Penoxsulam Summarv of Analytical Che mistry and Re sidue Data DP Barcode D425013



### UNITED STATES ENV IRO NMENTAL PROTECTION AGENCY WASHINGTON , DC 20460

MEMORANDUM DATE: December 4, 2015 OFF I CE OF CHEMICAL SAFETY AND POLLUT I ON PREVENTION



### SUBJECT: Pe n oxs ulam. Petition to Esta bli sh Perman e nt Tolerances (with Section 3 Registration) for Residues Resulting from Use of the Herbicide on Pome Fruit , Stone Fruit , Olive , Pomegranate , and Fruit , Small , Vine Climbing (Subgroup I 3

- 07F, Except Fuzzy Kiwifruit); and Crop Group Conversion for Tree Nuts. 

### S umm ary of Ana lyti ca l Chemistry a nd Residue Data. PC Code: I 

### 1 903 I 

### DP Barcode: 0425013 

### Decision N umb e r : 497353 

### Petition Nu mb e r : 4E8330 

### Risk Assessme nt Type: NA TXR 

### Number: NA 

### Registration Numb ers: 62719-499, 62719-611 

### Regulatory Ac tion : Section 3 Registration 

### Case Numb er : 7265 

### CAS Number: 219714

- 96-2 

### 40 CFR: § 180.605 

### MRID Numb er s: 49472601 and -0 2 

### FROM :

T HR U :
TO : Elizabeth Holman, Physical Scientist**£/ly ,-** **~** 

### J+£- ..__ Ri sk Assessment Branch II (RAB2) Health Effects Di vision (HED), 7509P William 

### T. Drew ,

# mist~ RAB2 / HED. 7509P Sid ne y Jackson/Barbara Madden Minor Use and Emergency Response Branch Reg istratio n Division (7505P)

Page 1 of25Penoxs u lam Summar.' of Analytical Chemistrv and Residue Data DP Barcode D4250 I 3 

### Table of Contents 1. 0 Exec u t ive Sum m a r y . ... .. ...... .. ....... . ........................................................................................ 4 

### 2.0 Regulato ry Recommendations
............. . ....... .. .......................... .. ..... . .......... .. ..... . .. .. ..... .. ...... 2_6 

### 2. 1 Da ta Defic ienc ies/ D a t a Needs
.. .. . .... .. . .. ....... .. ...... .. ...... .. .. .. ... . .. .. .. . .. .. ..... .. . .. ... . . .. .. . ... . . ... . . .. 

### 6 2.2 To le ra n ce Co n s iderati ons . .... . .. .. ... .. .. .. ...... ... ...... .. .. . ... .. .. . ... .. .. . ...... .. ...... . .. . ...... . .. . ...... . ...... . . 

### 6 2.2.1 En forcement Analytica l Method/Multi -R esidue Meth ods
..... . ....... . .......................... 

### 6 2.2.2 Recommende d To lerances ...... .. .. . .... .. .. .. ... . .. .. ... . .. .. ... . .. .. ..... .. .. .. .. .. . .. .. . .. . .. .. ..... .. ..... . §+ 

### 2
. 2.3 R evisio n s to P et it ioned-For To lerances ...... .. ...... ... .. . ...... .. ..... .. ...... .. . . ...... .. ....... ... ... 

### 18 2
. 2.4 International Harmonization
... . ................ . ........................................ . ..... . . .. ..... .. ... 

### l+Q 2.3 Labe l R ecommendatio n s . ....... ... ...... .. ...... ... ...... ... ..... ... . .. ... . .. .. ..... ... ..... . .. .. ..... . . . .... . .. . .... 

### l+Q 2.4 S ubm itt a l of A n a lyt ical R efe re n ce Standard s 

### (860.1650)
. .. .. . ... . ... . .. .. . .. .. . .. .. .. . .. ..... .. . .. 

### l+Q 3
. 0 Chemical Ide n t ity ... .. .. .. ...... .. ....... . ....... .. ............................................................... . ...........**~++** 

### 3. 1 Non1enclature
... . ............ . ....... .. ...... ... ....... . ....... .. . .. ....... .. ...... . ...... . .. .. ... . . .. ...... . .. . ..... .. .....**~++** 

### 3.2 Ph ys icoc h e mi ca l C h aracte ri s ti cs . ... ... . .. ... ...... ... . . ... ...... .. .. .. .. .. . ... ..... .. . . ... .. . . ...... .. . .. ... .... . 

## 2-R 3.3 Pest ic ide Use Pattern/D irect io n s for Use 

### (860.1200)
. .. .................. . ......... . ..... . ............ 

## 2-1-J 4.0 Metabolite/Degradate Residue Profile
........................... . ...... .. ......... .. ..... .. ......... . ........... 

### l.Q+4 4. 1 Na tu re of th e R es id u e ................... . ............ . .... . .......................... . .......................... .. . . ...... 

### 14 4 .1. l S u mmary of P l a n t and/or L ivestock Metabol i sm 

### (860.1300)
. .. . .. .. . .. ..... .. .. . ... . .. . . 

### l.Q+4 4.1.2 Summary of Confined Rotationa l Crops 

### (860.1850)
..... .. ...... . . . ...... .. .. . ... . . .. ..... . . .. 

## JlH 4. 1 .3 Summary of R at Me t abo li sm .. .. .. .. ... ... . .. ... .. . ... ..... .. .. .. .. .. .. .. ..... .. .. . ... . . .. ..... .. .. . ..... .**Jl~** 

### 4. 1 .4 S um ma r y of E n vironmenta l Degrada ti o n ......................... . .. . ...... . .. . ....... . ........ .. .. 

### 12-8 5.0 Residue Profi le ........................... . ....... .. .. . .... .. ................... . ....... . ......... .. ...... . . . ...... . ........ .. 

## UH 5.1 Residue Analytical Methods 

### (860. 1 340)
.......... .. ...... .. ...... .. .. .. . .. . .. .. .. .. .. . .. .. .. . .. .. .. . .. . .. _ll-8 

### 5 .1.l Da t a Co ll ec ti o n Me th ods
. ...... ... . . ... ... .. . ... ... . .. ... .. . ... ... . . ... . . ... .. . .. .. . .. .. .. . .. .. .. .. . . ... . .. . _ll -8 

### 5.2 Storage Stability 

### (860.1380)
. . ....... .. ....... .. .. . ..... . . .. ...... ... ...... .. ........ .. ...... . .. . ...... . ......... . 13+6 5.3 Residue Data ....... . ........... . .......................................... . ...... .. ...... . .. .. ...... . ...... . .. . ...... . ... . 

### HM 5
. 3 .1 Cro p F ie ld T ri a l s 

### (860. 1 500)
...... .. ... . ... .. ... . ... . ... . ... . .. .. ... . .. . ... . ... . .. . ... . .. . ... . .. . ... . .. . .. .. .. 17 5.3.2 Field Rotational Crops 

### ( 860.1900)
.. .. . ....... .. ....... .. ...... . .. . ...... .. ......... . ...... .. ........ .. 

## 12±4 5.3.3 Processed Food and Feed 

### (860.1520)
.......................... .. ...... .. ........ .. ...... . .. . ...... .. .**12~** 

### 5.3.4 Mea t , M il k , P o ul try a n d Eggs 

### ( 8 60.1 4 80)
.... .. ...... .. ..... .. ... . ........................... . .. .. .**12~** 

### 5.3.5. Food H andling 

### (860
. 1460)
........................ . ................... . ...... .. ................ . .. . ...... .. ..... 32

Page 2 of 25Penoxsulam Summary of Analytical Chemistry and Residue Data DP Barcode D425013 

### 5.3.6 

### Water, Fish and Irri gated Crops (860. 1400)
................. ................. ......................... 32 

### 5.4 Food Residue Profile
..................................................................................................**il~** 

### 6 .0 

### Tolerance Deri vation
..................................................................................................... 

## £1J;. References
................................................................................................... . ......... ... ........ ..... ...... .. 36 

### Attachment I: 

### Internati o na l R esi due Limit 

### Status
...................................................................... . 38 

### Attachment 2: 

### OECD MRL 

### (To lerance) Assessment Calc ul ations
.. ..... ...... ..... ..... ......... .. ............40

Page 3 

### of 25Penoxsulam Summary of Analytical Chemistry and R es idu e Data DP Barcode D425013 

### 1 .0 Exec u t ive S umm ary Penoxsulam is a sulfonam id e herbicid e currently registered for th e selec ti ve control of g ra ss , broadleaf , and sedge weeds. In the U.S., it was first r eg istere d for u se on rice and s ubsequently h as been regi stered fo r use on turf and for use in aquatic weed control. The herbicide's mode of action at the cellular leve l involves the inhibition of acetolactate sy nthase (ALS). The Inte rreg ional Research Project Numbe r 4 (IR-4) has submitted a Section 3 registration app licati on for new u ses of the herbicide penoxsulam. Specifically , the current proposal is for new uses o n pome fruit g roup 11-10 , stone fruit group 1 2-12. ol ive , and pomegranate; an extension of tolerances for grapes to the small fruit vine climbing subgro up l 3-07F, and a crop group update from the old tree nut crop group 14 to th e new tree nut crop gro up 14-12. The use s are for the ex i sting end-use product, Pinda r® GT, an emulsifiab le concentrate ( E C) containing 0.85% penoxsulam (EPA Reg. # 62719-611 ). The maximum si ngle application rate is 0.03 pounds active ingredient per acre (lb ai / A) with a seasonal maximum , harvest to harvest , of 0.05 pounds active ingredient per acre (lb ai / A). Penoxsulam ma y be used either as a pre- or postemergence weed control via grou nd application. In the current p e tition , PP #4E8330, IR-4 proposes th e establishment of permanent tolerances for residues of the herbicide penoxsulam in/on the ra w agric ultural commodities (RACs) listed in Tab le 2.2.2 (below), at the lev e l s shown therein. The nature of the residue in plants i s adequately und e rstood for the purposes of this new use petition, based on acceptab le grape and rice metaboli s m studies
. The nature of th e residu e in animals is adequate l y understood , based on acceptable ruminant and poultry metabolism studies. HED previously determined that , for tolerance enforcement and ri sk assessment purposes , the r esidue of concern ( RO C) in both crops and livestock is parent pen oxs ulam only. In fish and shellfish , for risk assessment purposes the ROC is parent penoxsulam plus metabolite 5-0Hpenoxsulam , but for tolerance e nforcement th e RO C is parent penox s ulam only. 

### Crop Field Trials: The number and geograp hic distribution of the field trials are adequate , and the use patterns are consistent with the proposed use patterns regarding maximum application rates , shortest pre-harvest intervals (PHls), a nd minimum re-treatme nt intervals (RTis). Adequate crop field trial studies were submi tt ed for sto ne and pome fruit. HED previously concluded that field tri al data from pome fruit and sto ne fruit could be used to support tolerances on olive and pomegranate , assuming that no quantifiable re s idues w ere observed in any of these field trials ( HED C hemSAC minutes. 09/ 01 /2010). Based on the pome and stone fruit field trial data reviewed fo r thj s petition , with no residue s observed above the LOQ of 0.01 ppm, there is adequate data to support the proposed tolerances of 0.01 ppm on o li ve and pomeg ranate. In add iti on , there is adequa t e data to support crop group conversion for tree nuts (from group 14 to group 14-12) and establishing a new tolerance at the sa me leve l of 0.0 I ppm. Finally, th e existing data on grape suppor t estab li sh ing a crop group tolerance at 0.0 I ppm for f ruit , sma ll , Page 4 of 25Penoxsulam Summary of Analytical Chemistry and Residue Data DP Barcode D425013 

### vine climbing , subgroup 13-07F , except fuzzy kiwifruit. The available residue data support tole rances for residues of penoxsu l arn , as listed in T ab le 2.2.2 (below). 

### Processing Studies: Separate processing studies were not submitted as part of the petition currently under review. As noted above , all pome fruit and stone fruit field tria ls had non q u antifiab le residues (<0.01 ppm). Furthermore. in one of the apple field trials an exaggerated use rate was used (SX), with no quantifiable residues being observed in this trial. l n add it io n , in a sing le p lum fie ld tr ia l, conducted at 

### - 1 .3X the proposed maximum seasonal use rate, residue s were also below the LOQ in dried plum processed from p l ums harvested at a 63-day PHI. F inall y, i t is noted that in the prev i ously reviewed grape processing study 

### (

- 5.8X the registered maximum seasonal rate for grape), there were no quant i fiable residues in either the grape RAC or in the g rape processed commodities. B ased on the available data , penoxsulam residues do not concentrate in processed fractions. Therefore, 

### HED concludes that the avai l able data are adequate and that separate tolerances for processed commodities are not required for the proposed uses. 

### Residue Analytical Methods: There are adequate e nforcement methods avail ab l e for t h e quantitation of pe noxsu lam in p lant and animal commodi ties. 

### Storage Stability: Adequate storage stability data are available to support the storage durations and conditions of samples from the submitted penoxsulam field tria l stud ies. 

### Meal. Milk, Poultry and Eggs: No addi t ional data are req ui red to support the pro p osed u ses of penoxsuJam currently under review. 

### HED continues to conclude that livestock tolerance are not requ i red , as there is no expectation of finite residues in livestock commod it ies ( i .e. , there is a 40 CFR §180.6(a)(3) situation). 

### MRL Harmonizat ion: The re are no Codex , Canad ian or Mexican maximum residue limits (MRLs) estab l ished for res idues of penoxsu lam on any crops, inc l ud i ng th ose unde r review fo r this petition. Therefore, the re are no harmon ization issues with re s pect to the proposed agricultural uses. 2 . 0 Re g ulatory Recommend ation s 

### HED has examined the residue chemistry database for penoxsu l a rn . P rov ided the s u bmitted Section F is revised as noted below , the re are no residu e chemistry issues that would preclude granting the requested Section 3 reg i strati on fo r pe noxsulam , and es tab li shme nt of the recommended to lerances in the proposed commod ities , as li sted in Table 2
. 2.2 (below)
. Specifically, as discussed be l ow in Section 2.2.3 , the revised Secti on F shou l d propose a revised tolerance expression for penoxsulam (40CFR 

### § 180.605) , with this expression being updated to include both cove rage and comp li ance sta tements for e nforcemen t purposes. In add ition , as listed in Table 2.2
. 2, the revised Section F should also correct some of the commodity definitions for the proposed commod i ties.
Page S of 25Penoxsu lam Summarv of Analvtical Chemistrv and Re si due Data DP Barcod e D425013


### 2.1 Data Deficiencie s /Data Needs None. 

### 2
. 2 To lerance C on s id erati ons 2.2.1 E nforcement A n a ly t i ca l Method/Mu lti-Re s idue Methods Re s id u e C h em i s tr y S u mmary 0355 9 1 4 ; M
. D o h e r t y; 2 9 Ja n uary 200 9 High performance liquid chromatographic methods with positive-ion electro spray interface (ESI) a nd tandem mass spectrometric detection (LC/MS/MS) were previously revi ewed and found to be acceptable fo r tolerance enforcement of penoxsu lam. Method GRM 01.25 was developed for rice commodities, and Method GRM 05
. 08 was developed fo r anima l commodities. Successful validat ion of both methods was repo11ed b y the registrant , and by an indep endent la borator y va lidation (ILV). No radiovalidation was required for e ith er of th ese methods. The limit of quantitat io n (LOQ), detem1ined a s the lowest leve l of method validat ion (LLMY), is 0.010 ppm fo r p enoxsu lam in a ll matrices
. Testing results of penoxsu lam analyzed according to the FDA Multi-Residue Method Test guideli ne s in PAM Vol. 

### 1, Appendix 11 (1/94) were previously submitted in con junction with the rice petition (PP# 3F6542; DP# 288 1 52, 8/11 / 04 , W. Cutchin). The multire s idue method data indicate that penoxsulam is not adequately recovered u si n g any of the multi r es idu e meth ods
. 

### 2.2.2 Recommended To lerances

TABL E 2
. 2
. 2. T o le ranc e Summary for P e nox s ul a m (40CFR §1 80
. 605)
.

