### 1 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

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

Date: October 29, 2014 PC Code: 128008 MEMORANDUM DP Barcode: D418672

SUBJECT: Registration Review: Draft Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Boscalid

FROM: Catherine Aubee, Biologist Katrina White, Ph.D., Environmental Toxicologist Environmental Risk Branch IV Environmental Fate and Effects Division (7507P)

REVIEWED BY: Thomas Steeger, Ph.D., Senior Science Advisor Jim Carleton, Ph.D., Senior Fate Scientist Environmental Risk Branch IV Environmental Fate and Effects Division (7507P)

THROUGH: Thomas Steeger, Ph.D., Acting Branch Chief Environmental Risk Branch IV Environmental Fate and Effects Division (7507P)

TO: Maria Piansay, Chemical Review Manager Jill Bloom, Team Leader Linda Arrington, Branch Chief Risk Management and Implementation Branch V Pesticide Re-Evaluation Division (7508P) Steeger, Thomas Digitally signed by Steeger, Thomas DN: cn=Steeger, Thomas, email=steeger.thomas@epa.gov Date: 2014.10.30 11:11:54 -04'00'

Steeger, Thomas Digitally signed by Steeger, Thomas DN: cn=Steeger, Thomas, email=steeger.thomas@epa.gov Date: 2014.10.30 11:12:34 -04'00' Steeger, Thomas Digitally signed by Steeger, Thomas DN: cn=Steeger, Thomas, email=steeger.thomas@epa.gov Date: 2014.10.30 11:13:13 -04'00' 2014.10.30 11:18:03 -04'00'

Digitally signed by Jim Carleton DN: cn=Jim Carleton, o=EPA/OPP, ou=EFED/ERBIV, email=carleton.jim@epa.gov, c=US Date: 2014.10.30 12:16:28 -04'00'

### 2 

# Table of Contents

1. Executive Summary ............................................................................................................. ... 2 2. Introduction .................................................................................................................. ........... 4 3. Use Characterization .......................................................................................................... ..... 5 4. Conclusions from Previous Risk Assessments ....................................................................... 7

a. Ecological Risk Assessment ................................................................................................ 7 b. Drinking Water Exposure Assessments ............................................................................... 8

c. Clean Water Act Programs .................................................................................................. 9 5. Environmental Fate and Transport.......................................................................................... 9

a. Transformation Products .................................................................................................... 14 6. Receptors...................................................................................................................... ......... 18

a. Ecological Incidents .......................................................................................................... . 21 7. Exposure Pathways of Concern ............................................................................................ 22 8. Analysis Plan ................................................................................................................. ....... 22

a. Stressors of Concern .......................................................................................................... 23 b. Measures of Exposure ........................................................................................................ 2 3

c. Measures of Effect ............................................................................................................ . 25 9. Endangered Species Assessments ......................................................................................... 26 10. Endocrine Disruptor Screening Program (EDSP).............................................................. 26 11. Preliminary Identification of Data Gaps ............................................................................ 26

a. Environmental Fate ............................................................................................................ 26 b. Effects ....................................................................................................................... ......... 29 12. References .................................................................................................................... ...... 36 Appendix A. Summary of registered products containing boscalid ............................................ 40 Appendix B. Submitted Environmental Fate Studies .................................................................. 42 Appendix C. Submitted Ecological Effects Studies ..................................................................... 50 Appendix D. Screening Tool for Inhalation Risk (v. 1.0) ........................................................... 61 Appendix E. Results from Screening Imbibition Program (SIP) .................................................. 63

1. Executive Summary



### The Environmental Fate and Effects Division (EFED) has completed the draft problem formulation for the ecological risk, environmental fa te, endangered species, and drinking water assessments to be conducted as part of the regist ration review of the fungicide boscalid (PC Code 128008, CAS Number 188425-85-6). The problem formula tion describes the methods to be used during the completion of drinking water and ecological risk assessments in support of registration review and provides an overview of the environmen tal fate, ecological effects, and potential risks associated with the use of boscalid. It describe s uncertainties which may be encountered in the risk assessment and identifies additional studies a nd other information that would be beneficial to its conduct. Below is a summary of data needs and uncertainties.

### 3 x The fate database is incomplete based on the environmental fate data requirements outlined in the Code of Federal Regulations Title 40 Part 158 (40CFR158) Subpart N 1 

### and data are needed to reduce uncertainty in risk assessments. A dditional data on the following fate parameters are recommended. Requested fate studies should be conducted using the technical grade active ingredient (TGAI).

x Anaerobic aquatic metabolism da ta for one sediment (OCSPP 2 

### Guideline 835.4400) 3 

### to reduce uncertainty in whether unextracted residues are an exposure concern;

x Aerobic soil metabolism data to reduce uncertain ty in whether unextracted residues are an exposure concern (OCSPP Guideline 835.4100 4 

### ); and

x Environmental Chemistry Methods (OCSPP Guideline 850.6100 5 

### ) for water, sediment, and soil 6 

### . An Environmental Chemistry Method for soil is needed with an LOQ of 0.02 μ g a.i./kg soil or lower, in anticipation of a possible definitive vegetative vigor toxicity test result for cabbage of as low as 0.00004 lb a.i./A.

x The following ecotoxicity studies are recommended, based on the most current ecological data requirements (40 CFR Part 158.630 7 

### et seq. ) and risk assessment guidance 8 

### :

x Acute toxicity to the waterflea ( Daphnia magna ) (OCSPP Guideline 850.1010) 9 

### ;

x Acute toxicity to the waterflea (OCSPP Guideline 850.1010) using typical end-use products that contain other active ingredients (representative TEPs containing boscalid + pyraclostrobin + lambda -cyhalothrin, boscalid+pyraclostrobin, and boscalid + chlorothalonil);

x Acute toxicity to estuarine/marine mysid shrimp ( Americamysis bahia ) (OCSPP Guideline 850.1035);

x Early life stage toxicity in estuarine/marine fish (OCSPP Guideline 850.1400);

x Chronic toxicity to estuarine/marine invertebrates (OCSPP Guideline 850.1350);

1 CFR. 2013. Title 40 (Protection of the Environment), Chapter 1 (Environmental Protection Agency), Subchapter E (Pesticide Prog rams), Part 158 (Data Requirements for Pesticides), Subpart N (Environmental Fate) http://www.ecfr.gov/cgi-bin/textidx?c=ecfr&SID=ff5c7fef3645e7cd5abceca0b597bccb&tpl=/ecfrbrowse/Title40/40cfr158_main_02.tpl

2 The Series 835 Fate Guidelines were completed when the Office of Chemical Safety and Pollution Prevention (OCSPP) was known as the Office of Prevention, Pesticides, and Toxic Substances (OPPTS).

3 USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.4300 Aerobic Aquatic Metabolism; OPPTS 835.4400 Anaerobic Aquatic Metabolism . EPA 712-C-08-018 & E. 712-C-08-019. October 2008. Office of Prevention, Pesticides, and Toxic Substances. United States Environmental Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.h tm (Accessed August 6, 2014).

4 USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.4100 Aerobic Soil Metabolism; OPPTS 835.4200 Anaerobic Soil Metabolism . EPA712-C-08-016 & E. 712-C-08-017. October 2008. Office of Prevention, Pesticides, and Toxic Substances. U.S. Environmental Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.htm (Accessed August 2 2, 2014).

5 USEPA. 2012. Ecological Effects Test Guidelines. OCSPP 850.6100: Environmental Chemistry Methods . EPA 712-C-001. January 2012. Office of Chemical Safety and Pollution Prevention. U.S. Environmental Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series850.htm (Accessed August 10, 2014).

6 Environmental chemistry methods (ECM) are recommended when there is a potential for a risk concern in an environmental media ( USEPA, 2012b). The limit of quantitation (LOQ) should be low enough to detect concentrations that could result in adverse effects to organisms. Currently, there is a risk concern for terrestrial plants and effects were observed for dicotyledonous plants at the lowest app lication rate tested; therefore additional data are being recommended. If new plant data are submitted and the definitive endpoint results in effect s at an application rate lower than the current LOQ for the ECM for soil, an ECM with a lower LOQ may be needed. However, the current ECM for soil may have a low enough LOQ to cover a new definitive terrestrial plant endpoint. Therefore, an ECM for soils may not be necessary at this time.

7 CFR. 2014. Title 40 (Protection of the Environment), Part 158 (Data Requirements for Pesticides) Subpart G (Ecological Effect s) §158.630 (Terrestrial and aquatic non-target organism data requirements table). http://www.ecfr.gov/cgi-bin/textidx?SID=b89b30110740e33a25b44c51806f0f62&node=40:25.0.1.1.9.7.1.1&rgn=div8 (last accessed 03/26/14).

8 Requested ecotoxicity studies should be conducted using TGAI, unless otherwise indicated.

9 USEPA. 1996. Ecological Effects Test Guidelines OPPTS 850.1010. Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphni ds. EPA 712-C-96.114. April 1996. http://www.epa.gov/opptsmnt/pubs/frs/publications/OPPTS_Harmonized/850_Ecological_Effects_Test_Guidelines/Drafts/850-1010.pdf (last accessed 03/26/14).

### 4 x Fish full-life cycle data with freshwa ter fish (OCSPP Guideline 850.1500; protocol submission recommended);

x Chronic Sediment toxicity data for three species of aquatic invertebrates (protocol submission recommended) 10 

### ; and,

x Tier II terrestrial plant vegetative vigor data (OCSPP Guideline 850.4150) using TEP. The previously submitted study did not yield a definitive endpoint for cabbage.

Additionally, the initial boscalid registration was accompanied by a data call-in for freshwater mollusc toxicity data. These data were not submit ted. In response to a subsequent BASF waiver request (DP Barcode D312672, 2005), EFED noted the following:

... mollusk biology differs greatly from other invertebrates, which precludes the use of nonmolluskan toxicity studies for assessing risks to mollusks. Further supporting concerns for freshwater mollusks is that review of the to xicity test on eastern oysters indicated that effects of boscalid on eastern oysters is li kely biologically significant. These results suggest that risks to freshwater mollusks are possible for some current and proposed uses of boscalid. A study on the toxicity of boscali d to freshwater mollusks would reduce some uncertainty in evaluating risks to freshwater mollusks although, in the absence of data on freshwater mollusks, risks will be assumed fo r instances where RQs exceed the LOC using the eastern oyster toxicity endpoints for future proposed uses of boscalid.

In the absence of toxicity data with a freshwater mollusc species, risk conclusions for estuarine/marine molluscs will continue to apply to freshwater molluscs.

2. Introduction



### Boscalid is a carboxamide fungicide 11 

### that degrades slowly in soil (time to 50% decline, DT 50 

### , ranges from 108 to 578 days) and aquatic systems (DT 50 

### ranges from 385 days to stable). It is practically nontoxic to terrestrial vertebrates and the honey bee ( Apis mellifera ) on an acute exposure basis; it is at least moderately toxic to aquatic organisms on an acute exposure basis at concentrations approaching its water solubility limit. Chronic exposure to animals may reduce growth. Terrestrial plants vary in sensitivity to boscalid exposure, with dicotyledonous (dicot) plants generally being most sensitive to growth inhibition ; a “no observed adverse effect” level (NOAEL) has not been established for this effect in dicot plants.

In fungal cells, the target mode of action is th e inhibition of mitochondrial adenosine triphosphate (ATP) production. Specifically, boscalid inhibits the succinate-ubiquinone oxidoreductase system in Complex III of the mitochondrial electron transf er chain (Wharton, 2010). This mode of action is shared with other pesticide active ingredien ts, including carboxin (CAS Number 5234-68-4) and flutolanil (CAS Number 66332-96-5), and more recently registered compounds such as fluxapyroxad (CAS Number 907204-31-3).

10 40 CFR Part 156.630 does not specify the sediment species that are recommended for testing. Testing on all three species ( Chironomus dilutus
, Hyalella azteca, and Leptocheirus plumulosus) is recommended based on differences in the in life histories (infaunal versus epibenthic) and differences observed in sensitivities of different species for diffe rent chemical classes. A protocol is recommended to be sub mitted for review prior to test initiation.

11 Group 7 according to the classification system of the Fungicide Resistance Action Committee (Fungicide Resistance Action Commi ttee, 2012).

### 5 The use on ornamentals reflects both the maximum single and annual application rates (0.7 lbs a.i./A and 2.1 lbs a.i./A/year, respectively) for use in standard exposure calculations. The use on golf course turf also allows a maximum single a pplication rate of 0.35 lbs a.i./A with a 14-day minimum retreatment interval (MRI) and a maximum annual application of 2.1 lbs a.i./A/year; the turf use has historically resulted in the highes t estimated drinking water concentrations (EDWCs) for human health exposure assessment. For uses where the annual maximum application rate is not specified on the label, or there are multiple crop cycles or rotations or differences in applicator practices, the annual application rate may be higher than rates that have been assumed in prior risk
assessments.

Boscalid was first registered in the United S tates under the synonym, nicobifen; its first risk assessment was completed in 2003 (USEPA, 2003, D278387+ 12 

### ). To determine if additional data are needed to support Registration Review, EFED examined the more recent environmental fate and ecological risk assessments for proposed new uses of boscalid (USEPA, 2010, D363523, 2013, D405817+, 2014c). EFED evaluated the full body of relevant ecotoxicity, environmental exposure, and usage information available to the Agency for boscalid, including ecological incident reports. The latest Agency science policies and risk assessment methodologies were used to inform the analysis plan and data recommendations.

3. Use Characterization



### Most registered boscalid products are water disp ersable granules (dry flowable) which may be applied via aerial spray, chemigation, ground spray, or airblast application. Certain products are designed for handsprayers (water soluble granules), as greenhouse foggers (aerosol), or as seed treatments (flowable concentrate). Terrestr ial food uses of boscalid include artichoke, bulb vegetables, bushberry, caneberry, canola (including rapeseed), carrot (including tops), celery, citrus, crops grown for oil, cucurb it vegetables, dried beans, dried peas, endive, fruiting vegetables, grapes, head and stems brassica, hops, leafy bras sica, leafy greens, lettuce, low growing berries (excluding cranberries), peanuts, persimmon, pome fruit, potato, root vegetables, small fruit and climbing vines (except kiwi), soybeans, spinach, st one fruits, strawberry, subtropical/tropical fruit, succulent beans, succulent peas, sunflower, tomat o, tree nuts, tuberous and corm vegetables, and turnip greens. Boscalid may be used on orn amentals (outdoor residential, greenhouse, and terrestrial non-food uses) and on greenhouse tomato. Boscalid is registered for terrestrial feed (animal) or non-food use on many of these sites and on alfalfa, cotton, legume vegetables, and golf course turf. There are no registered indoor (other than greenhouse and on endive) or aquatic uses for boscalid.

The maximum single and annual application rates for boscalid are as a root treatment for endive (one application at 0.02 lbs a.i./1000 lbs roots prior to cold storage and 0.03 lbs a.i./70 square feet of forcing tray 17.7 lbs a.i./A of forcing tray); however, this is an indoor use 13 

### and has less relevance for calculating field-based EECs. The ne xt-highest single application rates are for ornamentals (0.7 lbs a.i./A) and tomato (0.55 lbs a. i./A). The maximum labeled annual application

12 Throughout this doc ument, a “+” symbol following a Data Package (DP) Barcode indicates that multiple DP Barcodes are associated with that review.

13 Endive is typically grown during the summer for root growth, harvested and put into cold storage until winter. The roots are planted and ‘forced’ to grow new greens (typically in a dark barn). Therefore, this is considered an indoor use.

### 6 rate is 2.1 lbs a.i./A for uses on ornamentals a nd golf course turf (Emerald Fungicide, EPA Reg. No. 7969-196). For uses where the annual maximum application rate is not specified on the label, the occurrence of multiple crop cycles or rotations, or differences in applicator judgment, may result in an annual application rate that is higher than rates that have been assumed in prior risk
assessments.

Boscalid has fifteen active registrations, including one technical grade product. Active registrations are listed in Appendix A . Some boscalid end-use products are co-formulated with one or more additional active ingredients: the strobilurin 14 

### fungicide, pyraclostrobin (CAS Number 175013-18-0), the pyrethroid insecticide lambda -cyhalothrin (CAS Number 91465-08- 6), and the aromatic or chloroni trile fungicide chlorothalonil 15 

### . Similar to boscalid, the strobilurin fungicides also inhibit mitochondrial respiration but through action on a different molecular site (Wharton, 2010).

A Screening Level Usage Analysis (SLUA) was prepared for boscalid in 2014 by the Biological and Economic Analysis Division (BEAD) (USEPA , 2014b). The SLUA summarizes agricultural usage information reported for boscalid during 20 04-2012. These reports indicate that, on average during that time, most boscalid was applied on almonds, grapes, and potatoes (70,000 lbs a.i. each per year). Of these, almonds had the greatest percent crop treated, with an average of 40% and a maximum of 60% of almond crops being treated w ith boscalid among the states surveyed. The percent of crops treated with boscalid was sli ghtly greater for strawberry (average: 60% and maximum: 80% treated with an average of 20,000 lb s a.i./year, in total), cherries (average: 45% and maximum: 70% with 20,000 lbs a.i./year, total) and caneberries (average: 45% and maximum: 60% with 5,000 lbs a.i./year, total).

The chemical profile produced by BEAD discusse s use patterns for the current uses of boscalid (USEPA, 2014a). In the risk assessment, EFED w ill use results from ap plication scenarios that generate maximum exposures for a given, labeled use, unless otherwise specified. Additionally, in order to be protective, EFED will utilize th e use information that results in maximum exposure ( e.g. , concentration) estimates for a gi ven use pattern for the drinking water and ecological risk assessments. If the labels (and consequently the BEAD chemical profile) do not include all information needed to enable estimation of maximal exposures, such as the maximum single application rate, minimum application interval, an nual maximum rate allowed (lbs a.i./ year), and application method, EFED will make conservative assumptions regarding these use parameters.

Some boscalid use patterns are not sufficiently characterized to permit ready calculation of a maximum application rate per acre. More information on the following items would reduce uncertainty regarding such uses in the risk assessment:

x Some labels (Reg. # 7969-197, 7969-199, SD090006) provide a maximum single application rate and a maximum number of applications per crop cycle or season; however, a maximum application rate per acre per year is not provided. It is uncertain whether the chemical may be applied over multiple seasons in the same year fo r these labels. A maximum annual application rate per acre or a maximum number of seasons per ye ar is needed to permit estimation of the

14 Group 11 according to the classification system of the Fungicide Resistance Action Committee (FRAC, 2012).

15 Chlorothalonil has multi-site activity and complexes with sulphhydryl-containing proteins, leading to depletion of glutathione , a nonenzymatic antioxidant critical to the function of several enzymes important in detoxification and cellular respiration (Elskus, 2012).

