Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 1 of 48 UNITED STA

TES ENVIRONMENTA L PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDE AND TOXIC SUBSTANCES 

### MEMORANDUM Date: October 16, 2009 SUBJECT: Boscalid ; Petition for Establishing Permanent Tolerances o n Alfalfa and the

Citrus C rop Group 10 , and Amending the Established Tolerance on the Stone Fruit C rop Group 12. Summary of Analy tical Chemistry

and Residue Data. PC Code: 128008 DP Barcode: 364447 Decision No.: 405556 Registration No. : 7969 - 198 , 79 68 - 197, 7969 - 199 Petition No s .: 9F7527, 9F7 529 Regulatory Action: Section 3 Registration Risk Assessment Type: NA Case No.: NA T XR No.: NA CAS No.: 188425 - 85 - 6 MRID No.: see MRID Summary Table 40 CFR: 180.589 Ver.Apr.0 8 

### FROM: Amelia M. Acierto, Chemist

Risk Assessment Branch III Health Effects Division (7509P) THROUGH: Stephen Funk, Senior Science Advisor

Risk Assessment Branch III Health Effects Division (7509P TO: Tony

Kish, Risk Manager Team #22 Fungicide Branch Registration Division (7505P) MRID Sum ma ry Table MRID No. Study Type Com me nts 45903601 860.1500/1520 Citrus New DER; 45903601 .der.doc 47470201 860.1500 Stone Fruit New DER; 47470201.de r .doc 47584401 860.1500 Alfalfa New DER; 47584401.der.doc 47584402 860.1520 Citrus New DER; 47584402.der.doc 47584403 860.1480 Cattle New DER; 47584403.de r .docBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 2 of 48 This document was originally prepared under contract by Dy namac Corporation (1910 Sedwick Road, Building 100, Suite B; Durham, NC 27713). The document has been reviewed by the Health Effects Division (HED) and revised to reflect current Office of Pesticide Programs for (OPP) policies. Executive Summary Boscalid, 2 - chloro -N

- (4  ́ - chloro[1,1  ́ - biphenyl] - 2 - yl ) - 3 - py ridinecarboxamide, is a carboxamide (anilide) class fungicide that inhibits mitochondrial respiration, thereby inhibiting spore germination, germ tube elongation, mycelial growth, and sporulation in all major stages of fungal development and reproduction necessary for disease development in a variety of vegetable, fruit and row crops. There are currently two water- dispersible granular (WDG) boscalid end - use products (EPs) registered to BASF in the US for use on food/feed crops, one containing only boscalid and one which is a mixture of two active ingredients. The single active ingredient formulation is a 70% WDG (Endura® 

### Fungicide; EPA Reg. No. 7969 - 197) and the mixture formulation is a WDG containing 25.2% boscalid and 12.8% py raclostrobin (Pristine ® 

### Fungicide; EPA Reg. No. 7969 - 199). Only boscalid is addressed in this document; py raclostrobin is being evaluated separately . Permanent t olerances have been established under 40 CFR §180.589 (a) (1) for plant commodities, ranging from 0.05 ppm in/on peanuts and tuberous and corm vegetables (subgroup 1C) to 60 ppm in/on leafy greens except head and leaf lettuce (subgroup 4A) . Separate tolerances have also been established for indirect o r inadvertent residues of boscalid in rotational crops 40 CFR §180.589 (d) at levels ranging from 0.05 to 8.0 ppm. Tolerances for livestock commodities have been established under 40 CFR §180.589 (a)(2) for the combined residues of boscalid, and its metabo lites 2 - chloro -N - (4 ′ - chloro - 5 - hydroxy- biphenyl - 2 - yl )nicotinamide and the glucuronic acid conjugate of the 5 - hydroxy metabolite at levels ranging from 0.02 ppm in eggs to 0.35 ppm in meat by products of cattle, goats, horses, and sheep. BASF is proposing new uses for bosc alid on alfalfa using the 25% and 70% WDG formulations and on citrus fruits using the 25% WDG formulation. The proposed uses on alfalfa are for repeated broadcast foliar applications at up to 0.28 lb ai/A for the 25% WDG and 0.48 lb ai/A for the 70% WDG, with a minimum retreatment interval (RTI) of 14 days, for a maximum of 0.85 or 1.44 lb ai/A/season for the 25% and 70% WDG, respectively . A maximum of 3 applications to alfalfa are allowed per season with no more than 2 applications per cutting. The prop osed use on citrus fruits is for up to four broadcast foliar applications during fruit development at rates up to 0.29 lb ai/A with a minimum RTIof 10 days, for a maximum of 1.17 lb ai/A/season. All applications can be made using ground or aerial equipment, and the proposed PHI s are 14 days for alfalfa and 0 days for citrus fruits. In conjunction with these uses, BASF is proposing the following permanent tolerances for boscalid:

Alfalfa forage ................................ ................................ . 35 ppm Alfalfa hay ................................ ................................ ...... 85 ppm Citrus Crop Group 10 ................................ .................... 2.0 ppmBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 3 of 48 Base d on residue data from new stone fruit field trials conducted using the maximum labeled use rate for boscalid (25% WDG) on stone fruits, BASF is also requesting that the existing 1.7 ppm tolerance on the stone fruits crop group be increased as follows:

St one F ruit Crop Group 12 ................................ ........... 5.0 ppm The registrant has also submitted FIFRA Section 3 registration requests to add the uses for alfalfa forage and hay

and citrus fruits, crop group 10 on the labels of BAS 510F (EPA Reg. No. 7969 - 198) and Pristine® Fungicide ( EPA Reg. No. 7969 - 199), and the uses for alfalfa forage and hay on the label of Endura® Fungicide (EPA Reg. No. 7969 - 197 ). Inaddition, based on the potential increase in dietary exposure of livestock to boscalid due to the new use on alfalfa, BASF is propos ing new or amended boscalid tolerances on the following livestock commodities:

Milk ................................ ................................ ............... 0.2 ppm Milk fat (cream) ................................ ............................ 1.5 ppm Fat (cattle, goat, horse, and sheep) ................................ 1.5 ppm Meat (cattle, goat, horse, and sheep) ............................. 0.2 ppm Meat by products (cattle, goat, horse, and sheep) .......... 1.5 ppm Kidney (cattle, goat, horse, and sheep) ......................... 1.0 ppm Li ver (cattle, goat, horse, and sheep) ............................ 1.0 ppm Li ver (poultry

) ................................ .............................. 0.2 ppm Fat (poultry

) ................................ ................................ .. 0.2 ppm Meat by products (poultry

) ................................ ............. 0.2 ppm Fat (hogs) ................................ ................................ ...... 0.2 ppm Meat by products (hogs) ................................ ................. 0.2 ppm Kidney (hogs) ................................ ................................ 0 .2 ppm Li ver (hogs) ................................ ................................ ... 0.2 ppm The nature of boscalid residues in primary crops and livestock is considered adequately understood, based on the acceptable metabolism studies on lettuce, grapes, beans, goats and hens. For purposes of to lerances and dietary risk assessment, the HED , through its Metabolism Assessment Review Committee (MARC) , has concluded that the residue of concern in plant commodities is boscalid, and the residue of concern in livestock commodities include boscalid, its 5 - hydroxy

metabolite ( M510F01 ) and the glucuronic acid conjugate of the 5 - hydroxy metabolite (M510F02) . An adequate gas chromatograph/mass spectrometric (GC/MS) method (Method D0008) is available for enforcing boscalid tolerances in plant commodities, and an adequate GC/electron capture detection method (Method DFG S19) is available for enforcing the current tolerances in livestock commodities. These methods have been found adequate by the Analy

tical Chemistry Branch (ACB) of BEAD. An adequate data collection method is available for plant commodities . Boscalid residues in plant commodities were determined using liquid chromatography with tandem mass spectrometric detection (LC/MS/MS) method (BASF Method D9908). This method wasBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 4 of 48 ade quately

validated in conjunction with the analysis of field trial and processing study samples , and the validated limit of quantitation (LOQ) is 0.05 ppm for boscalid in all plant commodities tested. For data collection in livestock, residues of boscalid and its hydroxy metabolite M510F01 (including its glucuronide conjugate) were determined using a LC/MS/MS method (BASF Method 471/0 , modified), which was adequately validated in conjunction with analysis of feeding study

samples. The validated LOQ for each analy te is 0.01 ppm in milk and 0.025 ppm in tissues, for combined L OQs of 0.02 ppm in milk and 0.05 ppm in tissues. The combined residues are expressed in parent equivalents. The data requirements for testing with the multiresidue method s in the Pesticide Analytical Method (PAM I) have been fulfilled and were discussed in the earlier petitions . Residues of boscalid and its metabolite M510F01 were n ot adequately recovered using multiresidue method. Protocol A was not applicable. Protocol B was not applicable for boscalid and yielded inconsistent recoveries of M510F01. Residues of boscalid and M510F01 had good responses with GC/ECD on a DB - 1 column under Protocol C but neither analy te was recovered at ≥ 30% using Protocol D, E, and F. Adequate cattl e and poultry feeding studies are available covering the potential levels of dietary exposure for livestock to boscalid residues. Considering the existing and recommended tolerances for all feedstuffs, the dietary burden of livestock for boscalid residues in a reasonably balanced diet are 1 0.8 ppm for beef cattle, 22.5 ppm for dairy cattle, 4.0 ppm for poultry and 5.3 ppm for swine. Based on these levels of dietary exposure and the residue data from the feeding studies, the existing tolerances for milk , and fat, meat and meat by products of cattle, goats, horses and sheep are adequate. The existing tolerances for eggs, poultry meat, and meat and meat by products of hogs are also adequate; however, the tolerance s for hog fat , poultry fat, and poultry meat by products should each be increased to 0.20 ppm. The data generated from alfalfa, orange, lemon, and grapefruit field trials are adequate and support the proposed use s of the 25% WDG formulation of boscalid on alfalfa and citrus fruits . An adequate number of tests were conducted on the representative crops in the appropriate geographic regions, and the tests were conducted at ~1x the proposed use rate. Samples were collected around the proposed preharvest interval ( PHI) and analy zed for residues of boscali d . The available field trial data support tolerances of 30 ppm for alfalfa forage, 65 ppm for alfalfa hay, and 1. 6 ppm for the citrus fruit crop group 10. An adequate citrus processing study is available indicating that boscalid residues are reduced in j uice (<0.2x); therefore, a separate tolerance is not required for citrus juice. However , residues were shown to concentrate in both dried pulp (3.1x) and oil (59x). Based on the processing factors for dried pulp and oil and the highest average field trial (HAFT) residues for citrus fruits (1.39 ppm), the maximum expected boscalid residues would be 4.31 ppm in dried pulp and 82 ppm in oil, which would support tolerances of 4.5 ppm for dried citrus pulp and 85 ppm for citrus oil.Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 5 of 48 The new stone fruit f

ield data are adequate . When residue data from all the stone fruit field trials at the 1x rate with 0 - day PHIare pooled together by crop, the data support a tolerance of 3.5 ppm for the stone fruit crop group 12. Adequate confined, limited and extensive fi eld rotational crop studies are available supporting the existing tolerances for indirect residues of boscalid in rotational crops. These data support the 14 - day

plant - back interval currently specified for crops without boscalid uses. No additional rotational crop data are required for purposes of this petition. Regulatory Recommendations and Residue Chemistry Deficiencies HED has examined the residue chemistry database for boscalid and concludes that pending submission of a revis ed Section B for alfalfa, a revised Section F for alfalfa , citrus frui t , stone f ruit and livestock as noted below, and provided the forthcoming Human Health Risk Assessment does not identify any risks of concern, there are no residue chemistry deficiencies that would preclude establishing permanent tolerances for b oscalid on alfalfa forage and hay and on the citrus fruits crop group 10, and for increasing the existing tolerance on the stone fruit crop group 12, and the existing tolerances on hog fat, poultr y fat, and poultry

meat by products. However, the deficiencies noted below must be resolved as a condition of registration. Note to PM: HED recommends that the following tolerance definition entries in 40 CFR 180.589 be revised and that tolerances for the listed commodities be established , as follows: (a) G eneral. (1) Tolerances are established for residues of the fungicide boscalid, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specifi ed below is to be determined by measuring only - pyridinecarboxamide, 2 - chloro - N - (4' - chloro[1,1' - biphenyl] - 2 -yl) in or on the commodity. Alfalfa, forage ......................................... 30.0 ppm Alfalfa, hay

............................................. 65.0 ppm Citrus, dried pulp ................................ ....... 4.5 ppm Citrus, oil................................................ 85.0 ppm Fruit, citrus, group 10 ......................... 1.6 ppm Fruit, stone, group 12 ............... ............ 3.5 ppm (2 ) Tolerances are established for residues of the fungicide boscalid, including its metabo lites and degrada t es , in or on the food commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of 3 - pyridinecarboxamide, 2 - chloro - N - (4' - chloro[1,1' - biphenyl] - 2 -yl) and metabolites 2 - chl oro - N - (4' - chloro - 5 - hydroxy- biphenyl - 2 -yl)nicotinamide and glucuronic acid conjugate of 2 - chloro - N - (4' - chloro - 5 - hydroxy- biphenyl - 2 -yl)nicotinamide , calculated as the stoichiometric equivalent of boscalid, in or on the commodity. Hog, fat.................................................... . .. 0.20 ppm Poultry, fat .................................................................0.20 ppm Poultry, m eat by

products .................................0.20 ppmBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 6 of 48 The established tolerances of the following commodities remain unchanged. Cattle, fat................................................ . 0.30 pp m Cattle, meat................................................ 0.10 ppm Cattle, meat by

products .................................0.35 ppm Egg .........................................................0.02 ppm Goat, fat................................................... . 0.30 ppm Goat, meat................................................. 0.10 ppm Goat, meat by

products ................................... 0.35 ppm Hog, meat........................ ............................0.05 ppm Hog, meat by

products.....................................0.10 ppm Horse, fat....................................................0.30 ppm Horse, meat.................................................0.10 ppm Horse, meat by

products .................................0.35 ppm Milk.........................................................0 . 10 ppm Poultry, m eat .......................... .................................... 0. 05 ppm Sheep, fat ................................................. . 0. 30 ppm Sheep, meat............................................. . . 0.10 ppm Sheep, m eat by

products .............................. . . 0. 35 ppm The recommended tolerances in/on alfalfa, citrus and stone fruits are based on the crop field trial data . The appropriate tolerance levels were determined using the Agency ’s Standard Operating Proceedure (SOP) “Guidelines for Setting Pesticide Tolerances Based on Field Trial Data”. The adequacy

of the existing livestock tolerances were assessed using the available cattle and poultry feeding studies that cover the potential levels of dietary exposure of livestock to boscalid residues. The data indicate that the existing tolerances for meat (0.05 ppm) and meat by products (0.10 ppm) of hogs are adequate; however, the tolerance for hog fat should be increased to 0.20 ppm . The adequacy

of the existing tolerances for poultry were assessed using residue data from the 5.31 ppm dose group in the poultry feeding studies; this group represents 1.3x the calculated dietary burden for poultry . Maximum combined residues for this dose group were <0.02 ppm in eggs, <0.175 ppm in liver, <0.05 ppm in muscle, and <0.124 ppm in fat. Average combined residues were 0.02 ppm in eggs, 0.136 ppm in liver, 0. 05 ppm in muscle, and 0.081 ppm in fat. These data indicate that the existing tolerances for eggs (0.02 ppm) and poultry meat (0.05 ppm) are adequate; however, the tolerances for poultry fat and meat by

products should each be increased to 0.20 ppm.Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 7 of 48 Note to PM: HED recommends that the tolerance definition entry in 40 CFR 180.589 (d) Indirect or inadvertent residues should be revised to read as follows: (d) Indirect or inadvertent residues . Tolerances are established for residues of the fungicid e boscalid, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only - pyridinecarboxamide, 2 - chloro - N - (4' - chloro[1,1' - biphenyl] - 2 -yl) in or on the commodity.

