Page 1 of 53 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460 **OFFICE OF CHEMICA** **L SA FETY**  **AND POLLUTION PREVENTION**  **MEMORANDUM D**  **ATE :**  August 22 , 201 3 **SUBJECT: Boscalid** 

– Human Health Risk Assessment for a Section 3 Registration of N ew

U ses on G lobe Artichoke, Belgium Endive, P ersimmon, Greenhouse Grown T omato Transplants for the H ome C onsumer M arket, and Residential O rnamentals, L andscape G ardens, F ruit Trees and Nut Trees ; Plus Crop Group Expansions/Revisions for Bulb Vegetable Group 3 - 07, Fruiting Vegetable Group 8 - 10, Citrus Fruit Group 10 - 10, Pome Fruit Group 11 - 10, Berry Subgroups 13 - 07A, B, F, and G, Vegetable Root Subgroup 1B Except Sugar beet, and Oilseed Group 20 . **PC Code:** 128008 **DP Barcode:** D 405063, D398877, 406471, D406506 **Decision No.:** 459294, 470110, 467106, 468292 **Registration No. :**  7969 - 199, 7969 - 251, 7969 - GLG, 4 - UII **Petition No .:**  2E8068 **Regulatory Action:** Section 3 **Risk A**  **ss essment Typ**  **e :**  Single Chemical/Aggregate **Case No.:** NA **T XR No.:**  NA **CAS No.:** 1 88425 - 85 - 6 **MRID No.:** NA **40 CFR:** 180.58 9 **FROM:** Barry

O’Keefe , Senior Biologist My ron S. Ottley , Senior Bi ologist Steve Funk , Senior Chemist Cassi Walls, Senior Biologist Risk Assessment Branch III (RAB III) Health Effects Division (7509P) **THROUGH:** Christin e Olinger , Branch Chief

Risk Assessment Branch III (RAB III) Health Effects Division (7509P) **TO:** Heather Garvie , Risk Manager

Dominic Schuler, Risk Manager Robert Westin, Risk Manager Fungicide Branch Registration Division (7505P) and Andrew Ertman, Risk Manager Risk Integration, Minor Use and Emergency Response Branch Registration Division (7505P)Page 2 of 53

This document and attachments provide an assessment of the human health risk resulting from the proposed and registered uses of boscalid . The toxicology reevaluation was performed b y My ron Ottley , the drinking water assessment was conducted by Katrina White (EPA Environmental Fate and Effects Division (EFED)), the review of the residue chemistry data an dietary exposure assessment w ere condu cted b y Steve Funk, the occupational and residential exposure assessment was conducted b y Cassi Walls , and the human health risk assessment w as conducted b y Barry

O’Keefe .Page 3 of 53 **Table of Contents 1.0**  **Executive Summary** ................................ ................................ ................................ ........... 5 **2.0 HED Recommendations**  ................................ ................................ ................................ .... 7 **2.1 Data Deficiencies**  ................................ ................................ ................................ ............ 8 **2.2.1 En**  **forcement Analytical Method** ................................ ................................ ............... 8 **2.2.2 Recommended Tolerances**  ................................ ................................ ......................... 8 **2.2.3 Revisions to Petitioned**  **- For Tolerances**  ................................ ................................ .. 11 **2.2.4 International Harmonization**  ................................ ................................ ................... 11 **3.0 Introduction**  ................................ ................................ ................................ ...................... 12 **3.1 Chemical Identity**  ................................ ................................ ................................ ......... 13 **3.2 Physical/Chemical Characteristics**  ................................ ................................ ............. 14 **3.3 Pesticide Use Pattern**  ................................ ................................ ................................ .... 14 **3. 4**  **Anticipated Exposure Pathways** ................................ ................................ ................. 16 **3.5 Consideration of Environmental Justice**  ................................ ................................ .... 17 **4.0 Hazard Characterization and Dose**  **- Response Assessment**  ................................ .......... 17 **4.1 Toxicology Studies Available for Analysis**  ................................ ................................ . 17 **4.2 Absorption, Distribution, Metabolism and Excretion (ADME)**  .............................. 18 **4.2.1 Dermal Absorption**  ................................ ................................ ................................ ... 18 **4.3 Summary of Toxicological Effects**  ................................ ................................ .............. 19 **4.4 Safety Factor for Infants and Children (FQPA Safety Factor)**  ............................... 20 **4.4.1 Completeness of the Toxicology Database**  ................................ .............................. 20 **4.4.2 Evidence of Neurotoxicity**  ................................ ................................ ........................ 21 **4.4.3 Evidence of Sensitivity/Susceptibility in the Developing or Young An**  **imal** ........ 21 **4.4.4 Residual Uncertainty in the Exposure Database**  ................................ ................... 22 **4.5.1 Dose**  **- Response Assessment**  ................................ ................................ ...................... 22 **4.5.2 Recommendation for Combining Routes of Exposure for Risk Assessment**  ...... 24 **4.5.3 Cancer Classification and Risk Assessment**  **Recommendation** ............................ 24 **4.5.4 Summary of Points of Departure and Toxicity Endpoints Used in Human Risk**  **Assessment** ................................ ................................ ................................ ............................... 24 **5.0 Dietary Exposure and Risk Assessment**  ................................ ................................ ......... 26 **5.1 Residues of Concern Summary and Rationale**  ................................ .......................... 26 **5.2 Food Residue Profile**  ................................ ................................ ................................ .... 26 **5.3 Water Residue Profile**  ................................ ................................ ................................ .. 28 **5. 4**  **Dietary Risk Assessment** ................................ ................................ .............................. 29 **5.4.1 Description of Residue Data Used in Dietary Assessment**  ................................ .... 29 **5.4.2 Percent Crop Treated Used in Dietary Assessment**  ................................ .............. 30 **5.4.3 Acute Dietary Risk Assessment**  ................................ ................................ ............... 30 **5.4.4 Chronic Dietary Risk Assessments**  ................................ ................................ ......... 30 **5.4.5 Summary Table**  ................................ ................................ ................................ ......... 31 **6.0 Residential (Non**  **- Occupational) Exposure/Risk Characterization**  ............................. 31 **6.1 Residential Handler Exposure**  ................................ ................................ .................... 31 **6.2 Post**  **- Application Exposure**  ................................ ................................ .......................... 34 **6.3 Combined Residential Risk Estimates (Multiple Exposure Scenarios)**  ................... 34 **6.4 Residential Risk Estimates for Use in Aggregate Assessment**  ................................ .. 35 **6.5 Residential**  **Bystander Post -**  **application Inhalation Exposure** ................................ . 35Page 4 of 53

**6.6 Spray Drift**  ................................ ................................ ................................ .................... 35 **7.0 Aggregate Exposure/Risk Characterization**  ................................ ................................ .. 36 **7.1 Acute Aggregate Risk**  ................................ ................................ ................................ ... 36 **7.2 Short** **- Term Aggregate Risk**  ................................ ................................ ........................ 36 **7.3 Chronic Aggregate Risk**  ................................ ................................ .............................. 37 **8. 0**  **Cumulative Exposure/Risk Characterization** ................................ ............................... 37 **9.0 Occupational Exposure/Risk Characterization**  ................................ ............................ 37 **9.1 Short** **- /Intermediate**  **- Term Handler Risk**  ................................ ................................ ... 38 **9.2 Short** **- and Intermediate**  **- Term Post**  **- Application Risk**  ................................ .............. 39 **9.2.1 Dermal Post**  **- Application Risk**  ................................ ................................ ................. 39 **9.2.2 Inhalation Post** **- Application Risk**  ................................ ................................ ............ 39 **10.0 References**  ................................ ................................ ................................ ......................... 40 **Append ix A. Toxicology Profile and Executive Summaries**  ................................ .................. 41 **A.1 Toxicology Data Requirements**  ................................ ................................ ................... 41 **A.2 Toxicity Profiles**  ................................ ................................ ................................ ............ 42 **Appendix B. Physicochemical Properties of Boscalid.** ................................ ........................... 47 **Appendix C. Review of Human Research** ................................ ................................ ................ 47 **Appendix D. Summaries of Field Residue Data** ................................ ................................ ...... 48 **Appendix E. Summaries of Occupational Handler and Post -**  **application Exposure and Risk Estimates**  ................................ ................................ ................................ ................................ ...... 49 **Appendix F. International Residue Limits Status Sheet** ................................ ........................ 52Page 5 of 53

**1.0 Executive Summary**  Introduction Boscalid, 3 - py

ridinecarboxamide, 2 - chloro -N - (4' - chloro[1,1' - biphenyl ] - 2 - yl), is a fungicide active ingredient that works inside the mitochondria of fungi and stops fungi from producing the energy that they need to carry

on basic functions. Boscalid prevents energy production by binding to the enzy

me succinate ubiquinone reductase. Boscalid is currently registered on numerous agricultural crops and on golf course turf. Use Profile The proposed actions of boscalid are as follows: 1) The Interregional Research Project No. 4 (IR4) is proposing new agricultural uses (PP# 2F8069) on artichoke, Belgium endive, and persimmon; 2) BASF is proposing a new greenhouse tomato use for commercial production and for tomato transplants grown for the home consumer market ; 3) Bonide Products is proposing a new use on r esidential fruit and nut trees ; and 4) BA SF is proposing new uses on residential ornamentals and landscape gardens . Additionally, crop group expansions/revisions were requested for the b ulb vegetable group 3 - 07, fruiting vegetable 8 - 10, citrus fruit group 10 - 10, pome fruit group 11 - 10, berry sub groups 13 - 07A, B, F, and G, vegetable root subgroup 1B except sugar beet, and oilseed group 20. The proposed agricultural labels require occupational handlers to wear the following personal protective equipment (PPE): long - sleeved shirts, long pants, chem ical resistant gloves, and coveralls in a few cases. The 12 hour restricted entry interval (REI) listed on the labels is appropriate. Exposure Profile The proposed residential u se s result in short - term handler dermal and inhalation exposures for adults, short - term post - application dermal exposures for adults, youths (11 to 16 years old), and children 6 to 11 years old, and short - term post - application dermal and incidental oral exposures for children (1 to <2 ye ars old) . Exposure pathway s include dietary (food and drinking water), and residential exposure sources. Dietary exposures are also expected for acute and chronic durations. Occupational exposures are expected via dermal and inhalation routes for short - and intermediate - term durations. Hazard Assessment In subchronic and chronic feeding studies in rats, mice and dogs, boscalid generall y caused decreased body weights and body weight gains and effects on the liver as well as on the thyroid. While the dog appeared to be the most sensitive species in the subchronic studies, the sensitivity of the dog and the rat was similar in the chronic studies. Based on weak evidence of carcinogenic effects in male rats, boscalid is classified as, “suggestive evidence of carcinogenicity , but not sufficient to assess human carcinogenic potential.” Boscalid was negative in the mutagenicity battery , the neurotoxicity battery and the immunotoxicity

study . There were no susceptibility concerns and no residual uncertainties regarding developing offspring, and th e FQPA Safety Factor was reduced to 1X in the risk assessment. Boscalid has low acute toxicity via the oral, dermal, and inhalation routes of exposure and is not a dermal sensitizer, primary eye irritant, or skin irritant. Endpoints and points of departure were selected for chronic dietary , incidental oralPage 6 of 53

(short - and intermediate - term), dermal (all durations) and inhalation (all durations) exposure scenarios. As there were no toxic effects attributable to a single dose, an endpoint for acute dietary was not identified. The level of concern (LOC) for all exposure scenarios is a margin of exposure (MOE) <100 , with the exception of inhalation exposures where the LOC is an MOE of <1000 because a su

b chronic inhalation study is required for this risk assessment but is not available. Dietary Exposure The residue chemistry

and environmental fate data are adequate to assess human dietary exposure . The assessments are based on reliable data and will not underestimate exposure or risk. E stimated drinking water concentrations (EDWCs) were incorporated directly into the dietary exposure assessments. S ince no observed effects could be attributed to a single dose, an acute endpoint was not established. Therefore, an acute dietary exposure assessment was not conducted . The results of the slightly refined chronic dietary (food and drinking water) anal ys is are below the Agency ’s level of concern for all population subgroups. The dietary exposure for food and drinking water for the general U .S. population is 2 0 % of the chronic Population Adjusted Dose (c PAD) and 56 % of the cPAD for children 1 - 2 years old , the population subgroup with the highest estimated chronic dietary exposure to boscalid . Residential Exposure New residential uses were re quested in this action . Additionally , boscalid is currentl y registered for use on golf course turf . Residential exposure s from the proposed and existing residential use s w ere assessed using the updated 2012 HED Residential Standard Operating Procedures 1 (SOPs). Residential exposure is expected to be short - term only . Because the dermal and inhalation PODs are the same, the dermal and inhalation handler exposure estimates were combined using the aggregated risk index (ARI) approach. All residential handler dermal and inhalation exposure risk estimates were not of concern to HED, with ARIvalues rang ing from 24 to 3 30 . All residential post - application dermal exposure risk estimates were also not of concern to HED, with margins of exposure ( M OEs ) rang ing from 690 to 16 ,000. Aggregate Exposure There is potential for short - term and chronic exposure to boscalid via dietary (which is considered background exposure) and residential (which is considered primary) exposure pathway s. The aggregate MOEs are 310 for children 6 to 11 years old, 69 0 for youths 11 to 16 ye ars old, and 290 for adults. None of these aggregate risk estimates are of concern to HED. Occupational Exposure Based on the proposed agricultural use s , there is potential for short - and interme diate - term occupational exposure during mixing, loading, and other handling tasks; and during post application activities. The proposed labels require occupational handlers to wear the following personal protective equipment (PPE): long - sleeved shirts, lo ng pants, and chemical resistant

1 http://www.epa.gov/pesticides/science/residential - exposure - sop.htmlPage 7 of 53

gloves. Because the dermal and inhalation PODs are the same, the dermal and inhalation handler exposure estimates were combined using the ARI approach. All of the occupational handler ARIs are greater than 1.0 when asse ssed using labeled PPE (gloves) , and are not a concern to HED. All post - application scenarios resulted in dermal exposure MOEs greater than 100 on day 0 (12 hours after application) , and therefore , are not of concern to HED . The MOEs for boscalid ranged from 400 to 21,000. Dislodgable foliar residue ( DFR) studies are not required at this time for boscalid since the lowest dermal MOE (400) is greater than 4 times the LOC based on default input values. Based on the Agency's current practices, a quantitative non - cancer occupational post - application inhalation exposure assessment was not performed for boscalid at this time. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post - application inhalation exposure assessment for boscalid . The 12 hour restricted entry interval (REI) listed on the labels is appropriate. Review of Human Research This risk assessment relies in part on data from studies in which adult human subjects were intentionally

exposed to a pesticide or other chemical. These data, which include studies from the Pesticide Handlers Exposure Database , Version 1.1 (PHED 1.1), the Agricultural Handler Exposure Task Force (AHETF) d atabase, the Residential SOPs (lawns and turf) , and MRID 45773201 are subject to ethics review pursuant to 40 CFR 26, have received that review, and are compliant with applicable ethics requirements. For certain studies that review may have included review b y the Human Studies Review Board. Descriptions of data sources as well as guidance on their use can be found at http://www.epa.gov/pesticides/science/handler- exposure data .html and http://www.epa.gov/pesticides/science/post - app - exposure - data.html . Environmental Justice Considerations Potential areas of environmental justice concerns, to the extent possible, were considered in this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and L ow - Income Populations," (http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf . **2.0 HED**  **Recommendations** HED has examined the toxicology and residue chemistry database s for boscalid . Pending submission of revised Sections B and F, there are no toxicology or residue chemistry

issues that would preclude granting Section 3 registration for the requested uses of boscalid, or establishment of tolerances for residues of boscalid. Additional data are needed, as outlined below in Section 2.1. The specific tolerance recommendations are discussed in Section 2.2, and label modifications are discussed in Section 2.3.Page 8 of 53

