### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFF I CE OF C HE.\ ll CA L SA FETY A N D POLLUT I ON PREVENT I ON 

### MEMORANDUM Date: Subject:

From: Thro u gh: l 9-November-2015 

### Spinosad/Spinetoram. Addendwn to Human Health Aggregate Risk Assessment D415812 

### (T. Blo em 

### et al., 10-Mar-2015) to Support a New Use on Quinoa. PC Codes: I I 0003 and I I0008 DP Barcodes: 429673 and 429674 Decision Nos.: 483254 and 483225 Registrat ion Nos. : several Petit ion Nos.: 3E8203 and 3E8204 Regu l atory Actio n : Section 3 Registration R isk Assessment Type: S in g le Chemica l / Aggregate Case Nos.: 7448 and 7421 TXR No.: not app lic able CAS Nos.: 187166-40-1 , 187166 - 15-0 , and 1 3 1929-60- 7 MRID No.: not app l icable 40 CFR: 180.495 a nd 180.635 

### Tom Bloem ,

# Chemi**~ \~**  Risk Assessment Branch 1 (RABI) , Health Effects Division (HED, 7509P) Charles W. Smith III , Branch C hief 

# C**~** George F. Kramer, Ph.D. , Senior Chemist**---~~_..** 

### ........ 

### -z..-z--- RAB l/HED (7509 P) 

### To: Sidney Jackson/Barbara Madden RM 5 Registration Division (7505P) The Interregional Res earc h Proj ect No. 4 (IR-4) submitted an amendment to a recently completed sp ino sad/ spinetoram human health risk assessment (D415812, T. Bloem 

### et al., 10- Mar-2015) which proposed a Sectio n 3 registration for application of spinosad and spinetoram to quinoa and the establishment of permanent spinosa d and spinetoram tolerances in/on quinoa grain of 1.0 ppm and 0.04 ppm , respectively . This document provides an addendwn to this recently-comp leted hwnan health risk assessment in order to assess the additional proposed

. . 

### qumoa gram uses. 

### Proposed Application Scenario: A summary of the proposed spinosad and spinetoram quinoa app li cation s scenarios are provided in Attachment 1. The proposed spinetoram quinoa applicatio n scenario i s identical to the cu rrently registered sp inetoram cereal grain application scenario. For spinosad, th e proposed quinoa application scenar io i s id e ntic a l to the currently registered foliar cereal grain app l ication sce nario ; post-harvest application to quinoa grain, as is currently registered for several cereal grains , is not proposed. HED concludes that the proposed application directions are adequate. Page I of 5Spinosad and Spinetoram Hum an Heal th Ri s k Assessment 0429673 

### Tolerances: Residue data in/on quinoa grain have not been submitted (grain is the only quinoa commodity). It i s noted that quinoa is considered s im ilar to the small grains (cereal grains) and will be proposed for addition to the revised cerea l grain crop group (wheat or wheat and barley will be the representative crop(s)). Based on this, th e HED Chemistry Science Advisory Council (C hemSAC) recent ly implemented a po li cy allowing translation of w h eat , barley, or crop group 15 tolerances (residue data) to quinoa grain provided the application scenari os are simi lar (min utes of27-May-2015 ; 10-Jun-201 5; 29-Jul-2015). The proposed spi netoram quinoa application scenario i s identical to that registered for the cereal grains. Therefore , trans lation of the 0.04-p pm spinetoram cereal grain crop group 15 (except rice , sorghum , and millet) tolerance to quinoa grain is acceptable (0.04 -ppm tolerance proposed by the petition e r) . For spinosad, foliar a nd post-harvest treatment of cereal grains are registered , while on ly fol iar application to quinoa is proposed (foliar sce n ar io s are identical). Therefore , translation of the l .5-ppm sp ino sad cereal grain crop group 15 tolerance to quinoa grain i s not appropriate. IR-4 - proposed a 1.0 ppm spinosad quinoa grain tolerance for purposes of harmoni z in g with the Codex cerea l grain maximum residue limit (MRL ; quinoa is currently part of the Codex cereal grain crop group) . However, the Codex 

### MRL is also base d on post-harvest treatment and, therefore , is not reflective of the proposed foliar only quinoa application scenario. Based on th e available wheat grain data (summarized below) and adjusting these data for the propo se d application rate , HED concludes that a 0.02-ppm spinosad tol era nce in/on quinoa grain is appropriate. It is noted that the sp in eto r a m cereal grain tolerance is a lso based on the spinosad wheat grain residue data adjusted for application rate (03253 87 , T. Bloem , 12-Sep -2007). A 0.04-ppm sp ineto ram tolerance was established rather than 0.02 ppm as sp in e toram has four compou nds in the to lerance expression w hil e sp ino sad as on ly two (LOQ-to l e ranc es). The available sp in osad wheat 