### 7 maximum amount that may be applied to a given field during one year.

x Some labels do not include a mini mum retreatment interval.

x Some use instructions are provided on a product basis rather than an a.i. basis. Therefore, another product containing boscalid could be applie d to the same use site. EFED recommends that use limitations based on an a.i. basis be included on labels.

4. Conclusions from Previous Risk Assessments



### Previous risk assessments for boscalid have iden tified both acute and chronic risks to federally listed threatened/endangered (“listed”) and non-listed species that exceed Agency levels of concern (LOCs). Generall y, risks from targeted ( e.g ., handheld) and seed treatment applications were determined to result in less exposure poten tial and thus lower risk than the more broad-scale agricultural and turf uses. Risks for indoor uses (greenhouse and endive) are generally addressed qualitatively.

a. Ecological Risk Assessment

Boscalid has the potential to reach surface water and groundwater, and to be transported in air via the vapor phase or on particles in air 16 

### . It has been measured in all of these matrices through monitoring. It is also characterized as persistent to very persistent, and residues are expected to remain in the environment for months to years. Based on boscalid’s 1) octanol-water partition coefficient (K ow 

### ) near 1000; 2) its organic-carbon normaliz ed Freundlich solid-water distribution coefficients (K FOC 

### ) values greater than or near 1000 (mg/L)(mg/kg) -1/n 

### ; 3) previously identified risk concerns for sediment-dwelling organism s such as molluscs and hyallela (MRID 45405009); 4) increased sensitivity of some se diment dwelling aquatic inverte brates as compared to aquatic invertebrates in the water-column; and 5) pore-w ater and water-column estimated environmental concentrations (EECs) being similar, exposure in sediment is an important exposure pathway.

Previous ecological risk assessments for boscalid ha ve identified acute risk to listed species of freshwater fish (and by extensi on to aquatic-phase amphibians for which fish serve as surrogates) and to listed species of molluscs. Chronic risk wa s identified for non-listed and listed freshwater fish and aquatic-phase amphibian s and for mammals. Risks have also been identified for listed species of terrestrial and semi-aquati c plants and for certain non-listed species of plants (dicots). Adverse effects seen in chronic exposure studies w ith animals and with terrestrial plants generally reflect reductions in growth paramete rs following exposure to boscalid.

A seed treatment use was assessed in 2010 (USE PA, D379809); the assessment identified chronic risk to mammals, contingent upon seed availability and noted uncertainties regarding the risk of sublethal effects in listed species of birds (and by extension to terrestrial-phase amphibians and reptiles for which birds serve as surrogates).

16 Although boscalid is classified as non-volatile under field conditions (according to the classification system in Guideline 83 5.6100) (USEPA, 2008), based on monitoring data it still has the potential to be transported in air or on particles in air. Boscalid was measu red in air monitoring studies and was associated with particles in air (Schumer et al. , 2010). Based on results of the Screening Tool for Inhalation Risk model, exposure through inhalation is not a potential pathway of concern for either avian or mammalian species on an acute basis.

### 8 The major environmental fate and ecological risk c onclusions identified in previous assessments are summarized in Error! Reference source not found. and 2

. Table 1. Potential for direct effects identi fied in previous assessments for boscalid 1
Listed/or non-listed Birds 2 Mammals Terrestrial Invertebrates Aquatic Vertebrates 3 Aquatic Invertebrates Terrestrial Plants Aquatic Plants Non-listed C C Potential 5 A*, C* A*, C* Potential*

-- Listed A 4 , C C Potential 5 A*, C* A*, C* Potential*

-- A = Acute risk; C = Chronic risk; -- = Risk below LOC; * indicates a full data set is not available

1 Risk concerns were identified when the RQ exceeded the corresponding level of concern in a previous risk assessment or were id entified as a potential concern based on weight of evidence.

2 Birds serve as surrogates for terrest rial-phase amphibians and reptiles.

3 Fish serve as surrogates for aquatic-phase amphibians.

4 Acute risk of sublethal effects in listed species of birds, and therefore in reptiles and terrestrial-phase amphibians, could n ot be precluded based on the submitted ecotoxicity data; however, acute risk of mortality was considered unlikely.

5 Based on incident data



### Table 2. Potential environmental concerns iden tified in previous assessments for boscalid

Bioaccumulation 1 Groundwater Contamination 2 Sediment Persistence Residues of Concern Volatilization

No, log K ow <3 Yes Yes 4

, 1 K FOC >1000 L/kg

K OW near

1000 Yes 3 Boscalid and Unextracted

Residues No

1 Based on whether previous assessments indicated this was a risk concern or if previous assessments ran K ow Based Aquatic Bioaccumulation Model (KABAM) for chemicals with a log K ow >3.

2 Previous risk assessments indicated that boscalid has the potential to reach groundwater; however, it did not result in drinkin g water concentrations high enough to cause a concern for human health. Boscalid has also been found in groundwater based on monitoring data. Boscal id may be both an exposure concern for groundwater and sediment because of its moderate mobility.

3 Chemicals with half- lives greater than 60 days in soil, water, and sediment are classified as “persistent” (by EPA’s Toxic Release Inventory Program classifications), and chemicals with half- lives greater than 180 days are considered “very persistent” (USEPA, 2012a).

4 In previous assessments, sediment pore-water and water-column EECs were similar and a potential for risk to sediment dwelling organisms was identified based on the potential effects to molluscs, hyallela, and other sediment dwelling organisms. Some sediment-dwelling aquatic invertebrates were more sensitive than aquatic invertebrates tested in the water-column.


### b. Drinking Water Exposure Assessments

For drinking water, Estimated Drinking Water Concentrations (EDWCs) were previously based on the use of boscalid on turf (USEPA, 2013, D409880; Table 3 ). The Health Effects Division’s (HED) Metabolism Assessment Review Committee (MA RC) reported that the residue of concern for boscalid in human health drinking water is boscalid alone (Nelson et al. , 2003). Unextracted residues were also considered a residue of conc ern in the drinking water assessments because a range of polar and nonpolar solvents used for extr acting residues were not explored to determine if the amount of unextracted residues could potenti ally be available for exposure. Additionally, the extent to which unextracted residues cons ist of parent compound and/or degradate(s) is unknown. In 2013, surface- and groundwater-bas ed EDWCs for boscalid plus unextracted residues were below the level of c oncern (LOC) for human health. If additional information becomes available that chang es EFED’s understanding of the use pattern, fate inputs, residues of concern, or any other factors likely to result in changes to EDWCs, a new drinking water assessment will be conducted. If a new drinking water assess ment is conducted that results in significant changes from previously-calculated EDWCs, HED may wish to conduct a new dietary exposure and/or risk assessment.

### 9 Table 3. Tier I EDWCs for residues of boscalid and unextracted residues based on use on turf 1

Source of Drinking Water (Model) Boscalid and unextracted residue co ncentrations in drinking water ( μ g/L)

Acute Annual Average or Post Breakthrough Average Surface water (FIRST) 97.3 26.4Groundwater (PRZMGW) 773 697

1 These are the highest EDWCs for the proposed and relevant previously evaluated use scenarios; see USEPA, 2013, D409880 for addi tional information (USEPA, 2013, D409880, 2014c).



### c. Clean Water Act Programs

Boscalid is not identified as a cause of impairme nt for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 17 

### No Total Maximum Daily Loads (TMDL) or section 304(a) ambient water quality criteria have been developed for boscalid. 18 

### Aquatic life benchmarks 19 

### have been established for boscalid; how ever, any data submitted or otherwise located as part of the Registration Review proce ss that indicate greater sensitivity than data currently available may be used to revise a quatic life benchmarks if applicable.

5. Environmental Fate and Transport



### Boscalid has demonstrated systemic activity (translaminar and locally systemic) 20 

### and residues are persistent and stable to metabolism in plants, base d on available residue data reviewed by the HED. Boscalid has the potential to reach aquatic envi ronments, including surface and groundwater, for several months or more following terrestrial appli cation. The available data indicate that boscalid is likely to dissipate to some extent through va rious mechanisms, including runoff, erosion, and leaching to groundwater. Because boscalid degrade s slowly in soil and aquatic systems, the compound may persist in soil, in water, and in benthic sediment, once transported or partitioned to these environmental compartments. Boscalid has a moderate mobility, coupled with its persistence, it has the potential to both leach and partition into sediment.

Table 4 summarizes the physical-chemical properties of boscalid, along with the submitted environmental fate data (see bibliography in Appendix B ). Boscalid does not dissociate at environmentally relevant pH, has a moderate log K ow 

### (2.96), and is considered non-volatile from dry surfaces, water, and moist soil according to classification schemes in guideline OCSPP 835.6100 (USEPA, 2008). While boscalid is classified as non-volatile based on the classification scheme in the terrestrial field dissipation guideline (OCSPP 835.6100 21 

### ) and its vapor pressure and

17 Specific state causes of impairment that make up the national pesticides cause of impairment group are listed at http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

. 18 Specific state pollutants that make up the National Pesticides Pollutant Group and have TMDLs are listed at http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_group_name=PESTIC IDES

. 19 Aquatic Life Benchmarks are available at http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm.

20 Lewis, J. Raspberry Cane and Fruit Rot Fungicides . Available at http://www.perennia.ca/Fact%20Sheets/Horticulture/Fruit/Raspberry/Raspberry%20Cane%20and%20Fruit%20Rot%20Fungicides.pdf (Access ed August 22, 2014).

21 USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.6100 Terrestrial Field Dissipation . EPA 712-C-08-020. October 2008. Office of Prevention, Pesticides, and Toxic Substances. U.S. Environmental Protection Agency. Available at http://www.epa.gov/opptsfrs/publications/835_6100.pdf (Accessed July 30, 2009).

### 10 air-water partition coefficient; it has been measure d in air monitoring studies both in the vapor phase and associated w ith particles at low concentrations (Schumer et al. , 2010). Based on its log K ow 

### , it is considered unlikely to bioconcentrat e in terrestrial and aquatic organisms.

The range of half-lives for bos calid indicate that it is pers istent to very persistent. 22 

### Metabolism in soil under aerobic conditions is the primary route of degradati on. Based on submitted studies boscalid is stable to abiotic routes of degrad ation and some biotic routes including hydrolysis, aqueous photolysis, soil photolysis (based on 1 soil), aerobic aquatic metabolism (based on 2 pond systems), and anaerobic aquatic metabolism (based on 1 pond system).

Aerobic soil metabolism half-lives for parent alone ranged from 182 to 578 days in four soils (MRID 45643802). Aerobic soil metabolism rates ar e uncertain because 1) there were high amounts of unextracted residues observed in the st udies (up to 45% of applied radioactivity), 2) it is not known whether unextracted residues have to xicity similar to that of the parent compound, and/or 3) a range of polar and nonpolar solvents was not explored in the extraction procedure to determine whether the residues are available for exposure. Therefore, degradation rates were estimated for parent alone and for summed residues of parent plus unextracted residues. Half-lives calculated by summing parent and unextracted re sidues ranged from 848 to 2,553 days. The same issue with unextracted residues was present in the anaerobic aquatic metabolism study, wherein unextracted residues reached a maximum of 62% of applied radioactivity (MRID 45405213). The half-life for parent only was 385 days and for parent plus unextracted residues there was no detectable degradation.

Terrestrial field dissipation studies have been con ducted at fourteen different sites for bare ground applications and applications to turf, peach, and almonds. Dissipation half-lives ranged from 1 day to greater than 360 days, and carryover of resi dues from application to application and from year to year was observed at all 14 sites. There was uncertainty in the DT 50 

### of 1 day due to the high variability in the measured residues. Most boscalid was observed in the top soil layer; however, boscalid was also observed in the lowe st depth sampled (45 cm) at 3 of 14 sites.

Boscalid is classified as moderately mobile us ing the FAO classification system (FAO, 2000). Organic-carbon normalized Freundlich distribution coefficients (K FOC 

### s) range from 507 to 1110 ( mg/L)(mg/kg) -1/n 

### measured in six soils (MRID 45405216). 23 

### Boscalid may be transported to surface water and groundwater via runoff, leaching, a nd spray drift and it may also be present in sediment at amounts high enough to trigger the need to conduct a risk assessment for sedimentdwelling organisms 24 

### . It may be found in both surface water and sediment. Sorption coefficients tend to be higher in aquatic sediment than in surface soils (Allen-King et al. , 2002). Mobility tends to decrease ( i.e. , sorption to increase) as organic-carbon increases in soils and sediments.

22 Chemicals with half- lives greater than 60 days in soil, water, and sediment are classified as “persistent” (by EPA’s Toxic Release Inventory Program classifications), and chemicals with half- lives greater than 180 days are considered “very persistent” (USEPA, 2012a).

23 Soil-water distribution coefficients and organic-carbon normalized soil-water distribution coefficients were not calculated.

24 Previoius risk assessment have indicated that pore-water and water-column EECs are similar. The potential for exposure in the water column and in sediment is similar. Additionally, the 40 CFR § 158.630 states that sediment data are recommended if the “...half -life of the pesticide in the sediment is ≤ 10 days in either the aerobic soil or aquatic metabolism studies and if any of the following conditions exist: A. The soil partition coefficient (Kd) is ≥50 B. The log K OW

is ൒ ͵ C. The K OC is ≥ 1000.” Finally, previous risk assessments have identified risk concerns for sediment-dwelling organisms and some sediment-dwelling aqu atic invertebrates are more sensitive than aquatic invertebrates in the water-column.

### 11 Table 4. Chemical properties and environmental fate parameters of boscalid (unless otherwise specified)

Parameter Value and Units Description/Comments 1,2 Source (Study Classification) Selected Physical/Chemical Parameters

Chemical Class Anilide and pyridine -- -- PC Code 128008 -- -- Molecular Mass (g/mole) 343.21 g/mole -- --

Molecular Formula C 18 H 12 Cl 2 N 2 O -- --
Vapor pressure 2×10 -6 Pa at 25 o C 2×10 -8 Torr at 25 o C Non- volatile under field conditions (Mathur, 2002, D285692) Aqueous solubility (20 o C) 4.64 mg/L ± 0.06 mg/L at 20 o C (Mathur, 2002, D285692)

Henry’s Law Constant 1×10 -9 atm-m 3 /mol Estimated from vapor pressure at 25 o C and water solubility at 20 o C

Dissociation Constant pKa (20 o C) No dissociation at environmental relevant pH 4 to 9 (Mathur, 2002, D285692)

Log octanol-to-water partition coefficient (Log K OW )* 2.96 Not likely to bioconcentrate (Mathur, 2002, D285692)

Air

- water partition coefficient (K AW ) 6 × 10 -8 (log K AW = -7) Non- volatile from water surface. Estimated from vapor pressure at 25 o C and water solubility at 20 o C. Octanol-air partition coefficient (K OA ) 2×10 10 (log K OA = 10) Estimated from K AW and K OW

.

Persistence 3

Hydrolysis half- life 25 o C: Stable, pH 5 Stable, pH 7 Stable, pH 9 Does not hydrolyze. MRID s 45405205

Atmospheric Half-life Hydroxyl radical reaction rate: 1 day (estimated) Assumed 12-hour day; 1.5×10 6 OH molecules/cm 3 using EPIweb version 4.1 (USEPA, 2009a). Boscalid is not expected to undergo long range transport in the vapor phase. 2 Estimated Using EPIWeb Version 4.1

Aqueous photolysis half-life 22±1 o C, pH 5 Stable Adjusted for sunlight intensity at 40 q N latitude. MRIDs 45405206

Soil photolysis halflife 22±1 o C, pH 7.3: Stable, sandy loam Adjusted for sunlight intensity at 40 q N latitude. MRIDs 45405207

### 12 Parameter Value and Units Description/Comments 1,2 Source (Study Classification)

Aerobic soil metabolism half

- life (10 -30°C) SFO linear reg, temperature 27 o C: Parent Only (Parent+Unextracted Residues): 182 (848) days, clay loam 578 (1609) days, clay loam 408 (1000) days, silt loam

289 (2553) days, loam -- MRID 45643802

SFO nonlinear reg, temp 20 o C: Chloronicotinic acid 3.3 days, sandy loam -- MR ID 45405209 same as 46715226

SFO nonlinear reg, temp 20 o C: Parent Only: 108.3 days, sandy loam Not for use in modeling because only one replicate was used in the study. MRID 45405208

Anaerobic soil metabolism half-life No Data -- --

Aerobic aquatic metabolism half- life 19-21 o C Stable, loamy sand sediment, pond
water Stable, Loam sediment, pond area -- MRID 45405214

Anaerobic aquatic metabolism half

- life SFO nonlinear reg, 20 o C: Parent (parent+unextracted residues):

385 days (stable), sediment, North Dakota pond water -- MRID 45405213 Acceptable

Mobility 4

Organic -carbon normalized Freu ndlich solid -water distribution coefficient (K FOC ) in (mg/L)(mg/kg) -1/n

Freundlich solid

- water distribution coefficient (K F ) in (mg/L)(mg/kg) -1/n

Freundlich Exponent (1/n) Soil Source
or texture K F OC K F 1/n The relative standard deviation for K F values (88 %) was higher than the relative standard deviation for K FOC values ( 30%). Solid- water distribution

coefficient (K d ) and organic- carbon normalized solid- water distribution coefficients (K OC ) values were not previously calculated. MRID 45405216 Boscalid

German 1110 27.76 0.875

German 507 7.61 0.87

German 594 6.5 0.84

U.S. 987 3.9 0.89

U.S. 655 3.28 0.86

Canada 776 26.39 0.85

2-chloronicotinic Acid

MRID 45405217 Silt loam 6 0.078 0.94 Sandy loam No sorption observed

Loamy sand 1 0.01 0.93

Field Dissipation

### 13 Parameter Value and Units Description/Comments 1,2 Source (Study Classification)

Terrestrial field dissipation State/ Province Crop Half-life (days) % Carryover

ON bare 30 19.8 Highly variability in measured concentrations. MRID 45405222 MB bare 316 31.4

AB bare 372 48.8

ND bare 1 13.4 Highly variability in measured concentrations. MRID 45405221 CO bare 119 24.2

CA bare 77 19.9

-- MRID 45405220 ID bare 333 52.3

FL bare 27 11.9

NJ bare 108 15.6

-- MRID 45405219 turf 44 11.8

IL bare 244 16.7

turf 155 20.1

TX bare 143 21.0

turf 108 9.1

GA peach 282 6.2 Applications were made direction to the bare soil between orchard/vineyard rows at all three test sites (bareground plots) and to the orchard canopy at the Georgia and California test sites. MRID 4 5405218 bare 264 18.5

NY bare 356 33.1

CA almond >360 16.9

bare 150 20.2

Fish Bioconcentration

Fish bioconcentration factors (steady- state); depuration rate 70x (based on total radioactivity) Based on total radioactivity. Value is not specific to boscalid. Rapid depuration with half-life of 1 day. MRID 45405007

Analytical Methods

ECM/ILV: Water No ILV Studies without supporting ILVs are not reviewed. MRID 45405227

ECM/ILV: Soil Residues: Parent, 2-chloronicotinic acid , 2-hydroxy-N-(4'- chlorobiphenyl2-y1)nicotinamide

Solvents: Methanol followed by 50:50 methanol:water

Quantitation: HPLC-MS/MS LOQ=0.01 mg/kg Adequate (as reviewed in DER for MRID 45405218) MRID 45405225 (ECM)

MRID 45405226 (ILV)

Storage Stability Freezer storage stability of parent, 2- chloronicotinic acid, and 2

- HydroxyN-(4'-Chlorobiphenyl-2- yl)Nicotinamide in Soil Adequate (as reviewed in DER for MRID 45405220) MRID 45405223, 45405224

### 14 Parameter Value and Units Description/Comments 1,2 Source (Study Classification) Stability in acetonitrile Not reviewed MRID 45405104
AR=applied radioactivity; ECM=environmental chemistry method; ILV=independent laboratory validation; LOQ=limit of quantitation; DER=data evaluation record; * Temperature or pH not reported.

