be a synergistic effect of the combination of pe nthiopyrad plus chlorothalonil. Therefore, penthiopyrad TGAI alone was modeled to estim ate exposure for aquatic plants in this

assessment. Results are summarized in Table 3.27

.

Vascular Aquatic Plants No vascular plant toxicity studi es were submitted for any of the formulations of penthiopyrad.

Degradates

In addition, there were five acu te non-vascular plant studies us ing the five metabolites of penthiopyrad (DM-PCA, PCA, PAM, 753-A-OH and 753-T-DO) submitted and are summarized

in Appendix E . Based on the results of these test s, the penthiopyrad metabolites DM-PCA, PCA, and PAM were found to be less toxic than the parent penthiopyra d active ingredient.65 However, the two minor degradates753-A-OH a nd 753-T-DO were found to be within an order of magnitude of the toxicity of the parent TGAI to freshwater green algae, although nondefinitive, there is still a potential for effects re sulting from exposure to these two metabolites. However, the inclusion of 753-A-OH, a nd 753-T-DO in exposure modeling would not appreciably increase exposure estimates, and th e major degradates of penthiopyrad were much less toxic to aquatic non-vascular plants than the parent compound. Ther efore, penthiopyrad TGAI alone was modeled to estimate exposure for aquatic plants in this assessment.

Table 3.27. Acute Toxicity of Aquatic Plants to Penthiopyrad Technical, Fontelis and the

Treoris Formulations.
Test Species (Test Substance; Flow-through/Static; Duration) %

a.i. Endpoint (95% C.I.) (μg a.i./L, Measured) Slope Effect MRID Study

Classification

Non-vascular Plants: Freshwater Green Algae

Freshwater green algae

Pseudokirchneriella subcapitata (TGAI; Static; 72 hr) 98.8 72-hr EC 50 = 2200 μg a.i./L (95% CI 2000-2400 μg a.i./L) NOAEC = 450 μg a.i./L

EC 05 = 610 μg a.i./L

(Mean-measured) Slope = 2.96 ± 0.225 Cell density 47615004 Supplemental

Freshwater Algae

Pseudokirchneriella subcapita (TGAI; Static; 96 hr) 98.6 96-hr EC 50 = 1600 μg a.i./L (95% CI 1400-1900 μg a.i./L) NOAEC = 938 μg a.i./L

EC 05 = 760 μg a.i./L

(Initial-measured) Slope = 4.98 ± 2.08 Cell density 47615005 Acceptable

Freshwater green algae

Pseudokirchneriella subcapitata (Fontelis; Static; 72hr) 21.0 72-hr EC 50 = 1400 μg a.i./L (95% CI 1000-1500 μg a.i./L) NOAEC = 250 μg a.i./L

EC 05 = 390 μg a.i./L

(Mean-measured) Slope 2.98 ± 0.342 Cell density 47615230 Supplemental

Freshwater green algae

Pseudokirchneriella subcapitata (Treoris; Static; 72 hr) 8.91 a

22.8 b 72-hr EC 50 = 51 μg a.i./L (95% CI 34-76 μg a.i./L) NOAEC = 35.6 μg a.i./L

EC 05 = 18 μg a.i./L (Mean-measured) Slope 3.68 ± 1.18

Penthiopyrad

72-hr EC 50 = 170 μg a.i./L (95% CI 130-220 μg a.i./L)

NOAEC = 105 μg a.i./L

EC 05 = 65 μg a.i./L (Initial-measured) Slope 4.01 ± 0.771

Chlorothalonil Cell density 47737325 Supplemental66 Test Species (Test Substance; Flow-through/Static; Duration) %

a.i. Endpoint (95% C.I.) (μg a.i./L, Measured) Slope Effect MRID Study

Classification

Non-vascular Plants: Freshwater Blue-Green Algae, Freshwater Diatom, and Marine Diatom

Freshwater blue-green algae Anabaena flos-aquae (TGAI; Static, 96 hr) 98.6 EC 50 > 1660 μg a.i./L NOAEC = 1660 μg a.i./L (Initial-measured) Slope = NA None 47615007 Acceptable

Freshwater diatom Navicula pelliculosa (TGAI; Static, 96 hr) 98.6 96-hr EC 50 >1470 μg a.i./L

NOAEC = 1470 μg a.i./L (Initial-measured) Slope = NA None 47615008 Acceptable

Marine diatom

Skeletonema costatum (TGAI; Static, 96 hr) 98.6 96-hr EC 50 = 1200 μg a.i./L (95% CI 1000-1500 μg a.i./L) NOAEC = 417 μg a.i./L

EC 05 = 390 μg a.i./L

(Initial-measured) Slope = 3.30 ± 0.641 Cell density 47615006 Acceptable

Vascular Plants: Duckweed

Duckweed Lemna gibba (TGAI; Static; 7 days) 98.6 7-D EC 50 > 1205 μg a.i./L

NOAEC = 1205 μg a.i./L (Mean-measured) Slope = NA None 47615015 Acceptable

* Bolded values will be used in risk characterization Slope = NA - Probit slope calculations were no t available; no endpoi nts were affected.

a Penthiopyrad active ingredient

b Chlorothalonil active ingredient.

3.3.2 Terrestrial Effects Characterization

A summary of the most sensitive terrestrial animal toxicity data for penthiopyrad technical and its formulated products is provided in Table 3.28 and discussed further in Sections 3.3.2.1 through 3.3.2.3 . The available Tier II terr estrial plant toxicity data for penthiopyrad technical are provided in Section 3.3.2.4

.

Table 3.28. Summary of the Most Sensitive Acute and Chronic Toxicity Data for Terrestrial Animals Exposed to Penthiopyrad.

Species/

Chemical Acute Toxicity Chronic Toxicity

48-hr LD 50 (μg a.i./bee) 14-day LD 50 (mg/kg bw)

(Toxicity Classification) 8-day LC 50 (mg a.i./kg diet (ppm)) (Toxicity Classification) MRID NOAEC/LOAEC (mg a.i./kg diet (ppm)) (Endpoints) MRID

Bobwhite Quail ( Colinus virginianus )/ (TGAI) NA >2,250 (Practically non-toxic) >5,790 (Practically non-toxic) 47614977

&

47614979 5090 / >5090 (No endpoints were affected) 4761498267 Species/

Chemical Acute Toxicity Chronic Toxicity

48-hr LD 50 (μg a.i./bee) 14-day LD 50 (mg/kg bw)

(Toxicity Classification) 8-day LC 50 (mg a.i./kg diet (ppm)) (Toxicity Classification) MRID NOAEC/LOAEC (mg a.i./kg diet (ppm)) (Endpoints) MRID

Mallard Duck ( Anas platyrhynchos )/ (TGAI) NA ND >5,790 (Practically non-toxic) 47614981 1520 / 5090 (Reductions in number of eggs laid and eggs set) 47614983

Wistar rat ( Ratus norvegicus ) / (TGAI) NA >2,000 (Practically non-toxic) NA 47614875 Parental NOAEL =680 ppm (38 mg/kg bw/day)

Parental LOAEL =1000 ppm (54 mg/kg bw/day)

(Reduced body weight gain in F 1 adult ♂ , increased liver weight in P & F 1

adult ♀ & increased

relative adrenal weight with increased

incidence of cortical hypertrophy in F 1 ♀ .)

Offspring NOAEL =1000 ppm (54 mg/kg/day) Offspring LOAEL =5000 ppm (278 mg/kg/day) (Reduced body weight & body weight gain, delay in preputial separation,

& decrease in absolute thymus weights) 47614906

&

47614907

Honey Bee ( Apis mellifera )/ (TGAI) >500 (Practically non-toxic) NA NA 47615017 NA NA

Honey Bee ( Apis mellifera )/

Vertisan 30.9 (Practically non-toxic) NA NA 47615337 NA NA

Honey Bee ( Apis mellifera )/

Treoris >8.91 (Moderately toxic) NA NA 47737326 NA NA

NA - Not Applicable; ND - No Data68 3.3.2.1. Toxicity to Birds

Penthiopyrad TGAI

Avian acute oral toxicity studies using the TGAI were submitted for bobwhite quail ( Colinus virginianus ) and zebra finch ( Poephila guttata ) to establish the toxicity of penthiopyrad techincal

to birds. Results of th ese tests are presented in Table 3.29 below. The acute oral LD 50 value for the bobwhite quail is >2,218 mg/kg body weight (bw); therefore, penthiopyrad is classified as practically non-toxic to upla nd avian species on an acute oral exposure basis. No

sublethal/behavioral effects or trea tment-related clinical signs of toxicity on body weight or feed consumption were observed. An acute oral LD 50 value for the zebra finch could not be calculated due to significant regur gitation of the test material; 30% or more birds regurgitated the

test material at the ≥ 156 mg/kg bw levels. Although, no mort alities were observed in any test

concentration for the duration of the study; EFED determined that the observed regurgitation was an adverse effect of penthiopyrad (MRID 48489709). As a result, an effect dose (ED 50 ) of 335 mg/kg-bw was calculated using regurgitation as the effect. The NOAEL value was 93 mg/kgbw, the lowest concentration tested in which only one bird regurgitated.

Table 3.29. Avian Acute Oral Toxicity to Penthiopyrad Technical, and the Fontelis

Formulation.

Test Species %

a.i. LD 50 (mg/kg bw) Slope Toxicity Category MRID Study

Classification

Northern bobwhite quail ( Colinus virginianus ) (TGAI) 98.6 >2,218 Slope = NA Practically

non-toxic 47614977 Acceptable

Zebra Finch ( Poephila guttata ) (TGAI) 98.6 ED 50 =335 mg/kg bw 1
Slope = NA Moderately

toxic 47614978 Supplemental

Northern bobwhite quail ( Colinus virginianus )

Fontelis 21.0 >2,066 Slope = NA Practically

non-toxic 47615249 Acceptable

1 An effect dose (ED 50 ) was calculated using regurgitation as the eff ect, due to significant regurgitation an accurate

LD 50 (lethal dose) could not be determined. NA - Probit slope calculations were not available; no mortality was observed.

Avian sub-acute dietary toxicity tests were required for upland ga me and waterfowl bird species.

Results of the two submitted tests are listed in Table 3.30 below. The LC 50 values for the bobwhite quail and mallard duck ar e greater than the highest mean -measured treatment level of 5,790 mg a.i./kg-diet; therefore, pe nthiopyrad technical is classified as practically non-toxic to avian species on a subacute dietary exposure basis. No treatment-related sublethal effects related to body weight changes, clinical signs of toxicity, or food c onsumption were observed in the mallard duck sub-acute dietary toxicity study. However, the NOAEC and LOAEC were determined using ANOVA, followed by William’s test for the bobwhite quail study. Based on the results, the reviewer concl uded that body weight change was significantly (p<0.05) reduced at the 5790 mg a.i./kg bw level. Therefore, based on this effect a NOAEC value of 3320 mg a.i./kg-diet was reported for the bobw hite quail sub-acute dietary study.69 Table 3.30. Avian Subacute Dietary Toxicity to Penthiopyrad Technical (TGAI).

Test Species %

a.i. 8-Day LC 50 (mg a.i./kg-diet) (Measured/Nominal) Slope Toxicity Category MRID Study

Classification

Northern bobwhite quail ( Colinus virginianus ) 98.6 >5,790 (Mean-measured) Slope = NA Practically

non-toxic 47614979 Acceptable

Mallard duck ( Anas platyrhynchos ) 98.6 >5,790 (Mean-measured) Slope = NA Practically

non-toxic 47614981 Acceptable

NA - Probit slope calculations were not available; no effects were observed.

Two avian reproduction tests using the TGAI were submitted to establish the chronic toxicity of penthiopyrad to birds. Results from these studies are summarized in Table 3.31 below. For the bobwhite quail study the control mo rtality in this study (12.5%; 3 females and 1 male out of 16 pairs) exceeded the limit for an acceptable study. In addition, the effects that were seen in the necropsies of the dead control birds raise conc erns relating to potenti al impacts on reproduction of the other control birds, resulting in an overall decrease in th e mean number of eggs laid for the control birds. As a result, risk may potentially be underestimated, and th e results are not reliable for use within the risk assessment. Therefore, the most sensitive chroni c avian endpoint is based

on a 12% and 13% reductions in th e number of eggs laid and eggs set by mallard ducks the highest test concentration ( 5090 mg a.i./kg-diet), with a corresponding NOAEC of 1520 mg a.i./kg-diet.

Table 3.31. Avian Chronic Toxicity (over 20 w eeks) to Penthiopyrad Technical (TGAI).

Test Species %

a.i. NOAEC/LOAEC (mg a.i./kg-diet) Effect MRID Study

Classification

Northern bobwhite quail ( Colinus virginianus ) 98.6 NOAEC =5090

LOAEC >5090 None observed 47614982 Supplemental

Mallard duck ( Anas platyrhynchos ) 98.6 NOAEC =1520

LOAEC =5090 Reduction in number of eggs laid & eggs set 47614983 Acceptable

Formulated Products

In addition, an avian acute oral toxicity study was also submitted using the Fontelis formulation. Results of these tests are presented in Table 3.32 . The LD 50 value for the bobwhite quail exposed to the Fontelis formulation was >2066 mg a.i./kg bw and no lethal or sublethal

treatment-related effects were obs erved. Therefore Fontelis is cl assified as practically non-toxic to upland avian species on an acute oral exposure basis.70 Table 3.32. Avian Acute Oral Toxici ty to the Fontelis Formulation.

Test Species %

a.i. LD 50 (mg/kg bw) Slope Toxicity Category MRID Study

Classification

Northern bobwhite quail ( Colinus virginianus )

Fontelis 21.0 >2,066 Slope = NA Practically

non-toxic 47615249 Acceptable

NA - Probit slope calculations were not available; no mortality was observed.

3.3.2.2. Toxicity to Mammals

Five mammalian acute oral toxi city studies using the TGAI a nd four metabolites (DM-PCA, PCA, PAM, and 753-A-OH) were submitted to es tablish the toxicity of penthiopyrad to mammals. Results of these tests are presented in Table 3.33 below. The acute mammalian oral

LD 50 values exceed 2,000 mg/kg bw; therefore, penthiopyrad and DM-PCA, PCA, and 753-AOH metabolites are classified as practically non-toxic to mammals on an acute oral exposure basis. However, the PAM metabolite acute oral LD 50 value was > 300 mg/kg/bw (less than 2000 mg/kg/bw), and therefore PAM is classified as m oderately to slightly toxict to mammals on an acute oral exposure basis. No mortality, clinic al signs, or macroscopic pathologic abnormalities were observed in rats exposed to penthiopyrad TGAI. Exposure to the DM-PCA, PCA, and 753- A-OH metabolites of penthiopyrad re sulted in no mortal ities, clinical sign s, or macroscopic pathologic abnormalities in any animal. Exposure to the PAM resulted in no mortalities in the groups treated with 300 mg/kg bw, but all animals treated with 2000 mg/kg bw died within 4-6 hours of dosing. In addition, although there were no macroscopic findings at necropsy in any animal, and no clinical signs of an adverse reaction to treatment with 300 mg/kg bw. But at the 2000 mg/kg bw death was preceded by decrease d activity, tremor and clonic convulsion.

Therefore the LD 50 cut-off value (in accordance with the OECD test guideline 423, Annex 2) for PAM metabolite is 500 mg/kg bw for both female and male rats. The LD 50 cut-off is based on guidance within the OECD 423 test guideline for acu te oral toxicity testing, the guideline allows

the classification of the test subs tance into a series of toxicity classes that are defined by a fixed

cut-off LD 50 value. The procedure follows a clear flow -chart and stepwise process to determine

the LD 50 values for the test substance.

Table 3.33. Mammalian Acute Oral Toxicity to Penthiopyrad Technical (TGAI) and Metabolites (DM-PCA, PCA, PAM and 753-A-OH).

Test Species (Test Substance) % a.i. LD 50 (mg/kg- bw) Slope Toxicity Category MRID Study

Classification

Wistar rat (TGAI) 99.8 >2,000 Slope = NA Practically

non-toxic 47614875 Acceptable

Sprague-Dawley rat (DM-PCA) 99.71 >2,000 Slope = NA Practically

non-toxic 47614918 Acceptable

Sprague-Dawley rat (PCA) 99.92 >2,000 Slope = NA Practically

non-toxic 47614924 Acceptable71 Test Species (Test Substance) % a.i. LD 50 (mg/kg- bw) Slope Toxicity Category MRID Study

Classification

Sprague-Dawley rat (PAM) 99.97 a

100.0 b >300 <2,000 (cut-off LD 50 =500) 1
Slope = NA Moderately to slightly toxic 47614930 a

&

47614931 b Acceptable

Sprague-Dawley rat (753-A-OH) 98.91 >2,000 Slope = NA Practically

non-toxic 47614936 Acceptable

1 Based on guidance within the OECD 423 test guideline for acute oral toxicity testing, the guideline allows the

classification of the test substance into a series of toxicity classes that are defined by a fixed cut-off LD 50 value.

a MRID 47614930 - acute oral toxicity study using female Sprague-Dawley rats

b MRID 47614931 - acute oral toxicity study using male Sprague-Dawley rats

A 2-generation Wistar rat ( Ratus norvegicus ) reproduction study using the TGAI was submitted to establish the toxicity of penthiopyrad to ma mmals over prolonged periods. Results from this

test are listed in Table 3.34 below. Based on reduced body wei ght gain in first generation (F 1 ; offspring) adult males, increased liv er weight in parental (P) and F 1 adult females and increased relative adrenal weight with increased incidence of cortical hypertrophy in F 1 females, the LOAEL and NOAEL for parental toxicity were reported as 54 and 38 mg/kg bw/day, respectively. The offspring toxicity LOA EL and NOAEL were reported as 278 and 54 mg/kg bw/day, respectively based on reduced body weight and body weight gain, delay in preputial separation, and a statistically si gnificant (p<0.01) decrease in absolute thymus weights.

Table 3.34. Mammalian Chronic Toxicity of Penthiopyrad Technical (TGAI) *

Test Species %

a.i. NOAEL/

LOAEL (mg a.i./kg-diet; ppm) Effect MRID Study

Classification

Wistar rat

( Ratus norvegicus ) 98.8 Parental NOAEL = 680 ppm (38 mg/kg bw/day) Parental LOAEL =1000 ppm (54 mg/kg bw/day)

Offspring NOAEL =1000 ppm (54 mg/kg bw/day) Offspring LOAEL =5000 ppm (278 mg/kg bw/day) Reduced body weight gain in F 1 adult ♂

, increased liver weight

in P and F 1 adult ♀

and increased relative

adrenal weight with

increased incidence

of cortical hypertrophy in F 1 ♀

.

Reduced body weight and body weight gain, delay in preputial separation, and a statistically significant (p<0.01)

decrease in absolute

thymus weights. 47614906

&

47614907 Acceptable

* Bolded values will be used in risk characterization72 3.3.2.3. Toxicity to Terrestrial Invert ebrates and Beneficial Insects

Honeybees An acute contact toxicity study of bees is required, and 48-hr acute contact toxicity studies using penthiopyrad technical (TGAI), and the Fontelis, Vertisan, an d Treoris formulations were submitted to establish the toxicity of penthiopyrad to young adult honeybees ( Apis mellifera ). In addition, non-guideline acute oral toxicity studies were submitted for the pe nthiopyrad technical (TGAI) and the Fontelis, Vertisan, and Treoris form ulations. The results of the acute contact and

acute oral studies are summarized in Table 3.35

.

There was no mortality of bees at the limit dos e of 500 μg a.i./bee fo r penthiopyrad technical (TGAI), therefore, the reported LD 50 value is >500 μg a.i./bee. However, this study was classified as supplemental, due to the failure of conducting a negative cont rol concurrently with

the solvent control and treatme nt groups. The Fontelis formulation, also found no treatmentrelated effects, sublethal eff ects (although classified as not being dose-dependent) observed included cramps (contracting abdomen or enti re body), moribound (bees ca nnot walk and show only very feeble movements of legs and an tennae, only weak response to stimulation ( e.g., light, air movement), bees may recover but usually die, affected (bees still upr ight and attempting to walk but show signs of reduced co-ordination) , and apathy (bees showin g only slow or delayed reactions to stimulation ( e.g., light, air movement); bees are ei ther sitting motionless in the cage or staggering). However, based on the availa ble information, and the non-dose response, the

LD 50 value was >100 μg a.i./bee, the hi ghest concentration tested.

For the Vertisan formulation, there was a dose-res ponse increase in mortality of bees during the acute contact toxicity study and the calculated 48- and 96-hr LD 50 values were 30.94 μg a.i./bee and 23.49 μg a.i./bee, respectivel y. Additionally, sublethal effects were also observed and included lying on their back, apat hy (bees showing only slow or de layed reactions to stimulation ( e.g., light, air movement); bees ar e either sitting motionless in the cage or staggering), and lethargy (bees walking slowly dragging their legs). For the Treoris formulation (co-formulated with chlorothalonil), after 48 hours observed a control mortality of 4% (two dead bees), which was corrected for, and based on this correction, no treatment related effects were observed.

There was one bee that was observed at 48 hours to be lethargic (bees walking slowly dragging their legs), however, no other sublethal effects were obsereved; therefore, the LD 50 value for the

Treoris formulation was determined to be >8.91 μg penthiopyrad a.i./bee (equivalent to >22.8 μg chlorothalonil a.i./bee), the highest concentration tested.

The results of the supplemental non-guideline acute oral toxicity studies of young adult honeybees with the penthiopyrad tec hnical, the Fontelis, Vertisan, and Treoris formulations show

similar results to the acute cont act toxicity studies. For pent hiopyrad technical, there was 3% mortality occurring at the singl e treatment concentration of 500 μg a.i./bee; the reported LC 50 value is >500 μg a.i./bee. For the Fontelis formulation, no mortality was observed in any

treatment concentratio n; therefore the LC 50 value was >107.2 μg a.i./bee. For the Vertisan formulation, there was also a dose-response increa se in mortality of bees during the acute oral toxicity study; therefore th e calculated 48- and 96-hr LC 50 values were 56.7 μg a.i./bee and 50.7 μg a.i./bee, respectively. For the Treoris formul ation, although there was mortality observed in73 each concentration, there was not a dose-dependent increase in mortality of bees during the acute oral toxicity study; therefore the 96-hr LC 50 value is >10.9 μg penthiopy rad a.i./bee (equivalent to >28.1 μg chlorothalonil a.i./b ee), the highest concentratio n tested. Although the endpoint

values between the acute contact and acute oral studies appear to be slightly different, this

difference can be attributed to the measured va riations between dosing techniques. The same

nominal concentrations were used in both the acute contact and acute oral toxicity tests for all test materials tested (the TGAI, and the Font elis, Vertisan, and Treo ris formulations).

The penthiopyrad technical, the F ontelis, and the Vertisan formul ations are all categorized as practically non-toxic to honey bees on an acute contact expos ure basis. In terms of the active ingredient penthiopy rad, the Treoris formulation is categorized as moderately toxic to honeybees on an acute contact exposure basi s. The toxicity of the Treori s formulation in terms of the chlorothalonil active ingr edient is more toxic (>22.8 μg chlorothalonil a.i./L (MRID 47737326) when compared to the techni cal grade chlorothalonil (LD 50 >181 μg a.i./bee for (MRID 00077759)) ( Appendix F ). In addition, it is important to hi ghlight that chlorothalonil has been associated with numerous bee incidents, and chlo rothalonil has been documented inside the hive, within bees, and it has also been f ound sequestered in bee pollen (Mullin et al. , 2010). These

incidents and data demonstrate that chlorothal onil is making its way back to the colony. Although, the available toxici ty data indicates that the penthio pyrad technical does not result in effects to adult bees, the effect s to bees in relation to the association of penthiopyrad and

chlorothalonil in the co -formulated product, the Treoris formulation may increase the toxicity of penthiopyrad and chloroth alonil to bees. In addition, it should be noted that there are uncertainties associated with the honeybee toxi city data because they examine effects only on young adult forage (female) bees and not on potential effects to the queen, drones (males), juvenile (nurse) and larval bees.

Table 3.35. Honeybee Acute Toxicity to Penthi opyrad Technical (TGAI) and the Fontelis, the Vertisan, and the Treoris formulations.
Test Species/

Test Substance Exposure

Route % a.i. Endpoint Toxicity Category MRID Study

Classification

Honeybee ( Apis mellifera ) (TGAI) Acute

contact 98.8 48-hr LD 50 >500 μg a.i./bee Slope = NA Practically

non-toxic 47615017 Supplemental

Acute oral 98.8 48-hr LC 50 >500 μg a.i./bee Slope = NA N/A 47615016 Supplemental (non-guideline study)

Honeybee ( Apis mellifera )

Fontelis Acute

contact 20.7 48-hr LD 50 >100 μg a.i./bee Slope = NA Practically

non-toxic 47615237 Acceptable

Acute oral 20.7 48-hr LC 50 >107.2 μg a.i./bee Slope = NA N/A 47615237 Supplemental (non-guideline study)74 Test Species/

Test Substance Exposure

Route % a.i. Endpoint Toxicity Category MRID Study

Classification

Honeybee ( Apis mellifera )

Vertisan Acute

contact 20.8 48-hr LD 50 =30.9 μg a.i./bee (95% CI 21.6-49.9 μg a.i./bee) Slope = 1.22 (95% CI 0.95-1.48)

96-hr LD 50 = 23.5 μg a.i./bee (95% CI 17.0-35.4 μg a.i./bee) Slope = 1.25 (95% CI 1.00-1.51) Practically

non-toxic 47615337 Acceptable

Acute oral 20.8 48-hr LC 50 = 56.7 μg a.i./bee (95% CI 45.4-72.9 μg a.i./bee) Slope = 1.50 (95% CI 1.14-1.86)

96-hr LC 50 = 50.7 μg a.i./bee (95% CI 39.0-67.9 μg a.i./bee) Slope = 1.24
(95% CI 0.90-1.57) N/A 47615337 Supplemental (non-guideline study)

Honeybee ( Apis mellifera )

Treoris Acute

contact 8.91 a

22.8 b 48-hr LD 50 >8.91 μg penthiopyrad a.i./bee

48-hr LD 50 >22.8 μg

chlorothalonil a.i./bee Slope = NA Moderately

toxic 47737326 Acceptable

Acute

oral 8.91 a

22.8 b 48-hr LC 50 >10.9 μg penthiopyrad a.i./bee

48-hr LC 50 >28.1 μg

chlorothalonil a.i./bee Slope = NA N/A 47737326 Supplemental (non-guideline study)

Slope = NA - Probit slope calculations were no t available; no endpoi nts were affected. N/A = Not applicable for acute oral toxicity; is not a guideline study

a Penthiopyrad active ingredient

b Chlorothalonil active ingredient.

Other Terrestrial Inverteb rates and Beneficial Insects

As shown in Table 3.36 , additional terrestrial invertebrate toxicity studies were submitted for earthworms ( Eisenia fetida ), the parasitic wasp ( Aphidius rhopalosiphi ), the predatory mite ( Typhlodromus pyri ), the predatory bug ( Orius laevigatus ), and the green lacewing ( Chrysoperla

carnea ).

Earthworms

The results of the earthworm acute toxicity tests with penthiopyr ad technical, a nd the Fontelis formulation, show no treatment-related lethal or sublethal effects follo wing 14-days of exposure at 1,000 mg a.i./kg dry weight (d.w.) of soil (acute); therefore, the reported LC 50 values were >1000 mg/kg dw soil, the highest concentrati on tested. The results of the earthworm reproduction and growth toxicity studies with penthiopyrad techni cal show no treatment-related lethal or sublethal (growth or reproductive) e ffects following exposure; therefore, the reported75 NOAEC values were ≥ 48 mg/kg d.w. soil, the highest c oncentration tested. However, the reported results of the earthworm reproduction a nd growth toxicity st udy with the Fontelis

formulation show a treatment-related decrease in body weight and repr oduction in the 500 and 1000 mg/kg d.w. soil test concentrations. Therefore, the NOAEC and LOAEC values for the

Fontelis formulation were determined to be 250 and 500 mg/kg d.w. soil, respectively.

Earthworm acute and reproduction toxicity stud ies using the metabolites DM-PCA, PCA, and

PAM were submitted and are summarized in Appendix E . Based on the results of these tests, all tested penthiopyrad metabolites resulted in no tr eatment-related effects, similar to the parent penthiopyrad active ingredient. Therefore, only the parent toxicity data will be considered to characterize the risk (acute and reproductive) to earthworms on both an acute and chronic exposure basis.

Beneficial Insects Effects on two sensitive species, the parasitic was p, and the predatory mite, were studied in doseresponse tests on artificial substrat e (glass plates) with the suspension concentrate Fontelis (20% penthiopyrad) and the emulsifiab le concentrate Vertisan (20% penthiopyrad). The Fontelis

formulation LR 50 values (lethal rate to 50% of the te st population) were equivalent to an application rate of 0.29 lbs a.i./A for the parasitic wasp (MRID 47615019), and and 0.11 lbs a.i./A for the predatory mite (MRID 47615239). The Vertisan formulation LR 50 values were equivalent to an application rate of >0.211 lbs a.i./A for the parasitic wasp (MRID 47615338) and 0.266 lbs a.i./A for the predatory mite (MRID 47615339).