Commodity Parts per million Animal feed, nongrass, group 18, forage , excluding alfalfa 1.0 Animal feed, nongrass, group 18, hay, excluding alfalfa 2.0 Animal feed, nongrass, group 18, seed , excluding alfalfa 860.1200 Direction for Use ● A revised Section B for alfalfa is required to amend the label direction for the 70% WDG formulation since it could not be supported by the field trial data generated with a maximum seasonal use rate of 0.9 lb ai/A. The proposed label rate for the 70% formulation is 1.7x higher; the label should be revised to match the field trial rate. 860.1550 Proposed Tolerances ● Boscalid residues concentrate in citrus dried pulp (3.1x) and citrus oil (59x). A revised Section F is required to propose separate tolerances for citrus, dried pulp at 4.5 ppm, citrus, oil at 85 ppm, and Fruit, citrus, group 10 at 1.6 ppm. ● The available data for stone fruits will not support a tolerance level of 5.0 ppm. A revised Section F should be submitted with a tolerance for Fruit , stone, group 12 at 3.5 ppm..Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 8 of 48 ● The available data will not support the proposed tolerances for meat, meat by products, and fat of cattle goat, horse, and sheep at 0.2, 1.5, and 1.5 ppm , respectively . The existing t olerances will be maintained for meat, meat by products and fat of cattle, goat, horse and sheep at 0.10 ppm, 0.35 ppm, and 0.30 ppm, respectively . The available dat a will not support the proposed tolerance of 0.2 ppm for milk and the proposed tolerance of 1.5 for milk fat. The existing to lerance of 0.10 ppm will be maintained for milk, and it is adequate to cover milk fat. For all remaining livestock commodities, the proposed tolerances must be revised to reflect the recommended tolerance levels as specified in Table 1 1. Note to PM: Revisions of the livestock commodities data collection methods have been included in the registrant’s submissions. However, BASF have not indicated whether any of the changes were made in their attempt to resolve any of the deficiencies noted by the Agenc y in their 2003 petition (DP# 278385, M. Nelson, 8/15/2003). I f the methods have been revised and finalized, this should be clarified and the entire final versions of the enforcement and the data collection method s should be submitted to the Agency . Oth erwise, registration for the new or amended use patterns for the boscalid products should be made conditional until the deficiencies noted above are fully

resolved. Background The chemical structure and nomenclature of boscalid and its hydroxyl metaboli te and physicochemical properties of the technical grade of boscalid are presented in Tables 1 and 2. Table 1. Nom enclature of Boscalid and its Hydroxy Metabolite. Compound

N N O

Cl
Cl Common name Boscalid; Nicobifen Company experimental name BAS 510 F IUPAC name 2 - chloro -N - (4' - chlorobiphenyl - 2 - yl) - nicotinamide CAS name 3 - pyridinecorboxamide,2 - chloro -N - (4' - chloro[1,1' - biphenyl] - 2 - yl 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)Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 9 of 48 Table 1. Nom enclature of Boscalid and its Hydroxy Metabolite. Hydroxy- metabolite

N N O

Cl
Cl O H

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 Table 2. 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) Re lative 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 - oc tanol <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 

### 860.1200 Directions for Use BASF is proposing new use s for the 25% WDG on alfalfa and citrus fruits and for the 7 0% WDG formulation on alfalfa. Supplemental label s were provided. The use directions for alfalfa and citrus, including the directions for stone fruits are summarized below in Table 3.Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 10 of 48 Table 3. Summary of Directions for Use of Boscalid. Applic. Timing, Type, and Equip. 1 Formulation [EPA Reg. No.] Applic.

Rate (lb ai/A) Max. No.

Applic. pe r Season Max. Seasonal

Applic. Rate (lb ai/A) PHI

(days) Use Directions and

Limitations 2 Alfalfa 3 Broadcast foliar applications when conditions are favorable to disease development; ground or aerial equipment . 70% WDG [7969 - 197] 0.09 - 0.48 3 (2 per cutting) 1.44 14 The minimum RTI is 14 days. For aerial applications, use a minimum of 10 gal/A Do not make more than 2 applications per cutting or 3 applications per season. 25.2% WDG [7969 - 199] 0.19 - 0.28 3 (2 per cutting) 0.85 14 Citrus Fruits B roadcast foliar applications prior to infection; ground or aerial equipment 25.2% WDG [7969 - 199] 0.25 - 0.29 4 1.17 0 The minimum RTI is 10 days. For aerial applications, use a minimum of 10 gal/A Stone Fruits Broadcast foliar applications from pink bud through fruit development; ground or aerial equipment 25.2% WDG [7969 - 199] 0.17 - 0.23 5 1.1 4 0 The minimum RTI is 7 days. For aerial applications, use a minimum of 10 gal/A 1 Ground application may be made through the following types of irrigation systems: center pivot, lateral move, end tow, side wheel roll, traveler, big gun, solid set, or hand move. 2 Use directions allow for the use of spray adjuvants, and specify a 14 - day plant - back interval for rotational crops without registered uses for boscalid. 3 For stand establishment of fall seeded alfalfa, begin applications in fall through early winter prior to first snowfall or extended cool, wet conditions. For seed pod protection, begin applications at 10% to 30% bloom. 

### Conclusions . The submitted use directions are sufficient to allow for evaluation of the submitted residue data relative to the proposed use pattern. The available field trial data support the proposed use directions for the 25% WDG formulation on alfalfa and citrus fruits, and the suppl ement al field trail data on stone fruits support the current use on stone fruits. However, a revised Section B for alfalfa is required to amend the label direction for the 70% WDG formulation since it could not be supported by the field trial data generated with a maximum seasonal use rate of 0.9 lb ai/A. The proposed label rate for the 70% formulation is 1.7x higher; the label should be revised to match the field trial rate. 860.1300 Nature of the Residue - Plants PP#1F6313 ; DP# 278385; M. Nelson; 8/1 5/2003 HED MARC Decision Memo; DP# 286786; M. Nelson; 1/09/2003 

### The nature of boscalid residues in primary crops is adequately

understood, based upon acceptable grape, lettuce and bean metabolism studies; these studies were reviewed in the initial boscali d petition, PP#1F6313. No significant metabolism of boscalid occurred in grapes or lettuce; unchanged parent was the only component identified, accounting for 92 - 98% and 99% total radioactive residues (TRR), respectively . In bean plants, boscalid metabol ized slowly ; unchanged parent was the major component identified, accounting for up to 72% TRR in dry bean seeds, and 99% TRR in bean plants. Cleavage products, 1 - (chlorophenyl) - 2 - aminobenzene and 2 - chloronicotinic acid, were present in small amounts, acc ounting for <1% and <10% TRR, respectively .Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 11 of 48 HED has concluded that the parent compound, boscalid, is the sole residue of concern in primary crop for purposes of risk assessment and the tolerance expression. The cleavage products were not included, based on the limited cleavage which occurred, and the low levels of their ingestion expected from dietary

and environmental sources. 860.1300 Nature of the Residue - Livestock PP#1F6313; DP# 278385; M. Nelson; 8/15/2003 HED MARC Decision Memo; DP# 286786; M. Nelson; 1/09/2003 

### The nature of boscalid residues in livestock 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 (hydroxy metabolite), and M510F 02 (M510F01 glucuronide) were identified as the major residues, each with

 ≥ 10% TRR. 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 hydrolysis 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. 860.1340 Residue Analytical Methods - Plants PP#1F6313; DP# 2 78385, M. Nelson, 8/15/20 03 DP# 284510; D. Swineford and E. Kolbe; 8/12/2003 (PMV memo ) 

### An adequate GC/MS method (Method D0008) is available for enforcing boscalid tolerances in plant commodities. The Analy tical Chemistry

Branch of the Biological and Eco nomic Analysis Division (ACB/BEAD ) concluded that the method is acceptable for enforcement purposes in plants without the need for an EPA validation (DP# 284510; D. Swineford and E. Kolbe , 8/12/2003 , PMV memo ) . An adequate LC/MS/MS method (BASF Method D 9908, Version II) is also available for collecting residue data on plant commodities. Boscalid residues in all of the plant commodities associated with the current field trials and the citrus processing study were determined using this LC /MS/MS method. B riefly, the residues were extracted from plant commodities , except citrus oil, with methanol (MeOH) :water:2 N HCl (70:25:5; v/v/v) and centrifuged. For oil, samples were initially dissolved in hexane, and residues were partitioned into acetonitrile, conc entrated to dry ness and the re - dissolved in MeOH :water:2 N HCl (70:25:5; v/v/v). Residues from each commodity

were then diluted with 1N HCl saturated with NaCl, and partitioned into cyclohexane. Residues were concentrated to dry ness, re - dissolved in MeOH :water:4 mM ammonium formate (80:20:0.1, v/v/v), and analy zed by L C/MS/MS using the m/z 343 →307 transition to detect and quantify boscalid . Residues are quantified using an external calibration curve of boscalid standards . The validated L OQ was 0.05 ppm for each plant commodity and the LOD was reported to be 0.0 1 ppm for alfalfa forage and hay, citrus fruits and citrus fruit processed fractions .Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 12 of 48 The method was adequately validated in conjunction with each field trial, using control samples of each plant matrix fortified with boscalid at levels ranging from 0.05 to 50 ppm. 860.1340 Residue Analytical Methods - Livestock PP#1F6313; DP# 278385, M. Nelson, 8/15/2003 DER Reference 47584403 

### 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 successfully validated by ACB/BEAD. F or the current livestock feeding study, residues of boscalid and its hydroxy metabolite M510F01 (including the glucuronide conj ugate M510F02) were determined using a LC/MS/MS method ( BASF Method 471/0 , modified) which was previously reviewed in conjunction with earlier feeding studies. For this method, residues in milk and tissue matrices were extracted with MeOH, filtered and c oncentrated. To convert the glucuronide conjugate (M501F02) to the free hydroxy metabolite (M501F01), residues were re - dissolved in 0.1M sodium acetate buffer and incubated with β - glucuronidase/arylsulphatase for 1 hour at 37°C. The resulting hydrolysate was diluted with water, salinized , and acidified with 1M HCl. Residues were then partitioned into ethy l acetate and concentrated to dry

ness. Residues were re - dissolved in water:MeOH (7:3, v/v) and cleaned up by elution through a C - 18 SPE cartridge using water:MeOH (3:7, v/v). Residue samples from muscle also underwent an additional cleanup step using a silica gel SPE cartridge eluted with dichloromethane:acetone (8:2, v/v). Residues in the final eluates were concentrated to dry ness and re - dissolved in acetonitrile:water (1:1, v/v) for analysis. Residues of boscalid and M510F01 were determined by

L C/MS/MS using the m/z 343 →140 transition for boscalid and the 359 →140 transition for M501F01, with external standardization. Residues are expressed in terms of the individual analy tes, and the validated L OQs for each analy te are 0.01 ppm in milk matrices and 0.025 ppm in tissues. The reported LODs for each analy te were 0.0067 ppm in milk and 0.0167 ppm in tissues. For calculating combined residues, Metaboli te M510F01 residues are converted to parent equivalents using a conversion factor of 0.96. The above method was adequately validated prior to and in conjunction with the analysis of feeding study

samples, using control samples fortified with boscalid and M510F01 at 0.01 - 2.5 ppm for milk, skim milk and cream, and 0.025 - 2.5 ppm for liver, kidney, muscle and fat samples. 860.1360 Multiresidue Methods PP#1F6313; DP# 278385, M. Nelson, 8/15/20 03 

### Residues of boscalid and its metabolite M 510F01 were not adequately recovered using the multiresidue methods. Protocol A was not applicable. Protocol B was not applicable for boscalid and yielded inconsistent recoveries of M510F01. Residues of boscalid and its hydroxy metabolite M510F01 had go od 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 .Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 13 of 48 860.1380 Storage Stability DP# 322235, D. Dotson, 1 1/0 3/20 05 MRID 47584402.der 

### Adequate storage stability studies are available indicating that boscalid is relatively stable at ≤ - 20oC in fortified samples of cabbage (leafy vegetables), canola seed (oil seed), peach (fruit/fruiting vegetable), sugar beet roots (root crop), peas (legume vegetable), wheat grain (non oily grain), wheat forage (foliage), and wheat straw (dry feed) for up to 24 months. Inaddition to the above data, a concurrent storage stability study w as conducted in conjunction with the orange processing study ( MRID 47584402.der). Homogenized c ontrol samples of orange fruit s , dried pulp, juice and oil were each fortified with boscalid at 0.5 ppm and placed in storage at ≤ - 5°C . No zero - day analysis was conducted on the fortified samples prior to storage. The stored samples were analy zed in duplicate along with control samples freshly fortified with boscalid at 0.05 ppm and 2.0 ppm. The average recovery from the stored orange fruit, dried pulp, juice and oil samples (corrected for concurrent recoveries) were 117 % , 109 % , 119 % , and 126%, respectively . These data indicate that boscalid is stable at - 5°C for up to 109 days (3.6 months) in orange fruit, dried pulp, juice and oil. The storage durations and conditions of samples from the crop field trials submitted to support this petition are presented in Table 4. Table 4. Summary of Storage Conditions and Durations of Samples fromCrop Field Trial and

