### UN ITED STATES EN VIRON MENTAL PR OTECTION AG ENCY WASHINGTON, D.C. 204 60 OF FICE O F PREV ENTION, PES TICIDES, AND TOXIC SUBSTAN CES

MEMORANDUM Date: 04 -NOV - 2009 SUBJECT : AMENDMENT TO : Spiromesifen. Human -Healt h Risk Assess ment for Reques t to Reduce Rotational Crop P lantback Interva l (PBI) for Bulb Vegetables ( Crop Group 3 ). DP#: 363706 . PC Code: 02487 5 Decision No.: 397603 Petition No. : 8F7398 Risk Assessment Type: Sing le Chemic al A ggregate. TXRNo .: N A MRIDNo.: NA DP Barco de: 0 370 2 74 Registra tion Nos.: 264 -719 & 264 -850 Regu la tory Action: Amended Section 3 Case No. : NA CAS No.: 283594 -90 -1 40 CFR: § 180 .607 FROM:

THROUGH: TO: Sarah J . Levy, Chemis t 

# x3 

# /:7{ ' Robert Mitkus, Ph .D., T oxicologist R isk A s sessment Branch 1 (RAB1) H ealth Ef fects Division (HED) (7509P) George F . Kramer , Ph .D., B ranch Sen ior Chem ist

## ::;i**"- -"'-** **--** D ana Vo gel, B ranch Ch ief .**1: r-** **::.-** 

## __ -
_ RA Bl/HE D (7509P) / ,/-' -- Je nnifer Gai ne s /J ohn Hebert (RM Team 07) In secticid e B r anch/Registration D ivisio n (RD) (750 5P) The la st risk assessment for spiromesifen was conducted on I I -JUN-2009 (Memo , J . Tyle r et al ; D P#: 363706) . In this assess men t, HED required the peti tioner, Bayer CropS cience, to sub mit c onfirmatory re sidue analytical me thod data as a require ment for grant ing a Section 3 amendm ent. T he petiti oner had to c onfirm that the data -co llection method used in the extensive ro tational crop study on onion adequate ly r ecovers re sidues of co njugates c ontaining the 4 - hydroxymethyl mo iety . Bayer has now submitted data in which residues o f one of the moieties w ere found . Bayer ha s proposed chang ing the proposed tol erance f rom 0 .07 ppm t o 0.09 pp m for inadvertent residues inion vegetab le, bulb (crop group 3 -07) . HED concurs with this pro posed tolerance ; therefore, HED has r evised the last dietary risk assessment to reflect this t olerance increase for th is crop gro up only. Thi s is the only change made to the last spiromesifen ris k assessment (Mem o, J . Tyler , II -JUN -2009; DP# 363706) . The follow ing paragra p hs and/or s ections can rep lace the paragraphs and/or sections in the D P# 363706 memorandu m. Page I o f 4Introductio n Bayer CropScience has submitted a petition to amend the Oberon®2 Susp ension Co ncentrate (SC) Insecticide/Mitici de [a 2 po und ( lb) active ingred ient (ai) /gallon (gal) SC formulatio n o f spiromesifen (( 2 - oxo - 3 -(2,4 ,6 -trimethylpheny l) - I -oxasp iro[4 .4]non - 3 -en-4 -yl 3 ,3 - dimethylbutanoate))] and Oberon ® 4 SC Insectic ide/Mi ticide (a 41b ai/ga l S C formulation ) labels to include a 3 0 - day PBI for bulb vegetabl es , crop group 3 . In co njunction with the proposed label ame ndme nt , Bayer h as pro posed th e es tablishment o f perm anent tole rances for the com bined re si dues of spiromesifen , its e nol m etabolite (4 -hydroxy -3-(2,4 ,6 -tr imethylphenyl ) -I - oxaspiro[ 4.4]non-3-en-2 -on e) , and its metabolites containing the 4 -hydrox ymethyl moiety , c alculated as parent compo und equival ents , inion the followi ng commodi ties fro m crops grown as rotat ional crops : vegetabl e , bulb , group 3 -07 at 0 .09 ppm. 1.0 Executive S ummary Dietary Risk Estimates (Food 

### + Water): A conservative chronic dietary - risk assessment wa s c onducted u sing th e D ietary Ex£os ure Eva luation Model software with the Food Commodity Intake Database (DE EM -FCID , Versio n 2 .0 3). DEEM'M 7 .81 defa ult pr ocessi ng factors and 100% crop trea ted (CT) we re as sumed fo r all c ommodities ; and tole rance- level r esidues were as sumed for all commodi ties excep t f or the leafy - green and leafy - Brassic a vege table subgroups (4A and 5 B) . For these subgroups , the residue values were adjus ted t o ac count fo r the me tabolite BSN 2060-4-hydroxymethyl (free and co njugated) , which is a resid ue of concern i n leafy vege tables f o r risk assess ment purposes o nly . Drinking wate r was incorporated d irectly into th e dietary expo sure assess ment u sing the c hronic es timated d rinking wate r concentration (EDWC) of 188 ppb fo r gro undwa ter gene rated by the Provis ional Cra nberry Model. The chron ic dietary risk assessm ent shows that the chro nic die tary r i sk es ti mates do not exceed HED's level of co nce rn [i.e ., < 100% of the ch ro nic p opul a tion-adjus ted d ose (cPAD) ] . For the genera l U .S. pop ulation, the exposure for f ood and water utilized 50% of the cPAD . The chronic dietar y risk es timate f or th e highest exposed p opulation subgroup, all infants < I year o ld, is 78% of the cPAD. Recommendations/or To lerances: H ED h as exam ined the availa ble tox icology and residue chemistry d atabases f or spiromesifen. Pendi ng sub mission of a r evised Section B , a nd submittal of reference standards, there are n o residue chemistry issu es that would preclude granti ng a co nditional Section 3 amendment for the 2 an d 4 Ib /gal SC formula tions of spiromesifen to allo w a 3 0-day PB I for b ulb vegetab les and establis hment of a tolerance for the inadvertent or indire ct c ombined re sidues of sp iro mesifen , its eno l m etabolite , a nd its meta bolites containing the 4- hydroxyme thyl moie ty and its conjuga tes, c alculated a s the par ent compound equiva lents, as foll ows: Vegetab le, bu lb, group 3- 07 0 .09 pp m