1 All estimated values were estimated according to “ Guidance for Reporting on the Environmental Fate and Transport of the Stressors of Concern in Problem Formulations for Registration Review, Registration Review Risk Assessments, Listed Species Litigation Assessments, N ew Chemical Risk Assessments, and Other Relevant Risk Assessments ” (USEPA, 2010).

2 Volatility classifications are based on classifications on the Terrestrial Field Dissipation Guideline OCSPP 835.6100 (USEPA, 2 008).

3 Degradation kinetics were calculated using the single first order decay equation using either nonlinear regression of non-trans formed data or linear regression of log-transformed data. Persistence classification are based on criteria established for the Toxic Release I nventory, which considers chemicals persistent if the half-life in water, soil, or sediment is greater than 60-days and very persistent if the half-life is greater than 180-days (USEPA, 2012a). A half-life in air greater than 2-days is also considered persistent The minutes of the Scientific A dvisory Panel examining issues related to persistent, bioaccumulative, and toxics states, “ To protect against long range transport, a two-day degradation halflife in air is used internationally in regulations that identify persistent chemicals .” (USEPA, 2009b).

3 MRID 45405210, 45405211, 454052012 are considered unacceptable.

4 Mobility classifications are based on Food & Agriculture Organization of the United Nations (FAO) Mobility criteria (FAO, 2000 ; USEPA, 2006).


### Boscalid has been detected in surface water, groundw ater, and air or associated to particles in air (Reilly et al. , 2012; Schumer et al. , 2010). Concentrations measured through monitoring studies were not high enough to result in a risk concern in previous risk assessments. The maximum boscalid concentration in surface water detected was 36 μ g/L (Smalling and Orlando, 2011) and the maximum boscalid concentration in groundwater was 2.1 μ g/L (Reilly et al. , 2012). However, only limited data are available and those data are unl ikely to have captured peak concentrations. Targeted surface water and groundwater monitori ng data from the same areas show groundwater samples having similar to or higher concentrat ions as those observed in surface water (Reilly et al. , 2012).

Atmospheric samples were collected in an intens ive farming area (Strasbourg, France) in April and May in 2007 and analyzed for 71 current-use pe sticides. Boscalid was detected in 10 of 10 samples at concentrations ranging from 0.35 to 0.81 ng/m 3 

### air (Schumer et al. , 2010). Boscalid residues were associated with both atmospheric particles and the gas phase. Schumer (2010) reported that approximately 33% of boscalid residue s were in the gas phase and 67% were in the particle phase. Thus, it will likely have a longer half-life in the atmosphere and may undergo long range transport (Schumer et al. , 2010).

a. Transformation Products

Table 5 summarizes the transformation products obs erved in environmental fate studies. One major degradate (2-hydroxy-N- (4’ -chlorobiphenyl-2-yl)nicotinamide)) 25 

### and one minor degradate (2-chloronicotinic acid) 26 

### were observed in aerobic soil metabolism studies. 2-chloronicotinic acid is similar to a degradate (6-chl oronicotinic acid) that occurs with the neonicotinoid insecticides (acetamiprid and imidacloprid), and a butenolid e insecticide (flupyradifurone). The two degradates observed in the aerobic soil metabolism st udies were also found in most terrestrial field dissipation studies. The degradate M510F49 (2-hydroxy-N- (4’ -chlorophenyl-2-yl)-nicotonamide) was classified as a major degradate in one soil sample with a maximum amount of applied radioactivity associated with it being 14.4%; its aerobic soil metabolism half -life was estimated as

25 Observed in all five soils.

26 Observed in four of five soils.

### 15 1.7 days. All other boscalid degradates were clas sified as minor degradate s. Known degradates were not included in the exposure calculations in previous risk assessments because they occurred in small amounts and were not expected to significantly alter EECs.16Table 5. Boscalid and its known environmental degradates1Code Name/ SynonymChemical StructureStudy TypeRef.(MRID)Maximum %AR(day)Final %AR (studylength)PARENTBoscalid, Nicobifen, BAS 510 FIUPAC:2-chloro-N-(4’-chlorobiphenyl-2-yl)-nicotinamideCAS Number:188425-85-6SMILES:C1=CC=CC(=C1C2=CC=C(Cl)C=C2)NC(=O)C3=CC=CN=C3ClMW:343.21 g/molTRANSFORMATION PRODUCTS2-chloronicotinic acid; M510F47CAS Number:2942-59-8Formula:C6H4ClNO2MW:157.55 g/molSmile string:N1=CC=CC(=C1Cl)C(=O)OAerobic Soil456438023.1 (371 d)3.1 (371 d)Terrestrial Field45405218<0.01<0.01 mg/kg (360 d)Terrestrial Field45405219<0.01<0.01 mg/kg (359 d)Terrestrial Field454052200.04 mg/kg (21 d)<0.01 mg/kg (345 d)Terrestrial Field454052210.022 mg/kg (1 d)<0.01 mg/kg (429 d)Terrestrial Field454052220.019 mg/kg (1 d)<0.01 mg/kg (358 d)(2-hydroxy-N-(4’-chlorobiphenyl-2-yl)-nicotonamide); M510F49Formula: C18H13ClN2O2MW: 324.77 g/molSMILES:C1=CC=CC(=C1C2=CC=C(Cl)C=C2)NC(=O)C3=CC=CN=C3OAerobic Soil454052080.2 (364 d)0.2 (364 d)Aerobic Soil4564380214.4 (371 d)14.4 (371 d)Aerobic Aquatic4540521400AnaerobicAquatic454052130 0Terrestrial Field454052180.02 mg/kg (13 d)<0.01 mg/kg (316 d)Terrestrial Field454052190.02 mg/kg (121d)<0.01 mg/kg (359 d)Terrestrial Field454052200.03 mg/kg (7 d)0.02 mg/kg (345 d)Terrestrial Field454052210.005 mg/kg (3 d)<0.01 (429 d)Terrestrial Field454052220.01 (358 d)0.01 (358 d)17Code Name/ SynonymChemical StructureStudy TypeRef.(MRID)Maximum %AR(day)Final %AR (studylength)M510F50 Unknown 2Aerobic Soil454052080.2 (364 d)0.2 (364 d)AnaerobicAquatic454052130 0Unextracted ResiduesNot ApplicableAerobic Soil4540520862.7 (266 d)60.0 (364 d)Aerobic Soil4564380244.8 (371 d)44.8 (371 d)Aerobic Aquatic4540521413.4 (100 d)13.4 (100 d)AnaerobicAquatic4540521355.1 (361 d)55.1 (361 d)1When a study is not listed for a residue, that residue was present at less than the detection limit or was not looked for in the study.

### 18 6. Receptors



### A detailed description of the available ecotoxicit y data for boscalid is provided in the risk assessment for uses on alfalfa and citrus (USEPA, 2010, D363523). Higher-tier studies with honey bees have been subsequently subm itted and are included as lines of evidence in this problem formulation. Toxicity endpoint s used in risk estimation for boscalid are summarized in Error! Reference source not found. 6 and Error! Reference source not und.7 . These endpoints represent the most sens itive endpoints available from suitable, guideline toxicity studies.

Based on the available data, boscalid is character ized as moderately toxic to freshwater fish (and aquatic-phase amphibians for which freshwater fish serve as surrogates) and is at least moderately toxic to freshwater invertebrates on an acute exposure basis, at concentrations approaching the chemical’s water solubility limit (4.64 mg/L at 20 o 

### C); however, the submitted acute test with freshwater invertebrates (MRID 45405001) is not used quantitatively for risk estimation because it may have overestimated the actual exposure concentrations of the test organisms and thus underestimated the toxicity endpoint (see DP Barcode D363523 for discussion). Non-definitive toxicity endpoints indicate that boscalid is moderately toxic to benthic invertebrates, estuarine/marine fish and to non-mollusc estuarine/marine invertebrates on an acute exposure basis. However, it is highly toxic to estuarine/marine molluscs based on reductions in shell growth.

Chronic exposure to boscalid resulted in re duced survival for freshwater fish, and in reduced survival and growth (decreased length and dry weight) and impaired reproduction (reduced number of young) for freshwater invertebrates ( i.e. , waterflea; Daphnia magna ). Acceptable chronic toxicity data for other aquati c animals, including benthic freshwater invertebrates and estuarine/marine fish and i nvertebrates, are unavailable. Specifically, the chronic study for benthic freshwater invertebrates ( i.e. , midge; Chironomus riparius ) was inadequate because sediment was not spiked. However, the available supplemental data indicate that boscalid can reduce emergence and development in the midge and reduce growth (decreased dry weight) in the freshwater amphipod Hyalella azteca . No chronic studies were submitted for estuarine/marine fish or invertebrates.

Exposure of nonvascular aquatic plants, i.e ., freshwater green algae ( Pseudokirchneriella subcapitata ) to boscalid resulted in a 50% inhibition (IC 50 

### ) of cell growth at 1.34 mg/L; exposure of aquatic vascular plants ( Lemna gibba ; duckweed) to boscalid at 3.9 mg/L did not result in sufficient inhibition of fr ond growth or biomass to estimate an IC 50



### .
Table 6. Toxicity endpoints used in risk estimation and risk description for aquatic organisms exposed to boscalid residues Aquatic Animals (Acute Toxicity)
Study Type Species Endpoints 1 (mg a.i./L) Toxicity Classification (MRID)
Acute toxicity to freshwater fish Rainbow trout ( Oncorhynchus mykiss ) 96-hr LC 50 = 2.7 Moderately toxic (45404927)

### 19 Acute toxicity to freshwater invertebrate 2 Waterflea ( Daphnia magna ) 48 -hr EC 50 < 5.33 At least moderately toxic (45405001) Acute toxicity to estuarine/marine fish Sheepshead minnow ( Cyprinidon variegatus ) 96 -hr LC 50 > 3.86 Moderately toxic (45405004)

Acute toxicity to estuarine/marine invertebrates Mysid shrimp ( Americamysis bahia formerly Mysidopsis bahia ) 48 -hr LC 50 > 3.81 Moderately toxic (45405002)

Toxicity to estuarine/marine molluscs

– shell deposition Eastern oyster ( Crassostrea virginica ) 48-hr EC 50 = 1.02 (Slope 2.14, 95% CI 0.89 - 3.39) Highly toxic (45405003)
Aquatic Animals (Chronic Toxicity)

Study Type Species NOAEC & LOAEC (mg a.i./L) Effects (MRID)
Early life stage toxicity to freshwater fish Rainbow trout ( Oncorhynchus mykiss ) 0.116 & 0.241 Mortality (45405006) Chronic toxicity to freshwater invertebrates Waterflea ( Daphnia magna ) 0.79 & 1.54 Reduced number of young (46351406)

10- day sediment toxicity to

freshwater invertebrates Freshwater amphipod ( Hyalella azteca ) EC 50 > 1.066 NOAEC = 0.298

(pore water) Dry weight Moderately toxic (45405009)Chronic toxicity to sedimentdwelling invertebrates (spiked water) Freshwater midge ( Chironomus riparius ) 2.0 & 4.0 nominal (overlying water) Reduced emergence (45405008)
Aquatic Plants
Study Type Species Endpoints (mg a.i./L) Effects (MRID)
Toxicity to vascular aquatic plants Duckweed ( Lemna gibba ) IC 50 > 3.9 NOAEC = 0.99 Frond number, necrosis (45405013)

Toxicity to nonvascular aquatic plants Freshwater alga ( Pseudokirchneriella subcapitata ) IC 50 = 1.34 NOAEC = 0.49 Growth rate, biomass (45405017)

1 Dose-response slope values for the estuarine/marine mollusc are indicated in parentheses (value, 95% confidence interval). F or other studies, where slope data are not available, the default value of 4.5 (with 95% confidence intervals of 2.0 and 9.0) is used to derive the probability of an individual effect for aquatic animals (Urban and Cook 1986).

2 The acute toxicity data for freshwater invertebrate (MRID 45405001) are not used quantitatively in risk estimation because t hey likely underestimate toxicity (see DP Barcode D363523 for discussion).


### Based on the available data, boscalid is practically non-toxic to terrestrial invertebrates ( e.g. , young adult honey bees) on both an acute contact and acute oral exposure basis. The compound is also practically non-toxic to birds on both an acute oral and subacute dietary exposure basis, and to mammals on an acute oral exposure basis. However, adverse effects on honey bee larval development ( e.g ., reduced queen cell development) have been reported in incident data following applicat ion of boscalid, specifically as the Pristine ® 

### formulation (boscalid + pyraclostrobin), to almonds and other unspecified crops. EFED subsequently reviewed a series of special honey bee toxicity and foliar residue studies with boscalid and the Pristine ® 

### formulation, as follows (DP Barcode D927620 and D420653):

x Bocksch, S. 2012. Determination of side-effects of BAS 510-01 F on brood development of the honeybee ( Apis mellifera L.) in a feeding study (MRID

### 20 49009301);

x Niederdrenk, S. and C. W. Schneider . 2012. Assessments of effects of BAS 516 04 F on the production of honey bee queens ( Apis mellifera L.) in a semi field study in Phacelia tanacetifolia (MRID 49009303);

x Lawrence, J. and M. Riley. Determination of residues of Pristine fungicide (Pyraclostrobin + Boscalid) in royal jelly and pollen in almond tree in central California (MRID 49009304); and,

x Royer, S. 2014. Effect of Reg. No. 300355 (BAS 510F) on survival and development of honey bee brood ( Apis mellifera ), using an in vitro rearing method (MRID 49361801).

Generally, the current suite of higher-tier tests with boscalid and the Pristine ® 

### formulation does not support the claims regarding dimini shed honey bee queen cell production in colonies exposed to any one of these products alone.

In birds and mammals, chronic exposure to boscalid was associated with reproductive and growth effects, including reduced number of eggs and embryo mortality in bobwhite quail ( Colinus virginianus ) and reduced body weight in second generation offspring (F2) in rats ( Rattus norvegicus ). Based on the results of the Tier II terrestrial plant studies, cabbage ( Brassica oleracea ) appears to be particularly sensitive to boscalid exposure, while other dicot species and all tested monocots are relatively insensitive to boscalid exposure.

Table 7. Toxicity endpoints used in risk es timation and description for terrestrial organisms exposed to boscalid Terrestrial Animals ( Acute Toxicity)

Study Type Species Endpoints 1 (LD 50 mg a.i./kg bw)

(LC 50 mg a.i./kg diet) Toxicity Classification (MRID)

Acute oral toxicity to

upland game birds Bobwhite quail ( Colinus virginianus ) LD 50 > 2000 Practically nontoxic (45404922)
Subacute dietary toxicity to upland game birds and waterfowl Bobwhite quail ( Colinus virginianus ) Mallard duck ( Anas platyrhynchos ) LC 50 > 5000 Practically nontoxic (45404923) (45404924)
Acute oral toxicity to mammals 2 Norway rat ( Rattus norvegicus ) LD 50 > 5000 Practically nontoxic (45404814)

Acute contact and oral toxicity to honey bees Honey bee ( Apis mellifera ) LD 50 > 166 μ g/bee (oral) LD 50 > 200 μ g/bee (contact) Practically non- toxic (45405019)

Toxicity to soil dwelling invertebrates (14- day) 3 Earthworm ( Eisenia foetida ) LD 50 > 1000 mg a.i./kg dry weight

soil (nominal) NA (45405020)
Terrestrial Animals ( Chronic Toxicity)

Study Type Species NOAEC (mg a.i./kg diet) NOAEL (mg a.i./kg bw) Effects (MRID)

### 21 Avian reproduction with upland game birds Bobwhite quail ( Colinus virginianus ) NOAEC = 300 NOAEL = 25 Number of eggs laid, fertility rate, embryo mortality, and number

of 14- day survivors (45404925) Chronic toxicity to mammals 2

–twogeneration reproduction Norway rat ( Rattus norvegicus ) NOAEC = 100 NOAEL = 11.2 Decreased F2 body weight (45404906) Terrestrial Plants
Study Type Most Sensitive Species IC 25 & NOAEC (lbs a.i./A) Effects (MRID)

Tier II seedling emergence (Emerald, 69.9% a.i.) Monocot : Corn Dicot : Cabbage > 0.576 & 0.275 0.44 & 0.275 Seedling emergence Dry weight (47627401)
Tier II vegetative vigor (Emerald, 69.9% a.i.) Monocot : Corn Dicot : Cabbage > 0.626 & 0.035 < 0.035 & <0.035 Shoot length Dry weight (47627402)

1 Slope data were not available from the acute terrestrial animal studies. The default value of 4.5 (with 95% confidence inter vals of 2.0 and 9.0) is used to derive the probability of an individual effect (Urban and Cook 1986).