### grain pro cessing data (trans lated to spinetoram) indicate that tolerances in/on the processed commodities are unnecessary (030420 I , W. Cutchin , 12-0ct2004). B ased on th e ChemSAC decision to translate the small grain re s idue data to quinoa, the se data are sufficient to conclude that tolerances in/on quinoa processed commodities are also unnecessary. Sp ino sad Wheat G rain Res idu e Data: Spinosad was applied to wheat as three foliar applications at 0.45 l b ai /acre (4 .8x ) for a total seasonal app li cation rate of 1.35 lb ai/ac re (4.5x). App li cations were made at ear ly tillering , boot s tage , and at 2 1 days before harvest. The samp les were analyzed u s in g an adequately validated method (storage interva ls were also validated). Re s idues of spi nosad were < 0.005 - 0 . 09 ppm. 

### Agg regate Exposure and Risk Considerations: HED recently completed a spinosad/spinetoram chronic dietary exposure ana ly s i s which resulted in exposure estimates**64%** the chronic population adjusted do se (cPAD; 0423657, T. Bloem , 10-Mar-20 1 5); based on toxicological considerations, acute a nd caner analyses are unn ecessary. This ana lys is was performed using the consump tion data fonn the 2003 - 2008 U.S. Department of Agriculture 's (USDA 's) Nation a l Health an d Nutrition Exam in ati on Survey What We Eat in America (N HA NES / WWEIA). Although consumption estimates for quinoa are not avai lable in the NHANES / WWEIA data, HED concludes that t h e dietary exposure estimates from the previous assessment are protect ive for all sp inosad/spinetoram u ses including the propo sed quinoa use for the following reasons: Page 2 o f 5Sp in osad and Sp in et oram Hu man Heal t h Ri s k Assessme n t 04296 73

• Spinosad / s pin e toram tolerances are establis hed in/on all food crop s with the previous assessme n t assu min g 100% crop treated and resi due estimates ba se d on fie ld trai l data ( m axim um application rate , minimum re treatment interval , and minimum preharves t inte rva l). • Qui noa is prepared like othe r who le grai n s, s uch as ric e and barley, and may be used to make fl our in a mann er s imilar to w heat and other cereal grains. Therefore. the Agen cy con clude s that quinoa wi ll like ly s ub s titute in th e diet for cereal grain foods, w hich , as di sc u sse d abo ve, will contain sim il ar residues. • Th e quinoa u se pattern i s s imilar to that for w heat and b a rl ey . T he refore, increased expos ures to individu a ls thro ugh dr i nking water i s not expec ted. S in ce th e propo se d quinoa u se w ill no t result in hi g he r d ie ta ry exposure estimates (see above) and will no t res ult in res idential ex po s ure , HED co nclud es that the agg r egate exposure and ri s k est imates p rese nte d in th e mo s t recent human healt h r is k as sess me nt document ( D 4 1 58 12 , T. B l oe m 

### e t al., I O-Mar-20 1 5) , w h ich we re not of concern t o H E D , a de q u ate ly account for exposu res and ri s k resulting from a ll sp ino sad /s pi netora m u s e s i nclud i ng th e proposed quinoa u se . 

### Occupa tio 11 a l Expos u re a nd Ri s k Co n s id e ration s: H E D co nclud es tha t th e mo st recen t assess me nt of occ up ationa l expos ure assessment , which res u lt e d in MO Es 2:. 1600 , is protecti ve of pote nti a l ex p os ures re s ulting from application of s pin osad/spi netoram to quinoa . Therefore , a revised occupatio n al exposure assessment is unn ecessa r y. 

### HED R ecomme 11 d atio n s: The most re cently - completed co mprehensive ri s k assessment for sp in osad/s pin eto ram did n o t identify an y tox ico log ical deficienci es ( D415812 , T . Bloem 

### e t al. , 1 0 -M ar - 20 1 5). As indicated above, the aggregate and occupat io n al ex p osure estimates provided in this doc um e nt , which we re not of concern to H E D , are adequate to account for the prop osed quinoa u se. Th erefo re, HE D concludes that th ere are no human health concern s w hi c h wo uld prec lud e th e propo se d reg istration and estab li s hm e nt of th e tol e rances r e commended in Table 1. A re v ised Sec ti o n F is requested. Tab l e I : To le r a n ce S umm a r y. Commodi ty Propo sed Tolerance I-I ED-Recommended Co mments (ppm) ' To l erance (p pm) S p inosad (40 C FR 180.495(a)) IR- 4 propo s ed a 1. 0-ppm s pinosad quinoa grai n t o leranc e for purposes of harmonizing wi th the C odex cerea l gra in MRL (q uino a will be proposed for inclu s ion in the revi s ed cerea l grain c ro p gro up ). Ho wever. the Codex MRL is b as ed on po s t-harve s t treatment and, therefo r e . is not reflective of the propo s ed foliar only quinoa app li cation scenario. B ased on the available wheal g rain data and adjusting these data for the proposed quin oa. g rain 1. 0 0 . 02 application rat e . H E D concludes that a 0.02 -p prn spinosad tolerance i ni on quinoa g rain i s appropriate . II is noted that the spinetoram cereal grain toleranct: is al so b as ed on the s pino s ad wheat grain residue data adju s ted for applicati o n rate ( 032538 7 . T. Bloem. I 2 - Sep - 2007): a 0.0.t-ppm tolerance w as es tabli s hed r a ther than 0.02 ppm as s pinetoram h as four compound s in the to l erance expre ss ion while spinosad as onl y two (LOQtolerance s) . S p in etora m (40 C FR 180.635(a)) quino a. g rain 0 . 04 0 . 04 