Pro p osed o r Ex i s t ing * Proposed or Exi st ing * Reco mm e n ded Co rre ct Commodi ty Defl 11 itio11 ; Co mmodity Tolerance (o om) T o lerance (oom) C omments Fruit , Pome , g roup 11-10 0.01 0.01 Fruit. pome, group 11-10 Fruit. Stone, gro up 12-12 0.01 0.01 Fruit , stone. f!.roup 12-12 Fruit. s mall , vine 0.0 1 0.01 Based on available data on grape. climbing. subgroup 13- 07F , except fuzzy kiwifruit Nut, Tree grou p 14-12 0.01 0.01 Nut, tree, group 14

- 12; Conversion from tree nut group 14. Olive 0.01 0.01 Based on submitted s tone fruit and Pom egranate 0.01 0.01 pome fruit field trial data. Nut , tree , group 14 * 0.01 * Remove Conversion to tre e nut J:?,roup 14- 1 2. Grape* 0.01* Remov e Replace with tolerance on fruit, small, vine climbing , s ubgroup 13-07F , exc ep t fuzzy kiwifruit. Pi s tachio * 0.01 • Remov e Replace with th e tolerance on tree nut group 14-12. * A t olerance is currently established at the listed tolerance level in the corresponding commodity. Pa ge 6 of 25Penoxsulam Summary of Ana l ytical Chemistry and Residue Data DP Barcode D425013
2.2.3 Rev is ion s to Petitioned-For T o l e ra n ces 

### The current tolerance expression for penoxsulam ( 40CFR 

### § 180.605) needs to be updated to include both coverage and compl ianc e statements for enforcement purposes in order to comply with HED ' s guidance on tolerance express ions (S. Knizner; 5/ 27/ 2009). Spec ificall y, the tolerance expression for penoxsulam c ited in 40 CFR 

### § 180.605 should be revised to state: Tolerances are established for residues of penoxsulam, including its metabolites and degradates , in o r on the commodities li sted in the table be low
. Compliance with the tolerance levels specified below is to be determined by measuring only penoxsulam 2-(2 , 2-d iflu oroethoxy)-N

- (5 , 8-dimethoxy[ I 

### , 2 , 4]triazolo( 1 , 5

- c] pyrimidin-2-yl)-6-(trifluoromethyl) benzenesulfonamide, in or on the commodity. The petitioner shou ld subm it a revised Section F usin g the correct commodity definitions provided in Table 2.2.2. All proposed tolerance values for the s e commod iti es are correct as li sted a nd are identical to those recommended by HED. 2 .2.4 International Harmonization 

### There are no Codex , Canadian or Mexican MRLs established fo r residue s of p e nox s ulam on any crops , including those under review for this petition. Therefore , there are no harmonization issues with respect to the proposed agricultura l uses. 2.3 Labe l Recommendations 

### N one. 2.4 S ubmitta l of Ana lytic a l Referenc e Standards (860.1650) 

### The analytical standard for penoxsulam, with an expiration date of 2 1 January 20 17 , is cu rrent ly available in the EPA ' s National Pesticide Standards Repository (NPSR) , per E mail communication from Grego r y Verdin of the Bi o logical and Economic Analysis Division ' s ( BEAD ' s) Analytical Chem i stry Branch (ACB) on 14 September 20 1 5. The registrant is required to maintain reasonable amounts of the analytica l reference standard for penoxsulam in the NPSR. When necessary, a new reference s tanda rd , or updated certificate of analysis (COA), should be sent to the AC B , which is located at Fort Meade , MD. It should be s ent to the attention of e ith er Theresa Co le or Thuy Nguyen at the address listed below, a lo ng with a letter of tran s mittal. Pl eas e note that the 

### full 9-digit 

### ZIP Co d e i s required , or the mail will be return e d to the regi s trant . USE PA Natio n a l Pesticide Standards R e po s itory
Pa ge 7 of25Penoxsulam Summary of Analytical Chemistry and R es idu e Data 

### Analytical Chemistry Branch/BEAD/OPP 701 Mapes Road Fort George G. Meade , MD 20755

- 5350 DP Barcod e D42 50 1 3



### The letter of transmittal sho uld include the assay of th e standard , name of the analytical method us ed , a s tatem e nt of principal impurities , purification procedures e mplo ye d , s t o rage req uirem e nt s, and spec ial precaution s for safe h andlin g. R eplaceme nt of standards may be required period ically if s uppli es are ex hau s ted , if the s tandards expire , or if deco mp os iti on occurs during storage . M ate ri a l Safe t y Data She e ts (MS D Ss) or , a ltern ati vely , SDSs that comply with the Globally Hannoni zed Sys t em of Classification and Labe lin g of C hem ical s ( GHS ), s hou ld accompany all analytical stan d ard s , as spec ifi ed in 29CFR 

### § 1910.1200 by the Oc c upational Safe ty and Health Administration ( OSHA).


### 3.0 C hemica l Identity Th e nom e ncl a ture of pen oxs ul am is s ummarized in Tabl e 3. 1 , and th e physicochemical prope rti es are s ummari zed in Tab le 3.2. 

### 3
. 1 Nome nclature

Table 3. 1. Pen oxs ul a m No me nclat u re. Compound F F ) 0 ,.-CH , 

## o o 

# A 

# 6:11 S N.._N**~N** 

# ll'N--{

# ~ 0 H ....-::**~** N CF3 0 "C H 3 Co mm o n nam e Penoxsul a m Co mp any ex per iment a l nam e XDE-638 IUPAC name 3

- (2 , 2 -di Ouoroe thox y)- N- (5 , 8-dimethoxy[ 1 , 2 ,4) t riazo lo[ 1 , 5 -c)pyrimidin-2-yl )

- a ,a , a -trifluo rotolue ne -2

- sul fonam id e CAS name 2-(2 , 2-d ifluoro ethox y)-N -(5 , 8-dimethoxy[ 1 ,2,4 ]tri azolo[ 1 , 5

-c ]pyrimidin-2-y l) -6- (tri fluoromethyl)benzenesul fonam ide CAS reg is try numb er 2 197 14- 96-2 End

- use product (EP) Pi n dar® GT (EPA R eg. #62719-61 I)

Page 8 o f25Penoxsulam Summarv of Analvtical Chemistrv and Residue Data DP Barcode D425013 

### 3.2 Physicochemical C h aracteri sti cs

Tab l e 3.2. P h ys icoc h emical Prop e rtie s of Pcnox s ul a m . Parameter Value Reference 1 Me lting poin t/ range No t available pH 5.2 MRID 458 30707 D ensity 1.61 g/mL at 20 ° C MRJD 45830707 Water so lu bility at 19 °C Unbuff e red 4
. 91 mg/L MRID 45830720 pH 5 5.66 mg/L pH 7 408 mg/L pH 9 1460 mg/L Solvent so lubilit y at 19 ° C Xylene 0.017g/L MRID 45830720 1-0ctanol 0.035 g/ L Methanol 1.48 gf L Ethyl acetate 3.23 g/L Acetonitrile 15.3 g/L Acetone 20.3 g/L Dimethylsulfoxide 78.4 gfL Vapor pressure 7.16 x 10 · 16 mm Hg at 25 ° C MRID 45830720 Dissociation constant, pK a 5.1 (ambie nt) MJUD 45830720 OctanoVwater partition coefficient. Unbuffered

- 0.354 MRID 45830720 Log(Kow) pH 5 1.137 pH 7 -0.602 pH 9 -1.418 UV/ visible absorption spectrum Not available 1 As referenced m DP # 326985, 1 / 30 / 07. D
. So derberg. 

### 3.3 Pesticide Use Pattern/Direction s for Use (860.1200) Penoxsulam is proposed for new use s on pome fruit group 11-10 , stone fruit 12 -12 , ol i ve, and pomegranate. P enoxsulam is also requested for an ex tension of the tolerances from grapes to the crop s ubgroup 13-07F and a crop group update to the new tree nut croup gro up 14-12. The proposed formulated end

- use product is Pinda r® GT, an emulsifiab le concentrate containing 0 .8 5% penox s ulam (EPA Reg. #62 719-611 )
. A summary of the proposed new use directions is included in Table 3.3 below.
Table 3 .3. Summary of Proposed Uses for Penoxsulam. App l ic
. Timin g, Formu lation Applic. Rate Max. Seasona l PHI Use Directions (EPA Reg. Type, and E quip
. No
. ) (Jb ai/A) Applic. Rate (lb ai/A ) (days) an d Limitation s Pome Fruit Group 11

- 10 , S t o n e Fruit 12-1 2, Olive, and Pomegranate Crop Group extens io n from Gra p es to S u bgroup 13

- 07F

Crop Group updat e to the new Tree Nut Group 1 4- 12

Page 9 of 25Penox su lam Summary of Analvtical C hemi s try and Re s idue Data DP Ba r code D4250 1 3 Table 3.3. Summar y of Propo s ed Uses for Penoxsulam. Applic
. Timing , Formulation Applic. R a t e M ax. Sea s onal PHI Use Dir ect i o n s (E PA R eg. T y pe, and Equip. No.) {l b ai/A) Applic. Rate ( lb ai/A) ( da ys ) and Limit a tion s Groundboom, Apply pre- or Backpack Sprayer, Emulsifiable 0.02 to 0.03 lb po s temergence of Concentrate 0 .0 5 lb ai/ A 60 weeds in the Mechanicall y - (627 19- 61 I) a i/A dormant period Press uri ze d Handg un before bud swe ll. 

### Penox s ulam is also currently registered for occu pati ona l u se on grapes, tree nuts , rice , turf grass , aquatic vegetation , non-cropland , non-bearing cropland, non-bearing fruit tree s (including c i trus ), conifers , and eucalyptus. It i s also regi s tered for residential use on turfgras s and aquatic vegetatio n for weed contro l. 

### Co nclus ions: The proposed use directions are a dequate to allow evaluation of the residue data relative to the req uested u se s . The proposed maximum seasonal u se rat es, minimum RTis, and minimum PHTs are supported by the s ubmitted crop field trial data. 

### 4.0 Metabolite / D eg radat e Re si due Profile R es idu e C h e mi s try S ummar y; OP # 288 1 52 , 8 / 11 / 04 , W. C utchin R es idu e C h e mi s try S ummar y; 0 3559 14 ; M. Do herty; 29 Jan u a r y 2009 

### Plants: Th e m etabol is m of pen oxsu lam was prev i ously investigated , and adequately d escribed, in two d i fferent plant s : rice and grape. 

### H E D notes th at , s hou ld t h e u se pattern for the propo se d or existin g use s c han ge ( i. e . , from so il to fol iar applications) , or new use s are requested to ex pand be yo nd o rchard crops, additiona l nature of the re s idue data ma y be needed. 

### A nimals: The metabolism of penoxasulm was previousl y studied, and adequately described , in both ruminants and pou l try. 

### 4. 1 Na ture of the Re s idue R es idu e C hemi s try S umm a r y; DP # 288152 , 8 / 1 1/04 , W
. C ut ch in R esid u e C h e mi str y S umm a r y ; D355914 ; M
. Doh e rty; 2 9 Janu a r y 2009 

### Refer to th e previou s residue chemistry summary docum e nts fo r de tailed d escr iptions of the plant metabol ism studies w ith penoxsulam 

### in rice and grape , an d of the animal met abo li sm s tudi es in lactat ing goats and la yin g he ns. 

### 4.1.l Summary of Plant and/ or Live s tock Metaboli s m (860.1300) R es idu e C h emistry Su mm ary; DP # 288 1 52 , 8 / 11 / 04 , W . C utchin R esid u e C hemi s try S ummary; D 35 5914 ; M
. Dohert y ; 2 9 J a nu ary 2009 MAR C D ecis i o n Mem o TXR No. 0052 740 ( DP Ba rcode 0 305542, 7/ 1 9/04 , W
. C utchin) R es idu e C hemi s try S umm a r y; DP N um : 326985 , D
. So d erb erg , 1/30/0 7


### Page 10 of 25Penoxsulam Summary of Analytical Chemisrrv and R esidue Data DP Barcode D425013 

### Data have been s ubmitted and reviewed depicting the metabo li sm/degradation of penoxsulam in rice, grape , livestock and the environment. H ED has determined the plant and animal ROCs for pu rp oses of tolerance enforcement and ri sk assessment (see Table 4.1.1 , below).

TABLE4
. 1.l S ummary of Penoxsulam Metabolit es and Degrad a t es to be includ ed in the Ri s k Asses s ment and To lera nce E xpre ss ion. Matri x R es idu es Included in Ri s k A ssess ment Residues Inc lu ded in Toleranc e Ex press ion Plant s Primary crops Penoxsulam Penoxsulam Rotational crops Penoxsulam Penoxsulam Animals Ruminants Penoxsulam Penoxsulam Poultry Penoxsulam Penoxsulam Fish/ s hell fi s h Penoxsulam + 5-0H-penox s ulam Penoxsulam Drinking water Penoxsulam + BSTCA + 2-amino TCA + Not applicable 5-0H-penoxsulam + SFA + sulfonamide + 5 , 8

-di OH* ' See Attachment 2 fo r chemical s tructures of these compounds. 

### Conclusion: The nature of the res idu e in plants and animals has been adequately delineated to support the current petition
. If the u se pattern ex pand s in the future , add itional plant metabolism data may be requ ired. 

### 4.1.2 S ummary of C onfined Rotational Crops (860.1850) PP #3 F6542 ; DP Bar co d e 02881 52, 8/ 1 1/ 04 , W
. Cutc hin (4583072 0 .der.w pd ) 

### An acceptab le crop rotational crop stu d y was previously reviewed in the rice petition (P P# 3F6542)
. HED review of the study concluded that no qua nt ifiab le re si due s of penoxsu lam or 5-0H XDE

- 638 arc expected to be present in the RACs of small grai n s , leafy vegetables, and root crops planted 90 days following treatment with penoxsu lam at 0.045 or 0.090 lb ai / A (1 X or 2X the rate for rice). The data also indicate that residues of the metabolite BSTCA cou ld be present at >0
. 01 ppm in the fo l iage of root crops planted 90 days following treatment at 0.090 lb a i

/ A (2X). The Metabolism Assessment Review Committee (MARC) determined that penoxsu l am BSTCA is not a ROC for penoxsulam in rotated crops. It was noted that the submitted confined rotational crop study only included o ne p lant
- back interval ( PBl), 90 days
. I f in the future PB I s other than 90 days are proposed , an additional confined rotational crop study reflecting the proposed PBI would be required. 

### 4
. 1.3 S umm ary of Rat Metaboli s m Ri sk A ssess m e nt 0 3639 10 ; C. Swa rtz ; 9 Apri l 2009 

### In a metabo li sm stud y in rats , 14 

### C-penoxsu lam was rapidly and nearly completely absorbed at the low dose of 5.0 mg/kg, but at the hi gh dose of 250 mg/kg , there was evidence that absorption was largely incomplete (i.e. absorption was saturated). Both gender and dose affec ted the exc ret i on pattern. At the low do se, th e major route of excret ion of rad i oactivity was via the feces Page 11 of 25Penox s ulam Summar.• of Analytical Chemistrv and R esidue Data DP Barcode 0 4250 I 3 

### in mal es and v ia th e urin e in females. At th e high dose , rad ioac t iv ity was predo minantl y excreted v ia the feces i n both sexes . A s ignificant enterohepatic circulation was observed , particularly in ma les. Most ( > 90%) of the administered do se was e xcre ted withi n 36-48 ho u rs. There was n eg ligibl e radi oacti v ity in ti ss ues at 7 days and no evidence of accumulation in an y tissue/ organ. Although numerou s metabo l ite s wer e revealed in the ur in e, feces and bi le, nearl y all were < 1 % of the a dmini s tered do se. Pare nt compound and a 2- hydroxy ph e ny l derivative were the major compound s i n uri ne and fece s . 