2 Mammalian toxicity data provided and reviewed by OPP Health Effects Division (USEPA).

3 The submitted earthworm study was labeled as an acute test, although the duration (14 days) was considerably longer than most acute toxicity tests with invertebrates. The guideline-recommended duration for a chronic test with earthworms is 28 days.


### a. Ecological Incidents

The risk assessment will incorporate information from reports of ecological incidents associated with boscalid use. This infor mation may come from sources such as the Agency’s Ecological Incident Information System (EIIS) , OPP’s aggregate incident report database, or external portals such as the Avian Incident Monitoring System (AIMS) or the National Pesticide Information Center (NPIC).

The EIIS is an internal OPP database that houses ecological incidents that have been reported to the Agency. When available, EI IS includes date and location of an incident, type and magnitude of effects observed in va rious species, use(s) of pesticides known or suspected of contributing to the incident, and results of any chemical residue analysis or other analyses conducted during incident investigation. EIIS incidents are categorized according to the certainty that the incident resu lted from pesticide exposure. A search of the EIIS for ecological incidents run on August 12, 2014, identified six incidents of adverse effects on honey bees potentially associated with exposure to boscalid; in several cases, residues of multiple pesticides, including insectic ides, were detected in bee tissue and wax samples. Other incidents may have occurred due to boscalid exposures but may not have been reported due to various factors, such as a lack of reporting, or a lack of observation of effects. Therefore, the lack of incident re ports does not necessarily indicate the absence of incidents.

No plant or wildlife incidents have been reported through OPP’s aggregate incident report database and no avian incidents have been captured in the Avian Incident Monitoring System (AIMS; American Bird Conservancy 2013) 27 

### as of August 12, 2014. The AIMS

27 Available at: http://www.abcbirds.org/abcprograms/ policy/toxins/aims/aims/index.cfm

### 22 database contains publicly available reports on pesticide-related avian incidents through 2005.

7. Exposure Pathways of Concern



### 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 ecologi cal receptor. For an ecological pathway to be complete, it must include a source, a release mechanism, an environmental transport medium, a point of exposure for ecological receptors, and a feasible route of exposure.

The environmental fate properties of boscalid indicate the following transport mechanisms for potential exposure to aquatic and terrestrial organisms:

x Direct contact with residues on foliar and other surfaces

x Spray drift 28



### x Runoff

x Discharge of contaminated groundwater

Terrestrial organisms may be exposed to boscali d in dietary items, in surface water, and sediment. Based on the results of screening tools 29,30 

### , inhalation and drinking water for non-target organisms are not, by themselves, ex pected to be significant exposure pathways for boscalid ( Appendix D and Appendix E ).

8. Analysis Plan



### The uses, environmental fate, and ecological effects of boscalid are characterized and integrated to assess the risks. Risk is ex pressed using the ratio of exposure concentration to effects concentration, referred to as a Risk Quotient (RQ). Although risk is often defined as the likelihood and magnitude of adverse ecological effects, the RQ-based approach does not provide a quantitative estimate of likelihood and/or magnitude of an adverse effect. However, as outlined in the Overview Do cument (USEPA, 2004), the likelihood of effects to individual organisms from particular uses of boscalid is estimated using the probit doseresponse slope and either the level of concern (discussed below) or calculated RQ value.

The analysis plan outlined in this problem formulation may be revised depending upon information submitted by the public in response to the opening of the Registration Review docket for boscalid.

28 Boscalid has been detected in the vapor phase in air monitoring studies, but based on other data including its low acute toxic ity to mammals and birds, volatilization is not considered to be a transport mechanism of concern.

29 Screening Tool for Inhalation Risk (STIR v.1.0, November 19, 2010)

30 Screening Imbibition Program (SIP v.1.0, released June 15, 2010)

### 23 a. Stressors of Concern

i. Ecological Risk Assessment

The stressors of potential concern for non-ta rget organisms are boscalid and unextracted residues given that the identity of the unextra cted residues is uncertain. The only two transformation products observed in fate studies, that occurred at greater than 1% applied radioactivity, were 2-chloronicotinic acid and 2-hydroxy-N- (4’ -chlorobiphenyl-2-yl)- nicotonamide). Both of these residues were observed sporadically in fate studies and at very low levels at most sampling times. Including these residues in a total toxic residue approach, is not expected to significantly alter exposure estimates. Therefore, these residues were not considered residues of concern. Additionally, no available data on these degradates suggest that these residues would be more toxic than the parent.

The residues of concern are boscalid and unextracted residues. EFED will use a total toxic residues (TTR) approach for assessing risk to boscalid and unextracted residues in water. EFED will also estimate exposure for re sidues of boscalid alone, to get a better understanding of the uncertainty in exposure due to inclusion of unextracted residues in exposure assessments. This is consistent with the approach taken in previous assessments completed for boscalid.

ii. Drinking Water



### As discussed previously, the MARC reported that the residue of concern for boscalid in human health drinking water is boscalid only (Nelson et al. , 2003). Unextracted residues were also considered a residue of concern in previously completed drinking water assessments because a range of polar and nonpolar solvents were not ex plored to determine if the amount of unextracted residues could be decreased and the identity of the unextracted residues is unknown. EFED will use a TTR approach for estimating drinking water concentrations for human health. EFED will also estimate exposure to residues of boscalid alone, to gain a better unde rstanding of the uncertainty in exposure due to inclusion of unextracted residues. This is consistent with the approach taken in previous drinking water assessments for boscalid.

b. Measures of Exposure

EFED will use standard available models (identified in Table 8 ) to evaluate potential exposures to aquatic and terrestr ial organisms as described at http://www.epa.gov/pestic ides/science/models_db.htm

. Since the times when most of the previous exposure assessments were completed, two main changes in standard procedures have been made:

1) The North American Free Trade Agreement (NAFTA) Guidance for Evaluating and Calculating Degradation Kinetics in Environmental Media (NAFTA, 2012; USEPA,

### 24 2012c) was completed. Degradation kinetics may be recalculated consistent with the updated approach. 2) A new model for estimating concentrations in surface water was developed called the Surface Water Concentration Calculator (SW CC) (USEPA, 2014d). This model is an updated version of the standard model used in EFED to estimate exposure to pesticides in the aquatic environment.

The most up-to-date procedures and models wi ll be used in the Registration Review exposure assessments. Nonstandard modeling procedures that may be used in the risk assessment are discussed below. In the ab sence of chemical-specific data, the T-REX model will employ the standard defa ult 35-day foliar dissipation half-life.

Aquatic Assessment for Uses in Residential Areas

At the present time, EFED considers the use of the impervious scenario (a Pesticide Root Zone Model (PRZM) modeling scenario) as the most suitable available modeling approach for impervious runoff. This procedure was or iginally developed for the assessments completed for listed species in California. 31 

### The PRZM impervious scenario may be used in the SWCC along with a residential or ot her suitable scenario such as rights-of-way (ROW) to obtain EECs. The conceptual model for the residential scenario integrates simultaneous modeling of the individual use scen ario with an impervious scenario. This approach assumes that no watershed is completely covered by either 1⁄4-acre lots (the basis for the residential scenario) or undeveloped land (the basis for the ROW scenario) for residential and ROW use patterns; therefore, differential amounts of runoff will occur within the watershed. The impervious scenario was developed to represent the paved areas within a watershed not including roads, parking lots, sidewalks, and buildings outside the 1⁄4-acre lot (the 1⁄4-acre lot scenario accounts for impervious surfaces such as buildings within the represented area). By modeling a separate scenario for impervious surfaces, it is also possible to estimate that amount of expos ure that could occur wh en the pesticide is over-sprayed onto this surface. Using two sc enarios in tandem requires post-processing of the modeled output in order to derive a weighted EEC that represents the contribution of both the pervious ( i.e. , residential and ROW scenarios) and the impervious surfaces. The scenario assumes that a portion of the resident ial or ROW area is treated and a portion of impervious surface is treated. Exposure from both scenarios can also be weighted and aggregated. The daily time series from each SWCC model run for the residential and impervious surface scenarios are combined in a spreadsheet. The time-series data are weighted and summed based on assumed percenta ge of impervious surface, the percentage of the pervious surface treated, and percentage of each area treated. Exposures for the relevant durations ( e.g. , 1-day, 21-day and 60-day 1-in10 year return frequency concentrations) are then calculated from the co mposite time series in the standard fashion.

Irrigation Water

EFED does not currently have a standardi zed methodology for determining risk to nontarget plants from applications of irrigati on water where surface or groundwater has been

31 http://www.epa.gov/espp/litstatus/effects/redleg-frog/

### 25 contaminated by a pesticide applie d to crops. However, EFED anticipates that an irrigation water analysis will be conducted at the time of the risk assessment using exposure values generated from currently available models such as the SWCC or PRZM-Groundwater (PRZM-GW) for groundwater exposures. This ap proach will be used to determine a depth (in inches) of irrigation water on a one-acre fi eld necessary to cause an LOC exceedance to terrestrial plants and compared with representative cultural practices to characterize the potential risk associated with this exposure scenario.

Table 8. List of the various models and the related taxa for which the models will be used

Environment Taxa of Concern Exposure Pathway Model(s) or Pathway Link

Aquatic Fish/ Invertebrates/ Plants Runoff and spray drift to water SWCC http://www.epa.gov/oppefed1/model s/water/

Terrestrial Vertebrate Residues in/on dietary items T -REX (dietary item) http://www.epa.gov/oppefed1/model s/terrestrial/trex/trex_v1_5_webversi on.xlsm

Plant Runoff and spray drift to plants TerrPlant (Run

- off) http://www.epa.gov/oppefed1/model s/terrestrial/index.htm#terrplant

Residues in irrigation water Results from Aquatic Models http://www.epa.gov/oppefed1/model s/water/

Human Health EDWC Vertebrate Surface Water SWCC http://www.epa.gov/oppefed1/model s/water/ Ground water SCIGROW

PRZM-GW

All Environments All Spray Drift AgDRIFT (Spray drift) http://www.agdrift.com/AgDRIFt2/D ownloadAgDrift2_0.htm AGDISP (Spray drift) http://www.continuumdynamics.com/pr-agdisp.html



### Available Monitoring Data

The Agency is aware of pesticide monitoring c onducted by federal and state agencies. This information will be considered in the assess ment, to the extent that data on boscalid are available.

c. Measures of Effect

Toxicity data presented in Section 3 of this problem formulation will be used to calculate RQ values. Any additional information submit ted by the registrant or found in the open literature prior to conduct of th e risk assessment and meeting the standards established by the Agency will also be considered . The open literature studies are identified using EPA’s ECOTOXicology database (ECOTOX) 32 

### , which employs a literature search engine for

32 http://cfpub.epa.gov/ecotox/

### 26 locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The evaluation of both sources of data can also provide insight into the direct and indirect effects of pesticides on biotic communities fr om loss of species that are sensitive to the chemicals and from changes in structure a nd functional characteristics of the affected communities.

9. Endangered Species Assessments



### Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to listed species from registered uses of pesticides in Registration Review. The process for evaluating potential risks to listed species is further described at http://www.epa.gov/oppfead1/endanger/litstatus/riskasses.htm

.

10. Endocrine Disruptor Screening Program (EDSP)



### Boscalid was not included in the first group of 67 chemicals issued an order to conduct Tier 1 EDSP testing. For additi onal information on the EDSP, visit http://www.epa.gov/endo/

.
11. Preliminary Identification of Data Gaps



### a. Environmental Fate

Table 9 identifies environmental fate studies by master record identification (MRID) number that offer data for each guideline require ment, as well as study classifications and whether or not further data are needed in order to support risk assessment.

Whether unextracted residues may be availa ble for exposure is unknown in a number of submitted fate studies in which unextracted residues made up greater than 10% of applied radioactivity (<1 to 63%). This creates significant uncertainty in the risk assessment. Due to the uncertainty regarding the identit y of the unextracted residues and potential for exposure to unextracted residues, past asse ssments for boscalid have conservatively assumed that the unidentified residues are of toxicological concern when estimating halflives for use in aquatic modeling. Additi onally, past assessments of boscalid have conservatively assumed that unextracted residues exhibit the same toxicity to aquatic organisms as the parent compound. Including the unextracted residues in the exposure estimate does change certain c onclusions for ecological risk. Additionally, a range of polar and nonpolar solvents was not utilized in the extraction procedures, causing uncertainty as to whether the unextracted re sidues may be available for exposure to nontarget organisms. Additional aerobic so il metabolism data and anaerobic aquatic metabolism data are needed to better illuminate this uncertainty. Aerobic soil metabolism and anaerobic aquatic metabolism st udies employing a range of polar and nonpolar solvents for extraction would address this concern.

### 27 Table 9. Submitted environmental fate data and study classifications for boscalid and transformation products 1

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk assessment? Justification and Assumptions EPA will Make in Absence of Data

835.2120 Hydrolysis 45405205 Acceptable No --

835.2240 Aqueous photolysis 45405206 Acceptable No

835.2410 Soil photolysis 45405207 Acceptable No

835.2370 Photodegradation in Air No Data -- No --

835.4100 Aerobic soil metabolism 45643802 (4 soils) Acceptable

Yes The most recently completed ecological risk assessment indicated that assuming that the unextracted residues were parent affected EECs and subsequent risk conclusions. Therefore, data to reduce this uncertainty would be useful in future risk assessments. See text above table for additional information on this uncertainty. 45405209

same as 46715226 (Data for 2- CNA) Supplementalmay be used in modeling

45405208 (1 soil) MRID 45405208 Supplemental

– not for use in modeling

835.4200 Anaerobic soil metabolism 45405211 Unacceptable No -- 45405212 Unacceptable

835.4300 Aerobic aquatic metabolism 45405214 Supplemental No --

835.4400 Anaerobic aquatic metabolism 45405213 Acceptable Yes The test guideline (OCSPP 835.4400) for anaerobic aquatic metabolism recommends data in two sediments; however, data are currently only available for one sediment. This data gap could result in underestimation or overestimation of typical half

- lives in

su ch media. To account for this uncertainty, standard EFED procedure is to multiply a single anaerobic aquatic metabolism half

- life by three to derive a representative benthic half

- life for use as a model input. Additionally, there is currently uncertainty in whether unextracted residues are available for potential exposure. This uncertainty could be minimized with additional data on another sediment using extraction techniques that explore a range of polar and nonpolar solvents. Including unextracted residues for the benthic metabolism in EECs doubles the EEC and can impact risk conclusions.

### 28 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk assessment? Justification and Assumptions EPA will Make in Absence of Data

835.1230 835.1240 Adsorption/ desorption and leaching 45405216 (6 soils) Supplementalmay be used in modeling No --

45405217 (2-CNA, 2 soils) Supplemental

– may be used in modeling No --

835.1410 Volatility

– laboratory No Data -- No Not expected to be volatile under normal use conditions based on low vapor pressure and Henry’s Law Constant. While it has been observed in air in monitoring studies, the concentrations were below levels were effects could occur. 2

835.6100 Terrestrial field dissipation 45405218 Supplemental

No --

45405219 Acceptable -- 45405220 Acceptable -- 45405221 Acceptable -- 45405222 Supplemental --
835.6200 Aquatic field dissipation 45405215 Unacceptable No No direct applications to water.

### 29 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk assessment? Justification and Assumptions EPA will Make in Absence of Data

850.6100 Analytical method for soil 45405225 (ECM)

45405226

(ILV) Yes Submitted studies are inadequate to serve as the analytical method for soil. The LOQ of 0.01 mg/kg -soil (0.02 lbs a.i./A) is in sufficient to cover the lowest

measured terrestrial plant endpoint of 0.0004 lbs a.i./A ( 0.0002 mg/kg- soil) assuming a 1.5 g/mL soil density and six

- inch soil depth (MRID 47627402) (USEPA, 2012b). However, the lowest available endpoint is a greater than (>)

value and nondefinitive. T he final endpoint may be lower than 0.0004 lbs

a.i./A. Assuming that it may be as much as an order of magnitude lower, an analytical method with an LOQ of 0.02 μ g a.i./kg soil is needed.

Analytical method for water 45405227 (ECM) Not reviewable because an ILV is not available. Yes The lowest aquatic endpoint is 0.298 mg/L for sediment pore

- water (MRID 45405009). An ECM in water with an LOQ less than 0.298 mg/L is recommended to be available for monitoring because a potential for risk to aquatic organisms have been identified in previous risk assessments (USEPA, 2012b)

. In addition, the ILV component of this data requirement is needed.

Analytical method for sediment Not submitted -- Yes An ECM and ILV are needed to facilitate monitoring of residues of boscalid in sediment because there is a potential risk to sediment dwelling organisms in previous risk assessments (USEPA, 2012b).

850.1730 Fish bioconcentration 45405007 Acceptable No -- ILV=independent laboratory validation; ECM=environmental chemistry method; 2-CNA=2-chloronicotinic acid

1 The study was conducted on the parent unless otherwise specified.

2 Based on the results of the STIR model.



### b. Effects

Table 10 identifies ecological effects studies with boscalid, by MRID (or Accession number), for each guideline requirement, as we ll as study classifications and whether or not additional data are needed in order to s upport risk assessment. The rationale for any additional data requested is presented below the tables.

### 30 Table 10. Submitted ecological effects data for boscalid

Guideline Description

— Test Substance MRID or Acc. No. Study Classification Are data Needed for Risk Assessment? Comments (Justification and Assumptions EPA will Make in Absence of Data) Avian and Mammalian Testing

71-1 (850.2100) Avian acute oral toxicity, waterfowl

— TGAI None N/A No Other lines of evidence (data subacute dietary exposure and avian reproduction) suggest that waterfowl are no more sensitive

to boscalid exposure than the upland game species tested.

71-1 (850.2100) Avian acute oral toxicity, upland game bird species

— TGAI 45404922 Acceptable No

850.2100 Avian acute oral toxicity, passerine

species

— TGAI None N/A No Open literature data described in D405817+ indicate that acute risk of mortality to passerine birds is likely low.

Nonguideline Avian acute inhalation toxicity,

most sensitive species from oral

toxicity tests -- TGAI None N/A No Inhalation is not identified by STIR as a significant exposure route for boscalid.

850.2200 Avian dietary toxicity, waterfowl

species

— TGAI 45404924 Supplemental No Classified as supplemental due to poor rearing conditions and small sample size. However, the LC 50 was greater than the highest test concentration (LC 50 >5,000 mg

a. i. /kg diet), and new data would

be unlikely to impact the risk
assessment.