In addition, extended laboratory studies were completed on the predatory mite, the predatory bug, and the green lacewing to examine the e ffects of penthiopyrad on mortality and reproduction (fecundity and fer tility) with the suspension co ncentrate Fontelis (20.64% penthiopyrad) and the emulsifiable concentrate Vertisan (20.8% penthiopyrad). The Fontelis formulation 7-day LR 50 (lethal rate to 50% of th e test population) and 14-day ER 50 (effect rate on reproduction to 50% of the test population) values for the predatory mite were equivalent to an application rate >2.49 lbs a. i./A and 1.91 lbs a.i./A, re spectively (MRID 47615240). The Fontelis formulation 9-day LR 50 and 18-day ER 50 values for the green lacewing were both equivalent to an application rate of >2.49 lb s a.i./A (MRID 47615241). The Fontelis formulation 9-day LR 50 and 18-day ER 50 values for the predatory bug were both equivalent to an application rate of >2.49 lbs a.i./A (MRID 47615242) . The Vertisan formulation 7-day LR 50 and 14-day

ER 50 values for the predatory mite were equivalent to an application rate of 0.0911 lbs a.i./A and >0.0911 lbs a.i./A, respectively (MRID 47615340). The Vertisan formulation 11-day LR 50 and 14-day ER 50 values for the predatory bug were both equiva lent to an applicat ion rate of >2.49 lbs a.i./A (MRID 47615341). The Vertisan formulation 23-day LR 50 and ER 50 values for the green lacewing were equivalent to application ra tes of 2.08 lbs a.i./A and >0.829 lbs a.i./A, respectively (MRID 47615342).

It should be noted that th e Fontelis formulation LR 50 values for the parasitic wasp and predatory mite are approximately 1.3 to 4.3 times less than the maximum single app lication rate and 3 to 10.3 times less than the maximum annual applica tion rate for the Font elis formulation of penthiopyrad (0.39 and 0.94 lbs a.i./A, respectively). Th e Vertisan formulation LR 50 values for76 the predatory mite are approximately 1.5 times less than the maximum single application rate and 3.5 times less than the maximum annual applic ation rate for the Vertisan formulation of penthiopyrad (0.39 and 0.94 lbs a.i./A, respectively).

Table 3.36. Toxicity to Other Terrestrial Invertebrates a nd Beneficial Insects using Penthiopyrad Technical (TGAI), the Font elis and the Vertisan formulations.
Test Species /

Test Substance % a.i. Endpoint Effect MRID Study

Classification

Earthworm Eisenia fetida (TGAI) 98.6 14-day LC 50 >1000 mg a.i./kg d.w.

soil Slope = NA No effect 47615020 Supplemental (non-guideline study)

Earthworm Eisenia fetida

Fontelis 20.72 14-day LC 50 >1000 mg preparation/kg d.w. soil Slope = NA No effect 47615244 Supplemental (non-guideline study)

Earthworm Eisenia fetida (TGAI) 98.6 NOAEC ≥ 48 mg/kg d.w. soil LOAEC > 48 mg/kg d.w. soil No effect 47615024 Supplemental (non-guideline study)

Earthworm Eisenia fetida

Fontelis 20.72 NOAEC = 250 mg a.i./kg d.w. soil LOAEC = 500 mg a.i./kg d.w. soil Decrease in body weight

& reproduction 47615245 Supplemental (non-guideline study)

Parasitoid wasp Aphidius rholaposip h

Fontelis 20.64 48-hr LR 50 = 0.29 lbs a.i./A (3504.5 g/ha) Mortality 47615018 Supplemental (non-guideline study) Parasitoid wasp Aphidius rholaposip h

Vertisan 20.8 48-hr LR 50 >0.211 lbs a.i./A (>1.5 L/ha) Mortality 47615338 Supplemental (non-guideline study)

Predaceous mite Typhlodromus pyri

Fontelis 20.72 7-day LR 50 =0.11 lbs a.i./A (0.62 L/ha) Mortality 47615238 Supplemental (non-guideline study)

Predaceous mite Typhlodromus pyri

Vertisan 20.8 7-day LR 50 =0.266 lbs a.i./A (1.19 L/ha) Mortality 47615339 Supplemental (non-guideline study)

Predaceous mite Typhlodromus pyri

Fontelis 21.0 7-day LR 50 >2.49 lbs a.i./A (>14 L/ha; >2800 g a.i./ha)
14-day ER 50 =1.91 lbs a.i./A (10.78 L/ha; 2156 g a.i./ha) Reproduction 47615240 Supplemental (non-guideline study)

Green lacewing Chrysoperla carnea

Fontelis 21.0 9-day LR 50 >2.49 lbs a.i./A (>14 L/ha; >2800 g a.i./ha) 18-day ER 50 >2.49 lbs a.i./A (>14 L/ha; >2800 g a.i./ha) No effects 47615241 Supplemental (non-guideline study)

Predaceous bug Orius laevigatus

Fontelis 21.0 9-day LR 50 >2.49 lbs a.i./A (>14 L/ha; >2800 g a.i./ha)
18-day ER 50 >2.49 lbs a.i./A (>14 L/ha; >2800 g a.i./ha) No effects 47615242 Supplemental (non-guideline study)77 Test Species /

Test Substance % a.i. Endpoint Effect MRID Study

Classification

Predaceous mite Typhlodromus pyri

Vertisan 20.8 7-day LR 50 = 0.0911 lbs a.i./A (0.513 L/ha; 102.6 g a.i./ha)
14-day ER 50 >0.0911 lbs a.i./A (>0.513 L/ha; >102.6 g a.i./ha) Mortality 47615340 Supplemental (non-guideline study)

Predaceous bug Orius laevigatus

Vertisan 20.8 11-day LR 50 >2.49 lbs a.i./A (>14 L/ha; >2800 g a.i./ha)
14-day ER 50 >2.49 lbs a.i./A (>14 L/ha; >2800 g a.i./ha) No effects 47615341 Supplemental (non-guideline study)

Green lacewing Chrysoperla carnea

Vertisan 20.8 23-day LR 50 =2.08 lbs a.i./A (11.7 L/ha)
23-day ER 50 >0.829 lbs a.i./A (>4.67 L/ha) Mortality 47615342 Supplemental (non-guideline study)

3.3.2.4. Toxicity to Terrestrial Plants

Two Tier I terrestrial non-target plant studies were submitted for the suspension concentrate Fontelis to assess the toxicity of penthiopyrad to terrestrial plants . The results of the non-target terrestrial plant studies for the suspension concentrate Fontelis are summarized in Table 3.37

.

Based on the results of the submitted Tier I seed ling emergence toxicity test, application of

Fontelis at the nominal maximum label rate of 1.42 lbs a.i./A (1600 g a.i./ha), (measured rate of 1.39 lbs a.i./A, 1563 g a.i./ha for all species ex cept sugarbeet; 1.44 lbs a.i., 1627 g a.i./ha for sugarbeet), resulted in the fo llowing adverse effects: 14% inhi bition of seedling emergence and survival of ryegrass ( Lolium perenne , based on number planted), 12% inhibition on growth (dry weight) of wheat ( Triticum aestivum ), and 20% inhibition on growth (dry weight) in tomato ( Lycopersicon esculentum ). No other endpoints were signifi cantly affected, and overall, there were no species that had an inhibition of 25% or greater for any endpoi nt that was tested. Phytotoxic effects observed incl uded leaf curl, necrosis, wilting, and stem curl.

Based on the results of the submitted Tier I vegetative vigor toxicity test, application of Fontelis

at the nominal maximum label rate of 1.42 lbs a. i./A (1600 g a.i./ha), (measured rate of 1.39 lbs a.i./A, 1563 g a.i./ha for wheat, corn, cabbage, so ybean and lettuce; 1.44 lbs a.i./A, 1616 g a.i./ha for onion, ryegrass, sugarbeet, tomato and ryegrass) , resulted in adverse effects on dry weight (20% inhibition) and height (5% inhibition) in wheat ( Triticum aestivum ), and dry weight (8% inhibition) in soybean ( Glycine max ). There were no adverse effects on seedling condition, survival, dry weight and height of the remaining terrestrial plant sp ecies tested, and overall, there were no species that had an inhibition of 25% or greater for any endpoi nt that was tested. Therefore, based on these results the EC 25 >1.39 lbs a.i./A for both seedling emergence and vegetative vigor studies. However, it was noted that definitive NOAEC’s were not obtained for ryegrass, wheat, and tomato (seedling emerge nce study), and wheat and soybean (vegetative vigor study), as these species ex hibited treatment related reducti ons at the limit concentration relative to the negative control. Although Tier II studies are not required as no effects were greater than 25%, Tier II studi es would reduce the uncertainty regarding Endangered Species78 assessments. Without a valid/def initive NOAEC value, risk to listed plant species would be

assumed to an undefined area ar ound the application site.

Table 3.37. Summary of Tier I Toxicity of Fonetlis to Non-target Terrestrial Plants.

Plant type Test Species Seedling Emergence (MRID 47615037) Vegetative vigor (MRID 47615038)

Test level (lb a.i./A) Endpoint(s)

Affected Test level (lb a.i./A) Endpoint(s)

Affected

Monocots Corn 1.39 None 1.39 None

Onion 1.39 None 1.44 None

Ryegrass* 1.39 Survival & seedling

emergence (14% reduction) 1.44 None

Wheat* 1.39 Dry weight (12% reduction) 1.39 Dry weight (20% recuction) & height (5% reduction)

Dicots Sugarbeet 1.44 None 1.44 None Cabbage 1.39 None 1.39 None

Soybean* 1.39 None 1.39 Dry weight (8% reduction)

Lettuce 1.39 None 1.39 None

Tomato* 1.39 Dry weight (20% reduction) 1.44 None

Radish 1.39 None 1.44 None
* These species exhibited statistically significant reductions at the limit concentration relative to the negative control; therefore, Tier II toxicity studies will be required for these species and the respective studies.



## 4. Risk Characterization

4.1 Risk Estimation

Toxicity data and exposure estimates are used to evaluate the potential for adverse ecological effects on non-target species. As discussed pr eviously, this baseline -level assessment of penthiopyrad relies 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 concentrations are divided by acute and ch ronic toxicity values). The resulting RQs are compared to the Agency’s LOCs, as shown in Table 2.3 . LOCs are used by the Agency to indicate when the use of a pestic ide, as directed by the label, has the potential to cause adverse effects to non-target organisms.

4.1.1. Aquatic Organisms

The highest baseline-level aquatic EECs were used to derive RQs. These exposure estimates were based on the proposed uses of penthiopyrad on cranberries (u sing the Tier I Rice Model) and on succulent lugumes (using the PE model) both at a maximum annual application rate of79 0.94 lbs a.i./A, and represent concentrations in surface water (exposure estimates for ground water were lower). Additionall y, the lowest baseline-level aq uatic EECs were also used to derive RQs, because listed species LOCs were exceeded based on the maximum use patterns and RQs for other use patterns resulting in lower EECs also exceeded LOCs. Peak EECs are used to represent acute exposure to fish, aquatic invertebrates, and aquatic plants, and the highest 21-day and 60-day average EECs represent chronic ex posure to aquatic invertebrates and fish, respectively. In addition, to evaluate the acu te risk to non-target aquatic organisms resulting from exposure to the Fontelis and Vertisan form ulations via spray drift, EECs were calculated using AgDRIFT.

4.1.1.1. Aquatic Animals

Table 4.1 lists RQs calculated for aquatic animals e xposed to penthiopyrad, based on the highest

PE-calculated EECs listed in Table 3.6 , which were for the proposed succulent legume use. The acute RQs based on the highest EECs for the pro posed use patterns of penthiopyrad ranged from 0.02 to 0.16. The freshwater fish were the only ta xa that had an RQ above the Agency’s acute risk to listed species LOC of 0.05 (RQ = 0.16). Th erefore, the lowest calculated EECs listed in

Table 3.6 , which were for the proposed canola use, were also used to calculate RQ values. The acute RQ for freshwater fish based on the lo west calculated EEC was 0.04; based on the secondto-lowest exposure estimate for the proposed use on sugarbeets, the acute RQ was 0.07. Therefore, RQs for freshwater fish (only) are ab ove the Agency’s acute risk to listed species LOC of 0.05 for all proposed uses of penthiopy rad except canola (RQ values range from 0.04 to 0.16). There were no acute risk LOC exceedances for estuarine/marine fish or freshwater and/or

estuarine/marine invertebrates.

As shown in Table 4.1 , chronic RQ values for freshwater fish and invertebrates (including sediment-dwelling organsims) are le ss than the Agency’s LOC of 1.0 for chronic risk to fish and aquatic invertebrates, based on the highest EECs listed in Table 3.6 from the PRZM modeling scenario for the proposed succulent legume use.

Table 4.1a lists acute and chronic RQs calculated fo r aquatic animals exposed to penthiopyrad from use on cranberries, based on the EEC from th e Tier I Rice Model (529 μg/L). Acute RQs based on this EEC exceeded the LOC for non-listed freshwater fish (RQ = 1.8) and the LOC for

listed estuarine/marine fish and freshwater a nd estuarine/marine invertebrates (RQ range 0.21- 0.44). The chronic RQs based on this EEC ranged from 1.1 to 5.3 for freshwater and estuarine/marine fish and invertebrates, indica ting LOC exceedances for aquatic organisms. The chronic RQ value for sediment-dwelling organi sms was 0.19, which is less than the Agency’s

LOC of 1.0. Because the Tier I Rice Model is a poor estimator of exposure resulting from use on cranberries, additional provisional modeling is discussed in the ri sk description to characterize the potential risks from the pr oposed use on cranberries see Section 4.2.1

.

No chronic toxicity data are available for es tuarine/marine fish or invertebrates using penthiopyrad technical (TGAI); ther efore, the acute-to-chronic ra tios were used to estimate a

chronic NOAEC value for estuarine/marine fish and invertebrates. Based on the estimated chronic toxicity values for estuar ine/marine fish, the chronic RQ value for estuarine/marine fish80 would also not exceed the Agency’s LOC of 1.0 for chronic risk to fish. Estuarine/marine fish (LC 50 = 1381 μg a.i./L) are 4.8 times less sensitive to penthiopyrad on an acute exposure basis than freshwater fish (LC 50 = 290 μg a.i./L). Therefore, usi ng an ACR for freshwater fish and comparing the fathead and sheepshead minnow da ta, results in an ACR estimated NOAEC for sheepshead minnows of 476.2 μg a.i./L. To trigge r the Agency’s chronic risk LOC, however, the

estuarine/marine fish NOAEC would need to be at least 41 μg a.i./L (using the 60-day EEC and an LOC of 1) for every use except cranberries. Based on this calculation, estuarine/marine fish

would need to be 2 times more sensitive to penthiopyrad (which is within the realm of interspecies variation) than fres hwater fish on a chronic exposure basis to exceed the Agency’s

chronic risk LOC for listed and non-listed species for every use except cranberry. However, for the cranberry use, using the EEC estimated from the Tier I Rice model (529 μg a.i./L) and an LOC of 1, the Agency’s chronic risk LOC is exceeded based on the estimated ACR for estuarine/marine fish. Therefore, chronic risk cannot be precluded for estuarine/marine fish due to this uncertainity.

Estuarine/marine invertebrates (EC 50 = 1200 μg a.i./L) are roughl y twice as sensitive to penthiopyrad on an acute exposure basis than freshwater invertebrates (EC 50 = 2531 μg a.i./L). Using a derived ACR of 5.37 for freshwater invertebrates and comparing the daphnid and Eastern oyster data results in an ACR estimated NOAEC for estuarine/mari ne invertebrates of 223 μg a.i./L. To trigger the Agency’s chronic risk LOC, however, the estuarine/marine

invertebrate NOAEC would need to be at least 44 μg a.i./L (using the 21-day EEC and an LOC of 1) for every use except cranberries. Based on this calculation, estuarine/marine invertebrates would need to be 9 times more sensitive to penthiopyr ad (which is within th e relm of interspecies variation) than freshwater invertebrates on a chronic exposure basis to exceed the Agency’s chronic LOC for listed and non-listed species for every use except cranberry. However, for the cranberry use, using the EEC es timated from the Tier I Rice m odel (529 μg a.i./L) and an LOC of 1, the Agency’s chronic risk LOC is exceeded based on the estimated ACR for estuarine/marine invertebrates. Therefore, chr onic risk cannot be precl uded for estuarine/marine

invertebrates due to this uncertainity.

Table 4.2 lists the RQs that were calculated to ch aracterize the risk po tential relating to nontarget aquatic organisms exposed to the Fontelis or Vertisan formulations via spray drift. RQs were based on the spray drift EECs that were calculated using AgDRIFT (see Section 3.2.2.1 ). The Fontelis formulation is classified as “hig hly toxic” to freshwater fish, and “very highly

toxic” to freshwater invertebrates. The Vertisan formulation is classified as as “highly toxic” to freshwater fish and “moderately toxic” to freshw ater invertebrates. The acute RQs based on the highest spray drift EEC for pent hiopyrad using the Fontelis a nd/or Vertisan formulation (2.77 μg/L, using the highest proposed agriculture use a pplication rate of 0.39 lb s a.i./A) ranged from

0.01 to 0.046. There were no acute risk LOC exceedan ces for freshwater animals for either the

Fontelis or the Vertisan formul ations. Toxicity to estuarine/ marine invertebrates is not known, as there is no acceptable estuarine/marine fish or invertebrate toxicity data available for the

Fontelis or Vertisan formulation. Without estuarine/marine fish or invertebrate toxicity data risk potential relating to non-target es tuarine/marine organisms exposed to the Fontelis formulations via spray drift cannot be precluded.81 Further characterization of the av ailable fish and aquatic inverteb rate acute and chronic toxicity data for the penthiopyrad formulated products is also provided as pa rt of the risk description in

Section 4.2.1.1

.

Table 4.1. Aquatic Animal RQ Values for Exposure to Penthiopyrad TGAI Resulting from Proposed Uses Other Than Cranberries.

Taxa Exposure Endpoint Used (μg a.i./L) RQ values *

Based on Highest

Surface Water EEC 1 Based on Lowest

Surface Water EEC 2

Freshwater Fish Acute a LC 50 = 290 0.16 0.04

Estuarine/Marine Fish Acute a LC 50 = 1381 0.03 <0.01

Freshwater Invertebrates Acute a EC 50 = 2531 0.02 <0.01

Estuarine/Marine

Invertebrates Acute a EC 50 = 1200 0.04 0.01

Freshwater Fish Chronic b NOAEC = 100 0.41 0.12

Estuarine/Marine Fish Chronic b NOAEC = 476.2 3 0.09 0.03

Freshwater Invertebrates Chronic c NOAEC = 471 0.09 0.03

Estuarine/Marine

Invertebrates Chronic c NOAEC = 223 3 0.20 0.06

Sediment-Dwelling Organisms Chronic d NOAEC = 2720 4 0.01 --

* Bolded values indicate RQs that exceed the Agency’s acute ri sk LOC (0.05 - listed species; or 0.5 - non-listed species) or chronic risk LOC (1.0)

1 Based on the highest calculated surface water EEC valu e (45 μg/L) using PRZM/EXAMS - the proposed succulent legume use

2 Based on the lowest calculated surface water EEC value (13 μg/L) using PRZM/EXAMS - the proposed canola use

3 ACR estimated NOAEC; chronic toxicity data for estuar ine/marine fish and invertebrates are not available; therefore, a NOAEC was derived using an acute to chronic ratio (ACR) based on freshwater fish and invertebrate data, respectively, which was used to estimate the es tuarine/marine fish and invertebrate RQ values.

4 Only the highest and lowest test concentrations were measured, therefore, to estimate the NOAEC based on pore water concentrations a ratio (18.35) using the nominal sediment concentration LOAEC (100 mg a.i./kg) and measured pore water LOAEC (5.4 mg a.i./L) was used; See Section 3.3.2.2

.

a The peak EEC values for succulent legumes (45 μg/L) and canola (13 μg/L) were used to calculate acute RQ values for fish, aquatic invertebrates.

b The 60-day EEC values for succulent legumes (41 μg/L) and canola (12 μg/L) were used to calculate chronic RQ

values for fish.

c The 21-day EEC values for succulent legumes (44 μg/L) and canola (13 μg/L) were used to calculate chronic RQ values for aquatic invertebrates.

d The 21-day pore water EEC for succulent legumes (38 μg/L ) was used to calculate chro nic RQ values for sediment dwelling organisms.82 Table 4.1a. Aquatic Animal RQ Valu es for Exposure to Penthiopyrad TGAI Resulting from the Proposed Use on Cranberries (Tier I EEC).

Taxa Exposure Endpoint Used (μg a.i./L) RQ values *

Freshwater Fish Acute a LC 50 = 290 1.8

Estuarine/Marine Fish Acute a LC 50 = 1381 0.38

Freshwater Invertebrates Acute a EC 50 = 2531 0.21

Estuarine/Marine Invertebrates Acute a EC 50 = 1200 0.44

Freshwater Fish Chronic a NOAEC = 100 5.3

Estuarine/Marine Fish Chronic a NOAEC = 476 1 1.1

Freshwater Invertebrates Chronic a NOAEC = 471 1.1

Estuarine/Marine Invertebrates Chronic a NOAEC = 223 1 2.4

Sediment-Dwelling Organisms Chronic a NOAEC = 2720 2 0.19

* Bolded values indicate RQs that exceed the Agency’s acute ri sk LOC (0.05 - listed species; or 0.5 - non-listed species) or chronic risk LOC (1.0)

1 ACR estimated NOAEC; chronic toxicity data for estuar ine/marine fish and invertebrates are not available; therefore, a NOAEC was derived using an acute to chronic ratio (ACR) based on freshwater fish and invertebrate data, respectively, which was used to estimate the es tuarine/marine fish and invertebrate RQ values.

2 Only the highest and lowest test concentrations were measured, therefore, to estimate the NOAEC based on pore water concentrations a ratio (18.35) using the nominal sediment concentration LOAEC (100 mg a.i./kg) and measured pore water LOAEC (5.4 mg a.i./L) was used; See Section 3.3.2.2

.

a The single EEC for cranberries from the Tier I Rice Mode l (529 μg/L) was used to calculate RQ values for each

assessed taxon.

Table 4.2. Aquatic Animal RQ Values for Ex posure (via Spray Drift) to Fontelis and Vertisan Penthiopyrad Formulations.

Taxa Exposure Endpoint Used (μg a.i./L) (Test Substance) RQ values *

Based on Highest Spray Drift EEC 1

Freshwater Fish Acute LC 50 = 356 (Fontelis) 0.01

Freshwater Fish Acute LC 50 = 309 (Vertisan) 0.01

Freshwater Invertebrates Acute EC 50 = 59.6 (Fontelis) 0.046

Freshwater Invertebrates Acute EC 50 = 1215 (Vertisan) <0.01

* Bolded values indicate RQs that exceed the acute risk LOC (0.05 - listed species; or 0.5 - non-listed species).

1 Based on the highest calculated spray drift EEC value (2.77 μg/L) using AgDRIFT - Using the maximum proposed single agriculture application rate of 0.39 lbs a.i./A (Fontelis - Brassica vegetables; succulent legumes; and root vegetables and leaves)

4.1.1.2. Aquatic Plants

As shown in Table 4.3 , RQ values for listed non-vascular pl ants based on the Tier I Rice Model EEC for use on cranberries exceed the Agency ’s LOC of 1.0. These LOC exceedances are

characterized in the risk descri ption using provisional models to refine the exposure estimated from the proposed use on cranberries.83 RQ values for all listed and non-listed vascular and non-vascular aquatic pl ants are less than the Agency’s risk to listed and non- listed aquatic plant LO Cs of 1.0, based on the highest aquatic PE-calculated EEC, i.e ., 45 μg/L

, for the proposed use on succulent legumes. Therefore, the likelihood of adverse effects on aquatic plants as sociated with exposure to penthiopyrad TGAI and its Fontelis formulation is expected to be low with the exception of the proposed use on

cranberries.

Table 4.3. Aquatic Plant RQ Values for Exposure to Penthiopyrad.

Taxa RQ Based on the Highest PE EEC

of 45 μg/L for the Proposed Succulent Legume Use RQ

Based on the Tier I Rice Model EEC of 529 μg/L for the Proposed Cranberry Use

Aquatic vascular plants Non-Listed 1 <0.04 <0.44

Listed 2 0.04 0.44

Aquatic non-vascular plants Non-Listed 3 0.04 0.44

Listed 4 0.11 1.3

* Bolded values indicate RQs that exceed the aquatic plant LOC (1.0) for listed and/or non-listed aquatic plants.

1 based on L. gibba EC 50 >1205 μg/L

2 based on L.gibba NOAEC=1205 μg/L

3 based on S. costatum EC 50 =1200 μg/L

4 based on S. costatum NOAEC=417 μg/L

4.1.2. Terrestrial Organisms

4.1.2.1. Birds

Acute RQs are not calculated for birds because definitive acute and sub-acute toxicity endpoints

are not available. The bobwhite quail acute oral toxi city study and the mallard duck sub-acute study no treatment-related sublethal effect s were observed at the highest test

concentrations/doses tested. The estimated dose- and dietary-based EECs are all below the highest test concentration test ed for the northern bobwhite acut e oral and sub-acute dietary toxicity test, and the mallard sub- acute dietary toxicity test.

Although there was a slight reduction in body wei ght gain during the exposure period for the sub-acute bobwhite quail study, based on the availabl e toxicity data, it was determined that no treatment-related acute mortality or clinical sign s of toxicity were observed in any of the acute avian studies at the highest concen trations/doses tested. However, in the zebra finch acute oral toxicity study, regurgitation was in terpreted as a toxic effect. Fu rther discussion of the predicted exposure values relative to the levels at wh ich no mortality and reduc tion in body weight gain occurred is provided as part of the risk description in Section 4.2.2.1

.

As shown in Table 4.4 , chronic avian RQ values based on the highest application rate for penthiopyrad of 0.95 lbs a.i./A range from 0.02 to 0.26 and are less than the Agency’s chronic risk LOC of 1.0. Given that chronic RQs based on the highest applicati on rate are less than Agency’s LOC, RQs associated with agricultura l use patterns at lower application rates would

also be less than the chronic risk LOC. Ther efore, risks to birds and the terrestrial-phase84 amphibians and reptiles for which they serve as surrogates associated with chronic exposure to penthiopyrad are expected to be minimal.

Table 4.4. Avian RQs for Chronic Exposure to Penthiopyrad (Based on the maximum single application rate of 0.95 lbs a. i./A - for the proposed turf use)
DIETARY CATEGORY Chronic RQ

Short Grass 0.26

Tall Grass 0.12

Broadleaf Plants/Small Insects 0.15 Fruits/Pods/Seeds/Large Insects 0.02

4.1.2.2. Mammals

Similar to birds, acute RQs are also not calcu lated for mammals because definitive acute oral toxicity data are not available. Based on the available acute toxicity data, no mortality was observed in any of the mammalian studies at the highest concentrations/d oses tested. Further discussion of the predicted exposure values rela tive to the levels at which no mortality was observed is provided as part of the risk description in Section 4.2.2.2.

Based on the highest application rate of 0.95 lbs a.i./A for propos ed turf uses of penthiopyrad, RQs calculated for chronic mammalian exposure range from 0.04 to 0.59 for dietary exposure and 0.04 to 5.81 for dose-based RQs us ing upper-bound Kenaga values (see Table 4.5 ). The dietary-based RQs do not exceed th e Agency’s chronic risk LOC ( 1.0). Dose-based chronic RQs exceed the Agency’s chronic risk LOC for nine body-size/dietary categories, based on the highest application rate of 0.95 lbs a.i./A for the proposed pent hiopyrad turf use: 15g, 35g, and 1000g mammals that eat short grass (RQs = 2.7 to 5.8), tall grass (RQs = 1.2 to 2.7), and broadleaf plants/small insects (RQs = 1.5 to 3.3). In addition, dose-based RQs using the lowest application rate 0.21 lbs a.i./A (f or all cucurbits proposed uses) exceed chronic risk LOCs for two body-size/dietary categories: 15g and 35g mammals that eat short grass (RQs = 1.2 to 1.4).

These results indicate th at all proposed use patterns of pent hiopyrad exceed chronic risk LOCs for mammals for a number of body-size/dietary cate gories. Further discussion of the chronic mammalian exposure and risk associated is provi ded as part of the risk description in Section

4.2.2.2.85 Table 4.5. Mammalian RQs for Chronic Exposure to Penthiopyrad using the upper Upper Bound Kenaga values 1

Dietary Category Body

Size Proposed Turf Use (0.95 lbs a.i./A) (maximum non-agricultural use rate) Proposed Cucurbits Use (0.21 lbs a.i./A) (minimum agricultural use rate) Dietary-based

Chronic RQ Dose-based Chronic RQ Dose-based Chronic RQ

Short Grass 15 g

0.59 5.8 1.4 35 g 5.0 1.2 1,000 g 2.7 0.64

Tall Grass 15 g

0.27 2.7 0.64 35 g 2.3 0.54 1,000 g 1.2 0.29

Broadleaf

Plants/Small

Insects 15 g

0.33 3.3 0.78 35 g 2.8 0.67 1,000 g 1.5 0.36

Fruits/Pods/Large

Insects 15 g

0.04 0.36 0.09 35 g 0.31 0.07 1,000 g 0.17 0.04

Granivore (Seeds) 15 g

N/A 0.08 0.02 35 g 0.07 0.02 1,000 g 0.04 0.01

Bolded numbers indicate RQs that exceed the Agency ’s chronic risk LOC for mammals (1.0).

1 The body weight of chronic mammals was adjusted to 135g (body weight of test organisms during the study).

4.1.2.3. Terrestrial Invertebrates

Penthiopyrad is classified as ‘p ractically non-tox ic’ to honey bees on an acute contact and oral exposure basis, based on available data for the TGAI and the Fontelis, the Vertisan formulated products. However, the Treoris formulated produ ct is moderately toxic to honey bees on an acute contact basis. Additional characterization of the potential effects of penthiopyrad on terrestrial invertebrates, a nd beneficial insects, includi ng consideration of non-guideline laboratory studies with non-target arthropods, is provided as part of the risk description in

Section 4.2.2.2

.