### 4.1.4 S ummary of Environmental Degradation EFE D Dri n kin g W ate r M e mo; J
. W o lf , 2 8 Au g 201 5 , 04 28 41 9 

### P

e noxs ulam is expec ted to be m o derate ly per s istent in the aerobic terrestr ial e nvironment s, and less persistent in an ae robi c environments. T he de g radati on products tend to be m ore p e rsis t e nt than th e pare nt compound
. Pe no xs ulam is expected to di ss i pate rapidl y i n cl ear sha ll ow waters throu g h aqueous ph oto l ys is. Thus, in turbid , shaded or acid ic waters , photolysis of peno xs ulam i s expected to be s lower , and other d eg radation mechani s m s are expected to predominate. Lab orato ry da ta indicates that the four photo lytic half-lives rep o rted fo r pen oxs ulam in water range from 1.5 to 3.1 d ay s between pH 7 and pH 8 , and 14 da ys at pH 5.8. A report e d pKa value of 5.1 sugges t s that pH may have an effect up o n th e photolytic half-li fe. In aqueou s env ironments, penoxsul a m is s table to hydrol ys i s at pH 5 , 7 and 9
. S ubmitted mobilit y data for thr ee p e no xs ulam degradati o n products ( BST CA , 5-0Hpenoxsulam , an d BST) indicate env ironmental m ob ility rough ly equivalent to or slightl y greater than th e pare nt compound. Th e so il to water partiti o n coefficients ( Kd ) derived from the seve nt ee n so ils and one se dim e nt s tudied ran ge d from 0. 12 to 1 0.67 m L/g . Ca lcu l ated Koes ranged from 12 to I , 

### 141 m L/goc. Th e Koc value s for the sediment were 11 18 and 1141 mL/goc ( Kd s 

## = 1
. 38 and 1 .41 m L/g). There are no data r ega r d in g the mobility of th e remain ing tran sfo rmat io n products no r the co mbin ed parent/degradate residues. T h e lowes t ave ra ge Ko c was 45.3 m L/g oc for 5-0H-pen oxs u lam was u se d as an input fo r mod e lin g as it i s o ne of the RO C s and it appe ars to be one of the mo re per s iste nt de gra dates. In drinkin g wate r, a tot a l toxic residu e (TT R ) approach ha s be e n us ed , with estimated drinkin g water concentrations (EDWCs) used in ri sk assess me nt includin g pare nt plu s s ix deg rad a tion product s ( BST CA 

### + 2-am ino TCA + 5-0H-penoxsulam + S FA + s u l fonamide + 5 , 8-di OH )
. Th ese major degradation produ c ts were observed in o ne o r more e nvironmenta l fate studies. 

### 5
. 0 R es idu e Profile 5.1 R es idue Anal y ti c al M e thod s (860
. 1340 ) 5.1.1 Data C ollecti on M eth o d s MRID 4947260 1. dc r - P o me F ruit MRID 49472602.dcr

- Sto n e Fru i t

Pa ge 12 of 25Penoxsulam Summarv of Analytical Chemistry a nd Re sidue Data D P Barcode 0425013 

### Samples from a ll crop field trials associated with the petit ion currently und e r rev i ew we re an alyzed for residues of penoxsulam v ia LC/ MS/MS, using the met hod , " D ete rmin a tion of Res idu es of Pe noxsulam in Agricultural Co mmoditie s by Hi g h P e r formance Liquid Chro mato graph y with Tand e m Ma ss Spectrometry." A complete d esc ription of the method. including minor modificati ons, was pro v ided in the submiss io n. The method i s s imilar to data collection method GRM 04.09 which wa s prev iously r eviewed und e r DP# 3559 14 (l/29/ 2009 , M. D oherty). The fortification leve ls u se d in concurre nt method r ec ov e r y were adequate to bracket expected r esidue leve ls. The LOQ, determin ed as the LLMV, was 0.010 ppm in all matric es. The petitioner also presented calcu lated values fo r the limit of detection (LOD) and LOQ ba s ed on the recoveri es obtained at the LLMY fo rtificati o n levels (0.0 1 ppm ). The LOO was calculated by multiplying the standard deviation of re cove ry measure me nt s at th e LLMY by th e one -tai le d t-statistic ( confidence leve l no t rep orted) for seven r e plicat es, and th e LOQ was defined as 3X the LOD. The calculated LOD and LOQ in pome fru it we re 0
. 001 1 8 ppm and 0.00354 ppm, respectively. The calculated LOD and LOQ were 0
. 001 33 ppm an d 0.00399 ppm , respect ive ly, in sto ne fruit. 

### Conclusions. No additional dat a are required in s upp o rt of thi s dat a collection method. The data are adequate to suppo rt the proposed u ses. 

### 5
. 2 S t o r age S t abili ty ( 860.1380 ) M RID 4947260 l. der

- Po me F r u it MRID 4947260 2 .der

- S t on e Fru it P P #3 F6542; D P# 288 152 , 8/ 11 / 0 4, W . C u tc hin Re s idu e C h e mi s t r y S u m mar y; D3559 14; M. D o h ert y; 29 J a n uary 2009 

### Storage stability data were previously sub mitted ( D288 l 52) and indicate that residues of penoxsulam are s table und er fr oze n s tora g e condition s in rice g rain , straw, and immature forage fo r up to 732 days (24 month s), and in proce sse d rice bran , hull s, and polished rice for up to 390 days ( 12.8 months )
. In add ition , pre v iously s ubmitted data (0355914) indicate that re si due s of penoxsulam are stab le under frozen s torage cond ition s in grape and grape proce ss ed commodities fo r up to 359 d ays. In conj uncti o n with th e s ubj ect petition , IR

- 4 ha s s ubmitted the results of a s torage s tability s tud y with p e nox s ulam in pome fruit and s tone fruit. Hom oge ni ze d samp le s of untreated pome fruit and stone fruit were fortified w ith penoxsulam at 0.10 ppm , and stored frozen (at approximatel y - l 5°C) fo r up to 349 day s in pome fruit and 358 days i n stone fruit. Pome a nd stone f ruit sampl es were analy ze d for res i dues of penoxsulam u s ing LC/MS/MS Method " Determ inati on of Residues of Penoxsulam in Agri cu ltural Co mmoditie s by High Performance Liquid Chromatography with Tandem Mass Spectrometry." The method is similar to data collection method GRM 04.09 which was previously r ev ie we d under DP# 355914 (l/29/2009. M. D o herty). The method i s adequate fo r data collection ba se d on acceptable concurrent me th od recovenes. Th e reported method LOQ is 0
. 0 I ppm for penox s ulam in/on pome fruit and sto ne Pa ge 1 3of 2 5Pen oxsulam Summarv of A n alytica l Chemistry and Residue Data DP Barcode D 425 01 3 

### fmit. The d ata indicate th at re s idue s o f penoxsulam are s table s to red frozen for up to 349 da ys in/ o n pome fruit and up to 3 58 days in /o n s tone fru it. It is noted that no 0- d ay data were pro v id ed. T hese data are acceptable to s upport the storage cond iti ons and du r ati o n s of s amples from the s ubmitted field tr ia ls; howev e r, s torag e stab ilit y s tudie s s hould always include a 0

- d ay sampling inte rv a l to es tabli s h the res idu e le ve ls pres e nt at the lime s amples are placed into s torage (see OCSPP 860. l 3 80(d)(6) ( i)). The s tor age durations and co ndition s of sampl es from the c rop fie ld trial s and proc ess in g studies s ubmitte d to s upp ort this p e tition are pre se nte d in Tabl e 5 .2.

T ab l e 5.2
. S umm a r y of Sto r age Co ndi tions a nd Duration s o f Sa mpl es fr om Cro p Fi e ld Tri a l a n d Proc ess in g St udi es . Matrix Storage Actual Storage Duration 1 Interval of D emonstrated Storage T e mperature Stabilit y ( O

C) Pome fruit < -15 8-342 days (0.3 -11 .3 mo nth s) Res idu es of p e nox s ulam are s table inio n app le sto red frozen fo r up to 349 days. S tone fruits 8 -3 89 da y s (0 .3-1 2 .8 months ) Re s idue s ofp e no xsu lam were Dried plum 321 days ( I 0.6 month s) stable in / on fresh a nd dri e d plums s t o r e d frozen for up to 35 8 days. 1 Duration from harvest to extrac ti on. Samples were analyzed within 0 -1 day s of extraction
. 

### Conclusions. Th e submitted and prev iou s ly s ubmitted s tor age s tability data are adequate to s upport the storage condi ti o ns and durations of samples from the s ubmitted crop field trial s tudies currently under review. 

### 5.3 Re s idue Data 5
. 3.1 C rop F ie ld Trials ( 860
. 1500) MRID 49472601.der

- P o m e Fruit Field Tri a ls MR ID 49472602
. d er - Sto n e Fruit Fi e ld Tri a ls MRID 4 7444 40 3. d e r - G r ape Fie l d Tri a ls 

### Pom e Fruit: A tota l of six field trial s on pome fruit were conducted in the United States during the 2 01 2 and 20 1 3 growin g seasons. Four appl e fi e ld trial s were conducted in the No rth American Free Trade Ag ree men t (NAF T A) Growing Zones 2 (NJ; I trial) , 5 (MI; I trial), and I l ( ID and WA ; 2 trials) , and two pear trial s were conducted in Zones I 0 (CA; 1 trial) and 11 (ID; I trial ). The Agency pre v iou s ly determined (Minutes of the 9/ 1120 10 C hemSAC M ee tin g) th at a reduced number o f tri a ls (4 for app l e and 2 for pear) wou l d be acceptab le, bas e d on the expectation that res idu es would be nond e tectable
. Each fi e ld s ite consisted of one untr e ated pl ot a nd o n e treated plot. E ach treat e d plot r ec eiv e d two soil directed applications of th e 0.083 lb a i / gal emulsifiable concentrate (E C ) fo rmulati o n of Pa ge 14 o f25Penoxsulam Summary of Anal vtical Chemistry and Residue Data DP Barcode D425013 

### penoxsulam (PindarTM GT) , a multiple active ingredient (MAI) formulation that also contains oxytluorfen at 3.93 lb ai/ gal. D ata and information pertaining to oxytluo rf en are not addressed further herein. The first application was made at 0.0434-0.0459 lb ai/A , and the second application was made 28 -30 days later at 0.0177-0.0186 lb ai/A, for a total seaso nal rate of 0.0611-0.0643 lb ai/ A. At one trial ( 1017 ), an additional plot was treated at an exaggerated rate: the first applicat ion was made at 0.2272 lb ai / A, and the second application was made 30 days later at 0.0900 lb ai / A, for a total seasonal rate of 0
. 3172 lb ai / A (

- 5X the field application rate). B roadcast applications were made to the orchard floor using ground equipment , in 12- 25 gal/ A spray volumes w ith a crop oil concentrate (COC) or non-ionic s urfactant (N IS ) as an adju vant. Samples were harvested at commercial maturity , at PHis of 56-61 days. Res idue decline w as not investigated. Samples were maintained frozen at the te stin g facilities, durin g shipping, and we re stored frozen at the ana l ytical laboratories until analysis. The maximum storage duration for sample s between harvest and extraction was 342 days (11.3 months). For further details on these storage stabi lity data, see Section 5.2. Samples were analyzed for residues of penoxsulam u sing LC/ MS / MS. Th e LOQ was 0.0 l ppm. The LOQ was determined as the LLMV. Acceptable method validation and concurrent recovery data were reported for samples of pome fruit matrice s fortified with penoxsulam at 0
. 0 l and 

### O.l O ppm, thus validatin g th e method. The fortification levels used in method validation and concurrent method r ecove ry were adequate to bracket expected res idu e lev e ls. Concurrent recoveries and residues in treated samples were not corrected for apparent r es idue s in contro ls . A s ummary of the residue data is presented in Table 5.3
. 1.1 , be lo w. Following two soi l directed applications of a 0.083 lb ai/ ga l SC formulation of p enoxs ulam at a total application rate of 0.0611-0.0643 lb ailA, residues of penoxsulam were below the LOQ (<0.0 I ppm) i n/on all samples of apples and pears harvested at PHi s of 56-61 days. The maximum total application rate used in these trials is

- l .2-1. 3X the maximum pro po sed seaso nal application rat e. Residues were also below the LOQ in/on apples from o ne trial harv ested at a 60-day PH I following application at 0.3172 lb ai / A (5X th e rate used in the corresponding field trials).

Page 15 of 25Penoxsulam Summary of Analvtical Chemistry and Residu e Data DP Barcode D425013 Tab le 5.3. 1. 1. S umm ary of Resid u es fro m Pome F ru it F i el d Tria ls w i t h Pe n oxsu lam. Crop M atrix Analyte Total PHI nl Re s idue s (ppm) Application (days) Min. 2 Max
. 2 LAFT J HAFT 3 Median 3 Mean J SD 3 Rat e (lb ai / A) Apple Penox s ul am 0.0624-0
. 0643 56-6 I 4 < 0.0 1 < 0.0 1 < 0.0 1 < 0 .0 1 0.01 0.01 0 0.3 172 60 I <0.0 1 <0.0 1 < 0.0 1 <0.0 1 0.01 0.0 1 0 Pe ar 0.06 I I

- 0.0638 60 2 <0. 0 1 < 0
. 0 1 < 0.01 < 0
. 0 1 0
. 01 0.0 1 0 1 n = numb er of li el d trial s. 2 Values b ased on total number of samples. 3 Values based on per-trial average s. LAFT = lowest average lield trial. I I AFr = highest average lield trial. SO= s tandard deviation
. Fo r comp ut ation of the LAFT. I IAf-T. median. m ean. and s ta ndard dev ia ti o n. values < LOO are a ss umed to be at the LOQ (0.0 1 ppm). 

### Pome Fruit Co nclusions: OCSPP Residue Chemistry Test Guideline 860.1500 (Table I) requirements indicate that 18 trials are needed for a pome fruit cro p group tolerance , with 1 2 trials on apple and 6 trials on pear. Howeve r , HED previo u s ly concluded that six tota l pome fruit tri a l s (4 apple , 2 pear) for penoxsulam would be adequate, assuming that all residues we re below the LOQ of0 .01 ppm (Minutes of the 9/ 1 / 20 10 C hemSA C M eetin g)
. Therefore , g iven that the su bmitted six field trial s all had res idues below the LOQ , the submitted field trial data i s adequate to support th e proposed pome fruit crop group tolerance at 0.01 ppm. An acceptable method was used for residue quantitation , and adequate storage s tability data are available to support the samp le storage conditions and durations. 

### S ton e Fru it: A total of nin e stone fruit field trials were conducted in the United States during the 20 1 2 and 20 1 3 growing seasons. Three sweet cherry field trials were conducted i n NA 

### FT A Growing Zones 5 (MT; 1 trial) , I 0 (CA; I trial) , and 11 (WA; 1 trial ); one sour cherry field trial was conducted i n Zo n e 5 (M I ); two peach trial s were conducted in Zo ne s 2 (NJ; 

### l trial) and 10 (CA; I trial) ; and three plum field trials were conducted in Zo ne s 5 (M I ; I trial) , l 0 (CA; l trial) , and 12 (O R ; l trial). The Agency previously determined (Minutes of the 9/ 112010 ChemSAC Meeting) that a reduced number of trials (4 for cherry , 2 for peaches , and 2 for plum) would be acceptable, based on the expectation that residues would be nondetectable. Each field site consiste d of one untreated plot and one treated plot. Each treated plot received two soil directed app li cat ions of th e 0.083 lb ai/ gal SC formulation of penoxsu lam ( PindarTM GT) , an MAI fo r mulation that a l so co ntain s oxyfluorfen at 3.93 lb ai / gal. Dat a and information pertaining to oxyfluorfen are not addressed further herein. The first a pplicati on was made at 0.0447-0.0563 lb ai/ A , and the seco nd application was mad e 26-33 days later at 0.0178-0
. 0198 lb ai / A, for a total seasonal rate of 0.0629-0.0752 lb 

### ail A. Br oadcast application s we re made to the orchard floor using ground equipment, in 15-27 gal/ A s pray volumes with a COC o r NlS as an adjuvant. Samples of cherries , peaches , and plums were harvested at commercial maturity , at PH ls of 51

- 63 days. Additionally, at one plum trial (CA40) an add iti o n al sample was co ll ected at a 63 -d ay PHI an d was processed at the field site to produce dri ed plum (prune). Residue decline was not inve st igated
.