## -- Attac hm e nt I: Prop osed App l i ca t i on Scenario A ttac hm e nt 2 : I RL s Page 3 of 5S pin osa d a nd Spi n e t o r a m Hum a n H ea l t h Ri s k Assess m e nt D 429673 

### Attach m ent 1: Propo s e d App li catio n Sce n ario IR-4 req ues ted Secti o n 3 R egistrations for ap pl i catio n of sp inosad and spi neto ram to q uinoa. Table 

### A . I . I i s a s umm ary of th e e n d -u se pro d uc ts and target p es t s and T ab le 

### A . I .2 is a s umm ary of th e p ropose d appli ca ti on scenarios . The pro p osed labe l s also s p eci f y th e fo ll ow in g : (1) ad ju vants m ay b e a d ded to the spray so l ution; 

### (2) t he l abe ls specify a m inimum sp ray vo lume for ground an d aerial app l ication of 

### 5 ga ll ons pe r acre (GP A) an d 3 G P A, respect i ve l y; (3) th e s pi nos ad labe l does not spec i fy any rotat ional cro p restrict io n s w hi le th e sp in e toram l abe ls ind i cate th at la b e l e d crops m ay be rotated imme d ia te l y to a treated fie ld and n onlabe led crops may b e ro ta te d 30 d ays after ap p l i cation ; and (5) RE I 

### = 4 h o ur s. Tab l e A.1.1: S ummar y of End- Use Prod u cts. Trade Name Cone. Formulation Labe l Date Ta rget Crops Target Pests S oin osa d Entrust ® SC 2 lb a i/gallon s oluble concentrate 8-0ct-20 1 5 quinoa armyworm s : loopers: (EPA Reg. No . 627 1 9 - 62 1 ) lcafminers; thrip s ; cutworm s Spineto r am De l egate® WG 25% water- dispers ible granule 8-0ct - 2015 (EPA Reg. No. 627 1 9 - 54 1 ) armyworm s ; loopers ; Radiant® SC quinoa leafminers: thrips: cutwom1 s (EPA Reg. No . 627 1 9-545) I lb ai/ gallon s o lub l e concentrate 8 - 0ct - 2015

rr ab l e A. 1.2 : S ummar y o f P r opo sed Q uin o a Aoo li c ation S c ena r io s .

App. Timing ; Fommlation Single App. Rate Max. # Apps. Max. App. Rate PHI U s e Directions and Limitation s Type; and EQuip. (lb ai /ac re) (lb a i / acre) (days ) Spinetoram - RT l = 4

Radiant® 0.02 - 0.05 3 0. 1 4 2 1 For re s is tance management purpo s e s d o Delegate® not make more than two consecutive foliar broadcast aoolications.**~pray** RT l = 4 Spino s ad - 0.05-0.09 3 0.30 21 For resi s tance management purpo s es do not Entru s t ® make more than two consecutive annlications.

P age 4 of 5Sp in osa d and Sp in e tora m Human H ealth Ri s k Assessme nt 

### Attac h me n t 2 : I RLs Spinosad - S u mmary of US and Internatio na l To lera nces a nd Maxi mu m Res i d ue L imi ts Re sid ue Delinition 

## us Canada Spinosad ( 180.495): Srinosvn A ( Factor A: CAS # 131929-6 0 - 7: 2 -[ (6-dcoxy-2.3.-1 - tri-0 -methy l-a-L-manno-py ranosyl)oxy )-13 -[[5- (dimethylamino)-tctrahydro-6- methyl-2 11-p yran-2-yl ] oxy]-9-ethyl-2.3 . 3a.5a.5b . 6 . 9. I 0. I I .12.13.14. 1 6a. I 6btctradccahydro-14-methyl-111-as -l ndaceno[3.2 -d)oxacyclododccin-7. I 5 - dione: and Sninosvn D (Factor D: CAS # 131929-63-0: 2 -f(6 -deoxy-2.3.4-tri-0-m et hyl-a-Lmanno-p y rano sy l )oxy) -1 3- [[ 5 - (d imcthy I-amino ) -t ctrahydro- 6-methyl-2 11- pyran-2- yl]oxy l-9-ethy l-2,3.3a.5a.5b.6.9. I 0. 11 , 12. 1 3. I 4. I 6a, I 6b-tetradecahydro-4. I-I-meth y l111- as- ln daceno[3.2-d ] oxacyclododecin-7, 1 5-dione. Tolerance / Maximum R esidue Limit (ppm) Co mmodity 1 