4.1.2.4. Non-target Terrestrial and Semi-Aquatic Plants

Potential effects to riparian and upland vegeta tion are assessed from terrestrial plant seedling emergence and vegetative vigor data as a screen. Based on the results of the submitted Tier I terrestrial non-target plant studies for the suspen sion concentrate Fontelis 20% penthiopyrad a.i.;

see Table 3.30 ), adverse effects, (14% inhibition of seedling em ergence and survival of ryegrass,12% inhibition on growth (dry weight ) of wheat, and 20% inhibition on growth (dry weight) in tomato, and 20% inhibition on growth (dry weight) of wheat and 8% inhibition on growth (dry weight) of soybean), were seen for both monocot and dicot species in both the seedling emergence and vegetative vigor toxicity tests. There were no adverse effects on seedling condition, survival, dry weight and height of the remaining terrest rial plant species tested, and overall, there were no species that had an inhibition of 25% or gr eater for any endpoint that was86 tested. Therefore, based on these results the EC 25 >1.39 lbs a.i./A for both seedling emergence and vegetative vigor studies. However, it wa s noted that definitive NOAEC’s were not obtained for ryegrass, wheat, and tomato (seedling emerge nce study), and wheat an d soybean (vegetative vigor study), as these species exhibited treatment related, statistically significant (p<0.05),

reductions at the limit concentration relative to th e negative control. Al though Tier II studies are not required as no effects were greater than 25% , Tier II studies would reduce the uncertainty regarding Endangered Species assessments. W ithout a valid/definitive NOAEC value, risk to listed plant species would be assumed to an unde fined area around the application site. However,

the available data indicate that the other six test ed plants, did not exhib it adverse effects in the seedling emergence or vege tative vigor tests.

With respect to the monocots ryegrass and wheat, and the dicots tomato and soybean, due to the presence of effects at the singl e application rate of 1.39 lbs a.i. /A, without additional data an assumption of risk to listed plants will be ma de. However, there were less than 25% effects observed at a level above the highest proposed ap plication rate, risks to non-listed plants and

indirect effects to listed animal s with no obligate relationships with plants can be discounted. Risk to listed plants and animals w ith obligate relationships with plants cannot be discounted. Further discussion the uncertainty due to the pr esence of effects is included in the risk description for terrestrial plants and in Section 4.2.2.3

.

4.2. Risk Description

Penthiopyrad is characterized as a non-volatile, lipophili c compound that is moderately mobile in soil. Depending on soil type, the compound ma y move to ground water slowly via leaching and may move to surface water bodies via spray drift and runoff of di ssolved or sorbed residues. Penthiopyrad is expected to degrade mainly via indirect photolysis in soil; however, the compound may persist in many compartments of the environment, dissipating in shaded and aquatic areas by slow aerobic biodegradation and attenuated leaching; under anaerobic conditions, the compound is likely to persist. Gi ven the potential mobility and persistence of the compound under certain environmental conditions, non- target organisms have the potential to be exposed.

Based on the effects assessment, penthiopyrad is classified as moderately to highly toxic to freshwater fish and invertebrates and to aqua tic-phase amphibian (for which fish serve as surrogates) and is moderately toxi to estuar ine/marine fish and i nvertebrates on an acute exposure basis. For terrestria l species, the compound is practica lly non-toxic to mammals, birds (and to reptiles and terrestria l-phase amphibians for which bird s serve as surrogates), and to

terrestrial invertebrates on an acute exposure basis. Chronic exposure to penthiopyrad resulted in reductions in survival and growth in fish; redu ced survival, growth and reproduction in aquatic invertebrates, reduction in eggs set and laid in birds, a nd reduced growth in mammals.

The results of this base line-level risk assessment indicate th at the proposed uses of penthiopyrad (except use on canola) have the po tential for direct adverse acute effects on listed freshwater fish (a surrogate for aquatic-phase am phibians). Acute effects on listed estuarine/marine fish and invertebrates (via spray drift from the Fontelis formulation) cannot be precluded. The proposed use on cranberries results in additional potential e ffects, including potentia l direct adverse acute87 effects on listed and non-listed freshwater fish (a surrogate for aquatic-phase amphibians); acute

effects on listed freshwater inverteb rates, estuarine/marine fish a nd invertebrates; chronic effects

to freshwater fish and estuarine/marine invertebrates 7 ; and acute effects on listed estuarine/marine fish and invertebrates (via spra y drift from Fontelis fo rmulated product). All proposed uses of penthiopyrad resu lt in potential direct adverse chronic effects on listed and nonlisted mammals. In addition, due to effects seen at the single appl ication rate for both terrestrial monocot and dicot plant species in the seedling emergence and vegetative vigor toxicity tests, risk to terrestrial plants and an imals with obligate relationships with plants are assumed. Based

on the results of the ba seline-level assessment, the risk hypothesis [ ...the proposed penthiopyrad uses have the potential to reduce survival, repr oduction, and/or growth in terrestrial and aquatic organisms ] is supported. These results are based on all application ra tes for the proposed penthiopyrad uses. Although direct adverse effects to birds, te rrestrial-phase amphibians, and reptiles, from penthiopyrad use are not expected, indirect effects to these taxa are possible, given the effects on aquatic animals and terrestrial ma mmals could indirectly impact the terrestrial organisms that feed on these species.

4.2.1. Risks to Aquatic Animals

Acute RQs for freshwater fish exceed the Agency ’s listed species LOC (0.05), for all proposed use patterns of penthiopyrad except use on canol a. However, for proposed uses other than cranberry, acute and chronic RQs for estuarin e/marine fish, freshw ater invertebrates, estuarine/marine invertebrates, and sediment -dwelling organisms do not exceed the Agency’s LOCs, based on the highest PE-calculated surface water EECs (associated with the proposed use on succulent legumes). The toxico logical level of concern for lis ted freshwater fish is 14.5 μg

a.i./L. In order to result in no LOC exceedances for listed freshwater fish ( i.e. , result in an EEC <14.5 μg/L), the application rate for the proposed use on succulent legumes would have to be reduced to one treatment per year at 0.29 lbs a.i. /A. The application rate for the proposed use on sugarbeets (the use with the sm allest LOC exceedance) would have to be reduced to 2 treatments per year at 0.27 lbs a.i./A or th e proposed application rate of 0.39 lbs a.i./A could be limited to one treatment per year in order to result in no LOC exceedances.

For use on cranberries, an acute RQ exceeded the LOC for non-listed freshwater fish, acute risk LOCs were exceeded for listed aquatic animals, and chronic risk LOCs were exceeded for aquatic animals (other than sediment-dwelli ng organisms). Additional exposure modeling was conducted with provisional flooded agriculture m odels (Tier I Cranberry Model and PFAM) in order to characterize these potenti al risks because the Tier I Ri ce Model is a poor estimator of exposure resulting from use on cranberries ( Table 4.6 ). The provisional cranberry models support the risk conclusions based on the Tier I Rice Model with the exce ption that the chronic

risk LOC is not exceeded for estuarine/marine fi sh and freshwater invertebrates. Therefore,

chronic risk to estuarine/marine fish and freshw ater invertebrates is not expected to be of

concern. The acute risk LOC remains exceeded fo r non-listed freshwater fish, acute risk LOCs remain exceeded for listed aquatic animals, a nd chronic risk LOCs remain exceeded for

7 Based on the refined cranberry model calculated EEC values, and derived acute and chronic RQs. The Tier I rice model calculated EEC value results in potential direct advers e acute and chronic effects to all aquatic organisms, as well as aquatic non-vascular plants.88 freshwater fish and estuarine/marine inverteb rates. Estuarine/marine invertebrates (EC 50 = 1200 μg a.i./L) are roughly twice as sensitive to penthiopyrad on an acute exposure basis than freshwater invertebrates (EC 50 = 2531 μg a.i./L). For the cr anberry use, using the 21-day EECs estimated from the provisional flooded agricultu re models (Tier I Cranberry Model and PFAM; 245 and 293 μg a.i./L, respectively) and an LO C of 1, the Agency’s chronic risk LOC is

exceeded based on the estimated ACR for estuarine/ marine invertebrates. Therefore, chronic risk based on the cranberry use still cannot be precluded for estuarin e/marine invertebrates based on this uncertainity. In order to result in no LOC exceedances for listed aquatic organisms ( i.e.

, result in an EEC <14.5 μg/L) usi ng the provisional Tier I Cranberry Model, the application rate for the proposed use on cranberries would have to be reduced to one treatment per year at 0.055

lbs a.i./A.

Table 4.6. Provisional Aquatic Animal RQ Values for Exposure to Penthiopyrad TGAI Resulting from the Proposed Use on Cranberries. *

Taxa Exposure Endpoint Used (μg a.i./L) TICM 1

RQ values 2 PFAM RQ values 3

Freshwater Fish Acute a LC 50 = 290 0.86 1.0

Estuarine/Marine Fish Acute a LC 50 = 1381 0.18 0.22

Freshwater Invertebrates Acute a EC 50 = 2531 0.10 0.12

Estuarine/Marine Invertebrates Acute a EC 50 = 1200 0.21 0.25

Freshwater Fish Chronic a NOAEC = 100 2.3 2.9

Estuarine/Marine Fish Chronic a NOAEC = 476 0.49 0.61

Freshwater Invertebrates Chronic a NOAEC = 471 0.52 0.62

Estuarine/Marine Invertebrates Chronic a NOAEC = 223 1.1 1.3

* Bolded values exceed an LOC.

1 TICM means “Tier I Cranberry Model”.

2 The EECs for cranberries from the Tier I Cranberry Mode l (peak=250 μg/L, 21-d mean =245 μg/L, 60-d mean=233 μg/L) were used to calculate RQ values for characterization.

3 The EECs for cranberries from PFAM (peak=298 μg/L, 21-d mean=293 μg/L, 60-d mean=289 μg/L) were used to calculate RQ values for characterization.

There were no acute risk LOC exceedances for freshwat er fish or invertebrates for the Fontelis or the Vertisan formulations. Acute RQs were be low the Agency’s risk to listed species LOC (0.05), based on spray drift EECs associated with the highest proposed agriculture use application rate of 0.39 lbs a.i./A , only (uses under the Fontelis label at 0.39 lbs a.i./A are

Brassica vegetables; succulent legumes; and root ve getables and leaves and uses under the

Vertisan label at 0.39 lbs a.i./A are so ybeans, sugarbeets, and sunflowers) ( Table 4.2 ). However, acceptable estuarine/marine fish and inve rtebrate toxicity data are not available for either the Fontelis or Vertisan formulations. Estuarine/marine fish appear to be less sensitive to the Fontelis formulation compared with freshw ater fish; however, due to the presence of precipitate and the lack of centrif ugation of the test samples (the y instead were mixed with a topdown mixer), there is a concern that sample s do not represent only soluble penthiopyrad concentrations. There is the pot ential for exposure to the penthi opyrad Fontelis formulation due to the use on cranberries, therefor e, to alleviate uncertainty a ne w toxicity study is recommended.

Estuarine/marine invertebrates are of particular concern as they we re more toxic than freshwater89 invertebrates to the penthiopyrad TGAI. In add ition, the Fontelis formulation was approximately

42 times more toxic to freshwater invertebrate s than the penthiopyrad technical (TGAI). Therefore, based on these results, the Fontelis formulation toxicity to estuarine/marine invertebrates is not known, and c ould potentially be more toxic than the freshwater invertebrates

as was the case with the TGAI.

Therefore, based on the available information, th ere is a potential for adverse effects on listed freshwater fish and aquatic-phase amphibians du e to acute exposure of penthiopyrad for all proposed uses except canola (including use on cranbe rries). Specifically for the proposed use on cranberries (utilizing provisionally refined cranberry models), th ere is a potential for adverse

effects on non-listed freshwater fish and liste d freshwater fish and invertebrates, and

estuarine/marine fish and invertebrates based on acute exposure to penthi opyrad, and a potential

for adverse effects on freshwater fish and es tuarine/marine invertebrates based on chronic exposure to penthiopyrad. In a ddition, there is the potential fo r exposure to the penthiopyrad

Fontelis formulation due to the use on cranberries. Therefore, w ithout estuarine/marine fish or invertebrate toxicity data; risk to estuarine/marine organisms expos ed to the Fontelis formulation via spray drift is presumed.

4.2.1. Risks to Aquatic Plants

Penthiopyrad is not expected to directly impact the growth of non-listed and listed vascular and non-vascular aquatic plants. This conclusion is based on a lack of LOC exceedances by RQs for the highest peak aquatic PE-cal culated EEC for penthi opyrad proposed use patterns other than

cranberries.

For use on cranberries, the listed species LOC was exceeded for non-vascular plants (RQ=1.3). However, additional exposure modeling was co nducted with provisional flooded agriculture models (Tier I Cranberry Model and PFAM) that are expected to be superior estimators of exposure resulting from use on cranberries. These models indicate that the listed species LOC is not exceeded for non-vascular plants (RQ range 0.60-0.71). Therefore, penthiopyrad is not expected to directly impact any aquatic plants.

Table 4.7. Provisional Aquatic Plant RQ Values for Exposure to Penthiopyrad TGAI Resulting from the Proposed Use on Cranberries. *

Taxa Endpoint Used TICM 1

RQ values 2 PFAM RQ values 3

Aquatic non-vascular plants (Marine Diatom) Non-Listed S. costatum EC 50 =1200 μg/L 0.21 0.25

Listed S. costatum NOAEC=417 μg/L 0.60 0.71

* Bolded values indicate RQs that exceed the aquatic plant LOC (1.0) for listed and/or non-listed aquatic plants.

1 TICM means “Tier I Cranberry Model”.

2 The EECs for cranberries from the Tier I Cranberry Mode l (peak=250 μg/L) was used to calculate RQ values for

characterization.

3 The EECs for cranberries from PFAM (peak=298 μg/L) was used to calculate RQ values for characterization.90 4.2.2. Risks to Terrestrial Organisms

4.2.2.1. Birds, Terrestrial-Phase Amphibians and Reptiles

The avian chronic risk LOC is not exceeded for any of the proposed penthiopyrad use patterns, indicating that the like lihood of adverse effects on birds, terrestrial-phase amphibians, and reptiles due to chronic exposure is low.

Because there was no mortality at the highest trea tment levels tested in the submitted acute oral and sub-acute dietary avian studies, standard RQ s values for acute and sub-acute exposure were

not calculated in the Risk Estima tion section of this assessment. However, there was a reduction in body weight gain during the exposure period fo r the bobwhite quail sub-acute dietary study at the highest test concentration of 5,790 mg/kg-diet with no effect reported at 3,320 mg a.i./kgdiet. In order to gain a better understandi ng of how the EECs for the maximum proposed penthiopyrad application ra te relate to the toxicity data curre ntly available for birds, T-REX was used to calculate EECs and the EECs compared to the highest level test ed without any observed effect ( i.e. , 2,218 mg a.i./kg-bw in the acute oral st udy; 3,320 mg a.i./kg-diet in the subacute avian dietary study; and 1520 mg a.i. /kg-diet in the chronic avian study). The resulting dietarybased acute EECs for all size a nd dietary classes, based on th e upper-bound Kenaga values and the maximum proposed non-argicultural use (turf) ranged from 25 to 401 ppm ( Table 3.14 ), and

the dose-based acute EECs for all size and di etary classes, based on the upper-bound Kenaga values and the maximum proposed non-argicu ltural use (turf) ranged from 1.6 to 456 mg/kg-bw ( Table 3.14 ), which are all well below the highest levels tested without effects. Therefore, the likelihood of adverse effects on growth (weight gain) land direct effects on birds (and to terrestrial-phase amphibian and reptiles for wh ich birds serve as surrogates) from acute, subacute, or chronic exposure to penthiopyrad is expect ed to be low. Howe ver, given the potential for effects on freshwater fish, aquatic-phase amphibians, plants, and terrestrial mammals associated with the proposed uses of penthiopy rad, indirect effects to birds are possible.

As previously discussed in Section 3.3.2.1 , avian acute oral data ar e now required for passerine species, as well as either wa terfowl or upland game species . Although, no mortalities were observed in any test concentrati on for the duration of the zebra fi nch acute oral toxicity study, regurgitation was observed at every level and this effect is assume d to be a toxic response to the chemical exposure. An effect dose (ED 50 ) was calculated using regurgi tation as the effect, as a

LD 50 (lethal dose) could not be determined from the doses tested. The estimated dose-based EECs for the maximum application for the propose d turf use are greater than the estimated ED 50 value for passerine species (456.46 for birds consuming short grass vs. ED 50 value of 335 mg a.i./kg-bw). Therefore, at th e current maximum proposed applica tion rate there is the potential for direct risk to passerine species. If the ED 50 dose was used to calculate a ratio of EEC/ED 50 values based on the toxic effect of regurgita tion, the dietary-based acute ratio of EEC/ED 50 value exceeds the Agency’s acute risk LOC (0.05) for one body size/dietary category: 20g birds that eat short grass (ratio of EEC/ED 50 = 0.07), based on the highest applic ation rate of 0.95 lbs a.i./A for the proposed penthiopyrad turf use. In addition, the dose-based acute ratio of EEC/ED 50 values also exceed the Agency’s acute risk LO C (0.05) for four body-size/dietary categories for small birds (20g), based on the highest applica tion rate of 0.95 lbs a. i./A for the proposed91 penthiopyrad turf use: 2 0g birds that eat short grass (ratio of EEC/ED 50 = 1.3), tall grass (ratio of

EEC/ED 50 = 0.59), broadleaf plants/small insects (ratio of EEC/ED 50 = 0.72), and fruits/pods/seeds/large in sects (ratio of EEC/ED 50 = 0.08).

However at the lower proposed application rates ranging from 0.21 to 0.31 lbs a.i./A the resulting estimated dose-based EECs range from 1001 to 149 mg a.i /kg bw for birds consuming short grass, respectively. The estimated EEC values for these pr oposed application rates are less

than the ED 50 , and the LOAEL (156 mg a.i./kg bw), but still greater than the NOAEL of 93 mg a.i./kg bw. The one exception is for the maximu m proposed application rate for agricultural uses (0.39 lbs a.i./A), the resulting short grass dose-based EEC value is 187 mg a.i./kg bw, which is greater than the LOAEL value, indi cating the potential for direct risk to passerine species exists.

The dose-based acute ratio of EEC/ED 50 values calculated using the effect dose (toxic effect of regurgitation) also exce ed the Agency’s acute risk LOC (0.05) for three body-size/dietary categories for small birds (20g), based on the high est agricultural applic ation rate of 0.39 lbs a.i./A: 20g birds that eat s hort grass (ratio of EEC/ED 50 = 0.56), tall grass (ratio of EEC/ED 50 = 0.26), andbroadleaf plants/small insects (ratio of EEC/ED 50 = 0.31). Therefore, at the current proposed application rates of 0.95 (maximum non-agricultural) and 0.39 lbs a.i./A (maximum agricultural) there is the potential for direct sublethal effects to passerine species.

There is uncertainty using an eff ect dose based on a toxic effect ( i.e., regurgitation) when a

definitive LD 50 cannot be calculated. Therefore, to further characterize th e acute avian risk associated with penthiopyrad applicaition, the potential for passerine effects was characterized further using dose-based exposure values and ava ilable data for the other tested avian species (bobwhite quail and mallard duck), wa s also completed. As shown in Table 3.10 , dose-based exposures for small (20-g) birds exposed to th e maximum application ra te for penthiopyrad of 0.95 lbs a.i./A range from 6.34 to 456 mg a.i./kg- bw. Assuming that passerines are of equal sensitivity to acute dose-based exposures of pe nthiopyrad as the bobwhite quail, risks would not be expected because no avian mortalities were observed at the maximum dose level of 2,218 mg a.i./kg-bw. Given that no mortality was obser ved at the highest treatment level in either submitted acute oral study for the bobwhite qua il, it is unclear how much more sensitive passerine species would have to be as compared with upland game species to exceed acute risk LOCs. However, the LD 50 for passerine species would have to be at least the highest treatment level tested for upland game species to exceed the acute avian acute risk to listed species LOC. Submittal of an acceptable acute oral passerine toxicity study in accordance with OPPTS

850.2100 8 would reduce the uncertainty associated with risks to passerines. However, because of an apparent treatment-related regurgitati on occurred in the submitted passerine study, a subacute dietary toxicity study us ing the passerine species and th e penthiopyrad TGAI is more appropriate to assess risk to non- target passerine bird species. Without additional data, direct risk to passerine species is presumed in the absence of a definitive LD 50 , due to the presence of adverse effects (regurgitation) in all treatment concentrations.

8 USEPA 1996. http://www.epa.gov/ocspp/pubs/frs/pub lications/OPPTS_Harmonized/850_Ecological_Effects_Test_Guidelines/Dra fts/850-2100.pdf92 In addition, the potential for indire ct effects to birds from pent hiopyrad use cannot be discounted,

due to the risk to freshwater fi sh, aquatic-phase amphibians, freshw ater invertebrates, plants, and

terrestrial mammals.

KABAM-estimated RQs based on dose-based or dietary-based expos ures of birds to penthiopyrad through consumption of contam inated aquatic prey are listed in Table 4.8 . Acute and chronic RQs are less than the Agency’s levels of concern. Therefore, risks to birds and the terrestrial-phase amphibians and reptiles for which they serve as surrogates associated with acute and chronic exposure to penthiopyra d are expected to be minimal.

Table 4.8. KABAM RQs for birds ingest ing contaminated aquatic prey.

Wildlife species Acute Chronic Dose-based Dietary-based Dietary-based sandpipers 0.034 0.009 0.036

cranes 0.002 0.008 0.031

rails 0.017 0.010 0.039

herons 0.002 0.008 0.031 small osprey 0.002 0.004 0.015 white pelican 0.000 0.002 0.007

4.2.2.2. Mammals

Acute RQs were not derived for mammals in the Risk Estimation section of this assessment because no mortality was observed at the highest treatment level in the acute oral mammalian studies for penthiopyrad. In order to gain a better understa nding of how the EECs for the maximum proposed penthiopyrad application rate rela te to the toxicity da ta currently available for mammals, T-REX was used to calculate EECs and the EECs compared to the highest level tested without any observed effect ( i.e. , 2,000 mg a.i/kg in the acute oral study). The resulting dose-based acute EECs for all size and dietary classes, based on the upper-bound Kenaga values and the maximum proposed non-argicultura l use (turf) ranged from 25 to 401 ppm ( Table 3.14 ),

and the dose-based acute EECs for all size and dietary classes, based on the upper-bound Kenaga values and the maximum proposed non-argicu ltural use (turf) ranged from 0.85 to 382 mg/kg-bw ( Table 3.14 ), which are all well below the highest leve ls tested without effects. Therefore,

likelihood of direct adverse e ffects to mammals from acute exposure to penthiopyrad is considered to be low. However, given the poten tial for effects on freshwat er fish, aquatic-phase amphibians, plants, and terrestrial mammals asso ciated with the proposed uses of penthiopyrad, indirect effects to mammals are possible.

Based on the highest application rate of 0.95 lbs a.i./A for propos ed turf uses of penthiopyrad, the Agency’s chronic risk LOC is exceeded for the following nine body size/dietary categories: 15-g, 35-g, and 1000-g mammals eating short grass, ta ll grass, and broadlea f plants/small insects (RQs that exceed the LOC range from 1.5 to 5.8). Chronic risk LOC exceedances were based on a reproductive NOAEL of 38 mg a.i./kg bw/day (680 mg/kg-diet). For parents reduced body weight gain in F 1 adult males, an increased liver weight in P and F 1 adult females and increased relative adrenal weight with increased incidence of cortical hypertrophy in F 1 females, were observed at a treatment level of 54 mg/kg/day (1000 mg/kg-diet). Fo r offspring reduced body93 weight and body weight gain, dela y in preputial separa tion, and a decrease in absolute thymus weights were observed at a treat ment level of 278 mg/kg/day ( 5000 mg/kg-diet). No dietarybased RQs exceed the Agency’s chronic risk LOC.

Based on the lowest proposed a pplication rate of 0.21 lbs a.i./A (cucurbits proposed use) for penthiopyrad, the Agency’s chronic risk LOC is exceeded for the following two body size/dietary categories: 15-g and 35-g mammals that eat short grass (RQs that exceed the LOC range from 1.2 to 1.4. The results for the highest and lowest application rates indicate that all proposed (non-agricultural and agricultural) use patterns of penthiopyrad exceed the chronic risk

LOC for mammals in a number of body-size/dietary categories.

To further characterize chronic risk to mamm als the chronic dose-based RQs were calculated based on the mean Kenaga residue values and the highest application rate of 0.95 lbs a.i./A for the proposed use on turf. The resulting chronic dose-based RQ values ranged from 0.02 to 2.1 (see Table 4.9 below). The Agency’s chronic risk LOC is exceeded for the following three body size/dietary categories: 15g and 35g mammals th at consume short grass (RQs = 1.8 and 2.1), and 15g mammals that consume broadleaf plants/sma ll insects (RQ = 1.1). The only other proposed use that also results in the Agency’s chronic risk LOC exceedance based on chronic dose-based RQs (based on the mean Kenga residue values) is the proposed landscape ornamental use. The proposed landscape ornamental use is the only use that does not have a restriction to two consecutive applications on the label, therefor e, based on the annual maximum application rate of 3.0 lbs a.i./A and a maximum single applicatio n rate of 0.25 lbs a.i. /A, penthiopyrad can be applied up to 12 times annually for the proposed landscape ornamental use. The Agency’s chronic risk LOC is exceeded for the following three body size/dietary categories: 15g and 35g mammals that consume short grass (RQs = 1.6 and 1.9), and 15g mammals that consume broadleaf plants/small insects (RQ = 1.0). One not e for consideration is that the reliance on mean acute numbers implies that the EECs would be higher 50% of the time.

Table 4.9. Mammalian RQs for Chronic Expo sure to Penthiopyrad using the mean Kenaga residue values 1

Dietary Category Body

Size Proposed Turf Use (0.95 lbs a.i./A) (maximum non-agricultural use) Proposed Landscape Ornamental Use 2

(0.25 lbs a.i./A) (maximum single application rate)

3.0 lbs a.i./A (maximum annual application rate) Dose-based Chronic RQ* Dose-based Chronic RQ* Short Grass 15g 2.1 1.9 35g 1.8 1.6 1,000g 0.94 0.88 Tall Grass 15g 0.87 0.82 35g 0.74 0.70 1,000g 0.40 0.37

Broadleaf

Plants/Small

Insects 15g 1.1 1.0 35g 0.93 0.87 1,000g 0.50 0.4794 Dietary Category Body

Size Proposed Turf Use (0.95 lbs a.i./A) (maximum non-agricultural use) Proposed Landscape Ornamental Use 2

(0.25 lbs a.i./A) (maximum single application rate)

3.0 lbs a.i./A (maximum annual application rate) Dose-based Chronic RQ* Dose-based Chronic RQ*

Fruits/Pods/ Large Insects 15g 0.17 0.16 35g 0.14 0.14 1,000g 0.08 0.07

Granivore (Seeds) 15g 0.04 0.04 35g 0.03 0.03 1,000g 0.02 0.02

* Bolded numbers indicate RQs that exceed the Agency’s chronic risk LOC for mammals (1.0)

1 The body weight of chronic mammals was adjusted to 135g (body weight of test organisms during the study).

2 The proposed landscape ornamental use is the only use that does not have a restriction to two consecutive applications on the label, therefore, based on the annual maximum application rate of 3.0 lbs a.i./A and a maximum single application rate of 0.25 lbs a.i./A, penthiopyrad can be applied up to 12 times annually for the proposed landscape ornamental use.

An additional characterization used the lowest-observed adverse effect concentration (LOAEC) (1000 mg/kg-diet; 54 mg/kg/day) to bound the chronic risk potential to mammals and determined if the lowest concentration in the study that resulted in effects also would result in chronic risk to mammals. Based on the analysis, the Agency’s chronic risk LOC for mammals is still exceeded on a dose-basis for some body size/dietary categorie s for all uses except the cucurbit use (lowest application rate of 0.21 lbs a. i./A), using the upper-bound Kenaga values. The dose-based EEC values for the proposed turf use range from 0.85 for granivores (seeds) dietary category to 382 for the short grass dietary category, and the dose- based EEC values for the proposed cucurbit use range from 0.20 for granivores (see ds) dietary category to 92 for th e short grass dietary category. The resulting ratio of EEC/LOAEC values range from 0.03 to 4.1 for the proposed turf use, and 0.1 to 0.98 for the proposed cucurbit use. The lo west application rate where there are still chronic mammalian risk LOC exceedances is the proposed landscape ornamental use (0.25 lbs a.i./A). The proposed landscape ornamental use is the only use that does not have a restriction to two consecutive applicati ons on the label, therefore, base d on the annual maximum application

rate of 3.0 lbs a.i./A and a maxi mum single application rate of 0.25 lbs a.i./A, penthiopyrad can be applied up to 12 times annually for the propo sed landscape ornamental use. The resulting ratio of EEC/LOAEC values range from 0.02 to 3.8 fo r the proposed landscape ornamental use.

These additional characterizations further demons trate the potential chronic risk to mammals based on all proposed use patterns of penthi opyrad. Therefore, a ll proposed uses (nonagricultural and agri cultural) of penthiopyrad pose potential chronic risk s to listed and non-listed mammals from penthiopyrad at application rates ≥ 0.21 lbs a.i./A.