### Pa ge 16 o f25Penoxsulam S ummary of Analytical Che mi s try and R es idu e Dat a DP Barcode D 4250 1 3 

### Samples we r e maintained fr ozen at the testin g facilities , during s hippin g, and we re sto red frozen at th e analytica l laboratories until analy s is. The maximum s tora ge duration s for samp le s betwee n harv es t and extraction were 3 8 9 da ys ( 12 .8 month s) for fres h sto n e fru its and 32 1 day s ( 10. 6 month s) for dri e d p lum. F o r furth er details on these s tora ge stabil ity data , s ee Section 5.2. Samp le s were analyzed for res idu es of pe noxsulam usin g LC!MS/MS. The LOQ was 0.01 ppm. The LOQ was determined as the LLMV
. Acceptable me th od validation and concurrent recovery data were repo rte d fo r sampl es o f stone fruit matric es fo rtifi e d w ith penoxsulam at 0.0 1 and 0.10 ppm , thu s validatin g the method
. The fo1tification l ev el s u se d in m e thod va lidation and conc urrent method recove ry were adequate to bracke t expected residue levels. Concurrent recoveries and r es idu es in treated samples were not corrected fo r apparent r es idues in controls. A s umm ary of th e re s idue data i s presented in Tabl e 5.3.1.2. bel ow. Following tw o so il direc ted ap pli ca tion s of a 0.083 lb ai /g al SC fo rmulation of penoxsulam at a total application rate of 0.0629-0.0752 lb ai/A, residues of pe no xsu lam were below th e L OQ (<0 .01 ppm ) in/on all s amples of ch e rri es (swee t and so ur), p eac hes, and plum s harv ested at PHi s of 5 1-6 3 da ys. The maximum total app lication rate used in these trials i s - l 

### .3-l .5X the max imum proposed seasonal app li cat io n rate. Res idues we re a ls o below the LOQ in dried plum proc esse d from plums harv es ted at a 63-day PHI. The registrant did not perform an exaggerated rate st ud y to determine res idue conce ntration during processing of plum s to dried plums. R es idue s in a ll RAC samp le s were < LOQ , ho wever.

Table 5.3. J. 2. Summary o f R esid u es from S tone Fruit Fiel d Tria ls wit h Penox su lam . Cro p Matrix Analytc Total PHI n1 Residues (ppm) Application (days) Min
. 2 Max. 2 LAFT3 ll AFT3 Mcdian 3 Mean 3 SD 3 Rate (lbai / A) Che rry. sweet Pcn oxsulam 0.0629

- 0 .0 752 51

- 6 1 4 <0 .0 1 <0 .0 1 <0.01 <0.0 1 0.0 1 0.0 1 0 and so ur Peach 0.0639

- 0.0644 57 2 <0.0 1 <0.01 <0.01 <0.0 1 0.0 1 0.0 1 0 Plum 0.0642-0.0672 52

- 63 3 <0 .0 1 <0 .0 1 <0.01 <0.0 1 0.01 0.0 1 0 1 n = numbe r of field tria l s. 2 Values bas ed on tota l number of samp les. 3 Values bas ed on per- trial averages. LAFT = lowest average field trial. 11 /\FT = hi g hest average fie l d tri a l. SD = standard deviation
. For computation of the LAFT. 11/\FT. median. mean. and s tandard deviation. values < L OQ arc assumed to be at the LOQ (0.01 ppm). 

### S ton e Fruit Co nclusions: OCSPP Res idue C hemi stry T est Gu id e lin e 8 60 .1 500 (Tab le I ) re quirem e nt s indi cate that 21 tri a l s are nee d e d for a s ton e fruit crop grou p tolerance , with 6 che rry trials , 9 p eac h trials, and 6 plum (or fresh prune) trial s . How eve r , H ED previou s ly co nclud ed that eight total sto ne fruit trial s (4 for c herry , 2 for peaches , and 2 fo r plum) for penoxsulam would be ade qu ate , assumin g that a ll residues we r e below the LOQ of 0.0 I ppm (Mi nute s of the 9/1/20 1 0 ChemSAC Meeting)
. Therefore, g iven th at the sub mitted nin e field trial s (4 che rry, 2 peach, 3 plum ) all had re s idue s below the LOQ , the submitted fi e ld trial data i s adequate t o su pp ort the proposed sto ne fruit crop group tolerance at 0.0 I ppm. An acceptable

Pa ge 17 of 25Penoxsulam Summary of Analvtical C hemistrv and Residue Data DP Barcode D425013 

### method was used for residue quantitation , and adequate storage stability data are available to support the sample storage conditions and durations. Fruit , s mall , vi11 e cl imbi11 g, s ubg ro u p 1 3

- 0 7F, exce p t f u zzy k i wifru it : 

### Dow AgroSciences previous l y submitted crop field trial data for penoxsulam on grape. Four grape field trials were conducted in the United States in Zones I (NY; l trial) , I 0 (CA; 2 trials) , and 11 (WA; l trial) , during the 2007 growing season. At eac h test location, two so il applications were made with a 25 g/ L oil disper s ion (OD) formulation of penoxsulam. The first application was made nea r the end of the grape vine dormant stage (bud swell; BBCH 0-5) at a target rate of 0.0357 lb ai/ A, and the second application was made 81-130 da ys later , during th e growing stage (BBC H 77-79) , at a target rate 0.0179 l b ai / A, for a total seasonal rate of

- 0
. 054 l b ai/ A. The application rates used in the study correspond to
- 1. lX the max imum registered rates for applications at the dormant and growing stages , and to
- l .2X the maximum registered seaso n a l rate. Broadcast app l ications we re made to the v ineyard floor, using ground equipment , 

### in

- 20-26 gal/A s pray volumes with a COC as an adjuvant. Samples of untreated and treated grapes were harvested at commercial maturity , 59

- 60 day s after the last applicati on. Grape samples were ana lyzed for residues of penoxsu lam usi ng LC/ MS / MS Method O RM 04.09. The method is adequate based on acceptable concurrent method recoveries. The validated LOQ is 0.0 I ppm for grapes . The s torag e stability data for grape submitted in conjunction with this previous l y submitted petit ion adeq u ate ly suppo r ted the storage co nditions and durations of samples from the grape field trial s . The resu l ts of the grape fie ld tria ls are summa r ized in Tab le 5.3. l.3. Residues of penoxsulam were nonquantifiable (<0.0 1 ppm) in/on all samples of grape harvested 59-60 days follow i ng two soil broadcast applications of the 25 g/L OD fomrnlation at a total rate of 0.054

- 0
. 056 lb ai / A.

Tabl e 5.3.1.3. S u mm ary o f R es idu e D a t a fro m Cro p Fi e ld Tri a ls with P cnoxs ul a m . Crop matrix Total Applic. PH I Residue Levels (ppm) Rat e (days) n Min. Max. HAFT 1 Median Mean Std. (lbai / A) Dev. Grape 0.054-0.056 59-60 8 <0.01 < 0.01 <0.01 <0.01 < 0.01


### -- Fruil. small. vine climbing, subgroup 13-0 7 

### F. excepl (uzzv kiwikuil Conclus i ons: Based on the availab le , prev i ous ly submitted data o n grape , HED concludes that there is adequate data to support the crop group tolerance at 0.01 ppm for fruit , s mall , vine climbing , subgroup l 3

- 07F , except fuzzy kiwifruit. Tree N u t Co 11c/ 11 s io11 s: 

### Data was previously s ubmitted and r eviewed for tree nuts ( 0 3359 14 , M. D ohe 1 1y , 0 1/29/2009) and a tole r ance at 0.01 ppm was established. The use patterns, application 

### Page 1 8of 2 5Penoxsulam Summary of Analytical Chemistry and Residue Data DP Barcode D425013 

### rates , and representative commodities are the same for tree nut group 14 and tree nut group l 4

- 12. Therefore , H E D recommends in favor of allowing the conversion. 

### Olive and Pomegranate Conclusions: HED previously concluded that field trial data from pome fruit and sto ne fruit could be used to s upport tolerances on o li ve and pomegranate, assuming that no quantifiable residues we re observed in any of these field trials ( H E D ChemSAC minutes, 09/ 01 / 2010). Based on the pome and s tone fruit field trial data reviewed for this petition , with no residues observed above the LOQ of 0.01 ppm, there is adequate data to support the proposed tolerances of 0.01 ppm on olive and pomegranate. 

### 5.3.2 Field Rotational Cro ps (860.1900) Because the proposed u ses are all orchard crops , and th erefore are not rotated. no data pertaining to rotati onal crops and no rotational crop restrictions are required to support the propos ed uses. 

### 5.3.3 Processed Food and Feed (860.1520) MRID 49472601.der

- Pome Fruit Field Tria ls MRID 4947260 2 .de r - Sto n e Fruit F i eld Trial s MRID 47444403.de2.doc

- Grape Pr ocess in g 

### Separate processing studies were no t submitted as part of the petition currently under review. HED previously concluded that as l ong as all field trial residues were below the LOQ of 0
. 01 ppm , the reduced s ubmitted data set on pome fruit and sto ne fruit would be adequate to s upp ort the proposed uses on pome fruit , stone fruit, olive , and pomegranate (HED ChemSAC minutes, 

### 091 0 I 

### /20 I 

### 0)
. In one of the apple field trials an exaggerated use rate was used (5X). with no quantifiable residues being observed in this trial. In addition , in a single plum field trial , conducted at
- l .3X the proposed maximum seaso na l use rate , residues were also be low the LOQ in dried plum processed from plums harve sted at a 63 -d ay PHI. Finally, it is noted that in th e previously reviewed grape processing study (

- 5.8X the registered maximum seasonal rate for grape), there were no quantifiable residues in e ith er the grape RAC or in the grape processed commodities. Therefore, HED concludes that the avai lable data are adequate and that separate tolerances for processed commodities are not required for the proposed uses. 

### 5.3.4 Meat , Milk, Poultry and Eggs (860.1480) PP # S F7 012 ; DP # 326985, 1/30/07, D
. So d erberg 

### No animal feeding studies were submitted with this petition. The onl y livestock feedstuff associated with the proposed us es is app l e , wet pomac e , which may be fed to dairy cattle ; apple wet pomace is not considered a significant feedstuff of beef cattle, poultry , or sw in e. In addition, the only live stock feed item associated with the registered uses is a lm ond hulls, which may also be fed to dairy cattle; almond hulls are not considered a sig nificant feedstuff of beef cattle , poultry , or swine.

Pa ge 19 of 25Penox s ulam S umrnarv of Analvtical Chemi s try and Residue Data DP Barcode 04 25 013 

### A dietary burden for cattle, poultry , and sw ine was p r ev io u s ly calcu lated based on the contribution of penox s ulam resulting from rice and aquatic use s (PP#5F70 1 2; D P # 326985, I/ 30 / 07 , D. Soderberg). Dietary burdens of 0.220 ppm for beef and dairy cattle, 0. 1 70 ppm for poultry , and 0.166 ppm for swine were calculated , with the greatest contribution to each dietary burden (0. 150 ppm) coming from treated water. HED concluded that if no inadvertent res idues occurred in crops i rr igated with penoxsu l am-treated water, the aquatic u ses of penoxsulam could r es ult in a 40 CFR §I 80
. 6(a)(3) s ituation for ruminant and poultry commodities; i.e ., th e re wou ld be no reasonable expectation of finite residues in ruminant a nd poultry co m modi t ie s and no ruminant or poultry feeding study would need to be s ubmitted. Thi s conclusi o n was considered t e ntative , pending submission of a study on the magn itud e of the re s idue in i rrigated crops to s upport th e aquatic u ses. If significant re s idue s are found in crops irrigated with p e nox s ulamtreated wa t er , th e n li ves to c k feeding st udies ma y be required. Based o n th e available crop field trial s for the ex isting and proposed use s, the d i etary contribut ion of almond h ull s and app le w e t pomace to th e dairy cattle dietary burd e n would be minimal (0 .002 ppm). Th ese calculations are su mmarized in Ta ble 5.3.4 , below. Therefore , livestock tolerances are not required for the proposed uses , as the re is no expectation of fi ni te res idu es in live s tock commodities. T a bl e 5.3 .4. Ca lcu l ati on o f Li ves toc k Di e ta ry Burd e n fo r Pe n oxs ul a m 4 C r o p Co mm o d ity T y p e 1 R es id u e % DM 2 %D iet Di et ary Co ntribution 3 p pm input (pp m) Bee f Catt le Untreated feed NA NA NA NA NA 100 0 T ota l NA NA NA NA NA 100 0 Dair y C att le Apples P omace , wet 

## cc 0.01 Median 40 10 0.002 Untrea ted feed NA NA NA NA NA 90 0 T o t a l NA NA NA N A N A 1 0 0 0. 00 2 P o ul try Untreated feed NA NA NA NA NA JOO 0 T ota l NA NA N A NA NA 1 00 0 Sw in e Untreated feed A NA NA NA 100 0 T o t a l NA N A NA 1 00 0 I
. R = Roughage; CC = Carbohyd rat e Concentrate ; P C = Pr otein Conce ntrate. 2. % DM = P e rcent Dry Matter. 3. Contribu t ion = ([STMR or**HR ~**  % OM] x % diet) for beef and dairy cart l e. Contribution = (ST MR or HR x % di e t) for poultry and s win e. 4. Revi s ions o f Fe e dstuffs in Table I o f OPP TS T e st G u ideline 860
. / 000 and Guidanc e on Cons tru c ting Maximum R easonab l y Balan ced Diets (M RBD). ; Chem SAC memorandum ; 30 June 2008.

Page 20 of 25Penoxsulam S umma ry of Analytical Ch emi stry and R esi du e D a

ta D P Barcode D 4250 13 

### Co nclusio ns. No add i tional data are required to su pport th e proposed uses of penoxsulam currently under review. Based o n th e availab le crop field t ri a l results, the dietary contribution of a lm ond hull s and apple wet pomace to the d ai ry cattle di eta ry burden w o uld be minima l (0.002 ppm). Th e refo r e , HED conti nu es to co nclud e that li vestock tolerance are not required, as there i s no ex pectation of fin ite res idue s in li ves tock commodities ( i .e. , there i s a 40 

### CFR 

### § l 80.6(a)(3) situati o n ). 

### 5
. 3.5 F ood H a ndlin g ( 860
. 14 6 0) T here are n o proposed u ses that a re relevant to this g uid e li ne topic
. 

### 5.3. 6 W a t e r , F i s h , a nd Irri gated C r op s ( 860
. 1400) There are no proposed uses that a re relevant to this gu id e l in e topic
. 

### 5
. 4 F ood R es idu e Pro file The data s u bmitted in s upp ort of the curren t action (PP#4E8330) along with prev iou s ly r ev iewe d data , are adequate for purp oses of ri sk assessment and tolerance assess m ent for the proposed u ses und e r review. 

### HED previou s ly co nclud e d that as l ong as a ll field trial residues were below the LOQ of 0.0 1 ppm , the reduced subm itted data se t on pome frui t and sto n e fruit wou ld be adequate to support the proposed u ses on pome fr ui t, stone fruit, o li ve, a nd pomegranate 

### ( H ED C h e m SAC minutes , 09/ 0 1/20 10 ). R es idu es were a ll below the LOQ (0.0 1 ppm) in subm itted pome fru it and sto ne fruit field trials. Thes e dat a are a d eq u a te to s upp o rt th e proposed tolerances at 0.01 ppm in pome fruit, stone fruit, o li ve, and pom egranat e . 

### In add ition, based on prev iou s ly su bmi tted data , th e proposed crop group conversion fo r tree nuts (fro m gro up 

### 14 to gro up 14

- 12) is appropriate and the dat a on grape i s adequa te to support a crop group tolerance at 0.0 I ppm for fru it , small , vi n e climb i n g, su b gro up 1 3 -07 F , except fuz zy k iwifruit. Due to the lack of quantifiable residues in the availab le field trial data , re sid u e declin e co uld n o t be assessed over time. Quantifiable residues are not anticipated i n live s to ck commod ities , a nd l i vestock to le ran ces ha ve not been estab li shed and are not required based o n the proposed uses. Quantifiable res idu es of penoxsulam are n ot expected in rotational crops , g iven that all of the existing and registered crop s are orchard crops.


### 6.0 Tol eran ce Deri vati on Given that all fi eld trial residues were below the LOQ of 0.01 ppm , tolerances a re be in g se t a t 0.01 ppm in the proposed commodities. Adequate fie ld trial data were subm itted in s upport of the proposed u ses.