Processing Studies. Matrix Storage Temperature (°C) Actual Storage

Duration Interval of Demonstrated Storage Stability (months) Alfalfa Forage < - 5 5 - 13 24

– wheat forage Alfalfa Hay < - 5 5 - 13 24

– wheat straw Orange < - 10 1.0 - 6.2 24

– peach Orange Peel < - 10 1.0 - 5.3 24

– peach Orange Pulp < - 10 1.0 - 6.0 24

– peach Orange Dried Pulp < - 5 3.4 3.6 Orange Juice < - 5 3.4 - 3.5 3.6 Orange Oil < - 5 3.4 3.6 Grapefruit < - 10 2.8 - 4.9 24

– peach Lemon < - 10 0.8 - 4.5 24

– peach Cherry (Sweet and Tart) < - 5 3 .3 - 8.6 24

– peach Peach < - 5 4.9 - 8.0 24

– peach Plum < - 5 4.5 - 6.3 24

– peach 

### Conclusions . The available storage stability data are adequate and support the storage conditions and durations for samples of alfalfa, citrus fruits, and stone fruits f rom the current field trials and the acceptable citrus processing study . 860.1400 Water, Fish, and Irrigated CropsBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 14 of 48 There are no proposed/registered uses that are relevant to this guideline topic. 860.1460 Food Handling There are no proposed/registered uses that are relevant to this guideline topic. 860.1480 Meat, Milk, Poultry, and Eggs PP#1F6313; DP# 278385, M. Nelson, 8/15/20 03 DP# 322235; D. Dotson, 11/03/2005 45405110.der (cattle feeding study) 45643801.der (poultry feeding study) 47584403.der ( cattle feeding study) 

### Adequate cattle and poultry feeding studies are available . The current tolerances for livestock commodities are based on the residue data from the e arlier cattle and poultry feeding studies and the previously calculated dietary burd ens of livestock for boscalid. The maximum dietary burden for poultry

was originally

calculated to be 1.85 ppm (DP# 278385, M. Nelson, 8/15/2003), and the maximum dietary

burdens for other livestock were most recently calculated to be 16.4 ppm for beef c attle, 13.2 ppm for dairy cattle, and 1.79 ppm for swine (DP# 322235, D. Dotson, 11/03/2005). Cattle Feeding Studies. BASF Corporation submitted a new cattle feeding study conducted in 2008 in which two groups of lactating dairy cows were administered with encapsulated boscalid via balling gun for 29 consecutive days at the target doses of 35 ppm (Group 2; 3 cows) or 105 ppm (Group 3; 7 cows). Based on the average feed consumption, these dose levels are equivalent to 35.8 and 116.3 mg ai/kg feed (dry f eed weight basis) or 1.22 and 3.56 mg ai/kg body weight/day

for the low and high dose groups, respectively . These dose levels are intended to represent 1x and 3x the anticipated EU dietary burden of 35 ppm in the feed on a dry weight basis. The four additional cows in the high dose group were used to assess residue decline (depuration) following the final dosing. However, one of the four cows developed John’s disease and was euthanized. The cows were milked twice a day, and samples composited daily fo r each cow from the 1x and 3x dose groups on day - 1, 1, 4, 7, 10, 13, 16, 19, 22, 25 and 28. Three cows each from the 1x and 3x groups were sacrificed 24 hours after the final dose period. One cow in the high - dose group was sacrificed at days 36, 39 and 43 (i.e., 7, 10 and 14 days after the final dose). S amples of liver (representative samples from each lobe) , both kidneys , muscle (composite of round, flank, and loin), omental fat , perirenal fat, and subcutaneous fat were collected . The LC /MS /MS metho d (BASF No. 471/0, modified) was used for determining the residues of boscalid and its hydroxy

metabolite M510F01 (including glucoronide conjugate M519F02) in milk and tissue s. The modified method was adequately validated based on acceptable method validation and concurrent method recovery data. The limit of quantitation (LOQ) for each analy te in milk was 0.01 ppm (0.02 ppm combined) and 0.025 ppm (0.05 ppm combined) for each analy

te in tissues. All milk and tissue samples were stored frozen from coll ection to analysis. Milk, skim milk,Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 15 of 48 and cream were analy

zed within 4.76 days; liver, kidney and muscle, within 35 - 48 days; and fat within 48 - 70 days. The available storage stability data from earlier studies (DER for MRID 45405108) demonstrate that resi dues of boscalid and M510F01 are stable for up to 5.5 months in cow milk, liver, and muscle, and are adequate to support the storage intervals and conditions of milk, skim milk, muscle, liver, fat and kidney samples from this study . For the low dose gro up, the combined residues of boscalid in milk samples collected over the course of the dosing period were <0.02 - 0.03 ppm (parent, <0.01 - 0.023 ppm; M510F01, <0.01 ppm). For the high dose group, the combined residues were 0.03 - 0.12 ppm (parent, <0.021 - 0.112 ppm; M510F01, <0.01 - 0.017 ppm). Milk samples from day 22 and 28 of the study, and from the depuration cow remaining at day 42 of the study, were separated into skim milk and cream. Residues of boscalid and M510F01 in skim milk from all dosed groups were each <LOQ (<0.01 ppm) or at L OQ (0.012 ppm for parent boscalid in one high dose sample). Combined residues for boscalid and M510F01 in cream were 0.06 - 0.08 ppm for the low dose group and 0.14 - 0.50 ppm for the high dose group. Residues appeared to peak on day 7 and then plateau at a lower level for the remainder of the dosing period. For the residue decline study in the high dose cows, boscalid and M510F01 residues were each <LOQ (<0.01 ppm) in milk samples collected at days 2,7,10 after the dosing period with excepton of a sample from day 31 where the residues of boscalid were 0.037 ppm 2 days after dosing ceased. The residue declined to below the LOQ in milk 7,10 and 14 days after dosing. Inskim milk and cream samples collected during the depuration phase 14 days after dosing, the residues of boscalid and M510F01 were each <LOQ (<0.01 ppm). In all tissue samples collected 7,10, and 14 days after dosing of the high dose group, the residues of boscalid and M510F01 were each <LOQ (<0.025 ppm) e xcept in omental and perirenal fat in samples collected 7 days after dosing, where parent boscalid residues were 0.033 and 0.037 ppm, respectively . The residues declined to <LOQ in these matrices 10 and 14 days after dosing. Residues of boscalid and M5 10F01 in tissue samples collected immediately after 29 days of dosing at 1x and 3x the EU anticipated dietary burden were determined.. Combined residues of boscalid and M510F01in liver samples from the low and high dose groups were 0.08 - 0.11 ppm and 0.15 - 0.24 ppm, respectively . In kidney samples, combined residues were 0.10 - 0.11 and 0.11 - 0.24 ppm from the low and high dose groups, respectively . In muscle samples from both dosing groups, residues of boscalid and M510F01 were below the LOQ (<0.025 ppm each). In omental fat samples, combined residues were 0.08 - 0.23 ppm and 0.18 - 0.23 ppm from the low and high dose groups, respectively . In perirenal fat samples, combined residues of boscalid and M501F01 were 0.12 - 0.24 ppm and 0.199 - 0.28 ppm from the low and high dose groups, respectively . In subcutaneous fat samples, the combined residues were 0.10 - 0.20 ppm and 0.08 - 0,18 ppm from the low and high dose groups, respectively . The combined residue data from the 2008 dairy cattle feeding study are summarized in Table 5. The potential for secondary transfer of boscalid residue of concern in meat, milk, poultry, swine, and eggs exists since livestock feedstuffs that are associated with the proposed uses. Grain, aspirated fractions are no longer used and was replaced with cotton, gin by products as the latter yi elds higher contributions to the diet (beef cattle only ) . The calculat ed dietary burdens of boscalid to livestock are 1 0.8 ppm for beef cattle, 22.5 ppm for dairy cattle, 4. 0 ppm for poultry, and 5.3 pp m for swine (Table 8 ) .Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 16 of 48 Table 5 . Summary of Combined Residue Data from Recent Dairy Cattle Feeding Study with Boscalid. Matrix Feeding Level (ppm) Residue Levels (ppm) 1

n Min. Max. Median (STMdR) Mean

(STMR) Std. Dev. Milk 35.8 (1.0x) 3 30 <0.02 < 0. 03 0.02 0.02 0.008 Skim Milk 6 <0.02 <0.02 0.02 0.02 NA2 Cream 6 <0.06 <0.08 0.07 0.07 0.006 Liver 3 0.08 0.11 0.09 0.10 0.015 Kidney 3 < 0.10 < 0.11 0.11 0.11 0.009 Muscle 3 <0.05 <0.05 0.05 0.05 NA Fat (omental, perirenal, subcutaneous) 9 < 0 .08 < 0.24 0.20 0.1 8 0.059 Milk 116.3 (3.3x) 3 60 < 0.03 < 0.12 0.06 0.06 0.018 Skim Milk 12 <0.02 <0.02 0.02 0.02 NA Cream 12 < 0.14 < 0.50 0.25 0.26 0.111 Liver 3 0.15 0.24 0.21 0.20 0.043 Kidney 3 < 0.11 0.24 0.19 0.18 0.065 Muscle 3 <0.05 <0.05 0 .05 0.05 NA Fat (omental, perirenal, subcutaneous) 9 < 0.08 < 0.28 0.19 0. 20 0.057 1 The combined LOQ (0.02 ppm for milk matrices and 0.05 ppm for tissues) was used for values <LOQ when calculating the median, mean and standard deviation. Residue are e xpressed in parent equivalents. 2 NA = Not applicable. 3 Dose level compared to the calculated maximum dietary burden of 35.18 ppm for diary cattle. 

### Inthe earlier cattle feeding study, three groups of dairy cows (3 - 4 cows/dose group) were dosed orally w ith boscalid for 29 - 30 consecutive days at levels equivalent to 1.8, 5.9, and 20.2 ppm in the diet . These dose levels are respectively equivalent to 0.05x, 0.17x, and 0.57x the current maximum dietary

burden for dairy

cattle. Cows were milked twice daily, and the pooled daily milk samples for each cow from Study Days 1, 3, 6, 9, 12, 15, 18, 21, 24 and 28 were sampled for analysis. Whole milk samples from Day 21 were also separated into skim milk and cream. Animals were sacrificed within 24 hours of rece iving the final dose and samples of muscle, fat, liver, and kidney

were collected. Samples of milk and tissues were analy zed for residues of boscalid and M510F01 (free and conjugated) using an LC/MS/MS method (BASF Method 471/0), which was adequately vali dated in conjugation with the analysis of feeding study samples. The method L OQ for each analy te is 0.01 ppm in milk and 0.025 ppm in tissues, for combined L OQs of 0.02 ppm in milk and 0.05 ppm in tissues. Samples of milk and liver were also analy zed for non - extractable conjugated residues, determined as M510F53, using a GC/MS method (BASF Method 476/0), which was also adequately

validated. The method LOQ for M510F53 is 0.01 ppm in milk and 0.05 ppm in tissues. The sample storage durations and condition s for the feeding study were adequately supported by

the available storage stability data. The data on residue s of M510F53 in milk and liver will not be summarized in this report as M510F53 is not a residue of concern . For the low - dose group (1.8 ppm), the combined residues of boscalid and M510F01 (free and conjugated) were <0.02 ppm in all milk samples and skim milk, and <0.05 ppm in all samples of muscle, liver and kidneys. However, quantifiable residues of the parent , boscalid were detected at 0.023 - 0 .045 ppm in the low - dose cream samples and atBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 17 of 48 0.053 ppm in one of three fat samples. Residues of boscalid were generally <LOQ in kidneys, and residues of M510F01 were <LOQ in milk, cream, fat and muscle. In liver, residues consisted primarily of M510F01, with only

liver from the high - dose group having residues of boscalid above the LOQ. A summary of the residue data from the 5.9 and 20.2 ppm dose groups are presented in Table 6. Table 6 . Summary of Combined Residue Data from Earlier Dairy Cattle Feeding Study with Boscalid. Matrix Feeding Level (ppm) Residue Levels (ppm) 1

n Min. Max. Median (STMdR) Mean

(STMR) Std. Dev. Milk 5.9

(0.2x) 4 3 3 <0.02 0.0 23 0.02 0.02 < 0.00 1 Skim Milk 3 <0.02 <0.02 0.02 0.02 NA Cream 3 < 0. 110 <0.125 0.123 0. 119 0.00 8 Liver 3 <0.051 <0.064 0.055 0.057 0.007 Kidney 3 <0.063 <0.090 0.071 0.075 0.014 Muscle 3 <0.05 <0.05 0.05 0.05 NA Fat 3 <0.082 < 0. 1 2 0.1 1 0.1 04 0.0 20 Milk (Days 15 - 28) 3 20.2

(0.6x) 4 22 <0.021 <0.096 0.040 0.042 0.015 Skim Milk 4 <0.02 <0. 021 0.02 0.02 <0.001 Cream 4 <0.25 <0.38 0.37 0.34 0.062 Liver 3 0.17 0.18 0.18 0.18 0.006 Kidney 3 <0.17 <0.32 0.22 0.24 0.076 Muscle 3 <0.05 <0.058 0.05 0.053 0.005 Fat 3 <0.24 <0.29 0.28 0.27 0.026 1 The combined LOQ (0.02 ppm for milk matrices and 0.05 ppm for tissues) was used for values <LOQ when calculating the median, mean and standard deviation. Residues are expressed in parent equivalents. 2 NA = Not applicable. 3 Residues in milk plateaued by Day 15. 4 Dose level compared to calculated maximum dietary burden of 35.18 ppm for diary cattle. 