Page 2 of44.0 DIETARY EXPOSUREIRISK CHARACTERIZATION The exposure pathways resulting from use of this chemical are dietary (food and drinking water) and o ccupational; there are no residential uses. The residue chemistry data submi tted in support o f the prop osed uses were summarized in HED memoranda by J. Tyler (Memo, 6 / 1 110 9; DP# 3 55619) and S . Levy ( Memo, in progres s; DP# 370549). The chronic dietary exp osure as sessment was completed in a HED memorandum by S. Levy ( Memo, 11 /04 /09; DP# 370550) . 4 .1 Food Residue Profile Th e submitted extensive field rotational crop trial data for green and bulb onion are adequate . Bulb and green onions were planted - 30 days following application of spiromesifen at the maximum seasonal app lication rate to p rimary crops which may be rotated . The data support a 30 -d ay PBI for the bulb vegetable crop group (group 3-07) and the proposed tolerance of 0 .09 ppm for the indirect or inadvertent comb ined residues of spiromesifen, its enol metabol ite, and its metabolites containing the 4-hydroxymethyl moiety and its conjugates, calculated as the pare nt compound equi valents, inion the rotational crop commodities of bulb vegetab les crop group . 4.3 Chronic Dietary Exposure and Risk A conservative chronic dietary assessment was conducted assuming tolerance-level residues for all commodities excep t for the leafy -green and leafy-Brassica vege table subgroup s (4A and 5B). For these subg roups, the residue values were adjusted to account for the metabolite BSN 2060-4 - h ydroxymethyl (free and conjugated), which is a residue of concern in leafy vegetab les for risk a ssessment purposes only . DEEM '· 7 .81 default processing factors and 100% CT were assumed f or all commo dities . Drinking water was incorporated direc tly into the dietary asses sment using the chronic EDWC of 188 ppb for groundwater generated by the Provisional Cranberry Model. The chronic dietary risk assessment shows that for all included commodities , the chronic d ietary risk estimates do not exceed HED's level of concern (l.e ., <100% cPAD) . For the general U.S . population the exposure for food and water utilized 50 % of the cPAD. The chronic d ietary risk estimate for the highest reported exposed population subgroup, all infants < I year o ld, is 78 % of the cPAD.

Page 3 of 4The value for the highest exposed p opu l at ion I S bolded. Table 4 . Summ ary of Die tary (Fo od and Drink ing Water) Exposure Risk for Spi rome sifen . Acute Dietary (9 5" Percentile) Chron ic Dietar y Population Su bgroup Dietary Expos ure Dietar y Exposure (mg /kg/day ) %a PAD (mg/kg/day) %cPAD G eneral U.S . Population 0 .010916 50 All Infan t s «I y ear old) 0 .017139 78 Children 1 - 2 years old 0.015 491 70 Children 3 -5 years old 0.014955 68 Children 6 -1 2 years o ld NA 0.01 1114 5 1 Youth 13 -19 years old 0 .0089 28 41 Adu lts 20 -49 ye ars o ld 0.010600 48 Adults 50 + years old 0.010514 48 Females 13 -49 yea rs 0 .010698 4 9 ol d 

## • 7 .2 R esidue Chemistry 860 .1200 D irections fo r U se • T he p roposed l abels s hould b e revised to i nclude specify " bulb vegetab les (crop group 3 - 07) " instead of " bulb vege tables (crop gro up 3 ) " un der the Rotational Plant-Back Intervals sections. 860. 1340 Residue Analytical Me thods • The p ropos e d a nalytical e nforcement me thods [Me thod 00631/MOOI (plants) and Meth od 1103 33 (rotatio nal crops)] sh ould b e modi fied as deta il ed in the 11/ 15/07 peti tion meth od validation m emo (see DP# 30572 1) . 860 .16 50 S ubmitta l of Ana lytical Reference S tandards • Reference standards for the 4 - hydroxymethyl metabolite and deut erated standards for the enol and 4 - hydroxymethyl metabo lites must sub mitted to the ACB Repository.

cc: S . Levy, R. Mitkus RDl : RAB I Chemists (l1 -NOY -2009); RAB 1 Branc h (06 -MAY- 2009) ; G . Kramer (0 4-NOY -2009) ; D. Vogel (0 4 - NOY ·2009) S . Levy : S -10 953: Pot omac Yard 1 (PYI): (703) 305-0783: 7509P : RAB I Page 4 of4