Page 21 of 25Penoxsulam Summary of Analvtical Chemistry an d Residue Dat a DP Barcode D4 250 13 

### The rationales fo r the establishment o r revision of to lerance s associated w i th the current action are li sted in Table 6, below. An 

### International Residue Limit Statu s sheet is appended as Attachment 1. T h e re are no Codex, Canadian or Mexican MRLs estab l ished for residues of penoxsulam on any crops, includi ng those under rev i ew for this petition. Therefore, there are no harmonization is sues with resp ect to the proposed agricultu ral uses.

T A BL E 6
. T o lera n ce S u mm ary fo r Pe n oxs u la m (40 C FR**.6 5).** 

Pr o p osed o r Ex is t in g* P r o po se d o r Ex is t in g* Reco mm e nd e d Co rr ect Comm odity De fi11 itio11 ; Co mm odi ty To lera n ce ( ppm ) T o le r a n ce ( ppm ) Co mm e nts Fruit, Pome , group I 1-10 0.01 0.01 Fruit, pome, p;roup 11 - I 0 Fruit, Stone, gro up 12-12 0.01 0.01 Fruit. s ton e, group 12-12 Fruit , small, vine 0.01 0.01 Based on available data on g rape . climbing , s ubg roup 13- 07F. except fuzzy kiwifruit Nut, Tree group 14-12 0.01 0.01 Nut, fr ee, group 1./-12; Co nvers ion from tr ee nut group 14. Olive 0.01 0.01 Based on sub mitted s ton e fruit and Pomegranate 0.01 0.0 1 pomc fruit field trial data. Nut, tree, !?TOUP 14 0.01 • Remove Conversion to tree nut gro up 14-1 2. Grape 0.01 • R e move Replace with tol e ranc e on fruit, small, vine climbing, subgroup I3-07F, except fuzzy kiwifruit. Pi stachio 0.01• Remove Replace with the tolerance on tree nut gro up 14-1 2. 

### * A tolerance is currently es tabli s hed at the listed tolerance level in the corresponding commodity. 

### R e fer e n ce s P enoxsulam. Section 3 Registra tion Application for Us·e o.fGF-443 SC in Aquatic Sites and R eques t for a Tolerance Exemption (PP# 5F70 12) on Fish and Shellfish. Summmy of Analytical Chemistry and Residue D ata; 0326985 ; 0. Soderberg ; 1/30 / 07 

### PP# 3F6542. New Che mi cal

- Penoxsulam (XDE-638) inion Rice. Request for Petition Me/hod Validation; 0303172; W. Cutc hin: 7 / 19/ 04 

### Penoxsulam. Section 3 Reg istration Applicat ion For Use ofGF--143 T&V on Grape and Tree Nuts Includin g Pistachio. Su mma1 y of Analytical Chemist1y and R es idue Data; D355914; M. Doherty ; 29 January 2009
. 

### Penoxsulam : Revised Human Health Risk Assessment for Proposed Uses on Grapes and Tree Nuts; D 3639 IO; C. Swartz; 9 April 2009

Page 2 2of25Penox s ulam Summarv of Analvtical Chemi stry and R es idue Data DP Barcode D42SO 13 

### Penoxsulam Drinking water exposure concentrations for th e proposed new us es on pom e fi-ttit group 11-10 (plus oliv e andpomegranate). s tone fru i t group (12-12) , conve r sion of nut tree group 12 to tree nu/ group 14

- 1 2, and group ex pansion from grapes to include sma/lfruil vine climbing subgroup (13-07 F) and updaled assessm en l for drinking waler expo s ure for !h e other uses. 04284 1 9; J
. Wolf; 28 Aug 20 1 5. 

### Minutesfrom ChemSAC meet ing ; Chem istry Science Adv i sory Council (ChemSAC), Health Effects Division (HED), Office of Pesticide Programs (O P P), Office of C h e mi cal Safety and Pollution Prevention (OCSPP), USEPA; I 

### September 2010. 

### Revis ions of F

eedstuffs in Table 1 of OP PTS Test Guideline 8 60.1000 and Guidance on Cons tructing Maximum Reasonably Balanced Diets (M RBD).; ChemSAC. HED/ OPP / OCS P P/USEPA; 30 June 2008.


### Atta ch m e n ts Attachme nt 1: Inte rn at i ona l Res idue Lim it S tatu s s heet. Attachment 2: Chemical Names and Structures of Penoxsulam a nd Metabo li tes .

Page 23 of 25Penoxsulam Summary of Analytical Che mi strv and R esidue Data DP Barcode 04 250 13


### Attachment 1: Internationa l Residue Limit Status 

### Penoxsulam (11903 l ; Request D ate: 26 Aug u st 2015) Summarv of US and International Tolerances and 

### Maximum Residue L imits 

### Residue Definil ion: 

# us Canada Mexico 2 Codex 40 CFR 180.605: None No n e Plant: penoxsu lam (2-(2,2-d ifluoro ethoxy)

-N- (5, 8-dimethoxy[ l ,2,4] triazolol l , 5-c]pyrimid in2

- yl)-6

- ( triflu orome th yl)be nzenes ulfonamide) 

### Tolerance (ppm) / Maximum Residue Limit Commodity'**(mg k~)**  

# us Canada Mexico 2 Codex Fruit , pome , group 11- l 0 0.01 Fruit , sto n e, group 1 2 -1 2 0.01 Fruit , small, vine climbing , subgroup 0.01 l 3

- 07F, except fuzzy kiwifruit Nut, tree, group 14-12 0.01 Olive 0.01 Pomeg ran ate 0.01

Completed: M. Negussie ; 09/ 03/15

1 I

ncludes only commodities of intere s t for thi s action. Tolerance values should be the HED recommendation s and not tho se proposed by the applica nt.
2 Mexico adopts US tolerances and/or Codex MRL s for it s export purposes.

Pa ge 24 of 25Penoxsulam Summary of Analytical Chemistry and Residue Data Attachment 2. C h e mical Na mes and St ru ct ure s o f Pcnox s ul a m and Metabolit es. Common nam e: Compan y code P

enoxsulam: XDE-638

Penoxsulam-5-0H; 5-0H XDE-638

Pen oxsu lam-5,8-DiOH: Di-OH XDE-638 Chemic al name 2-(2 , 2-difluoroethoxy)-N-(5 , 8- dimethoxy[ I,2,4] triazolo[ 1 ,5-c] pyrimidin

-2-yl) -6- (trifluoromethyl) benzenesul fonam ide

2-(2,2-di flu oroetheoxy)-N

-(5,6

- dihydro-8

- methoxy-5- oxo[ 1 ,2,4]triazolo[ 1,5-c]-pyrimidin2-y l)-6-(tri tluorometh yl)- benzenesul fonam ide

2-(2,2-difl uoroethoxy)- N- [ I ,2.4]triazolo[ 1,5-c ]pyrimidin-2-yl6- (trifluoromethyl)benzenesul fonam ide



### Page 25 of 25 Chemical structure DP Barcode D425013Penoxsulam (PC Co de 1190 3 1 ]/I

nterreg ion a l R esea rch Pr oject No. 4 ( IR-4) 

### B.7 .6 Residues Resulting from Supervised Trials (An nex IIA 6.3; Annex IHA 8.3) B. 

### 7.6
. 1 Residues in Target C rops B
. 7.6
. 1.1 Pome Fruit D oc ument ID : MRlD No. 49472601 PMRA No. Not Available 

### R eport: Arse no vic , 

### M. ( 2014) Pen ox sulam + Ox ytluorfen: Magnitud e of the Residue on P o me Fruits. Laboratory Project ID : l 0944. l 3 -WUR02. Un publish e d s tudy prepared by IR-4 Project. 171 p . 

### Guidelines: E P A OC S PP Harmoni zed Test Guidelin e 8 60. 1 50 0 Crop F ield Trials (Aug u s t 1996) PMRA Regul ato ry Directive DIR 98-02

- Res idue C hemi stry Guidelines, Sec ti o n 9

- Crop F ie ld Trials PMRA Regulatory Directi ve D IR20 l 0-05

- Revis ion s to the Residue C hemi st r y Crop Fie ld Trial Re quire ment s O EC D Gu id e lin e 5 09 C rop Field Trial (Septe mber 2009) 

### GLP Com pliance : No deviations from re g ulatory r equi reme nts we re re ported which would have an impact on the validity of the study. 

### Acc eptabili ty: The s tud y i s cons id ered full y reliabl e. T he accep tabi l ity of this stu d y fo r regu latory purpos es i s ad dressed in the U .S
. EPA R es idu e Ch e mi s try Summary Do c um e nt , 042 50 1 3 , E. Holm an , 12/ 04/ 20 15. 

### Evaluator: Douglas A. 

### D o tson , Ph.D. , C h e mi st /).**j)~** Note: Thi s Darn Evaluation Record ( DER) was originally prepared under contract b y Versar. Inc. (68 5 0 Versar Cente r, Springfield. VA 2215 1 ; s ubmitted 3 / 1 O f 1 5)

. Th e DER has been reviewed b y I ! ED and revi sed to reflect current Otlice of Pe s ticide Pro g ram s (O PP ) policies
. 

### EXECUT IVE SUMMARY T he Inte rregional Research Pro ject Number 4 ( IR -4) s ubmitted field trial d ata for the sulfonamide herb icide , penoxsulam, on pome fruit from six fi e ld trial s conducted in the U nite d States during the 2012 and 20 1 3 growin g season s. F o ur apple field trials we re cond ucted in the North Americ an Free Trade Agree me nt (NAFTA) Growin g Zones 2 (NJ ; 1 trial) , 5 (M I ; l tri a l ), and 11 ( ID and WA ; 2 trial s), and two p ear trials were conduct e d in Zones I 0 (CA ; I tri a l ) a nd 11 ( ID; I trial). The Agency prev i ous l y determined (Minutes of the 9/ 1/ 20 10 C he m SAC M eetin g) th at a redu ced number o f trial s (4 fo r apple and 2 for pear) would be acceptable , based on the ex p ec tation that r es idues wo uld b e nondet ec table. Eac h fi e ld s ite co n s i s ted of one untreated plot and one treated plot. Eac h treat ed plot received two soil directed applications of the 0.083 lb ai/gal s u s pen si on concentrate (SC) formulation of penoxsulam ( Pind arTM GT) , a multipl e active ingredient (MAI ) formulat ion that also contains ox y fluorfen at 3. 9 3 lb a i / gal. D ata and in formation pertaining to oxytluorfen are not addre ssed further herei n. T he fir st applicatio n was mad e at 0.0434-0.0459 lb ai/A , an d th e second application was m ade 28

- 30 day s later at 0.0 177- 0.018 6 lb ai / A , for a total seaso nal rate of
EPA MRID # : 4947260 1 Page I of7 PM RA # of document: Not Avai I ablePenoxsulam [PC Code 119031 ]/Interregional Res earch Project No. 4 ( IR-4) 

### 0.0611-0.0643 lb 

### a ilA. At one trial ( IO 17) , an add ition al plot was treated at an exaggerated rate: the first application was made at 0.2272 lb a i / A, and the seco nd application was made 30 days later at 0
. 0900 lb ai / A , for a total seasonal rate of 0.3172 lb ai/ A (

- 5x the field app li cation rate). Broadcast applications were made to the orc hard floor using gro und equipment, in l 2-25 gal/ A spray volumes with a crop oil concentrate (COC) or non-ionic surfactant (NIS) as an adjuvant. Samples were harvested at commercial maturity , at preharvest intervals (PH i s) of 56-61 days. Residue decline was not in vestigated. Sa mpl es were maintained frozen at th e testing facili ties , during s hippin g, and were stored fro ze n at the analytical laboratories until analysis. The maximum storage interval for san1ples between harvest and extraction was 342 days (l 

### 1. 3 months). Samp le s were analyzed within l day of extraction. To support sample storage durations , a concurrent storage stability study was conducted with the field trial study. The data demonstrate that res idu es of penoxsulam were stable in/on fo rtifi ed samples of apples stored frozen for up to 349 days; however , no 0-day data were provided. Thes e data are acceptable to support the storage conditions and durations of sampl es from the submitted field trials; however, storage stability studies should always include a 0-day sampling interval to establish the residue levels present at the time sam ple s are placed into storage (see OCSPP 860. l 380(d)(6)( i)). Samples were ana l yzed for residues of penoxsulam using a high performance liquid chromatography method with tandem ma ss spectrometry detection (LC/ MS /MS). The limit of quantitation (LOQ) was 0.01 ppm. The LOQ was determined as the lowest limit of method va lid ation (LLMV) Acceptable method validation and concurrent recovery data were reported for samples of pome fruit matrices fortified with penoxsulam at 0.0 l and 0.1 ppm , thus validat in g the method. The fortification levels used in method validati on and concurrent method recovery were adequate to bracket expected re s idue level s. Concurrent recoveries and residues in treated samp les were not corrected for appa r ent residues in controls. Follow in g two soil directed applications of a 0.083 lb ai/ga l SC formulation of penoxsulam at a total application rate of 0.0611-0.0643 lb 

### ailA, residues of penoxsulam were below the LOQ (< 0.0 I ppm ) in/on all samples of apples and pears harvested at PH l s of 56 -61 days. Residues were also below the LOQ in/on apples from one trial harvested at a 60 -d ay PHI following application at 0.3172 lb ai / A (5x the rate used in the corresponding field trials). 

### I. MATERIALS AN D METHO D S A. MATERIALS Tab le B. 7.6 .1.1-1. Nomenclatu r e for Pcnox s ulam. Common name Pcnoxsulam I dentity 2- ( 2.2-difluorocthoxy) -N- ( 5.8-dimcthox y [ I .2.4]triazolof I .5

- c I pyrimidin

- 2- y l) -6- (1rifluoromcthyl) benzcncsul fonamidc CAS no. 2197 14- 96 -2 Comoany cxoe rim enta l name XDE-638 Other synonyms (i f aoolicablc) NJ\

E

PA MRID # : 49472601 Page 2 of7 PMRA # of document: ot AvailablePenox s u larn [PC C ode 1 1 903 1 )/ In te rreg io n a l Resea rch Projec t No. 4 (I R -4) Tab le B. 7. 6. 1.1

- 1. N om e n c lat ur e for P e n o xs ul a m .



### B
. S t u dy De s ign 1. 

### Tes t P r oc edure Six field t ri als were conducted on app les and p ear s duri ng th e 20 12 and 20 1 3 growi ng seasons r eflecting two so il d i rected applications with a 0.083 lb ai/gal SC formulation of pc noxsulam (P i ndarTM GT) at a total rate of 0.061 1 -0.0643 lb ai / A. 

### At o ne tr ia l ( ID 17 ), an a ddi tiona l p lo t was treated at a total rate 0 .3172 1 b 

### ai lA for the season. Field tria l locations by N A FTA growing zone are summar i zed in T able B. 7
. 6
. 1 . l

- 2.
T a b le B. 7. 6. 1.1

- 2. T r ia l N um b e r s a n d G e o g rap hi ca l L o catio n s . Crop o. NAFTA Gro\\ingZone Total Trial s I 2 3 4 5 6 7 8 9 10 11 12 Apple Sub. 1 1 1 2 4 Req. 2 4/ 3 2 / 1 3/ 2 I/ I 1 / 1 5 1 4 16 / 12 Pear Sub. 1 I I 2 Req. 2 1 /1 3 / 2 4/ 3 8 1 6 1 Th e Agency previ o usly determined ( Minutes of the 9/1 / 20 I0 ChcmSA C Meeting) that a reduced numb er of trials (4 for apple and 2 for pear) would be acceptable. based on the expectation that re sidues would be nondctectable
. 2 As per Table 5 of 860.1500 for apple and pear: the se cond number renccts a 25% reduction in the number of field tria l s allowed for the crop as a representative commodity in support of a crop group/ subgroup tolerance or when application re s ult s in no quantifiable residue s. 