**2.1 Data Deficiencies**  870.3465 Subchronic Inhalation study

 A subchronic Inhalation study is required because the use of an oral p oint of departure (POD) for inhalation exposure results in MOEs as low as 370 for occupational exposure, which is not sufficient to alleviate concern (TXR0056585. K. Rury . 03/04/2013). Therefore , a 10X database uncertainty factor has been added for inhalation exposures. **2.2 Tolerance Considerations**  **2.2.1 Enforcement Analytical Method**  There are adequate residue anal ytical methods for tolerance enforcement and data collection. An adequate gas chromatography/mass spectrometry ( GC/MS ) method (Method D0008) is available for enforcing boscalid tolerances in plant commodities. The Analytical Chemistry branch/Biological and Economic Analysis Division (ACB/BEAD ) concluded that the method is acceptable for enforcement purposes in plants without the need for an EPA validation (DP284510; D. Swineford and E. Kolbe, 8/12/2003, PMV memo **).** An enforcement method is available for determining the residues of concern in livestock. Method DFG S19 is a GC/electron capture detection method that was suc cessfully validated by ACB/BEAD. For the most recent livestock feeding study , residues of boscalid and its hydrox y metabolite M510F01 (including the glucuronide conjugate M510F02) were determined using a LC/MS/MS method (BASF Method 471/0, modified) whic h was previously reviewed in conjunction with earlier feeding studies. Residues of boscalid and its metabolite M510F01 were not adequatel y recovered using the multiresidue methods. Protocol A was not applicable. Protocol B was not applicable for boscalid and yi elded inconsistent recoveries of M510F01. Residues of boscalid and its hydrox y metabolite M510F01 had good responses with GC/ECD on a DB - 1 column under Protocol C. Neither analy

te was recovered at ≥30% using Protocols D, E, and F. The study has been forwarded to FDA for a future updating of PAM, Vol. I . **2.2. 2**  **Recommended Tolerances** For the use of boscalid on globe artichoke, Belgium endive, and persimmon, tolerances are required. Based on evaluation of the field trial dat a with the Organization of Economic Cooperation and Development (OECD) tolerance calculation procedure (Appendix II), the tolerances listed in Table 2.2.2.1 are appropriate. With the establishment of the tolerance for Belgium endive, the existing tolerance for Section 18 emergency exemption for Belgium endive should be removed.Page 9 of 53

Several crop group conversions were requested. Most were crop group or subgroup updates. The request to replace v egetable, root subgroup 1A, except sugar beet , garden bee t, radish, and turnip at 1 .0 ppm with v egetable, root, except sugar beet , subgroup 1B at 1.0 ppm is not acceptable. The original tolerance was established based on data for carrot only (D P 287829, M. Nelson, MRID 45405113). No field trial data were submitted for radish, the other representative commodity . Therefore the request must be amended to v egetable, root, except sugar beet , subgroup 1B, except garden beet, radish, and turnip at 1 .0 ppm. The proposed changes and their evaluation are summarized in T able 2.2.2.1. **Table 2.2.2.1**  **. Tolerance Summary for Boscalid.**  Commodity Proposed/Existing Tolerance (ppm) Recommended/ Harmonized Tolerance (ppm) Comments; Correct Commodity

Definition **40 CFR 180.589(a)** General
. It is recommended that tolerances be established for residues of the fungicide boscalid, including its metabolites and degradates, in or on the commodities listed below . Com pliance with the tolerance levels specified below is to be determined by measuring only boscalid, 3 -py ridinecarboxamide , 2 - chloro - N - (4 ′ - chloro[1,1' -biphenyl] - 2 - yl), in or on the following raw agricultural commodities: Artichoke, globe 6.0 6.0 Endive, belgium 5.0 6.0 OECD statistical calculation estimates 6.0 ppm Persimmon 7.0 8.0 OECD statistical calculation estimates 8.0 ppm Vegetable, bulb, group 3 - 07 3.0 5.0 Group update. Harmonization with Codex (VA 0035 Bulb vegetables: 5 mg/kg) Vegetable, bulb, group 3 3.0 Remove Group update. Vegetable, fruiting, group 8 - 10 1.2 3.0 Group update. Harmonization with Codex (Fruiting vegetables other than cucurbits VO 0050: 3 mg/kg) Vegetable, fruiting, group 8 1.2 Remove Group update. Fruit, citrus, group 10 - 10 1.6 2.0 Group update. Harmonization with Codex (Citrus fruits FC 0001: 2 mg/kg) Fruit, citrus, group 10 1.6 Remove Group update. Fruit, pome, group 11 - 10 3.0 3.0 Group update. Fruit, pome, group 11 3.0 Remove Group update. Caneberry subgroup 13 - 07A 6.0 10.0 Subgroup update. Harmonization with Codex (Berries and other small fruits, FB 0018: 10 mg/kg) Caneberry subgroup 13A 6.0 Remove Subgroup update. Bushberry subgroup 13 - 07B 13.0 13.0 Subgroup update. Bushberry subgroup 13B 13.0 Remove Subgroup update. Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13 - 07F 3.5 5.0 Subgroup update. Harmonization with Codex (Grapes FB 0269: 5 mg/kg)Page 1 0 of 53

**Table 2.2.2.1**  **. Tolerance Summary for Boscalid.**  Commodity Proposed/Existing Tolerance (ppm) Recommended/ Harmonized Tolerance (ppm) Comments; Correct Commodity

Definition Grape 3.5 Remove Group update. See subgroup 13 - 07F. Berry, low

growing, subgroup 13 - 07G except cranberry 4.5 4.5 Subgroup update. Straw berry 4.5 Remove Group update. See subgroup 13 - 07G. Oilseed group 20 3.5 5.0 Group update. Harmonization with Canada (canola oil and mustard seed oil, 5.0 ppm) Canola, seed 3.5 Remove Group update. See group 20. Sunflower, seed 0.60 Remove Group update. See group 20. Cotton, undelinted seed 1.0 Remove Group update. See group 20. Vegetable, root, except sugar beet, subgroup 1B 1.0 2.0 Vegetable, root, except sugar beet, subgroup 1B, except garden beet, radish, and turnip. Subgroup update. Harmonization with Codex (Root and tuber vegetables, VR 0075: 2 mg/kg) Vegetable, root subgroup 1A, except sugar beet, garden beet, radish, and turnip 1.0 Remove Group update. Turnip, greens 18.0 40.0 Turnip, greens Translation of data from mustard greens, for which a tolerance of 18.0 ppm exists (Brassica leafy greens). Harmonization with Codex (Leafy vegetables VL 0053: 40 mg/kg) **40 CFR 180.589( b**  **)** Section 18 emergency exemptions Endive, belgium 16 Remove Replaced by tolerance under 40 CFR 180.589(a) **40 CFR 180.589( d** **)** Indirect or inadvertent residues Flax, seed 3.5 Remove Group update. See group 20. Cotton, gin byproducts 0.30 Remove Duplicate of existing 40 CFR 180.589(a) entry. No new tolerances are proposed for boscalid based on the proposed residential use on pome fruit, stone fruit, and tree nuts using the proposed label for the Bonide Products, Inc FT09 (EPA File Sy mbol 4 - UII) . The existing tolerances based on the BASF Pristine ® label cover the se residential uses on pome fruit, stone fruit, and tree nuts . The Bonide Products, Inc FT09 label compares favorably

with the BASF Pristine ® label. Therefore, the existing tolerances for pome fruit, stone fruit, and tree nuts will also cover the proposed new residential uses.Page 11 of 53

**2.2. 3**  **Revisions to Petitioned -**  **For Tolerances** 860.1550 Proposed Tolerances
 The available data for Belgium endive will not support a tolerance level of 5.0 ppm. A revised Section F should be submitted with a tolerance for Belgium endive at 6.0 ppm
.  The available data for persimmon will not support a tolerance level of 7.0 ppm. A revised Section F should be submitted with a tolerance for persimmon at 8.0 ppm
. Several crop group conversions were requested. Most were crop group or subgroup updates. The request to replace vegetable, root subgroup 1A, except sugar beet, garden beet, radish, and turnip at 1.0 ppm with vegetable, root, except sugar beet, subgroup 1B at 1.0 ppm is not acceptable. The original tolerance was established based on data for c arrot only (D287829, M. Nelson, MRID 45405113). No field trial data were submitted for radish, the other representative commodity . Therefore the request must be amended to vegetable, root, except sugar beet, subgroup 1B, except garden beet, radish, and t urnip. Moreover, the tolerance should be revised to 2.0 ppm in order to harmonize with Codex. The request to create a tolerance for turnip greens is acceptable. Turnip greens may be covered by translation of field trial residue data for mustard greens. Data for the latter were used in establishing the Brassica leafy greens subgroup 5B tolerance at 18.0 ppm. However, the proposed value of 18 ppm is not acceptable. A value of 40.0 ppm is recommended in order to harmonize with Codex. The proposed conv ersions of certain existing crop groups (including the removal of certain commodity

or commodity

group/subgroup tolerances), with the exception of the conversion of vegetable, root, subgroup 1A except sugar beet, garden beet, radish, and turnip at 1.0 ppm to vegetable, root subgroup 1B, except sugar beet, at 1.0 ppm are acceptable. The exceptions of garden beet, radish, and turnip must be maintained. **2.2. 4**  **International Harmonization** Codex MRL s and/or Canadian MRL s have not been established for boscalid in/on globe artichoke, Belgium endive, or persimmon. Therefore, there is no issue of harmonization with Codex or Canada for these commodities (see Appendix F ). Some harmonizations with Codex were not possible because the corresponding commodity group/sub group tolerance in the US is higher than the Codex MRL . Decreasing the tolerance value has the potential to create apparent violation of the label use instructions when boscalid is used according to the label. Subgroup 13.07G could not be changed from 4. 5 ppm to harmonize with Codex (strawberry , 3 mg/kg). Pome fruit group 11 - 10 could not be changed from 3.0 to harmonize with Codex (apple, 2 mg/kg). Bushberry subgroup 13 - 07B could not be changed from 13.0 ppm to harmonize with Codex (small berry, 10 mg/kg).Page 12 of 53

Many of the group crop updates include changes in the tolerances in order to harmonize with Codex. These are bulb vegetable group 3 - 07 (3.0 to 5.0 ppm); fruiting vegetables group 8 - 10 (1.2 to 3.0 ppm); citrus fruit group 8 - 10 (1.6 to 2.0 ppm); canebe rry subgroup 13 - 07A (6.0 to 10.0 ppm); small vine fruit subgroup 13 - 07F (3.5 to 5.0 ppm); root vegetable subgroup 1B (1.0 to 2.0 ppm). The update from canola, sunflower, and cotton seeds to oilseed group 20 includes a revision in the tolerance from 3.5 pp m to 5.0 ppm in order to harmonize with Canada. Also, the proposed turnip greens tolerance (18 ppm) is based on the proposed addition of turnip greens (turnip tops) to crop subgroup 5B, for which adequate data were previously presented for the representative commodity mustard greens. The tolerance proposal of 18.0 ppm is changed to 40.0 ppm in order to harmonize with Codex. **2.3 Label Recommendations**  860.1200 Directions for Use
 The proposed Pristine ® label ( EPA Reg. No. 7969 - 199) and the proposed Endura® label ( EPA Reg. No. 7969 - 197) provide directions for use on “root vegetables, 1B (except sugar beet).” This must be modified to use on “vegetable, root, except sugar beet, subgroup 1B, except garden beet, radish, and turnip” . The specifi c crops garden bee t , radish, and turnip must be removed from the description of root vegetables for treatment with Pristine ®

.  The proposed Pristine® label (Reg. No. 7969 - 199) and the proposed Endura ® label (EPA Reg. No. 7969 - 197) provide directions for u se on the low growing berry subgroup 13 - 07G . Cranberry

must be removed from the list of crops. The title “low growing berry subgroup” should be changed to “berry , low growing , subgroup 13 - 07G, except cranberry .” **3.0 In**  **troduction** B oscalid , 3 - py

ridinecar boxamide, 2 - chloro -N - (4' - chloro[1,1' - biphenyl ] - 2 - yl), is a fungicide active ingredient that works inside the mitochondria of fungi and stops fungi from producing the energy that they need to carry

on the basic functions in life like obtaining food, growing and reproducing. Boscalid prevents energy production by

binding to the enzy

me succinate ubiquinone reductase. Boscalid is currentl y registered on alfalfa, beans, berries, Brassica vegetables (subgroups 5A and 5B), bulb vegetables, canola, carrots, celery , certain root vegetables, citrus, cotton, cucurbit vegetables, edible peas, fruiting vegetables, herbs (herbs subgroup 19A), grapes, lettuce, Leafy Greens Subgroup 4A, except head and leaf lettuce, and leaf petioles subgroup 4B, mint, peanuts, pistachios, pome fruits, potatoes, soy beans, spinach, stone fruit s , strawberries, tree nuts, tropical fruits (avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star apple) sunflower, seed treatment of rapeseed, greenhouse grown tomato es, imported bananas, and imported coffee, as well as golf course turf.Page 13 of 53

The proposed actions of boscalid are as follows: 1) The Interregional Research Project No. 4 (IR4) is proposing new agricultural uses (PP# 2F8069) on artichoke, Belgium endive, and p ersimmon; 2) BASF is proposing a new greenhouse tomato use for commercial production and for tomato transplants grown for the home consumer market ; 3) Bonide Products is proposing a new use on r esidential fruit and nut trees ; and 4) BASF is proposing new u ses on residential ornamentals and landscape gardens . Additionally, crop group expansions/revisions were requested for the b ulb vegetable group 3 - 07, fruiting vegetable 8 - 10, citrus fruit group 10 - 10, pome fruit group 11 - 10, berry subgroups 13 - 07A, B, F, and G, vegetable root subgroup 1B except sugar beet, and oilseed group 20. **3.1 Chemical Identity**  The chemical structure and nomenclature of boscalid and its hydrox ylmetabolite are presented in Tables 3.1. **Table 3.1.**  **Nom enclature of Boscalid and its**  **Hydroxy Metabolite.** Compound

Common name Boscalid; Nicobifen Company experimental name BAS 510 F IUPAC name 2 - chloro -N - (4 ׳ - chlorobiphenyl - 2 - yl)nicotinamide CAS name 2 - chloro -N - (4' - chloro[1,1' - biphenyl] - 2 - yl) - 3 - py ridinecarboxamide Molecular weight 343.2 CAS registry number 188425 - 85 - 6 End -use product (EPs) 25.2% WDG (Pristine ® Fungicide; EPA Reg. No. 7969 - 199, also contains 12.8% pyraclostrobin) 70% WDG (Endura® Fungicide; EPA Reg. No. 7969 - 197) Hydroxy- metabolite

Common name Boscalid hydroxy metabolite Company experimental name M510F01 (glucuronide conjugate

– M510F02) CAS name 2 - chloro -N - (4' - chloro - 5 - hydroxy- biphenyl - 2 - yl)nicotinamide Molecular weight 359.2 N N O