### Poultry feeding study. Inthe poultry feeding study, three groups of l aying hens w ere dosed orally once a day for 29 consecutive days with boscalid at levels equivalent to of 1.02, 5.31, and 19.6 ppm in the diet, which are respectively equivalent to 0.25 x, 1.3x , and 4.8 x of the maximum dietary burden of poultry

to boscalid . Each group consisted of 3 or 5 subgroups with 4 hens per subgroup. During the dosing period, eggs were collected twice each day and pooled by

day and subgroup . H ens were sacrificed within 5 hours of the final dose, with the exception of hens in two subgroups from the high - dose that were sacrificed at 3 and 10 days post - dose to study depuration. Samples of muscle, fat and liv er were collected at sacrifice and pooled by subgroup. Residues of boscalid and M510F01 (free + conjugated) in eggs and tissue s were determined using an LC /MS /MS method (BASF No. 471/0, modified) , which was adequately validated in conjunction with the an alysis of feeding study samples. The validated L OQ for each analy te is 0.01 ppm in eggs and 0.025 ppm in tissues , for combined L OQs of 0.02 ppm in eggs and 0.05 ppm in tissues. The sample storage durations and conditions for the feeding study were adequately

supported by

the available storage stability data. For the low - dose group (1.02 ppm), the combined residues of boscalid and M510F01 (free and conjugated) were <0.02 ppm in all samples of eggs, and <0.05 ppm in all muscle and fat samples.Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 18 of 48 Inliver, b oscalid residues were <LOQ in all samples, and residues of M510F01 were quantifiable in only one sample at 0.026 ppm, for combined residues of <0.051 ppm. In the mid - and high dose groups, residues of boscalid were <LOQ in liver and muscle, and residues o f M510F01 were generally

<LOQ in muscle and fat. Residues in eggs from the high - dose group were comprised of approximately equal amounts of boscalid and M510F01. A summary of the residue data from the 5.31 and 19.6 ppm dose groups are presented in Table 7 . Table 7 . Summary of Combined Residue Data from Poultry Feeding Study with Boscalid. Matrix Feeding Level (ppm) Residue Levels (ppm) 1

n Min. Max. Median (STMdR) Mean

(STMR) Std. Dev. Eggs (Days 1 - 28) 5.31 (1.3x) 3 30 <0.02 <0.02 0.02 0.02 NA Li ver 3 < 0.106 < 0.175 0.126 0.136 0.036 Muscle 3 <0.05 <0.05 0.05 0.05 NA Fat 3 < 0.052 < 0.124 0.066 0.081 0.038 Eggs (Days 7 - 28) 4 19.6 (4.8x) 3 34 0.027 0.065 0.049 0.047 0.012 Liver 3 < 0.316 < 0.466 0.429 0.404 0.078 Muscle 3 <0.05 <0.05 0.05 0. 05 NA Fat 3 < 0.135 < 0.196 0.186 0.172 0.033 1 The combined LOQ (0.02 ppm for eggs and 0.05 ppm for tissues) was used for values <LOQ when calculating the median, mean and standard deviation. Residue are expressed in parent equivalents. 2 NA = Not appl icable. 3 Dose level compared to the calculated maximum dietary burden of 4.10 ppm for poultry. 4 Residues in eggs plateaued by Day 7. 

### Livestock Dietary Burdens . As alfalfa forage and hay are major livestock feedstuffs, the dietary burdens for livestock were recalculated for this petition. Based on the recent changes in calculating residues in reasonably balanced livestock diets ( Table 1, Feedstuffs, June 2008), the dietary burden for livestock from boscalid residues was recalculated to be 1 0.8 ppm for beef cattle, 22.5 ppm for dairy cattle, 4. 0 ppm for poultry and 5.3 ppm for swine (Table 8 ).Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 19 of 48 Table 8 . Calculation of Dietary Burdens of Boscalid Residues to Livestock. Feedstuff Ty pe 1 % Dry Matter2 % Diet 2 Recommended Tolerance (ppm) Dietary Contribution (ppm) 3 Beef Cattle Alfalfa, hay R 89 10 65 7.3 Cotton, gin byproducts R 90 5 55 3.06 Field corn, grain CC 88 80 0.2 0.18 Canola, meal PC 88 5 3.5 4 0.2 TOTAL BURDEN -- -- 100 -- 10.8 Dairy Cattle Alfalfa, forage R 35 20 30 17.2 Grass, hay R 88 25 8.0 2.27 Apple, wet pomace CC 40 10 10 2.50 Field corn, grain CC 88 35 0.2 0.08 Canola, meal P 88 10 3.5 4 0.4 TOTAL BURDEN -- -- 100 -- 22.5 Poultry Field corn, grain CC 88 75 0.2 0.15 Alfalfa, meal PC 90 5 65 4 3.25 Canola, meal PC 89 15 3.5 4 0.53 Peanut, meal PC 85 5 0.15 0.0075 TOTAL BURDEN -- -- 100 -- 4.0 Swine Field corn, grain CC 88 85 0.2 1.70 Alfalfa, meal PC 90 5 65 4 3.25 Canola, meal PC 89 10 3.5 4 0.35 TOTAL BURDEN -- -- 100 -- 5.3 1 R: Roughage; CC: Carbohydrate concentrate; PC: Protein concentrate. 2 OPPTS 860.1000 Table 1 Feedstuffs (June 2008). 3 Contribution = ([tolerance /% DM] X % diet) for beef and dairy cattle; contribution = ([tolerance] X % diet) for poultry and swine. 4 The tolerance for canola seed (3. 5 ppm) was used for meal, and the tolerance for alfalfa hay (65 ppm) was used for alfalfa meal. 

### Conclusions . The available cattle and poultry feeding studies are adequate and cover the potential levels of dietary exposure of livestock to boscalid residu es. The magnitude of the residues of boscalid and M510F01 was adequately determined in the new (2008) feeding study

with lactating diary

cows dosed orally

for 29 consecutive with boscalid at levels equivalent to 35.8 ppm (low dose, 1x the anticipated dietary burden) and 116.3 ppm (high dose, 3x the anticipated dietary burden) in the diet (dry

feed weight basis). Over the entire dosing period, the maximum combined residues in milk samples were 0.0 3 and 0.12 ppm for the low and high dose group, respectively . Following 29 days of dosing , the combined residues in tissues from the low and high dose groups were, respectively, 0.11 and 0.24 in liver and kidney samples; less than the combined LOQ ( < 0.05 ppm) in muscle samples ; 0.23 ppm in omental fat; 0.24 and 0 .28 ppm in perirenal fat; and 0.20 and 0.18 ppm in subcutaneous fat.Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 20 of 48 For hogs, the adequacy

of the existing tolerance s were assessed using residue data from the 5.9 ppm dose group in the cattle feeding studies; this group represents 1.1x the calculated dietary burden for swine. Maximum combined residues for this dose group were <0.064 ppm in liver, <0.090 ppm in kidney, <0.05 ppm in muscle, and <0.12 ppm in fat. Average combined residues were 0.057 ppm in liver, 0.075 ppm in kidneys, 0.05 ppm in muscle , and 0.104 ppm in fat. The data indicate that the existing tolerances for meat (0.05 ppm) and meat by products (0.10 ppm) of hogs are adequate; however, the tolerance for hog fat should be increased to 0.20 ppm. For poultry, the adequacy of the existing tolerance s were assessed using residue data from the 5.31 ppm dose group in the poultry feeding studies; this group represents 1.3x the calculated dietary burden for poultry . Maximum combined residues for this dose group were <0.02 ppm in eggs, <0.175 ppm in liver, <0.05 ppm in muscle, and <0.124 ppm in fat. Average combined residues were 0.02 ppm in eggs, 0.136 ppm in liver, 0.05 ppm in muscle, and 0.081 ppm in fat. These data indicate that the existing tolerance s for eggs (0.02 ppm) and poultry meat (0 .05 ppm) are adequate; however, the tolerances for poultry fat and meat by

products should each be increased to 0.20 ppm. 860.1500 Crop Field Trials DP# 278385, M. Nelson, 8/15/2003 DP# 323288, D. Soderberg, 6/14/2007 47584401.der (alfalfa) 45903601.de 1 (citrus fruits ) 47470201.de 2 (stone fruit s ) 

### BASF submitted field trial data on alfalfa , oranges, lemons and grapefruits in support of new uses for boscalid (WDG) on alfalfa and the citrus fruits crop group. BASF also submitted new stone fruit field trial data supporting an amended tolerance for stone fruits. The results from the new field trials and the previously submitted stone fruit field trails are summarized in Table 9 and discussed below. Table 9 . Summary of Residue Data fromCrop Field Trials with Boscalid (WDG) . Crop matrix (DER) Treatment

Info. Total

Applic. Rate (lb ai/A) PHI

(days) 1 Residue Levels (ppm) 2

n Min. Max. HAFT 3 Median Mean Std. Dev. Citrus Fruits (proposed use = 1. 17 lb ai/A total application rate, 0 - day PHI) 4 Orange ( 4 5903601 .de 1 ) Concentrated 1.19 - 1.22 0 12 0.179 1.425 1.393 0.388 0.610 0.467

Dilute 1.20 - 1.21 0 14 0.238 0.676 0.588 0.353 0.418 0.146 Grapefruit ( 45903601 .de 1 ) Concentrated 1.20 0 6 0.115 0.847 0.836 0.143 0.365 0.364

Dilute 1.20 0 6 0.064 0.272 0. 261 0.125 0.155 0.086 Lemon ( 45903601 .de 1 ) Concentrated 1.18 - 1.23 0 6 0.522 1.51 1.239 0.671 0.822 0.370

Dilute 1.18 - 1.20 0 4 0.600 0.936 0.872 0.775 0.771 0.140 Stone Fruits (proposed use = 1.15 lb ai/A total application rate, 0 - day PHI) 5 Cherry (47470201.de2) NA 1.15 0 14 <0.05 2.98 1.63 1.47 1.57 0.89 1 14 <0.05 2.69 1.95 1.09 1.28 0.81 Peach (47470201.de2) 1.15 0 12 0.56 3.79 1.94 0.76 1.15 1.03 1 12 0.46 3.87 2.74 0.75 1.19 1.15 Plum (47470201.de2) 1.15 0 10 <0.05 0.79 0.67 0.14 0. 34 0.31 1 10 <0.05 0.57 0.71 0.11 0.26 0.24Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 21 of 48 Table 9 . Summary of Residue Data fromCrop Field Trials with Boscalid (WDG) . Crop matrix (DER) Treatment

Info. Total

Applic. Rate (lb ai/A) PHI

(days) 1 Residue Levels (ppm) 2

n Min. Max. HAFT 3 Median Mean Std. Dev. Cherry (45405121.der) NA 1.35 0 2 1.28 1.70 1.49 1.49 1.49 NA Peach (45405121.der) 1.14 - 1.17 8 0.47 1.20 1.19 0.74 0.77 0.29 Plum (45405121.der) 1.15 - 1.17 8 0.09 0.85 0.70 0.50 0.47 0.23 Cherry ( 46665 505 .der) Concentrated 1.15 - 1.16 0 6 0.641 1.635 1.635 0.999 1.056 0.370

Dilute 1.15 0 6 0.736 1.505 1.505 1.313 1.229 0.309 Peach ( 46665505 .der) Concentrated 1.14 - 1.16 0 9 0.157 0.663 0.663 0.479 0.450 0.157

Dilute 1.14 - 1.17 0 9 0.193 0.746 0.746 0. 422 0.434 0.203 Plum ( 46665505 .der) Concentrated 1.14 - 1.15 0 6 0.081 0.566 0.566 0.154 0.214 0.182

Dilute 1.14 - 1.15 0 6 0.103 0.344 0.344 0.198 0.211 0.105 Alfalfa (proposed use = 0.85 lb ai/A tot al application rate, 14 - day PHI) 6 Alfalfa Forage (475 84401.der) Trt #2 7 0.88 - 0.92 12 - 15 24 1.10 20.30 17.67 5.04 7.05 5.20 12 - 16 24 0.81 19.40 17.23 4.98 6.25 5.09 43 - 73 22 < 0.05 0.53 0.37 0.12 0.17 0.14 Trt #3 0.86 - 0.93 19 - 23 24 0.11 6.16 6.10 1.94 2.05 1.66 20 - 23 24 0.32 5.59 5.06 2.12 2. 29 1.62 49 - 76 22 <0.05 0.50 0.50 0.11 0.16 0.13 Trt #4 0.59 - 0.62 12 - 15 24 0.97 15.68 14.47 3.95 4.94 3.78 12 - 16 24 0.85 15.32 15.07 3.59 5.56 4.51 43 - 70 22 <0.05 0.38 0.32 0.08 0.12 0.09 Trt #5 0.57 - 0.62 19 - 23 24 0.05 5.44 5.38 1.21 1.75 1.58 20 - 23 24 0.29 3.64 3.46 2.12 2.03 1.07 49 - 76 22 <0.05 0.44 0.44 0.07 0.14 0.14 Alfalfa Hay (47584401.der) Trt #2 7 0.88 - 0.92 12 - 15 24 3.36 43.02 42.62 14.00 17.37 11.19 12 - 16 24 5.22 51.12 48.91 16.10 20.93 13.64 43 - 73 22 0.07 3.63 2. 38 0.37 0.62 0.78 (Trt #3 0.86 - 0.93 19 - 23 24 0.14 20.84 19.84 6.37 6.97 5.93 20 - 23 24 1.52 15.26 14.72 6.72 7.24 4.44 49 - 76 22 <0.05 1.36 1.17 0.24 0.49 0.45 Trt #4 0.59 - 0.62 12 - 15 24 3.11 33.78 31.34 10.80 15.30 9.21 12 - 16 24 4.48 40.06 3 9.33 16.89 18.23 11.40 43 - 70 22 <0.05 0.72 0.70 0.27 0.31 0.19 Trt #5 0.57 - 0.62 19 - 23 24 0.42 12.46 12.23 3.80 5.29 4.45 20 - 23 24 1.88 21.60 18.31 7.44 7.50 4.76 49 - 76 22 <0.05 1.12 1.10 0.25 0.45 0.40 1 For the alfalfa field trials, the thr ee separate harvest intervals are the PHIs for the 1 st , 2 nd and 3 rd cuttings. 2 The validated LOQ for boscalid is 0.05 ppm in plant commodities. For all calculations, the LOQ (0.05 ppm) was used for all values reported as <LOQ. 3 HAFT = Highest average fi eld trial result. 4 The citrus field trails were conducted using either concentrate or dilute spray volumes. 5 For stone fruits, the data are reported separately for the three MRIDs (47470201, 46665505, and 45405121). In MRID 45405121, applications to sto ne fruits we re made using either concentrate or dilute sp r ay volumes .Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 22 of 48 6 For the alfalfa field trials, T reatments #2 and #3 included three boscalid applications at ~0.3 lb ai/A/application with the first and second applications made prior to the 1st cutting and the final application made prior to the 2nd cutting. Treatments #4 and #5 included two applications at ~0.3 lb ai/A/application, with the first application made prior to the 1st cutting and the second application made prior to the 2nd cutting. 7 Treatment #2 represents the worse case use on alfalfa and reflects the proposed use pattern. As residues (bolded) from the 1 st and 2 nd cutting were similar in magnitude and both reflected the proposed 14 - day PHI, all values from these two cutting were used to access tolerances for forage and hay. 