### Locations and deta i led use pattern s for the tria ls are provided in Table 8.7
. 6.1
. 1-3.

Tab l e B .7 .6. 1.1 -3
. Stu d y Use Patt e rn . Location : Ci t y. End-use Application Surfactant/ State: Year Product 1 Method of Application: Timing of Volume Rate per Retreatment Total Rate Adjuvant2 (Trial ID ) Applicatio n (gal/ A) Application Interval (lb ai /A) (lb ai/ A) (days ) Ap p le Filer. ID: 2012 0.083 lb I
. So i l directed: Maturing fruit 25 0.0440 

### -- 0 .06 24 

### coc ( 1

017) ai/ gal SC 2. So il directed: Maturin g fruit 25 0.0184 30 1
. Soi l directed ; Maturing fruit 25 0.2272 

### -- 0
. 3 172 

### co c 2
. Soil directed: Maturing fruit 25 0.0900 30 Holt. Ml: 2013 0.083 l b I
. So il directed: Fruiting 20 0.0459 

## -- 0
. 0643 NIS (M I OI) ai/gal 

### c 2
. S oil directed: Fruit 20 0.0 184 30

EPA M R ID # : 49472601 Page 3 of7 PMRA # of document: Not Avai lablePenoxs ul am [P C Code 1 1 9031 ] / Int erreg i o na l R esearch P ro

j ec t No. 4 (I R -4) T a bl e B .7. 6
. 1.1 -3. Stud y Use P a tt er n. Location : C it y. End

- u se Applicati on S urfactan t/ S tate: Year Pro du ct 1 Method of App li ca tio n: T i mi ng of Vo lu me R a t

e pe r R e trca tm ent To ta l Ra te A dju va nt 2 (Trial 1 0 ) A ppli ca ti on (gal/ A ) A pplicati on Inter va l ( lb a i /A) ( lb ai/ A) (d a)S) C r

eam R id ge , 0.0 8 3 lb I
. So il di r ec t e d : Gr ee n / s m a ll fru i t 1 3 0.0 45 2 

### -- 0
. 0 63 5 N IS NJ : 20 12 ( J 08 ) ai / g al S C 2
. Soil directed : Gr ee n fruit 1 2 0. 0 18 3 28 Pro s se r. W A: 0
. 083 lb I
. Soil di r ected : rrui t ing 18 0
. 0449 

## -- 0.0 629 IS 20 12 ( W A35 ) ai / gal S C 2
. Soil d i r ected: Fru iti ng 17 0.0 18 0 30 P ea r Dav i s , C A: 20 12 0.0 8 3 l b I
. So il direc ted : Fruitin g 22 0.04 3 4 

## - - 0. 06 1 1 

### co c (C A l 4 7 ) ai /g al S C 2
. Soil directed : F rui ti ng 23 0
. 0 177 28 Buhl. ID : 20 13 0
. 0 83 lb I
. Soil dircctc:d : Earl y fruit 20 0. 0 4 52 

### -- 0
. 0 638 IS ( ID O i ) ai /ga l S C 2. So i l d irec ted : r ruit ing 2 1 0.0 1 86 29

.. 1 Multipl e acti ve in gn: d i e nt ( M AI) s us pe nsio n co nce ntrate (SC) fom1u la ti on ( Pind ar GT) co ntainin g 0. 0 8 3 lb a 1 /gal pe noxsu lam a nd 3
. 93 lb ai /ga l o xy fluorfen
. 2 COC = cro p o il concen t rate : NIS = no n- io n ic s urfactan t. 

### A ppl es and p ea r s were g rown a nd m a intain e d acc o r d in g to ty pical ag ri c ultural pr ac ti ces . Irr igat io n w as u s e d to s up pl em e nt r ainfa ll at a ll tria l s ites w ith the except io n of th e 

### MI a nd N J s it es . 1 

### o unu s u a l we ath e r co nd iti o n s we re repo rted to ha ve a d ve r se ly affec t e d cro p g rowth or y ie lds d u ring th e s tu d y . 

### S amp l e Handlin g and Prep a ration Dupli c at e c o ntro l and tre ated sampl es of appl es and p e ars we re h arves ted 56

- 61 d ays aft e r th e la s t app li c at ion. Sample s were p laced in fro ze n s tora ge at th e field s ites wi thin 1 .5 ho ur s of harv e s t , except fo r s ampl es fro m the 2 012 C A tria l , w h ich we re tran s porte d d i rec tl y to the a n al yt ica l lab o ra t o ry, IR

- 4 Wes te rn Reg ion L a b o rat o ry at U ni ver s it y of C a l ifo rni a , D av i s ( WR L; Dav i s , C A ), on the day of ha r ves t. Sa mpl es fro m th e re m a inin g 20 12 tria ls we re s h ip p ed froze n v ia A CD S freeze r tru c k to th e WRL , w he re th ey we re ho m oge ni zed in th e pre s e nce o f dr y ice and s to re d froze n ( < - I 5 ° C)
. Sa mpl es fr o m th ese t ri al s , alon g with s ampl es prepare d for th e s t

o rag e s tabi lity s tud y , w ere s ub s equ e nt ly tran s ferre d ( within 1 97- 3 03 d ay s o f re c e ipt) v ia ACD S freeze r tru c k to th e F ood and E nv i ro nm e nta l Q u ality Lab o ra t ory (FE QL ; Ri c hl and W A) fo r a n a lys is. Sa m pl es from the 2 013 tri a ls wer e s hi pp e d via ov e rni ght air e x pre ss o n dry ice direct ly t o F E Q L. w he re th ey we r e ho m oge ni zed in th e prese nce o f dry ice . At FEQL , sample s we re s t

o re d frozen ( < -I 5 °C) until ex tracti o n for an a ly s is. 

### 2
. D es cription of Analy tical Proc e dure s Res idues of p e noxs ul am w ere d e termin e d in ap p le s and p ear s u s in g a w orkin g L C/ MS / M S me thod s i m il ar t o the me thod , · ' D e te rminati o n o f R es idu es o f P e noxs ulam in A gri c ultur a l C omm o d it ie s b y Hi gh Pe r formance Li q ui d C h ro m at og rap hy with Tandem Mass S pectro metry . " A c ompl e te d escri pti o n o f me th o d , includi ng mino r m o difi cation s , w as p rov ide d in th e s ubmi ss ion. T h e method is s im il ar to data c o ll e cti on method GRM 04
. 09 w hich w as pre vio u s ly rev iewed und e r D P # 3559 14 ( 1 / 29 / 2009 , M
. Do her ty)
.

E

PA MRID # : 49472 60 1 Page4of 7 PMRA # o f do cum ent : No t Avail a bl ePenox s ulam [PC Code 119031 ]/ Interreg ional Research Project No. 4 ( IR-4 ) 

### Briefly ,

## homo**g~nized s~p~e~** **~ere** extracted

## wit**acet~mitrij~ (A** **CN ~wat~!** **C§ ~)Q,** **:v )**  and centrifuged. An aliquot of the s upernatant was di luted with 0.1 N HCI and purified by solid phase extract ion (SPE) on Strata-XL cartridges. Re s idue s were eluted w ith AC N
. The eluate was brought to volume with a stable i sotope internal standard sol ution of [' 5 

### N- 1 3 

### C]pe noxsulam , then was furthe r diluted with ACN:methanol:water containing 0 .1 % acetic acid (15: 15:70 , v:v:v) and additional internal standard so lution. The final so luti on was analyzed by LC/MS/MS. The LOQ (determ in ed as the LLMV) was 0.01 ppm in pome fruits
. The petitioner a lso presented calculated values for the LOO and LOQ based on the recoverie s obtained at th e LLMV fort ification levels (0.0 1 ppm). The LOD was calcu lated by multipl ying the standard de v iation of recovery measur eme nts at th e LLMV by the one-tailed t-statistic (co nfiden ce lev el not reported) for seven replicates , and the LOQ was defined as 3x the LOO. The calculated LOD and LOQ were 0.00118 ppm and 0.0 0354 ppm , respectively. 

### II. RESULTS AND DISCUSSION Method performance was evaluated durin g method val idation and by use of concurrent recovery samples by fortifying samp les of untreated pome fruit with penoxsulam at 0.0 I and
. 0. 1 ppm. All recoveries were within the acceptable ran ge of 70

- 120% ; therefore the method was considered to be valid for the analys is of penoxsulam re s idue s on pome fruits (Tab le B.7 .6. 1.1-4 ). The fortificat ion level s used in method val idati on and concurrent recovery were adequate to bracket expecte d res idue l eve ls. M ethod va li dation and concurrent recoveries were not corre cted for apparent residue s in cont rol s. For determination of residues of penoxsulam, th e detector response was linear (coeffic i ent of de termination , 

## r2 2:: 0.9929 ) within the range of 0. 1- 2.0 n g/mL. Repr ese ntative chromatograms of co ntrol samp le s, fort ified sam pl es, and treated sampl es w e re prov id e d. The contro l chromatograms ge nerall y had no peak s of interes t above the chromatographic backg round. The fortified samp le c hromato g rams contained only the analyte of intere st, and peaks were sy mm e trical and well defined. Apparent res idu es of penoxsulam in contro ls were below the LOQ ( < 0.0J ppm). R esidues in treated samples were not corrected for re s idue s in controls.

Tab le B. 7.6. 1.1-4 . S umm ary o f M eth o d V a lid a tion a nd Procedural/Concurrent R ecoveries of P e n oxsu l am fr o m P o m c Fru its. Matrix 

# I Analyte 

# I Fortificati on 

# I Sample size 

# I Recoveries 1 

# I Mean :I: Std. Dev. Leve l (p pm ) ( n) (%) (%) Me tho d Validat i on App le 

## I Penoxsulam 

## I 0.0 1- 0. 1 

## I 6 

## I 75-99 

## I 88 ± 10 Co n c u rre nt R ecoveries Pome fruit 

### I Pen oxsu lam 

### I 0.0 1- 0. 1 

### I 6 

## I 82-116 

## I 94 ± 1 6 1 Each recovery value is the average of duplicate analyses
. Method validation and concurrent recoverie s were not correcte d for apparent re s idue s in controls
. 

### The field re s idu e samples were s tored frozen ( < -15 ° C) for a ma x imum of 342 days (11.3 month s) from harvest to extraction for anal ys i s (T able B.7.6. l. 

### l-5a ). All s amples we re analyzed withi n I day of ext raction. To s upport samp le storage du rations, a concurrent s t orage stab ili ty s tud y was conducted with the fi e ld trial study; the re s ults a re pr esented in Table B. 7.6.1.1-5b. The data demon strate that res i dues of penoxsulam were stab l e in/on fortified sa mples of app l e EPA MRID # : 494 72 601 Page 5 of7 PMRA # of d ocu m ent: Not Availab lePenoxsu lam [PC Code 11 9031 )/ Interreg ional Research Proj ect No. 4 ( IR- 4) 

### stored frozen fo r up to 349 day s. No 0-day data were provided. These data are acceptable to s upport the sto rage cond iti o n s and durations of samples from the subm i tte d field trials; how ever, storage stability studies s hould a lway s include a 0-day sampling interval to estab l ish the residue level s present at the time samp les are placed in to s tora ge (see 

### OCSPP 860. 1 380(d)(6)(i))
.

Tabl e B.7.6. I.I- Sa. S umm ary of S torage Co n ditio n s. Matrix Anal)1e Storage Actual Storage Durati o n ' Interval of Dem ons trated S torage Stabi lity Tempcrature (OC) Pomc fruit Penoxsu l am < -15 8-342 days (0.3 - I I .3 months) Re sid ue s of penoxsulam were s tabl e in/on apples s tored fTozen for up to 349 days. 2 1 Interv al from h arvest 1 0 extracuon. Samples were ana l yzed within 0- 1 da ys of extraction. 2 Refer to Table B.7.6. 1 .1-Sb.

Tab le B. 7.6. 1.1- Sb. S tabilit y o f P e n oxs ul a m Re s idue s in Apple S tore d Frozen (<-15 °C)
. Commod i ty /\nalyte S pike S torage Fresh Fortification Stored Sample Mean Co rrected % Level interval Recove ry(%) Recoverie s (%) Recovery(%) recovery 1 (pp m) ( days) Appl e Pcnoxsulam 0. 1 349 97 98, 108
. 1 22 109 11 3 1 Co rrected for recovery in the freshly fortifie d samp le
. 

### The resu lts from the submitted field tria ls are presented in Tab les B. 7.6. 1 .1-6 and 8.7.6.1.1

- 7. Following two so il directed applicat ions of a 0.083 lb ai / gal 

### SC formulat ion ofpenoxsulam at a total application rate of 0.0611-0.0643 lb ai / A, residues of penoxsulam we re below th e LOQ (<0.01 ppm) in/on all samples of apples and pears harve sted at PH I s of 56

- 6 1 da ys. Residues were a lso below th e LOQ in / on app les from one trial harvested at a 60-day PHI fo llowin g application at 0.3172 lb ai / A (Sx the rate used in the corresponding field trials).

T ab le B.7. 6. 1.1 -6
. R es idu e Dat a fr o m P o me Fruit Field Trial s with Pcnox s ulam. 1 Location: Ci t y. State; Year Zone C rop Commodity Tota l Rate PHI Residue s (ppm) 2 [ Average! (Trial ID ) Variety ( lb ail/\) (days) App le Filer. ID: 2012 ( ID 17) 11 Red Delicious Fruit 0.0624 60 NO. ND [ <0.0 1) 0.3172 60 ND. ND [ <0.0 1) Holt
. Ml: 2013 (MIOI) 5 Thome Empire Frui t 0.0643 6 1 ND, ND [ <0.0 1] Cream Rid ge. J: 20 1 2 (N J08 ) 2 R o me Frui t 0
. 0635 56 ND. N D [ <0.0 1) Pro sse r. WA ; 20 1 2 (WA35) II Fuji Fruit 0.0629 6 1 ND. ND [< 0.0 1) P ear Davi s, C/\; 20 I2 (CA 14 7) 10 Shinko Fruit 0.061 I 60 NO. N D [< 0.0 1] Buhl. ID: 2013 (IDOi) I I Bartlett Fruit 0.0638 60 ND. ND [< 0.0ll 1 A multiple active ingredient (MA I ) suspension concentrate (SC) formulation ( Pin dar GT) co ntainin g 0.083 lb ai/gal penoxsulam and 3.93 lb ai / ga l oxyf1uorfen wa s u s ed
. 2 ND = 1 ot detected (< L O O ). The LOQ was 0.01 ppm. and the L OO w as 0
. 00 118 ppm. Per-trial averages w er e cal c ulated by the study revi ewe r u s in g the LOQ for valu1:s rep orted as < LOQ. /\II sam ple s were ana l yzed in duplicate.

E PA MRID # : 49472601 Page 6 of7 PMRA # of document: Not AvailablePenoxsulam [PC Code 1 19031 )/ Interregional Re search Project No. 4 ( IR-4) Tab le B.7 .6. 1.1 -7. Sum mary o f Re s id ue s fr o m Po m c Fru it F ield Trial s w ith Pen oxs u lam. C rop Matrix Analyte Total PH I n l Res idu es ( ppm ) App lica1 i on ( days) Min
. 2 Max. 1 LAFT3 l-IAFT3 lcdi an 3 Mean 3 SD 3 Ra1e ( l

b ai/A) Apple Penoxsulam 0
. 0624

- 0
. 0643 56

-61 4 <0
. 0 1 < 0.0 1 <0.0 1 <0.0 1 0.0 1 0
. 0 1 NA 0
. 3 172 60 I <0.0 1 < 0
. 0 1 <0.0 1 < 0
. 0 1 0
. 0 1 0
. 0 1 NA Pear 0
. 06 11- 0.0638 60 2 <0.0 1 < 0.0 1 < 0.0 1**~H** 0.01
. 0.0 1 NA 1 n = number of field tria l s . · 2 Value s based on 101al number of**ampl~ s.**  3 Va lu e s base d on per-trial ave rage s. 1.,.A FT = lowes t average fi e ld tri a l, HAFT= hi g hest average field trial. SD = standa rd deviation
. For ' complila t foh
. of the L'AFi'

. H AFT. median. mean. and s tancfard deviation. values '< LOQ

- are as s umed to be at the LOQ{0
. 0 1 pptn) : NA :;: No t appl itable: '**~** . ··! -.-. r '" · " • .... , - • • : •• • .. .. . ·: , • : 

### Ill
. C ON CLUS IO NS The pome fru i t fiel d trials are co n sidered to be sc ie ntific ally acceptable. Follow ing two s oil directed app li cations of a 0.083 lb ai/ga l SC formulation of penoxsulam at a total application rate of 0.06 11- 0 .06 43 lb a i / A , res idue s of pen oxs ul am we re below th e LOQ (< 0.0 I 

### ppm ) inion all samp les of app les and pe ars harveste d at PHis of 56-61 days. Residues we r e also below the LOQ inion app l es from one trial har vested at a 60 -d ay PH I followin g app li cation at 0.3 172 lb 

### ai l A (5x th e rate used in the co rr es pondin g field trials). An acc e ptable method was u sed for res idu e quantitation , a nd adequate storage s tability data we re subm itte d to s upp o rt the study
. 