Cl
Cl

N N O

Cl
Cl O HPage 14 of 53

**3.2 Physical/Chemical Characteristics**  If released to air, a vapor pressure of 5.4 x 10 - 9 mm Hg at 20 o C indicates boscalid will exist solely in the particulate phase in the atmosphere. Particulate - phase boscalid will be removed from the atmosphere b y wet or dry deposition. Boscalid will not volatilize from dry soil surfaces based upon its vapor pressure. Boscalid is stable to direct photoly sis by sunlight. If released to soil, boscalid is expected to have low mobility based upon an estimated Koc of 970. Volatilization from moist soil surfaces or water surfaces is not expected to be an important fate process based upon a Henry's Law constant of 5.1 x 10 - 10 atm - cu m/mole. A biodegradation half - life in soil ranging from 96 to 578 day s and a dissipation half - life range of 27 to 372 day s indicate that biodegradation is not an important environmental fate process. If released into water, boscalid is expected to adsorb to suspended solids and sediment based upon the estimated Koc. An estimated bioconcentration factor (BCF) of 38 suggests the potential for bioconcentration in aquatic o rganisms is moderate. Boscalid is stable to hydrolysis. The phy siochemical properties of boscalid are summarized in Appendix B. **3.3 Pesticide Use Pattern**  Globe artichoke, Belgium endive, and persimmon IR - 4 is proposing the use of Pristine Fungicide on globe artichokes, Belgium endive, and persimmons. Pristine Fungicide (EPA Reg . No. 7969 - 199) is a MAI WDG fungicide containing 12.8% py raclostrobin and 25.2% boscalid. Belgium endive may be treated at a maximum rate of 0.025 lb ai/1000 lb roots prior to cold storage and 0.028 lb ai/70 ft2 prior to forcing, each at one application per season. The maximum single application rate for artichoke and persimmon is 0.36 lb ai/A using aerial, ground, or chemigation equipment. Pristine may be applied 3 times p er crop cycle at a maximum crop - cycle application rate of 1.08 lb ai/A/y r. Greenhouse tomato use for commercial production and for tomato transplants grown for the home consumer market BASF is proposing the use of Pagent® Fungicide on greenhouse grown t omatoes. Pagent® Fungicide label (EPA Reg . No.7969 - 251) is a MAI WDG fun gi cide containing 12.8% py raclostrobin and 25.2% boscalid. Pagent may be applied at a maximum single application rate of 0.36 lb ai/A (or 0.0036 lb ai/gal). Pagent may be applied 3 times per crop cycle at a maximum crop - cycle application rate of 1.08 lb ai/A (or 0.0108 lb ai/gal). Handlers may appl y Pagent using high or low pressure sprayer, or a backpack sprayer. R esidential fruit and nut trees Bonide Products is proposing a new product, Bonide® Fruit Tree Spray Concentrate (FT09), for use on home orchard fruit and nut trees via a homeowner applicator. Bonide® Fruit Tree Spray Co ncentrate (EPA Reg No.4 - UII) is a MAI SC fungicide containing 0.500% lambda - cy halothrin, 3.06% py raclostrobin, and 5.622% boscalid . The maximum single application rate is 0.22 lb ai/A with no more than 4 or 5 applications per ye ar, depending on the tree typ e. The retreatment interval ranges from 7 to 10 day s. Residential handlers may appl y FT 09 using handheld spray equipment.Page 15 of 53

R esidential ornamentals and landscape gardens BASF is proposing a new product, Homeowner Garden Spray Fungici de, for use on re sidential ornamentals and landscape gardens via a residential applicator. Homeowner Garden Spray Fungicide (EPA Reg No. 7969 - GLG) is a MAI SC fungicide containing 9.0% py raclostrobin and 18.0% boscalid . The maximum single application rate for this produc t is 0.0033 lb ai/gal via residential handheld spray equipment or hose - end sprayers. The proposed uses of boscalid are summarized in Table 3.3 . **Table 3.3**  **. Use Profile for Proposed Boscalid Uses**  **Proposed Use**  **Product**

**Form ulation**  **[EPA Reg. No.] Application** 

**Equipment Max. Single** 

**Applic. Rate (lb ai/A** **) Max. No.** 

**Applic. Per**  **Season Max.** 

**Seasonal Applic.**  **Rate (lb**  **ai/A/yr )**  **PHI**

**(days) Use Directions and** 

**Lim itations**  Globe Artichoke Persimmon Pristine Fungicide

[EPA Reg. No.7969 - 199] WDG 25.2% boscalid G round, Aerial, or Chemigation 0.36 3 1.1 0 Continue treatment on a 7 to 14 day interval.

Belgium endive Make one app as a spray to roots when brought into cold storage prior to forcing. Apply again at the beginning of forcing after the roots have been packed in forcing trays. Prior to cold

storage: 0.028 lb ai/1000 lb roots 1 NA 19 Prior to Cold Storage: make one app as a spray to the roots as they move along a conveyor belt used to bring the roots from field transportation into cold storage bins. Prior to forcing: 0.028 lb ai/70ft2 of forcing tray 1 Prior to Forcing: make one app as a spray to roots at the beginning of forcing, after they have been packed into forcing trays.

Gr eenhouse tomatoes Pagent® Fungicide

[EPA Reg . No.7969 - 251] WDG 25.2 % boscalid Chemigation, Gr ound, or Handheld spray equipment 0.36 lb ai/A

or 0.0036 lb ai/gal

3 1.1 0 For commercial production: Apply as a foliar spray in a minimum of 100 gal/A water volume. Allow at least 7 days between applications. Do not make more than one application before alternations to a fungicide with a different mode of action for at least on application.

0. 28 lb ai/A or 0.0028 lb ai/gal 0.85 NA For tomato transplants grown for the home consumer market : Do not exceed 100 gal/A spray volume. Allow at least 7 days between applications. Do not use in transplant production for commercial field - grown tomatoes.Page 16 of 53

**Table 3.3**  **. Use Profile for Proposed Boscalid Uses**  **Proposed Use**  **Product**

**Form ulation**  **[EPA Reg. No.] Application** 

**Equipment Max. Single** 

**Applic. Rate (lb ai/A** **) Max. No.** 

**Applic. Per**  **Season Max.** 

**Seasonal Applic.**  **Rate (lb**  **ai/A/yr )**  **PHI**

**(days) Use Directions and** 

**Lim itations**  Do not apply more than 2 consecutive applications in any crop production cycle.

Residential fruit and nut trees Bonide® Fruit Tree

Spray Concentrate (FT09) [EPA Reg. No. 4 - UII] SC 5.62 % boscalid Handheld spray equipment 0.0076 lb ai/gal

0.000051 lb ai/ft2 0.22 lb ai/A Pome

Fruit and Tree nuts: 4 Stone Fruit: 5 Pome Fuit: 21 Stone Fruit: 14 Almonds: 25 Tree Nuts: 14 Apply thoroughly as a foliar

cover spray to both sides of plant leaves and surfaces. Spray leaf surfaces to the point of drip but do not exceed 2 fl oz of product per 1,500 ft2

Residential ornamentals Homeowner Garden

Spray Fungicide [EPA Reg. No. 7969 - GLG] SC 18.0 % boscalid Handheld spray equipment 0.0033 lb ai/gal

0.33 lb ai/A 1 6 NA For manual spray applications: spray until foliage is wet. For hose - end sprayers: typically hose - end applicators are designed to deliver the desired dial setting per gallon of water in 30 seconds. Retreatment interval is 14 days. 1 Assumed 100 gallons treats 1 acre based on other similar labels; HED recommends that the Homeowner Garden Spray Fungicide (EPA Reg . No. 7969 - GLG) label should be clarified by including the spray volume (i.e., number of gallons of spray treated per acre). This infor mation is needed so that the application rate can be presented in terms of lbs ai/A as well as, lbs ai/gal (which is currently on the label). **3.4 Anticipated Exposure Pathways**  The Registration Division has requested an assessment of human health risk to support proposed new use s of boscalid on the following: 1) agricultural crops globe artichoke, Belgium endive, and pers immon; 2) greenhouse tomato use for commercial production and for tomato transplants grown for the home consumer market ; 3) residential fruit and nut trees ; and 4) residential ornamentals and landscape gardens . Humans may be exposed to boscalid in food an d drinking water, since boscalid may be applied directly

to growing crops and application may result in boscalid reaching surface and ground water drinking water sources . There are residential uses of boscalid so there is exposure to residential handlers and those entering treated areas following application. In occupational settings, applicators may be exposed while handling boscalid . There is a potential for post - application exposure for workers re - entering treated fields and residents re - entering treated areas .Page 17 of 53

Risk assessments have been completed for proposed and existing uses of boscalid . This risk assessment considers all of the aforementioned exposure pathways based on the proposed new uses of boscalid , but also c onsiders existing uses of boscalid , particularl y in the dietary and residential exposure assessment s . **3.5 Consideration of Environmental Justice**  Potential areas of environmental justice concerns, to the extent possible, were considered in this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and L ow - Income Populations," (http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf . As a part of every

pesticide risk assessment, OPP considers a large variety of consumer subgroups according to well - established procedures. In line with OPP policy, HED estimates risks to population subgroups from pesticide exposures that are based on patterns of that subgroup’s food and water consumption, and activities in and around the home that involve pesticide use in a residential setting. Extensive data on food consumption patterns are compiled by th e U.S. Department of Agriculture’s National Health and Nutrition Examination Survey , What We Eat in America, (NHANES/WWEIA) and are used in pesticide risk assessments for all registered food uses of a pesticide. These data are anal yz ed and categorized by subgroups based on age and ethnic group. Additionally , OPP is able to assess dietary exposure to smaller, specialized subgroups and exposure assessments are performed when conditions or circumstances warrant. Whenever appropriate, non - dietary

exposures b ased on home use of pesticide products and associated risks for adult applicators and for toddlers, youths, and adults entering or playing on treated areas post - application are evaluated. Further considerations are currentl y in development as OPP has comm itted resources and expertise to the development of specialized software and models that consider exposure to b ys tanders and farm workers as well as lifestyl e and traditional dietary patterns among specific subgroups. **4.0 Hazard Characterization and Dose**  **- Response Assessment**  **4.1 Toxicolog** **y Studies Available for Analysis**  The available toxicity

database includes:  acute toxicity

battery ,  oral subchronic studies (rat, mouse and dog) ,  dermal subchronic study (rat) ,  oral developmental (rat, rabbit), reproductive (rat), neurotoxicity (rat, acute and subchronic) and immunotoxicity (rat) studies ,  oral chronic (rat, dog) and carcinogenicity (rat, mouse) studies ,  mutagenicity

battery ,  metabolism and pharmacokinetics studies (rat) , and  special oral subchro nic (rat) studies on hepatic enzy me induction, thy

roid hormone induction and reversibility of these inductions .Page 18 of 53

Anticipated exposure routes include oral, dermal and inhalation. While acute and subchronic oral and dermal studies are available, a subchroni c inhalation study was not included in the submitted toxicity

database. **4. 2**  **Absorption, Distribution, Metabolism and Excretion (ADME)** In metabolism and kinetics studies, boscalid was absorbed to some degree , 17% in the low dose (50 mg/kg/day) and 3.5% at 500 mg/kg/day . These values were increased approximately three fold when biliary

excretion data were incorporated . The lower percentages of high - dose absorption w ere considered to be due to saturation, whi ch was supported b y the decreased urinary and biliary

excretion, and greater fecal excretion observed in the high - dose group. There did not appear to be any biologicall y relevant differences in the total absorption between the single dose and the 15 - day repeated dose regimens nor were there any remarkable gender- related differences. Maximum plasma concentration (T max ) was achieved in 8 hours regardless of dose. Elimination of radioactivity from the plasma appeared to be biphasic with a rapid decline from T max to 24 hours (t 1/2 ~8.1 hr) followed b y a slower elimination phase (t 1/2 ~29.9 hr) . There did not appear to be biologically

significant gender - related differences in pharmacokinetic parameters. The AUC values and maximum plasma concentrations did not re flect the 10 - fold difference in administered dose. Tissue distribution data showed that radioactivity was most prevalent in organs/tissues associated with absorption, metabolism and elimination processes such as liver, kidney s, gut, and adipose tissue. Ti ssue burdens for the low - and high - dose groups did not, however, reflect the 10 - fold difference in dose. Radioactivity in the thy

roid and bone marrow appeared to be greatest at the 168

– hour time point. The metabolite characterization findings were consis tent with Phase I oxidation followed by

Phase II conjugation processes. The most prominent metabolites in the urine, bile, and liver were M510F01 (a hydrox yl ation product) and M510F02 (a glucuronide conjugate). In the feces, parent compound (representing unabsorbed material) was the most prevalent component. Excretion of administered radioactivity was primarily

via the feces (~80 - 98%) for all treatment groups regardless of dose level or label position. Urinary excretion accounted for the majority of the remainder of the radiolabel. Although excretion profiles were similar for the single high dose and repeat high - dose groups, somewhat greater urinary excretion of radioactivity was observed for the low - dose group. Biliary excretion represented approximate ly 40 to 50% of the fecal radioactivity

in the low - dose group but onl y about 10% in high - dose group. This was also confirmed b y the plasma kinetics and AUC data. Excretory patterns did not significantl y differ by gender or position of the radiolabel. **4.2.1 Dermal Absorption**  Based on the results of an available dermal absorption study in rats, the d ermal a

bsorption f

actor (DAF) of boscalid was determined to be 15% in the previous risk assessment , as represented b y 11% being absorbed plus 4% found as bo und residue on the skin following a 24 hr exposure and 24 hr sacrifice. The 10 hr exposure and 10 hr sacrifice DAF is 11%, based on 8% being absorbed and 3% found as bound residue on the skin.Page 19 of 53

**4.3 Summary of Toxicological Effects**  Boscalid is a carboxami de (anilide) fungicide that acts in the fungal cell by inhibiting mitochondrial respiration and subsequent production of adenosine triphosphate (ATP ) and by inhibiting the succinate - ubiquinone oxidase reductase s ys tem in Complex II of the mitochondrial ele ctron transport chain. In mammals, the primary targets are the liver and the thy roid (indirectl y from liver adaptive response). In subchronic and chronic feeding studies in rats, mice and dogs, b oscalid generally caused decreased body weights and body we ight gains (primaril y in mice) and effects on the liver (increase in weights, changes in enz ym e levels and histopathological changes) as well as on the thy roid (increase in weights and histopathological changes). Mode of action studies conducted in rats indicate d that bo s calid has a direct effect upon the liver and that the thy roid effects are secondary . A reversibility study in rats indicated that both liver and thy roid parameters returned to control values after the animals were placed on control diet. Absolute and/or relative thyroid weights were elevated in rats and dogs, but there were no histopathological changes observed in the thyroid in either mice or dogs. In a developmental toxicity study in rats, no developmental toxicity was observed in the fetuses at the highest dose tested ( l imit dose). No effects were noted in the dams in this study . In a developmental toxicity

study in rabbits, an increased incidence of abortions or earl y delivery was observed at the l imit dose. There was quantitative evidence of increased susceptibility in the two - generation reproduction study in rats, where decreases in body weights and body weight gains in male offspring were seen at a dose that was lower than the dose that induced parental/s ys temic toxicity . There was quantitative evidence of increased susceptibility in the developmental neurotoxicity study in rats, where decreases in pup body weights (PND 4) and body weight gains (PND 1 - 4) were seen in the absence of any maternal toxicity. In a two - ye ar chronic t oxicity study and a two - year carcinogenicity study in male and female rats, the combined data showed an increase d trend in thy roid follicular cell adenomas that appeared to be treatment - related in males. This was supported b y thyroid hypertrophy and hy per plasia of follicular cells at the same dose as well as increased thy roid weights plus mechanistic data. The mouse carcinogenicity study was negative. Boscalid was negative in the mutagenicity battery . There was not evidence of neurotoxicity in rats in th e acute, subchronic or developmental studies up to the l imit dose . No neurotoxic observations were noted in any of the other studies in any species. In acute studies, there is relatively low toxicity

(toxicity categories III or IVfor oral, dermal, inhalation, primary

eye irritation and primary skin irritation).Page 20 of 53

**4.4 Safety Factor for Infants and Children (FQPA Safety Factor)**  A database of acceptable developmental, reproduction, and neurotoxicity (acute, subchronic and developmental ) studies is av ailable. Based on the weight - of - evidence considerations, it is determined that there is a low concern for increased susceptibility and pre - or post - natal toxicity resulting from exposure to boscalid . There was no evidence of increased susceptibility in the rat developmental study as no developmental toxicity

was seen at the highest dose tested ( l imit dose). There was evidence of increased qualitative susceptibility in the rabbit developmental study as characterized b y an increased incidence of abortions or earl y delivery at the l imit dose. It could not be ascertained if the abortions were the result of a treatment - related effect on the dams, the fetuses or both. It was concluded that the degree of concern is low because the increased abortions or early

d elivery was seen onl y at the l imit dose and the abortions may have been due to maternal stress. There was evidence of increased quantitative susceptibility seen in the rabbit developmental study and the developmental neurotoxicity study , in that reduced b ody weights were seen in the offspring at dose levels wh ere no parental toxicity was observed. However, the degree of concern is low because the dose selected for chronic dietary and non - dietary

exposure risk assessments would address the conc ern for the body weight effects, and the effect was shown to be reversible in the developmental neurotoxicity study . Therefore, it was determined that the FQPA Safety Factor can be reduced to 1X because there is no evidence of susceptibility following in utero exposure to rats and there are low concern and no residual uncertainties in the developmental toxicity study in rabbits, in the 2 - generation reproduction study or in the developmental neurotoxicity study after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment. **4. 4**  **. 1**  **Completeness of the Toxicology Database** The toxicity

database is considered complete and adequate for risk assessment , with the exception of a subchronic inhalation study . All studies needed to assess susceptibility concerns, such as developmental and reproduction studies, have been submitted. Additional studies, such a developmental neurotoxicity study , acute and subc hronic neurotoxicity studies and an immunotoxicity

study are also available. The subchronic inhalation study is required because the use of an oral point of departure (POD) results in MOEs as low as 370 for occupational exposure, which the Hazard and Science Policy Council has determined is not sufficient to alleviate concern (TXR0056585. K.Rury . 03/04/2013). Therefore, a 10x database uncertainty factor has been added for inhalation exposure.Page 21 of 53