### Citrus Fruits, Crop Group 10. BASF submitted field trial data for boscalid on citrus fruits. Twenty four field trials conducted in the US in Zones 3, 6, and 10 during the 2001 - 2002 growing season on oranges (13 tri als), grapefruit (6 trails), and lemons (5 trials). In each test, boscalid (70% WDG) was applied to citrus trees as four broadcast foliar applications during fruit development and maturation at rates of 0.294 - 0.320 lb ai/A/application and RTI s of 7 - 11 days, for total rates of 1.18 - 1.23 lb ai/A/season (1x proposed use rate). Applications were made with ground equipment using either concentrate spray volumes of 74 - 93 gal/A (12 trials) or dilute spray volumes of 149 - 362 gal/A (12 trials). All applications included the use of adjuvants (rates not reported). Single control and duplicate treated samples of citrus fruits were harvested at maturity on the day

of the final application (0 - day after treatment [ D AT ] , proposed PHI). Samples were stored frozen for up to 6.2 months prior to analysis, an interval supported by available storage stability data. Citrus fruit samples were analy zed for residues of boscalid using an L C/MS/MS method (BASF Method D9908), which was adequately validated in conjunction with the analysis of field trial s amples. The method limit of quantitation (L OQ) for boscalid is 0.05 ppm in citrus fruits . Following four concentrated spray applications of boscalid (WDG) at rates totaling 1.18 - 1.23 lb ai/A (1x rate) , boscalid residues at 0 DAT were 0.179 - 1.43 ppm in/on 12 orange samples, 0.115 - 0.847 ppm in/on 6 grapefruit samples, and 0.522 - 1.51 ppm in/on 6 lemon samples . Following four dilute spray applications of boscalid (WDG) at rates totaling 1.18 - 1.2 0 lb ai/A (1x rate) , boscalid residues at 0 DAT were 0.238 - 0.676 ppm in/on 14 orange samples, 0.064 - 0.272 ppm in/on 6 grapefruit samples, and 0.936 - 0.872 ppm in/on 4 lemon samples. No residue decline data were provided. Average boscalid residues for the concentrated sprays were 0.610 ppm for oranges, 0.365 ppm for grapefruit, and 0.822 ppm for lemons, and average boscalid residues for the dilute sprays were 0.418 ppm for oranges, 0.155 ppm for grapefruit, and 0.771 ppm for lemons. Based on the average residues, the concentrated sprays resulte d in higher residue levels on all three ty pes of citrus fruits, although the difference was marginal for lemons which had the highest residues of any of the citrus fruits. Compared to the dilute sprays, average residues from the concentrated sprays were 1 .45x higher for oranges, 2.35x higher for grapefruit and 1.07x higher in lemons . . Some of the oranges were separated into wet peel and pulp. Following four foliar applications of boscalid (WDG) to orange trees at rates totaling 1.19 - 1.22 lb ai/A, average boscalid residues at 0 DAT from each field trial were 0.206 - 1.39 ppm for whole orange fruit (RAC), 0.661 - 5.40 ppm for peel, and <0.05 - 0.151 ppm for wet pulp. As compared to the whole fruit, Boscalid residues were lower in orange pulp and higher in peel . When the residue data are pooled for both spray volume ty

pes, the average boscalid residues were 0.507 ppm for oranges, 0.260 ppm for grapefruit, and 0.802 ppm for lemons, and HAFTBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 23 of 48 residues were 1.39 ppm for oranges, 0.836 ppm for grapefruit, and 0.71 0 ppm for lemons. The pooled residue data for each commodity will be used to assess separate possible tolerances on oranges, lemons and grapefruits. Conclusion. The submitted field trial data are adequate and support the use of boscalid (WDG) on citrus fruits as either dilute or concentrated broadcast foliar applications during fruit development and maturation at rates of up to 0.29 lb ai/A. The highest residues which were found were 1.43 ppm in oranges, 0.85 ppm in grapefruit, and 1.51 ppm in lemons The data support a maximum of 4 applications per season and a maximum seasonal use rate of 1.16 lb ai/A, a minimum RTIof 10 days, and a minimum PHIof 0 days. Some of the oranges were separated into wet peel and pulp. As compared to the whole fruit, b oscalid residues were lower in orange pulp and higher in peel . Stone Fruits, Crop Group 12 . Adequate field trial data supporting the use of boscalid (WDG) on stone fruits were previously submitted (DP# 278385, M. Nelson, 8/15/2003; and DP# 323288, D. Soderberg, 6/14/2007). The se earlier studies supported the use of boscalid on stone fruits as up to 5 broadcast foliar applications during fruit development at rates of up to 0.23 lb ai/A, at a minimum RTIof 7 days, for a total of 1.15 lb ai/A/season. The label specified PHI for stone fruits is 0 days. The previously submitted residue data on stone fruits (T able 9 ) support the current 1.7 ppm tolerance on stone fruits. BASF has submitted additional field trial data for boscalid on stone fruits from ei ghteen field trials conducted in the U.S. and Canada during 2007 on representative stone fruit species, including 5 trials on sweet cherries in Zones 5 and 10; 2 trials on tart cherries in Zone 5; 6 trials on peaches in Zones 1, 2, 5, 6 and 10; and 5 trial s on plums in Zones 5 and 10. The end - use product, Pristine, EPA Reg. No. 7969 - 199, a water- dispersible granular (WDG) formulation containing 25.2% boscalid and 12.8% py raclostrobin, was applied to the stone fruits as five broadcast foliar applications during fruit development at a target rate of 0.23 lb ai/A and at retreatment intervals (RTI s) of 7 days between crop growth stages BBCH 75 and 89 (i.e., 28, 21, 14, 7, and 0 days before harvest), for a total rate of 1.15 lb ai/A/season. All applications were made using ground equipment in volumes of 20 - 150 gal/A (187 - 1403 L/ha) . N o adjuvants were used. Single control and duplicate treated samples of each ty pe of stone fruit were harvested from each test on the day

of the last application (0 DAT) and at 1 DAT. To evaluate residue decline, additional duplicate treated samples were harvested at 5 and 10 DAT from one test each on cherry, peach and plum . Samples were stored frozen (≤ - 5°C) for up to 8.6 months prior to analysis, an interval supported by avail able storage stability data. Stone fruit samples were analy zed for residues of boscalid using an adequate LC/MS/MS method (BASF Method D9908, V er . II). The method was validated for data collection based on acceptable concurrent method recoveries. The limit of quantitation (L OQ) is 0.05 ppm for boscalid in/on stone fruits , and the limit of detection (LOD) was not reported . Following five foliar applications of boscalid (WDG) at rates totaling 1.15 lb ai/A, boscalid residues at 0 DAT were <0.05 - 2.84 ppm in sweet cherries, 1.22 - 2.98 ppm in sour cherries,Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 24 of 48 0.56 - 3.79 ppm in peaches, and <0.05 - 0.79 ppm in plums harvested at 0 DAT. Residues at 1 DAT were <0.05 - 2.69 pp m in 14 samples of sweet cherries, 0.96 - 2.62 ppm in sour cherries, 0.46 - 3.87 ppm in 12 samples of peaches, and <0.05 - 0.57 ppm in 10 samples of plums. Average boscalid residues at 0 and 1 DAT were respectively 1.57 and 1.28 ppm in sweet cherries, 1.15 and 1.19 ppm in peaches, and 0.34 and 0.26 ppm in plums. The highest average field trial (HAFT) residues at 0 and 1 DAT were respectively 1.63 and 1.95 ppm for cherries, 1.94 and 2.74 ppm for peaches, and 0.67 and 0.71 ppm for plums . Data from the residue de cline tests indicate d that average boscalid residues in/on cherries, peaches, and plums decreased over time. Conclusion. The available stone fruit field trial data are adequate to supp ort a tolerance increase from 1.7 ppm to 3.5 ppm for the stone fruits crop group 12. The recommended tolerance is based on the tolerance spreadsheet using the pooled data from field trials for representative crops of cherries, peaches, and plum treated at 1x rate with the PHI of 0 day . When residue data from all the adequat e stone fruit field trials (1x rate with 0 - day PHI) are pooled by

crop, the data support The data support the use of boscalid (WDG) on stone fruits up to five broadcast foliar applications during fruit development at 0.23 lb ai/A/application, for a total application rate of 1.15 lb ai/A. The data support a minimum RTIof 7 days and a minimum PHIof 0 days. Alfalfa. BASF submitted field tri al data for boscalid from 12 alfalfa field trials conducted in the United States in Zones 1, 2, 5, 7, 9, 10, and 11 and Canada in Zones 5 and 5B during the 2007 growing season. Each test site included one control plot (Treatment #1) and four treated plots (Treatments #2 - 5) . The treated plots received 2 or 3 broadcast foliar applications o f boscalid during vegetative development using ground equipment at volumes of 20 - 34 gal/A . All applications included the use of adjuvants. The application rates and timing of applications were as follows: Treatment #2 received a total of 3 applications at the rate of 0.28

– 0.32 lbs ai/A/application or a total of 0.88 - 0.92 lb ai/A with retreatment intervals (RTI) of 12 - 15 and 28 - 53 days. Applications 1, 2, and 3 were made approximately 28 days before the 1 st 

### cutting , 14 days before the 1 st 

### cutting , and 14 days before the 2 nd 

### cutting . Treatment #3 received a total of 3 applications as in treatment #2 with RTI of 13 - 14 and 29 - 53 days. Applications 1, 2 and 3 were made approximately 35 days before the 1 st 

### cutting, 21 days before the 1 st 

### cutting, and 21 days before 2 nd 

### cutting. Treatment #4 received a total of 2 applications at the rate of 0.29 - 0.31 lbs ai/A/application or a total of 0.59

– 0.62 lb ai/A with RTIof 28 - 53 days. Applications were made 14 days before the 1 st 

### cutting and 14 days before the 2 nd 

### cutting. Treatment #5 received a total of 2 applications at the rate of 0.28 - 0.32 lbs ai/A/application or a total of 0.57

– 0.62 lb ai/A with RTIof 29 - 53 days. Applications were made 21 days before the 1 st 

### cutting and 21 days before the 2 nd 

### cutting.Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 25 of 48 With the exception of one test site, three cuttings of alfalfa were harvested from each plot according to ty

pical agricultural practices, with the 3 rd 

### cutting being made at normal maturity (beginning bloom stage). The exact treatment - to - harvest intervals for each cutting are presented below along with the residue levels in forage and hay . At each cutting, s ingle control and duplicate treated samples of alfalfa forage and hay were collected from each test , with hay samples being field - dried to a moisture content of ~10 - 2 0% prior to sampling. After sampling, forage and hay

samples were held in frozen (< - 5°C) storage for up to 13 months prior to extraction for analysis. This duration is supported by the available storage stability data. Samples of alfalfa forage and hay were analy zed for residues of boscalid using an L C/MS/MS method (BASF Method D9908), which was adequate ly validated for data collection based on acceptable concurrent method recoveries. The limit of quantitation (LOQ) was 0.05 ppm for boscalid in alfalfa forage and hay, and the reported limit of detection (LOD) was 0.004 ppm. For Treatment #2 (3 applications each at ~0.3 lb ai/A with an ~14 - day PHI), residues of boscalid in/on forage were 1.10 - 20.3 ppm at 12 - 15 days after the second application (1 st 

### cutting), 0.81 - 19.4 ppm at 12 - 16 days after the third application (2 nd 

### cutting), and <0.05 - 0.53 ppm at 43 - 73 days after the third application (3 rd 

### cutting). Residues of boscalid in/on hay were 3.36 - 43.02 ppm at 12 - 15 days after the second application (1 st 

### cutting), 5.22 - 51.12 ppm at 12 - 16 days after the third application (2 nd 

### cutting), and 0.07 - 3.63 ppm at 43 - 73 days after the third application (3 rd 

### cutting). For the 1 st 

### , 2 nd 

### , and 3 rd 

### cuttings, boscalid residues averaged, respectively, 7.05, 6.25 and 0.17 ppm in/on forage and 17.37, 20.93 and 0.62 ppm in/on hay . For Treatment # 3 (3 applications each at ~0.3 lb ai/A with an ~21 - day PHI), residues of boscalid in/on forage were 0.11 - 6.16 ppm at 19 - 23 days after the second application (1 st 

### cutting), 0.32 - 5.59 ppm at 20 - 23 days after the third application (2 nd 

### cutting), and <0.05 - 0.50 ppm at 49 - 76 days after the third application (3 rd 

### cutting). Residues of boscalid in/on hay were 0.14 - 20.84 ppm at 19 - 23 days after the second application (1 st 

### cutting), 1.52 - 15.26 pp m at 20 - 23 days after the third application (2 nd 

### cutting), and <0.05 - 1.36 ppm at 49 - 76 days after the third application (3 rd 

### cutting). For the 1 st 

### , 2 nd 

### , and 3 rd 

### cuttings, boscalid residues averaged, respectively, 2.05, 2.29 and 0.16 ppm in/on forage and 6.97, 7.24 and 0.49 ppm in/on hay . For Treatment #4 (2 applications each at ~0.3 lb ai/A with an ~14 - day PHI), residues of boscalid in/on forage were 0. 97 - 15.68 ppm at 12 - 15 days after the first application (1 st 

### cutting), 0. 85 - 15.32 ppm at 12 - 16 days aft er the second application (2 nd 

### cutting), and < 0.05 - 0. 38 ppm at 43 - 70 days after the second application (3 rd 

### cutting). Residues of boscalid in/on hay were 3.11 - 33.78 ppm at 1 2 - 15 days after the first application (1 st 

### cutting), 4.48 - 40.06 ppm at 12 - 16 days after the second application (2 nd 

### cutting), and < 0.05 - 0.72 ppm at 43 - 70 days after the second application (3 rd 

### cutting). For the 1 st 

### , 2 nd 

### , and 3 rd 

### cuttings, boscalid residues averaged , respectively, 4.94 , 5.56 and 0.1 2 ppm in/on forage and 15.30 , 18.23 an d 0. 31 ppm in/on hay . For Treatment # 5 (2 applications each at ~0.3 lb ai/A with an ~2 1 - day PHI), residues of boscalid in/on forage were < 0. 05 - 5.44 ppm at 1 9 - 23 days after the first application (1 st 

### cutting), 0. 29 - 3.64 ppm at 20 - 23 days after the second application (2 nd 

### cutting), and < 0.05 - 0. 44 ppm at 49 - 76 days after the second application (3 rd 

### cutting). Residues of boscalid in/on hay were 0.42 - 12.46 ppm at 1 9 - 23 days after the first application (1 st 

### cutting), 1.88 - 21.60 ppm at 20 - 23 days after the seco nd application (2 nd 

### cutting), and < 0.05 - 1.12 ppm at 46 - 76 days after the second application (3 rdBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 26 of 48 cutting). For the 1 st 