### REFERENCES D355914 , P e no xsulam. Section 3 Re g istration App li cation For Use of GF -4 43 T&V on Grap e a nd Tree Nuts In c l uding
. P is tachio. Su mm ary o f Analytical Chem i stry and Residue D ata , M. D ohe rt y, 1 / 29/ 2009

EPA MRID # : 4947260 1 Page 7 of7 PMRA # of docum ent: Not AvailablePenoxsulam [ P C Code 119031 ]/Interregiona l Research P r oject No. 4 ( IR-4) 

### B.7.6 R es idu e s R e s ultin g fro m S up erv is e d T ri a ls (A nn ex ll A 6
. 3 ; A nn ex IH A 8
. 3) B .7. 6
. 1 R e s idu e s i n T ar ge t C r o p s B
.7.6.1.2 Sto n e Fru i t Doc um e nt ID: 

### MRIO No. 494 726 02 PMRA No. Not Ava ilable R e p o rt: 

### Arse nov ic, M
. 

### (20 14) Pe no xs ul am+ O xytlu o rfe n: M ag nitu de o f th e Res id ue o n S tone Frui ts. Laborat ory Project ID : I 0899 .1 3-WUR O I
. Unpub li shed st udy prepa r e d by IR- 4 P r o

j ec t. 20 8 p . G uid e lin es: 

### EPA O CS PP Harm oni ze d Test Guid e lin e 860. 1 5 0 0 Crop Fie ld T ri a ls (August 1996) PMRA R eg ul a t o ry Direc ti ve O IR 98

- 02

- Res id ue C he mi s try Guid e lin es, Sec tio n 9 - Crop Fiel d T ri a ls PMRA Reg ul atory Di rec ti ve DIR2 0 I 0-05

- Rev is i o ns to th e Res id ue C he mi s try Cro p F ie ld Trial Req uire ment s OEC D Guideline 509 Crop Fi e ld Tria l (September 2009) GL P Co mpli a n ce: 

### No dev iat ion s fro m r eg ul ato ry re quire ment s were re po rted whi c h wo uld have a n impac t o n th e va lidi ty o f th e s tu dy. Acce pt ab ili ty : 

### The study is cons id ere d to be fu ll y reliab le. T he acce ptabilit y of thi s s tud y fo r reg ul a t ory pur poses is addresse d in th e U. S. E PA Res idu e Ch e mi stry Summary Documen t, 0425013 , E. H olman , 12 / 04/20 1 5. Eva lu ator : 

### Do ug l as A. Dotson, Ph.D ., C he mi s t 

# IJ.**~** Note: This Data Evaluation R ecord ( DER ) was origina ll y prepared under contract by Versar. I nc . (6850 Versar Ce nt er. Sprin gfie ld , VA 22 1 51 ; s ubmiucd 3/ 10 / 15 ). The DE R has been reviewed by H ED an d revi se d to renect curren t Omce of Pe sticide Progra m s (O P P) po licies. 

### EXEC UT I V E S UM MA RY 

### The Interregional Researc h Project N u mbe r 4 ( IR- 4) sub mitt ed fi e ld tri a l d ata fo r the s ul fo namid e he r b ic id e, pe n oxs ul a m , o n s to ne fr ui t fro m nin e fi e ld tri a ls co n d uc te d in th e Uni te d States du ring the 20 12 and 20 1 3 growi ng seaso ns. Three sweet c herry field tri a ls were co nducted i n th e No rth A meri ca n F ree Trade Ag ree me nt (NAFTA) Grow in g Zo n es 5 (M I ; I tria l), I 0 (CA; I tria l), a nd 11 (WA; I tria l) ; one sour c her ry fi e ld t ria l was con d ucted in Zone 5 (M l) ; two peach trial s were conducted i n Zo nes 2 (N J ; l t r ia l) and I 0 (CA; I trial) ; a nd thr ee plum fi e ld tri a ls we re co ndu c te d in Zo n es 5 ( MI ; l tri a l), 10 (CA; l tri a l) , a nd 12 (O R ; l tri a l ). The Agency p reviously determi ned (Mi nutes of the 911 / 20 10 C hemSAC Meeting) th at a red uced number of tr ia ls (4 fo r c he rry, 2 fo r p eac h es , and 2 fo r p lum ) wo uld be accep tab le, base d o n th e expectat io n th at res idu es wo ul d be no nde t ectab le. Eac h fi e ld s ite co ns iste d of o ne untrea t e d plot a nd one tr eate d pl o t. Eac h treate d p lo t rece i ve d two so il d irec t ed applicat io ns of the 0.083 lb ai / ga l s u s pe nsion concen trate (SC) formu lation of penoxsu l am (P inda r TM GT) , a mu lt ip le active in gred i e nt (M A I ) formul ati o n th at a lso co nta in s oxy fl uo rfe n at 3.93 lb a i /g a l. Da t a and in format i on pe rt ainin g to oxy flu orfe n are no t add r esse d
EPA MRJD ff : 49472602 Page I of8 PMRA #o f documen t : Not Ava ilab lePenoxsu lam [P C Code 1190 3 1 ]/ Int erregio nal Research Pro jec t No
. 4 ( IR- 4) furt h er h e rei n. Th e first a pplication was m ade at 0.0447-0 .056 3 lb a i / A, and the seco nd applicat ion was made 26-33 d ays later at 0.0 1 78

- 0.0198 lb 

### ai lA, fo r a total se asonal rate o f 0.0629-0.0752 lb ai / A
. Broadc as t applications we r e m ade to th e o rc h ard floor usin g gro und eq uipm e nt , in 15- 27 gal/A s pra y vo lum es w ith a crop oil co nc e ntra te (C OC ) o r n on- ioni c su rfa c ta nt (N I S) as a n adj u van t. San1ples of che rri es, p eac h es, a nd plums we r e har vested at co mm e rc ia l m aturit y, at pre har ves t inte rval s ( PHJ s) of 51-63 da ys. Additi ona ll y , a t o n e plum trial (CA40) a n add iti onal s ampl e wa s co ll ec te d at a 63-day 

### PH I and was processed a t th e fi e ld si te to produ ce dri ed plum ( prun e). R es idu e declin e was not investigated
. Sa m ples were maintain ed fro ze n at th e testin g facilities , during s hippin g, and were s to red fro ze n a t th e a nal yt ica l la b orator ies until ana lys i s . The m ax imum s torage inte r vals fo r samp les be tw een harv es t and ex tra c ti o n were 389 days ( 12
. 8 month s) for fres h sto n e fr uit s and 321 da y s (10.6 m o nth s) for dried plum. All sample s we r e a n a lyze d on th e da y of extract ion. To s upp or t sampl e s torage durati o n s , a co n c urrent s tora ge s tabilit y s tud y w a s co ndu cted w ith th e field trial s tudy. T he d a ta demonstrate th a t r es idu es of p e nox s ulam we re stabl e in /o n fort ifi e d sampl es of fres h a nd dri e d plum stored fro zen fo r up to 358 d ays; h oweve r , no 0-day data were pro v id ed. These data are acc e ptabl e to support th e storage conditions and durati o n s of s amp l es from the s ubmitt e d fi e ld tri a ls; h oweve r , storage stab ility stu d ies s hould a lw ays in clude a 0- d ay sam p lin g inte rval to es tabli s h the res idu e le ve ls prese nt at th e tim e sampl es are placed into s to rage (see OCSPP 860
. I 38 0(d) (6)( i)). Sa mpl es w e re anal yz ed fo r residues of p enoxs ul a m u s in g a hi g h performanc e li quid c hrom atograp h y method w ith ta ndem mas s spec trom e try detect io n ( L C/ M S / MS)
. The limit of quantit a tion was 0.0 1 ppm. Th e LOQ was d e te rmin e d as th e lo west limit of m e th od va lid a tion (LLMV). Acce pt ab le m e th o d va lidati o n and co n curren t recove ry dat a we re re ported for sampl es o f sto n e fruit matri ces fortified with p e no xs ulam at 0 .0 I and 0.1 ppm , thu s va lidatin g th e meth od. Th e fort ifi c ation leve l s used in m et h o d va lid a ti on and co ncurrent m e thod r ec o ve ry we r e ade quate to bracket e xpected res idu e leve ls. Co ncurrent r ec ove ri es and residues in tre ate d sampl es we re not co rre cted for appare nt res i dues in co ntro ls. Fo ll ow ing two so il directed applicat io n s of a 0.08 3 lb ai / ga l SC formula ti o n of pen oxs ulam at a to tal ap plicati o n rate of 0.0629-0.0752 lb a i/ A , resid u es of penox s u lam were b e lo w the L O Q (<0.0 

### I ppm ) in / on a ll sam p le s of c h e rri es (swee t and sour) , peaches , and plums h arvested at PHi s of 5 1- 63 days. R es idues were also be low the LOQ in dried plum proce sse d from plums h a r vested at a 63-day PHI. Th e r eg i s trant did not p e rform an exagge ra t e d rat e s tud y to d e termine res idu e concentration during process in g of plums to dried p lum s. R es idu es in all RAC sampl es were < LOQ , how eve r. 

### I. MATERIALS AND METHODS A. MATERIALS
T able B. 7.6. 1.2-1. No menclature f o r P e n oxs u l am. Co mm o n nam e P cnoxs ul a m I dentit y 2- ( 2
. 2

- diflu o roethoxy) -N

- ( 5.8-dirneth o x y [ 1 .2.4Jtriazo l o f 1 .5

- c j p y rimidin-2- y l)

- 6

- (tri fluo rom c th y l) bcn ze n e s ul fonamidc CAS n o. 2 1 97 14-96-2 Comnanv exue rim e ntal nam e XD E -638 E

PA MR ID # : 49472602 Page 2 of8 PMRA # of d oc ument : Not Avai lab l ePcnox s ulam [PC Code 11 903 1 ] / Int erregiona l Re search Projec t No. 4 ( IR-4) Tabl e B. 7.6. 1.2-1. Nome n clat ur e fo r P enoxs ul am . Other s y n onyms (i f aool i cablc) 

### I NA F I' ) 0 ,.- CH , 0 0

### ~ 

# 6:11**N~** " S N N

# l'N-1~ 0 H .....-:: 

### hN C F
. , 0 'C H 3 

### B. S tud y De s ig n 1. 

### Te s t Procedure 

### Ni ne field trials we re co nducted o n cherries (swee t and sour), peaches, and plums during the 2012 

### and 20 1 3 

### gro win g seasons refl ec tin g two so il direc ted applications w ith a 0.083 

### lb a i /gal SC formulation or pen oxs ulam (Pindar TM 

### GT) at a tota l rate of 0.06 29 -0.0752 

### lb ai /A
. Fi eld trial loca ti ons by NAFTA grow ing zo ne are s ummari zed in Tabl e B.7.6.1.2-2. 

### Two che rry trial s were conducted at the same loca tion. H ED has detem1ined that th ese trial s ar e indep e ndent as de tailed in th e table below.

Ind ependent Tria l Dete rmin ation' Crop Trial Nos. Differences Dec is ion Cherry Ml03 & Ml04 Sa m e l

oca ti o n In dependent**~:** U l ster (swee t) vs. Montmorency (ta n ) Timing : 19-day offset in fir st so il di r ec t ed app li ca ti on a nd 26 -d ay offset in harvest *No other diffe r en ces found 1 A ll assc.:ssments are based on the rep lic ate tri al guidance presented in draft memo 568_Cntena fo r Ind epe nd ence ofTrial s 04 / 23 / 20 13 (EPA and PMRA). Tab l e B. 7.6. 1. 2-2. Tria l Nu m bers a n d Geograp h ical Locations. Cro p No
. NAFTA G rowing Zone Total Trials I 2 3 4 5 6 7 8 9 10 11 12 Che rry. so ur Sub
. 1 I I (tan) R cq. 2 1/ 1 5 /4 I/ I 1 /0 8 1 6 C herry, s weet Sub. 1 I I I 3 R

eq. 2 2 / 2 2 / 2 3 / 2 1 /0 8 / 6 Peach Sub
. 1 I I 2 R

eq . 2 I/ I 413 110 I/ I I ll 4/ 3 1 2 /9 Plum Sub
. 1 I I I 3 Rcq
. 2 1 /1 5 1 4 1 /0 111 8 1 6 1 The Agency previously determined (Minutes of the 9/ 1/20 1 0 ChemSAC Meeting) th a t a reduced number of tri a l s (4 fo r cherry. 2 fo r pe ac h. and 2 for plum) wo uld be acceptable. based on the ex pectation th at r esidues would b e nondetectablc
. 2 As per Tab le 5 of 860
. 1500 fo r c hc.:rry. peach. and plum ; the seco nd number rcnect s a 25 % r educ ti o n in the number of field 1rial s al lowed for th e crop as a repre sentative commodity in s uppon o f a crop g roup/ s ub gro up tol e rance or wh e n app li cat i o n r es ult s in no quan tifi ab l e re s id ues. E PA MRID # : 494 72 602 P age 3 of8 PMRA # of document: Not AvailablePcn oxs ulam [PC Co de 119031 ]/ I nterreg ional R esea r c h Pr o j ec t No. 4 ( IR-4)
Lo ca tion s and detailed u se patte rns fo r th e trial s a r e prov ided in Table B
. 7.6.1 .2

- 3.
Table B .7.6. 1. 2-3. S tu d y Us e P a tt ern. Loca1ion : C it y. End-use Applica ti o n S urfa c 1 a nt Stale: Year Product 1 Method of Application: Timing of Volume Rate per R etreat
- Total I (Trial ID) Applicatio n (ga l /A) Application ment Rate /\djuvant 2 ( lb ai /A) Int erva l ( lb ai/ A) (days) C h er r y, s wee t Parlier. CA: 20 12 0.083 lb I
. Soil directed: Bud swe ll 15 0.0452


### -- 0.0630 N I S (C/\ 4 I ) ai/gal SC 2. So il directed ; 131oomi ng/fruitin g 15 0.0 178 29 ll olt. M l : 20 13 0.083 lb I
. Soil direc1ed: Early bud 22 0 .0 492 

## -- 0.0687 N I S (M I 03) ai/ga l SC 2. So il directed ; B ud 22 0 .0 195 33 Prosse r. WA ; 2012 0.083 lb I
. Soil directed; 13ud 19 0.0447 

## -- 0.0629 N I S (WA ii } ai/ga l SC 2. Soil directed; Setting fr uit 18 0.0 182 30 C herry. so ur Hoh
. Ml: 20 13 0.083 lb I

. Soil direc t ed; Early bud 20 0.0563


### -- 0.0752 N I S ( Ml 0 4 ) ai /ga l SC 2. So il directed: Bloom 21 0.0 189 30 P eac h Parlier, CJ\; 20 1 2 0.083 lb I
. So il directed: Fruitin g 25 0 .0459 

## -- 0.0644 N IS (C/\42) ai/ ga l SC 2. Soil directed; F ruiting 26 0.0 185 28 Crea m Ridge. N J : 0.083 lb I

. So il directed; S m a ll g re e n fruit 18 0 .0454


### -- 0.0639 NI S 20 12 (NJ0 4) ai / ga l SC 2. Soil directed: Green fruit 18 0.0 185 28 P lu m Parlier. CA: 20 12 0.083 lb I
. Soil directed: Fruiting 21 0.0 4 58 

## -- 0.06 42 

### coc (CA40) ai/ga l SC 2. So il directed: Fruitin g 2 1 0.0 184 26 Holt. Ml : 20 1 3 0.083 lb I. Soi l directed: Fruiting 1-2" 21 0.0 476 