In addition, the potential for indire ct effects to terrestrial mamm als from penthiopyrad use cannot be discounted, due to the risk to freshwater fish, aquatic-phase amphibians, freshwater invertebrates, plants, and terrestrial mammals.95 KABAM-estimated RQs based on dose-based or dietary-based exposur es of mammals to penthiopyrad through consumption of contam inated aquatic prey are listed in Table 4.10 . Dosebased chronic RQs for two of six size classes of mammal (shrews and moles) exceeded the Agency’s chronic risk level of concern (1.0). Acute RQs and dietary-based chronic RQs for all size classes of mammal were less than the Agency’s levels of concern. These results indicate that the maximum use patterns of penthiopyrad may exceed chronic risk LOCs for some mammals (such as shrews and moles) that ingest benthic invertebrates. LOCs were not exceeded for mammals (minks and otters) that do not consume benthic invert ebrates because these mammals consume fish instead and penthiopyrad is readily metabolized in fish (according to the submitted fish BCF study, MRID 47614995). Study-deri ved metabolism rates in fish cannot be extrapolated to metabolism rates in benthic invertebrates since the latter often metabolize compounds slower than fish. Therefore, there is concern for bioaccumulation of penthiopyrad in

benthic invertebrates. Concern for bioaccumula tion in mammals centers on this uncertainty in bioaccumulation in benthic invertebrates. An oyster BCF study could reduce this uncertainty.

Table 4.10. KABAM RQs for mammals inge sting contaminated aquatic prey.

Wildlife species Acute Chronic 1

Dose-based Dose-based Dietary-based fog/water shrew 0.010 2.0 0.36

rice rat/star-nosed mole 0.009 1.8 0.27

small mink 0.004 0.71 0.11 large mink 0.004 0.79 0.11

small river otter 0.004 0.85 0.11 large river otter 0.002 0.45 0.056

1 Bolded values exceed the chronic risk LOC (1.0).

The proposed penthiopyrad uses on landscape orname ntals, sugarbeets, and canola do not result in LOC exceedances for any mammalian size class. More specifically, if the water column (20.5 μg/L) and pore water (20.0 μg/L) 1-in-10-ye ar 4-day mean EECs for use on landscape ornamentals are input into KABAM, then there are no LOC exceedances. However, for the use with the next highest EECs, tree nuts, the chronic LOC is exceeded for the smallest mammal size class (shrew). This indicates that propos ed uses of penthiopyrad other than landscape ornamentals, sugarbeets, and canola may result in chronic LOC exceedances for mammals that

consume benthic invertebrates. If the proposed use on succulent legumes is reduced to one treatment per year at 0.39 lbs a. i./A, then the chronic LOC is not exceeded for any size class of

mammals.

The applicant has informally claimed uncertainty in the submitted log K OW value (4.62) used in this assessment [undated letter to the Unite d Kingdom’s Chemicals Regulation Directorate (CRD)]. The shorter than expected time to steady state in the submitted fish BCF study is additional evidence that the log K OW of penthiopyrad may be lower than 4.62. On the other hand, KOWWIN v1.67 estimates a log K OW of 4.95 for penthiopyrad. The applicant has not submitted information that refutes the log K OW value of 4.62. If both the currently submitted

K OW study is refuted and an acceptable K OW study is submitted with a lower value, then KABAM risk estimates may be reduced. Using the 1-in-10-year 4-day mean EECs from use on96 succulent legumes that were used to produce RQs in Table 4.10 , the log K OW of penthiopyrad

would have to be 4.31 or less in orde r to result in no risk exceedances.

4.2.2.3. Terrestrial Invertebrates

Honeybees Although penthiopyrad TGAI and the Fontelis form ulation were found not to adversely affect honeybees, toxic effects (although cl assified as not being dose-dependent) were observed in the Fontelis formulation study (MRID 47615237). Th e toxic effects observed included cramps (contracting abdomen or entire body), moribound (b ees cannot walk and show only very feeble movements of legs and antennae, on ly weak response to stimulation ( e.g., light, air movement), bees may recover but usually die, affected (bees still upright and attemp ting to walk but show signs of reduced co-ordination), and apathy (bees showing only slow or delayed reactions to stimulation ( e.g., light, air movement); bees are eith er sitting motionless in the cage or staggering). The presence of subl ethal effects using the Fontelis formulation, indicate that there

could still be toxic sublethal effect s to bees that could negatively impact the hive and/or colony.

The Vertisan formulated product resulted in defini tive toxicity values for honey bees, and it was the only formulation that did for hon eybees. In addition to lethal e ffects, other toxic effects that

were observed in the Vertisan formulati on study (MRID 47615337) included the sublethal effects of lying on their back, ap athy (bees showing only slow or de layed reactions to stimulation ( e.g., light, air movement); bees ar e either sitting motionless in the cage or staggering), and lethargy (bees walking slowly dragging their legs). The presence of bot h lethal and sublethal effects using the Vertisan formulation, indicate that toxic effects to honey bees could negatively impact the hive and/or colony.

The co-formulated product Treoris also exhibited lethal and sublethal toxic effects in the acute contact study (MRID 47737326), the sublethal ef fect observed was lethargy (bees walking slowly dragging their legs). It is important to highlight that chlorothal onil has been associated with numerous bee incidents, and that chloro thalonil has been documented inside the hive, within bees, and it has also been found sequester ed in bee pollen (Mullin et al., 2010). These

incidents and available data dem onstrate that chlorothalonil is ma king its way back to the colony. Although, the available toxici ty data indicates that the penthio pyrad technical does not result in effects to adult bees, the effect s to bees in relation to the association of penthiopyrad and

chlorothalonil in the co -formulated product, the Treoris formulation may increase the toxicity of penthiopyrad and chloro thalonil to bees.

Based on the submitted toxicity data for the formulations of penthiopyrad (both the active ingredient (Fontelis and Vertisan ), and co-formulated with chloro thalonil (Treoris) formulations) toxic effects were observed in honeyb ees. Therefore, these results i ndicate that adverse effects to

terrestrial invertebrates such as pollinators in and around the use areas for the proposed uses of penthiopyrad are possible.97 Earthworms No adverse lethal or sublethal (growth repr oductive) effects were observed in earthworms exposed to penthiopyrad at 1000 mg a.i./kg dw so il (acute effects) or 48 mg a.i./kg dw soil (growth and reproductive effects). Assuming a soil depth of 15cm, the expected concentration of penthiopyrad in soil at the maximu m application rate of 0.95 lbs a.i./A is 0.53 mg/kg soil. The predicted maximum concentration of penthiopyra d in soil is approximately 472x lower than the

concentration at which no effects to earthworms were observed; therefore, direct exposure to penthiopyrad in the soil is not likely to result in adverse effects for earthworms.

Beneficial insects As previously discussed in Section 3.3.2.3 , non-guideline toxicity data with the Fontelis and

Vertisan formulations are also available for tw o sensitive standard arthropod species, including the parasitic wasp ( Aphidius rhopalosiphi ) and predatory mite ( Typhlodromus pyri ). The reported Fontelis formulation LR 50 values were 0.29 lbs a.i./A for the parasitic wasp and 0.11 lbs a.i./A for the predatory mite, are approximately 2 times less than the maximum application rate, equivalent, or 6 to 7 times highe r than the maximum application ra te of 0.39 lbs a.i./A for this formulated product (Fontelis). Given that 50% mortality of th e parasitic wasp and predatory mite was observed at exposure concentrations ra nging from 1 to 2 times less than the maximum application rate of 0.39 lbs a.i./A for two of the studies, it is possi ble that the use of Fontelis on brassica vegetables, legumes (succulent), root vegetables and leaves may adversely affect sensitive arthropod species.

Vertisan is proposed for use at a maximum rate of 0.39 lbs a.i./A. The reported Vertisan

formulation LR 50 values were >0.211 lbs a.i./A for the parasitic wasp and 0.266 lbs a.i./A for the predatory mite, are approximately 1.5 times less than the maximum application rate of 0.39 lbs a.i./A for this formulated product (Vertisan). Extended laboratory studies completed for the predatory mite provide additional information rela ting to the effects of pe nthiopyrad on mortality and reproduction (fecundity and fe rtility) of the Vertisan formul ated product. The 7-day LR 50 and 14-day ER 50 values for the predatory mite were 0.0911 lbs a.i./A and >0.0911 lbs a.i./A, respectively. From the extended labo ratory tests, the predatory mite LR 50 was approximately four times lower than the maximum application ra te of 0.39 lbs a.i./A and two times lower than the minimum application rate of 0.2 1 lbs. a.i./A for this formulated product Vertisan. Given that 50% mortality of the parasitic wasp and predat ory mite and the predatory mite extended 7-day

LR 50 were observed at exposure concentrations 1.5 to 2 times less than the maximum application rate of 0.39 lbs a.i./A, it is possible that the use of penthiopyrad on soybeans, sugarbeets, and sunflowers may adversely affect sensitive arthropod species.

Based on the available data, direct adverse effects to terrestrial invertebrates are considered low for penthiopyrad technical, but not for the formul ations. It is possible that adverse effects to terrestrial invertebrates, including pollinators and beneficial insects, may occur based on exposure to the Fontelis Vertisa n, and Treoris formulated products in and around the use areas of the proposed uses of penthiopyrad. However, at this time, risk to these taxa cannot be quantified. Submittal of an acceptable honeybee acute contact toxicity study for penthiopyrad technical, completed in accordance with OPPTS 850.3020 would eliminate the data gap, however, the98 observed toxicity appears to be low for the t echnical grade material, and a new study is not

needed at this time.

4.2.2.4. Terrestrial Plants

Tier I plant studies demonstrate the need for ad ditional information to determine the potential risk of penthiopyrad to affect te rrestrial plants. Effects were s een at the single application rate that was tested (1.39 lbs ai./A) for both monocot and dicot terrestrial plan t species in the seedling emergence (ryegrass, wheat and tomato) and vegetati ve vigor (wheat and s oybean) toxicity tests; therefore, additional information is needed for these species. Ryegrass exhibited 14% inhibition of seedling emergence and survival, wheat exhib ited12% inhibition on growth (dry weight), and tomato 20% inhibition on growth (dry weight) in the seedling emergence test. Wheat exhibited 20% inhibition on growth (dry weight), and s oybean exhibited 8% inhibition on growth (dry weight) in the vegetative vigor test. There were no adverse effects on seedling condition, survival, dry weight and height of the remaining terrestrial plant sp ecies tested, and overall, there were no species that had an inhibition of 25% or greater for any endpoi nt that was tested. Therefore, based on these results the EC 25 >1.39 lbs a.i./A for both seedling emergence and vegetative vigor studies. However, it was noted that definitive NOAEC’s were not obtained for ryegrass, wheat, and tomato (seedling emerge nce study), and wheat and soybean (vegetative vigor study), as these species ex hibited treatment related reducti ons at the limit concentration relative to the negative control.

With respect to the monocots ryegrass and wheat, and the dicots tomato and soybean, due to the presence of effects at the singl e application rate of 1.39 lbs a.i. /A, without additional data to define a NOAEC an assumption of risk to listed plants will be made. However, there were less

than 25% effects observed at a level above the highest proposed applica tion rate, risks to nonlisted plants and indirect effects to listed anim als with no obligate relationships with plants can be discounted. Risk to listed plants and anim als with obligate relationships with plants cannot be discounted. Ryegrass, wheat, tomato, and soybean exhibited statistically significant reductions

at the limit concentration relative to the negative control, although Tier II studies are not required as no effects were greater than 25%, Tier II st udies would reduce the uncertainty regarding listed species. As a result accurate RQ values could not be calculated, and risk to listed monocot plants inhabiting dry and semi-aquatic areas exposed to penthiopyrad via runoff a nd drift for aerial and ground applications is assumed. Additionally, the di cots, tomato exhibited effects in the seedling emergence test and soybean exhibited effects in the vegetative vigor test at the tested single application rate (1.39 lbs a.i./A). As a result, accurate RQ valu es could not be calculated, and risk to listed dicot plants inhabiting dry and semi-aquatic areas exposed to penthiopyrad via runoff and drift for aerial and ground applications is assumed. The single application rate that was tested is above the single maximum applica tion rate for the proposed uses; however, with effects seen at this application rate, there is the pote ntial of effects seen at the current proposed uses. Therefore, to eliminate uncertainty, risk can likely be reduced with the submission of tier II toxicity studies for these four species. Due to effects seen at the si ngle application rate for both terrestrial monocot and dicot plant species in the seedling emergence and vegetative vigor toxicity tests, risk to terrestrial plants and an imals with obligate relationships with plants are

assumed.99 

## 5. Federally Threatened and Endangered (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 risk 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 proposed new registration of penthiopyrad on agricultural and non-agricultu ral use sites. Given that penthio pyrad can be used on both turf and landscape ornamental areas, it is expected that its use coul d occur nationwide.

5.1. Action Area

For listed species assessment pur poses, the action area is consider ed to be the area affected directly or indirectly by pent hiopyrad use and not merely the immediate area where penthiopyrad is applied. At the initial sc reening-level, the risk assessm ent considers broadly described taxonomic groups and conservatively assumes that listed species within those broad groups are co-located with the pesticide trea tment area. This means that listed terrestrial plants and wildlife are assumed to be located on or adjacent to th e treated site and listed aquatic organisms are assumed to be located in a surface water body adjacen t to the treated site. The assessment also assumes that the listed species are located with in an assumed area, which has the relatively highest potential exposure to the pesticide, and that exposures are likely to decrease with

distance from the treatment area. Section 3.1 of this risk assessmen t presents the proposed pesticide use sites that are used to establish initi al co-location of species with treatment areas.100 5.2. Taxonomic Groups Potentially at Risk

If the assumptions associated with the screeni ng-level action area result in RQs that are below the listed species LOCs, a "no effect" determina tion conclusion is made with respect to listed species in that taxa, and no furt her refinement of the action area is necessary. Furthermore, RQs below the listed species LOCs for a given ta xonomic group indicate no concern for indirect effects on listed species that de pend upon the taxonomic group for which the RQ was calculated. However, in situations where the screening a ssumptions lead to RQs in excess of the listed species LOCs for a given taxonomic group, a potentia l for a "may affect" conclusion exists and may be associated with direct effects on listed species belonging to that taxonomic group or may extend to indirect effects upon listed species that depend upon that taxonomic group as a resource. In such cases, additional information on the biology of listed species, the locations of these species, and the locations of use sites ar e considered to determine the extent to which screening assumptions regarding an action area a pply to a particular listed organism. These subsequent refinement steps will consider how th is information would impact the action area for a particular listed organism and potentially in clude areas of exposure that are downwind and downstream of the pesticide use site.

Assessment endpoints, exposure pathways, and the conceptual models addressing proposed new penthiopyrad uses, and the associated exposur e and effects analyses conducted for the penthiopyrad screening-leve l risk assessment are in Sections 2 to 3 . The assessment endpoints used in the screening-level risk assessment include those defined operationally as reduced survival and reproductive impairment for both aquatic and terrestrial animal species and survival, reproduction, and growth of aqua tic and terrestrial plant species from both direct acute and chronic exposures. These assess ment endpoints are intended to addr ess the standard set forth in the Endangered Species Act requiring federal agencies to ensure that any action they authorize does not appreciably reduce the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species. Risk estimates (RQs) which, integrating exposure and effects, are calculated for broad based taxonomic groups in the screening-level risk assessment presented in Section 4.

Both acute listed species and ch ronic risk LOCs are considered in the screening-level risk assessment to identify direct and i ndirect effects to taxa of listed species. This section identifies direct effect concerns, by taxa, that are triggered by exceeding endangered LOCs in the screening-level risk assessment, with an evaluation of the potential probability of individual effects for exposures that may occur at the es tablished endangered species LOC. Data on exposure and effects collected under field and laboratory conditions are evaluated to make determinations on the predictive utility of the dir ect effect screening assessment findings to listed species. Additionally, the results of the screen for indirect effects to listed species, using direct

effect acute and chronic LOCs for each taxonomic group, is presented and evaluated. Identified potential direct and indi rect risks to listed sp ecies that may result from the proposed uses of penthiopyrad (except use on cra nberries) are summarized in Table 5.1. The potential direct and indirect risks to listed species that may result from the proposed cranberry use is summarized in

Table 5.1a.101 Table 5.1. Potential Effects to Federally List ed Taxa Associated with Direct or Indirect Effects from the Proposed Uses of Penthiopyrad (all uses except cranberries).

Listed Taxon Direct

Effects Uses of Concern Indirect

Effects Uses of Concern

Terrestrial and semiaquatic plants -

monocots Yes All uses Yes 2 All uses

Terrestrial and semiaquatic plants - dicots Yes All uses Yes 2 All uses

Birds No None Yes 1,2,3 All uses Terrestrial-phase amphibians No None Yes 1,2,3 All uses

Reptiles No None Yes 1,2,3 All uses

Mammals Yes All uses Yes 1,3 All uses

Terrestrial invertebrates Yes a All uses Yes 1 All uses Aquatic vascular and non-vascular plants No None Yes 3 All uses

Freshwater fish Yes All uses except canola Yes 1,3 All uses Aquatic-phase

amphibians Yes All uses except canola Yes 1,3 All uses

Freshwater

invertebrates No None Yes 1,3 All uses

Mollusks No None Yes 1,3 All uses

Marine/estuarine fish Yes b All uses Yes 1,3 All uses

Marine/estuarine

invertebrates Yes b All uses Yes 1,3 All uses

Sediment-dwelling organisms No None Yes 3 All uses

a RQs were not calculated due to lack of a standard quantification methodology for non-listed species. Therefore, the

‘LOC exceedance’ was based on lines of evidence includi ng application rate, toxicity data (both pollinators and beneficial insects), and the mode of action of penthiopyrad.

b Risk cannot be precluded via spray drift of the Fontelis formulation to water bodies with lack of data for the

Fontelis formulation for estuarine/marine fish and invertebrates.

Potential indirect effects on a taxon attributable to:

1 direct effects on plants (t errestrial and semi-aquatic)

2 direct chronic effects on mammals

3 direct acute effects on freshwater fish and aquatic-phase amphibians

Table 5.1a. Potential Effects to Federally List ed Taxa Associated with Direct or Indirect Effects from the Proposed Uses of Penthiopyrad on Cranberries*.

Listed Taxon Direct

Effects Uses of Concern Indirect

Effects Uses of Concern

Terrestrial and semiaquatic plants -

monocots Yes All uses Yes 2 All uses

Terrestrial and semiaquatic plants - dicots Yes All uses Yes 2 All uses

Birds No None Yes 1,2,3 All uses Terrestrial-phase amphibians No None Yes 1,2,3 All uses

Reptiles No None Yes 1,2,3 All uses

Mammals Yes All uses Yes 1,3 All uses

Terrestrial invertebrates Yes a All uses Yes 1 All uses102 Listed Taxon Direct

Effects Uses of Concern Indirect

Effects Uses of Concern

Aquatic vascular and non-vascular plants No None Yes 3 All uses

Freshwater fish Yes Cranberry Yes 1,3 All uses Aquatic-phase

amphibians Yes Cranberry Yes 1,3 All uses

Freshwater

invertebrates Yes Cranberry Yes 1,3 All uses

Mollusks Yes Cranberry Yes 1,3 All uses

Marine/estuarine fish Yes b Cranberry Yes 1,3 All uses

Marine/estuarine

invertebrates Yes b Cranberry Yes 1,3 All uses

Sediment-dwelling organisms No None Yes 3 All uses

* Based on the refined cranberry model calculated EEC values, and derived acute and chronic RQs. The Tier I rice model calculated EEC value results in potential direct advers e acute and chronic effects to all aquatic organisms, as well as aquatic non-vascular plants.

a RQs were not calculated due to lack of a standard quantification methodology for non-listed species. Therefore, the

‘LOC exceedance’ was based on lines of evidence includi ng application rate, toxicity data (both pollinators and beneficial insects), and the mode of action of penthiopyrad.

b Risk cannot be precluded via spray drift of the Fontelis formulation to water bodies with lack of data for the

Fontelis formulation for estuarine/marine fish and invertebrates.

Potential indirect effects on a taxon attributable to:

1 direct effects on plants (t errestrial and semi-aquatic)

2 direct chronic effects on mammals

3 direct acute effects on freshwater fish and invertebrates, aquatic-phase amphibians, estuarine/marine fish and invertebrates; and direct chronic effect s on freshwater fish and estuarine/marine invertebrates (based on the refined cranberry model calculated EEC values, and derived acute and chronic RQs).

5.2.1. 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 eff ects to individual list ed species and aquatic animals that may indirectly affect the listed spec ies of concern (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 penthiopyrad on par with the acute toxicity endpoint selected for RQ calculation. To accomplish this interpretation, th e Agency uses the slope of the dose-response relationship available from the t oxicity study used to establish th e acute toxicity measures of effect for each taxonomic group that is relevant to this assessment. The individual effects probability associated with the acute RQ is ba sed on the mean estimate of the slope and an assumption of a probit dose-response relationship. In addition to a single effects probability estimate based on the mean, upper and lower esti mates of the effects probability are also provided to account for variance in the slope, if available. Based on the available acute toxicity for penthiopyrad, a summary of the probit dose-response analysis is provided in Table 5.2 . If no dose response information is available to estim ate a slope for this analysis, a default slope assumption of 4.5 (with lower and upper bounds of 2 to 9) (Urban and Cook, 1986) is used.103 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 calculated acute RQ, if available.

Table 5.2. Summary of Penthiop yrad Probit Dose Response Analysis for Listed Species (Based on the Proposed Cranberry Use)

Taxa (study type) Acute Effect Slope (95% C.I.) Chance of Individual Effect at Listed Species LOC (95% C.I.) 1 Chance of Individual Effect at Derived Acute RQ 2,3,4,5

(95% C.I.)

Bird (oral dose) No mortality observed Slope NA = 4.5 (2 – 9) 1 in 2.94E+05 (1 in 440 to 1 in

8.86E+18) 1 Not calculated; no mortality

observed

Bird (dietary) No mortality observed Slope NA = 4.5 (2 – 9) 1 in 2.94E+05 (1 in 440 to 1 in

8.86E+18) 1 Not calculated; no mortality

observed

Mammal (oral dose) No mortality observed Slope NA = 4.5 (2 – 9) 1 in 2.94E+05 (1 in 440 to 1 in

8.86E+18) 1 Not calculated; no mortality

observed

Freshwater fish (acute) Mortality and sublethal

effects Slope NA = 4.5 (2 – 9) 1 in 4.18E+08 (1 in 216 to 1 in 1.75E+31) 1 in 1 (1 in 1 to 1 in 1) 2

Freshwater invertebrates (acute) Immobilization and sublethal

effects Slope 10.3 (6.06 – 14.5) 1 in 3.34E+40 (1 in 6.32E+14 to 1 in 9.03E+78) 1 in 6.83E+11 (1 in 50,000 to 1 in 2.34E+22) 3

Estuarine/marine fish (acute) Mortality and sublethal

effects Slope NA = 4.5 (2 – 9) 1 in 4.18E+08 (1 in 216 to 1 in 1.75E+31) 1 in 34 (1 in 5 to 1 in 12, 900) 4

Estuarine/marine invertebrates (acute) Shell deposition Slope = 3.59 (2.26 – 4.92) 1 in 6.66E+05 (1 in 610 to 1 in 1.30E+10) 1 in 10 (1 in 5 to 1 in 252) 5

1 Although no mortality was observed, the chance of indivi dual effect at the listed speci es LOC (0.1) for terrestrial animals was calculated using the default slope of 4.5 (2 – 9), and the threshold of 0.1 (the listed species LOC).

2 Acute RQ for freshwater fish = 1.8.

3 Acute RQ for freshwater invertebrates = 0.21.

4 Acute RQ for estuarin e/marine fish = 0.38.

5 Acute RQ estuarine/marine invertebrates = 0.44.

As shown in Table 5.2 , the probability for acute direct effects ( i.e. , mortality) to individual listed freshwater fish at the highest derived RQ value is 1 in 1 (100%). The probability for acute direct effects ( i.e. , mortality) to individual listed estuarine/marine fish is 1 in 34 (2.9%). The probability for acute direct effects ( i.e. , mortality) to individual listed estuarine/marine invertebrates is 1 in 10 (10%). The probability for acute direct effects ( i.e. , mortality) to

individual listed freshw ater invertebrates at the highest derived RQ value is 1 in 6.83E+11 (<0.01%). The chance of an individual effect wa s not derived for taxa other than those listed above. In summary, the chance of individual eff ects to listed freshwater fish species based on effects of penthiopyrad is high (100%) for th e highest derived RQs based on the maximum104 application rate EECs of all th e proposed uses of penthiopyrad. In addition, the chance of

individual effects to listed estuarine/marine fi sh and invertebrate speci es based on effects of penthiopyrad is low (2.9 and 10%, respectively) for the highest derived RQs based on the maximum application rate EECs of all the proposed uses of penthiopyrad.

5.2.2. Listed Species Occurrence Associated with Penthiopyrad 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 2.2.1). The database uses location information for listed species at the county level and compares it to agricultural census data (from 2007) 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.

The results of this base line-level risk assessment indicate th at the proposed uses of penthiopyrad have the potential for direct adverse acute effects on listed an d non-listed freshwater fish (a surrogate for aquatic-phase amphibians); acute effects on listed freshwater invertebrates, estuarine/marine fish and invertebrates; chronic effects to freshwater fish and estuarine/marine invertebrates; acute effects on list ed estuarine/marine fish and inve rtebrates (via spray drift from Fontelis formulated product); and chronic e ffects on listed and non-liste d mammals based on all proposed use patterns. Due to effects seen at the single application ra te for both terrestrial monocot and dicot plant species in the seedling emergence and vegetative vigor toxicity tests, risk to terrestrial plants and animals with ob ligate relationships with plants are assumed. Although direct adverse effects to birds, terrestrial-phase am phibians, and reptiles, from penthiopyrad use are not expected, indirect effects to these taxa are possible, given the chronic effects on mammals could indirectly impact terres trial organisms that feed on these species. Therefore, all listed species occurring nationwide ma y potentially be affected by the proposed new registration of penthiopyrad. Because there is a pot ential for indirect effects to all listed taxa and all proposed uses of penthiopyrad may occur anywhere in the United States or its territories, state and county-level summaries fr om LOCATES are not provided. However, based on the U.S. Fish and Wildlife Services Endange red Species Program th ere are a total of 1,383 listed species in the United States that may be di rectly or indirectly affected by the proposed new uses of penthiopyrad (http://www.fws.gov/ endangered/species/us-species.html).

This preliminary analysis indicates that there is a potential for penthioyprad use to overlap with listed species and that a more refined assessmen t is warranted. The more refined assessment

should involve clear delineation of the action area associated with proposed uses of penthioyprad and the best available information on the temporal and spatial co-location of listed species with respect to the action area. This analysis has not been conducted for this assessment.105 

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Environmental Contamination and Toxicology. 100: 23-73.108 6.1. Submitted Product Chemistry a nd Environmental Fate Studies

MRID 47614817. Tognucci, A. (1999) Determina tion of the Vapour Pressure of MTF-753. Project Number: 728368, 753/2/03. Unpublishe d study prepared by RCC Umweltchemie Ag. 20 p.

MRID 47614820. Labano, S. (2009) Penthiopyrad: Calcul ation of Henry's Law Constant. Project Number: 08/LKC/03, 753/2/56. U npublished study prepared by LKC Switzerland, Ltd. 6

p.

MRID 47614828. Franke, J. (2008) Determination of the Water Solubility of MTF-753 Including Effect of pH and Temperature. Proj ect Number: A79435, 753/2/54. Unpublished study prepared by Harlan Laboratories, Ltd. 69 p.

MRID 47614829. Tognucci, A. (1999) Determination of the Solubility of MTF-753 in Water and in Organic Solvents. Project No.: 728370, 753/2/04. Unpublished study prepared by RCC Umweltchemie Ag. 29 p.

MRID 47614832. Franke, J. (2008) Determinati on of the Partition Coefficient (NOctanol/Water) of MTF-753 Incl uding Effect of pH and Te mperature. Project Number: A79424, 753/2/55. Unpublished study prepared by Harlan Laboratories, Ltd. 44 p.

MRID 47614837. Tognucci, A. (1999) Hydrolysis De termination of MTF-753 at Different pH Values. Project Number: 728381, 753/2/06. Unpublished study prepared by RCC Umweltchemie Ag. 23 p.

MRID 47614839. Burgener, A. (1999) Aqueous Photolysis of MTF-753 under Laboratory Conditions. Project Number: 728414, 753/ 2/07. Unpublished study prepared by RCC Umweltchemie Ag. 33 p.

MRID 47614840. Tognucci, A. (1999) Determination of the Dissociation Constant of MTF-753 in Water. Project Number: 728403, 753/ 2/08. Unpublished study prepared by RCC Umweltchemie Ag. 20 p.

MRID 47614841. Schreitmuller, J. (2006) Dissocia tion Constant of MTF-753: Final Report. Project Number: 728403. Unpublished study prepared by RCC Umweltchemie Ag. 4 p.

MRID 47614959. Mamouni, A. (2008) (Carbon 14)-MTF -753: Degradation and Metabolism in

Four Soils Incubated Under Aerobic C onditions. Unpublished study prepared by RCC, Ltd. 224 p.

MRID 47614961. Mamouni, A. (2008) (Carbon 14)-MTF -753: Degradation and Metabolism in

on North American Soil Incubated Under Aerobic Conditions. Project Number: A56226, A56226/OCR, 753/7/12. Unpublished study prepared by RCC, Ltd. 115 p.109 MRID 47614963. Satsuma, K. (2005) Metabolic Fate of MTF-753 in Aerobic Soil: Final Report. Project Number: IET/03/8002, IET/03/8002/O CR, 753/7/04. Unpublished study prepared by Institute of Environmental Toxicology. 105 p.

MRID 47614964. Mamouni, A. (2007) (Carbon 14)-MTF -753: Degradation and Metabolism in

One Soil Incubated Under Anaerobic Conditions. Project Number: A59580, A59580/OCR. Unpublished study prepared by RCC, Ltd. 118 p.

MRID 47614965. Mamouni, A. (2008) (Carbon 14)-MTF-753: Phototransformation on Soil Surfaces Under Laboratory Conditions . Project Number: A56204, A56204/OCR, 753/7/11. Unpublished study prepared by RCC, Ltd. 127 p.