### , 2 nd 

### , and 3 rd 

### cuttings, boscalid residues averaged , respectively, 1.75 , 2.03 and 0.1 4 ppm in/on forage and 5.29 , 7.50 and 0.45 ppm in/on hay . Overall, boscalid residues were higher in/on forage and hay from the treatments using 3 applications rather than 2 applications, and the residues were higher in forage and hay from treatments having the ~14 - day PHIrather than the ~21 - day PHI . The worst - case treatment for residues was Treatment #2, and the highest residues were found in forage and hay from 1 st 

### and 2 nd 

### cuttings. For Treatment #2, average boscalid residues from the 1 st 

### and 2 nd 

### cuttings were 7.05 and 6.25 ppm for forage and 17.37 and 20.93 ppm for hay . Conclusion. The maximum residues of boscalid were found in the treatment (Treatment 2) after 2 or 3 foliar applications of boscalid at ~0.3 lb ai/A/application. The residues collected at 12 - 16 days DALA after the 1 st 

### and 2 nd 

### cutting were 20.30 and 19.40 ppm, respectively in/on forage and 43.02 and 51.12 ppm in/on hay . In general, boscalid residue decline occurred after the 3 rd 

### cutting of forage and hay . The submitted alfalfa field trial data are adequate and would support the use of two or three broadcast foliar applications of boscalid (25.2% , WDG formulation) to alfalfa at up to ~0.30 lb ai/A/application, with no more than two applications per cutting, for maximum seasonal use rates 0.6 or 0.9 lb ai/A. The data also support a minimum RTIof 14 days and minimum PHI s of either 14 or 21 days. However, the alfalfa field trial data will not support the proposed use rates of the 70% WDG as the proposed maximum single (0.48 lb ai/A) and seasonal (1.44 lb ai/A) application rates for the 70% WDG are approximately 1.6x higher than the rates used in the alfalfa field . 860.1520 Processed Food and Feed 47584402.der (citrus) 

### BASF submitted residue data from an orange processing study conducted in FL (Zone 3) during 2008 . A 70% water di spersible granule (WDG) formulation of boscalid was applied to Valencia orange trees during fruit maturation as two broadcast foliar applications at rates of 0.30 lb ai/A/application at a retreatment interval (RTI) of 10 days, for a total rate of 0.60 lb ai/A. Applications were made using airblast ground equipment in volumes of ~100 gal/A of water and included the use of Crossfire® adjuvant (0.5% v/v). Single control and treated bulk samples of oranges were harvested one day after the second application ( 1 DAT), and were processed within 4 days into dried pulp, juice, and oil using commercial processing procedures. The data collection LC /MS/MS method (BASF Method D9908 , Version II) used to analy ze boscalid residues in/on orange fruit and processed commo dities was adequately validated prior to and in conjunction with the analysis of processing samples. The limit of quantitation (LOQ) was 0.05 ppm in citrus fruits, and the limit of detection (LOD) was 0.01 ppm.Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 27 of 48 Following two broadcast foliar applications of boscalid (WDG) at rates totaling ~0.6 0 lb ai/A, boscalid residues averaged 0.22 ppm in/on whole fruit. The average boscalid residues in the process ed commodities were 0.694 ppm in dried pulp, <0.05 ppm in juice, and 13.1 ppm in oil. These data indicate that boscalid residues were reduced in juice by 0.23 x, but concentrated 3.2x in dried pulp and 59 x in oil. The theoretical processing factors for citrus are 2x for juice , 3.3x for dried pulp and 1000x for oil (OPPTS 860.1520, Table 3) . For the storage stability

study, whole orange fruit s , dried pulp and oil were stored at < - 5°C f or up to 3.6 months prior to analysis . The conditions and duration for sample storage are supported by a concurrent storage stability study in which control samples of each matrix were fortified with boscalid at 0.5 ppm and stored under the same conditions as the RAC and processing study samples. After 3.6 months of frozen storage, the corrected recoveries of boscalid were 109 - 126% from all four citrus matrices.
Table 1 0 . Re sidue Data fromOrange Processing Study with Boscalid (WDG) RAC Processed

Commodity Total Rate

(lb ai/A) PHI

(days) Residues (ppm) 1 Processing Factor3 Orange Fruit (RAC) 0.602 1 0.2210, 0.2209 (0.2210) --

Dried Pulp 0.5884, 0.8002 (0.694) 2 2.7x, 3.6x (3.2x) Juice <0.05, <0.05 (<0.05) <0.23x, <0.23x (<0.23x) Oil 13.6 , 12.49 (13.05) 2 6.1x 5.7x (59x) 1 The LOQ is 0.05 ppm for all commodities. 2 Residues are average of 3 replicates each. Mean of multiple analyses are in parenthesis . 2 The processing factor was calculated by dividing the residue in the processed commodity by the residue in the associated RAC sample. The LOQ was used to calculate the processing factor for the value below the LOQ. Mean processing factors are in parenthesis.. 

### Conclusions . The orange processing study is adequate. As boscalid residues were reduced in juice (<0.2x), a separate tolerance is not required for citrus juice. However, separate tolerances are required for citrus dried pulp and oil. Bas ed on the processing factors for dried pulp (3.1x) and oil (59x) and the HAFT residues (see Table 9 ) for citrus fruits (orange

– 1.39 ppm), the maximum expected boscalid residues would be 4.31 ppm in dried pulp and 82 ppm in oil. These data support tolerances of 4.5 ppm for dried citrus pulp and 85 ppm for citrus oil. 860.1650 Submittal of Analytical Reference Standards Analy tical reference standards for boscalid and its hydroxy metabolite (with an expiration date s of 4/1/2014) are currently available in the EPA National Pesticide Standards Repository (personal communication with Dallas Wright; ACB/BEAD; 7/22/09). 860.1850 Confined Accumulation in Rotational Crops PP#1F6313; DP# 278385, M. Nelson, 8/15/03Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 28 of 48 HED MARC Decision Memo; DP# 286786; M. Nelson; 1/09/2003 

### The nature of the residue in rotational crops is adequately understood and was summarized in a previous residue chemistry summary document. The MARC has concluded that the residue of concern in rotated crops for purposes of risk assessment and the tolerance expression is parent compound . 860.1900 Field Accumulation in Rotational Crops PP#1F6313; DP# 278385, M. Nelson, 8/15/20 03 DP# 322235, D. Dotson, 11/03/2005 DP# 323288, D. Soderberg, 6/14/20 07 

### A dequate limited and extensive field rotational crop studies are available supporting the existing tolerances for indirect residues in rotational crops. Th ese data support the label - specific plant back interval of 14 days for crops without boscalid uses. No additional rotati onal crop data are required for purposes of this petition. 860.1550 Proposed Tolerances For purposes of both the tolerance expression and dietary risk assessment, HED has concluded that the residues of concern in plant commodities include only boscalid, and the residues of concern in livestock commodities include boscalid , its 5 - hydroxy metabolite, and the glucuronide conjugate of the 5 - hydroxy metabolite. Permanent tolerances are established for residues of boscalid in/on various plant commodities at l evels ranging from 0.05 to 60 ppm [40 CFR §180.589(a)(1)] . S eparate tolerances are also established for indirect or inadvertent residues of boscalid in rotational crops at levels ranging from 0.05 to 8.0 ppm [40 CFR §180.589(d)]. Tolerances are also esta blished for the combined residues of boscalid, its 5 - hydroxy metabolite and the glucuronic acid conjugate of the 5 - hydroxy metabolite, at levels ranging from 0.02 ppm to 0.35 ppm [40 CFR §180.589(a)(2)]. The proposed and recommended tolerances for boscali d are presented in Table 11. An adequate number of field trials conducted at ~1x the existing or proposed use rate s are available on alfalfa, citrus fruits (orange, lemon, grapefruit) and stone fruits (cherry, peach and plum) to support permanent toleranc es. The Agency ’s SOP “ Guidelines for Setting Pesticide Tolerances Based on Field Trial Data” w as utilized for determining the appropriate tolerance level for each commodity (Appendix II). For alfalfa forage and hay, residue data from both the 1 st 

### and 2 nd 

### cuttings of Treatment #2 (1x rate) were used to assess tolerances as both cuttings were collected around the proposed 14 - day PHI , and residue levels were similar for the two cuttings. The recommended tolerances for alfalfa forage and hay are 30 and 65 pp m, respectively . For the citrus fruits, the residue data were pooled by crop, and separate possible tolerance s were calculated for oranges (1. 6 ppm), lemons (1. 6 ppm), and grapefruits ( 1.1 ppm) using the tolerance spreadsheet. As the minimum and maximum recommended tolerances differ by less than 5x, a crop group tolerance is appropriate for citrus, and the recommended tolerance is 1.6 ppm.Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 29 of 48 For stone fruits, all the adequate residue data were pooled by crop (including previously reviewed studies), and sep arate possible tolerances were calculated for cherry (3.5 ppm), peach (3.0 ppm) and plum (1.6 ppm) using the tolerance spreadsheet . As the minimum and maximum recommended tolerances differ by less than 5x, a crop group tolerance is appropriate for stone f ruits, and the recommended tolerance is 3.5 ppm . As boscalid residues were reduced in orange juice (<0.2x), a separate tolerance is not required for citrus juice. However, boscalid residues were shown to concentrate in dried pulp (3.1x) and oil (59x). B ased on these processing factors and the HAFT residues for citrus fruits (1.39 ppm), the maximum expected boscalid residues would be 4.31 ppm in dried pulp and 82 ppm in oil. These data support tolerances of 4.5 ppm for dried citrus pulp and 85 ppm for citrus oil. For assessing the existing tolerances on livestock commodities, adequate cattle and poultry feeding studies are available that cover the potential levels of dietary exposure of livestock to boscalid residues. The 35.8 ppm dose group (1x dietary burden) from the cattle feeding study was used to assess the current tolerances on milk (0.10 ppm) and on the fat (0.30 ppm), meat (0.10 ppm) and meat by

products (0.35 ppm) of cattle, goats, horses, and sheep. For this dose group, the maximum combined re sidues of boscalid and M510F01 (free and conjugated) were <0.03 ppm in milk, <0.08 ppm in cream, ≤0.11 ppm in liver and kidneys, <0.05 ppm in muscle and <0.24 ppm in fat. These data indicate that the existing tolerances for milk and fat, meat and meat by products of cattle, goats, horses and sheep are more than adequate. Separate tolerances for liver and kidney

are not required. For hogs, the adequacy

of the existing tolerance s were assessed using residue data from the 5.9 ppm dose group (1.1x dietary burden for swine) in the cattle feeding studies . Maximum combined residues for this dose group were <0.064 ppm in liver, <0.090 ppm in kidney, <0.05 ppm in muscle, and <0.12 ppm in fat. These data indicate that the existing tolerances for meat (0.05 ppm) and meat by

products (0.10 ppm) of hogs are adequate; ho wever, the tolerance for hog fat should be increased to 0.20 ppm. Separate tolerances of hog liver and kidney are not necessary . For poultry, the adequacy of the existing tolerance s were assessed using residue data from the 5.31 ppm dose group in the poultry feeding studies; this group represents 1.3x the calculated dietary burden for poultry . Maximum combined residues for this dose group were <0.02 ppm in eggs, <0.175 ppm in liver, <0.05 ppm in muscle, and <0.124 ppm in fat. These data indicate that the existing tolerance s for eggs (0.02 ppm) and poultry meat (0.05 ppm) are adequate; however, the tolerances for poultry fat and meat by

products should each be increased to 0.20 ppm. A separate tolerance for liver is not necessary . The Codex Alimentarius Commission , Canada and Mexico have not established any maximum residue limits (MRL s) for residues of boscalid in/on alfalfa forage and hay or citrus fruits (Appendix I). However, there is an existing Codex MRL for stone fruits at 3 mg/kg, and Canada has e stablished MRL s at 1.7 mg/kg for the various member of the stone fruits crop group. Canada also has also establish ed MRL s for various livestock commodities. The Canadian MRL s for stone fruits and livestock commodities are currently harmonized with the re spective US tolerances; however, once the recommended increases are made to US tolerances , the USBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 30 of 48 tolerances on stone fruits, poultry fat and meat by

products and hog fat will no longer be harmonized with the Canadian MRL s. Table 1 1 . Tolerance Sum ma ry fo r Boscalid . Commodity Proposed Tolerance (ppm Existing

Tolerance (ppm) Recommended

Tolerance (ppm) Comments; Correct Commodity

Definition 40 CFR 180.589(a)(1) Alfalfa, f orage 35 -- 30 Adequate alfalfa forage and hay residue data are available. Alfalfa , h ay 85 -- 65 Citrus, dried pulp None -- 4.5 An adequate orange processing study is available indicating that boscalid residues can concentrate in dried pulp (3.1x) and oil (59x) Citrus, oil None -- 85 Fruit, citrus, group 10 2.0 -- 1. 6 Adequate orange, grapefruit, and lemon residue data are available. Fruit, stone, group 12 5.0 1.7 3.5 An increase in the established tolerance is required based on adequate cherry, peach and plum residue data. 40 CFR 180.589(a)( 2 ) Cattle, fat 1.5 0.30 0.30 Based on the residue data from the 35.8 ppm dose group in the cattle feeding studies and the calculated dietary burden for dairy cattle (35.2 ppm), the existing tolerances are adequate. Separate tolerances for liver and kidney are not necessary. Cattle, kidney 1. 0 -- None Cattle, liver 1.0 -- None Cattle, meat 0.2 0.10 0.10 Cattle, meat byproducts 1.5 0.35 0.35 Egg 0.02 0.02 0.02 The existing tolerance on eggs is adequate. Goat, fat 1.5 0.3 0 0.30 See Cattle above . Goat, kidney 1.0 -- None Goat, liver 1 .0 -- None Goat, meat 0.2 0.1 0 0.10 Goat, meat byproducts 1.5 0.35 0.35 Hog, fat 0.2 0.1 0 0. 20 Based on the residue data from the 5.9 ppm dose group in the cattle feeding studies and the calculated dietary burden for swine (5.30 ppm), the existing to lerances on hog meat and meat byproducts are adequate. However, the tolerance for hog fat should be increased to 0.20 ppm. Hog, meat 0.05 0.05 0.05 Hog, meat byproducts 0.2 0.1 0 0.10 Hog, kidney 0.2 -- None Hog, liver 0.2 -- None Horse, fat 1.5 0 .3 0 0.30 See Cattle above . Horse, kidney 1.0 -- None Horse, liver 1.0 -- None Horse, meat 0.2 0.1 0 0.10 Horse, meat byproducts 1.5 0.35 0.35 Milk 0.2 0.1 0 0.10 The existing tolerance for milk willBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 31 of 48 Table 1 1 . Tolerance Sum ma ry fo r Boscalid . Commodity Proposed Tolerance (ppm Existing