**4.4.2 Evidence of Neurotoxicity**  There was no evidence of neurotoxicity based on an acute neurotoxicity study , a 90 - day neurotoxicity

study and a developmental neurotoxicity study (all in rats). There was no evidence of neurotoxicity

in the other subchronic and chronic studies in the database. **4. 4**  **.3 Evidence**  **o f**  **Sensitivity/Su sceptibility in the Developing o**  **r Young Animal** There is no evidence of susceptibility following in utero exposure to rats and there are low concern and no residual uncertainties in the developmental toxicity study in rabbits, in the 2 - generation reproduction study or in the developmental neurotoxicity study after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment. There was no evidence of increased susceptibility in the developmental rat study as no developmental toxicity

was seen at the highest dose tested ( l imit dose). There was evidence of qualitative (not quantitative) increased susceptibility in the developmental rabbit study

as characterized by

an increased incidence of abortions or e arl y delivery at the l imit dose. It could not be ascertained if the abortions were the result of a treatment - related effect on either the dams, the fetuses , or both. The degree of concern is low because the increased abortions or early

delivery was seen o nl y at the Limit Dose and the abortions may have been due to maternal stress. There was quantitative evidence of increased susceptibility in the two - generation reproduction study in rats, where decreases in body weights and body weight gains in male offsp ring were seen in the F 2 generation at a dose that was lower than the dose that induced parental/s ys temic toxicity . However, the degree of concern is low because the dose selected for chronic dietary and non - dietary

exposure risk assessments would address the concern for the body weight effects. There also was quantitative evidence of increased susceptibility in the developmental neurotoxicity

study in rats, where decreases in pup body weights on post - natal day four (PND 4) and body weight gains (PND 1 - 4) were seen in the absence of any maternal toxicity . However, the degree of concern is low because the decreases in pup body weights seen on PND 1 - 4 (and not at any other time periods) were reversible, in that no treatment - related effects on body weight, body weight gain or any other parameter were noted at PND 21. HED has concluded that there are no residual uncertainties for pre - and post - natal toxicity as the degree of concern is low for the susceptibility seen in the above studies, and the dose and endpoints selected for the overall risk assessments will address the concerns for the body weight effects seen in the offspring. Although the dose selected for overall risk assessments (21.8 m g/kg/day) is higher than the NOAELs in the two - generation reproduction study (10.1 mg/kg/day) and the developmental neurotoxicity study (14 mg/kg/day), these differences are considered to be an artifact of the dose selection process in these studies. For example, there is a 10 - fold difference between the LOAEL (106.8 mg/kg/day) and the NOAEL (10.1 mg/kg/day) inPage 22 of 53

the two generation reproduction study . A similar pattern was seen with regard to the developmental neurotoxicity study , where there is also a 10 - f old difference between the LOAEL (147 mg/kg/day) and the NOAEL (14 mg/kg/day). There is onl y a 2 - 3 fold difference between the L OAEL (57 mg/kg/day) and the NOAEL (21.8 mg/kg/day) in the critical study used for risk assessment. Because the gap between the NOAEL and LOAEL in the 2 - generation reproduction and developmental neurotoxicity studies was large and the effects at the LOAEL s were minimal, the true no - observed - adverse - effect - level was probably considerabl y higher. Therefore, the selection of the NOAEL of 21.8 mg/kg/day from the 1 - year dog study is conservative and appropriate for the overall risk assessments. In addition, the endpoints for risk assessment are based on thyroid effects seen in multiple species (mice, rats and dogs) and after various exposure durations (subchronic and chronic exposures) which were not observed at the LOAELs in either the two - generation reproduction or the developmental neurotoxicity studies. Based on these data, it is concluded that there are no residual uncertainties for pre - and post - natal toxicity . (D290022 A. Lev y. 09/08/2003) **4. 4**  **.4 Residual**  **Uncertainty in the Exposure Datab ase**  There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessments were performed us ing tolerance level residues, average percent crop treated estimates and 100% crop treated assumptions (for new proposed crops) . EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to boscalid in drinking water. EPA used similarly conservative assumptions to assess post - application exposure of adults and children . Inaddition, the residential exposure assessment is based on the updated 2012 Residential SOPs employing surrogate study data, inclu ding conservative exposure assumptions based on Day 0 contact to turf and surfaces treated at the maximum application rate. These data are reliable and are not expected to underestimate risks to adults or children. The Residential SOPs are based upon rea sonable “worst - case” assumptions and are not expected to underestimate risk. Although some of the residue values used in the dietary

exposure assessment were slightly refined, th ese assessments will not underestimate the exposure and risks posed b y boscalid . **4. 5**  **Toxicity Endpoint and Point of D**  **eparture Selections 4.5.1**  **Dose -**  **Response Assessment** The endpoints and points of departure for this risk assessment as based on those of the previous risk assessment. The rationales for each selection, along with a detailed description of the toxicity studies used for various exposure scenarios are presented in that document (D290022. Y. Donovan 09/08/2003). Following is a summary : **Acute dietary endpoints** : As there were no toxic effects attributable to a single dose, including the developmental toxicity studies, an endpoint of concern was not identified to quanti fy acute dietary risk to the general population or to the subpopulation females 13 - 49 ye ars old. The changes in brain morphometrics seen in the developmental neurotoxicity study were not selected as they were observed only

at a dose exceeding the l imit dose (1442 mg/kg/day). Therefore, an acute RfD was not established for any population for boscalid .Page 23 of 53

**Chronic dietary endpoint** : HED selected the NOAEL of 21.8 mg/kg/day for establishing the chronic RfD based on the combined results of the following three studies: chronic rat, carcinogenicity

rat and chronic dog. While this NOAEL is higher than the NOAELs in the 90 - day study in dogs (7.6 mg/kg/day) , the two - generation reproduction study (10.1 mg/kg/day) and the developmental neurotoxicity study (14 mg/kg/day), these differences are considered an artifact of the dose selection process in these studies as shown below: Study NOAEL (mg/kg/day) LOAEL

(m g/kg/day) L OAEL :NOAEL

Ratio 90 - day - dog 7.6 78.1 10.3 2 - generation reproduction - rat 10.1 101.6 10.0 developmental neurotoxicity - rat 14.0 147 10.5 1 - year - dog 21.8 57.4 2.6 Because the gap between the NOAEL and LOAEL in these studies was large and the effects at the L OAELs were minimal (dog = increased alkaline phosphatase activity and hepatic weights; 2 - generation = decreased body weights and body

weight gains in offspring; developmental neurotoxicity

= decrease in pup body

weight gains on post - natal day s 1 - 4), the true no - observed adverse - effect - level was probably considerably

higher. Therefore, the selection of the NOAEL of 21.8 mg/kg/day

from the 1 - year dog study is conservative and appropriate for the overall risk assessments. In addition, the endpoints for risk assessment are based on thy roid effects seen in multiple species (mice, rats and dogs) and after various exposure durations (subchronic and chronic exposures) which were not observed at the LOAELs in either the two - generation reprod uction or the developmental neurotoxicity studies. **Occupational and Residential endpoints:**  All of the incidental oral, dermal and inhalation endpoints are based on the co - critical chronic toxicity rat, carcinogenicity rat and 1 - ye ar dog studies. N either d ermal nor sy stemic toxicity was seen at the l imit dose (1000 mg/kg/day) in the 28 - day dermal toxicity

study in rats. The oral NOAELof 21.8 mg/kg/day was selected because of the concerns for the decreases in the body weight and body weight gains seen in the offspring in the two - generation reproduction and the developmental neurotoxicity studies. Additionally , this dose would be protective of the thy roid and hepatotoxicity

seen via the oral route in multiple species (mice, rats and dogs) after various expo sure durations (90 - day , 1 - year and 2 - ye ars). There are no concerns that the effects will worsen following longer treatment. For the dermal endpoints, a dermal study is available; however, the selected endpoint addresses potential effects on offspring, which are not normally examined in the dermal study . This endpoint is likely

to be conservative because no sy stemic effects were observed in the dermal study up to the limit dose of 1000 mg/kg/day . In the reproduction study , the parental NOAEL is 112.6/118 0.8 mg/kg/day

based on decreases in body weight and body

weight gain as well as hepatocy te degeneration in males only . No such effects were observed in the 28 - day dermal study . The use of an oral point of departure (POD) for inhalation exposure results i n MOEs as low as 370 for occupational exposure, which is not sufficient to alleviate concern (TXR0056585. K.Page 24 of 53

Rury . 03/04/2013). Therefore a 10X database uncertainty factor has been added for inhalation exposures. **4.5.2 Recommendation for Combining Routes**  **of Exposure for Risk Assessment** As per FQPA, 1996, when there are potential residential exposures to a pesticide, aggregate risk assessment must consider exposures from three major sources: oral, dermal and inhalation exposures. Since all endpoints are from the same study , exposures from oral, dermal and inhalation exposure routes can be aggregated. **4.5.3 Cancer Classification and Risk Assessment Recommendation**  The Cancer Assessment Review Committee (CARC) classified boscalid as, “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential”, and, therefore, the quantification of human cancer risk is not recommended (TXR0051289 . J. Kidwell . 11/14/2002 ) . The classification was based on dat a which were combined from two 2 - ye ar rat studies where males had a significant increasing trend and significant differences in pair - wise comparison with the controls for thy roid follicular cell adenomas. The increased incidence of these adenomas exceeded the historical control mean and range. This was supported by thy roid hy pertrophy and hyp erplasia of follicular cells, increased thyroid weights and mechanistic data. Combined study

data for female rats showed onl y a borderline significant increasing tr end for thy roid follicular cell adenomas. No increase over controls was noted in males or females for carcinomas. There was no increase in the incidence of any tumors of either sex in the 18 - month mouse study . All mutagenic studies were negative with or without activation. Based on the overall weak evidence of carcinogenic effects, the CARC indicated that a dose - response assessment for cancer (either linear low - dose extrapolation or margin of exposure calculation) was not needed. **4.5.4 Summary of Point**  **s of Departure and Toxicity Endpoints Used in Human Risk Assessment**  **Table 4.5.4.1 .**  **Summary of Toxicological Doses and Endpoints for Boscalid for Use in Dietary and Non**   ** Occupational Hum** **an Health Risk Assessments. Exposure/**  **Scenario Point of** 

**Departure Unce**  **rtainty/F**

**QPA Safety Factors**  **RfD, PAD,**

**Level of Concern for**  **Risk Assessment**  **Study and Toxicological Effects** Ac ute Dietary (All Populations, including Infants and Children and Females 13 - 49 years of age) NA NA NA No appropriate endpoint attributable to a single dose was not identified Chronic Dietary (All Populations) NOAEL=

21.8 mg/kg/day UF A= 10x

UF H=10x FQPA SF= 1x Chronic RfD =

0.218 mg/kg/day cPAD = 0.218 mg/kg/day Co - critical chronic rat, carcinogenicity rat,

and 1 - year dog studies LOAEL = 57 - 58 mg/kg/day based on liver and thyroid effectsPage 25 of 53

**Table 4.5.4.1 .**  **Summary of Toxicological Doses and Endpoints for Boscalid for Use in Dietary and Non**   ** Occupational Hum** **an Health Risk Assessments. Exposure/**  **Scenario Point of** 

**Departure Unce**  **rtainty/F**

**QPA Safety Factors**  **RfD, PAD,**

**Level of Concern for**  **Risk Assessment**  **Study and Toxicological Effects** Incidental Oral Short - Term

(1 - 30 days) & Intermediate - Term (1 - 6 months) NOAEL=

21.8 mg/kg/day UF A= 10x

UF H=10x FQPA SF= 1x Residential

LOC for MOE = 100 Co - critical chronic rat, carcinogenicity rat,

and 1 - year dog studies LOAEL = 57 - 58 mg/kg/day based on liver and thyroid effects Dermal Short - Term (1 - 30 days) & Intermediate - Term (1 - 6 months) NOAEL=

21.8 mg/kg/day UF A= 10x

UF H=10x FQPA SF= 1x Residential

LOC for MOE = 100 Co - critical chronic rat, carcinogenicity rat,

and 1 - year dog studies LOAEL = 57 - 58 mg/kg/day based on liver and thyroid effects Inhalation Short Term (1 - 30 days) & Intermediate Term (1 - 6 months) NOAEL=

21.8 mg/kg/day UF A = 10x

UF H = 10x UF DB = 10x FQPA SF= 1x Residential

LOC for MOE = 10 0 0 Co - critical chronic rat, carcinogenicity rat,

and 1 - year dog studies LOAEL = 57 - 58 mg/kg/day based on liver and thyroid effects Cancer (oral, dermal, inhalation) Classification: “suggestive evidence of carcinogenicity, but not sufficient to assess human

carcinogenic potential”; quantification of human cancer risk is not recommended. Point of Departure (POD) = A data point or an estimated point that is derived fr om observed dose - response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF DB = to account for the absence of key data (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. **Table 4.5.4.2 .**  **Summary of Toxicological Doses and Endpoints for Bo scalid for Use in Occupational Hum**  **an Health Risk Assessments**  **Exposure/ Scenario**  **Point of**

**Departure Uncertainty** 

**Factors Level of Concern** 

**for Risk Assessment**  **Study and Toxicological Effects** Dermal Short Term (1 - 30 days) NOAEL=

21.8 mg/kg/day UF A = 10x

UF H =10x FQPA SF= 1x Occupation al

LOC for MOE = 100 Co - critical chronic rat, carcinogenicity rat,

and 1 - year dog studies LOAEL = 57 - 58 mg/kg/day based on liver and thyroid effects Dermal Intermediate Term (1 - 6 mo nths) NOAEL=

21.8 mg/kg/day UF A = 10x

UF H = 10x FQPA SF= 1x Occupation al

LOC for MOE = 100 Co - critical chronic rat, carcinogenicity rat,

and 1 - year dog studies LOAEL = 57 - 58 mg/kg/day based on liver and thyroid effects Inhalation Short - Term

(1 - 30 days) NOAEL=

21.8 mg/kg/day UF A = 10x

UF H=10x UF DB = 10x FQPA SF= 1x Occupation al

LOC for MOE = 100 0 Co - critical chronic rat, carcinogenicity rat,

and 1 - year dog studies LOAEL = 57 - 58 mg/kg/day based on liver and thyroid effects Inhalation Intermediate term (1 - 6 mo nths) NOAEL=

21.8 mg/kg/day UF A = 10x

UF H =10x UF DB = 10x FQPA SF = 1x Occupation al

LOC for MOE = 100 0 Co - critical chronic rat, carcinogenicity rat,

and 1 - year dog studies LOAEL = 57 - 58 mg/kg/day based on liver and thyroid effects Cancer (oral, dermal, inhalation) Classification: “suggestive evidence of carcinogenicity, but not sufficient to assess human

carcinogenic potential”; quantification of human cancer risk is not recommended.Page 26 of 53