MRID 47614966. Volkel, W. (2009) (Carbon 14)-DM-PC A: Rate and Route of Degradation and Time-Dependent Sorption in Four So ils: Final Report. Project Number: A59567, A59567/OCR, 753/7/18. Unpublished study prepar ed by Harlan Laboratories, Ltd. 112 p.

MRID 47614967. Volkel, W. (2007) (Carbon 14)-M TF-753: Adsorption/Desorption on Soils. Project Number: A59556, A59556/OCR, 753/7/ 05. Unpublished study prepared by RCC, Ltd. 106 p.

MRID 47614971. Morriss, A. (2009) Determination of the Adsorption Coefficient (Koc) for PAM Using a Batch Equilibrium Method: Final Report. Project Number: CEMS/3837/OCR, CEMS/3837, CEMR/3837. Unpublished study prepared by CEM Analytical Services, Ltd. 48 p.

MRID 47614972. Edwards, J. (2009) Determination of the Adsorption Coefficient (Koc) for 753-A-OH Using a Batch Equilibrium Met hod: Final Report. Project Number: CEMS/4207, CEMS/4207/OCR, CEMR/4207. Unpublished study prepared by CEM Analytical Services, Ltd. 47 p.

MRID 47614973. Edwards, J. (2009) Determination of the Adsorption Coefficient (Koc) for 753-T-DO Using a Batch Equilibrium Method: Final Report. Project Number: CEMS/4206, CEMS/4206/OCR, CEMR/4206. Unpublished study prepared by CEM Analytical Services, Ltd. 45 p.

MRID 47614974. Seyfried, B. (2007) MTF-753: R eady Biodegradability in a Manometric Respirometry Test. Project Number : A59613, A59613/OCR, 753/7/06. Unpublished study prepared by RCC, Ltd. 40 p.

MRID 47614975. Adam, D. (2008) (Carbon 14)-MTF-753: Route and Rate of Degradation in Aerobic Aquatic Sediment Systems. Project Number: A59591, A59591/OCR, 753/7/09. Unpublished study prepared by RCC, Ltd. 160 p.110 MRID 47614976. Adam, D. (2007) (Carbon 14)-MTF-753: Route and Rate of Degradation in an Anaerobic Aquatic Sediment System. Pr oject Number: A59602, A59602/OCR, 753/7/08. Unpublished study prepared by RCC, Ltd. 106 p.

MRID 47615162. Huang, F. (2008) Terrestrial Field Dissipation of Penthiopyrad (MTF-753) on Bare Soil in California, USA. Proj ect Number: DUPONT/19660, DUPONT/19660/OCR, 50214. Unpublished study prepared by ABC Labora tories, Inc., and E.I. du Pont de Nemours and Company. 310 p.

MRID 47615163. Huang, F. (2008) Terrestrial Field Dissipation of Penthiopyrad (MTF-753) on Bare Soil in Georgia, USA. Project Number: DUPONT/19661, DUPONT/19661/OCR, 50217. Unpublished study prepared by ABC Labora tories, Inc., and E.I. du Pont de Nemours and Company. 313 p.

MRID 47615164. Huang, F. (2008) Terrestrial Field Dissipation of Penthiopyrad (MTF-753) in Missouri, USA. Project Numb er: DUPONT/19662, DUPONT/19662/OCR, 50216. Unpublished study prepared b A BC Laboratories, Inc., and E. I. du Pont de Nemours and Company. 307 p.

MRID 47615165. Huang, F. (2008) Terrestrial Field Dissipation of Penthiopyrad (MTF-753) in Washington, USA. Project Numb er: DUPONT/19663, DUPONT /19663/OCR, 50215. Unpublished study prepared by A BC Laboratories, Inc., and E. I. du Pont de Nemours and Company. 383 p.

MRID 47615166. Huang, F.; Rice, A. (2008) Terrest rial Field Dissipation of Penthiopyrad (MTF-753) on Bare Soil in Ontari o, Canada. Project Number: DUPONT/19664, DUPONT/19664/OCR, 50218. Unpublished study pr epared by ABC Laboratories, Inc., and E.I. du Pont de Nemours and Company. 286 p.

MRID 47615167. Huang, F.; Rice, F.; Gant, A. (2008) Terrestrial Fi eld Dissipation of Penthiopyrad (MTF-753) on Bare Soil in Saskatchewan, Canada . Project Number: DUPONT/19665, DUPONT/19665/OCR, 50219. Unpublished study prepared by ABC Laboratories, Inc., and E.I. du P ont de Nemours and Company. 278 p.

MRID 47615172. Huang, F.; Rice, F.; Gant, A. (2009) Terrestrial Fi eld Dissipation of Penthiopyrad (MTF-753) on Turf in New York, 2007, USA. Project Number: DUPONT/21865, DUPONT/21865/OCR, 62316. Unpublished study prepared by ABC Laboratories, Inc. 300 p.

MRID 47615173. Huang, F.; Rice, F.; Gant, A. (2009) Terrestrial Fi eld Dissipation of Penthiopyrad (MTF-753) on Turf in Georgia, 2007, USA. Project Number: DUPONT/21866, DUPONT/21866/OCR, 62323. Unpublished study prepared by ABC Laboratories, Inc. 256 p.111 6.2. Submitted Ecotoxicity Studies

MRID Citation

47614977 Gallagher, S.; Beavers, J. (2005) MTF-753: An Acute Oral Toxicity Study with the Northern Bobwhite. Project Number: 236/118/OCR, 236/118, 8147. Unpublished study prepared by Wildlife International, Ltd. 51 p.

47614978 Hubbard, P.; Beavers, J. (2009) MTF-753: An Acute Oral Toxicity Study with the Zebra Finch (Poephila guttatta). Pr oject Number: 236/130, 236/130/OCR, 753/8/61. Unpublished study prepared by Wildlife International, Ltd. 56 p.

47614979 Gallagher, S.; Martin, K.; Beavers, J. (2008) MTF-753: A Dietary LC50 Study with the Northern Bobwhite. Project Number: 236/121, 236/121/OCR, 753/8/10. Unpublished study prepared by Wildlife International, Ltd. 66 p.

47614980 Martin, K.; Nixon, W. (2007) Analytical Me thod Validation for the Determination of MTF-753 in Avian Diet. Project Nu mber: 236C/144, 236C/144/OCR, 753/8/11. Unpublished study prepared by Wildlife International, Ltd. 30 p.

47614981 Gallagher, S.; Martin, K.; Beavers, J. (2008) MTF-753: A Dietary LC50 Study with the Mallard. Project Number: 236/1 22, 236/122/OCR, 753/8/09. Unpublished study prepared by Wildlife International, Ltd. 67 p.

47614982 Temple, D.; Martin, K.; Beavers, J.; et al. (2008) MTF-753: A Reproduction Study

with the Northern Bobwhite: Final Re port. Project Number: 236/125/OCR, 236/125, 753/8/20. Unpublished study prepared by Wildlife International, Ltd. 161 p.

47614983 Temple, D.; Martin, K.; Beavers, J.; et al. (2008) MTF-753: A Reproduction Study with the Mallard: Final Report. Proj ect Number: 753/8/21, 236/126, 236/126/OCR. Unpublished study prepared by Wildlife International, Ltd. 158 p.

47614984 Palmer, S.; Kendall, T.; Krueger, H. (2007) MTF-753: A 96-H our Static Acute Toxicity Test with the Rainbow Trout (Onc orhynchus mykiss): Final Report. Project Number: 236A/112A, 236A/112A/OCR, 753/8/17. Unpublished study prepared by Wildlife International, Ltd. 59 p.

47614985 Kendall, T.; Nixon, W. (2007) Analytical Method Validation for the Determination

of MTF-753 in Freshwater and Sa ltwater. Project Number: 236C/145, 236C/145/OCR. Unpublished study prepared by Wildlife International Ltd. 54 p.

47614986 Anai, M. (2005) A 96-Hour Acute Toxici ty Test of MTF-753 with Common Carp: Final Report. Project Number: 93440 , 93440/OCR, E04/3440. Unpublished study prepared by Kurume Laboratory. 51 p.

47614987 Palmer, S.; Kendall, T.; Krueger, H. (2007) MTF-753: A 96-H our Static Acute Toxicity Test with the Bluegill (Lepom is macrochirus): Final Report. Project Number: 236A/111, 236A/111/OCR, 753/8/ 12. Unpublished study prepared by Wildlife International, Ltd. 59 p.112 MRID Citation

47614988 Minderhout, T.; Kendall, T.; Krueger, H. (2009) Penthiopyrad: A 96-Hour StaticRenewal Acute Toxicity Test with the Fathead Minnow (Pimephales Promelas): Final Report. Project Number: 236A /120, 236A/120/OCR. Unpublished study prepared by Wildlife International, Ltd. 59 p.

47614989 Bormann, K. (2008) Assessment of Toxic Effects of DM-PCA in Rainbow Trout (Oncorhynchus mykiss) Using the 96 Hour Static, Acute Limit Test: Final Report. Project Number: 20071562/01/ AAOM, 20071562/01/AAOM/OCR, 753/8/35. Unpublished study prepared by Eurofins - GAB GmbH. 38 p.

47614990 Peither, A. (2008) PCA: Acute Toxicity to Zebra Fish (Brachydanio rerio) in a 96-

Hour Static Test: Fina l Report. Project Number : B57374, B/57374/OCR, 753/8/27. Unpublished study prepared by RCC, Ltd. 38 p.

47614991 Oishi, N. (2008) Acute Toxicity Study of PAM in Rainbow Trout: Final Report. Project Number: B130/077/075, B130/077/075/ OCR. Unpublished study prepared by Biosafety Research Center. 58 p.

47614992 Minderhout, T.; Kendall, T.; Krueger, H. (2009) 753-A-OH: A 96- Hour Static Acute Toxicity Test with the Rainbow Trout (Onc orhynchus mykiss): Final Report. Project Number: 236A/129, 236A/129/OCR. Unpub lished study prepared by Wildlife International, Ltd. 57 p.

47614993 Minderhout, T.; Kendall, T.; Krueger, H. (2009) 753-T-DO: A 96- Hour Static Acute Toxicity Test with the Rainbow Trout (Onc orhynchus mykiss): Final Report. Project Number: 236A/126, 236A/126/OCR. Unpub lished study prepared by Wildlife International, Ltd. 58 p.

47614994 Minderhout, T.; Kendall, T.; Krueger, H. (2008) MTF-753: An Early Life-Stage Toxicity Test with the Fathead Minnow (Pim ephales promelas): Final Report. Project Number: 236A/119, 236A/119/OCR, 753/8/ 31. Unpublished study prepared by Wildlife International, Ltd. 97 p.

47614995 Burri, R. (2008) Bioconcentration: Fl ow-Through Fish Test with [Carbon 14]MTF753 in Rainbow Trout (Oncorhynchus mykiss). Project Number: A59545, A59545/OCR. Unpublished study prepared by Harlan Laboratories, Ltd. 96 p.

47614996 Maeda, M. (2005) A 48-Hour Acute Imm obilization Test of MTF-753 with Daphnia magna: Final Report. Project Numb er: 93439, 93439/OCR, 753/8/04. Unpublished study prepared by Kurume Laboratories. 41 p.

47614997 Borrmann, K. (2008) Assessment of Toxi c Effects of DM-PCA on Daphnia magna Using the 48 Hour Static, Acute Lim it Test: Final Report. Project Number: 20071562/01/AADM, 20071562/01/AADM/OCR, 753/8/34. Unpublished study prepared by Eurofins - GAB GmbH. 37 p.113 MRID Citation

47614998 Schmidt, T. (2008) PCA: Acute Toxicity to Daphnia magna in a 48-Hour Immobilization Test: Final Report. Project Number: B57396, B57396/OCR. Unpublished study prepared by RCC, Ltd. 38 p.

47614999 Oishi, N. (2008) Acute Immobilization Study of PAM in Daphnia Magna: Final Report. Project Number: B131/077/0 76, B131/077/076/OCR. Unpublished study prepared by Biosafety Research Center. 63 p.

47615000 Mitsui Chemicals Agro, Inc. (2010) Su bmission of Product Chemistry, Toxicity, Residue, Environmental Fate and Fate Da ta in Support of th e Application for Registration of Penthiopyrad Technical . Transmittal of 41 of 292 Studies.

47615001 Minderhout, T.; Kendall, T.; Krueger, H. (2009) 753-A-OH: A 48- Hour Static Acute Toxicity Test with the Cl adoceran (Daphnia magna): Fi nal Report. Project Number: 236A/128, 236A/128/OCR. Unpublished study pr epared by Wildlife International, Ltd. 56 p.

47615002 Minderhout, T.; Kendall, T.; Krueger, H. (2009) 753-T-DO: A 48- Hour Static Acute Toxicity Test with the Cl adoceran (Daphnia magna): Fi nal Report. Project Number: 236A/125, 236A/125/OCR. Unpublished study pr epared by Wildlife International, Ltd. 58 p.

47615003 Palmer, S.; Kendall, T.; Krueger, H. (2007) MTF-753: A Flow-Through Life-Cycle Toxicity Test with the Cl adoceran (Dophnia magna): Fina l Report. Project Number: 236A/113, 236A/113/OCR. Unpublished study pr epared by Wildlife International, Ltd. 79 p.

47615004 Sueta, S. (2005) Algal Growth Inhibiti on Test of MTF-753 with Pseudokirchneriella subcapitata: Final Report. Project Number: 93438, 93438/OCR. Unpublished study prepared by Kurume Laboratories. 45 p.

47615005 Palmer, S.; Cartee, T.; Kendall, T.; et al. (2009) Penthiopyrad: A 96-Hour Toxicity Test with the Freshwater Alga (Pseudoki rchneriella subcapit ata): Final Report. Project Number: 236A/121, 236A/121/OCR. Un published study prepared by Wildlife International, Ltd. 66 p.

47615006 Palmer, S.; Cartee, T.; Kendall, T.; et al. (2009) Penthiopyrad: A 96-Hour Toxicity Test with the Marine Diatom (Skeletonema costatum): Final Report. Project Number: 236A/122, 236A/122/OCR. Unpublished study pr epared by Wildlife International, Ltd. 66 p.

47615007 Palmer, S.; Cartee, T.; Kendall, T.; et al. (2009) Penthiopyrad: A 96-Hour Toxicity Test with the Freshwater Alga (Anabaena flos-aquae): Final Report. Project Number: 236A/123, 236A/123/OCR. Unpublished study pr epared by Wildlife International, Ltd. 66 p.114 MRID Citation

47615008 Palmer, S.; Cartee, T.; Kendall, T.; et al. (2009) Penthiopyrad: A 96-Hour Toxicity Test with the Freshwater Diatom (Navic ula pelliculosa): Final Report. Project Number: 236A/124, 236A/124/OCR. Unpub lished study prepared by Wildlife International, Ltd. 66 p.

47615009 Dengler, D. (2008) Assessment of Effects of DM-PCA on the Growth of the Single Cell Green Alga Desmodesmus subspicatus Using the 96 Hour Static, Limit Test: Final Report. Project Number : 20071562/01/AADS/OCR, 20071562/01/AADS, 753/8/32. Unpublished study prepared by Eurofins - GAB GmbH. 41 p.

47615010 Peither, A. (2008) PCA: Toxicity to Pseudokirchneriella subcapitata (Formerly Selenastrum capricornutum) in a 96-Hour Algal Growth Inhibition Test: Final Report. Project Number: B57418, B57418/ OCR. Unpublished study prepared by RCC, Ltd. 49 p.

47615011 Oishi, N. (2008) Growth Inhibition Study of PAM in a Green Alga: Final Report. Project Number: B132/077/077/, B132/077/077/ OCR. Unpublished study prepared by Biosafety Research Center, F ood, Drugs and Pesticides. 59 p.

47615012 Palmer, S.; Cartee, T.; Kendall, T.; et al . (2009) 753-A-OH: A 96-H our Toxicity Test with the Freshwater Alga: (Pseudokirchneri ella subcapitata): Fi nal Report. Project Number: 236A/130, 236A/130/OCR. Unpub lished study prepared by Wildlife International, Ltd. 70 p.

47615013 Palmer, S.; Cartee, T.; Kendall, T.; et al . (2009) 753-T-DO: A 96-H our Toxicity Test with the Freshwater Alga (Pseudokirchneriel la subcapitata): Final Report. Project Number: 236A/127, 236A/127/OCR. Unpub lished study prepared by Wildlife International, Ltd. 70 p.

47615014 Krueger, H.; Thomas, S.; Kendall, T. (2008) MTF-753: A Prolonged Sediment Toxicity Test wtih Chironomus riparius Using Spiked Sediment: Final Report. Project Number: 236A/114, 236A/114/OCR. Un published study prepared by Wildlife International, Ltd. 101 p.

47615015 Sindermann, A.; Kendall, T.; Krueger, H. (2008) MTF-753: A 7- Day Toxicity Test with Duckweed (Lemma gibba G3): Final Report. Project Number: 236A/118, 236A/118/OCR, 753/8/24. Unpublished study prep ared by Wildlife International, Ltd. 70 p.

47615016 Feije, R. (2005) MTF-753: A Single-Dose Oral Laboratory Test to Evaluate the Effect on Survival of the Honeybee Apis mellifera L. Project Number: LK003AMO, LK003AMO/OCR. Unpublished study prepar ed by MITOX Consultants. 29 p.

47615017 Feije, R. (2005) MTF-753: A Single-Dose La boratory Test to Eval uate the Effect of Topical Application on Survival of the Honeybee Apis mellifera L. Project Number: LK005AMT, LK005AMT/OCR, 753/8/06. Unpub lished study prepared by MITOX Consultants. 28 p.115 MRID Citation

47615018 Forster, A.; Davies, N. (2007) A Tier 1 Laboratory Study to Determine the Median

Lethal Rate of MTF-753 20 SC to the Parasitic Wasp Aphidius rhopalosiphi (Hymenoptera: Braconidae). Project Nu mber: ER/07/AF519, AF/519/OCR, AF/519. Unpublished study prepared by Ecotox Limited. 51 p.

47615019 Forster, A.; Davies, N. (2007) A Tier 1 Laboratory Study to Estimate the Median

Lethal Rate of MTF-753 20SC to the Pred atory Mite Typhlodromus pyri (Acari: Phytoseiidae). Project Number: AF/ 518, AF/518/OCR, ER/07/AF518. Unpublished study prepared by Ecotox Limited. 50 p.

47615020 Kolzer, U. (2006) Acute Toxicity of MTF-753 Technical on Earthworms, Eisenia fetida Using an Artificial Soil Test: Final Report. Project Number: 20051281/01/NLEF, 20051281/01/NLEF/OCR, 753/8/07. Unpublished study prepared by GAB Biotechnologie Gmbh. 32 p.

47615021 Stabler, D. (2008) Acute Toxicity of DM -PCA on Earthworms, Eisenia fetida Using

an Artificial Soil Test- Limit Tes t: Final Report. Project Number: 20071562/01/NLEF, 20071562/01/NLEF/OCR, 753/8/36. Unpublished study prepared by Eurofins - GAB GmbH. 28 p.

47615022 Stabler, D. (2008) Acute Toxicity of PCA on Earthworms, Eisenia fetida Using an Artificial Soil Test: Final Report. Pr oject Number: S08/01596, S08/01596/OCR, 753/8/38. Unpublished study prepared by Eurofins - GAB GmbH. 31 p.

47615023 Stabler, D. (2008) Acute Toxicity of PA M on Earthworms, Eisenia fetida Using an Artificial Soil Test: Final Report. Pr oject Number: S08/01594, S08/01594/OCR, 753/8/39. Unpublished study prepared by Eurofins - GAB GmbH. 31 p.

47615024 Luhrs, U. (2007) Effects of MTF-753 on Reproduction and Growth of Earthworms

Eisenia fetida in Artificial Soil with 5% Peat: Final Report. Project Number: 36521022, 36521022/OCR, 753/8/18. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 34 p.

47615025 Stabler, D. (2008) Sublethal Toxicity of DM-PCA to the Earthworm Eisenia fetida in Artificial Soil: Final Report. Project Number: S08/00760, S08/00760/OCR, 753/8/37. Unpublished study prepared by Eurofins - GAB GmbH. 33 p.

47615026 Stabler, D. (2009) Sublethal Toxicity of PCA to the Earthworm Eisenia Fetida in Artificial Soil: Final Report. Proj ect Number: S08/03213, S08/03213/OCR. Unpublished study prepared by Eurofins - GAB GmbH. 33 p.

47615027 Stabler, D. (2009) Sublethal Toxicity of PAM to the Earthworm Eisenia fetida in Artificial Soil: Final Report. Proj ect Number: S08/03212, S08/03212/OCR. Unpublished study prepared by Eurofins - GAB GmbH. 32 p.116 MRID Citation

47615028 Kolzer, U. (2006) Assessment of the Side Effects of MTF-753 Technical on the Activity of the Soil Microflora: Fina l Report. Project Number: 20051281/01/ABMF, 2005128/01/ABMF/OCR. Unpublished study prepared by GAB Biotechnologie Gmbh & GAB Analytik GmbH. 53 p.

47615029 Stabler, D. (2008) Assessment of the Side Effects of DM-PCA on the Activity of the Soil Microflora: Final Report. Project Number: 20071562/01/ABMF, 20071562/01/ABMF/OCR. Unpublished study prepared by Eurofins - GAB GmbH. 52 p.

47615030 Stabler, D. (2008) Assessment of the Side Effects of PCA on the Activity of the Soil Microflora: Final Report. Projec t Number: S08/01595, S08/01595/OCR. Unpublished study prepared by Eurofins - GAB GmbH. 55 p.

47615031 Stabler, D. (2008) Assessment of the Side Effects of PAM on th e Activity of the Soil Microflora: Final Report. Projec t Number: S08/01593, S08/01593/OCR. Unpublished study prepared by Eurofins - GAB GmbH. 54 p.

47615032 Palmer, S.; Kendall, T.; Krueger, H. (2007) MTF-753: A 96-Hour Static-Renewal Acute Toxicity Test with the Saltwater Mysid (Americamysis bahia): Final Report. Project Number: 236A/115, 236A/115/OCR. Un published study prepared by Wildlife International, Ltd. 58 p.

47615033 Palmer, S.; Kendall, T.; Krueger, H. (2008) MTF-753: A 96-Hour Shell Deposition Test with the Eastern Oyster (Crassostrea virginica): Final Report. Project Number: 753/8/26, 236A/117, 236A/117/OCR. Unpub lished study prepared by Wildlife International, Ltd. 66 p.

47615034 Palmer, S.; Kendall, T.; Krueger, H. (2007) MTF-753: A 96-Hour Static-Renewal Acute Toxicity Test with the Sheepshead Minnow (Cyprinodon va riegatus): Final Report. Project Number: 236A/116, 236A /116/OCR, 753/8/15. Unpublished study prepared by Wildlife International, Ltd. 58 p.

47615035 Rosenkranz, B.; Luhrs, U. (2009) Effects of MTF-753 20 SC and DM-PCA on the Breakdown of Organic Matter in Litter Ba gs in the Field: Final Report. Project Number: 36121081, 36121081/OCR. Unpublished st udy prepared by Institut fuer Biologische Analytik und Consulting IBACON. 120 p.

47615036 Luhrs, U.; Schabio, S. (2009) Effects of DM-PCA on the Breakdown of Organic Matter in Litter Bags in the Fiel d: Final Report. Project Number: 43391081, 43391081/OCR. Unpublished study prepared by In stitut fuer Biologische Analytik und Consulting IBACON. 122 p.

47615037 Porch, J.; Martin, K.; Krueger, H. (2 008) MTF-753 20SC: A Toxicity Test to Determine the Effects of the Test Substance on Seedling Emergence of Ten Species of Plants: Final Report. Project Number: 236/128, 236/128/OCR, 753/8/22. Unpublished study prepared by Wildlife International, Ltd. 70 p.117 MRID Citation

47615038 Porch, J.; Krueger, H.; Martin, K. ( 2008) MTF-753 20SC: A Toxicity Test to

Determine the Effects of the Test Substan ce on Vegetative Vigor of Ten Species of Plants: Final Report. Project Number: 236/129, 236/129/OCR, 753/8/23. Unpublished study prepared by Wildlife International, Ltd. 80 p.

47615039 Dengler, D. (2008) Toxicity Testi ng of MTF-753 (Penthiopyrad) on MicroOrganisms with the Sludge Respiration Inhibition Test: Fi nal Report. Project Number: 20071563/01/AAHT/OCR, 20071563/01/AAHT, 753/8/33. Unpublished study prepared by Eurofins - GAB GmbH. 36 p.

47615040 Kendall, T.; Nixon, W. (2009) Evaluati on of the Stability of 753-T-DO in Freshwater. Project Number : 236C/155, 236C/155/OCR. Unpublished study prepared by Wildlife International, Ltd. 35 p.

47615041 Luhrs, U. (2009) Effects of MTF-753 20 SC and DM-PCA on the Brekdown of Organic Matter in Litter Ba gs in the Field: Amended Fi nal Report. Project Number: 36121081, 36121081/OCR. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 7 p.

47615225 Gallagher, S.; Kendall, T.; Krueger, H. (2008) Penthiopyrad (DPX-LEM17) 200 g/L SC: A 96-Hour Static Acute Toxicity Te st with the Rainbow Trout (Oncorhynchus mykiss). Project Number: DUP ONT/19760, 112A/222, DUPONT/19760/OCR. Unpublished study prepared by Wildlife International, Ltd. 46 p.

47615226 Gallagher, S.; Kendall, T.; Krueger, H. (2007) Penthiopyrad (DPX-LEM17) 200 g/L SC: A 48-Hour Static Acute Toxicity Test with the Cladoceran (Daphnia magna). Project Number: DUPONT/22839, 112A/ 221, DUPONT/22839/OCR. Unpublished study prepared by Wildlife International, Ltd. 46 p.

47615227 Gallagher, S.; Kendall, T.; Kruegar, H. (2009) Penthiopyrad (DPX-LEM17) 200 g/L SC: A 48-Hour Static Acute Toxicity Test with the Cladoceran (Daphnia magna). Project Number: DUPONT/25552, 112A/ 251, DUPONT/25552/OCR. Unpublished study prepared by Wildlife International, Ltd. 47 p.

47615228 Gallagher, S.; Kendall, T.; Krueger, H. (2009) Penthiopyrad (DPX-LEM17) 200 g/L SC: A 48-Hour Static Acute Toxicity Te st with the Fed Cladoceran (Daphnia magna). Project Number: DUP ONT/28095, 112A/292, DUPONT/28095/OCR. Unpublished study prepared by Wildlife International, Ltd. 46 p.

47615229 Gallagher, S.; Kendall, T.; Krueger, H. (2009) Penthiopyrad (DPX-LEM17) 200 g/L SC: A 48-Hour Static Acute Toxicity Te st with the Cladoceran (Daphnia magna) with Mixed Ages. Projec t Number: DUPONT/28096, 112A/293, DUPONT/28096/OCR. Unpublished study prepared by Wildlife International, Ltd. 52 p.118 MRID Citation

47615230 Porch, J.; Kendall, T.; Krueger, H. (2 008) Penthiopyrad (DPX-LEM17) 200 g/L SC: A 72-Hour Toxicity Test with the Freshwat er Alga (Pseudokirchne riella subcapitata). Project Number: DUPONT/19759, 112A/ 223, DUPONT/19759/OCR. Unpublished study prepared by Wildlife International, Ltd. 62 p.

47615231 Gallahger, S.; Kendall, T.; Krueger, H. (2009) Penthiopyrad (DPX-LEM17) 200 g/L SC: A 96-Hour Static Acute Toxicity Test with the Saltwater Mysid (Americamysis bahia). Project Number: DUP ONT/27154, 112A/278, DUPONT/27154/OCR. Unpublished study prepared by Wildlife International, Ltd. 42 p.

47615232 Gallagher, S.; Kendall, T.; Krueger, H. (2009) Penthiopyrad (DPX-LEM17) 200 g/L SC: A 96-Hour Static Acute Toxicity Te st with the Sheepshead Minnow (Cyprinodon variegatus). Project Number: DUPONT/27153, 112A/279A, DUPONT/27153/OCR. Unpublished study prepared by Wildlife International, Ltd. 43 p.

47615233 Gallagher, S.; Kendall, T.; Krueger, H. (2009) Penthiopyrad (DPX-LEM17) 200 g/L SC: A 96-Hour Shell Deposition Test with th e Eastern Oyster (Crassostrea virginica). Project Number: DUPONT/27155, 112A/ 280, DUPONT/27155/OCR. Unpublished study prepared by Wildlife International, Ltd. 49 p.

47615234 Minderhout, T.; Kendall, T.; Krueger, H. (2009) Penthiopyrad (DPX-LEM17) 200 g/L SC: A 48-Hour Static Acute Toxicity Test with the Mayfly (Centroptilum triangulifer). Project Number: DUPONT/26632, 112A/290, DUPONT/26632/OCR. Unpublished study prepared by Wildlife International, Ltd. 48 p.

47615235 Minderhout, T.; Kendall, T.; Krueger, H. (2009) Penthiopyrad (DPX-LEM17) 200 g/L SC: A 48-Hour Static Acute Toxicity Te st with Caddisflies (Chimarra atternima). Project Number: DUPONT/26633, 112A/ 289, DUPONT/26633/OCR. Unpublished study prepared by Wildlife International, Ltd. 50 p.

47615236 Gallagher, S.; Claude, M.; Kendall, T.; et al. (2009) Penthiopyrad (DPX-LEM17) 200 g/L SC: A Semi-Static Life-Cycle Toxic ity Test with the Cladoceran (Daphnia magna). Project Number: DUP ONT/26161, 112A/261, DUPONT/26161/OCR. Unpublished study prepared by Wildlife International, Ltd. 73 p.