## -- 0.0657 N IS (M l02) ai/gal SC 2. So il direc ted: F ruitin g 20 0.0 181 28 Brooks. OR: 2012 0.083 lb I

. So il directed: Green frui t 26 0.0474


### -- 0.0672 NIS (OR I ?) ai / ga l SC 2
. Soi l directed; Green frui t 27 0.0 198 27 1 Mu lu ple active in g redient ( MAI ) s uspen s ion concen trate (SC) fo nnul ati on ( Pin da r GT) co nt aining 0.083 lb ai / gal penoxsulam and 3
. 93 lb ai / gal oxynuorfen. 2 COC = crop oi l conce ntrat e; N IS = non-i o ni c surfac tant. Che rri es, peach es, a nd plums were grown and m a intain e d according to typ i ca l agricu ltur a l pra c tic es. Irri ga tion was u se d to s uppl e m e nt rainfall at th e CA and WA trial s ites. No unusual wea th er co nditi ons were r epo rt ed to h ave advers e ly aff e cted c rop g rowth o r y ie ld s durin g th e s tud y. S amp l e Ha n d l in g a nd P r e p a ra ti o n Du plicate contro l and treat e d sa mpl es o f c h e rrie s, peach es, and plums we re harves ted 51-63 da ys afte r th e las t appl ication. Ad diti o nall y, at the CA40 tri a l , additional control and tre a te d p lum sample s were harve s te d at a 63-day PHI , and subsamp les we re pro cessed to produ ce dri ed plum s (p run es) w ithin I day of h arves t. Samp les of dri ed p lum wer e prepared by dr y ing halve d fruit in a dr ye r fo r - 1 6 hour s. All sam ples we re pl ace d in fro ze n storage a t the field s ites w ithin 2. 75 hour s of harve st/pro cess in g . Samples from th e 20 I 2 trials w e re s h ipp e d fro ze n via ACDS fr eeze r tru c k t o the a n a lytic a l laborato ry, I R-4 Western R egion Lab o rat o ry at U ni ve r s ity of Califo rni a, D av i s (W RL ; Davis , CA) , where they we re hom oge ni ze d in the pres ence of dry ic e EPA MRID # : 49472602 Page 4 of & PMRA #o f docume nt : No t AvailablePcnoxsulam [PC Code 11 9031 ]/Interre g ional Research Project No. 4 (IR-4) and sto red frozen ( < - l 5°C). Samples from these tri a l s, along with samples prepared for the s torage stab ility s tud y, were subsequently transferred (within 226-328 days of receipt) via ACDS freezer truck to the Food and Environmental Quality Laboratory ( F EQL; Richland WA) for a nal ysis. Samples from the 2013 trial s were sh ipp ed fro ze n via ACDS freezer truck or overnight air express on dry ice directly to FEQL within 2-33 days of collection. At the ana l y tical laboratory , samples were homo ge ni zed in the presence of dry ice and were stored frozen 

### ( < - l 5 ° C) until extrac ti on fo r analysis. 2. D esc ripti o n of A n a lyt i ca l Procedure s R es idu es of penoxsu lam were determined in stone fruits u s ing a wo rking LC / MS / MS method s imil ar to the method , " Determination of Residues of Penoxsulam in Agricu ltu ra l Co mmoditi es by Hi g h Perfonnance Liquid Chromatography with Tandem Mass Spectrometry." A complete description of method , i ncluding minor modifications , was provided in the submiss ion. The method is s imil ar to data co ll ection method GRM 04.09 w hich was previously reviewed under OP# 3559 14 (1 / 29/ 2009, M. D o h erty). Briefly, homo genized samples were ex tracted w ith acetonitrile (ACN):wa ter (80:20 , v:v) and centrifu ged. An aliquot of the supernatant was diluted with 0.1 N HCI and purified by so lid phase ex traction (S PE ) on S trata-XL cartridges. R esidues were e luted with ACN. The eluate was brought to volume wi th a stable i sotope inte rnal s tand a rd sol uti o n of 

### [1 5 N- 13 C]penoxsulam , then was further diluted w ith ACN:methano l :water containing 0.1 % acetic ac id ( 15 : 1 5:70 , v:v:v) and additional internal standard sol ution. The final sol ution was analyzed by LC/ M S / M S
. The LOQ (dete rmined as the LLMV) was 0.0 I ppm o n stone fruits
. The petitioner also presented calculated values for the L OD and LOQ based on t h e rec overies obtained a t the LLMV fo rtifi catio n level s (0.0 I ppm). The LOO was ca lculated by multip ly in g the stan dard deviation of recovery measu rements at the LLMV by the one-tailed t-st a ti stic (co nfid ence le ve l not reported) fo r 9 (s ton e fruit) or 6 (dried plum) replicates, and the LOQ was defined as 3x the LOO. The calculated LOO and LOQ were 0.00 1 33 ppm a nd 0.00399 ppm, r es pectively , for sto ne fruit. The ca lculated LOD and LOQ we re 0.00495 ppm and 0.01486 ppm, respectively , for dried plum. 

### II. R ESUL TS AN D DIS CU SSION Method performanc e was evaluated during method validation and b y us e of concurrent recovery samples by fortify in g samples of untreated stone fruits with p enoxsulam at 0.0 I and 0
. 1 ppm. R ecove rie s were ge n era ll y within the acceptable range of 70-120%; therefore , the method was considered to be va l id for the analysis of penoxsulam residues on stone fru it s (Tabl e B.7.6.1. 2- 4). The fortification leve l s used in method va lid a ti on and concurrent recovery were adequate to bracket expected residue le ve l s. Method validat ion and concu rrent recoveries were not co rrected for apparent residues in controls. For determination of residues of penoxsulam, the detector r esponse was lin ear (coeffic ient of determinat ion, 1 2 ;::: 0.9898) within the range of 0.1-2.0 n g/mL. Repr ese nt a tive chromatograms of control samples , fortified samples, and treated sa mpl es were provided. The contro l
EPA MRID # : 49472602 Page 5 of8 PMRA II of document: Not AvailablePenox s ul am [PC Code I 1903 1 ] / Interregiona l Research Pr oject No. 4 ( I R-4) chromatograms ge n e ra lly h ad n o peaks of interest above the chromatograph ic background. Th e fort i fied sample c hromatograms co n tained o nl y the analyte of interest , and peaks were sym m e tri cal a nd well d e fined. A ppare nt res idu es of penox s ul am in controls were below th e LOQ ( <0.0 l ppm). Residues in treat e d samples we re not corrected for residu es in controls.

T ab le B .7.6 .1 .2-- t S umm a r y of Method Va lidati o n and Pr oce dural/Co n c urre nt Rec ove rie s o f P e n oxs ul am from S t o n e Fru it s. Matrix 

# I Anal)1e 

# I Fortification 

# I Sample si ze 

# I Recoverie s 1 

# I Mean ± Sid. Dev
. 2 Leve l (ppm) ( n) (%) (%) l\l e th od Va lid at ion Stone fruit s 

### I Penoxsulam 

### I 0
. 0 1-0
. I 

### I 6 

### I 79 -112 

### I 93 :!: 12 Dried p l um 

## I I 0
. 0 1-0
. 1 

## I 6 

## I 106- 115 : 12 3. 1 23 

## I I IS ± 7.1 Concurrent Reco ve rie s Sto n e fruits 

### I Pen ox sulam 

### I 0
. 0 1-0. 1 

### I 9 

### I 79- 109 

### I 87 :!: 9.8 Dried plum 

### I 

## I 0.0 1 

## I 3 

## I 86

-91 

## I 89 ± 2.6 1Eac h recovery value is the average of duplica t e ana l yses. Method va l 1 dat1on and co ncurrent recoverie s were not corrected for apparent re s idues in control s. 2 Mean recovery and standard deviation for combined fortification levels were determi n ed by s tud y r ev i ewe r. The field residue samp l es were s tored frozen ( <- 15 °C) fo r a maximum of 389 da ys ( 1 2
. 8 months) for fre s h stone fruit and 321 days ( I 0.6 months) for dried plu m from harvest/processin g to ex traction for a n a lys is (Table 8. 7.6. 1 .2-Sa)
. A ll samples we r e a n a lyze d on th e day of extract io n. T o s upport samp le s torag e durations , a concurrent storage s ta bilit y study was conducted with the fie ld tri a l study; the resu l ts a r e presented i n T ab le B.7.6.1.2-Sb. The data demonstrate th at residues o f penoxsu l am we re stable in / o n fort i fied samp les of fre s h and dried plum stored frozen for up to 358 days; no 0- da y data we r e prov id ed. These data are acceptabl e to s upport the s torage condit ions and duratio n s of samples from the subm itted field tri als; however , s tora ge stabi lity s tudi es s h o uld a lways include a 0-day sa mplin g inte rval to es ta bli s h the res idue levels prese nt at the time sample s are p laced into sto rage (see O CSPP 860.1380(d)(6)(i)).

T a bl e B .7.6. 1. 2-Sa. S umm a r y of S torage Co ndit ion s . Matrix Ana l yte Storage Actual Storage Duration 1 Interval of Demon s trated Storage Stability Temperature (OC) Stone fruit s Penoxsulam < - IS 8-389 days (0.3-12.8 months) Residues of penoxsu lam were stable in/ on fresh Dried p l um 32 1 days ( I 0.6 months) and dried plums sto red frozen for up to 358 days. 2 1 Interval from harve s t to extraction
. Sample s were anal yzed on the day of extraction. 2 Refer to Tab l e B
.7
. 6. 1 .2

- Sb.
T ab le B. 7. 6.1.2-Sb. S tabilit y of Pe n oxs u la m R es idue s i n P l u m M a t ri ces S t o red Froze n (<- 1 5 ° C). Commodity Analyte Spike Storage Fres h Fonification Stored Sample Mean Leve l interval Recoveries(%) Reco ve rie s(%) Recovery(%) (ppm) (days) Plum Pcnoxsulam 0
. 1 358 11 6 104, 1 02, 1 06 1 04 Dried plum 124 123. 124. 11 3 120 1 Corrected for rec overy in fre s hl y fortified s amples. C orrected % recovery 1 90 97
Th e resu lt s fr o m the sub mitted field tria l s are pre se nted in Tables B.7.6.1.2-6 and B.7.6.1.2-7. Followin g two so il d irec ted a pplic a ti o n s of a 0.083 lb ai/ga l SC fo rmulati o n of penoxsulam at a E PA MRID #: 49472602 Pa ge 6 of8 PMRA fl of document: Not Avai l ablePe noxsu l am [ PC Code 11 903 1 ]/ Inte rr eg io nal R esea r c h Projec t No . 4 ( IR-4) total app li catio n rate of 0.0629-0.0752 lb ailA, resid u es of p e n oxs ul a m we re be low the L OQ (<0.0 1 p pm ) in / on a ll samp les of c h e rri es (swee t a n d so ur ), p eac h es, a n d plum s h arves ted a t PHT s of 5 1 -63 days. Res idues were also be low the L OQ i n d ri ed p lum p rocessed fro m p lum s h a r ves te d a t a 63- d ay PHI.
T ab le B
. 7.6. 1.2-6. R e s idu e Da t a fro m Sto n e f ruit F ie ld T ri a ls w i t h Pe n ox s u l a m . 1 Locati o n : City. State: Year Zone Crop Commodity Total Rate Pill Re sidues (pp m )2 (Averagcj (Trial ID) Variety ( lb ai /A) (days) C he rr y, swee t Parlier. CA; 20 12 (CA4 I ) JO Bing Fruit 0.0630 59 ND. ND [ <0.0 1] Holt. M l : 20 13 ( M103) 5 Ulster Fruit 0.0687 5 1 ND. ND i <0.0 1) Pros se r, \VA: 2012 (\VA 11 ) 11 Bony swee t Fruit 0.0629 61 ND, ND 1 < 0.0 1 ] C h err y , s o ur Holt. Ml: 2013 (M J 04) 5 Montmorency tart Fruit 0.0752 61 ND. ND [<0. 0 1 ) Pe ac h Parlier. CA: 2012 (CA42) 10 June Flame Fruit 0 .0 644 57 ND. ND [ <0. 0ll Cream Ridge. N J ; 20 1 2 (N J04) 2 Loring F ru it 0.0639 57 NO , ND [<0.0 1] P lum Parlier. CA; 2012 (CA40) 1 0 French prune Fruit 0.0642 63 ND, NO, (0
. 0024) [ <0.0 1] Dried plum ND [ <0.0 1] ll oh, Ml: 2013 (M l02) 5 S tanley Fruit 0.0657 59 ND, (0.0014) f <0.0 1 ] Brook s. O R : 20 1 2 (OR 17) 12 Brooks Fru it 0.0672 52 NO, ND [ <0.0 I J 1 A multiple active ingredient (MA I ) suspension concentrate (SC) formulation ( Pindar G T) containing 0.083 lb ai/gal penoxsulam and 3.93 lb ai/g al oxyOuorfc n was used. 2 ND 

### = Not detected (< LOD). The LOQ was 0.0 I ppm. a nd the LODs were 0
. 00 133 a nd 0.00495 ppm for fresh and dried fruit. n.:spectivcly. Re s idues between the LOO and LOQ arc presented in parentheses. Per-trial averages were calculated by the study reviewer using th e LOQ for va lues reported as <LOQ. A ll sa mple s were analyzed in dupl i cate. Tab le B .7.6. 1.2-7
. S u m m a r y o f Re s id u e s from S t o n e Fru it F i e ld Tria ls w ith Pe n o xs ul am. Crop Matrix Ana l yte Total PHI n ' R esidues (ppm) App lication (days) Min
. 2 Max. 2 LAFTl llAFT 3 Median 3 Mean 3 SD 3 Rat e ( lb ai/ A) Cherry. sweet Penox s ulam 0.0629

- 0.0752 51-61 4 <0.0 1 < 0.0 1 < 0.01 < 0.01 0.01 0.0 1 NA and sou r Peach 0.0639-0 .0 644 57 2 <0. 01 < 0.0 1 < 0.0 1 <0 .01 0.01 0.0 1 NA Plum 0.06 42- 0.0672 52-63 3 < 0.01 < 0.01 < 0.01 < 0.0 1 0.0 1 0.0 1 NA 1 n = numbe r of field tria l s. 1 Value s based on total number of samples. 3 Value s based on per- trial averages. LAFT = lowe st average field tri al, H AFT= hi g hest average field t rial, SO = standard deviation. for computat i o n of th e LAFT. I IAFT, median, mea n, a nd s t andard deviatio n. va lues< LOQ arc assumed to be at the LOQ (0.0 I ppm)
. NA = Not applicable
. 

### III. CONCLUSIONS T h e s to n e fruit fi e ld tria l s are co n s id e re d sc ie nt ifi ca ll y acce pt a bl e. Fo ll ow in g two so i l d irec ted applications of a 0.083 l b ai /ga l SC form u lati o n of penoxsu lam a t a to ta l a p p li cati o n r ate of 0.0629-0
. 0752 lb a i / A, res idu es of p e n oxs ul a m we re b e low th e LO Q ( < 0.0 1 p pm ) i n/o n a ll samp les of c h e rr ies (sweet and sour), peac h es, an d plu m s harvested at PHi s of 51

- 63 days
. R es id u es we r e a lso be low th e LO Q in dri e d plum p ro cesse d fr o m p lum s h arves t e d a t a 63- d ay
EPA MR ID #: 49472602 Page 7 of8 PMRA If of document : No t Ava il ablePenox s ul am [P C Code 11 903 1 ]/ I

nte rreg ion a l Research Proj ec t No. 4 ( IR-4 ) PHI. T h e registrant did n o t perfo 1 m a n exaggerated rate s tud y to determine re si du e co nc e ntrati o n du r in g p rocess i n g o f p lum s to dr ie d p lum s. R es idu es in a ll RAC sam pl es we r e < LO Q , howeve r. An acceptable m e th od was used fo r re s idu e quantitation , and a d eq u ate s torage s t ab ility data we re s ubmitt e d to s upp o rt th e s tudy. 

### RE FE R ENCES D355 9 14 , Pe noxsulam. Sec ti o n 3 R egis trati o n Application For Use of GF-44 3 T 

### & Von G rap e a nd Tree Nut s In c luding Pi s tac h io . Sum mary o f Ana lyti ca l C h em i s tr y and Residu e Dat a, M. Do h e rt y, 1/ 29/ 2009

E PA MR ID #: 49472602 P age 8 of8 PMRA # of document: Not Avai lab l e