Point of Departure (POD) = A data point or an estimated point that is derived fr om observed dose - response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF DB = to account for the absence of key data (i.e., lack of a critical study). MOE = margin of exposure. LOC = level of concern. N/A = not applicable. **5.0 Dietary Exposure and Risk Assessment**  **5.1 Residues of Concern Summary and Rationale**  The residues of concern for dietary risk assessment and the tolerance expression are summarized in Table 5.1 (HED MARC, DP2 86786 , M . Nelson , 1/9/0 3 ) . HED has concluded that the residue of concern in plants i s boscalid for purposes of tolerance enforcement and risk assessment. The nature of boscalid residues in lives tock is adequately understood , based upon acceptable 14 C metabolism studies conducted on lactating goat s and laying hens. In both goat s and hen s , parent boscalid, M510F01 (hydrox y metabolite), and M510F 02 (M510F01 glucuronide) were identified as the majo r residues, each with ≥ 1 0 % T RR . N o amide bridge cleavage products were identified. Based on the structural similarity of boscalid and M510F 01, and the fact that the enzy matic hydrol ys is step in the proposed enforcement method will release M510F 02 back to free M510F 01, HED concluded that the combined residues of parent boscalid , M510F 01 and M510F02 are the residues of concern in livestock matrices for purposes of risk assessment and the tolerance expression. For drinking water, the resid u e of concern for boscalid is the parent onl y. **Table 5.1. Summary of Metabolites and Degradates to be included in the Risk Assessment and Tolerance**  **Expression .**  **Matrix Residues included in Risk**  **Assessment Residues included in**  **Tolerance Expression** Plants Primary Crop parent parent

Rotational Crop parent parent Livestock Ruminant p arent , M510F 01 & M510F02 p arent , M510F 01 & M510F02

Poultry p arent , M510F 01 & M510F02 p arent , M510F 01 & M510F02 Drinking Water p arent only Not Applicable **5 .2**  **Food Residue**  **Profile** Field trial data on artichoke (MRID 48897401) , Belgium endive (MRID 48897402) , and persimmon (MRID 48897403) have been submitted to support the proposed tolerances. These data are adequate to support dietary risk assessment as well as the propose d tolerances of boscalid on artichoke, Belgium endive, and persimmon. The number and geographic distribution of the field trials are adequate. The anal ytical method was demonstrated to be acceptable via concurrent recoveries of fortified control samples. The intervals of frozen storage of samples are covered b y previous storage stability studies, and no corrections for loss of residue are needed. The trials were conducted according to the proposed label s (single and seasonal application rates,Page 27 of 53

PHI) . Summaries of the residue data from the crop field trials are presented in Appendix D, Table D - 1 through D - 3. Greenhouse Grown Tomato Transplants Grown for Home Consumer Market BASF Corporation has requested the addition of greenhouse tomato use for commerci al production and for tomato transplants grown for the home consumer market to the PageantTM Fungicide label (EPA Reg. No. 7969 - 251). This product is identical to PristineTM Fungicide ( EPA Reg. No. 7969 - 199), which includes use on greenhouse tomatoes, but does not cover tomato transplants for consumers or use of lathe type structures. No residue chemistry data were submitted with this request. Residues on tomato fruits from such use of PristineTM Fungicide ( EPA Reg. No. 7969 - 199) for tomato transplants in green house, lath house, and other production structures would be expected to be less than those found in the greenhouse trials supporting the approved greenhouse use. The existing tolerance for fruiting vegetables will cover the requested new uses of the PageantTM Fungicide ( EPA Reg. No. 7969 - 251) formulation. Residential Use of FT09 (EPA File Sy mbol 4 - UII) on Pome Fruit, Stone Fruit, and Tree Nuts The submitted use directions are sufficient to allow for evaluation of the proposed residential use of FT09 b ased on comparison to the existing BASF Pristine ® label for agricultural uses. The BASF formulation is a water dispersible granule. It is a solid material that forms a dispersion when mixed with water. The Bonide formulation is a suspension concentrate or suspension of solid materials in water. It al so will form a dispersion when mixed with water. The formulations are expected to behave similarly when applied in the same manner (same rate) to crops. The Organization of Economic Cooperation and Development (OECD) Crop Field Trial Guidance recognizes such formulations as yielding the same residues at PHIs greater than 7 day s. All relevant Bonide PHIs exceed 7 days, and therefore the resulting residues based on formulation will not be greater than residues from the BASF formulation. The PHIs for the Bonide formulation are equal to or longer/greater than the BASF Pristine® formulation PHI s. Therefore, residues from use on the Bonide formulation are anticipated to be no more than or less than residues from the BASF formulation, based o n comparison of the PHIs. The application rates (lbs ai/A) for the Bonide formulation, both per application and per season, are approximately

equal to or less than the corresponding application rates for the BASF Pristine® formulation. Therefore, resid ues from the use of the Bonide formulation are anticipated to be no more than or less than residues from the BASF formulation, based on comparison of the application rates. Residential use of the Bonide FT09 per the proposed label will not yield residues in excess of those from agricultural use of the BASF formulation Pristine ® per the approved label. Processed Food and Feed There are no proposed uses that are relevant to this guideline topic. There are no processed commodities on artichoke, Belgium en dive, or persimmon of regulatory interest.Page 28 of 53

Livestock There are no proposed uses that are relevant to this guideline topic. There are no feed items associated with artichoke, Belgium endive, or persimmons. Therefore, the previous livestock dietary intake calculations and resulting tolerance recommendations are not changed. Rotational Crops The nature of the residue in rotational crops is adequately understood and was summarized in a previous residue chemistry summary document (DP278385, M. Nelson, 8/15/0 3). HED has concluded that the residue of concern in rotated crops for purposes of risk assessment and the tolerance expression is parent compound. Adequate limited and extensive field rotational crop studies are available supporting the existing toleran ces for indirect residues in rotational crops. These data support the label - specific plant - back interval of 14 day s for crops without boscalid uses. No additional rotational crop data are required for purposes of this petition. **5.3 Water Residue Profil**  **e** The drinking water residues used in the dietary risk assessment were provided by EFED (D409880, K. White, 04/17/2013) and incorporated directly into th e dietary assessment. Water residues were incorporated in the DEEM - FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.” The drinking water assessment considered new uses on Belgium endive, globe artichoke, and persimmon and new uses on tomatoes in greenhouses and lath houses, and homeowner garden spray and ornamental applications. All existing uses were also considered. Surface water estimated drinking water concentrations ( EDWC ) were determined in previous as sessments. See Tier I Drinking W ater Exposure Assessment for the Section 3 New Use of Boscalid on Various Agricultural Crops Including Cranberries (White, 2012, D405064 ) for a discussion of modeling and estimating surface water concentrations. The EDWCs for boscalid in surface water were calculated using the screening model FIRST (FQPA Index Reservoir Screening Tool; v.1.1.1; dated 03/25/08)
. Screening Concentration in Ground Water (SCI GROW v2.3, Jul. 29, 2003) is a regression model used as a screening tool to estimate pesticide concentrations found in ground water used as drinking water. Tier 1 ground water EDWCs for boscalid were derived with PRZM - GW (Pesticide Root Zone Model for Ground water, version 1.0, August 31, 2012 ), using the GW - GUI(Graphical User Interface, version 1.0, August 31, 2012 ). PRZM - GW is a one - dimensional, finite - difference model that estimates the concentrations of pesticides in groundwater. It accounts for pesticide fate in the crop root zone by simulating pesticide transport and degradation through the soil profile after a pesticide is applied to an agricultural field. PRZM - GW permits the assessment of multiple years of pesticide applicatio n (up to 100 years) on a single site. Six standard scenarios, each representing a different region known to be vulnerable to ground water contaminations, are available for use with PRZM - GW for risk assessment purposes. The maximum Tier 1 estimated chroni c ground water EDWC is 697 ppb. The maximum Tier 1 estimated chronic surface water EDWC is 26.4 ppb. This is based on turf use. The ground water value is higher than the surface water value and was therefore used in the assessment. ThePage 29 of 53

EFED models and their descriptions are available at the EPA internet site : http://www.epa.gov/oppefed1/models/water/ . See Table 5.3.1 . **Table 5.3.1**  **. Tier I EDWCs**  **B ased on**  **B oscalid**  **U se on**  **Turf .**  **1 Source of**  **Drinking Water Acute**  **(μg/L) Annual Average or Post**  **Breakthrough Average (μg/L)**  Surface water 97.3 26.4 Ground water 773 **697** 1 These are the highest EDWCs for the proposed and relevant previously evaluated use scenarios. **5.4 Dietary Risk Assessment**  **5.4.1 Description of Residue Data Used in Dietary Assessment**  The dietary

exposure analy sis incorporates all current and proposed tolerances for residues of boscalid , including its metabolites and degradates. S ince no observed effects could be attributed to a single dose, an acute endpoint was not established. Therefore, an acute dietary exposure assessment was not conducted . A partially refined chronic dietary anal ys is was conducted . The chronic dietary exposure and risk assessment is based on tolerance - level residues for all commodities . The data used in the 200 9 dietary

assessments were also used in this current analy sis except for the addition of tolerances fo r globe artichoke, Belgium endive, and persimmon. The Biological Economic Analy sis Division ( BEAD ) has provided percent crop treated information for boscalid ( J. Alsadek, BEAD, 03/08/2013). The EDWC for boscalid ( 697 μg/L ) was calculated based on a turf scenario for ground water. The anal ys is includes HED - recommended tolerance level residue values for the herb subgroup 19A, although these tolerances were never finalized. The tolerances were recommended in connection with PP# 6E7164 and PP#7F7169 (DP 336632, C. Olinger, 11/27/2007) . At the request of the Registration Division, a value of 0.5 ppm was used for honey, based on the existing tolerance in the European Union. No new experimental processing data were incorporated into this anal ys is. The processing factors from earlier dietary assessments were derived as follows. For processed commodities where data were available to show no concentration (apple juice, dried plum prunes , rice bran, wheat flour, sunflower oil, mint oil, tomato puree, tomato juice, soy bean oil , and cottonseed oil), the processing factor was set to 1. For processed commodities where the raw agricultural commodity

( RAC ) tolerance is adequate to cov er the very slight concentration seen in the processing study

(wheat germ, wheat bran, and tomato paste), the residue was set at the RAC level and the processing factor was reduced to 1. For processed commodities with established tolerances (raisin, peanut oil , and citrus oil ), the processed commodity tolerance was used and the processing factor was set to 1.0 . For all other processed commodities for which data were not available, DEEM (version 7.81) processing factors were used ( DP# 336633, D. Davis, 12/ 17/2007).Page 30 of 53

Boscalid is classified as “ not likely to be carcinogenic to humans” . Therefore, a cancer dietary exposure assessment was not conducted. **5.4.2 Percent Crop Treated Used in Dietary Assessment**  BEAD has provided percent crop treated information for boscalid ( J. Alsadek, BEAD, 03/08/2013). As a refinement, the weighted average %CT was incorporated . One hundred percent crop treated was assumed for commodities with no % CT data. The following average percent crop treated estimates were used in the chronic dietary risk assessments for the crops that are currentl y registered for boscalid: almonds 40%; apples 15%; apricots 25%; green beans 5%; blueberries 35%; broccoli <2.5%; cabbage 5%; caneberri es 45%; cantaloupes 5%; carrots 15%; cauliflower 5%; celery <2.5%; cherries 45%; cucumbers 5%; dry beans/dry peas <2.5%; garlic 5%; grapes 30%; hazelnuts 5%; lettuce 25%; nectarines 15%; onions 20%; peaches 20%; peanuts <1%; pears 15%; green peas <1%; pep pers <2.5%; pistachios 30%; plums/prunes 5%; potatoes 20%; pumpkins 10%; squash 5%; strawberries 55%; tomatoes 5%; walnuts <1%; watermelons 25%. **5.4.3 Acute Dietary Risk Assessment**  S ince no observed effects could be attributed to a single dose, an acute endpoint was not established. Therefore, an acute dietary exposure assessment was not conducted . **5.4.4 Chronic Dietary Risk Assessment**  **s** The chronic dietary analy s i s was performed using tolerance level residues , average percent crop treated estimates, and 100% crop treated assumptions for new proposed uses . Dietary risk estimates were determined considering exposures from food plus drinking water. Boscalid exposure from the existing uses , including tolerance modifications to harmonize with Codex , and the proposed new use s on persimmon, Belgium endive , and globe artichoke results in estimated risk s that are below the Agency ’s level of concern for food plus drinking water. The highest exposure and risk estimates for food plus drinking water utilized 2 0 % of the chronic population adjusted dose (cPAD) for the U.S. population and 56 % for children 1 - 2 years old, the most highl y exposed population subgroup.Page 31 of 53

**5.4. 5**  **Summary Table Table**  **5. 4.**  **5 Summary of Dietary**  **(Food and Drinking Water) Exposure and Risk for Boscalid**  **1,2** Population Subgroup Ac ute Dietary Chronic Dietary Cancer Dietary Exposure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % cPAD Dietary Exposure (mg/kg/day) Risk General U.S. Population

N/A N/A 0.042751 20

N/A N/A All Infants (< 1 year old) 0.091079 42 **Children 1 -**  **2 years old 0.121118**  **56** Children 3 - 5 years old 0.088299 41 Children 6 - 12 years old 0.047744 22 Youth 13 - 19 years old 0.029796 14 Adults 20 - 49 years old 0.036670 17 Adults 50+ years old 0.038128 18 Females 13 - 49 years old 0.036893 17 **1** The population subgroup with the highest estimated chronic dietary (food + drinking water) exposure and risk is indicated by bold text. **2**NA = not applicable **6.0 Residential**  **(Non -**  **Occupational) Exposure/Risk Characterization** The proposed residential uses for boscalid will result in residential handler and post - application exposures. In addition, the existing use on golf course turf ( Emerald Fungicide label; EPA Reg. No. 7969 - 1 96 4) was reassessed in this document to reflect updates to HED’s 2012 Residential SOPs 2 along with policy

changes for body

weight assumptions , since the revisi on s to these exposures could impact the human health aggregate risk assessment for boscalid . Registered and proposed products do not lead to any residential handler or post - application risk estimates of concern. **6.1 Residential Handler Exposure**  The residential handler assessment includes short - term exposures via the dermal and inhalation route s from treating gardens, trees, and turf. HED’s LOC for the MOE is defined b y the uncertainty factors that are applied to the assessment. HED applies a 10X factor to account for variability among species and a 10X factor to account for variability with in species. The total uncertainty factor that has been applied to the non - cancer 2 Available: http://www.epa.gov/pesticides/science/residential - exposure - sop.htmlPage 32 of 53

dermal assessment of boscalid is 100X for residential exposure. Residential dermal exposure and risk resulting in MOEs greater than or equal to 100 will not be of concern to HED (LOC = 100). For inhalation exposures, an additional 10X uncertainty factor is added because of the database gap for lack of an available subchronic inhalation toxicity study . Therefore, the total uncertainty factor that has been applied to the non - cancer inhalation assessments of boscalid is 1000X for residential handler exposure. Residential inhalation exposure and risk resulting in MOEs greater than or equal to 1000 will not be of concern to HED (LOC = 1000). Dermal and inhalation risk estimat es were co mbined in this assessment because the PODs are based on the same toxicological study , thus the effects for th ese exposure routes are the same . Dermal and inhalation risk estimates were combined using the total aggregated risk index (ARI) methodo logy since the LOCs for dermal exposure (100) and inhalation exposure (1 , 000) are different. The LOC ARI is 1; therefore, ARIs of less than 1 are risk estimates of concern. Summaries of the inhalation and dermal risk estimates for residential handlers are included in Table 6.1 . The maximum application rate for each exposure scenario is presented as the worst case scenario. The residential handler ARIs range from 24 to 330 . Therefore, the dermal and inhalation risk estimate s to residential handlers ar e not of concern to HED for any of the residential handler scenarios.Page 33 of 53

**Table 6.1. Residential Handler Non -**  **cancer Exposure and Risk Estimates for Boscalid. Exposure Scenario**  **Dermal Unit**  **Exposure (m** **g/lb ai) Inhalation** 