47615237 Warmers, C. (2007) Penthiopyrad (D PX-LEM17) 200 g/L SC: Acute Oral and Contact Toxicity to the Honey Bee, Apis mellifera L.: Final Report. Project Number: DUPONT/21548, 20071176/01/BLEU, DUPONT /21548/OCR. Unpublished study prepared by Eurofins - GAB GmbH. 36 p.

47615238 Hernadi, D. (2008) Penthiopyrad (DPX- LEM17) 200 g/L SC: A Laboratory Test to Evaluate the Effects on the Predatory Mite Typhlodromus pyri (Acar i, Phytoseiidae): Final Report. Project Numb er: DUPONT/19757, 07/448/335RA, DUPONT/19757/OCR. Unpublished study prep ared by LAB Research, Ltd. 38 p.119 MRID Citation

47615239 Hernaldi, D. (2008) Penthiopyrad 20 0 g/L SC (DPX-LEM17-063): A Laboratory Test to Study the Effects on the Parasito id Aphidius rhopalosiphi (Hymenoptera, Braconidae): Final Report. Project Number: DUPONT/19758, 07/448/335FD, DUPONT/19758/OCR. Unpublished study prep ared by LAB Research, Ltd. 45 p.

47615240 Adelberger, I. (2008) Penthiopyrad (DPX-LEM17) 200 g/L SC: An Extended Laboratory Rate Response Test to Study the Effects on the Predatory Mite, Typhlodromus pyri (Acari, Phytoseiid ae): Final Report. Project Number: DUPONT/25383, S08/01791, DUPONT/ 25383/OCR. Unpublished study prepared by Eurofins - GAB GmbH. 38 p.

47615241 Klug, T. (2008) Penthiopyrad (DPX-LEM 17) 220 g/L SC: An Extended Laboratory Rate Response Test to Study the Effect s on the Predatory Bug Orius laevigatus Fieber (Heteroptera, Ant hocoridae): Final Report. Project Number: DUPONT/25384, S08/01793, DUPONT/25384/OCR. Unpublished st udy prepared by Eurofins - GAB GmbH. 48 p.

47615242 Klug, T. (2008) Penthiopyrad (DPX-LEM 17) 200 g/L SC: An Extended Laboratory Rate Response Test to Study the Effect s on the Green Lacewing, Chrysoperla carnea steph. (Chrysopidae, Neuroptera): Final Report. Project Number: DUPONT/25385/REVISION/1, S08/01792, DUPONT/25385/OCR. Unpublished study prepared by Eurofins - GAB GmbH. 43 p.

47615243 Lehmhus, J. (2009) DPX-LEM17 20SC: A Field Study to Evaluate Effects on Predatory Mites (Acari-Phytoseiidae) in A pple Orchards in Germany and in Grape Vineyards in Italy, 2008: Final Re port. Project Number: DUPONT/25551, S08/01756, DUPONT/25551/OCR. Unpublished st udy prepared by Eurofins - GAB GmbH. 68 p.

47615244 Vertesi, A. (2007) Penthiopyrad (DPX- LEM17) 200 g/L SC: Acute Toxicity to the Earthworm, Eisenia fetida in Artificial Soil: Amended Fi nal Report. Project Number: DUPONT/19762/REVISION/1, 07/ 448/125G, 17233. Unpublished study prepared by LAB Research, Ltd. 34 p.

47615245 Vertesi, A. (2008) Penthiopyrad (DPX-LEM17) 200 g/L SC: Effects on Reproduction and Growth of the Earthworm, Eisenia fetida, in Artificial Soil: Final Report. Project Number: DUPONT/1 9763, 07/448/211G, DUPONT/19763/OCR. Unpublished study prepared by LAB Research, Ltd. 48 p.

47615246 Stabler, D. (2007) Penthiopyrad (DPX-LEM17) 200 g/L SC: Assessment of the

Effects on Soil Microflora: Final Report. Project Number: DUPONT/21549, 20071176/01/ABMF, DUPONT/21549/OCR. Unpublished study prepared by Eurofins - GAB GmbH. 41 p.120 MRID Citation

47615248 Zaucha, T. (2009) Product Identity and Composition of End-Use Product Penthiopyrad (DPX-LEM17) 200 g/L SC. Project Number: DUPONT/22438, DUPONT/22438/OCR. Unpublished study prepared by E.I. du Pont de Nemours and Company. 76 p.

47615249 Hubbard, P.; Beavers, J. (2009) Penthi opyrad (LEM17) 200 g/L SC: An Acute Oral Toxicity Study with the Nort hern Bobwhite (Colinus vi rginianus). Project Number: DUPONT/27842, 112/639, DUPONT/27842/OCR. Unpublished study prepared by Wildlife International, Ltd. 55 p.

47615335 Gallagher, S.; Kendall, T.; Krueger, H. (2009) Penthiopyrad (DPX-LEM17) 200 g/L EC: A 96-Hour Static Acute Toxicity Te st with the Fathead Minnow (Pimephales promelas) . Project Number: 112A/309, DUPONT/29168. Unpublished study prepared by Wildlife International, Ltd. 46 p.

47615336 Gallagher, S.; Kendall, T.; Krueger, H. (2009) Penthiopyrad (DPX-LEM17) 200 g/L EC: A 48-Hour Static Acute Toxicity Test with the Cladoceran (Daphnia magna). Project Number 112A/257A, DUPONT /25537. Unpublished study prepared by Wildlife International, Ltd. 46 p.

47615337 Jeyalakshmi, T. (2009) Penthiopyrad (DPX-LEM17) 200 g/L EC: Acute Oral and Contact Toxicity to the Honey Bee, Apis mellifera L. Project Number: 08205, DUPONT/25529. Unpublished study prepared by International Institute of Biotechnology and Toxicology. 47 p.

47615338 Moll, M. (2008) Penthiopyrad (DPX-LEM 17) 200 g/L EC: A Laboratory Test to Study the Effects on the Parasitoid A phidius rhopalosiphi (Hymenoptera, Braconidae). Project Number: 43481001, DUPONT/25522. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 40 p.

47615339 Moll, M. (2008) Penthiopyrad (DPX-LEM 17) 200 g/L EC: A Laboratory Test to Evaluate the Effects on the Predatory Mite, Typhlodromus pyri (Acari, Phytoseiidae). Project Number 43482063, DUPONT/25523. Unpublis hed study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 34 p.

47615340 Moll, M. (2009) Penthiopyrad (DPX-LEM 17) 200 g/L EC: An Extended Laboratory Rate Response Test to Study the Effect s on the Predatory Mite, Typhlodromus pyri (Acari, Phytoseiidae). Project Number: DUPONT/25381, 43483062. Unpublished study prepared by Institut fuer Biologisch e Analytik und Consulting IBACON. 46 p.

47615341 Moll, M. (2009) Penthiopyrad (DPX-LEM 17) 200 g/L EC: An Extended Laboratory Rate Response Test to Study the Effect s on the Predatory Bug Orius Laevigatus Fieber (Heteroptera, Anthocorid ae). Project Number: DUPONT/25386, 43485052. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 43 p.121 MRID Citation

47615342 Moll, M. (2009) Penthiopyrad (DPX-LEM 17) 200 g/L EC: An Extended Laboratory Rate Response Test to Study the Effect s on the Green Lacewing, Chrysoperla carnea Steph (Chrysophidae, Neuroptera) . Project Number: DUPONT/25387, 43484047. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 44 p.

47615343 Stabler, D. (2009) Penthiopyrad (DPX-LEM17) 200 g/L EC: Assessment of the Effects on Soil Microflora. Proj ect Number: S08/01794, DUPONT/25532. Unpublished study prepared by Eurofins - GAB GmbH. 41 p.

47737323 Gallagher, S.; Kendall, T.; Krueger, H. (2009) Chlorothaloni l/Penthiopyrad (DPXQFA61) SC (250 g/L:100 g/L) : A 96-Hour Static Acute Toxicity Test with the Rainbow Trout (Oncorhynchus my kiss). Project Number: DUPONT/25536, DUPONT/25536/OCR, 112A/253. Unpublishe d study prepared by Wildlife International, Ltd. 51 p.

47737324 Gallagher, S.; Kendall, T.; Krueger, H. (2009) Chlorothaloni l/Penthiopyrad (DPXQFA61) SC (250 g/L:100 g/L) : A 48-Hour Static Acute Toxicity Test with the Cladoceran (Daphnia magna). Project Number: DUPONT/25538, DUPONT/25538/OCR, 112A/252. Unpublishe d study prepared by Wildlife International, Ltd. 52 p.

47737325 Porch, J.; Kendall, T.; Krueger, H. (2009) Chlorothalonil/Penthiopyrad (DPXQFA61) SC (250 g/L:100 g/L) : A 72-Hour Toxicity Test with the Freshwater Alga (Pseudokirchneriella subcapitat a). Project Number: DUPONT/25534, DUPONT/25534/OCR, 112A/249. Unpublishe d study prepared by Wildlife International, Ltd. 62 p.

47737326 Jeyalakshmi, T. (2009) Chlorothalonil/P enthiopyrad (DPX-QFA61) SC (250 g/L:100 g/L): Acute Oral and Contact Toxicity to the Honey Bee, Apis mellifera L.. Project Number: DUPONT/24930, DUPONT/24930/OCR, 08279. Unpublished study prepared by International Institute of Biotechnology and Toxicology . 37 p.

47737327 Moll, M. (2008) Chlorothalonil/Penthi opyrad (DPX-QFA61) SC (250 g/L:100 g/L): A Laboratory Test to Study the Effects on the Parasitoid A phidius rhopalosiphi (Hymenoptera, Braconidae). Project Number: DUPONT/24931, DUPONT/34931/OCR, 43471001. Unpublished st udy prepared by Institut fuer Biologische Analytik und Consulting IBACON. 40 p.

47737328 Moll, M. (2008) Chlorothalonil/Penthi opyrad (DPX-QFA61) SC (250 g/L:100 g/L): A Laboratory Test to Evaluate the Effect s on the Predatory Mite, Typhlodromus pyri (Aacari, Phytoseiidae): Final Re port. Project Number: DUPONT/25524, DUPONT/25524/OCR, 43472063. Unpublished st udy prepared by Institut fuer Biologische Analytik und Consulting IBACON. 33 p.122 MRID Citation

47737329 Moll, M. (2009) Chlorothalonil/Penthi opyrad (DPX-QFA61) SC (250 g/L:100 g/L): An Extended Laboratory Test to Evalua te the Effects on the Predatory Mite, Typhlodromus pyri (Acari, Phytoseiid ae): Final Report. Project Number: DUPONT/25382, DUPONT/25382/O CR, 43473062. Unpublished study prepared by Institut fuer Biologische Anal ytik und Consulting IBACON. 50 p.

47737330 Moll, M. (2009) Chlorothalonil/Penthi opyrad (DPX-QFA61) SC (250 g/L:100 g/L): An Extended Laboratory Test to Evaluate the Effects on the Lacewing, Chrysoperla carnea (Neuroptera: Chrysopidae): Fi nal Report. Project Number: DUPONT/25389, DUPONT/25389/OCR, 43474047. Unpublished st udy prepared by Institut fuer Biologische Analytik und Consulting IBACON. 44 p.

47737331 Moll, M. (2009) Chlorothalonil/Penthi opyrad (DPX-QFA61) SC (250 g/L:100 g/L): An Extended Laboratory Test to Evaluate the Effects on the Predatory Bug, Orius laevigatus (Heteroptera, Anthocorid ae): Final Report. Project Number: DUPONT/25388, DUPONT/25388/O CR, 43475052. Unpublished study prepared by Institut fuer Biologische Anal ytik und Consulting IBACON. 40 p.

47737332 Luhrs, U. (2008) Chlorothalonil/Penthi opyrad (DPX-QFA61) SC (250 g/L: 100 g/L): Acute Toxicity to the Earthworm, Eisenia fetida in Artificial Soil with 5% Peat. Project Number: DUPONT/25540, DUP ONT/25540/OCR, 43476021. Unpublished study prepared by Institut fuer Biologisch e Analytik und Consulting IBACON. 31 p.

47737333 Luhrs, U. (2008) Chlorothalonil/Penthiopyrad (DPX-QFA61) SC (250 g/L : 100 g/L): Effects on Reproduction and Growth of the Earthworm, Eisenia fetida, in

Artificial Soil with 5% Peat: Fina l Report. Project Number: DUPONT/25541, DUPONT/25541/OCR, 43477022. Unpublished st udy prepared by Institut fuer Biologische Analytik und Consulting IBACON. 41 p.

47737334 Feil, N. (2009) Chlorothalonil/Penthi opyrad (DPX-QFA61) SC (250 g/L:100 g/L):

Assessment of the Effects on So il Microflora. Project Number: DUPONT/25533/REVISION/2, DUPONT/25533/REVI SION/2/OCR, 43478080. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 46 p.

6.3. Chlorothalonil Ecotoxicity Studies Discussed (Previously Submitted)

Davies PE, and White RWG. 1985. The Toxicology a nd Metabolism of Chlorothalonil in Fish. I.

Lethal Levels for Salmo gairdneri, Galaxias maculates, G. truttaceus and G. auratus and

the Fate of 14C-TCIN in S. gairdneri

. Aquat Toxicol7(1/2):93-105.

Mezcua, M., Hernando, M.D., Piedra, L., Aguera, A., Fernandez-Alba, A.R. 2002. Chromatography-Mass Spectometry and Toxicity Evaluation of Selected Contaminants in

Seawater. Chromatographia 56(3/4):199-205.123 MRID 45710221 Douglas, M. (1992) The Acut e Toxicity of Chlorothalonil to Daphnia magna : Lab Project Number: VCM 8(A)/920231. U npublished study prepared by Huntingdon Research Centre Ltd. 24 p.

MRID 42432801 Hughes, J.; Williams, T. (1992) The T oxicity of Technical Chlorothalonil Fungicide to Selenaestrum capricornutum : Lab Project Number: B038-001-1. Unpublished study prepared by Malcolm Pirnie, Inc. 37 p.

MRID 00077759 Atkins, E.L., Jr. and L.D. An derson (1969) Effect of Pesticides on Apiculture: Project No. 1499; Resear ch Report CF-4863. Annual Report Oct 1968. (Unpublished Study Received Mar 16, 1970 under 0F0961; Prepared by Univ. of California-Riverside, Dept. of Entomology, Submitted by Nor-Am Agricultural Products, Inc. Naperville, Ill.; CDL: 093272-B).124 

### Appendix A. STIR v.1.0 (S creening T ool for I nhalation R isk) Input/Output

The S creening T ool for I nhalation R isk (STIR v.1.0, November 19, 2010) was used to calculate an upper bound estimate of exposure using penthiopyr ad’s vapor pressure and molecular weight for vapor phase exposure as well as the maximum application rate and me thod of application for spray drift. STIR incorporates results from several toxicity studies including acute oral and inhalation rat toxicity en dpoints obtained from the “six-pack” of core studies, which are a series of six guideline studies that ar e submitted to the Registration Di vision of the Office of Pesticide Programs for technical and formulat ed products of a pesticide (LD 50 >2000 mg/kg bw and LC 50 >5.59 mg/L air, respectively) as well as the most sensitive acute oral avian toxicity endpoint (Northern bobwhite quail LD 50 >2250 mg/kg bw). Based on th e results of th e STIR model, inhalation exposure alone was not determined to be a potential pathway of concern for avian and/or mammalian species on an acute basis.

Inhalation exposure via spray drift and vapor-phase of the pesticide alone do not appear to be of concern. The analysis of the inha lation route of in STIR does not consider that aggregation with other exposure pathways such as dietary, dermal , or drinking water may contribute to a total exposure that has a potential fo r effects to non-target animals. However, the Agency does consider the relative importance of other routes of exposure in situ ations where data indicate that pesticide exposures through other routes may be potentially signi ficant contributo rs to wildlife risk (USEPA, 2004).



## Screening Tool for Inhalation Risk

This tool is designed to provide the risk a ssessor with a rapid method for determining the potential significance of the inhalation expos ure route to birds and mammals in a risk

assessment.



## Input

Application and Chem ical Information

Enter Chemical Name Penthiopyrad

Enter Chemical Use turf Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) air

Enter Chemical Molecu lar Weight (g/mole) 359.42 Enter Chemical Vapor Pressure (mmHg) 2.20E-08 Enter Application Rate (lb a.i./acre) 0.95 Toxicity Properties

Bird

Enter Lowest Bird Oral LD 50 (mg/kg bw) 2250 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178

Mammal

Enter Lowest Rat Oral LD 50 (mg/kg bw) 2000
Enter Lowest Rat Inhalation LC 50 (mg/L) 5.59 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.224125 

## Output

Results Avian (0.020 kg )
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 4.26E-04 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 5.35E-05 Adjusted Inhalation LD 50 5.48E+01 Ratio of Vapor Dose to Adjusted Inhalation LD 50 9.76E-07 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg) 9.13E-02 Ratio of Droplet Inhalation Do se to Adjusted Inhalation LD 50 1.67E-03 Exposure not Likely Significant

Results Mammalian (0.015 kg )
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 4.26E-04 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 6.72E-05 Adjusted Inhalation LD 50 4.65E+02 Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.45E-07 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg) 1.15E-01 Ratio of Droplet Inhalation Do se to Adjusted Inhalation LD 50 2.47E-04 Exposure not Likely Significant126Appendix B. Chemical Names, Structures, and Maximum Reported Amounts of Penthiopyrad and ItsDegradates.Table B.1. Penthiopyrad andIts Environmental Degradates.Code Name(Mitsui, DuPont)Chemical NameChemical StructureStudy TypeMRIDMaximum%AR (day)Final %AR(study length)PARENTPenthiopyradMTF-753DPX-LEM17IUPAC:(RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-pyrazole-4-carboxamideCAS:N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide (9CI)CAS-no:183675-82-3Formula:C16H20F3N3OSMW:359.42 g/molAerobic soil metabolism (MRID 47614959,-61,-63)10-79 (161)28-29 (360)34-36 (196)Anaerobic soil metabolism (MRID 47614964)67-72 (120)Soil photolysis (MRID 47614965)4.9-8.7 (15)Aqueous photolysis (MRID 47614839)88-100 (15)Hydrolysis (MRID 47614837, 47614838)>100 (5)Anaerobic aquatic metabolism (MRID 47614976)99 (100)Aerobic aquatic metabolism (MRID 47614975)52-67 (185)Terrestrial field dissipation (MRID 47615162,-63,-64,-65,-66,-67,-72,-73)1.5 (362)0.9 (151)<LODA(251)3.8 (272)2.4 (168)5.8 (324)<LODA(195)<LODA(208)DEGRADATES753-T-DOIN-PGH58(RS)-N-[5-hydroxy-5-(1,3-dimethylbutyl)-2-oxo-2,5-dihydrothiophen-4-yl]-1-methyl3-trifluoromethyl-1H-pyrazole-4-carboxamideFormula:C16H20F3N3O3SMW:391.41 g/molAerobic soil 47614959 8.1 (161) 8.1 (161)Anaerobic soil 47614964 4.5 (0) 2.5 (120)Anaerobic aquatic 47614976 0.9 (4) ndA(100)Aerobic aquatic 47614975 2.3 (185) 2.3 (185)Field studies 47615172 1.5 (58) <1 (208)127Code Name(Mitsui, DuPont)Chemical NameChemical StructureStudy TypeMRIDMaximum%AR (day)Final %AR(study length)753-F-DOIN-PGH59(RS)-N-[5-hydroxy-5-(1,3-dimethylbutyl)-2-oxo-2,5-dihydrofuran-4-yl]-1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxamideFormula:C16H20F3N3O4MW:486.83 g/molAerobic soil 47614961 4.4 (90) 2.8 (360)Anaerobic soil 47614964 5.8 (0) ndA(120)Soil photolysis 47614965 7.4 (15) 7.4 (15)Aerobic aquatic 47614975 1.9 (185) 1.9 (185)Field studies 47615162 <3 (0-362) <3 (362)753-A-OHIN-PGH53(RS)-N-[2-(3-hydroxy-1,3-dimethyl-butyl)thiophen-3-yl]-1-methyl-3-trifluoromethyl-1Hpyrazole-4-carboxamideFormula:C16H20F3N3O2SMW:375.42 g/molAerobic soil 47614959 7.2 (62) 4.9 (161)Anaerobic soil 47614964 0.8 (0) ndA(120)Aerobic aquatic 47614975 7.5 (182) 7.5 (182)Field studies 47615173 2.0 (45) <1 (195)753-A-OHisomerM12(RS)-N-[2-(1-hydroxymethyl-1,3-dimethylbutyl)thiophen-3-yl]-1-methyl-3-trifluoromethyl-1Hpyrazole-4-carboxamideFormula:C16H20F3N3O2SMW:375.42 g/molAerobic soil 47614959 4.3 (161) 4.3 (161)753-A-COOHisomerM11(RS)-3-methyl-1-{3-[(1-methyl3-trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acidFormula:C16H18F3N3O3SMW:389.40 g/molAerobic soil 47614959 5.4 (120) 5.2 (161)DM-753IN-PGH60(RS)-N-[2-(1,3-dimethylbutyl)thiophen-3-yl]-3-trifluoromethyl-1H-pyrazole-4-carboxamideFormula:C15H18F3N3OSMW:345.39 g/molAnaerobic aquatic 47614976 1.1 (7) ndA(100)128Code Name(Mitsui, DuPont)Chemical NameChemical StructureStudy TypeMRIDMaximum%AR (day)Final %AR(study length)PAMIN-PGH451-methyl-3-trifluoromethyl-1Hpyrazole-4-carboxamideFormula:C6H6F3N3OMW:193.13 g/molAerobic soil 47614961 3.9 (90) 1.9 (360)Anaerobic soil 47614964 3.9 (14-28) 2.5 (120)Soil photolysis 4761496548B(15) 48B(15)Anaerobic aquatic 47614976 2.7 (4) 0.9 (100)Aerobic aquatic 47614975 2.7 (111) 1.8 (185)Field studies 47615164 24 (29) <4 (251)PCAIN-MR5071-methyl-3-trifluoromethyl-1Hpyrazole-4-carboxylic acidCAS-no:113100-53-1Formula:C6H5F3N2O2MW:194.11 g/molAerobic soil 47614959 3.0 (161) 3.0 (161)Anaerobic soil 47614964 2.8 (120) 2.8 (120)Soil photolysis 4761496541B(7) 35B(15)Anaerobic aquatic 47614976 1.3 (14) 0.9 (100)Aerobic aquatic 4761497511.9(111) 9.3 (185)Field studies 47615166 11 (35) <1.5 (168)DM-PCAIN-DRJ753-trifluoromethyl-1H-pyrazole-4-carboxylic acidCAS-no:543739-84-0Formula:C5H3F3N2O2MW:180.08 g/molAerobic soil 4761495928(161) 28 (161)Anaerobic soil 47614964 7.1 (120) 7.1 (120)Anaerobic aquatic 47614976 2.5 (100) 2.5 (100)Aerobic aquatic 47614975 5.4 (185) 5.4 (185)Field studies 47615162 25 (120) 5.5 (362)UnextractedResidues(N/A)(N/A)Aerobic soil 4761495940(161) 40 (161)Anaerobic soil 4761496433(56) 33 (120)Soil photolysis 4761496513-26B(10) 11-23B(15)Anaerobic aquatic 47614976 3.3 (100) 3.3 (100)Aerobic aquatic 4761497514.1(185) 14.1 (185)Carbon dioxideCarbon dioxideFormula:CO2MW:44.1 g/molSMILES:O=C=OOOAerobic soil 4761496126(360) 26 (360)Anaerobic soil 47614964 5.4 (14) 4.7 (120)Soil photolysis 4761496526-52B(15) 26-52B(15)Anaerobic aquatic 47614976 0.6 (100) 0.6 (100)Aerobic aquatic 47614975 8.8 (185) 8.8 (185)And means “not detected.”LOD means “limit of detection.”BReported values of %AR for the soil photolysis study are 2x raw values for PAM andPCA due to mixing of radiolabels in the applied test compound. For carbon dioxide andunextracted residues, %AR values for this study are ranges of 1-2x the raw values, the latter of which represent the mean of values that would result from single-labeled testcompound.129 Figure B.1. Environmental Transformati on Route of Penthiopyrad (MRID 48081904, p 84).130 

### Appendix C. Aquatic Model Input/Output Data.

Table C-1. Summary of Model Input Files.

File name Date

Input/Output File for SCI-GROW Penthiopyrad_eco.sci Aug. 8, 2011

Input Files for PRZM/EXAMS Alfa-NC-Jul15.pzr

Sep. 14, 2011 Bean-IL-Jul15.pzr Berr-FL-Jan15.pzr Bulb-STX-Feb21.pzr Cabb-STX-Feb21.pzr

Cano-ND-Jun1.pzr Sep. 27, 2011 Corn-TX-Jul15.pzr

Sep. 14, 2011 Cott-MS-Aug1.pzr Cucu-STX-Apr1.pzr Frui-FLpep-Nov1.pzr Leaf-CAlet-Apr15.pzr Legu-MS-Sep15.pzr Nuts-OR-Oct1.pzr Orna-CAres-Apr1.pzr Pean-NC-Aug29.pzr Pome-PA-Jun1.pzr Pota-FL-Mar1.pzr Root-FL-Nov1.pzr Sorg-KS-Aug15.pzr Ston-MI-Jun15.pzr Suga-MN-Aug1.pzr Sunf-ND-Jun15.pzr Turf-CA-Nov1.pzr Whea-TX-Apr1.pzr

Input Files for PFAM WIcran6.PFA Sep. 22, 2011

Input/Output Files for KABAM KABAM_penthiopyrad_9-19-11.xls Sep. 19, 2011 KABAM_penthiopyrad_lowEECs_9-19-11.xls Sep. 19, 2011

Input files attached:

Penthiopyrad_eco.sci Penthiopyrad PE files.zip WIcran6.PFA KABAM_penthiopyra d_9-19-11.xls KABAM_penthiopyra d_lowEECs_9-19-11. x131 Example Input/Output Data for Individual Simulations

SCI-GROW Input/Output File

SciGrow version 2.3 chemical:Penthiopyrad

time is 8/ 8/2011 19:46:24

----------------- --------------- --------------- --------------- ---------- Application Number of Total Use Koc Soil Aerobic rate (lb/acre) applications (l b/acre/yr) (ml/g) metabolism (days)

----------------- --------------- --------------- --------------- ---------- 0.950 3.0 2.850 7.30E+02 140.0

----------------- --------------- --------------- --------------- ---------- groundwater screening cond (ppb) = 4.87E-01

************************************************************************

PRZM/EXAMS Example Input/Output File

stored as Legu-MS-Sep15.out Chemical: Penthiopyrad PRZM environment: MSsoybeanSTD.txt modified Tueday, 26 August 2008 at 06:16:40 EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 06:14:08 Metfile: w03940.dvf modified Tueday, 26 August 2008 at 06:14:14 Water segment concentrations (ppb)

Year Peak 96 hr 21 Da y 60 Day 90 Day Yearly

1961 17.22 16.92 16.21 13.43 9.578 2.44

1962 15.31 15.11 14. 52 13.52 12.99 11.12

1963 18.35 18.12 17. 78 14.74 13.48 11.77

1964 37.94 37.41 34. 92 31.77 31.54 18.84

1965 30.97 30.8 30.2 29.35 28.88 25.46

1966 27.29 27.18 26. 85 26.41 26.05 23.62

1967 26.13 25.98 25.25 23.66 23.4 21.73

1968 25.38 25.29 25. 09 24.53 24.18 21.72

1969 25.35 24.58 23.7 21.71 21.49 19.78

1970 38.18 37.65 35. 95 34.14 32.59 24.03

1971 36.72 36.38 35.26 31.01 30.01 27.8

1972 33.86 33.74 33. 36 32.43 31.87 28.67

1973 29.63 29.57 29. 32 28.84 28.47 25.86

1974 29.47 29.32 28. 59 27.68 27.22 25.31

1975 51.38 50.48 47.43 44.14 40.2 28.58

1976 39.18 39.07 38. 56 37.66 37.08 33.48

1977 37.92 37.65 36. 75 34.18 33.06 30.48

1978 36.55 36.32 35. 49 33.96 33.53 30.83

1979 45.5 45.1 43.85 40.54 38.4 33.25

1980 41.6 41.43 41.12 40.34 39.75 35.3

1981 36.66 36.32 35. 15 33.78 33.34 30.79

1982 44.15 43.79 42. 77 40.11 39.82 31.59

1983 42.6 42.24 41.77 39.16 38.57 35.17

1984 46.37 45.93 44. 17 43.04 40.39 35.89

1985 40.46 40.37 40. 03 39.55 39.09 35.31132 1986 35.39 35.25 34. 68 34.22 33.54 31.23