Tolerance (ppm) Recommended

Tolerance (ppm) Comments; Correct Commodity

Definition Milk , fat (cream) 1.5 -- None adequately cover residues in both whole milk and m ilk fat Poultry, liver 0.2 -- None Based on the residue data from the 5.31 ppm dose group in the poultry feeding study and the calculated dietary burden for poultry (4.10 ppm), the existing tolerance for meat is adequate and the tolerances of fat and meat byproducts should be increased to 0.20 ppm. A separate tolerance for liver is not necessary. Poultry, fat 0.2 0.05 0.20 Poultry, meat 0.05 0.05 0.05 Poultry, meat byproducts 0.2 0.1 0 0.20 Sheep, fat 1.5 0.3 0 0.30 Se e Cattle above . Sheep, kidney 1.0 -- None Sheep, liver 1.0 -- None Sheep, meat 0.2 0.1 0 0.10 Sheep, meat byproducts 1.5 0.35 0.35 

### References DP Numbers : 278385, 282532, 286787, 287829 Subject: PP#1F06313. BAS 510 F (Common Name: Boscalid), New Fungicide Active

Ingredient. Residue Chemistry Summary

Document. From: M. Nelson To: M. Rodriquez/C. Giles - Parker Dated: 08/15/20 03 MRIDs: 45405021 - 45405028, 45405101 - 45405128, 45405202 - 45405204, 45623401 -

45623413, and 45643801 DP Number : 322235 Subject: PP#s 1F6313, 3E6791, 4F6875, and 5E6933: Boscalid, Registrant’s Response to

Deficiencies Cited in Tolerance Petition 1F6313. Summary of Analy tical Chemistry

and Residue Data for Rotational Root Crops, Direct Uses on Celery, Spinach, Bananas, Strawberries, Almonds, and Potatoes, and Seed Treatment Uses on Bulb Vegetables, Brassica Leafy Vegetables, Legume Vegetables, Peanuts, and Sunflowers. From: D. Dotson To: J. Bazuin/T. Kish Dated: 11/3/20 05 MRIDs: 46145101 , 46145102, 46160103, 46210606, and 46351401 - 46351405Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 32 of 48 DP Number : 323288 Subject: Boscalid. Petition for a Tolerance for Belgian Endive; Petition for Increased

Tolerances on Strawberry and the Berries Crop Group; Submission of Reques ted Field Trial Data on Cucumber, Mustard Greens and Sunflower; and Supplemental Field Trial Data on Fruiting Vegetables, Radishes, Spearmint, Peppermint, Grapes, and Stone Fruits; and Submission of Field Trials and a Processing Study for Cotton. Summary of Analy tical Chemistry

and Residue Data . From: D. Soderberg To: C. Swartz Dated: 6/04/20 07 MRIDs: 46512002, 46512003, 46637701, 46665501, 46665502, 46665503, 46665504,

46665505, 46665506, 46713801, 46685902, 46685901 Attachments: Appendix I - International Residue Limits Appendix II - Tolerance Assessment Calculations Template Version April 2008Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 33 of 48 Appendix I
– International Residue Limits 

# INTERNATIONAL RESIDUE LIMIT STATUS Chemical Name: 3 - pyridinecarboxamide, 2 - chloro N - (4' - chloro[1,1' - biphenyl] - 2 - yl Common Name: Boscalid X Proposed tolerances X Reevaluated tolerance  Other Date: 8/05/09 

# Codex Status (Maximum Residue Limits) 

# U. S. Tolerances □ No Codex proposal step 6 or above □ No Codex proposal step 6 or above for the crops requested Petition Numbers: PP#9F7527 and PP#9F9529 DP#: 364447 Other Identifier: Residue definition (step 8/CXL): Boscalid Reviewer/Branch: P. Deschamp/RAB3 Residue definition: boscalid for plant commodities; and combined residues of bosc alid and M510F01 (free and conjugates) for animal commodities Crops/Commodities MRL (mg/kg) Crops/Commodities Recommended Tolerance (ppm) Alfalfa, forage 35 Alfalfa, hay 85 Fruit, citrus, group 10 2.0 Stone fruits 3.0 Fruit, stone, group 12 5 .0 Egg 0.02 Egg 0.02 Fat of cattle, goat, horse and sheep 0.30 Meat (mammalian other than marine) 0.7 Meat of cattle, goat, horse and sheep 0.20 Edible offal, mammalian 0.2 Meat byproducts (cattle, goat, horse and sheep) 1.5 Milks 0.1 Milk 0.20 Hog, Fat 0.20 Hog, kidney 0.2 Hog, meat byproducts 0.20 Hog, liver 0.20 Poultry fat/meat 0.02 Poultry, fat 0.20 Poultry, liver 0.20 Poultry, edible offal 0.02 Poultry, meat byproducts 0.20Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 34 of 48 

# INTERNATIONAL RESIDUE LIMIT STATUS Chemical Name: 3 - pyridinecarboxamide, 2 - chloro N - (4' - chloro[1,1' - biphenyl] - 2 - yl Common Name: Boscalid X Proposed tolerances X Reevaluated tolerance  Other Date: 8/05/09 

### Limits for Canada Limits for Mexico □ No Limits □ No Limits for the crops requested X No Limits □ No Limits for the crops requested Residue definition: boscalid for plant commodities; and combined residues of boscalid and M510F01 (free and conjugates) for animal commodities Residue definition: NA. Mexico defers to US tolerances or Codex MRLs for its export purposes. Crops/Commodities MRL (mg/kg) Crops/Commodities MRL (ppm) apricot, plumcot, plum, peach, sweet cherry, and tart cherry 1.7 Eggs 0.02 Fat of cattle, goats, hogs, hors es, and sheep 0.3 Fat of poultry 0.05 Meat of cattle, goats, hogs, horses, and sheep 0.1 Meat of poultry 0.05 Meat byproducts of cattle, goats, hogs, horses, and sheep 0.35 Meat byproducts of poultry 0.1 Milk 0.1 Notes/Special In structions: S.Funk, 10/14/2009.Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 35 of 48 Appendix II. Tolerance Assessment Calculations. For each of the crops listed below, the Guidance for Setting Pesticide Tolerances Based on Field Trial Data (SOP), along with the tolerance spreadsheet, was used for calculating recommended tolerances. As specified in the SOP, the minimum of the 95% upper confidence limit (UCL) on the 95 th 

### percentile and the point estimate of the 99 th 

### percentile was selected as the tolerance value in cases when the dataset was large (greater than 15 samples) and reasonably lognormal. For datasets that were small (≤15 samples) and reasonably lognormal, the upper bound estimate of the 95th percentile based on the median residue value was compared to the minimum of the 95% UCLon the 95th percentile and the point estimate of the 99th percentile, and the minimum value was selected as the tolerance value. For datasets that were not lognormal, the upper bound on the 89 th 

### percentile was selected as the tolerance value (distribution - free method). The rounding procedures specified in the SOP were also used. Citrus, Crop Group 10 The dataset used to assess a tolerance for boscalid residues in/on citrus fruit consisted of field trial data for the representative crops of orange, grapefruit, and lem on, and represented application rates of 1.18 - 1.23 lb ai/A ( 4 applications at ~0.29 - 0.32 lb ai/A/application) with a PHIof 0 day . As specified by the SOP, the field trial application rates and PHI s are within 25% of the maximum label application rate and minimum label PHI , respectively . The residue values used to calculate the tolerance are provided in Table II - 1. All field trial sample results for orange, grapefruit, and lemon were above the LOQ (0.05 ppm). The datasets for orange was large (26 samples) and the datasets for grapefruits and lemons were relatively small (10 - 12 samples). The dataset for each crop was entered into the tolerance spreadsheet. Visual inspection of the lognormal probability plots for each crop (Figures II - 1, II 3, and II - 5) indicates that the datasets for all three crops are reasonably lognormal. The results from the approximate Shapiro - Francia test statistic (Figures II - 2, II - 4, and II - 6) confirmed that the assumption of lognormality should not be rejected. Using the tolerance spreadsheet, the recommended tolerances are 1.6 ppm for orange and lemon , and 1.1 ppm for grapefruit. Because the minimum and maximum recommended tolerances differ by less than 5x, a crop group tolerance is appropriate for citrus. The recommended value is 1. 6 ppm, the maximum of the recommended individual tolerances.Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 36 of 48 Table II - 1. Boscalid Residues in/on Citrus Fruits following Four Foliar Applications of Boscalid

(WDG) at Rates Totaling ~1.20 lb ai/A/season. Regulator: EPA EPA EPA Chemical: Bo scalid Boscalid Boscalid Crop: Orange Grapefruit Lemon PHI: 0 day 0 day 0 day App. Rate: 4 at 0.29 - 0.31 lb ai/A 4 at 0.30 - 0.31 lb ai/A 4 at 0.29 - 0.32 lb ai/A Submitter: BASF BASF BASF MRID Citation: MRID 45903601 MRID 45903601 MRID 45903601 Residue s Residues Residues 0.179 0.064 0.522 0.233 0.097 0.590 0.237 0.102 0.664 0.238 0.115 0.677 0.241 0.120 0.742 0.260 0.135 0.807 0.271 0.147 0.936 0.300 0.151 0.968 0.306 0.249 1.510 0.316 0.272 0.326 0.824 0.332 0.847 0.352 0.354 0.469 0.471 0.499 0.544 0.561 0.644 0.676 0.676 0.714 1.190 1.360 1.425Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 37 of 48 Figure II - 1. Lognormal Probability Plot of Boscalid Residues in/on Oranges Following Four

Foliar Applications Totaling ~1.2 0 lb ai/A. Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 2.0000

1.0000

0.5000

0.2500

0.1250 y = 0.5647x - 0.8496 R 2 = 0.937

PercentilesConcentrations EPA Boscalid Orange 0 day 4 at 0.29-0.31 lb ai/A BASF MRID 45903601



### Figure II - 2. Data Summary Sheet for Residues of Boscalid in/on Oranges Following Four Foliar

Applications Totaling ~1.20 lb ai/A. Regu lator : EP A Che mical : Bo scal id Crop : Orang e PHI : 0 day App. Rate :

4 at 0.2 9-0.3 1 lb ai/A Subm itter : BASF MRID Cit ation : MRI D 459 0360 1

n: 26 min : 0.18 max : 1.43 me dian ; 0.35 av erage : 0.51 95th Perc enti le 99t h Pe rcent ile 99 .9th Perc enti le 1.1 1. 4 1.6 (1.3 ) (1 .6) (- -) 1.1 1. 6 2.5 (1.6 ) (3 .0) (- -) 1. 4 1. 6 UP LMe dian9 5th 2. 5 0.937 0 p- value > 0 .05 : Do not rejec t lo gnorm alit y as sumpt ion EU Me thod I Norma l EU Me thod I Lo g Nor mal

Appro xima te Sha piro -Fra ncia Norm ality Tes t EU Metho d II Dist ribu tion -Free Cali forn ia M ethod μ + 3 σBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 38 of 48 Figure II - 3. Lognormal Probability Plot of Boscalid Residues in/on Grapefruit Following Four

Foliar Applications Totaling ~1.20 lb ai/A. Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000

0.5000

0.2500

0.1250

0.0625 y = 0.7979x - 1.7092 R 2 = 0.8631

PercentilesConcentrations EPA Boscalid Grapefruit 0 day 4 at 0.30-0.31 lb ai/A BASF MRID 45903601



### Figure II - 4. Data Summary Sheet for Residues of Boscalid in/on Grapefruit Following Four

Foliar Applications Totaling ~1.20 lb ai/A. Regu lator : EP A Che mical : Bo scal id Crop : Gr ape fruit PHI : 0 day App. Rate :

4 at 0.3 0-0.3 1 lb ai/A Subm itter : BASF MRID Cit ation : MRI D 459 0360 1

n: 12 min : 0.06 max : 0.85 me dian ; 0.14 av erage : 0.26 95th Perc enti le 99t h Pe rcent ile 99 .9th Perc enti le 0. 80 1. 0 1.2 (1.1 ) (1 .3) (- -) 0. 70 1. 3 2.5 (1.7 ) (4 .0) (- -) 0.60 1. 1 UPLMe dian9 5th 1. 1 0.863 1 p- value > 0 .05 : Do not rejec t lo gnorm alit y as sumpt ion EU Me thod I Norma l EU Me thod I Lo g Nor mal

Appro xima te Sha piro -Fra ncia Norm ality Tes t EU Metho d II Dist ribu tion -Free Cali forn ia M ethod μ + 3 σBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 39 of 48 Figure II - 5. Lognormal Probability Plot of Boscalid Residues in/on Lemon Following Four

Foliar Applications Totaling ~1.20 lb ai/A. Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 2.0000

1.0000

0.5000 y = 0.316x - 0.2687 R 2 = 0.9132

PercentilesConcentrations EPA Boscalid Lemon 0 day 4 at 0.29-0.32 lb ai/A BASF MRID 45903601



### Figure II - 6. Data Summary Sheet for Residues of Boscalid in/on Lemon Following Four Foliar

Applications Totaling ~1.20 lb ai/A. Regulator: EPA Chemical: Boscalid Crop: Lemon PHI: 0 day App. Rate:

4 at 0.29-0.32 lb ai/A Submitter: BASF MRID Citation: MRID 45903601

n: 10 min: 0.52 max: 1.51 median; 0.71 average: 0.80 95th Percentile 99th Percentile 99.9th Percentile 1.3 1.5 1.7 (1.7) (2.0) (--) 1.3 1.6 2.0 (1.9) (3.0) (--) 1.9 1.7 UPLMedian95th 6.0 0.9132 p-value > 0.05 : Do not reject lognormality assumption EU Method I Normal EU Method I Log Normal

Approximate Shapiro-Francia Normality Test EU Method II Distribution-Free California Method μ + 3 σ