**Unit Exposure**  **(m g/lb ai)**  **Ma xim**  **um**

**Application Rate 1**  **Area**

**Treated or Am**  **ount Handled**  **Daily 2**  **Dermal Inhalation**  **Total ARI 7** 

**Dose (m** **g/k g/day)**  **3 MOE**  **4 Dose**  **(m g/k** **g/day) 5**  **MOE 6**  Mixer/Lo ader/Applicator Liquid Garden/Trees : manually pressurized handwand 63 0.018 0.0076 lb ai/gal 5 gal 0.0045 4,900 0.0000086 2,500,000 48 Liquid Garden/Trees : manually pressurized handwand 63 0.018 0.0000051 lb ai/ft2 1200 ft2 0.00072 30,000 0.0000014 16,000,000 300 Liquid Garden/Trees : hose - end sprayer 58 0.0014 0.0000051 lb ai/ft2 1200 ft2 0.00067 33,000 0.00000011 200,000,000 330 Liquid Garden/Trees : hose - end sprayer 58 0.0014 0.0076 lb ai/gal 11 gal 0.0091 2,400 0.0000015 15,000,000 24 Liquid Garden/Trees : backpack sprayer 130 0.14 0.0000051 lb ai/ft2 1200 ft2 0.0015 15,000 0.000011 2,000,000 140 Liquid Garden/Trees : backpack sprayer 130 0.14 0.0076 lb ai/gal 5 gal 0.0093 2,400 0.000067 330,000 22 Liquid Garden/Trees : sprinkler can 58 0.0014 0.0000051 lb ai/ft2 1200 ft2 0.00067 33,000 0.00000011 200,000,000 330 Liquid Garden/Trees : sprinkler can 58 0.0014 0.0076 lb ai/gal 5 gal 0.0041 5,300 0.00000067 33,000,000 53 1 Based on the proposed garden/tree use on Bonide FT09 label (EPA Reg. No. 4 - UII) 2 Based on HED’s 2012 Residential SOPs (http://www.epa.gov/pesticides/science/residential - exposure - sop.html ). 3 Dermal Dose = Dermal Unit Exposure (mg/lb ai) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled (A/day or gallons/day) × D ermal Absorption Factor (15%) ÷ Body Weight (80 kg). 4 Dermal MOE = Dermal NOAEL (21.8 mg/kg/day) ÷ Dermal Dose (mg/kg/day). 5 Inhalation Dose = Inhalation Unit Exposure (21.8 mg/lb ai) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled (A/day or gallons/day) ÷ BW (80 kg). 6 Inhalation MOE = Inhalation NOAEL (mg/kg/day) ÷ Inhalation Dose (mg/kg/day). 7 Aggregate Risk Index (ARI) = 1÷ (1 ÷ RI dermal) + (1 ÷ RI inhalat io n) Risk Index (RI) = MOE ÷ LOC ; Inhalation LOC = 1,000 and Dermal LOC = 100Page 34 of 53

**6.2 Post**  **- Application Exposure**  There is the potential for dermal post - application exposure for individuals as result of being in an environment that has been previously treated with boscalid . Incidental oral exposure to children 1 to <2 years old is not expected from treated turf because boscalid is only registered for use on golf course turf only

and proposed for use on residential gardens and trees. Short - term dermal exposures were assessed for adults, youth 11 to 16 years old, and children 6 to 11 years old. A series of assumptions and exposure factors served as th e basis for completing the residential post - application risk assessment. Each assumption and factor is detailed in the 2012 Residential SOPs 6

. Summary of Residential Post - application Non - Cancer Exposure and Risk Estimates All the short - term MOEs for each scenario are greater than the LOC of 100 , and therefore, are not of concern . A TTR study is **not** required at this time for boscalid since the lowest dermal MOE (10,000) is greater than 10 times the L OC based on default values for the fraction of application rate available for transfer after a turf application. Additionally, DFR studies are not required at this time for boscalid since the lowest dermal MOE (690) is greater than 4 times the LOC based on default input values. **Table 6.2. Residentia**  **l Post -**  **application Non -**  **cancer Exposure and Risk Estim ates for Boscalid.**  **Lifestage Post**  **- application Exposure Scenario**  **Application Rate**  **1 Dose** 

**(m g/k** **g/day) MOEs**  **2 Use Site**  **Route of Exposure** Adult Gardens Dermal 0.33 lb ai/A 0.032 690 Child (6 - 11 yrs) 0.022 1000 Adult Fruit and Nut Trees Dermal 0.22 lb ai/A 0.0019 11,000 Child (6 - 11 yrs) 0.0013 16,000 Adult Lawn/Turf Dermal Golfing 0. 3 5 lb ai/A 0.0015 14,000 Youth (11 - 16 yrs) Dermal Golfing 0.0018 12,000 Child (6 - 11 yrs) Dermal Golfing 0.0021 10,000 1 Based on the proposed tree use on Bonide FT09 label (EPA Reg. No. 4 - UII); the proposed garden use on Homeowner Garden Spray SC ( EPA Reg. No. 7969 - GLG); the proposed tomato transplant use on Pagent® Fungicide ( EP A Reg. No.7969 - 251); and the registered golf turf use on Emerald ® Fungic ide label (EPA Reg. No. 7969 - 196 ). 2 Dermal MOE = Dermal NOAEL ( 21.8 mg/kg/day) ÷ Dermal Dose (mg/kg/day). **6.3 Combined Residential Risk Estimates (Multiple Exposure Scenarios)**  Because dermal post - application exposure s to treated gardens , fruit or nut trees, and turf could conceivabl y co - occur within the same day for adult s and children 6 to 11 year olds , combined exposures from these scenarios were co nsidered . However, all four of these use sites/scenarios are proposed on different labeled products containing boscalid; therefore, the probability of co occurrence is considered improbable. Therefore, assessments of these combined exposures were not conducted.Page 35 of 53

**6 .4**  **Residential Risk Estimates for Use in Aggregate Assessment** The scenarios with the highest exposures and corresponding lowest MOEs provided in Tables 6.1 and 6.2 reflect the residential risk estimates that are recommended for use in the aggregate assess ment for boscalid. Table 6.4 presents the residential risk estimates that are recommended for use in the aggregate assessment for boscalid .  The recommended residential dermal exposure for use in the adult aggregate assessment reflects dermal exposure fro m post - application activities on treated gardens.  The recommended residential dermal exposure for use in the youth (11 - 16 y r) aggregate assessment reflects dermal exposure from post - application golfing on treated turf .  The recommended residential dermal exposure for use in the child (6 - 11 y r) aggregate assessment reflects dermal exposure from post - application activities in treated gardens. **Table 6. 4**  **. Recommendations for the Residential Exposures for the Boscalid Short -**  **term Aggregate Assessments.**  **Lifestage Route of** 

**Exposure Scenario**  **Dose 1**  **(m g/k** **g/day) MOE**  **2** Adult Dermal Post - application activities in treated gardens 0.032 690 Youth (11 - 16 yr old) Dermal Post - application golfing on treated turf 0.0018 12,000 Child (6 - 11 yr old) Dermal Post - application activities in treated gardens 0.022 10,000 1 Daily Dose = See table 6.1 for adult handler scenarios and Table 6.2 for post - application scenarios. 2 MOE = NOAEL/Daily Dose **6.5 Residential Bystander**  **Post -**  **application Inhalation Exposure**  Based on the Agency's current practices, a quantitative post - application inhalation exposure assessment was not performed for boscalid at this time primarily because of the low acute inhalation toxicity

(Toxicity Category IV), low vapor pressure ( 5.3 x 10 - 9 mm Hg at 20 0 C ), and the low proposed use rates (0.22 to 0.36 lb ai/A). However, volatilization of pesticides may be a source of post - application inhalation exposure to individuals nearby pesticide applications. The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 3 . The Agency is in the process of evalu ating the SAP report and may , as appropriate, develop policies and procedures to identify the need for and, subsequently , the way to incorporate post - application inhalation exposure into the Agency's risk assessments. If new policies or procedures are dev eloped, the Agency may revisit the need for a quantitative post - application inhalation e xposure assessment for boscalid . **6.6 Spray Drift**  Spray drift is alway s a potential source of exposure to residents nearby to spraying operations. This is particularl y the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from the ground application method employed for boscalid . The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State 3 Available: http://www.ep a.gov/scipoly/SAP/meetings/2009/120109meeting.htmlPage 36 of 53

Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices (see the Agency ’s Spray Drift website for more information4 ). The Agency has completed its evaluation of the new database submitted by the Spray

Drift Task Force, a membership of U.S. pesticide registrants, and is developing a policy on how to appropriatel y apply

the data and the AgDRIFT computer model to its risk assessments for pesticides applied b y air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency

may impose further refinements in spray drift management practices to reduce off - target drift with specific products with si gnificant risk estimates associated with drift. Although a quantitative residential post - application inhalation exposure assessment was not performed as a result of pesticide drift from neighboring treated agricultural fields, an inhalation exposure asses sment was performed for flaggers. This exposure scenario is representative of a wors t case inhalation (drift) exposure and may be considered protective of most outdoor agricultural and commercial post - application inhalation exposure scenarios
. **7.0 Aggregate**  **Exposure/Risk Characterization** In accordance with FQPA, HED must consider and aggregate (add) pesticide exposures and risks from three major sources: food, drinking water, and residential exposures. In an aggregate assessment, exposures from relevant sources are added together and compared to quantitative estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can be aggregated. When aggregating exposures and risks from various sources, HED considers both the route and duration of exposure. For boscalid , potential exposures from food, drinking water, and residential scenarios were aggregated. This assessment considers the changes in the 2012 Residential SOPs implemented in January 2012. HED confirms that there are no exposure risks of con cern resulting from boscalid on globe artichoke, Belgium endive, or persimmon , nor from utilizing the 2012 Residential SOPs to estimate residential exposure and risk. **7.1 Acute Aggregate Risk**  The aggregate acute risk estimates include exposure to resid ues of boscalid in food and drinking water, and does not include dermal, inhalation , or incidental oral exposure. However, since no observed effects could be attributed to a single dose, an acute endpoint was not established. Therefore, an acute dietary exposure assessment was not conducted. **7.2 Short** **- Term Aggregate Risk**  There is potential short - term exposure to boscalid via dietary (which is considered background exposure) and residential (which is considered primary) exposure pathways. For adults, these pathway s lead to exposure via oral (background) as well as dermal and inhalation (primary) routes. The most conservative scenario s w ere chosen for each. For a description of the residential exposure scenarios considered in the aggregate assessment, see Section 6.4.

4 Available: http://www.epa.gov/opp00001/factsheets/spraydrift.htmPage 37 of 53

The non - cancer aggregate MOE s are 490 for children 6 to 11 years old, 1,300 for youths 11 to 16 ye ars old, and 410 for adults. None of these aggregate risk estimates are of concern to HED. **Table 7.2.1**  **. Short**  **- Term**  **Aggregate Risk Calculations Lifestage**  **Scenario Dermal Exposure**  **Oral Exposure Total**  **Combined MOE**  **2 NOAEL**  **mg/kg/day Exposure** 

**mg/kg/day MOE**  **1 NOAEL**  **mg/kg/day Ch**  **ronic Dietary**

**(Food + Water) mg/kg/day**  **MOE 1**  Child 6 - 11 yrs Post - application activities

in treated gardens 21.8 0.022 990 21.8 0.0 47744 460 310 Youth 11 - 16 yrs Post - application golfing on treated turf 21.8 0.0018 12,000 21.8 0.0 29796 730 690 Adult Post - application activities

in treated gardens 21.8 0.032 680 21.8 0.0 42751 5 10 29 0 1 The Level of Concern MOE is 100. 2 Total Combined MOE = 1/ [(1/MOE Dermal ) + (1/MOE Oral )] **7.3 Chronic Aggregate Risk**  Chronic exposure from the residential pathway is not anticipated based on the current boscalid use pattern. The chronic aggregate risk (food and drinking water) is below HED’s LOC (i.e., <100% cPAD for the general U.S. population and all population subgro ups ) . The dietary exposure is estimated at 0.0 42751 mg/kg/day for the general U.S. population ( 2 0 % of the cPAD) and 0. 121118 mg/kg/day

( 56 % of the cPAD) for children 1 - 2 years old, the population subgroup with the highest estimated chronic dietary exposure to boscalid . See Section 5. 4.4 for details. **8.0 Cumulative Exposure/Risk Characterization**  Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to boscalid and any other substances and boscalid does not appear to produce a toxic metabolite produced b y other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that boscalid has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity

and to evaluate the cumulative effects of such chemicals, see the policy statements released b y EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/. **9.0 Occupational Exposure/Risk Characterization**  Boscalid is proposed for new occupational uses on globe artichoke, Belgium endive, persimmon, and greenhouse grown tomatoes. Application methods, maximum application rates, and use sites are summarized in Section 3.3 and Table 3.3. Based on the proposed use pattern s , there is a potential for short - and intermediate - term occupational exposure to bosc alid during handling (mixing, loading, and applying) and post - application activities. Boscalid uses are propos ed for multiple applications, with the retreatment intervals rang ing from 7 to 28 day s. Additionally , for both dermal and inhalation exposures the same endpoint and point of departure were selected for short - and intermediate - term durations, and therefore, short - term exposure and risk estimates are considered to be protective of intermediate - term exposure and risk estimates . The proposedPage 38 of 53

labels require occupational handlers to wear the following personal protective equipment (PPE): long - sleeved shirts, long pants, chemical resistant gloves, and coveralls in a few cases . The 12 hour restricted entry

interval (REI) listed on the labels is appropriate. **9.1 Short** **- /Intermediate**  **- Term Handler Risk**  HED uses the term handlers to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct job functions or tasks related to applications and exposures can vary depending on the specifics of each t ask. Job requirements (amount of chemical used in each application), the kinds of equipment used, the target being treated, and the level of protection used b y a handler can cause exposure levels to differ in a manner specific to each application event. Based on the anticipated use patterns from the proposed label s , ty pes of equipment and techniques that can potentially be used, occupational handler exposure is expected from the proposed uses. HED’s LOC for the MOE is defined by the uncertainty

factors that are applied to the assessment. HED applies a 10X factor to account for variability among species and a 10X factor to account for variability within species. The total uncertainty factor that has been applied to the boscalid occupational dermal expo sure assessment is 100X. Occupational dermal exposure and risk resulting in MOEs greater than or equal to 100 will not be of concern to HED. For inhalation exposures, an additional 10X uncertainty factor is added because of the lack of an available sub chronic inhalation toxicity study . Therefore, the total uncertainty factor that has been applied to the non - cancer inhalation assessments of boscalid is 1000X for residential handler exposure. Occupational inhalation exposure and risk resulting in MOEs greater than or equal to 1000 will not be of concern to HED (LOC = 1000). Dermal and inhalation risk estimates were co mbined in this assessment because the PODs are based on the same toxicological study , thus the effects for th ese exposure routes are the same . Dermal and inhalation risk estimates were combined using the total aggregated risk index (ARI) methodology since the LOCs for dermal exposure (100) and inhalation exposure (1 , 000) are different. The LOC ARI is 1; therefore, ARIs of less than 1 are risk estimates of concern. Summaries of the short - and intermediate - term non - cancer risk estimate s for occupational handlers appl ying boscalid are provided in Appendix E , Table E - 1. The dermal MOEs range from 410 (mixing/loading of WDG formulation to support aerial and chemigation applications to artichoke and persimmon) to 1800 (appl ying with aerial equipment to typical artichoke) at baseline PPE. All of the dermal MOEs are greater than the LOC of 100 when assessed using labeled PPE (baseline + glove s) and are not a concern to HED. The inhalation MOEs range from 1500 (mixing/loading of WDG formulation to support aerial and chemigation applications to artichoke and persimmon) to 400,000 (applying with manuall y pressurized equipment to greenhouse tomatoes) at baseline PPE (no respirato r). All of the inhalation MOEs are greater than the LOC of 1 , 00 0 when assessed at baseline PPE and are not a concern to HED. F urthermore, all of the ARIs are greater than 1.0 when assessed using labeled PPE (baseline + gloves) , and are not a concern to H ED.Page 39 of 53