1987 33.39 33.31 33. 03 32.51 32.14 29.05

1988 33.32 33.1 32.75 32.05 31.79 28.12

1989 38.45 38.08 37. 34 35.92 34.06 29.19

1990 35.79 35.68 35. 34 34.63 34.06 30.12

Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly

0.032258064516129 51.38 50.48 47.43 44.14 40.39 35.89

0.0645161290322581 46.37 45.93 44.17 43.04 40.2 35.31

0.0967741935483871 45.5 45.1 43.85 40.54 39.82 35.3

0.129032258064516 44.15 43.79 42.77 40.34 39.75 35.17

0.161290322580645 42.6 42.24 41.77 40.11 39.09 33.48

0.193548387096774 41.6 41.43 41.12 39.55 38.57 33.25

0.225806451612903 40.46 40.37 40.03 39.16 38.4 31.59

0.258064516129032 39.18 39.07 38.56 37.66 37.08 31.23

0.290322580645161 38.45 38.08 37.34 35.92 34.06 30.83

0.32258064516129 38.18 37.65 36.75 34.63 34.06 30.79

0.354838709677419 37.94 37.65 35.95 34.22 33.54 30.48

0.387096774193548 37.92 37.41 35.49 34.18 33.53 30.12

0.419354838709677 36.72 36.38 35.34 34.14 33.34 29.19

0.451612903225806 36.66 36.32 35.26 33.96 33.06 29.05

0.483870967741936 36.55 36.32 35.15 33.78 32.59 28.67

0.516129032258065 35.79 35.68 34.92 32.51 32.14 28.58

0.548387096774194 35.39 35.25 34.68 32.43 31.87 28.12

0.580645161290323 33.86 33.74 33.36 32.05 31.79 27.8

0.612903225806452 33.39 33.31 33.03 31.77 31.54 25.86

0.645161290322581 33.32 33.1 32.75 31.01 30.01 25.46

0.67741935483871 30.97 30.8 30.2 29.35 28.88 25.31

0.709677419354839 29.63 29.57 29.32 28.84 28.47 24.03

0.741935483870968 29.47 29.32 28.59 27.68 27.22 23.62

0.774193548387097 27.29 27.18 26.85 26.41 26.05 21.73

0.806451612903226 26.13 25.98 25.25 24.53 24.18 21.72

0.838709677419355 25.38 25.29 25.09 23.66 23.4 19.78

0.870967741935484 25.35 24.58 23.7 21.71 21.49 18.84

0.903225806451613 18.35 18.12 17.78 14.74 13.48 11.77

0.935483870967742 17.22 16.92 16.21 13.52 12.99 11.12

0.967741935483871 15.31 15.11 14.52 13.43 9.578 2.44

0.1 45.365 44.969 43. 742 40.52 39.813 35.287 Average of yearly averages: 26.551

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run: Output File: Legu-MS-Sep15

Metfile: w03940.dvf PRZM scenario: MSsoybeanSTD.txt EXAMS environment file: pond298.exv Chemical Name: Penthiopyrad Description Variable Name Value Units Comments Molecular weight mwt 359.4 g/mol Henry's Law Const. henry 7.6e-9 atm-m^3/mol Vapor Pressure vapr torr Solubility sol 1.4 mg/L133 Kd Kd mg/L Koc Koc 720 mg/L Photolysis half-life kdp 0 days Half-life Aerobic Aquatic Metabolism kbacw 287 days Halfife Anaerobic Aquatic Metabolism kbacs 0 days Halfife

Aerobic Soil Metabolism asm 240 days Halfife Hydrolysis: pH 7 0 days Half-life Method: CAM 2 integer See PRZM manual Incorporation Depth: DEPI cm Application Rate: TAPP 0.44 kg/ha Application Efficiency: APPEFF 0.95 fraction Spray Drift DRFT 0.05 fraction of application rate applied to pond Application Date Date 15-09 dd/mm or dd/mmm or dd-mm or dd-mmm Interval 1 interval 7 days Set to 0 or delete line for single app. app. rate 1 apprate kg/ha Interval 2 interval 14 days Set to 0 or delete line for single app. app. rate 2 apprate 0.17 kg/ha

Record 17: FILTRA

IPSCND 1

UPTKF

Record 18: PLVKRT

PLDKRT

FEXTRC 0.5 Flag for Index Res. Run IR EPA Pond Flag for runoff calc. RUNOFF none none, monthly or total(average of entire run)

PFAM-VVWM Example Output File

Variable Volume Water Model, Version 0.0

*******************************************

Performed on: 9/22/2011 at 17:29

Standard Reservoir

Chemical # 1

Peak 1-in-10 = 2.98E+02 ppb Chronic 1-in-10 = 2.40E+02 ppb

4-day avg 1-in-10 = 2.96E+02 ppb 21-day avg 1-in-10 = 2.93E+02 ppb 60-day avg 1-in-10 = 2.89E+02 ppb 90-day avg 1-in-10 = 2.89E+02 ppb

YEAR Peak 4-day 21-day 60-day 90-day Yearly Avg

1 9.80E+01 9.69E+01 9.54E+ 01 9.47E+01 9.43E+01 6.98E+01

2 1.62E+02 1.61E+02 1.59E+ 02 1.57E+02 1.55E+02 1.26E+02

3 1.95E+02 1.94E+02 1.91E+ 02 1.87E+02 1.84E+02 1.56E+02

4 2.25E+02 2.24E+02 2.22E+ 02 2.18E+02 2.16E+02 1.76E+02

5 1.96E+02 1.94E+02 1.89E+ 02 1.86E+02 1.84E+02 1.67E+02

6 2.10E+02 2.09E+02 2.06E+ 02 2.04E+02 2.02E+02 1.64E+02

7 1.93E+02 1.90E+02 1.85E+ 02 1.79E+02 1.76E+02 1.54E+02

8 2.36E+02 2.35E+02 2.33E+ 02 2.30E+02 2.28E+02 1.92E+02

9 2.49E+02 2.47E+02 2.42E+ 02 2.41E+02 2.39E+02 2.16E+02

10 2.97E+02 2.95E+02 2.93E+02 2.90E+02 2.87E+02 2.49E+02134 11 3.09E+02 3.08E+02 3.06E+02 3.04E+02 3.01E+02 2.76E+02

12 2.63E+02 2.61E+02 2.57E+02 2.60E+02 2.71E+02 2.00E+02

13 2.21E+02 2.20E+02 2.18E+02 2.17E+02 2.14E+02 1.78E+02

14 2.73E+02 2.70E+02 2.66E+02 2.64E+02 2.61E+02 2.08E+02

15 2.46E+02 2.44E+02 2.41E+02 2.40E+02 2.36E+02 2.10E+02

16 2.98E+02 2.96E+02 2.91E+02 2.80E+02 2.71E+02 2.30E+02

17 3.04E+02 3.02E+02 3.00E+02 2.97E+02 2.96E+02 2.41E+02

18 2.35E+02 2.34E+02 2.32E+02 2.28E+02 2.27E+02 1.88E+02

19 2.23E+02 2.22E+02 2.18E+02 2.14E+02 2.12E+02 1.84E+02

20 1.79E+02 1.78E+02 1.75E+02 1.71E+02 1.67E+02 1.40E+02

21 2.01E+02 1.99E+02 1.98E+02 1.95E+02 1.93E+02 1.66E+02

22 2.62E+02 2.61E+02 2.57E+02 2.55E+02 2.53E+02 2.30E+02

23 2.46E+02 2.44E+02 2.41E+02 2.40E+02 2.38E+02 1.97E+02

24 2.25E+02 2.24E+02 2.21E+02 2.20E+02 2.17E+02 1.85E+02

25 2.02E+02 2.00E+02 1.95E+02 1.92E+02 1.91E+02 1.81E+02

26 2.09E+02 2.07E+02 2.06E+02 2.04E+02 2.02E+02 1.75E+02

27 2.04E+02 2.04E+02 2.02E+02 1.99E+02 1.98E+02 1.72E+02

28 2.04E+02 2.03E+02 2.02E+02 1.98E+02 1.97E+02 1.75E+02

29 2.35E+02 2.33E+02 2.29E+02 2.24E+02 2.24E+02 1.86E+02

30 1.53E+02 1.51E+02 1.46E+02 1.37E+02 1.44E+02 1.70E+02

*********************************************************************** Effective compartment halflives av eraged over simulation duration:

washout halflife (days) = 228.8117 water col metab halflife (days) = 711.1456 hydrolysis halflife (days) = 1.0016146E+08 photolysis halflife (days) = 2.0871076E+10 volatile halflife (days) = 65048.11 total water col halflife (days) = 172.6528

zero burial benthic metab halflife (days) = 1.7515901E+08 benthic hydrolysis halflife (days) = 7.8759188E+09 total benthic halflife (days) = 1.7134827E+08

***********************************************************************

**************** Inputs *******************

Chemical # 1

406.000000000000 Water Column System Halflife(except photo & hydrolysis = 100000000.000000 Benthic Compartment Halflife (except hydrolysis) = 100000000.000000 Photolysis Halflife = 100000000.000000 Hydrolysis Halflife = 359.400000000000 Molecular Wieght = 2.200000000000000E-008 Vapor Pressure = 1.40000000000000 Solubility =

720.000000000000 Koc = 20.0000000000000 Aerobic Reference Temper = 20.0000000000000 Anaerobic Reference Temper =

40.0000000000000 Reference Latitude = 55000.0000000000 Enthalpy of Henry = 20.0000000000000 Henry Reference Temperature

****************** End of Run ************************135 

### Appendix D. Example T-REX Output for Penthiopyrad.

Table D.1. Dose- and Dietary-based Upp er Bound Kenaga EECs and Chronic RQs Based on the Proposed Use of Penthiopyrad for Turf (0.95 lbs a.i./A) (Acute RQs were not calculated [NC] because non-definitive toxi city endpoints exist for birds and mammals)

Table D.1.a. Upper Bound Kenaga, Chro nic Avian Dietary Based Risk Quotients

NOAEC (ppm) EECs and RQs

Short Grass Tall Grass Broadleaf

Plants/

Small Insects Fruits/Pods/

Seeds/ Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

1520 400.79 0.26 183.70 0.12 225.45 0.15 25.05 0.02 Size class not used for dietary risk quotients

Table D.1.b. Upper Bound Kenaga, Ch ronic Mammalian Dietary Based Risk Quotients

NOAEC (ppm) EECs and RQs

Short Grass Tall Grass Broadleaf

Plants/

Small Insects Fruits/Pods/

Seeds/ Large Insects
EEC RQ EEC RQ EEC RQ EEC RQ

200 400.79 2.00 183.70 0.92 225.45 1.13 25.05 0.13
Size class not used for dietary risk quotients

Table D.1.c. Upper Bound Kenaga, Chroni c Mammalian Dose-Based Risk Quotients

Size

Class (grams) Adjusted

NOAEL EECs and RQs

Short Grass Tall Grass Broadleaf

Plants/

Small Insects Fruits/Pods/

Seeds/ Large Insects Granivore

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 19.05 382.12 20.06 175.14 9.19 214.94 11.28 23.88 1.25 5.31 0.28

35 15.42 264.10 17.13 121.05 7.85 148.56 9.64 16.51 1.07 3.67 0.24

1000 6.67 61.23 9.18 28.06 4.21 34.44 5.17 3.83 0.57 0.85 0.13136 

### Appendix E. Penthiopyrad Degradate Toxicity Summary.

Table E.1. Freshwater Fish Acute Toxi city to Penthiopyrad Metabolites
Test Species/

Test Substance (Flow-through/Static/ Static-renewal) Purity (%) 96-hour LC 50 (95% C.I.) (μg/L or mg/L, mean-measured) Slope Toxicity Category MRID Study

Classification

Rainbow Trout ( Oncorhynchus mykiss ) (DM-PCA); (Static) 99.87 LC 50 > 99.19 mg/L Slope = NA Practically

non-toxic 47614989 Acceptable

Zebra Fish ( Brachydanio rerio ) (PCA); (Static) 99.1 LC 50 > 96.7mg/L Slope = NA Practically

non-toxic 47614990 Acceptable

Rainbow Trout ( Oncorhynchus mykiss ) (PAM); (Static-renewal) 100 LC 50 > 100.3 mg/L Slope = NA Practically

non-toxic 47614991 Acceptable

Rainbow Trout ( Oncorhynchus mykiss ) (753-A-OH); (Static) 98.91 LC 50 > 9300 μg/L Slope = NA Moderately

toxic 47614992 Acceptable

Rainbow Trout ( Oncorhynchus mykiss ) (753-T-DO); (Static) 99.84 LC 50 = 5004 μg/L (95% CI 4108-6472 μg/L) (soluble mean-measured) Slope = NA Moderately

toxic 47614993 Supplemental

Table E.2. Freshwater Invertebrate Acute Toxicity to Penthiopyrad Metabolites

Test Species/

Test Substance (Flow-through/Static) Purity (%) 48-hour EC 50 (95% C.I.) (μg/L or mg/L, mean-measured) Slope Toxicity Category MRID Study

Classification

Waterflea ( Daphnia magna ) (DM-PCA); (Static) 99.9 EC 50 > 99.42 mg/L Slope = NA Practically

non-toxic 47614997 Acceptable

Waterflea ( Daphnia magna ) (PCA); (Static) 99.1 EC 50 > 91.75 mg/L Slope = NA Practically

non-toxic 47614998 Acceptable

Waterflea ( Daphnia magna ) (PAM); (Static) 100 EC 50 > 100.5 mg/L Slope = NA Practically

non-toxic 47614999 Acceptable

Waterflea ( Daphnia magna ) (753-A-OH); (Static) 98.91 EC 50 > 8700  g/L Slope = NA Moderately

toxic 47615001 Acceptable

Waterflea ( Daphnia magna ) (753-T-DO); (Static) 99.84 EC 50 > 4478  g/L Slope = NA Moderately

toxic 47615002 Supplemental137 Table E.3. Acute Toxicity of Aquatic Non-Vasc ular Plants to Penthiopyrad Metabolites

Test Species(Test Substance; Flowthrough/Static; Duration) Purity (%) Endpoint (95% C.I.) (μg/L or mg/L, Measured) Slope Effect MRID Study

Classification

Green Alga ( Desmodesmus subspicatus ) (DM-PCA); (Static) 99.9 EC 50 > 85.5 mg/L (mean-measured) Slope = NA No effect 47615009 Acceptable

Green Algae ( Pseudokirchneriella subcapitata ) (PCA); (Static) 99.1 EC 50 = 83 mg/L (95% CI 78-88 mg/L) (mean-measured) Slope = 5.96  0.908 (Cell density)

& 5.97  0.909 (yield) Cell density & yield 47615010 Acceptable

Green Algae ( Pseudokirchneriella subcapitata ) (PAM); (Static) 100 EC 50 > 100.4 mg/L (mean-measured) Slope = NA No effect 47615011 Supplemental

Green Algae ( Pseudokirchneriella subcapitata ) (753-A-OH); (Static) 98.91 EC 50 > 8430  g/L (mean-measured) Slope = NA No effect 47615012 Acceptable

Green Algae ( Pseudokirchneriella subcapitata ) (753-T-DO); (Static) 99.8 EC 50 = 1800  g/L (95% CI 1600-2000  g/L)

NOAEC ≤ 459  g/L

(initial measured) Slope = 4.64  0.421 (Cell density)

& 5.00  0.456 (yield) Cell density & yield 47615013 Supplemental

Aquatic Organisms Toxicity Comparisons of Penthiopyrad TGAI and its Metabolites Acute aquatic toxicity data (fis h, aquatic invertebrates, and algal studies) are available for the following five degradates of Penthiopyrad: DM-PCA, PCA, PAM, 753-A-OH, and 753-T-DO. A comparison using the molecular weights of the parent and resp ective degradates was used to determine if the degradate was of greater or less toxicity in relation to the parent penthiopyrad. To compare the parent and degradate acute toxic ity the same species of fish (Rainbow trout) was used for all but one degradate (P CA) toxicity test. PCA however, used zebra fish instead, and therefore there is greater uncertainty associated with this comparison. The available acute fish toxicity data for DM-PCA, PC A, PAM, and 753-A-OH indicated that no effects were observed in the highest test concentration that was tested. Both the parent and all degradates utilized the same species, Daphnia magna , in examining effects to freshwater invertebrates. The available

acute Daphnia data indicated that the de gradates, DM-PCA and PCA, exhibited no effects (lethal or sublethal) at the highest te st concentration tested. The other degradates; PAM, 753-A-OH, and 753-T-DO, exhibited subletha l effects at lower concentrat ions, and no immobility was observed in any test concentrati on. The available non-vascular aqua tic plant toxicity data for the degradate utilized the same species ( Pseudokirchneriella subcapitata ) for all degradates except for DM-PCA, which utilized another green algal species, Desmodesmus subspicatus . The available algal toxicity data for PAM and 753-A-OH, indicated that no effects were observed in138 the highest concentration tested. The othe r degradates: DM-PCA; PCA, and 753-T-DO all exhibited toxicological effects that included in hibition of biomass (DM-PCA), and inhibition of cell density and yield (P CA and 753-T-DO).

When the toxicity endpoints of the degradates were compared to the parent compound, it was determined that the degradates were considerably less toxic (1 to 3 orders of magnitude) to fish than the parent (Table 1). When the Daphnid degr adate toxicity data was compared to the parent compound, the degradates, DM-PCA, PCA, and PAM, were all 3 orders of magnitude less toxic to aquatic invertebrates than the parent com pound (Table 1). The ot her two degradates, 753-AOH and 753-T-DO, were of within the same magnitude of toxicity to aquatic invertebrates as the parent compound (Table 1); however, no treatmen t related effects were observed for the two transformation product degradates. When the algal degradate toxicity data was compared to the parent compound, the degradates, DM-PCA, PCA, a nd PAM, were all 3 orders of magnitude less toxic to algae than the parent compound (Table 1). The 753-A-OH degradate toxicity was within the same order of magnitude as the parent compound, however, no e ffects were observed. Whereas, the 753-T-DO degradate was found to be of similar toxicity to algae as the parent compound is (Table 1). However, the 753-T- DO degradate is a minor degradate, and transformation product to a less toxic major degr adate, and therefore, is not expected to negatively impact non-target organisms.

Table E.4. Comparison of Degradate Toxici ty Compared to the Parent Compound*

Test Material Test Species LC/EC 50 Toxicity

Value (mg/L) Molecular weight (g/mol) Degradate toxicity (mg/L) expressed in terms of the parent compound 1
Parent Penthiopyrad

TGAI Rainbow Trout 0.290 359.42 --

DM-PCA Rainbow Trout >99.19 180.08 >197.97

PCA Zebra Fish >96.7 194.11 >179.05

PAM Rainbow Trout >100.3 193.13 >186.66

753-A-OH Rainbow Trout >9.3 375.42 >8.90

753-T-DO Rainbow Trout 4.6-5.0 391.41 4.59
Parent Penthiopyrad

TGAI Daphnia magna 2.53 359.42 --

DM-PCA D. magna >99.42 180.08 >198.43

PCA D. magna >91.75 194.11 >169.89

PAM D. magna >100.5 193.13 >187.03

753-A-OH D. magna >8.7 375.42 >8.33

753-T-DO D. magna >4.48 391.41 >4.11 Parent Penthiopyrad

TGAI Pseudokirchneriella subcapitata (green alga) 2.2 359.42 --

Parent Penthiopyrad

TGAI P. subcapitata (green alga) 1.6 359.42 --

DM-PCA Desmodesmus subspicatus (green alga) >85.5 180.08 >170.65

PCA P. subcapitata (green alga) 83.0 194.11 153.68

PAM P. subcapitata (green alga) >100.4 193.13 >186.85

753-A-OH P. subcapitata (green alga) >8.43 375.42 >8.07139 Test Material Test Species LC/EC 50 Toxicity

Value (mg/L) Molecular weight (g/mol) Degradate toxicity (mg/L) expressed in terms of the parent compound 1

753-T-DO P. subcapitata (green alga) 1.8 391.41 1.65

1 [(MW parent/MW degradate) * (toxic ity endpoint degradate (mg/L))]

* Bold values indicates potentially equal degradate toxici ty when compared to the parent, penthiopyrad

technical.

Table E.5. Mammalian Acute Oral Toxi city to Penthiopyrad Metabolites

Test Species (Test Substance) Purity (%) LD 50 (mg/kg-bw) Slope Toxicity Category MRID Study

Classification

Sprague-Dawley rat (DM-PCA) 99.71 >2,000 Slope = NA Practically

non-toxic 47614918 Acceptable

Sprague-Dawley rat (PCA) 99.92 >2,000 Slope = NA Practically

non-toxic 47614924 Acceptable

Sprague-Dawley rat (PAM) 99.97 a

100.0 b >300 < 2,000 (cut-off LD 50 = 500) Slope = NA Moderately to slightly toxic 47614930 a

&

47614931 b Acceptable

Sprague-Dawley rat (753-A-OH) 98.91 >2,000 Slope = NA Practically

non-toxic 47614936 Acceptable

a MRID 47614930 - acute oral toxicity study using female Sprague-Dawley rats

b MRID 47614931 - acute oral toxicity study using male Sprague-Dawley rats

Table E.6. Toxicity to Earthworms
Test Species /

Test Substance Purity (%) Endpoint Effect MRID Study

Classification

Earthworm Eisenia fetida

DM-PCA 99.87 14-day LC 50 >1000 mg/kg d.w. soil Slope = NA No effect 47615021 Supplemental (non-guideline study)

Earthworm Eisenia fetida

PCA 99.1 14-day LC 50 >1000 mg/kg d.w. soil Slope = NA No effect 47615022 Supplemental (non-guideline study)

Earthworm Eisenia fetida

PAM 99.7 14-day LC 50 >1000 mg/kg d.w. soil Slope = NA No effect 47615023 Supplemental (non-guideline study)

Earthworm Eisenia fetida

DM-PCA 99.87 NOAEC = 48 mg/kg d.w. soil LOAEC > 48 mg/kg d.w. soil No effect 47615025 Supplemental (non-guideline study)

Earthworm Eisenia fetida

PCA 99.1 NOAEC = 50 mg/kg d.w. soil LOAEC > 50 mg/kg d.w. soil No effects 47615026 Supplemental (non-guideline study)

Earthworm Eisenia fetida

PAM 99.7 NOAEC ≥ 50 mg a.i./kg d.w. soil LOAEC > 50 mg a.i./kg d.w. soil No effects 47615027 Supplemental (non-guideline study)140 

### Appendix F. Comparison of Treori s Formulation and the Chlorothalonil Active Ingredient (TGAI) Toxicity.

Table F.1. Comparison of Chlorothalonil Toxi city (Treoris formulated product and TGAI)

Taxa (Study) Test Species Test Substance (Flow-through/Static) Endpoint (95% C.I.) (μg a.i./L, mean-measured) 1 MRID

Freshwater

Fish (Acute) Rainbow Trout Treoris * 96-hr LC 50 = 25.4 μg a.i./L (95% CI 11.6-51.1 μg a.i./L) 47737323

Rainbow Trout Chlorothalonil TGAI LC 50 = 10.5 μg a.i./L Davies &

White (1985) 2

Freshwater

Invertebrates (Acute) Daphnia magna Treoris * 48-hr EC 50 = 45 μg a.i./L (95% CI 29.2-62.7 μg a.i./L) 47737324

Daphnia magna Chlorothalonil TGAI 48-hr EC 50 = 54 μg a.i./L 45710221

NonVascular Aquatic plants (Acute) Freshwater green algae

Pseudokirchneriella subcapitata Treoris * 72-hr EC 50 = 170 μg a.i./L (95% CI 130-220 μg a.i./L)

NOAEC = 105 μg a.i./L

EC 05 = 65 μg a.i./L (Initial-measured) 47737325

Green Alga ( Selenastrum capricornutum ) Chlorothalonil TGAI EC 50 = 6.8 μg a.i./L

5-day EC 50 = 190 μg a.i./L 5-day NOAEC = 50 μg a.i./L Mezcua et
al ., 2002 3

42432801 Honeybee (Acute Contact) Apis mellifera Treoris * 48-hr LD 50 >22.8 μg

chlorothalonil a.i./bee 47737326

Apis mellifera Chlorothalonil TGAI 48-hr LD 50 > 181 μg/bee 00077759

* Treoris is a co-formulaiton of penthiopyrad (8.91% a.i.) and chlorothalonil (22.3% a.i.); in the reported toxicity studies (rainbow trout, daphnia , green algae, and honeybee, the chemical analysis indicat ed that chlorothalonil was

22.8% a.i. within the Treoris formulation.

1 In terms of the chlorothalonil active ingredient for the Treoris formulation that is co-formulated with penthiopyrad; Treoris formulated product cont ains 22.3% chlorothalonil.

2 Davies PE; White RWG. 1985. The Toxicology and Metabolism of Chlorothalonil in Fish. I. Lethal Levels for Salmo gairdneri, Galaxias maculates, G. truttaceus and G. auratus and the Fate of 14C-TCIN in S. gairdneri

. Aquat

Toxicol 7(1/2):93-105.

3 Mezcua, M., Hernando, M.D., Piedra, L., Aguera, A., Fernandez-Alba, A.R. 2002. Chromatogrophy-Mass Spectometry and Toxicity Evaluation of Selected Contaminants in Seawater. Chromatographia 56(3/4):199-205.141 

### Appendix G. Provisional Tier I Cranberry Model Equations.

The Provisional Cranberry Model is a re finement of the Tier I Rice Model v1.0 (Equations 1 and 2), which is a simple equilibriu m partitioning equation that calculates a single, screening-level concentr ation in rice paddy water and releas ed tailwater based on a compound’s application rate and soil mobility.

Equations 1-2: Tier I Rice Model v1.0 (USEPA, 2007b).



#  

d b sed sed w ai

w 

### K d d m C
  3 2

0 

### 10 ' 10

 

###    (1)

and, if appropriate:

OC d 

### K K 01

. 0  (2)

where,

C w0 = initial water concentration [μg/L]

m ai ' = mass applied per unit area [kg/ha]

K d = water-sediment partitioning coefficient [L/kg]

K OC = organic carbon partitioning coefficient [L/kg]

d

w = water column depth = 0.10 m

d sed = sediment depth = 0.01 m

θ sed = porosity of sediment = 0.509

ρ b = bulk density of sediment = 1300 kg/m 3

First, the Tier I Rice Model was provisionally modified (Equation 3) to include as inputs degradation rate constants in or der to estimate single, screenin g-level concentr ations in paddy water at a given time after application.

Equation 3: Provisional Modi fied Rice Model (Jones, 2006).

d kt

ai

w 

### K e m C 00013

. 0 00105

. 0 '

   (3)

where,

C

w = water concentration [μg/L] t = interval since last application [d] k = upper 90 th percentile of aerobic aquatic me tabolism study rate constants [1/d]

Then, the provisional Modified Rice Model water column depth was lengthened to a depth that is used to flood cranberry bogs ( i.e. , 12 inches; Cape Cod Cranberry Growers Association, 2001).142 i.e.

, d

w = water column depth = 0.305 m

In order to model degradation prior to the flood at harvest, the a pplication rates for n number of pre-harvest applica tions were independently degrad ed over the interim until flooding and then summed (Equation 4).

Equation 4: Degradation in a Dry Bog.



# 

 

###   n
t k

n ai ai n 

### e m m

1 2 

### ' ' (4)

where,

m ai ' = mass per unit area at flood [kg/ha]

m ai '

n = mass applied per unit area on the n th application [kg/ha]

k 2 = upper 90 th percentile of aerobic soil meta bolism study rate constants [1/d]

t n = interval from the n th application to harvest [d] n = number of pre- harvest applications

These four equations and parameter sets c onstitute the provisi onal Tier I Cranberry Model (Equations 1-4).143 Equations 2, 4, and 5: Provisional Tier I Cranberry Model.