## us Ca n ada M cxico 2 quinoa. grai n O.Q2 cerea l grains - 1 .5 

## -- Comple t ed: 1 Includc s on l y commoditie s of interest for this ac ti on. Tolerance val u es arc I IED recommendations. 2 Mexico adopts U tolerance s and/or Codex MRLs for its expon purpo ses . Po = p ost harve s t treatment s uch as treatment of stored grains. 0 42 96 73

Mexico 2 Codex

Codcx3 I cerea l grai n s P o; 0.0 I (*)sweet corn (co rn- o nthe-cob): 2 wheat bran , unprocessed
Spinetoram - S u mmary of US and I nternational To lerances and Ma x i m um Resi du e L i m i ts Re s idue Definition 

## us C anada Spinetoram ( 18 0.635): X DE-175-J ( l-H-as-indacen o[3 .2 - d]oxac y clododccin7. I 5-dione. 2- ( (6 -d coxy-3 - 0-ethyl -2.4-di-O-methyl - a - L - mannop yranosyl) oxy ]- I 3-lf(2R.5 .6R) -5- (d im e th ylamino)tetrahydro-6 - meth yl - 21-1 - pyran-2-yl I oxy J-9- ethyl-2.3.3a.4.5.5a.5b.6.9. I 0. I I , 1 2. I 3. 1 4. 1 6a, 1 6b - hexadecahydro 14 -mcthy l-. ( 2R.3aR,5aR.5bS. 9 . I 3S . I4R. I 6aS . I 6bR) ; XDE -1 75 - L: I H- as - indaccno [3.2- d]oxacyclododccin-7. I 5-dione. 2-[(6-deoxy-3 - 0 - et hyl-2.4 -di- O-mcthy l-a-Lmannopyrano sy l) oxyJ- 1 3- ll (2 R .5S.6R)-5 - (dimethy lamino) 1 e 1

rahydro-6-mc 1h y l211-pyran-2-yJloxy l-9-ct h yl-2 , 3.3a.5a.5b,6.9, I 0, 11 , 12 . 1 3. 14 , 16a. 1 6b 1e1radecahydro-4, I 4-dimet hyl-, (2S,3aR .5aS. 5b S,9S , 1 3S, 1 4R. I 6aS. I 6bS): ND-J ((2R.3a R .5aR.5bS.9S. I 3S. I4R. l 6aS, I 6 bR)-9-ethy l-14 - met h y l- I 3- fr( 2S.5S.6 R )-6 - me1hy l-5-(met hy lami n o)te 1 rahydro - 2 H-p yran-2- y l) oxy]-7, I 5-dioxo2 . 3.3a,4.5,5a.5b.6. 7.9. I0 , I I , 1 2. 13 , 14 . I 5, 16 a, I 6b- octadcca hyd ro- 1 I-I- asindaccn o [ 3,2-d loxacyc l ododccin-2-y l 6 -d eoxy- 3 - 0 - e th y l- 2.4-di-O-mc th y l- a lphaL-mannopyranoside): and NF-J ((2 R ,3S.6S) - 6 - ( [ (2 R ,3a R.5aR . 5bS.9S. I 3S, I 4 R. I 6aS. I 6bR)- 2-[(6-dcoxy-3 - 0 - ethyl - 2 , 4 - di - O - methyl-alpha-Lmannopyrano sy l) oxy )-9- et h y l-14-meLhy l-7 , I 5-dioxo-2. 3.3a.4.5 , 5a.5b.6.7.9 . I 0. 1 I .12 , 1 3, 14 , 1 5, I 6a. I 6b- octadcca hydro -1 H-as- ind aceno(3.2- d]oxacyc l ododecin- I 3-y l] ox y )-2-methyltetrahydro- 2 H- pyran-3 - iY l(mcth y l)fonnamidc) Tolerance/Maximum Re s idue Limit (oom) Co mmodit y' 

## u s Canada Mexico 2 quinoa. g ra in 0.0-1 0. I barle y . oats. r y e . "heat: 0.04 licld com. popcorn J?rain Co mpleted : 1 Include s only commodities of intere s t for thi s action. Tolerance values arc I I ED recommendations . 2 Mexico adopts U tolerance s and/or Codex MRLs for its expon purpo se s.

Pa ge 5of5 

### -- Mexico 2 Codex

Codex 3



### --