**9.2 Short** **- and Intermediate**  **- Term**  **Post -** **Application Risk**  HED uses the term post - application to describe exposures that occur when individuals are present in an environment that has been previously treated with a pesticide (also referred to as re entry exposure). Such exposures may occur when workers enter previously treated areas to perform job functions, including activities related to crop production, such as scouting for pests or harvesting. Post - application exposure levels vary over time and depend on such things as the ty pe of activity , the nature of the crop or target that was treated, the ty pe of pesticide application, and the chemical’s degradation properties. In addition, the timing of pesticide applications, relative to harvest activities, can greatl y reduce the potential for post - application exposure. **9.2.1 Dermal Post**  **- Application**  **Risk** Based on the proposed use patterns, short - and intermediate - term post - application dermal exposures to workers re - entering treated areas is possible. Therefore, a post - application risk assessment for dermal exposures is needed. It should be noted that there is no post - application dermal exposure anticipated for the proposed Belgium endive use, because the roots are treated with py raclostrobin prior to forcing in the tray s. Thus there would be negligible exposure to the residue when the crop is harvested or maintained. All post - application scenarios resulted in MOEs greater than 100 on day 0 (12 hours after application) and therefore are not of concern to HED . The MOEs for boscalid ranged from 400 to 21,000. DFR studies are not required at this time for boscalid since the lowest dermal MOE (400) is greater than 4 times the LOC based on default input values. The short - and intermediate - term non - cancer post - application risk estimates for workers are provided in Appendix E , Table E - 2 . Restricted Entry

Interval The REI specified on the proposed label is based on the acute toxicity of boscalid . Boscalid is classified as Toxicity

Category III via the dermal route and for skin irritation potential. Short and intermediate - term post - application risk estimates were not a concern on day 0 (12 hours following application) for all post - application activities. Under 40 CFR 156.208 (c) (2) (iii), ai ’s classified as Acute III or IV for acute dermal, eye irritation and primary skin irrigation are assigned a 12 - hour REI. Therefore, the [156 subpart K] Worker Protection Statement interim REIof 12 hours is adequate to protect agricultural workers from p ost - application exposures to boscalid. **9.2.2 Inhalation Post** **- Application**  **Risk** Based on the Agency's current practices, a quantitative post - application inhalation exposure assessment was not performed for boscalid at this time primarily because of the low acute inhalation toxicity

(Toxicity Category IV), low vapor pressure ( 5.3 x 10 - 9 mm Hg at 20 o C) an d the low proposed use rate (0.22 to 0.36 lb ai/A). However, there are multiple potential sources of post - application inhalation exposure to individuals performing post - application activities in previously

treated fields. These potential sources include volatilization of pesticides andPage 40 of 53

resuspension of dusts and/or particulates that contain pesticides. The Agency sought expert advice and input on issues rel ated to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 5 . The Agency is in the process of evaluating the SAP report as well as available post - application inhalation exposure data generated b y the ARTF and may , as appropriate, develop policies and procedures, to identify the need for and, subsequently , the way

to incorporate occupational post - application inhalation exposure into the Agency's risk assessments. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post - application inhalation exposure assessment for boscalid . Although a quantitative occupatio nal post - application inhalation exposure assessment was not performed, an inhalation exposure assessment was performed for occupational/commercial handlers. Handler exposure resulting from application of pesticides outdoors is likely to result in higher e xposure than post - application exposure. Therefore, it is expected that these handler inhalation exposure estimates would be protective of most occupational post - application inhalation exposure scenarios. The Worker Protection Standard for Agricultural Pe sticides contains requirements for protecting workers from inhalation exposures during and after greenhouse applications through the use of ventilation requirements [40 CFR 170.110, (3) (Restrictions associated with pesticide applications)]. **10.0 References**  S. Funk, 4/ 30 /13, DP 398877 . Boscalid and P yr aclostrobin: Application by Bonide Products, In c. to Register an End Use Product Containing P yraclostrobin, Boscalid, and L ambda Cy halothrin for Homeowner Use on Pome Fruit, Stone Fruit, and Tree Nuts. S. Funk, 4/ 30 /13, DP 406471 . Py raclostrobin and Boscalid: Request to Add Indoor Use on Greenhouse Tomato for Commercial Production and on Greenhouse/Lathhouse Transplants for Consumer Home Market. PagentTM Fungicide Reg. No. 7969 - 251. S. Funk, 4/ 3 0 /13, DP 40506 3 . Boscalid : Petition for the Establishment of Permanent Tolerances and Registration for Use on Belgium Endive, Persimmon, and Globe Artichoke. Request for Crop Group Expansions/Revisions for Bulb Vegetable Group 3 - 07, Fruiting Vegetable 8 - 10, Citrus Fruit Group 10 - 10, Pome Fruit Group 11 - 10, Berry Subgroups 13 - 07A, B, F, and G, and Oilseed Group 2 0. Summary of Analy tical Chemistry

and Residue Data . S. Funk, 6 /24 /13 , DP 410743. Revised: Boscalid. Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments to Support New Uses on Globe Artichoke, Belgium Endive, and Persimmon. C. Walls, 4/30/ 13, DP 405533 . Boscalid . Occupational and Residential Exposure Assessment for proposed new uses of boscalid on globe artichoke, Belgium endive, persimmon, greenhouse
5 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.htmlPage 41 of 53

grown tomato transplants grown for home consumer market, and residential ornamentals, landscape gardens, fruit trees and nut trees . K . White , 4/ 17 /13, DP40 9880 . Tier I Drinking Water Exposure Assessment for the Section 3 New Uses of Boscalid on Various Agricultural Crops and Homeowner Use s. **A ppendix**  **A .**  **Toxicology Profile and Executive Summaries A.1**  **Toxicology Data Requirements** The requirements (40 CFR 158.500) for food uses are in the table below. Use of the new guideline numbers does not imply that the new (1998) guideline protocols were used. **Table A.1: Toxicology Studies**  **Required Subm** **itted Satisfied**  870.1100 Acute Oral Toxicity ................................ ................................ ................................ 870.1200 Acute Dermal Toxicity ................................ ................................ ............................... 870.1300 Acute Inhalation Toxicity ................................ ................................ .......................... 870.2400 Acute Eye Irritation ................................ ................................ ................................ 870.2500 Acute Dermal Irritation ................................ ................................ .............................. 870.2600 Skin Sensitization ................................ ................................ ................................ yes yes yes yes yes yes yes

yes yes yes yes yes yes

yes yes yes yes yes 870.3100 90 - Day Oral Toxicity in Rodents ................................ ................................ 870.3150 90 - Day Oral Toxicity in Non - Rodents ................................ ................................ 870.3200 21/28 - Day Dermal Toxicity ................................ ................................ ....................... 870.3250 90 - Day Dermal Toxicity ................................ ................................ ............................ 870.3465 90 - Day Inhalation Toxicity ................................ ................................ ........................ yes yes yes no (CR) yes (CR) yes

yes yes no no yes

yes yes

--- no 870.3700 Prenatal Developmental Toxicity Study (Rodent) ................................ ...................... 870.3700 Prenatal Developmental Toxicity Study (Non - Rodent) ................................ 870.3800 Reproduction and Fertility Effects ................................ ................................ yes yes yes yes

yes yes yes

no yes 870.4100 Chronic Toxicity (Rodent) ................................ ................................ ......................... 870.4100 Chronic Toxicity (Non - Rodent) ................................ ................................ ................. 870.4200 Carcinogenicity ( Two Rodent Species; Rat and Mouse ) ................................ 870.4300 Combined Chronic Toxicity/Carcinogenicity ................................ ............................ yes no yes no yes

yes yes no yes

--- yes yes 870.5100 Bacterial Reverse Mutation Test ................................ ................................ ................ 870.5300 in vitro Mammalian Cell Gene Mutation Test ................................ ............................ 870.5375 in vitro Mammalian Chromosome Aberration Test ................................ .................... 870.5385 Mammalian Bone Marrow Chromosomal Aberration Test ................................ 870.5395 Mammalian Erythrocyte Micronucleus T est ................................ .............................. 870.5550 Unscheduled DNA Synthesis in Mammalian Cells in Culture ................................ yes yes yes

--- yes no yes

yes yes no yes yes yes

yes yes

--- yes

- -- 870.6100 Delayed Neurotoxicity of Organophosphorus Substances (Acute, Hen) .................... 870.6100 Delayed Neurotoxicity of Organophosphorus Substances (28 - Day, Hen) ................. 870.6200 Neurotoxicity Screening Battery (Acute, Rat) ................................ ........................... 870.6200 Neurotoxicity Screening Battery (Subchronic, Rat) ................................ ................... 870.6300 Developmental Neurotoxicity Study ................................ ................................ no (CR) no (CR) yes yes no (CR) no

no yes yes no - --

- -- yes yes

- -- 870.7200 Companion Animal Safety ................................ ................................ ......................... 870.7485 Metabolism and Pharmacokinetics ................................ ................................ 870.7600 Dermal Penetration ................................ ................................ ................................

in vitro Dermal Penetration ................................ ................................ ........................ 870.7800 Immunotoxicity ................................ ................................ ................................ no (CR) yes no (CR) no yes no

yes yes no yes -- -

yes

---

---

--- CR : Conditionally RequiredPage 42 of 53

**A.2 Toxicity Profile**  **s Table A.2.1. Acute Toxicity of**  **Boscalid Table A.2.1. Acute Toxicity Profile** 
**– Boscalid (BAS 510 F) Technical**  **Test Material GDLN**  **Study Type MRID**  **Results Tox**  **Category** Technical 870.1100 Acute Oral - rat 45404814 LD 50 > 5000 mg/kg IV Technical 870.1200 Acute Dermal - rat 45404815 LD 50 > 2000 mg/kg III Technical 870.1300 Acute Inhalation 45404816 LC 50 (M & F): > 6.7 mg/L IV Technical 870.2400 Primary Eye Irritation 45404817 Not irritating to the eye IV Technical 870.2500 Primary Dermal Irritation 45404818 Not irritating to the skin IV Technical 870.2600 Dermal Sensitization 45404819 Study unacceptable as challenge dose was inadequate N/A

**Table A.2.2. Non -**  **acute Toxicity Profile for Boscalid**  **Table A.2 Repeated Dose Toxicity Profile of Boscalid (BAS 510 F) Technical. Guideline No.**  **Study Type Results**  **870.3100** 90 - Day oral toxicity

rodents (rats) **NOAEL** : 34/159 mg/kg/day (M/F) **LOAEL** : 137/395 mg/kg/day (M/F): M = increases in absolute and relative thyroid weights and increased incidence of thyroid hyperplasia as well as follicular epithelial hypertrophy; F = increases in absolute and relative thyroid weights. **870.3100** 90 - Day oral toxicity

rodents (mice) **NOAEL** : 197/2209 mg/kg/day (M/F) **LOAEL** : 788/2209 mg/kg/day (M/F): M = increased liver weights and increased incidence of marked fattyPage 43 of 53 **Table A.2 Repeated Dose Toxicity Profile of Boscalid (BAS 510 F) Technical. Guideline No.**  **Study Type Results**  change in the liver; F = not attained **870.3150** 90 - Day oral toxicity in

nonrodents (dogs) **NOAEL** : 7.6/8.1 mg/kg/day (M/F) **LOAEL** : 78.1/81.7 mg/kg/day (M/F): M = increased alkaline phosphatase activity and hepatic weights; F = increased alkaline phosphatase activity and hepatic weights. **870.3200** 21/28 - Day dermal toxicity

(rats) **NOAEL** : 1000 mg/kg/day (HDT) **LOAEL** : >1000 mg/kg/day **870.3700** Prenatal developmental in

rodents (rats) **Maternal NOAEL** : 1000 mg/kg/day **Maternal LOAEL** : cannot be established **Developmental NOAEL** : 1000 mg/kg/day **Developmental LOAEL** : cannot be established **870.3700** Prenatal developmental in

nonrodents (rabbit) **Maternal NOAEL** : 300 mg/kg/day **Maternal LOAEL** : 1000 mg/kg/day based on abortions or early delivery. **Developmental NOAEL** : 300 mg/kg/day **Developmental LOAEL** : 1000 mg/kg/day based on abortions or early delivery. **870.3800** Reproduction and fertility

effects (rat) **Parental systemic NOAEL** :112.6/1180.8 mg/kg/day (M/F) **Parental systemic LOAEL** :1165.0/>1180.8 mg/kg/day (M/F) decreased body weight and body weight gain (F 1 ) as well as hepatocyte degeneration F 0 and F 1 ) in males only. **Offspring systemic NOAEL** :11.2/115.8 mg/kg/day (M/F) **Offspring systemic LOAEL** :112.6/1180.8 mg/kg/day (M/F): decreased body weight for F 2 pups in males and females of both generations. **Reproductive NOAEL** :1165.0/1180.8 mg/kg/day (M/F) **Reproduct ive LOAEL**  :>1165.0/1180.8 (M/F) **870.4100a** Chronic toxicity rodents

(rat) **NOAEL** : 21.9/30.0 mg/kg/day (M/F) **LOAEL** : 110.0/150.3 mg/kg/day (M/F): M = thyroid toxicity (weights and microscopic changes); F = thyroid toxicity (weights and microscopic changes). Thyroid follicular cell adenomas: M = 0/20, 0/20, 2/20,1/20; F = 0/20, 0/20, 1/20,0/20. **870.4100** Chronic toxicity dogs **NOAEL** : 21.8/22.1mg/kg/day (M/F) **LOAEL** :57.4/58.3 mg/kg/day (M/F): M = elevated ALP activities and elevated hepatic weights; F = noPage 44 of 53 **Table A.2 Repeated Dose Toxicity Profile of Boscalid (BAS 510 F) Technical. Guideline No.**  **Study Type Results**  effects **870.4200** Carcinogenicity rats **NOAEL** : 23.0/29.7 mg/kg/day (M/F) **LOAEL** : 116.1/155.6 mg/kg/day (M/F): M = increased incidence of thyroid follicular cell hyperplasia and hypertrophy; F = decrease in body weight gain and increased incidence of thyroid follicular cell hyperplasia and hypertrophy. Thyroid follicular cell adenomas: M = 0/50, 0/50, 1/50, 4/50; F = 0/50, 1/50, 0/50, 3/50. **870.4200** Carcinogenicity mice **NOAEL** :65/443 mg/kg/day (M/F) **LOAEL** : 331/1804 mg/kg/day (M/F): M = decreases in body weight and body weight gains; F = decreases in body weight and body weight gains. No evidence of carcinogenicity. **870.4300** Chronic

feeding/Carcinogenicity rat See 870.4100a and 870.4200. **870.5100** Gene Mutation bacterial

reverse mutation assay Negative without and with S - 9 activation up to limit dose of 5000 μg/plate. **870.5300** In vitro mammalian cell

forward gene mutation assay (CHO cells/HGPRT locus) Negative without and with S - 9 activation up to the limit of solubility of 25 μg/mL.
**870. 5375**  In vitro mammalian

cytogenetics assay in Chinese hamster V79 cells Negative without and with S - 9 activation up to 3500 μg/mL with precipitation showing at concentrations of 100 μg/mL and higher. **870.5395** Cytogenetics - mammalian

erythrocyte micronucleus test in the mouse Negative at doses up to 2000 mg/kg.