# 

 

###   n
t k

n ai ai n 

### e m m

1 2 

### ' ' (4)

where,

m ai ' = mass per unit area at flood [kg/ha]

m ai '

n = mass applied per unit area on the n th application [kg/ha]

k 2 = upper 90 th percentile of aerobic soil meta bolism study rate constants [1/d]

t n = interval from the n th application to harvest [d] n = number of pre- harvest applications

followed by:



#  

d b sed sed w kt

ai

w 

### K d d e m C
  3 2



### 10 ' 10

 



###    (5)

and, if appropriate:

OC d 

### K K 01

. 0  (2)

where,

C

w = water concentration [μg/L] t = interval since flood [d] k = upper 90 th percentile of aerobic aquatic me tabolism study rate constants [1/d]

K d = water-sediment partitioning coefficient [L/kg]

K OC = organic carbon partitioning coefficient [L/kg]

d

w = water column depth = 0.305 m

d sed = sediment depth = 0.01 m

θ sed = porosity of sediment = 0.509

ρ b = bulk density of sediment = 1300 kg/m 3144Appendix H. Submitted Ecological Effects Studies for Penthiopyrad and Analysis of Data Gaps.Table H.1. Submitted Ecological Effects Studies for Penthiopyrad and whether Additional Data are Necessary.OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeed850.1010Daphnid AcuteToxicity47614996 Although no precipitate was observed in the study, thethree highest test concentrations were above the watersolubility limit of the test item (1375g a.i./L).AcceptableYes --47615226 Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the testsubstance; there were noissues with the study.Acceptable47615227 Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. The lowerbound confidence interval for the EC50 was below thelowest concentration tested; in addition 100% of treateddaphnids displayed lethargy (the sublethal effect observed)in all test concentrations except the highest level wherethere was complete mortality. It was concluded that theselection of the test concentrations were not appropriateand could not accurately quantify the risk of thepenthiopyrad SC formulation toDaphnia. The study cannotbe upgraded.Supplemental47615228 Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Testorganisms were fed during the study, and that is considereda guideline deviation. In addition, the sublethal effectobserved was lethargy, which was 100% in the threehighest treatment levels, and 65% in the lowest treatmentlevel Therefore, it was concluded that the selection of thetest concentrations were not appropriate and could notaccurately quantify the risk of the penthiopyrad SCformulation toDaphnia. The study cannot be upgraded.Supplemental145OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeed47615229 Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Testorganisms were fed during the study, and were also olderthan recommended in the guideline; both are considered tobe guideline deviations. Neonates are considered a moresensitive life stage for Daphnia magna than 14/28 dayadults, and therefore, the relevance of the study is limited.The study cannot be upgraded.Supplemental47615336 Penthiopyrad Emulsifiable Concentrate (EC) Formulation(DPX-LEM17 20EC) was the testsubstance; there were noissues with the study.Acceptable47737324 Multi-Active Ingredient (Chlorothalonil/ Penthiopyrad;250g/L:100g/L) Suspension Concentrate (SC) Formulation(DPX-QFA61 SC) was the test substance; there were noissues with the study.Acceptable47615234 Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Controlmortality was 20% in this study, exceeding the 10%maximum acceptable control mortality. There alsoappeared to be issues with solubility at the highest testlevel, as the test solution appeared cloudy white with asurface film, without reportof centrifugation prior toanalysis.Invalid47615235 Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. A precipitatewas observed in the two highest test concentrations, and thetest material was not centrifuged prior to being measured.Failure to centrifuge is an important flaw in the studydesign, and it raises the concern of potentiallyunderestimating the toxicity of the penthiopyrad SCformulation.Invalid146OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeed850.1025Oyster AcuteToxicity Test47615033 None AcceptableNoAn acute toxicitystudy with the SC(Fontelis)formulation isneeded forestuarine/marineinvertebrates.47615233Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Wheneverthere is a precipitate observed or if any treatmentconcentration is at or near the solubility limit,centrifugation is needed to ensure that measuredconcentrations are of the soluble concentration of the activeingredient and not total (solid + soluble). However in thisstudy samples were not centrifuged, which raises a concernthat samples do not represent only soluble penthiopyradconcentrations. Due to the high Kow(log =4.6) ofpenthiopyrad there is concern about the sorption of thechemical to any organic matterpresent in the test water.The failure to centrifuge the concentrations prior tomeasurement is an important flaw in the study design, andit impacts the reliability of this study.Invalid850.1035Mysid AcuteToxicity47615032 None AcceptableNoAn acute toxicitystudy with the SC(Fontelis)formulation isneeded forestuarine/marineinvertebrates.47615231Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. At testinitiation the solutions of the highest two test levels (2500and 5000 μg a.i./L) were cloudy white, with a precipitate onthe surface, and all other test solutions appeared clear andcolourless. At test termination however, all solutionsappeared the same as beforewith the addition of a whiteprecipitate on the surface ofthe 1300, 2500,and 5000 μga.i./L test solutions. Test samples were not centrifuged,which raises a concern that samples do not represent onlysoluble penthiopyrad concentrations. Due to the high Kow(log =4.6) of penthiopyrad there is concern about thesorption of the chemical toany organic matter present inthe test water. The failure to centrifuge the concentrationsprior to measurement is animportant flaw in the studydesign, and it impacts the reliability of this study.Invalid147OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeed850.1075Fish AcuteToxicity47614984Penthiopyrad was not stable under static conditions in the38 to 300 μg a.i./L nominal treatment levels. The measuredconcentrations at 96 hrs in these treatments were 77.0% to79.9%, of measured concentrations at test initiation. Theeffect of the observed instability at the lower concentrationsis not considered to have impact on the study outcome.AcceptableYes;however notforestuarine/marinefishAn acute toxicitystudy with the SC(Fontelis)formulation isneeded forestuarine/marinefish.47614986No measurements or details of the renewal of the testsubstance in the diluter stock solution were reported.Without information regarding the dilutor stock, it is notpossible to verify the stability of penthiopyradconcentrations over time. The study is upgradeablewithdocumentation showing additional penthiopyradmeasurements during the study that verify stablepenthiopyrad concentrations or measurements of the testsubstance in the diluter stock solution that verifies stablepenthiopyrad concentrations or details of renewal of the testsubstance in the diluter stock solutions. This study isupgradeable.Supplemental47614987The study cannot be upgraded, as the test material was notcentrifuged prior to being measured. This raises a concernthat samples do not represent only the soluble penthiopyradconcentrations.Invalid47614988Although there was some uncertainty associated with thelack of measurement of test concentrations at test materialrenewal, there were three measurements of the testconcentrations and so there is some confidence in themean-measured concentrations. In addition, all themeasured concentrations werewell within 20% of meanmeasured concentrations for all but the second lowest testconcentration.Acceptable148OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeed47615034Although there was some uncertainty associated with thelack of measurement of test concentrations at test materialrenewal, there were three measurements of the testconcentrations and so there is some confidence in themean-measured concentrations. In addition, all themeasured concentrations were within 20% of nominalconcentrations for all but the highest test concentration.Acceptable47615225Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the testsubstance; there were noissues with the study.Acceptable47615232Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Test sampleswere not centrifuged; they instead were mixed with a topdown mixer, which raises a concern that samples do notrepresent only soluble penthiopyrad concentrations. Thisstudy does not satisfy data requirement and it cannot beupgraded.Supplemental47615335Penthiopyrad Emulsifiable Concentrate (EC) Formulation(DPX-LEM17 20EC) was the testsubstance; there were noissues with the study.Acceptable47737323Multi-Active Ingredient (Chlorothalonil/ Penthiopyrad;250g/L:100g/L) Suspension Concentrate (SC) Formulation(DPX-QFA61 SC) was the test substance. Fish were notexposed to stable formulation concentrations throughoutthe exposure duration of the test as both penthiopyrad andchlorothalonil were not stable under the static testconditions. Chlorothalonil concentrations at 96 hoursranged from 23 to 76% of initial test levels andpenthiopyrad concentrations ranged from 23 to 94% ofinitial test levels. This study may be used to satisfy datarequirement.Supplemental149OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeed850.1300 Life-CycleToxicity Daphnid47615003 None AcceptableYes --47615236Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the testsubstance; there were noissues with the study.Acceptable850.1400 Fish Early LifeStage Toxicity47614994 None Acceptable Yes --850.2100Avian Acute OralToxicity47614977 None AcceptableNoPasserine study isconsidered a datagap. However, anew study was notrequested due toissues withregurgitation. Asubacute-dietarystudy isrecommendedinstead.47614978Significant regurgitation of the test material (≥30% of birdsat≥156 mg a.i./kg bw levels), as a result an LD50could notbe calculated. However, the observed regurgitation wasdetermined to be a toxic effect related to chemicalexposure, therefore, an effect dose (ED50) was calculatedusing regurgitation as the observed effect forcharacterization purposes only. This study does not satisfythe data requirement; and the study cannot be upgraded.Supplemental47615249Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the testsubstance; there were noissues with the study.Acceptable850.2200Avian Sub-acuteDietary Toxicity47614979 None AcceptableYes**Yes, a subacutedietary study with apasserine species.47614981NoneAcceptable850.2300AvianReproduction47614982The control mortality in this study (12.5%; 3 females and 1male out of 16 pairs) exceededthe limit for an acceptablestudy. The effects that were seen in the necropsies of thedead control birds raise concerns relating to potentialimpacts on reproduction of the other control birds, resultingin an overall decreased eggs laidmean for the control birds.As a result, risk may potentially be underestimated. Thisstudy does not satisfy data requirement; it will not be usedquantitatively in the risk assessment, and the study cannotbe upgraded.SupplementalNoA bobwhite quailreproduction studyis needed to fulfillthe datarequirement.47614983 None Acceptable150OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeed850.3020Honeybee AcuteContact Toxicity47615017A negative control was not tested concurrently with thesolvent control during this study. This study does notsatisfy data requirement and it cannot be upgraded.SupplementalNoAn acute contacttoxicity study isneeded for thepenthiopyradtechnical activeingredient.47615237 None Acceptable47615337 None Acceptable47737326 None Acceptable850.4100Terrestrial PlantToxicity(SeedlingEmergence)47615037It was noted that definitive NOAECs were not obtained forryegrass, sugarbeet, wheat, and tomato, as these speciesexhibited statistically significant reductions at the limitconcentration relative to the negative control (and/or pooledor formulation controls), therefore, Tier II toxicity studieswill be required for these species.AcceptableNoA Tier II seedlingemergence toxicitytest is needed forryegrass, sugarbeet,wheat, and tomato.850.4150Terrestrial PlantToxicity(Vegetative Vigor)47615038It was noted that definitive NOAEC’s were not obtained forwheat, and soybean, as these species exhibited statisticallysignificant reductions at the limit concentration relative tothe negative control (and/or pooled or formulationcontrols), therefore, Tier II toxicity studies will be requiredfor these species.AcceptableNoA Tier II vegetativevigor toxicity testis needed for wheatand soybean.850.4400Aquatic PlantToxicity TestusingLemna47615015 None Acceptable Yes --850.5400Algal ToxicityTest47615004 The test was only conducted for 72 hours, and OCSPP(form. OPPTS) guidelines suggest a testing period of 96hours for algae toxicity studies. This study does not satisfydata requirement and it cannot be upgraded.SupplementalYes47615005 None Acceptable47615006 None Acceptable47615007 None Acceptable47615008 None Acceptable151OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeed47615230Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. The test wasonly conducted for 72 hours, and OCSPP (form. OPPTS)guidelines suggest a testing period of 96 hours for algaetoxicity studies. This study does not satisfy datarequirement and it cannot be upgraded.Supplemental47737325Multi-Active Ingredient (Chlorothalonil/ Penthiopyrad;250g/L:100g/L) Suspension Concentrate (SC) Formulation(DPX-QFA61 SC) was the test substance. The test wasonly conducted for 72 hours, and OCSPP (form. OPPTS)guidelines suggest a testing period of 96 hours for algaetoxicity studies. In addition, algae were not exposed tostable formulation concentrations throughout the exposureduration of the test, although penthiopyrad was consideredto be relatively stable, chlorothalonil and the totalformulation were not stable under the static test conditions.This study does not satisfy data requirement and the studycannot be upgraded.SupplementalNAOECD213None; HoneybeeAcute OralToxicity47615016Non-guideline study; a negative control was not testedconcurrently with the solvent control during this study.SupplementalCan only beconsideredsupplementalinformation foruse by theAgency.--47615237Non-guideline: The results forthe acute oral study can onlybe considered supplemental information for use by theAgency.Supplemental47615337Non-guideline: The results forthe acute oral study can onlybe considered supplemental information for use by theAgency.Supplemental47737326Non-guideline: The results forthe acute oral study can onlybe considered supplemental information for use by theAgency.Supplemental152OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeedNAOECD218ProlongedSediment ToxicitywithChironomusriparius47615014Non-guideline study; According to OECD 218, sedimentshould be sampled from every test concentration analyzedfor concentrations of the testchemical prior to adding testorganisms. This was not provided in the submitted studyreport. The analytical measurements were made only fromthe lowest and the highest test concentrations, and not allsix test concentrations. This study may be used to fulfil thedata requirement.Supplemental Yes --NANone; BeneficialInsects - Effectson the ParasiticWasp47615018Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Nonguideline study; Testing for effects on arthropods speciesother than bees was carried out using the formulatedproduct Penthiopyrad 20 SC rather than the activesubstance. In addition, there are no OCSPP guidelines forthe parasitic wasp, and therefore the results for the studycan only be considered supplemental information for use bythe Agency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--47615239Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Nonguideline study; there are no OCSPP guidelines for a rateresponse laboratory test for the parasitic wasp, andtherefore the results for the study can only be consideredsupplemental information for use by the Agency.Supplemental47615338Penthiopyrad Emulsifiable Concentrate (EC) Formulation(DPX-LEM17 20EC) was the test substance. Nonguideline study; there are no OCSPP guidelines for a rateresponse laboratory test for the parasitic wasp, andtherefore the results for the study can only be consideredsupplemental information for use by the Agency.Supplemental153OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeedNANone; BeneficialInsects - Effectson the PredatoryMite47615019Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Nonguideline study; Testing for effects on arthropods speciesother than bees was carried out using the formulatedproduct Penthiopyrad 20 SC rather than the activesubstance. In addition, there are no OCSPP guidelines forthe predatory mite, and therefore the results for the studycan only be considered supplemental information for use bythe Agency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--47615238Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Nonguideline study; there are no OCSPP guidelines for a rateresponse laboratory test for the predatory mite, andtherefore the results for the study can only be consideredsupplemental information for use by the Agency.Supplemental47615339Penthiopyrad Emulsifiable Concentrate (EC) Formulation(DPX-LEM17 20EC) was the test substance. Nonguideline study; there are no OCSPP guidelines for a rateresponse laboratory test for the predatory mite, andtherefore the results for the study can only be consideredsupplemental information for use by the Agency.Supplemental47615240Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Nonguideline study; there are no OCSPP guidelines for anextended rate-response laboratory test for the predatorymite, and therefore the results for the study can only beconsidered supplemental information for use by theAgency.Supplemental154OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeed47615340Penthiopyrad Emulsifiable Concentrate (EC) Formulation(DPX-LEM17 20EC) was the test substance. Nonguideline study; there are no OCSPP guidelines for anextended rate-response laboratory test for the predatorymite, and therefore the results for the study can only beconsidered supplemental information for use by theAgency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--NANone; BeneficialInsects - Effectson the PredatoryBug47615241Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Nonguideline study; there are no OCSPP guidelines for anextended rate-response laboratory test for the predatorybug, and therefore the results for the study can only beconsidered supplemental information for use by theAgency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--47615341Penthiopyrad Emulsifiable Concentrate (EC) Formulation(DPX-LEM17 20EC) was the test substance. Nonguideline study; there are no OCSPP guidelines for anextended rate-response laboratory test for the predatorybug, and therefore the results for the study can only beconsidered supplemental information for use by theAgency.SupplementalNANone; BeneficialInsects - Effectson the GreenLacewing47615242Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Nonguideline study; there are no OCSPP guidelines for anextended rate-response laboratory test for the greenlacewing, and therefore the results for the study can only beconsidered supplemental information for use by theAgency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--155OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeed47615342Penthiopyrad Emulsifiable Concentrate (EC) Formulation(DPX-LEM17 20EC) was the test substance. Nonguideline study; there are no OCSPP guidelines for anextended rate-response laboratory test for the greenlacewing, and therefore the results for the study can only beconsidered supplemental information for use by theAgency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--NAOECD207None; AcuteToxicity toEarthworms47615020Non-guideline study; OECD guideline 207 (1984) statesthat the artificial soil test should be carried out undercontinuous light but in this study a photoperiod of 16 hlight: 8 h dark is adopted. This deviation could potentiallyimpact the exposure of earthworms to the test substance. Inaddition, there are no OCSPP guidelines for an acuteearthworm toxicity test, and therefore the results for thestudy can only be considered supplemental information foruse by the Agency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--47615244Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Nonguideline study; there are no OCSPP guidelines for an acuteearthworm toxicity test, and therefore the results for thestudy can only be considered supplemental information foruse by the Agency.SupplementalNANone; SubchronicEarthwormToxicity47615024Non-guideline study; the OCSPP guideline (850.6200) for asubchronic earthworm toxicity test was not used, andtherefore the results for the study can only be consideredsupplemental information for use by the Agency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--47615245Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Nonguideline study; the OCSPP guideline (850.6200) for asubchronic earthworm toxicity test was not used, andtherefore the results for the study can only be consideredsupplemental information for use by the Agency.Supplemental156OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeedNANone; Effects onthe Activity ofSoil Microflora(NitrogenTransformation)47515028Non-guideline study; there are no OCSPP guidelines forassessing the impacts on soil microbial activity, andtherefore the results for the study can only be consideredsupplemental information for use by the Agency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--47615246Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Nonguideline study; there are no OCSPP guidelines forassessing the impacts on soil microbial activity, andtherefore the results for the study can only be consideredsupplemental information for use by the Agency.Supplemental47615343Penthiopyrad Emulsifiable Concentrate (EC) Formulation(DPX-LEM17 20EC) was the test substance. Nonguideline study; there are no OCSPP guidelines forassessing the impacts on soil microbial activity, andtherefore the results for the study can only be consideredsupplemental information for use by the Agency.SupplementalNANone; Effects onthe Breakdown ofOrganic Matter inLitter Bags47615035&47615041Non-guideline study; there are no OCSPP guidelines forassessing the effects on the breakdown of organic matter inlitter bags in the field, and therefore the results for the studycan only be considered supplemental information for use bythe Agency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--NANone; Effects onMicroorganismswith SludgeRespirationInhibition Test(BiologicalMethods forSewageTreatment)47615039Non-guideline study; there are no OCSPP guidelines forassessing the effects on biological methods for sewagetreatment, and therefore the results for the study can onlybe considered supplemental information for use by theAgency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--157OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeedNANone; Field Studyto Evaluate Effectson PredatoryMites47615243Penthiopyrad Suspension Concentrate (SC) Formulation(DPX-LEM17 20SC) was the test substance. Nonguideline study; there are no OCSPP guidelines for fieldstudies on predatory mites, and therefore the results for thestudy can only be considered supplemental information foruse by the Agency.SupplementalYes; consideredsupplementalinformation foruse by theAgency.--Table H.2. Submitted Ecological Effects Studies for Degradates of Penthiopyradand whether Additional Data are Necessary.OCSPPGuidelineDataRequirementSubmittedStudies (MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?Current AdditionalData Need850.1010Daphnid AcuteToxicity47614997DM-PCA was the test substance. Although, the particulatematter, dissolved and total organic carbon (DOC/TOC)content of dilution water were not reported, the DM-PCAmetabolite of penthiopyrad ishighly soluble (8240 mg/L).Therefore, the absence of this information (particulatematter and DOC/TOC) does not impact the toxicity resultsseen for the metabolite, and it was determined that thevalidity of the study was not impacted by these deficiencies.AcceptableYes --47614998PCA was the test substance. Although, the particulatematter, dissolved and total organic carbon (DOC/TOC)content of dilution water were not reported, the PCAmetabolite of penthiopyrad ishighly soluble (1.2 g/L).Therefore, the absence of this information (particulatematter and DOC/TOC) does not impact the toxicity resultsseen for the metabolite, and it was determined that thevalidity of the study was not impacted by these deficiencies.Acceptable158OCSPPGuidelineDataRequirementSubmittedStudies (MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?Current AdditionalData Need47614999PAM was the test substance. Although, the particulatematter, dissolved and total organic carbon (DOC/TOC)content of dilution water were not reported, the PAMmetabolite of penthiopyrad ishighly soluble (>100 mg/L).Therefore, the absence of this information (particulatematter and DOC/TOC) does not impact the toxicity resultsseen for the metabolite, and it was determined that thevalidity of the study was not impacted by these deficiencies.Acceptable47615001 753-A-OH was the test substance. There were no issues. Acceptable47615002753-T-DO was the test substance. There is uncertainty inthe representation of the soluble exposure concentration atthe highest treatment level since there was a rank orderreversal in the mean-measuredsoluble concentrations of753-T-DO between the highest and second highesttreatment levels, as compared to the nominal and noncentrifuged mean-measured concentrations. This study doesnot satisfy data requirement and the study cannot beupgradedSupplemental Yes --850.1075Fish AcuteToxicity47614989DM-PCA was the test substance. The particulate matter anddissolved or total organic carbon (DOC/TOC) content of thedilution water were not reported and these constituentswhen above guideline standards can result in theunderestimation of toxicity as compared to standard testconditions. However, the DM-PCA metabolite ishighlysoluble (8240 mg/L), and the absence of the informationregarding the concentration of particulate matter andDOC/TOC would not impact the toxicity results seen forthe metabolite.Acceptable Yes --159OCSPPGuidelineDataRequirementSubmittedStudies (MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?Current AdditionalData Need47614990PCA was the test substance. The particulate matter anddissolved or total organic carbon (DOC/TOC) content of thedilution water were not reported and these constituentswhen above guideline standards can result in theunderestimation of toxicity as compared to standard testconditions. However, the PCA metabolite ishighly soluble(1.2 g/L), and the absence of the information regarding theconcentration of particulate matter and DOC/TOC wouldnot impact the toxicity results seen for the metabolite.Acceptable47614991 PAM was the test substance.There were no issues. Acceptable47614992 753-A-OH was the test substance. There were no issues. Acceptable47614993753-T-DO was the test substance. There is uncertainty inthe representation of the exposure concentration at thehighest treatment level, as a precipitate was present at testinitiation and for the duration of the test, and the 753-T-DOsoluble concentration was not stable over the exposureperiod in the highest treatment. Although this study issupplemental, it can be used to satisfy the data requirement.Supplemental Yes --850.5400Algal ToxicityTest47615009DM-PCA was the test substance. The source and type ofwater used to prepare the test medium was not reported.This is considered a deviation from the OECD guideline201 and OCSPP (form. OPPTS) guideline 850.5400. Inaddition, the pH ranged from 7.05 to 9.86, which is well inexcess of the 1.5 units allowed under OECD Guideline 201.Australia’s (APVMA) experience finds that this often foundas it is caused by the CO2consumption of the algae due totheir rapid growth or their high densities. However, thesedeviations are not expected to impact the validity of thisstudy or the reliability of the results.Acceptable Yes--160OCSPPGuidelineDataRequirementSubmittedStudies (MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?Current AdditionalData Need47615010PCA was the test substance. It is a deviation from theOECD guideline to use purified water instead of deionizedor distilled water. In addition, the pH ranged from 6.1 to8.4 at test initiation; 6.5 to 9.6 at test termination, which iswell in excess of the 1.5 units allowed under OECDGuideline 201. Australia’s (APVMA) experience finds thatthis often found as it is caused by the CO2consumption ofthe algae due to their rapid growth or their high densities.However, these deviations arenot expected to impact thevalidity of this study or the reliability of the results.Acceptable47615011PAM was the test substance. The test was only conductedfor 72 hours, and OCSPP (form. OPPTS) guidelines suggesta testing period of 96 hours for algae toxicity studies. Thisstudy does not satisfy data requirement and it cannot beupgraded.Supplemental47615012753-A-OH was the test substance.It is a deviation from theOECD guideline to use purified water instead of deionizedor distilled water. In addition, the OECD 201 guidelinestates that test item results should be compared to solventcontrols. However, these deviations are not expected toimpact the validity of this study or the reliability of theresults, as the results for the control organisms were withinthe expected range.Acceptable Yes --161OCSPPGuidelineDataRequirementSubmittedStudies (MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?Current AdditionalData Need47615013753-T-DO was the test substance. Significant differencesbetween the solvent control and negative control suggest apossible inhibitory effect of the solvent. However, since testitem results have been compare to negative controls theendpoints were considered conservative. Given the lowrecovery of the test item by the end of the study (below theLOQ, 300 μg/L), OECD 201 indicates that results based oninitial measured concentrations may not be appropriate. Inaddition, there is evidence of decreasing growth inhibitionover time as concentrations decline and therefore the use ofinitial measured values in CRD, PMRA, or APVMA riskassessments would not be considered appropriate.However, based on EPA guidance the initial measuredconcentrations should be usedin cases of significant loss ofthe chemical, in addition, EPA guidance compares thetreatment group(s) to the negative control. Due to theuncertainty in the representation of the soluble exposureconcentration that the test organisms were exposed to forthe duration of the test, the reliability of the results wasimpacted. This study does not satisfy data requirement andit cannot be upgraded.Supplemental Yes --NAOECD207None; AcuteToxicity toEarthworms47615021DM-PCA was the test substance. Non-guideline study;OECD guideline 207 (1984) states that the artificial soil testshould be carried out under continuous light but in thisstudy a photoperiod of 16 h light: 8 h dark is adopted. Thisdeviation could potentially impact the exposure ofearthworms to the test substance. In addition, there are noOCSPP guidelines for an acuteearthworm toxicity test, andtherefore the results for the study can only be consideredsupplemental information for use by the Agency.SupplementalYes;consideredsupplementalinformationfor use by theAgency.--47615022PCA was the test substance. Non-guideline study; there areno OCSPP guidelines for an acute earthworm toxicity test,and therefore the results for the study can only beconsidered supplemental information for use by theAgency.Supplemental162OCSPPGuidelineDataRequirementSubmittedStudies (MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?Current AdditionalData Need47615023PAM was the test substance. Non-guideline study; there areno OCSPP guidelines for an acute earthworm toxicity test,and therefore the results for the study can only beconsidered supplemental information for use by theAgency.SupplementalNASubchronicEarthwormToxicity47615025DM-PCA was the test substance. Non-guideline study; theOCSPP guideline (850.6200)for a subchronic earthwormtoxicity test was not used, and therefore the results for thestudy can only be considered supplemental information foruse by the Agency.SupplementalYes;consideredsupplementalinformationfor use by theAgency.--47615026PCA was the test substance. Non-guideline study; theOCSPP guideline (850.6200)for a subchronic earthwormtoxicity test was not used, and therefore the results for thestudy can only be considered supplemental information foruse by the Agency.Supplemental47615027PAM was the test substance. Non-guideline study; theOCSPP guideline (850.6200)for a subchronic earthwormtoxicity test was not used, and therefore the results for thestudy can only be considered supplemental information foruse by the Agency.SupplementalNAEffects on theActivity of SoilMicroflora(NitrogenTransformation)47515029DM-PCA was the test substance. Non-guideline study;there are no OCSPP guidelines for assessing the impacts onsoil microbial activity, and therefore the results for thestudy can only be considered supplemental information foruse by the Agency.SupplementalYes;consideredsupplementalinformationfor use by theAgency.--47615030PCA was the test substance. Non-guideline study; there areno OCSPP guidelines for assessing the impacts on soilmicrobial activity, and therefore the results for the study canonly be considered supplemental information for use by theAgency.Supplemental163OCSPPGuidelineDataRequirementSubmittedStudies (MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?Current AdditionalData Need47615031PAM was the test substance. Non-guideline study; there areno OCSPP guidelines for assessing the impacts on soilmicrobial activity, and therefore the results for the study canonly be considered supplemental information for use by theAgency.SupplementalNANone; Effectson theBreakdown ofOrganic Matterin Litter Bags47615036DM-PCA was the test substance. Non-guideline study;there are no OCSPP guidelines for assessing the effects onthe breakdown of organic matter in litter bags in the field,and therefore the results for the study can only beconsidered supplemental information for use by theAgency.SupplementalYes;consideredsupplementalinformationfor use by theAgency.--164Appendix I. Submitted Environmental Fate Studies for Penthiopyrad.Table I.1. Submitted Environmental Fate Studies for Penthiopyrad and Whether Additional Data are Necessary.OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?Current AdditionalData Need835.2120 Hydrolysis 47614837 Test concentrations may have exceeded the aqueoussolubility of the test compound.Acceptable Yes --835.2240 Aqueousphotolysis47614839 None. Acceptable Yes --835.2410 Soil photolysis 47614965 Mixed radiolabels were used in the test systems. Also,the extraction procedure was not considered exhaustive(and up to 12.3-24.6%AR was unextracted).Supplemental Yes --835.4100 Aerobic soilmetabolism47614959 Studies of Soils I and IV were terminated before thefirst DT50 of the test compound had passed. Also, theextraction procedure was not considered exhaustive(and up to 39.9%AR was unextracted).Supplemental Yes --47614961 Only one soil was studied. The extraction procedurewas not considered exhaustive (and up to 36.5%AR wasunextracted).Supplemental47614963 Only one soil was studied. The extraction procedurewas not considered exhaustive (and up to 26.8%AR wasunextracted). Also, the taxonomy of the test soil, whichmay have been a volcanic soil, was not reported.Supplemental835.4200Anaerobic soilmetabolism47614964 The extraction procedure was not considered exhaustive(and up to 33.2%AR was unextracted).Supplemental Yes --835.4300 Aerobic aquaticmetabolism47614975 The studies were terminated before the first DT50 of thetest compound had passed.Supplemental Yes --835.4400 Anaerobic aquaticmetabolism47614976 One test system was studied rather than two. Supplemental Yes --165OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?Current AdditionalData Need835.1230 Batch equilibrium 47614967 It is not clear which reported values are raw versuscalculated values. And study calculations, such as themass of test item sorbed to soil at equilibrium, were notdescribed and demonstrated. Therefore, calculatedsorption parameters could not be confirmed using theraw data. Also, at least one soil should have had anorganic matter content less than 1%.Supplemental Yes --835.6100 Terrestrial fielddissipation47615162 None. Acceptable Yes --47615163 None. Acceptable47615164 None. Acceptable47615165 Some intervals were not analyzed to a depth of noresidue detection.Acceptable47615166 Some intervals were not analyzed to a depth of noresidue detection.Also, full soil taxonomicclassifications were not provided.Acceptable47615167 Some intervals were not analyzed to a depth of noresidue detection.Also, full soil taxonomicclassifications were not provided.Acceptable47615172 Some intervals were not analyzed to a depth of noresidue detection.Acceptable47615173 Some intervals were not analyzed to a depth of noresidue detection.AcceptableStorage stability 47615161None. Acceptable Yes --Analytical methodin soil47615105/47614867None. Acceptable Yes --Analytical methodin water47614868/47614869The ECM is acceptable for surface water and groundwater with an LOQ below toxicological LOCs for theresidues of concern (withthe exception that 753-F-DOis not an analyte). The ECM is unacceptable fordrinking water due to lack of independent validation.Acceptable Yes --Analytical methodin air47614870 Air ECM lacks an independent validation report. Unacceptable& upgradeableYes --166OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?Current AdditionalData Need165-4(850.1730)Fishbioaccumulation47614995 TOC concentrations were high in the test systems anduntreated water.Supplemental Yes --835.3110 Readybiodegradability47614974 None. Acceptable Yes --Table I.2. Submitted Environmental Fate Studies for Degradatesof Penthiopyrad and Whether Additional Data are Needed.OCSPPGuidelineDataRequirementSubmittedStudies(MRID)Study IssuesReviewClassificationSufficient forRiskAssessment?CurrentAdditional DataNeed835.4100 Aerobic soilmetabolism47614966 DM-PCA was the testsubstance. Acceptable Yes --835.1230835.1240Batch equilibrium 47614966 DM-PCA was the test substance. Acceptable47614968 PCA was the test substance. An HPLC method was used. Andthe log Koc for PCA fell outside of the range of the referenceitems used in this study, as did the retention time of PCA.Unacceptable47614969 PCA was the test substance.It is questionable whetherequilibrium was reached after 4 hours and whether it is a validapproach to use data from a soil that is has been discounteddue to anomalous results, to establish the equilibrium time.Unacceptable47614971 PAM was the test substance. At least one soil should have hadan organic matter content less than 1%.Acceptable47614972 753-A-OH was the test substance. At least one soil shouldhave had an organic matter content less than 1%.Acceptable47614973 753-T-DO was the test substance. At least one soil should havehad an organic matter content less than 1%.Acceptable