Avian dietary toxicity, upland game bird

— TGAI 45404923 Supplemental No Classified as supplemental due to poor rearing conditions and small sample size. However, the LC 50 was greater than the highest test concentration (LC 50 >5,000 mg

a. i. /kg diet), and new data would

be unlikely to impact the risk
assessment.

71-4 (850.2300) Avian reproduction, waterfowl species

— TGAI 45404925 Acceptable No

71-4 (850.2300) Avian reproduction, upland game bird

species

— TGAI 45404925 Acceptable No

### 31 Guideline Description

— Test Substance MRID or Acc. No. Study Classification Are data Needed for Risk Assessment? Comments (Justification and Assumptions EPA will Make in Absence of Data)

850.2400 Wild mammal toxicity

— TGAI None N/A No EFED is not currently recommending a wild mammal toxicity test per OCSPP 850.2400. Instead, EFED will evaluate risk to mammals based on toxicity data for laboratory rat or other mammals tested. EFED will consult with HED to identify

the most appropriate acute and

chronic toxicity endpoints.

850.2500 Simulated or actual field testing

— TEP None N/A No Not triggered based on ecotoxicity data, predicted EECs,

fate properties, and use pattern criteria. Aquatic Animal Testing

72-2 (850.1010) Freshwater invertebrate, acute

toxicity

— TGAI 45405001 Supplemental Yes Precipitate not filtered/centrifuged; water quality; uncertainty with measured concentrations. Data are not suitable for quantitative use in risk assessment.

72-2 (850.1010) Freshwater invertebrate, acute

toxicity

— TEP None N/A Yes ( TEP containing boscalid + pyraclostrobin ) Rat acute oral studies indicate that when boscalid is co

formulated with pyraclostrobin and/or lambda

- cyhalothrin, the LD 50 values measured for the coformulated products are lower than the LD 50 for boscalid alone.

Therefore, EPA recommends data on a represe ntative typical end-use product containing boscalid+pyraclostrobin. In the

absence of data, EFED may assume that hazard and risk is greater from exposure to this type of end product than from exposure to boscalid alone.

### 32 Guideline Description

— Test Substance MRID or Acc. No. Study Classification Are data Needed for Risk Assessment? Comments (Justification and Assumptions EPA will Make in Absence of Data)

72-2 (850.1010) Freshwater invertebrate, acute

toxicity

— TEP None N/A Yes ( TEP containing boscalid + pyraclostrobin

+ lambda

cyhalothrin) As noted in D398874, lambda

cyhalothrin is a pyrethroid, a class of chemicals that is known to exhibit greater than additive toxic effects when applied with other chemicals. Additionally, rat acute oral studies indicate that

when boscalid is co

- formulated

with pyraclostrobin and/or lambda

- cyhalothrin, the LD 50values measured for the coformulated products are lower than the LD 50 for boscalid alone.

Therefore, EPA recommends data on a representative typical

end- use product containingboscalid+lambacyhalothrin+pyraclostrobin. In the absence of data, EFED may assume that hazard and risk is greater from exposure to this type of end product than from exposure to boscalid alone.

72-2 (850.1010) Freshwater invertebrate, acute

toxicity

— TEP None N/A Yes ( TEP containing boscalid + chlorothalonil ) EPA recommends data on a representative typical end

- use product containing boscalid+chlorothalonil. In the

absence of data, EFED may assume that hazard and risk is greater from exposure to this type

of end use product than from exposure to boscalid alone.

72-3 (850.1025) Estuarine/Marine Mollusc acute toxicity

— TGAI 45405003 Acceptable No

72-3 (850.1035) Estuarine/Marine
crustacean acute toxicity

— TGAI 45405002 Acceptable Yes The study yielded a nondefinitive endpoint (LC 50 > 3,810 μ g a. i./L); the ratio of the highest concentration tested to previously calculated EECs is not high enough to evaluate risk to listed species for some uses.

850.1075 Freshwater fish, acute toxicity,

warm water species

— TGAI 45404928 Supplemental No Classified as supplemental due to water quality deviations and uncertainty with measured concentrations. New data are not recommended at this time because they are unlikely to impact the risk assessment.

### 33 Guideline Description

— Test Substance MRID or Acc. No. Study Classification Are data Needed for Risk Assessment? Comments (Justification and Assumptions EPA will Make in Absence of Data)

850.1075 Freshwater fish, acute toxicity, cold

water species

— TGAI 45404927 Supplemental No Classified as supplemental due to absence of measured concentrations. New data are not recommended at this time.

850.1075 Estuarine/Marine fish acute toxicity

— TGAI 45405004 Acceptable No The study yielded a nondefinitive endpoint (LC 50 > 3,860 ug a. i./L); the ratio of the highest concentration tested to previously calculated EECs is not high enough to evaluate risk to listed

species for some uses. In the absence of additional data on acute toxicity to estuarine/marine

fish, EPA may use an acute-tochr onic ratio for freshwater fish to assess acute risk to estuarine/marine fish.

72-4 (850.1300) Freshwater invertebrate, reproduction test

— TGAI 46351406 Acceptable No

850.1350 Estuarine/marine invertebrate, reproduction test

— TGAI None N/A Yes In the absence of data, EPA will be unable to assess chronic risk to

estuarine/marine invertebrates. Risk may be assumed.

850.1400 Freshwater fish, early life stage

test

— TGAI 45405006 Supplemental No Classified as supplemental due to water quality deviations and uncertainty with measured concentrations. New data are not recommended at this time because they are unlikely to impact the risk assessment

850.1400 Estuarine/marine fish, early life stage
test

— TGAI None N/A Yes In the absence of data, EPA will be unable to assess chronic risk to estuarine/marine fish. Risk may be assumed.

850.1500 Freshwater fish life cycle test None N/A Yes Aquatic EECs (up to 152 ug a.i./L in D416697+) exceed the FW fish

early life

- stage (ELS) NOAEC (116 μ g a.i./L); a full life cycle test is recommended when the EEC is at least one- tenth the NOAEC. A protocol should be submitted for review prior to test initiation.

### 34 Guideline Description

— Test Substance MRID or Acc. No. Study Classification Are data Needed for Risk Assessment? Comments (Justification and Assumptions EPA will Make in Absence of Data)

Estuarine/marine fish life cycle test None N/A No This data recommendation may be triggered in the future depending on results of the e/m early life stage test.

850.1950 Simulated or actual field testing for aquatic organisms None N/A No Not triggered based on ecotoxicity data, predicted EECs,

fate properties, and use pattern criteria. Sediment Testing

850.1735 Whole sediment 10- d freshwater invertebrate

— TGAI 45405009 Supplemental No Classified as supplemental because boscalid recoveries varied substantially based on

analytical method; solvent controls sig. different from negative controls. Given boscalid’s persiste nce, a chronic study is recommended (see below).

850.1740 Whole sediment 10- d estuarine/marine

invertebrate

— TGAI None N/A No Given boscalid’s persistence , it is recommended that the registrant

proceed directly to a chronic

sediment test (see below).

Agency

- wide guideline Whole sediment chronic freshwater

estuarine/marine invertebrate (three species)

— TGAI 45405008 Supplemental Yes Earlier submission classified as supplemental because boscalid was applied to overlying water and not directly to sediment and because measured concentrations were not provided. In the absence of data, EPA may assume that hazard and risk to invertebrates exposed to boscalid residues in sediment are greater than those from exposure in the water column. It is recommended that the registrant conduct tests with three species (including freshwater and estuarine/marine) and to submit a protocol for review prior to test initiation. Insect Pollinator Testing

850.3020 Honey bee acute contact toxicity

— TGAI and TEP 45405019 48470202 Acceptable Supplemental No

Nonguideline Honeybee acute oral toxicity study

— TGAI and

TEP 45405019 48470202 Acceptable Supplemental No

### 35 Guideline Description

— Test Substance MRID or Acc. No. Study Classification Are data Needed for Risk Assessment? Comments (Justification and Assumptions EPA will Make in Absence of Data)

Nonguideline Larval Toxicity Test

— TGAI 49361801 Supplemental No

850.3030 Honeybee toxicity of residues on foliage

— TEP None N/A No

850.3040 Field testing for pollinators

– TGAI and TEP 49009301 49009303 48470201 Supplemental Supplemental Supplemental No This guideline number (850.3040) was used as a placeholder to recommend higher tier (semi-field) studies evaluating effects of boscalid a.i. and Pristine ® exposure , respectively, on honey bee brood

development ; one study with Pristine ® (MRID 49009303) also examined queen cell development.

Nonguideline Determination of residues in royal jelly and pollen

–

TEP (Pristine ®

,

boscalid + pyraclostrobin) 49009304 Supplemental No The formulated product (Pristine ® ) was not applied while bees were actively foraging and

there is uncertainty as to the extent that residues may have differed had bees been actively foraging. Control colonies were not treated with adjuvant; ideally, the controls should be treated in the same manner as the treatment groups minus the use of Pristine ®

. Terrestrial Plant Testing

850.4100 Seedling emergence (10 species)

— TEP 47627401 Acceptable No Measured treatment rates were not reported.

850.4150 Vegetative vigor (10 species)

— TEP 47627402 Supplemental Yes (cabbage

only) Treatment rates were too high to establish definitive endpoints for the most sensitive dicot (cabbage). In the absence of data, EPA may conclude risk to listed and nonlisted species of dicot plants. Aquatic Plant Testing

850.4400 Aquatic plant growth, vascular plant

— TGAI 45405013 Acceptable No

### 36 Guideline Description

— Test Substance MRID or Acc. No. Study Classification Are data Needed for Risk Assessment? Comments (Justification and Assumptions EPA will Make in Absence of Data)

850.4500* Aquatic Plant, freshwater green

alga species

— TGAI 45405017 Supplemental No Classified as supplemental because study conditions were poorly described. New data are

not recommended at this time because they are unlikely to impact the risk assessment Aquatic Plant, freshwater diatom

— TGAI 45405014 Acceptable No

Aquatic Plant, marine diatom

— TGAI 45405016 Acceptable No

850.4550 † Aquatic Plant, cyanobacterium

— TGAI 45405015 Supplemental No Classified as supplemental because of uncerta inty with measured concentrations. The EC 50 and IC 50 were greater than the highest concentration tested ( i.e , > 4 mg/L nominal). New data are not recommended at this time because they are unlikely to impact the risk assessment.

Other

Nonguideline 14

- day toxicity to soil- dwelling invertebrates (earthworm ) 45405020 Supplemental No Classified as a supplemental, nonguideline study; deficiencies included an insufficient acclimation period and the absence of measured concentrations and stability data. For earthworms, a 28

- day study

is generally preferred, though there is no active EPA guideline requirement for this. TGAI = Technical Grade Active Ingredient TEP = typical end-use product * Algal toxicity tests are now under guideline OCSPP 850.4500 (formerly 850.5400) † Cyanobacterium tests are now under guideline 850.4550 (formerly 850.5400)



### 12. References



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### 37 http://pubs.usgs.gov/of/2012/1213/pdf/ofr2012-1213_report_508_rev092712.pdf (Accessed August 8, 2014). FAO. 2000. Appendix 2. Parameters of pesticides that influence processes in the soil. In FAO Information Division Editorial Group (Ed.), Pesticide Disposal Series 8. Assessing Soil Contamination. A Reference Manual . Rome: Food & Agriculture Organization of the United Nations (FAO). Available at http://www.fao.org/DOCREP/003/X2570E/X2570E06.htm (Accessed July 10, 2009). Fungicide Resistance Action Committee. 2012. FRAC code list fungicides sorted by mode of action including FRAC code numbering. Available at http://www.frac.info/frac/index.htm (Accessed August 23, 2012). Mathur, S. 2002.D285692. Secondary Product Chemistry Review of MP . D. B. 3285692. October 31, 2002. Registration Division. Office of Pesticide Programs. United States Environmental Protection Agency. NAFTA. 2012. Guidance for Evaluating and Calculating Degradation Kinetics in Environmental Media . December 2012. NAFTA Technical Working Group on Pesticides. Available at http://www.epa.gov/oppfea d1/international/naftatwg/guidance/degradationkin.pdf (Accessed April 11, 2014). Nelson, H., Bietlot, H., & Levy, A. 2003. BAS 510F in/on Various Plant and Animal Commodities. HED Metabolism Assessme nt Review Committee (MARC) Memo

. D286786. January 9,2003. Health Effects Divison. Office of Pesticide Programs. United States Environmental Protection Agency. Reilly, T., Smalling, K., Orlando, J. L., & Kuivila, K. M. 2012. Occurrence of boscalid and other selected fungicides in surface water and groundwater in three targeted use areas in the United States. Chemosphere, 89 , 228-234. Schumer, C., Mothiron, E., Appenzeller, B. M. R., Rizet, A., Wennig, R., & Millet, M. 2010. Temporal variations of concentrations of currently used pesticides in the atmosphere of Strasbourg, France. Environmental Pollution, 158 , 576-584. Smalling, K., & Orlando, J. L. 2011. United States Geological Survey. Occurrence of Pesticides in Surface Water and Sediments from Three Central Califorina Coastal Watersheds, 2008-09 . Data Series 600. Available at Occurrence of Pesticides in Surface Water and Sediments from Three Central Califorina Coastal Watersheds, 2008-09 (Accessed March 11, 2013). USEPA. 2003.D278387+. EFED Risk Assessment for Section 3 Registration of BAS 510 F (Nicobifen) . D. D278387, D278389, D278390, D278418. May 28, 2003. Environmental Fate and Effects Division. Office of Prevention, Pesticides, and Toxic Substances. U.S. Environmental Protection Agency. USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs . Environmental Fate and Effects Division. Office of Pesticide Programs. U.S. Environmental Protection Agency. Available at http://www.epa.gov/espp/consultation/ecorisk-overview.pdf (Accessed June 19, 2009). USEPA. 2006. Standardized Soil Mobility Classification Guidance . Memorandum From S. Bradbury to E. F. a. E. Division. April, 21, 2006. Environmnental Fate and

### 38 Effects Division. Office of Pesticide Program s. Office of Prevention, Pesticides, and Toxic Substances. United State Environmental Protection Agency. USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.6100 Terrestrial Field Dissipation . EPA 712-C-08-020. October 2008. Office of Prevention, Pesticides, and Toxic Substances. U.S. Environmental Protection Agency. Available at http://www.epa.gov/opptsfrs/publications/835_6100.pdf (Accessed July 30, 2009). USEPA. 2009a. Estimation Program Interface (EPI) Suite: United States Environmental Protection Agency. Available at http://www.epa.gov/oppt/exposure/pubs/episuite.htm (Accessed August 24, 2012). USEPA. 2009b. SAP Minutes No. 2009-01. A set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: Selected Issues Associated with the Risk Assessment Process for Pesticides with Persistent, Bioaccumulative, and Toxic Characteristics. October 28-31, 2008. January 29, 2009. FIFRA Scientific Advisory Panel. Office of Sc ience Coordination and Policy. Available
at http://www.epa.gov/scipoly/sap/meetings/2008/102808_mtg.htm (Accessed July 9, 2009). USEPA. 2010.D363523. Boscalid Section 3: Environmental Fate and Ecological Risk Assessment for the Proposed New Uses on Alfalfa and Citrus (Group 10)

. D363523. February 19, 2010. Environmental Fate and Effects Division. Office of Prevention, Pesticides, and Toxic Substances. U.S. Environmental Protection Agency. USEPA. 2010. Guidance for Reporting on the Environmental Fate and Transport of the Stressors of Concern in the Problem Formulation for Registration Review, Registration Review Risk Assessments, Li sted Species Litigation Assessments, New Chemical Risk Assessments, a nd Other Relevant Risk Assessments . January 25, 2010. Environmental Fate and Effects Division. Office of Chemical Safety and Pollution Prevention. U.S. Envi ronmental Protection Agency. Available at http://www.epa.gov/pesticides/science/ efed/policy_guidance/team_authors/endan gered_species_reregistration_workgroup/esa_reporting_fate.htm (Accessed July 5, 2012). USEPA. 2012a. Criteria Used by the PBT Profiler . September 4, 2012. Office of Chemical Safety and Pollution Prevention. United States Environmental Protection Agency. Available at http://www.pbtprofiler.net/criteria.asp (Accessed September 7, 2012). USEPA. 2012b. Environmental Chemistry Method Guidance . Memorandum From D. Brady to Environmental Fate and Effects Division. December 20, 2012. Environmental Fate and Effects Division. Office of Pesticide Programs. Office of Chemical Safety and Pollution Prev ention. U.S. Environmental Protection Agency. USEPA. 2012c. Standard Operating Procedure for Using the NAFTA Guidance to Calculate Representative Half-life Values and Characterizing Pesticide Degradation . November 30, 2012. Environmental Fate and Effects Division. Office of Pesticide Programs. U.S. Environmental Protection Agency. Available
at

### 39 http://www.epa.gov/oppefed1/ecorisk_ders/degradation_kinetics/NAFTA_Degrad ation_Kinetics.htm (Accessed December 16, 2013). USEPA. 2013.D405817+. Environmental Fate and Ecological Risk Assessment for the Proposed New Uses of Boscalid for Various Agricultural Crops, Ornamentals, and Residential Gardens . D405817+. August 13, 2013. Environmental Fate and Effects Division. Office of Pesticide P rograms. U.S. Environmental Protection Agency. USEPA. 2013.D409880. Tier I Drinking Water Exposure Assessment for the Section 3 New Use of Boscalid on Various Agricultural Crops and Homeowner Uses

. D409880. April 30, 2013. Environmental Fate and Effects Division. Office of Pesticide Programs. U.S. Environmental Protection Agency. USEPA. 2014a. BEAD Chemical Profile for Registration Review: Boscalid (128008)