**870.5500** In vitro unscheduled DNA synthesis (primary rat hepatocytes) Negative response up to 50 μg/mL. Cytotoxicity at 100 - 500 μg/mL. **870.6200** Ac ute neurotoxicity screening battery (rat) **NOAEL** :2000/1000 mg/kg/day (M/F) **LOAEL** : >2000/2000 mg/kg/day (M/F): F = piloerection **870.6200** Subchronic neurotoxicity screening battery (rat) **NOAEL** :1050.0/1272.5 mg/kg/day (M/F) **LOAEL** : >1050.0/1272.5 mg/kg/day (M/F)Page 45 of 53 **Table A.2 Repeated Dose Toxicity Profile of Boscalid (BAS 510 F) Technical. Guideline No.**  **Study Type Results**  **870.6300** Developmental neurotoxicity (rat) **Maternal NOAEL:** 1442 mg/kg/day **Maternal LOAEL:** >1442 mg/kg/day **Offspring NOAEL:** 14 mg/kg/day **Offspring LOAEL:** 147 mg/kg/day (decreased body weights on PND 4 and decreased body weight gain on PNDs 1 - 4)

**870.7485** Metabolism and pharmacokinetics (rat) BAS 510 F was readily absorbed and excreted following single oral 50 mg/kg; at single 500 mg/kg or 15 doses of 500 mg/kg, absorption was saturated. Excretion mainly by feces (80 - 98%). Biliary excretion 40 - 50% of fec al activity at 50 mg/kg, 10% at 500 mg/kg. Urine, about 16% at 50 mg/kg, 3 - 5% at 500 mg/kg. Absorption about 56% at 50 mg/kg and 13 - 17% at 500 mg/kg. Excretory patterns similar by gender or radiolabel position. Metabolites (hydroxylation and conjugatio n products) were consistent with Phase I oxidation reactions followed by Phase II conjugation with glucuronic acid or sulfate, or by conjugation of the parent with glutathione with cleavage to sulfate metabolites. **870.7800** Immunotoxicity MRID 48203801 (2003) 0, 100, 1000, or 10000 ppm 0, 7.45, 73.1, or 736.2 m/k/d A cceptable / Guideline NOAEL = **736.2 m g/kg/day**  **LOAEL = not established**

**870.7600** Dermal Penetration (rat) Maximum % absorption: 0.01 mg/cm2 = 10.93 (24 hour exposure, 24 hour sacrifice) 0.10 mg/cm2 = 3.76 (24 hour exposure, 24 hour sacrifice) 1.00 mg/cm2 = 1.48 (10 hour exposure, 72 hour sacrifice) **none** SPECIAL STUDY: Hepatic enzyme induction (rat) 1. hypertrophy of zone III hepatocytes 2. >20% increase in liver weight 3. increase in CYP450 activity 4. slight to extensive microscopic SER proliferation 5. not a peroxisome proliferator 6. enzymes in CYP450 subfamily not induced 7. no notable microscopic increase in size or number of peroxisomes CONCLUSION: inducer of total CYP450 acti vity **none** SPECIAL STUDY: Hormone and enzyme induction (rat) 1. slight (statistically significant) decrease in circulating T 3 and T 4 only in males 2. increase in circulating TSH levels both sexes 3. increase in all 3 liver microsomal glucuronyltransferases CONCLUSION: disruption of thyroid homoeostasis by decreasing circulating T 3 and T 4 and increasing TSH;Page 46 of 53 **Table A.2 Repeated Dose Toxicity Profile of Boscalid (BAS 510 F) Technical. Guideline No.**  **Study Type Results**  likely the result of hepatic microsomal glucuronyltransferase induction **none** SPECIAL STUDY: Reversibility study (dietary): 4 - week administration followed by 4 weeks recovery or 13 weeks recovery (rat) 4 weeks dosing: at 2500 and 15000 ppm: increase in TSH (68% and 87%); increase in absolute and relative thyroid weights, hypertrophy of thyroid follicular epithelial cells and diffuse follicular hyperplasia, increase in absolute and relative liver weights and centrilobular hypertrophy as well as liver portal fatty changes. 4 weeks dosing + 4 weeks recovery: no increases in TSH; increase in absolute and relative thyroid weights; thyroid hypertrophy and hyperplasia decreased to control values; all liver effects reversed to control. 4 weeks dosing + 13 weeks recovery: no increases in TSH; increase in absolute and relative thyroid weights; thyroid hypertrophy and hyperplasia decreas ed to control values; all liver effects reversed to control. CONCLUSION: induction of liver microsomal enzyme system resulting in increased glucuronidation of thyroxine, resulting in an increase in TSH secretion as a compensatory response of the physiolog ical negative feedback system; increased TSH resulted in increased thyroid weight.Page 47 of 53

**Appendix B. Physicochemical Properties of**  **Boscalid .**  **Table B. Physicochemical Properties of Boscalid.** 

Parameter Value References Melting point/range 142.8 - 143.8  C MRIDs 45404802 and 45404804 - 45404809 pH NA (does not dissociate in water) Relative Density (20oC) 1.381g/cm3 Water solubility (20oC) 4.64 mg/L at pH 6 Solvent solubility (g/100 mL at 20oC) acetone 16 - 20 ethyl acetate 6.7 - 8.0 methanol 4 - 5 2 - propanol <0.01 acetonitrile 4 - 5 dichloromethane 20 - 25 toluene 2 - 5 n - heptane <0.01 1 - octanol <0.01 olive oil 2.9 N,N - DMF >25 Vapor pressure 7 x 10 - 9 hPa Dissociation constant, pKa None (does not dissociate in water) Octanol/water partition coefficient, Log(KOW) 2.96 UV/visible absorption spectrum UV molecular extinction (e[lmol - 1 cm- 1 ]): 3.15 x10 4 at 228 nm; 1.53 x10 3 at 290 nm **Appendix C**  **. Review of Human Research**  The PHED Task Force, 1995. The Pesticide Handlers Exposure Database, Version 1.1. Electronic Database. Task Force Members: Health Canada, U.S. EPA, and the National Agricultural Chemicals Associations, released February 1995. The Agricultural Handler Exposure Task Force (AHETF) , 2011. The Occupational Handler Unit Exposure Surrogate Reference Table. U.S. EPA. Released June 21, 2011. Data from the Outdoor Residential Exposure Task Force (ORETF). HED Residential Standard Operating Procedures (2012).Page 48 of 53

**Appendix D. Summaries of Field Residue Data** 
**T able D**  **- 1.**  **Summary of Residue Data from Globe Artichoke**  **Crop Field Trials with Boscalid.** Commodity Total Applic.

Rate (lb ai/A) [kg ai/ha] PHI

(days) Analyte Residue Levels 1 (ppm) n Sample Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std. Dev. Artichoke Flower Head 1.081 - 1.105

(1.21 - 1.24) 0 Boscalid 3 1.159 2.596 1.446 2.563 1.722 1.910 0.582 1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. Statistics were calculated by the study reviewer. 2 LAF T = lowest average field trial; HAFT = highest average field trial. **Table D -**  **2. Summary of Residue Data from**  **Belgium Endive Crop Field Trials with Boscalid.**  Commodity Rate 1 PHI (days) Analyte Residue Levels 2 (ppm) n Sample Min. Sample Max. LAFT 3 HAFT 3 Median Mean Std. Dev. **Treat me**  **nt 02: One pre -**  **cold -**  **storage application to**  **roots** Belgium endive heads 1.14 - 1.18 g ai/100 lb

of roots 25 - 27 Boscalid 3 <0.05 0.15 <0.05 0.13 <0.075 <0.085 0.041 **Treat me**  **nt 03: One pre -**  **forcing application to**  **roots in packing tray** Belgium endive heads 0.177 - 0.192 g ai/ft2 17 - 19 Boscalid 3 0.25 2.97 0.28 2.26 1.75 1.43 1.028 **Treat me**  **nt 04: One pre -**  **cold -**  **storage application to**  **roots + One pre -**  **forcing application to**  **roots in packing tray** Belgium endive heads 1.16 - 1.17 g ai/100 lb

of roots and 0.182 - 0.199 g ai/ft2 17 - 19 Boscalid 3 0.43 1.41 0.455 1.255 1.05 0.92 0.416 1 Rate for boscalid , as calculated by the study reviewer based on the certificate of analysis of applied product in the study report. 2 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and stan dard deviation, the LLMV (0.0 5 ppm) was used for any results reported as <LLMV 3 LAF T = lowest average field trial; HAFT = highest average field trial. **Table D -**  **3 Summary of Residue Data from**  **Persimmon Crop Field Trials with Boscalid.**  Commodity Total Applic.

Rate (lb ai/A) [kg ai/ha] PHI

(days) Analyte Residue Levels 1 (ppm) n Sample Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std. Dev. Persimmon Fruit 1.110 - 1.1 26

(1.2 4 - 1.2 6 ) 0 Boscalid 3 0.184 3.285 0.198 3.019 0.862 1.360 1.475 1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. Statistics were calculated by the study reviewer. 2 LAF T = lowest average field trial; HAFT = highest average field trial.Page 49 of 53

**Appendix E. Summaries of**  **Occupational Handler and Post -**  **application Exposure and Risk Estimates Table E**  **- 1.**  **Occupational Handler Non -**  **Cancer Exposure a nd Risk Estimates for Boscalid**  **. Exposure Scenario**  **Crop Dermal Unit**  **Exposure (**  **μ g/lb ai)**  **1 Inhalation** 

**Unit Exposure (**  **μ g/lb ai)**  **1 Ma** **xim um** 

**Application Rate**  **2 (lb ai/A)**  **Area**

**Treated or Am**  **ount Handled**  **Daily 3**  **Dermal Inhalation**  **ARI 8**  **Baseline Baseline**  **Dose (m** **g/k g/day)**  **4 MOE**  **5 Dose**  **(m g/k** **g/day) 6**  **MOE 7**  Mixer/Loader Aerial applications of WDG and Chemigation application of

WDG Artichoke

Persimmon 227 8.96 0.18 350 0.054 410 0.014 1 , 500 1.1 Airblast application of WDG Persimmon 227 8.96 0.18 40 0.0061 3,600 0.0016 14,000 10 Chemigation application of

WDG and Groundboom application of WDG Greenhouse

tomatoes 227 8.96 0.18 60 0.0092 2,400 0.0024 9,000 6.5 Groundboom application of WDG Artichoke 227 8.96 0.18 80 0.12 1,800 0.0032 6,700 4.9 Applicator Aerial application Artichoke Persimmon 5 0.068 0.18 350 0.0012 18,000 0.00011 200,000 95 Airblast application Persimmon 1770 4.71 0.18 40 0.048 460 0.00085 26,000 3.9 Groundboom application Greenhouse tomatoes 78.6 0.34 0.18 60 0.0032 6,800 0.000092 240,000 53 Groundboom application Artichoke 78.6 0.34 0.18 80 0.0042 5,100 0.00012 180,000 40 Flagger Flagger Artichoke

Persimmon 11 0.35 0.18 350 0.0026 8,400 0.00055 40,000 27 Mixer/Loader/ApplicatorPage 50 of 53

**Table E -**  **1. Occupational Handler Non**  **- Cancer Exposure a**  **nd Risk Estimates for Boscalid .**  **Exposure Scenario Crop**  **Dermal Unit Exposure**  **( μ**  **g/lb ai) 1**  **Inhalation**

**Unit Exposure (**  **μ g/lb ai)**  **1 Ma** **xim um** 

**Application Rate**  **2 (lb ai/A)**  **Area**

**Treated or Am**  **ount Handled**  **Daily 3**  **Dermal Inhalation**  **ARI 8**  **Baseline Baseline**  **Dose (m** **g/k g/day)**  **4 MOE**  **5 Dose**  **(m g/k** **g/day) 6**  **MOE 7**  Backpack application of WDG Greenhouse

tomatoes 13,200 140 0.0018 lb ai/gal 40

gal 0.0036 6,100 0.00025 86,000 36 Manually pressurized handwand app of WDG Greenhouse tomatoes 100,000 30 0.0018 lb ai/gal 40

gal 0.027 810 0.000054 400,000 7.9 Mechanically pressurized handgun of WDG Artichoke Persimmon 1300 3.9 0.0018 lb ai/gal 1000

gal 0.0088 2,500 0.00018 120,000 21 Mechanically pressurized handgun of WDG Greenhouse tomatoes 3500 120 0.0018 lb ai/gal 1000

gal 0.024 920 0.0054 4,000 2.8 Mechanically pressurized handgun of WDG Belgium

Endive

– prior to cold storage 1300 3.9 0.000028 lb ai/ lb root 200,000

lb root 0.014 1,600 0.00027 80,000 13 Mechanically pressurized handgun of WDG Belgium

Endive

– prior to forcing 1300 3.9 0.0004 lb ai/ft2 10,890

ft2 0.011 2,100 0.00021 100,000 17 1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (March 2013) ; 2 Based on proposed label (See Table 4 ). 3 Exposure Science Advisory Council Policy #9.1. 4 Dermal Dose = Dermal Unit Exposure ( μg/lb ai) × Conversion Factor (0.001 mg/ μg) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled Daily (A or gal/day) × DAF (%) ÷ BW (kg). 5 Dermal MOE = Dermal NOAEL (mg/kg/day) ÷ Dermal Dose (mg/kg/day). 6 Inhalation Dose = Dermal Unit Exposure ( μg/lb ai) × Conversion Factor (0.001 mg/ μg) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled Daily (A or gal/day) ÷ BW (kg). 7 Inhalati on MOE = I

nhalation NOAEL (mg/kg/day) ÷ Inhalation Dose (mg/kg/day). 8 Aggregate Risk I

ndex (ARI) = 1÷ (1 ÷ RIdermal ) + (1 ÷ RIinhalatio n ) Risk I ndex (RI) = MOE ÷ LOC; I nhalation LOC = 1,000 and Dermal LOC = 100Page 51 of 53

**Table E**  **- 2.**  **Occupational Post -**  **application Non**  **- Cancer Exposure and Risk Estimates for Boscalid**  **. Crop/Site**  **Activities Transfer Coefficient**  **(cm 2**  **/hr) DFR**  **1**

**(μg/cm 2**  **) Dermal Dose** 

**(m g/k** **g/day) 2**  **MOE 3** 

Artichoke Hand Harvesting 1,100

1.01 0.0167 1,300

Hand Weeding, Thinning, Pruning 70 0.0011 21,000 Irrigation (Hand Set) 1,900 0.029 760 Scouting 210 0.0032 6,900 Transplanting 230 0.0035 6,300

Persimmon Scouting, Hand Pruning,

Training 580
1.01 0.0088 2,500 Hand weeding, Propping, Orchard Maintenance 100 0.0015 14,000 Hand Harvesting 1,400 0.021 1,000 Transplanting 230 0.0035 6,300 Thinning 3,600 0.055 400

Greenhouse Tomatoes Hand Harvesting,

Pinching, Hand Pruning, Scouting, Turning, Tying, Hand Weeding, 1200 1.01 0.018 1,200 Irrigation (Hand Watering), Transplanting 230 0.0035 6,300 1 DFR = Application Rate × F × (1 - D) t × 4.54E8 μg/lb × 2.47E - 8 acre/cm2 ; where F = 0.25 and D = 0.10 per day 2 Daily Dermal Dose = [DFR (μg/cm2 ) × Transfer Coefficient × 0.001 mg/μg × 8 hrs/day × dermal absorption (%)]  BW (kg). 3 MOE = POD (mg/kg/day) / Daily Dermal Dos e. Daily Dermal Dose = [DFR (μg/cm2 ) × TC × 0.001 mg/μg × 8 hrs/day × dermal absorption factor (%) ]  BW (kg) .Page 52 of 53

**Appendix F**  **. International Residue Limits Status Sheet**  **Boscalid (** 128008); 02/21/2013) Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 40 CFR §180.589. Pla

nt commodities: boscalid, 3 -pyridinecarboxamide, 2 - chloro - N - (4 ′ - chloro[1,1' - biphenyl] - 2 - yl), Plant commodities: 2 - chloro -N

- (4' - chloro[1,1' - biphenyl] - 2 - yl) - 3 - pyridinecarbox amide - Pla nt commodities: boscalid. The residue is fat soluble.

Commodity 1 Tolerance (ppm) /Maximum Residue Limit ( ppm ) US Canada Mexi co 2 Codex 3 Artichoke, globe 6.0 None None Belgium endive (witloof chicory) 6.0 None None Persimmon 8.0 None None Vegetable, bulb, group 3 - 07 5.0 5.0 Vegetable, fruiting, group 8 - 10 3.0 1.4 3.0 Fruit, citrus, group 10 - 10 2.0 2.0 Fruit, pome, group 11 - 10 3.0 3.0 2 (Apple) Caneberry, subgroup 13 - 07A 10.0 6.0 10 (Berries and other small fruits) Bushberry subgroup 13 - 07B 13.0 10 (Berries and other small fruits) Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13 - 07F 5.0 3.5 5 (Grapes) Berry, low

growing, subgroup 13 - 07G except cranberry 4.5 4.5 Straw berry 11 Lo w bush blueberry 3 (Straw berry)
Oilseed group 20 5.0 5.0 Canola oil Mustard seed oil 1 Vegetable, root, except sugar beet, subgroup 1B, except garden beet, radish, and turnip 2.0 0.7 Carrot 0.7 Rutabaga root 0.7 Burdock root 0.7 Ginseng root 0.7 Horseradish [1 sugar beet 1 turnip root 1 radish root] 2 (Root and tuber vegetables)

Turnip, tops 40 1.0 40 (Leafy vegetables)Page 53 of 53 1 Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and not those proposed by the applicant. 2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes. 3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as p roposed have not been finalized by the CCPR and the CAC.