### Stone Fruits, Crop Group 12Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 40 of 48 The dataset s used to assess a tolerance for bosc alid residues on stone fruit s consisted of field trial data for the representative crops of cherries, peaches and plums, and represented application rates of 1.15 lb ai/A (5 applications at ~0.230 lb ai/A/application) with a PHIof 0 day . As specified by the SOP, the field trial application rates and PHI s are within 25% of the maximum label application rate and minimum label PHI , respectively . The residue values used to calculate the tolerance are provided in Table II - 2. HED notes that the data set includ es values from all adequate cherry, peach and plum field trials, including the previously reviewed stone fruit data. (DP # 278385, M. Nelson, 8/15/03 ; and DP# 323288, D. Soderberg, 6/14/2007 ). With the exception of on cherry sample and two plum samples, the field trial sample results were above the LOQ (0.05 ppm). The datasets for cherries, peaches, and plums were each relatively large ( 28 - 38 samples). The dataset for each crop was entered into the tolerance spreadsheet. Visual inspection of the lognormal probability plots for each crop (Figures II - 7, II - 9, and II - 11) indicates that the datasets for cherry and peach are not lognormal; whereas, the dataset for plum is reasonably

lognormal. The results from the approximate Shapiro - Francia test statistic (Figures II - 8, II - 10, and II - 12) confirmed that the assumption s of lognormality . Using the tolerance spreadsheet, the recommended tolerances are 3.5 ppm for cherry, 3.0 ppm for peaches, and 1. 6 ppm for plums. Because the minimum and maximum recommended tolerances differ by less than 5x, a crop group tolerance is appropriate for stone fruits. The recommended value is 3.5 ppm, the maximum of the recommended individual tolerances.Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 41 of 48 Table II - 2. Boscalid Residues in/on Stone Fruits following Five Foli ar Applications of Boscalid

(WDG) at Rates Totaling ~1.15 lb ai/A/season. Regulator: EPA EPA EPA Chemical: Boscalid Boscalid Boscalid Crop: Cherry Peach Plum PHI: 0 day 0 day 0 day App. Rate: 5 at 0.23 lb ai/A 5 at 0.23 lb ai/A 5 at 0.23 lb ai/A Submitter: BASF BASF BASF MRID Citation: MRID s 45405121,

46665505, 47470201 MRID s 45405121, 46665505, 47470201 MRID s 45405121, 46665505, 47470201 Residues Residues Residues 0.050 1.360 0.157 0.590 0.050 0.245 0.060 1.415 0.193 0.636 0.050 0.246 0.641 1.460 0.194 0.640 0.081 0.315 0.736 1.470 0.315 0.663 0.088 0.344 0.756 1.500 0.315 0.700 0.090 0.455 0.906 1.505 0.334 0.723 0.100 0.461 1.004 1.580 0.395 0.730 0.103 0.537 1.030 1.635 0.400 0.730 0.109 0.549 1.092 1.700 0.422 0.746 0.130 0.55 3 1.211 1.760 0.472 0.751 0.130 0.566 1.220 2.300 0.476 0.780 0.135 0.590 1.270 2.530 0.479 0.800 0.149 0.620 1.280 2.840 0.486 0.819 0.150 0.740 1.307 2.980 0.492 0.900 0.172 0.790 0.512 0.920 0.240 0.851 0.514 1.170 0.518 1.200 0.560 2.820 0.580 3.790 1 Residue values <LOQ are listed in bold .Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 42 of 48 Figure II - 7. Lognormal Probability Plot of Boscalid Residues in/on Cherries (Sweet and Tart)

Following Five Foliar Applications Totaling ~1.15 lb ai/A. Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 3.0000 1.5000 0.7500 0.3750 0.1875 0.0938 0.0469 y = 0.7749x + 0.0893 R 2 = 0.6638

PercentilesConcentrations EPA Boscalid Cherry 0 day 5 at 0.23 lb ai/A BASF MRID 45405121, 46665505, 47470201



### Figure II - 8. Data Summary Sheet for Residues of Boscalid in/on Cherries (Sweet and Tart)

Following Five Foliar Applications Totaling ~1.15 lb ai/A. Regu lator : EP A Che mical : Bo scal id Crop : Cherr y PHI : 0 day App. Rate : 5 at 0.2 3 lb ai/A Subm itter : BASF MRID Cit ation : MRI D 454 0512 1, 46 6655 05, 47470 201

n: 28 min : 0.05 max : 2.98 me dian ; 1.33 av erage : 1.38 95th Perc enti le 99t h Pe rcent ile 99 .9th Perc enti le 3.0 3. 0 4.0 (3.0 ) (4 .0) (- -) 5.0 10 19 (9.0 ) (20) (- -) 3. 5 3. 5 UP LMe dian9 5th 8. 0 0.663 8 p- val ue <= 0.0 1: Re ject logn orma lity assu mpti on EU Me thod I Norma l EU Me thod I Lo g Nor mal

Appro xima te Sha piro -Fra ncia Norm ality Tes t EU Metho d II Dist ribu tion -Free Cali forn ia M ethod μ + 3 σBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 43 of 48 Figure II - 9. Lognormal Probability Plot of Boscalid Residues in/on Peaches Following Five

Foliar Applications Totaling ~1.1 5 lb ai/A. Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 4.0000

2.0000

1.0000

0.5000

0.2500

0.1250 y = 0.5998x - 0.5239 R 2 = 0.916

PercentilesConcentrations EPA Boscalid Peach 0 day 5 at 0.23 lb ai/A BASF MRID 45405121, 46665505, 47470201



### Figure II - 10. Data Summary Sheet for Residues of Boscalid in/on Peaches Following Five Foliar

Applications Totaling ~1.15 lb ai/A. Re gu la to r: EP A Ch em ic al : Bo sca li d Cr op : Pe ac h PH I: 0 da y Ap p. R ate: 5 a t 0. 23 l b ai /A Su bmit te r: BAS F MR ID Ci ta ti on : MR ID 4 54 05 12 1, 46 66 55 05 , 47 47 020 1

n: 38 mi n: 0.1 6 max: 3.7 9 me di an ; 0.5 9 aver age: 0.7 3 95 th Per ce nt il e 99 th P er ce nt il e 99 .9 th P er ce nt il e 1. 9 2. 5 3. 0 (2 .5 ) (3 .0 ) (- -) 1. 7 2. 5 4. 0 (2 .5 ) (4 .0 ) (- -) 1. 6 3. 0 UPLM ed ia n9 5t h 3. 5 0. 91 60 0. 05 >= p -v al ue > 0 .01 : R ej ec t lo gno rm al it y as su mp tio n EU Me th odI No rm al EU Me th odI Lo g No rm al

App ro xi ma te Sh api ro -F ra nc ia No rm al it y Tes t EU M et ho d II Di st ri bu ti on -F re e Ca li fo rn ia M et ho d μ + 3 σBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 44 of 48 Figure II - 11. Lognormal Probability Plot of Boscalid Residues in/on Plums Following Five Foliar

Application s Totaling ~1.15 lb ai/A. Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000

0.5000

0.2500

0.1250

0.0625

0.0313 y = 0.8637x - 1.4629 R 2 = 0.9486

PercentilesConcentrations EPA Boscalid Plum 0 day 5 at 0.23 lb ai/A BASF MRID 45405121, 46665505, 47470201



### Figure II - 12. Data Summary Sheet for Residues of Boscalid in/on Plums Following Five Foliar

Applications Totaling ~1.15 lb ai/A. Regu lator : EP A Che mical : Bo scal id Crop : Pl um PHI : 0 day App. Rate : 5 at 0.2 3 lb ai/A Subm itter : BASF MRID Cit ation : MRI D 454 0512 1, 46 6655 05, 47470 201

n: 30 min : 0.05 max : 0.85 me dian ; 0.24 av erage : 0.32 95th Perc enti le 99t h Pe rcent ile 99 .9th Perc enti le 0. 80 0.90 1.1 (0 .90) (1 .1) (- -) 1.0 1. 8 3.5 (1.6 ) (3 .5) (- -) 1. 1 1. 1 UP LMe dian9 5th 1. 4 0.948 6 p- value > 0 .05 : Do not rejec t lo gnorm alit y as sumpt ion EU Me thod I Norma l EU Me thod I Lo g Nor mal

Appro xima te Sha piro -Fra ncia Norm ality Tes t EU Metho d II Dist ribu tion -Free Cali forn ia M ethod μ + 3 σ



### Alfalfa Forage and HayBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 45 of 48 The dataset used to establish tolerances for boscalid on alfalfa forag e and hay consisted of field trial data representing the three applications of boscalid (WDG) at rates of 0.28 - 0.32 lb ai/A (~0.85 lb ai/A/season) and a 14 - day PHI . The residues from the 1 st 

### and 2 nd 

### cuttings of Treatment #2 had similar levels of resi due s; therefore, values from both cuttings were used in the tolerance calculations. As specified by the SOP, the field trial application rates and PHI s are within 25% of the maximum label application rate and minimum label PHI , respectively . The residue value s used to calculate the tolerance are provided in Table II - 3. The forage and hay

datasets (48 samples each) were entered into the tolerance spreadsheet. Visual inspection of the lognormal probability plots (Figures II - 13 and II - 15) provided in the spre adsheet indicate that the datasets are reasonably lognormal. The result from the approximate Shapiro - Francia test statistic (Figures II - 14 and II - 16) confirmed that the assumption of lognormality

should not be rejected. Using the tolerance spreadsheet, the recommended tolerances are 30 ppm for alfalfa forage and 65 ppm for alfalfa hay .Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 46 of 48 Table II - 3. Boscalid Residues in/on Alfalfa Forage and Hay following Three Foliar Applications of

Boscalid (WDG) at Rates Totaling ~0.85 lb ai/A/season. Regulator: EPA E PA Chemical: Boscalid Boscalid Crop: Alfalfa Forage Alfalfa Hay PHI: 12 - 16 days (Cuttings 1+2) 12 - 16 days (Cuttings 1+2) App. Rate: 3 at 0.28 - 0.32 lb ai/A 3 at 0.28 - 0.32 lb ai/A Submitter: BASF BASF MRID Citation: MRID 47584401 MRID 47584401 Residu es Residues 0.81 5.07 3.36 15 .00 1.04 5.10 3.92 16.64 1.10 5.39 5.22 16.72 1.32 5.42 5.33 17.35 1.35 5.48 5.65 18.07 1.49 5.98 7.66 19.11 1.69 6.06 7.72 19.53 2.42 6.39 7.91 19.99 2.47 7.96 8.08 20.31 2.51 8.06 9.47 21.64 2.73 8.56 9. 74 21.96 2.82 8.79 11.41 23 .00 2.93 8.79 11.45 24.22 2.97 11.11 11.54 25.22 3.09 11.82 11.59 31.13 3.42 12.98 11.82 31.23 3.45 13.17 12.39 32.64 3.78 14.06 12.9 0 35.77 4.21 15.04 12.99 42.22 4.39 15.05 13.01 42.38 4.41 15.12 13.22 43.02 4.57 15.21 13.83 45.77 4.93 19.40 14.13 46.69 5.00 20.30 14.13 51.12Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 47 of 48 Figure II - 13. Lognormal Probability Plot of Boscalid Residues in/on Alfalfa Forage Following

Three Foliar Applications Totaling ~0.85 lb ai/A. Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 21.0000

10.5000

5.2500

2.6250

1.3125

0.6563 y = 0.8336x + 1.5899 R 2 = 0.979

PercentilesConcentrations EPA Boscalid Alfalfa Forage 12-16 days (Cuttings 1+2) 3 at 0.28-0.32 lb ai/A BASF MRID 47584401



### Figure II - 14. Data Summary Shee t for Residues of Boscalid in/on Alfalfa Forage Following Three

Foliar Applications Totaling ~0.85 lb ai/A. Re gu la to r: EP A Ch em ic al : Bo sc al id Cr op : Al fa lfa F or ag e PH I: Ap p. R ate: Su bmit te r: BA SF MR ID Ci ta ti on : MR ID 4 75 84 40 1

n: 48 mi n: 0. 81 max: 20 .3 0 me di an ; 5. 04 aver age: 6. 65 95 th Per ce nt il e 99 th Per ce nt il e 99 .9 th P er ce nti le 16 19 25 (1 8) (2 5) (- -) 20 35 65 (3 0) (5 5) (- -) 18 25 UPLM ed ia n9 5t h 30 0.9 79 0 p- va lu e > 0. 05 : D o no t rej ec t lo gn or ma lit y as su mp ti on 12 -1 6 da ys ( Cut ti ng s 1 + 2) 3 at 0 .2 8- 0. 32 lb a i/ A

EU Me th odI No rm al EU Me th odI Lo g No rm al

App ro xi ma te Sh api ro -F ra nc ia No rm al it y Tes t EU M et ho d II Di st ri bu ti on -F re e Ca li fo rn ia M et ho d μ + 3 σBoscalid Summary of Analytical Chemistry and Residue Data DP#: 364447



### Page 48 of 48 Figure II - 15. Lognormal Probability Plot of Boscalid Residues in/on Alfalfa Hay Following Three

Foliar Applications Totaling ~0.85 lb ai/A. Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 52.0000

26.0000

13.0000

6.5000

3.2500 y = 0.6712x + 2.7472 R 2 = 0.9829

PercentilesConcentrations EPA Boscalid Alfalfa Hay 12-16 days (Cuttings 1+2) 3 at 0.28-0.32 lb ai/A BASF MRID 47584401



### Fi gure II - 16. Data Summary Sheet for Residues of Boscalid in/on Alfalfa Hay Following Three

Foliar Applications Totaling ~0.85 lb ai/A. Re gu la to r: EP A Ch em ic al : Bo sc al id Cr op : Al fa lf a Ha y PH I: Ap p. R ate: Su bmit te r: BA SF MR ID Ci ta ti on : MR ID 4 75 84 40 1

n: 48 mi n: 3. 36 max: 51 .1 2 me di an ; 14 .5 7 aver age: 19 .1 5 95 th Per ce nt il e 99 th Per ce nt il e 99 .9 th P er ce nti le 40 50 60 (5 0) (6 0) (- -) 50 75 13 0 (6 5) (1 10 ) (- -) 50 60 UPLM ed ia n9 5t h 80 0.9 82 9 p- va lu e > 0. 05 : D o no t rej ec t lo gn or ma lit y as su mp ti on 12 -1 6 da ys ( Cut ti ng s 1 + 2) 3 at 0 .2 8- 0. 32 lb a i/ A

EU Me th odI No rm al EU Me th odI Lo g No rm al

App ro xi ma te Sh api ro -F ra nc ia No rm al it y Tes t EU M et ho d II Di st ri bu ti on -F re e Ca li fo rn ia M et ho d μ + 3 σ