. Memorandum From L. Yourman, J. Alsadeck & M. RAnville to M. Piansay. Biological and Economic Analysis Division. Office of Pesticide Programs. U.S. Environmental Protection Agency. USEPA. 2014b. Boscalid: Screening Level Usage Analysis . February 14, 2014. Biological and Economic Analysis Division. Office of Pesticide Programs. U.S. Environmental Protection Agency. USEPA. 2014c. Drinking Water and Ecological Risk Assessment in Support of the Boscalid Section 3 New Use on Stone Fruit Group 12-12, Tree Nut Group 14-12, Herb Subgroup Subgroup 19A, and Dill Seed . D416697+. August 2014. Environmental Fate and Effects Division. Office of Pesticide Programs. U.S. Environmental Protection Agency. USEPA. 2014d. Surface Water Concentration Calculator User Manual . USEPA/OPP 734F14001. July 1, 2014. Environmental Fate and Effects Division. Office of Pesticide Programs. U.S. Environmental Protection Agency. Available at http://www.epa.gov/oppefed1/models/water/#swcc (Accessed August 11, 2014). Wharton, P. S. 2010. Fungicides - A practical approach to resistance management for potato diseases . Available at http://www.potatodiseases.org/pdf/FungicideResistance-Management.pdf (Accessed August 11, 2014).40Appendix A. Summary of registeredproducts containing boscalidRegistration#NameStatusPercentActiveIngredientActive Ingredient(s)4-488BONIDE FT09Registered (16-May-2013)5.622boscalid0.5lambda-Cyhalothrin3.06Pyraclostrobin499-553TC-308ConditionallyRegistered (20-Dec2011)1.75Pyraclostrobin3.5boscalid7969-196EMERALD FUNGICIDERegistered (23-Jul-2003)70boscalid7969-197ENDURA FUNGICIDERegistered (23-Jul-2003)70boscalid7969-198BOSCALID TECHNICALRegistered (23-Jul-2003)99boscalid7969-199PRISTINE FUNGICIDERegistered (23-Jul-2003)25.2boscalid12.8Pyraclostrobin7969-248BAS 516 ST SEED TREATMENTFUNGICIDEConditionallyRegistered (30-May-2007)25.2boscalid12.8Pyraclostrobin7969-251PAGEANT INTRINSIC BRANDFUNGICIDEConditionallyRegistered (28-Feb-2008)25.2boscalid12.8Pyraclostrobin7969-255HONOR INTRINSIC BRANDFUNGICIDEConditionallyRegistered (03-Jul-2007)11.2boscalid16.8Pyraclostrobin417969-274CORONET FUNGICIDE SEEDTREATMENTConditionallyRegistered (22-May-2008)18boscalid9Pyraclostrobin7969-348Encartis FungicideRegistered (01-Nov-2012)54.14Chlorothalonil2.2boscalid7969-353Homeowner Garden Spray FungicideRegistered (20-Nov-2013)18boscalid9PyraclostrobinOR070001ENDURA FUNGICIDEUnder Review (02-May-2007)70boscalidSD090006PRISTINE FUNGICIDERegistered (22-Jan-2010)25.2boscalid12.8PyraclostrobinSD090007EMERALD FUNGICIDERegistered (22-Jan-2010)70boscalid

### 42 Appendix B. Submitted En vironmental Fate Studies

MRID Citation Reference 63-0 Reports of Multiple phys/chem Characteristics 45404803 Kastel, R. (2001) Physical and Chemical Properties of PS 300 355 (BAS 510 F): Final Report: Lab Project Number: PCF 01895: Unpublished study prepared by BASF Aktiengesellschaft. 15 p. (OPPTS 830.6302, 830.6303, 830.6304, 830.6313, 830.7000, 830.7200, 830.7300)
45438501 Sears, L. (2001) BAS 510 F Active Ingredient: Comp rehensive Data Summary: Lab Project Number: M11: 2001/5001183: 1998/10640. Unpublished study prepared by BASF Canada. 522 p.
45438502 Sears, L. (2001) BAS 510 02F Active Ingredient: BAS 510F: Comprehensive Data Summary End Use Product: Lab Project Number: M

- 111: 2001/5001185. Unpublished study prepared by BASF Canada. 160
p. 45438503 Sears, L. (2001) BAS 510 02F Active Ingredient: BAS 510F Pyraclostrobin: Comprehensive Data Summary End Use Product: Lab Project Number: M

- 111: 2001/5001186. Unpublished study prepared by BASF Canada. 82 p. 63-3 Physical State 45404802 Daum, A. (2001) Determination of the Melting Point an d the Appearance of BAS 510 F: Final Report: Lab Project Number: PCP05375: 1999/10991. Unpublished st udy prepared by BASF Aktiengesellschaft. 9 p. (OPPTS 830.7200)
45405311 Yacoub, R. (2000) BAS 516 02F: Determination of Physical State, Bulk Density, and pH: Lab Project Number: 48146: 2000/5255. Unpublished study prepar ed by BASF Corporation. 10 p. (OPPTS 830.6303, 830.7000, 830.7300)
45405321 Yacoub, R. (2000) BAS 510 02F: Determination of Physical State, Bulk Density, and pH: Final Report: Lab Project Number: 44129: 2000/5211. Unpublished st udy prepared by BASF Corporation. 10 p. (OPPTS 830.6303, 830.7000, 830.7300)
47285603 Horsler, C. (2007) Physical and Chemical Properties of Pyraclostrobin/Boscalid 100/200 g/L FS, BAS 516 09 F: Storage Stability for Up to 8 Weeks at 40 Degr ees Celsius in Commercia l Packs. Project Number: MX/06/034/1, 2006/1024716. Unpublished study prepared by Battelle UK Ltd. 22 p.
48311301 Reed, L. (2010) Physical and Chemical Characteristics of TC-308 [BAS 516 HA F]. Project Number: 09/0529, 2516. Unpublished study prepared by Whitmi re Micro-Gen Research Laboratories, Inc. 11 p. 63-5 Melting Point 45404802 Daum, A. (2001) Determination of the Melting Point an d the Appearance of BAS 510 F: Final Report: Lab Project Number: PCP05375: 1999/10991. Unpublished st udy prepared by BASF Aktiengesellschaft. 9 p. (OPPTS 830.7200) 63-7 Density 45404806 Kastel, R. (1999) Physical Properties of 300 355 (P AI): Lab Project Number: PCF 01962: 199/10203. Unpublished study prepared by BASF Aktie ngesellschaft. 13 p. (OPPTS 830.7950) 45405311 Yacoub, R. (2000) BAS 516 02F: Determination of Physical State, Bulk Density, and pH: Lab Project Number: 48146: 2000/5255. Unpublished study prepar ed by BASF Corporation. 10 p. (OPPTS 830.6303, 830.7000, 830.7300)
45405321 Yacoub, R. (2000) BAS 510 02F: Determination of Physical State, Bulk Density, and pH: Final Report: Lab Project Number: 44129: 2000/5211. Unpublished st udy prepared by BASF Corporation. 10 p. (OPPTS 830.6303, 830.7000, 830.7300)
47285603 Horsler, C. (2007) Physical and Chemical Properties of Pyraclostrobin/Boscalid 100/200 g/L FS, BAS 516 09 F: Storage Stability for Up to 8 Weeks at 40 Degr ees Celsius in Commercial Packs. Project Number: MX/06/034/1, 2006/1024716. Unpublished study prepared by Battelle UK Ltd. 22 p.

### 43 48311301 Reed, L. (2010) Physical and Chemical Characteristics of TC-308 [BAS 516 HA F]. Project Number: 09/0529, 2516. Unpublished study prepared by Whitmi re Micro-Gen Research Laboratories, Inc. 11 p. 63-8 Solubility 45404804 Daum, A. (1998) Determination of the Solubility of BAS 510 F in Water at 20 Degrees C by Column Elution Method and by HPLC: Final Report: Lab Project Number: PCP04888: 1998/10961. Unpublished study prepared by BASF Aktiengesellschaft. 16 p. (OPPTS 830.7840)
45404805 Daum, A. (1998) Determination of the Solubility of BAS 510 F Pure Active Ingredient (PAI) in Organic Solvents at 20 Degrees Celsius: Final Report: Lab Project Number: PCP048676: 1998/10953. Unpublished study prepared by BASF Aktiengesellschaft. 13 p. (OPPTS 830.7840) 63-9 Vapor Pressure 45404806 Kastel, R. (1999) Physical Properties of 300 355 (P AI): Lab Project Number: PCF 01962: 199/10203. Unpublished study prepared by BASF Aktie ngesellschaft. 13 p. (OPPTS 830.7950)
63-10 Dissociation Constant 45404807 Daum, A. (1998) Determination of the pKa of BAS 510.F in Water at 20 Degrees Celsius: Lab Project Number: PCP04896: 1998/10967. Unpublished study prep ared by BASF Aktiengesellschaft. 13 p. (OPPTS 830.7370) 63-11 Oct/Water partition Coef. 45404809 Daum, A. (1998) Determination of the Octanol/Water-Pa rtition Coefficient of BAS 510 F by HPLC: Final Report: Lab Project Number: PCP05017: 1998/11082. Unpublished study prepared by BASF Aktiengesellschaft. 17 p. (OPPTS 830.7570) 132-1 Dissipation of Dislodgeable Foliar & Soil Residues 45405301 Haughey, D.; Jones, J. (2001) BAS 510 UCF Turf Tr ansferable Residue Study: Final Report: Lab Project Number: 2001/5001157. Unpublished study prepared by BASF Agro Research. 54 p. (OPPTS 875.2100) 45405302 Haughey, D.; Jones, J. (2001) BAS 510 UCF Disl odgeable Foliar Residue Study in Tomatoes: Final Report: Lab Project Number: 64150: 2001/5000837. Unp ublished study prepared by BASF Agro Research and Crop Management Strategies, Inc. 61 p. (OPPTS 875.2100)
45405303 Haughey, D.; Jones, J. (2001) BAS 510 UCF Dislod geable Foliar Residue Study in Grapes: Final Report: Lab Project Number: 2001/5000839: 64078. Unpublished study prepared by BASF Agro Research. 73 p. (OPPTS 875.2100)
45405304 Haughey, D.; Jones, J. (2001) BAS 510 UCF Dislodgeable Foliar Residue Study in Peaches: Final Report: Lab Project Number: 63916: 1999/5191. Unpublished study prepared by BASF Agro Resear ch and Research for Hire. 72 p. (OPPTS 875.2100)
45405305 Haughey, D.; Jones, J. (2001) BAS 510 UCF Dislodgeable Foliar Residue Study in Strawberries: Final Report: Lab Project Number: 1999/5193: 63914. Unpublis hed study prepared by BASF Agro Research and Research for Hire. 72 p. (OPPTS 875.2100)
45672102 Haughey, D. (2002) Response to PMRA Request for Clarification for: BAS 510 02F Crop Fungicide and BAS 510 02F Turf Fungicide: Lab Project Number: 2002/5002770: 64150: 200281. Unpublished study prepared by BASF Agro Resear ch. 271 p. (OPPTS 875.2100) 161-1 Hydrolysis 45405205 von Gotz, N. (1999) Hydrolysis of BAS 510 F: Lab Project Number: 41874: 1999/11285. Unpublished study prepared by BASF Aktiengesellschaft. 21 p. 161-2 Photodegradation-water 45405206 von Gotz, N. (1999) Aqueous Photolysis of BAS 5 10 F: Final Report: Lab Project Number: 41875: 1999/111804. Unpublished study prepared by BASF Aktiengesellschaft. 28 p. 161-3 Photodegradation-soil 45405207 von Goetz, N. (2000) Soil Photolysis of BAS 5 10 F: Final Report: Lab Project Number: 41859: 2000/1014989. Unpublished study prepared by BASF Aktiengesellschaft. 37 p.
162-1 Aerobic soil metabolism

### 44 45405208 Stephan, A. (1999) Metabolism of BAS 510F (Carbon 14-Diphenyl and Carbon 14-Pyridin) in Soil Under Aerobic Conditions: Lab Project Number: 42381: 1999/1 1807. Unpublished study prepared by BASF Aktiengesellschaft. 105 p.
45405209 Ebert, D.; Harder, U. (2000) Degradation of (Ca rbon 14)-Chloronicotinic Acid in Soil under Aerobic Conditions: Lab Project Number: 54518: 2000/1013280. Unpublished study prepared by BASF Aktiengesellschaft. 31 p.
45405210 Paulick, R. (2001) Aerobic Soil Metabolism of (Carbon 14)-BAS 510 F: Lab Project Number: 64052: 2001/5001022. Unpublished study prepared by BASF Corporation. 63 p.
45643802 Paulick, R. (2002) Aerobic Soil Metabolism of (C arbon 14)-BAS 510 F: Lab Project Number: 2002/5002772: 64052. Unpublished study prepared by BASF Agro Research. 93 p.
162-2 Anaerobic soil metabolism 45405211 Staudenmaier, H. (2000) Anaerobic Metabolism of BAS 510 F in Soil (Carbon 14-Pyridine Label): Final Report: Lab Project Number: 41858: 2000/10149 90. Unpublished study prepared by BASF Aktiengesellschaft. 50 p.
45405212 Staudenmaier, H.; Schafer, C. (2000) Anaerobic Me tabolism of BAS 510 F in Soil (Carbon 14-Diphenyl Label): Final Report: Lab Project Number: 42382: 2000/1014986. Unpub lished study prepared by BASF Aktiengesellschaft. 57 p. 162-3 Anaerobic aquatic metab. 45405213 Paulick, R.; Baucom, M. (2001) Anaerobic Aquatic Me tabolism of (Carbon 14)-BAS 510 F: Lab Project Number: 42385: 2001/5001021. Unpublished study prepared by BASF Corporation and AgVise Laboratories. 80 p. 162-4 Aerobic aquatic metab. 45405214 Ebert, D. (2000) Degradation of BAS 510 F in Aerobic Aquatic Environment: Final Report: Lab Project Number: 2000/1000135: 41856. Unpublished study pr epared by BASF Aktiengesellschaft. 85 p. 163-1 Leach/adsorp/desorption 45405216 Seher, A. (1998) BAS 510 F-Soil Adsorption / Desorption Study of 300 355: Lab Project Number: 1998/10513: PI970023. Unpublished study prep ared by BASF Aktiengesellschaft. 64 p. 45405217 Seher, A. (2001) Adsorption/Desorption-Study of 107371 (M510f47) on 3 US Soils: Final Report: Lab Project Number: 2001/1000967: 9100031. Unpublished study prepared by BASF Aktiengesellschaft. 39 p. 164-1 Terrestrial field dissipation 45405218 Oliver, G.; Saha, M.; Jackson, S. (2001) 1999 Field Dissipation of BAS 510..F in Orchard/Vineyard Use Patterns: Lab Project Number: 47616: 2000/5277. Un published study prepared by AgriScope, LLC., Research For Hire and ACDS Research, Inc. 400 p.
45405219 Jackson, S.; Saha, M.; McDonell, J. et al. (2001) 1999 Field Dissipation of BAS 510..F in Turf Use Patterns: Lab Project Number: 46626: 2001/5000833. Unpublished study prepared by Crop Management Strategies, Inc., Alvey Ag Research, and South Texas Ag Research. 559 p.
45405220 Jackson, S.; Saha, M.; McDonell, J. (2001) 1999 F ield Dissipation of BAS..F in Raw Crop Use Patterns: Lab Project Number: 46699: 2001/5000936. Unpublishe d study prepared by Research For Hire, Smith Biological Services, and Research Options, Inc. 399 p.
45405221 Jackson, S.; Saha, M.; McDonell, J. (2001) 1999 F ield Dissipation of BAS 5 10..F in Terrestrial Use Patterns: Lab Project Number: 46767: 2001/5000937: ADPEN -903-2K-B46767- 001. Unpublished study prepared by BASF Agro Research , Northern Plaines Ag Research, and Agrisan, Inc. 243 p.
45405222 Jackson, S.; Saha, M.; McDonell, J. (2001) 1999 F ield Dissipation of BAS 5 10..F in Terrestrial Use Patterns for Canada: Lab Project Nu mber: 58847: 2001/5000938: ADPEN -903-2K-D58647-001. Unpublished study prepared by BASF Agro Research , Vaughn Agricultural Res earch Services, and ICMS, Inc. 285 p. 45405223 Gooding, R. (2001) Freezer Storage Stability Stud y of BAS 510 F, 2-Chloronicotinic Acid, and 2- Hydroxy -N-(4'-Chlorobiphenyl-2-yl)Nico tinamide in Soil Using LC-MS/ MS: Lab Project Number: 46656: 2001/5000904. Unpublished study prepared by BASF Corporation. 62 p.

### 45 45405224 Stephan, A. (2000) Storage Stability of BAS 510 F in Soil: Final Report: Lab Project Number: 41865: 2000/1000136. Unpublished study prepared by BASF Aktiengesellschaft. 43 p.
45405225 Saha, M. (2001) Validation of BASF Method No. D0004 and D0004/1: The Determination of Residues of BAS 510 F and its Metabolites in Soil Using LC -MS/MS: Lab Project Number: 46625: 2001/5000881. Unpublished study prepared by BASF Corporation. 137 p.
45405226 Saha, M.; South, N. (2001) Independent Meth od Validation of BASF Analytical Method D0004/1: Amended Final Report: Lab Project Number: AG000097: 43695: 2001/5000882. Unpublished study prepared by Battelle Memorial Institute. 41 p.
45405227 Saha, M. (2001) Analytical Method CP-No. 327: The Determination of BAS 510 F in Water: Lab Project Number: 2001/5001127. Unpublished study prepar ed by Wildlife International, Ltd. 20 p. 165-1 Confined rotational crop 45405204 Hamm, R.; Veit, P. (2001) Confined Rotational Crop Study with (Carbon 14)-BAS 510 F: Lab Project Number: 41838: 2000/1014862: Unpublished study prep ared by BASF Aktiengesellschaft. 257 p. (OPPTS 860.1850) 165-2 Field rotational crop 45405203 Haughey, D.; Abdel-Baky, S. (2001) Limited Rotatio nal Crop Study for the Use of BAS 510 F: Final Report: Lab Project Number: 46697: 2001/5000966. Un published study prepared by BASF Corporation. 88 p. (OPPTS 860.1900)
45623409 Versoi, P.; Abdel -Baky, S. (2002) Magnitude of the Residue of BAS 510 F in Peas and Beans Planted As Rotational Crops and of BAS 500 F In Peas and Beans When Applied as a Foliar Spray: Final Report: Lab Project Number: 130001: 2001/5003311: 66690. Unpublished study prepared by BASF Agro Research. 118 p. (OPPTS 860.1900 and 860.1500)
45623411 Jordan, J. (2002) Field Rotational Study for BAS 510 F on Grasses, Alfalfa and Clover As Livestock Feed Crops: Final Report: Lab Project Number: 2002/5002063: 66692: F -96/1. Unpublished study p repared by BASF Agro Research. 105 p. (OPPTS 860.1900)
45623412 Jordan, J. (2002) Cereal Grains and Soybean Field Rotational Crop Study for BAS 510 F: Final Report: Lab Project Number: 2002/5001341: 64382: RCN 2001129 . Unpublished study prepared by BASF Agro Research. 231 p. (OPPTS 860.1900)
45623413 Jordan, J. (2002) Cotton Field Rotational Crop Study for BAS 510 F: Final Report: Lab Project Number: 2002/5002425: 66690: BAS 510 UCF. Unpublished study prepared by BASF Agro Research. 51 p. (OPPTS 860.1900)

165-4 Bioaccumulation in fish 45405007 Chapelo, S.; Caley, C. (2000) Bioaccumulation and Metabolism of (Carbon 14) BAS 510 Rainbow Trout: Final Report: Lab Project Number: 18219: 2000/1 017222: 394178. Unpublished study prepared by Inveresk Research. 176 p. 171-4B Residue Analytical Methods 45405027 Jones, J. (2001) Method for Determination of BAS 5 00 F, BF 500-3, and BAS 510 F Residues in Plant Matrices Using LC/MS/MS: Final Report: Lab Project Number: 64692: 2001/5001020: D9908. Unpublished study prepared by BASF Agro Research. 79 p. (OPPTS 860.1340)
45405028 Jordan, J. (2001) Independent Method Validation of BASF Analytical Method D0008 Entitled "Method for Determining BAS 510 F in Plant and Turf Cloth Ma trices Using GC/MS and Dislodgeable Foliar Sample Using HPLC/UV": Lab Project Number: 2001/5000880: 64954: D0008. Unpublished study prepared by BASF Corporation. 61 p. (OPPTS 860.1340)
45405101 Adbel -Baky, S.; Jones, J. (2001) Validation of BASF Analytical Method D0008, Method for Determining BAS 510 F in Plant and Turf Cloth Matrices Us ing GC/MS and Dislodgeable Foliar Samples Using HPLC/UV: Final Report: Lab Project Number: 6427 6: 2001/5000977: D0008. Unpublished study prepared by BASF Agro Research. 97 p. (OPPTS 860.1340)

### 46 45405103 Class, T. (2001) Assessment and Validation of the Adapted Multi-Residue Method DFG S19 Determination of BAS 510 F and its Metabolite M510F01 in Animal Matr ices: Final Report: Lab Project Number: P/B 453 G: 2000/1017227: DFG S19. Unpublished study pr epared by PTRL Europe. 88 p. (OPPTS 860.1340) 45405105 Fabian, E. (2001) The Validation of BASF Method 476/ 0: The Determination of BAS F Residues (as M510F53) in Liver and Milk by Microwave Treatment: Final Report: Lab Project Number: 96997: 476/0: 2000/1017224. Unpublished study prepared by BASF Aktiengesellschaft. 42 p. (OPPTS 860.1340)
45405106 Grosshans, F. (2001) The Validatio n of BASF Method 471/0: The Determination of BAS 510F and the Metabolite M510F01 in Animal Ma trices: Final Report: Lab P roject Number: 42392: 471/0: 2000/1017223. Unpublished study prepared by BASF Aktiengesellschaft. 74 p. (OPPTS 860.1340)
45405107 Fomenko, J. (2001) PAM I Multiresidue Testing for BAS 510 F and its Hydroxy Metabolite (M 510 F01): Lab Project Number: A054. 006: 2001/5000875: 46647. Unpublished study prepared by Maxim Technologies, Inc. 89 p. (860.1360) 171-4C Magnitude of the Residue [by commodity] 45405102 Kampke -Thiel, K. (2001) Independent Laboratory V alidation of the Adapted Multi-Residue Method DFG S19 for the Determination of BAS 510 F and its Metabolite M510F01 in Animal Matrices: Final Report: Lab Project Number: 42397: 2000/1017226: P453 G. Unpublished study prepared by BASF Aktiengesellschaft. 127 p. (OPPTS 860.1340)
45405108 Grosshans, F. (2001) Investigation of the Stability of Residues of BAS 510 F and MF510F01 in Sample Material of Animal Origin Under Usual Storage Cond itions: Final Report: Lab Project Number: 42403: 2000/1017229. Unpublished study prepared by B ASF Aktiengesellschaft. 47 p. (OPPTS 860.1380)
45405109 Funk, H.; Mackenroth, C. (2001) Investigation of the S tability of Residues of BAS 510 F in Matrices under Normal Storage Conditions: Lab Project Number: 4 1851: 200/1014855. Unpublished study prepared by BASF Aktiengesellschaft. 33 p. (OPPTS 860.1380)
45405111 Haughey, D.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Almonds: Final Report: Lab Project Number: 63902: 2000/5226: 99135. Unpublis hed study prepared by BASF Corporation. 53 p. (OPPTS 860.1500)
45405112 Versoi, P.; Adbel-Baky, S. (2000) Th e Magnitude of BAS 510 F Residues in Dry Bulb and Green Onions: Final Report: Lab Project Number: 2000/5207: 63894: 99171 (PA/1). Unpublished study prepared by BASF Corporation. 55 p. (OPPTS 860.1500)
45405113 Versoi, P.; Abdel-Baky, S. (2000) Th e Magnitude of BAS 510 F Residues in Carrots: Final Report: Lab Project Number: 63896: 2000/5208: 99180 (FL/3). Unpub lished study prepared by BASF Corporation. 50 p. (OPPTS 860.1500)
45405114 Haughey, D.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Strawberries: Final Report: Lab Project Number: 63910: 2000/5227: 99157 (PA/1). Unpublished study prepared by BASF Corporation. 50 p. (OPPTS 860.1500)
45405115 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Pistachios: Final Report: Lab Project Number: 63898: 2000/5229: 99337 (CA/ 10). Unpublished study prepared by BASF Corporation. 42 p. (OPPTS 860.1500)
45405116 Versoi, P.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Canola: Final Report: Lab Project Number: 58645: 2001/5000048: 2000110 (ND/5). Unpublished study prepared by BASF Agro Research. 69 p. (OPPTS 860.1500)
45405117 Haughey, D.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Grapes: Final Report: Lab Project Number: 63892: 2000/5228: 2000110 (ND/5). Un published study prepared by BASF Corporation. 56 p. (OPPTS 860.1500)
45405118 Versoi, P.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Red Raspberries and Highbush Blueberries: Final Report: Lab Project Number: 2000/5195: 63912: 99277/NY/1. Unpublished study prepared by BASF Corporation. 53 p. (OPPTS 860.1500)

### 47 45405119 Haughey, W.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Tomatoes: Final Report: Lab Project N umber: 46786: 2001/5000832: 2000204. Unpu blished study prepared by BASF Agro Research. 54 p. (OPPTS 860.1500)
45405120 Haughey, D.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Dry, Snap, and Lima Beans: Final Report: Lab Project Number: 2001/5000905: 46764: 2000177. Unpublished study prepared by BASF Agro Research. 89 p. (860.1500)
45405121 Wofford, T.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Stone Fruit: Amended Final Report: Lab Project Number: 63904: 2001/5000831: 99101. Unpublished study prepared by BASF Corporation. 80 p. (OPPTS 860.1500)
45405122 Wofford, J.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Peanut Raw Agricultural Commodities and Peanut Process Fra ctions: Final Report: Lab Project Nu mber: 64106: 2001/5000870: 2000148. Unpublished study prepared by BASF Agro Research. 116 p. (OPPTS 860.1500. 860.1520)
45405123 Wofford, J.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Potato: Final Report: Lab Project Number: 64126: 2001/5000879: 2000161. Unpub lished study prepared by BASF Agro Research. 63 p. (OPPTS 860.1520, 860.1500)
45405124 Versoi, P.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Canola Seed Processed Fractions: Amended Final Report: Lab Project Number: 58646: 2001/5001064: 2000111. Unpublished study prepared by BASF Agro Research. 98 p. (OPPTS 860.1520)
45405125 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Grape Processed Fractions: Final Report: Lab Project Number: 46650: 2001/50006 5: MG6176. Unpublished study prepared by BASF Corporation. 75 p. (OPPTS 860.1520)
45405126 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Tomato Processed Fractions: Final Report: Lab Project Number: 46788: 2001/5000967: 2000210. Unpublished study prepared by BASF Corporation. 133 p. (OPPTS 860.1520)
45405127 Versoi, P.; Abdel-Baky, S. (2000) Th e Magnitude of BAS 510 F Residues in Bell and Chili Peppers: Final Report: Lab Project Number: 63918: 2000/5209: 99345 (GA/2). Unpublished study prepared by BASF Corporation. 57 p. (OPPTS 860.1500)
45405128 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Head and Leaf Lettuce: Final Report: Lab Project Number: 64114: 2001/50000 51: 2000132. Unpublished study prepared by BASF Agro Research. 71 p. (OPPTS 860.1500)
45405201 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Pecans: Final Report: Lab Project Number: 63900: 2000/5230. Unpublis hed study prepared by BASF Corporatio n. 47 p. (OPPTS 860.1500)
45405202 Wofford, J.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Plum Processed Fractions: Final Report: Lab Project Number: 63906: 2000/5275. Unpublished study prepared by BASF Corporation. 70 p. (OPPTS 860.1520)
45623401 Wofford, J.; Abdel-Baky, S. (2002) The Magnitude of BAS 510 F Residues in Cabbage: Final Report: Lab Project Number: 66704: 2001/5002617: F

- 96/1. Unpublished study prepared by BASF Agro Research. 51 p. (OPPTS 860.1500)
45623402 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Radishes: Final Report: Lab Project Number: 2001/5002572: 6694: 2001/5000 848. Unpublished study prepared by BASF Agro Research. 50 p. (OPPTS 860.1500)
45623403 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Cucurbits: Final Report: Lab Project Number: 2001/5002593: 66698: BAS 510 UCF. Unpublished study prepared by BASF Agro Research. 51 p. (OPPTS 860.1500)
45623404 Wofford, J.; Abdel-Baky, S. (2002) The Magnitude of BAS 510 F Residues in Broccoli: Final Report: Lab Project Number: 2001/5002616: 66702: FR0108. Unpub lished study prepared by BASF Agro Research. 43 p. (OPPTS 860.1500)

### 48 45623405 Haughey, D.; Abdel-Baky, S. (2002) Magnitude of BAS 510 F and BAS 500 F Residues in Dry and Succulent Peas: Final Report: Lab Project Number: 2001/5003246: 66696: F200112. Unpublished study prepared by BASF Agro Research. 95 p. (OPPTS 860.1500)
45623406 Wofford, J.; Abdel-Baky, S. (2002) Magnitude of BAS 510 F and BAS 500 F Residues in Mustard Greens- -2001 Field Study: Final Report: Lab Project Number: 2001/5003339: 67080: CF -A 587. Unpublished study prepared by BASF Agro Research. 68 p. (OPPTS 860.1500)
45623407 Versoi, P.; Abdel-Baky, S. (2002) The Magnitude of BAS 510 F and BAS 500 F Residues in Sunflower and Sunflower Processed Fractions: Final Report: Lab Project Number: 2001/5002552: 66710: RCN 2001289. Unpublished study prepared by BASF Agro Research. 113 p. (OPPTS 860.1500 and 860.1520)
45623408 Versoi, P.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F and BAS 500 F Residues in Mint and Mint Processed Fractions: Final Report: Lab Project Number: 66700: 2001/5002467: F200107. Unpublished study prepared by BASF Agro Research. 95 p. (OPPTS 860.1500 and 860.1520)
45623409 Versoi, P.; Abdel

- Baky, S. (2002) Magnitude of the Residue of BAS 510 F in Peas and Beans Planted As Rotational Crops and of BAS 500 F In Peas and Beans When Applied as a Foliar Spray: Final Report: Lab Project Number: 130001: 2001/5003311: 66690. Unpub lished study prepared by BASF Agro Research. 118 p. (OPPTS 860.1900 and 860.1500)
45623410 Versoi, P.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F and BAS 500 F Residues in Soybean Processed Fractions: Final Report: Lab Project Number: 2001/5002529: 66714: RCN 2001214. Unpublished study prepared by BASF Agro Research. 108 p. (OPPTS 860.1520)
45623412 Jordan, J. (2002) Cereal Grains and Soybean Field Rotational Crop Study for BAS 510 F: Final Report: Lab Project Number: 2002/5001341: 64382: RCN 2001 129. Unpublished study prepared by BASF Agro Research. 231 p. (OPPTS 860.1900)
45623413 Jordan, J. (2002) Cotton Field Rotational Crop Study for BAS 510 F: Final Report: Lab Project Number: 2002/5002425: 66690: BAS 510 UC F. Unpublished study p repared by BASF Agro Research. 51 p. (OPPTS 860.1900)
45643801 Stewart, J. (2002) A Meat and Egg Magnitude of the Residue Study with BAS 510 F in Laying Hens: Final Report: Lab Project Number: 2002/5002466: 130019 . Unpublished study prepared by BASF Agro Research. 202 p. (OPPTS 860.1480)
45903601 Jordan, J. (2002) Magnitude of BAS 500 02 F and BA S 510 02 F Residues in Citrus: Final Report: Lab Project Number: 2002/5002446: 64978: 2001339(FL) . Unpublished study prepared by BASF Agro Research. 129 p. (OPPTS 860.1500)
45903602 Leonard, R. (2003) Magnitude of BAS 500 F and BAS 510 F Residues in Soybean: Final Report: Lab Project Number: 2002/5004272: 140578: 2002191(GA). Unpublished study pr epared by BASF Agro Research. 157 p. (OPPTS 860.1500) 860.1340 Residue analytical method 46351401 Grosshans, F. (2001) The Validatio n of BASF Method 471/0: The Determination of BAS 510F and the Metabolite M510F01 In Animal Matrices: Amended Fi nal Report. Project Number: 42392, 2004/5000681, 471/0. Unpublished study prepared by BASF Ag Research Station (Basf Aktieng). 92 p.
46351402 Fabian, E. (2001) The Validation of BASF Method 476/0: The Determination of BAS 510 F Residues (as M510F53) in Liver and Milk by Microwave Trea tment: Amended Final Report. Project Number: 96997, 2004/5000682, 476/0. Unpublished study prepared by BASF Ag Research Station (Basf Aktieng). 61 p.
46351403 Class, T. (2001) Assessment and Validation of the Adapted Multi -Residue Method DFG S19 Determination of BAS 510 F and its Metabolite M510F01 in Animal Matrices: Amended Final Report. Project Number: P/B/453/G, 2004/5000683, DFG/S19. Un published study prepared by BASF Ag Research Station (Basf Aktieng). 90 p.
46351405 Sasturain, J. (2000) Technical Procedure: Method for the Determination of BAS 480 F, BAS 490 F, BAS 500 F and BAS 510 F in Plant Matrices: Final Report. Project Number: 445/0, 2000/1014864. Unpublished study prepared by BASF Ag Research Station (Basf Aktieng). 16 p.

### 49 47020701 Willard, T. (2006) Magnitude of the Residue of Py raclostrobin and Boscalidin Cotton Raw Agricultural Commodities Resulting from Seed Treatment with BAS 500 UKF and BAS 510 04F: Final Report. Project Number: 2006/7007191, AA030704. Unpublished study pr epared by BASF Agro Research and American Agricultural Ser vices Inc. 151 p. 860.1380 Storage stability data 46351404 Funk, H.; Mackenroth, C. (2001) Investigation of the S tability of Residues of BAS 510 F in Plant Matrices Under Normal Storage Conditions. Project Number: 41851, 2001/1015028. Unpublished study prepared by BASF Ag Research Station (Basf Aktieng). 46 p.

860.1900 Field accumu lation in rotational crops 46210606 Leonard, R. (2004) Sugar Beet, Garden Beet and Turnip Field Rotational Crop Study for BAS 510 02 F Residues: Final Report. Project Number: 130727, 2002/ 5004273, F/96/1. Unpublished study prepared by BASF Agro Research. 74 p. Non-Guideline Study 45405215 Fent, G. (2001) Degradation and Distribution of BAS 510 F in a Water-Sedimen t System Under Outdoor Conditions: Final Report: Lab Project Number: 2000/1017038: BAS37. Unpublished study prepared by BASF Aktiengesellschaft. 42 p.

### 50 Appendix C. Submitted Ec ological Effects Studies

72-1 Acute Toxicity to Freshwater Fish

MRID Citation Reference

48600214 Salinas, E. (2011) BAS 640 00 F - Acute Toxicity Study in the Fathead Minnow (Pimephales promelas). Project Number: 2011/1173957/OCR, 381191, 19F0047/10E129. Unpublished study prepared by BASF Aktienges ellschaft, Labor fuer Oekotoxicologie. 45p.

141-1 Honey bee acute contact

MRID Citation Reference

48470201 Noe, J.; Lueckmann, J. (2010) Assessment of Potential Side-Effects of Pristine (BAS 516 04 F) on the Honeybee (Apis mellifera L.) in a Bee Brood Study under Semi -Field Conditions in Germany 2009. Project Number: 2010/1007154, 373826. Unpublished study prepared by BASF SE Aktiengesellschaft. 82 p.

850.1075 Fish acute to xicity test, freshwater and marine

MRID Citation Reference

48600214 Salinas, E. (2011) BAS 640 00 F - Acute Toxicity Study in the Fathead Minnow (Pimephales promelas). Project Number: 2011/1173957/OCR, 381191, 19F0047/10E129. Unpublished study prepared by BASF Aktienges ellschaft, Labor fuer Oekotoxicologie. 45p.

850.1300 Daphnid chronic toxicity test

MRID Citation Reference

46351406 Jatzek, J. (2004) BAS 510 F: Determination of the Chronic Effect on the Reproduction of the Water Flea Daphnia magna Straus: Fin al Report. Project Number: 51E0618/003004, 2004/7007516, 2004/1015009. Unpublished study prepared by BASF Aktiengesellschaft. 42 p.

### 51 850.3020 Honey bee acute contact toxicity

MRID Citation Reference

48470201 Noe, J.; Lueckmann, J. (2010) Assessment of Potential Side-Effects of Pristine (BAS 516 04 F) on the Honeybee (Apis mellifera L.) in a Bee Brood Study under Semi -Field Conditions in Germany 2009. Project Number: 2010/1007154, 373826. Unpublished study prepared by BASF SE Aktiengesellschaft. 82 p.

48470202 Bocksch, S. (2003) Assessment of Side Effects of BAS 516 04 F to the Honey Bee, Apis mellifera L. in the Laboratory. Project Number: 2003/1012075, 20091103/01/BLEU. Unpublished study prepared by Arbeitsge meinschaft GAB Biotechnologie. 29 p.

48580701 Becker, R.; Lueckmann, J. (2011) Response of BASF Regarding EFED Review: Review (DP Barcode D363523) of Formulated Product Pollinator Toxicity Tests of Pristine (Boscalid (PC Code 128008) and Pyraclos trobin (PC Code 099100): Assessment of Potential Side -Effects of Pristine (BAS 516 04 F) on the Honeybee (Apis mellifera L.) in a Bee Brood Study under Semi -Field Conditions in Germany 2009.2 (MRID 484702- 01). Project Number: 2011/1209608. Unpublished study prepared by BASF Corporation. 17p.

48600218 Kling, A. (2011) BAS 640 00 F - Acute Oral and Contact Toxicity to the Honey Bee Apis mellifera L. in the Laboratory. Project Nu mber: 2011/1232121/OCR, S11/03380, 381192. Unpublished study prepared by Eurofins - GAB GmbH. 36p.

850.3040 Field testing for pollinators

MRID Citation Reference

48727101 Lawrence, J. (2012) Determination of Residues of Pristine Fungicide (Pyraclostrobin + Boscalid) in Royal Jelly and Pollen in Almo nd Trees in Central California. Project Number: 373827, 2012/7000038, S12/00011. Unpublished protocol prepared by EurofinsAgrisearch Americas, Inc. 31p.

49009301 Bocksch, S. (2012) Determination of Side-effects of BAS 510 01 F on Brood Development of the Honeybee (Apis mellifera L.) in a Feeding Test. Project Number: 4112 72, S11/02725, S11/02725/01. Unpublished study prepared by Eurofins AgroScience Services EcoChem GmbH. 286p.

49009302 Schneider, C.; Becker, R. (2012) Risk Perspe ctive of Boscalid and its Potential Effects on Honey Bee Brood. Project Number: 2012/1166152. Unpublished study prepared by BASF SE. 18p.

### 52 49009303 Niederdrenk, S.; Schneider, C. (2012) Assessments of Effects of BAS 516 04 F on the Production of Honey Bee Queens (Apis mellifera L.) in a Semi Field Study in Phacelia tanacetifolia. Project Number: 2012/1261980. Un published study prepared by BASF SE. 74p.

49009304 Lawrence, J.; Riley, M. (2012) Determination of Residues of Pristine Fungicide (Pyraclostrobin + Boscalid) in Royal Jelly and Pollen in Almond Trees in Central California: Final Report. Project Number: 373827 S12/00011 2012/7005408. Unpublished study prepared by Eurofins -Agrisearch Americas Inc. 242p.

850.4100 Terrestrial plant toxicity, Tier 1 (seeding emergence)

MRID Citation Reference

47627401 Martin, J.; Holmes, C. (2008) BAS 510 04 F - Seedling Emergence Test. Project Number: 986/6181, 321609, 2008/7014468. Unpublished study prepared by Springborn Smithers Laboratories. 171 p.

850.4150 Terrestrial plant toxicity, Tier 1 (vegetative vigor)

MRID Citation Reference

47627402 Martin, J.; Holmes, C. (2008) BAS 510 04 F - Vegetative Vigor Test. Project Number: 986/6182, 321610, 2008/7014469. Unpublished study prepared by Springborn Smithers Laboratories. 162 p.

850.4225 Seedling emergence, Tier II

MRID Citation Reference

47627401 Martin, J.; Holmes, C. (2008) BAS 510 04 F - Seedling Emergence Test. Project Number: 986/6181, 321609, 2008/7014468. Unpublished study prepared by Springborn Smithers Laboratories. 171 p.

850.4250 Vegetative vigor, Tier II

MRID Citation Reference

### 53 47627402 Martin, J.; Holmes, C. (2008) BAS 510 04 F - Vegetative Vigor Test. Project Number: 986/6182, 321610, 2008/7014469. Unpublished study prepared by Springborn Smithers Laboratories. 162 p.

850.1735 Whole sediment: acute freshwater invertebrates

MRID Citation Reference

48600216 Domer, S. (2011) Acute Toxicity of BAS 640 00 F to Daphnia magna Straus in a 48 Hour Static Test. Project Number: 2011/1125619/OCR, 381190. Unpublished study prepared by BASF SE. 25p.

81-1 Acute oral toxicity in rats

MRID Citation Reference

46210601 Gamer, A.; Hellwig, J. (2004) BAS 516 02F - Ac ute Oral Toxicity Study in Wister (sic) Rats - UDP Method: Final Report. Project Number: 2003/1007136, 10A0657/001152. Unpublished study prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology. 23 p.

47285606 Gamer, A.; Landsiedel, R. (2007) BAS 516 09 F: Acute Oral Toxicity Study in Rats. Project Number: 10A0421/061132, 2007/1018931. Unpublished study prepared by BASF Aktiengesellschaft. 22 p.

81-2 Acute dermal toxicity in rabbits or rats

MRID Citation Reference

47285607 Remmele, M.; Landsiedel, R. (2007) BAS 516 09 F: Acute Dermal Toxicity Study in Rats. Project Number: 11A0421/061133, 2007/1018932. Unpublished study prepared by BASF Aktiengesellschaft. 26 p.

81-3 Acute inhalation toxicity in rats

MRID Citation Reference

### 54 47285608 Ma-Hock, L.; Mellert, W. (2007) BAS 516 09 F: Acute Inhalation Toxicity Study in Wistar Rats: 4 -Hour Liquid Aerosol Dust Exposure. Pr oject Number: 13I0421/067022, 2007/1045024. Unpublished study prepared by BASF Aktiengesellschaft. 43 p.

81-4 Primary eye irritation in rabbits

MRID Citation Reference

47285609 Remmele, M.; Landsiedel, R. (2007) BAS 516 09 F: Acute Eye Irritation in Rabbits. Project Number: 11H0421/062245, 2007/1018934. Unpublished study prepared by BASF Aktiengesellschaft. 23 p.

81-5 Primary dermal irritation

MRID Citation Reference

46242301 Manciaux, X. (2003) BAS 510 02 F Acute Dermal Irritation in Rabbits: Amended Final Report. Project Number: 20686/TAL, 18H0393/009023, 2 004/5000275. Unpublished study prepared by Centre International de Toxicologie. 22 p.

46270101 Manciaux, X. (2003) BAS 510 02 F: Acute Dermal Irritation in Rabbits. Project Number: 20886/TAL, 18H0393/009023, 2004/5000275. Unpublished study prepared by Centre International de Toxicologie. 22 p.

47285610 Landsiedel, R.; Remmele, M. (2007) BAS 516 09 F: Acute Dermal Irritation/Corrosion in Rabbits. Project Number: 2007/1018933, 18H0421/062244. Unpublished study prepared by BASF Aktiengesellschaft. 22 p.

870.1100 Acute oral toxicity

MRID Citation Reference

### 55 46210601 Gamer, A.; Hellwig, J. (2004) BAS 516 02F - Ac ute Oral Toxicity Study in Wister (sic) Rats - UDP Method: Final Report. Project Number: 2003/1007136, 10A0657/001152. Unpublished study prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology. 23 p.

47013505 Gamer, A.; Landsiedel, R. (2006) BAS 516 08 F: Acute Oral Toxicity in Rats. Project Number: 10A0301/051096, 2006/1010589. Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 23 p.

47285606 Gamer, A.; Landsiedel, R. (2007) BAS 516 09 F: Acute Oral Toxicity Study in Rats. Project Number: 10A0421/061132, 2007/1018931. Unpublished study prepared by BASF Aktiengesellschaft. 22 p.

48311302 Durando, J. (2010) Acute Oral Toxicity Up and Do wn Procedure in Rats: TC-308. Project Number: 29599, 2713, P320/UDP/WMG. Unpublished study prepared by Eurofins/Product Safety Laboratories. 18 p.

48600207 Cords, S.; Lammer, E. (2011) BAS 640 00 F - Acu te Oral Toxicity Study in Rats. Project Number: 2011/1072531/OCR, 11/BF/OT086, 10A0047/10X259. Un published study prepared by Bioassay Labor fuer Biologische Analytik GmbH. 26p.

48707803 Durando, J. (2011) Acute Oral Toxicity Up and Down Procedure in Rats: FT09. Project Number: P320/UDP, 30253. Unpublished study prepared by Eurofins/Product Safety Laboratories. 17p.

49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 510 09 F). Project Number: 2014/7000742. Unpublished study prepared by BASF Corporation. 7p.

870.1200 Acute dermal toxicity

MRID Citation Reference

47013506 Gamer, A.; Landsiedel, R. (2006) BAS 516 08 F: Acute Dermal Toxicity Study in Rats. Project Number: 11A0301/051097, 2006/1010590. Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 25 p.

47285607 Remmele, M.; Landsiedel, R. (2007) BAS 516 09 F: Acute Dermal Toxicity Study in Rats. Project Number: 11A0421/061133, 2007/1018932. Unpublished study prepared by BASF Aktiengesellschaft. 26 p.

### 56 48311303 Durando, J. (2010) TC-308: Acute Dermal Toxicity Study in Rats. Project Number: 29600, P322/RAT/WMG, 2714. Unpublished study prepared by Eurofins/Product Safety Laboratories. 16
p.

48600208 Cords, S.; Lammer, E. (2011) BAS 640 00 F - Acute Dermal Toxicity Study in Rats. Project Number: 2011/1072532/OCR, 11/BF/DT087, 11A0047/ 10X260. Unpublished study prepared by Bioassay Labor fuer Biologische Analytik GmbH. 28p.

48707804 Durando, J. (2011) Acute Dermal Toxicity Study in Rats: FT09. Project Number: P322/RAT, 30254. Unpublished study prepared by Eurofins/Product Safety Laboratories. 1 5p.

49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 510 09 F). Project Number: 2014/7000742. Unpublished study prepared by BASF Corporation. 7p.

870.1300 Acute inhalation toxicity

MRID Citation Reference

47013507 Ma-Hock, L.; Landsiedel (2006) BAS 516 08 F: Ac ute Inhalation Toxicity Study in Wistar Rats: 4- Hour Dust Exposure. Project Number: 13I0301/057014, 2006/1007449. Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 30 p.

47285608 Ma-Hock, L.; Mellert, W. (2007) BAS 516 09 F: Acute Inhalation Toxicity Study in Wistar Rats: 4 -Hour Liquid Aerosol Dust Exposure. Pr oject Number: 13I0421/067022, 2007/1045024. Unpublished study prepared by BASF Aktiengesellschaft. 43 p.

48311304 Durando, J. (2010) TC-308: Acute Inhalation Toxicity Study in Rats. Project Number: P330/WMG, 29601, 2709. Unpublished study prepar ed by Eurofins/Product Safety Laboratories. 23 p.

48600209 Wittmer, E. ; Landsiedel, R. (2011) BAS 640 00 F - Acute Inhalation Toxicity Study in Wistar Rats - 4-Hour Liquid Aerosol Exposure (Head- Nose Only). Project Number: 2011/1223793/OCR, 350935, 13I0047/10I106. Unpublished study prepar ed by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 89p.

48707805 Durando, J. (2011) Acute Inhalation Toxicity Study in Rats: FT09. Project Number: P330, 30255. Unpublished study prepared by Eurofins/Product Safety Laboratories. 23p.

### 57 49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 510 09 F). Project Number: 2014/7000742. Unpublished study prepared by BASF Corporation. 7p.

870.2400 Acute eye irritation

MRID Citation Reference

47013508 Remmele, M.; Landsiedel, R. (2006) BAS 516 08 F: Acute Eye Irritation in Rabbits. Project Number: 11H0301/052238, 2006/1010592. Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 22 p.

47285609 Remmele, M.; Landsiedel, R. (2007) BAS 516 09 F: Acute Eye Irritation in Rabbits. Project Number: 11H0421/062245, 2007/1018934. Unpublished stu dy prepared by BASF Aktiengesellschaft. 23 p.

47322901 Remmele, M.; Landsiedel, R. (2007) BAS 516 08 F - Acute Eye Irritation in Rabbits. Project Number: 2007/1050817, 11H0301/052348. Unpublished study prepared by BASF Aktiengesellschaft. 25 p.

48311305 Durando, J. (2010) TC-308: Primary Eye Irritation Study in Rabbits. Project Number: 29602, P324/WMG. Unpublished study prepared by Eurofins/Product Safety Laboratories. 16 p.

48600210 Wolf, T. (2011) BAS 640 00 F - Acute Eye Irr itation / Corrosion in Ra bbits. Project Number: 2011/1072533/OCR, 11IH0047/10X258, SL/LT/099/11. Unpublished study prepared by Seibersdorf Labor GmbH. 26p.

48707806 Durando, J. (2011) Primary Eye Irritation Study in Rabbits: FT09. Project Number: P324, 30256. Unpublished study prepared by Eurofins/Product Safety Laboratories. 16p.

49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 510 09 F). Project Number: 2014/7000742. Unpublis hed study prepared by BASF Corporation. 7p.

870.2500 Acute dermal irritation

MRID Citation Reference

### 58 46242301 Manciaux, X. (2003) BAS 510 02 F Acute Dermal Irritation in Rabbits: Amended Final Report. Project Number: 20686/TAL, 18H0393/009023, 2 004/5000275. Unpublished study prepared by Centre International de Toxicologie. 22 p.

46270101 Manciaux, X. (2003) BAS 510 02 F: Acute Dermal Irritation in Rabbits. Project Number: 20886/TAL, 18H0393/009023, 2004/5000275. Unpublished study prepared by Centre International de Toxicologie. 22 p.

47013509 Remmele, M.; Landsiedel, R. (2006) BAS 516 08 F: Acute Dermal Irritation/Corrosion in Rabbits. Project Number: 18H0301/052237, 2006/1010591. Unpubli shed study prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 20 p.

47285610 Landsiedel, R.; Remmele, M. (2007) BAS 516 09 F: Acute Dermal Irritation/Corrosion in Rabbits. Project Number: 2007/1018933, 18H0421/062244. Unpublished study prepa red by BASF Aktiengesellschaft. 22 p.

48311306 Durando, J. (2010) TC-308: Primary Skin Irrita tion Study in Rabbits. Project Number: 29603, P326/WMG, 2711. Unpublished study prepared by Eurofins/Product Safety Laboratories. 16 p.

48600211 Wolf, T. (2011) BAS 640 00 F - Acute Dermal Irritation / Corrosion in Rabbits. Project Number: 2011/1072534/OCR, 18H0047/10X261, SL/LT/188/11. Unpublished study prepared by Seibersdorf Labor GmbH. 23p.

48707807 Durando, J. (2011) Primary Skin Irritation Study in Rabbits: FT09. Project Number: P326, 30257. Unpublished study prepared by Eurofins/Product Safety Laboratories. 16p.

49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 510 09 F). Project Number: 2014/7000742. Unpublished study prepared by BASF Corporation. 7p.

870.2600 Skin sensitization

MRID Citation Reference

### 59 49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 510 09 F). Project Number: 2014/7000742. Unpublished study prepared by BASF Corporation. 7p.

83-4 2-generation repro.-rat

MRID Citation Reference

45404906 Schilling, K.; Gembardt, C.; van Ravenzwaay, B. (2001) BAS 510 F Two Generation Toxicity Study in Wistar Rats Continuous Dietary Admini stration: Final Report: Lab Project Number: 70R0179/97136: 2001/1000117. Unpublished study prepared by BASF Aktiengesellschaft. 924 p. {OPPTS 870.3800}

Non-Guideline Study

MRID Citation Reference

45405008 Holmes, C.; Aufderheide, J. (2001) Acute Tox icity of BAS 510 F in Whole Sediment to the Amphipod, Hyalella azteca: Lab Project Number: 2 001/5000043: 64340: 46319. Unpublished study prepared by ABC Laboratories, Inc. 48 p. {OPPTS 850.1735}

45405009 Holmes, C.; Aufderheide, J. (2001) Acute Tox icity of BAS 510 F in Whole Sediment to the Amphipod, Hyalella azteca: Lab Project Number: 2 001/5000043: 64340: 46319. Unpublished study prepared by ABC Laboratories, Inc. 48 p. {OPPTS 850.1735}

45405215 Fent, G. (2001) Degradation and Distribution of BAS 510 F in a Water-S ediment System Under Outdoor Conditions: Final Report: Lab Project Numb er: 2000/1017038: BAS37. Unpublished study prepared by BASF Aktiengesellschaft. 42 p.

48298805 Mullin, C.; Frazier, M.; Fr azier, J.; et al. (2010) High Levels of Miticides and Agrochemicals in North American Apiaries: Implications for Honey Bee Health. PLoS ONE: 5(3): 1-19.

48600215 Weltje, L. (2005) Chronic Toxicity of Boscalid (BAS 510 F) to the Non- Biting Midge Chironomus riparius Exposed via Spiked -Sediment. Project Number: 2005/1022464/OCR, 2323 63. Unpublished study prepared by BASF SE. 31p.

### 60 48600217 Hoffmann, F. (2011) Effect of BAS 640 00 F on the Growth of the Green Alga Pseudokirchneriella subcapitata. Project Number: 2011/1150026/OCR, 381 189. Unpublished study prepared by BASF SE. 35p.

48600219 Schoebinger, U. (2011) Acute Toxicity of BAS 640 00 F on Earthworms, Eisenia fetida in Artificial Soil with 5 % Peat. Project Number: 2011/1232120/OCR, S11/03381, S11/03381/L1/NLEF. Unpublished study prepared by Eurofins - GAB GmbH. 30p.

48727201 Schneider, C. (2012) Assessments of Effects of BAS 516 04 F on the Production of Honeybee Queens (Apis mellifera L.) in a Semi Field Study in Phacelia tanacetifolia. Project Number: 2012/7000030. Unpublished study prepared by BASF SE. 19p.

48727202 Schneider, C. (2012) An Overview of Potential Fa ctors Influencing Honey Bee Queen Development. Project Number: 2012/1009644. Unpublished study prepared by BASF SE. 22p.

49361801 Royer, S. (2014) Effect of Reg. No. 300355 (BAS 510 F) on Survival and Development of Honey Bee Brood (Apis mellifera), Using an In Vitro Rearing Method. Project Number: 2013/1275399, 428347. Unpublished study prepared by BASF SE. 35p.

### Appendix D. Screening Tool for Inhalation Risk (v. 1.0)



### Boscalid TGAI (Based on Rat Inhalation Study, MRID 4540816) 95.3% a.i.

### Pristine (Based on Rat Inhalation Study, MRID 4728560) Approx. 24% boscalid, 12% pyraclostrobin Endpoint adjusted for percent boscalid a.i.

### Appendix E. Results from Screen ing Imbibition Program (SIP)