### Revised Addendum to Azoxystrob in Human H ealth Ri s k Assessment DP No. 428619
UN ITf:D S TATES E NV I RONMENTAL PROTE CT I ON AGENCY WASH I NGTON, D.C. 20460

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. Revised Addendum to Human Health Aggregate Risk Assessment D42369 I a nd D418374, Dated 417/ 20 I 5, to Support a New Use on Quinoa.
PC Code: 128810 Decision No .: 495749 Pe ti t i on Nos. : 4£8319 D P B arcode: 0428619 R eg is tr at io n Nos.: 100-1178 , 100-1324 R eg ul a t ory Ac ti o n : Sect ion 3 Registration Case No.: 7020 Ri s k Assess me nt T y p e: Single Chemical / Aggregate TXR No.: NA CAS No

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### Intro du ction Laura No llen ,

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### /1.0\5 Ri sk Assessment

## Bran~l**RAB** 3) Hea lth Effec ts Di v is ion (7509 P ) Don a ld Wilbur, Senior Chemist

# ~~ C hri st in e Olinger , Branch Chief

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# r-/ '- · Hea lth Effec ts Divis ion (7509P) Andrew Ertman , Biologi s t Barba ra Madden , Biologi s t, Team L eader Minor Us e Team Regi s trati on Di vision (7505P)

This document provid es an addendum to the rece ntly-completed Hea lth Effec ts Division (HED) human health assess me nt ( 04 23691 and D418374 , Kristin Rury, 417/ 20 15 ) in order to assess an additiona l proposed tolerance and proposed r egis trati ons of a use of the fungicide, azoxystrobin , in or on quinoa gra in. The revised addendum provides additional information regarding exposure a nd risk consideration s .

P age I of3Revised Addendum to Azoxystrobin Human He alth Risk Assessment DP No. 428619


### Use Profile and Proposed Tolerance/Registration Azoxystrobin is a P-methoxyacrylate fungicide currently registered for use on a var i ety of field , vegetab le , fruit , and nut crops as well as on ornamental plants and tu rf. It is also used to control mold on indoor surfaces. Its biochemical mode of action is inhibition of e lectron transport. HED recently comp leted a human health risk assessment for the proposed establishment of severa l tolerances of the fungicide azoxystrob in , associated w ith two pesticide petitions. A pesticide petition (P P # 4E8319) was previously s ubmi tted by the Interregional Research Project Number 4 ( IR-4 ) to propose tol erances w i thout U.S. r eg istration for azoxystrobin in/on Ti palm , and to incorporate recent revisions to the crop group li stin gs of the Stone Fruit Crop Group 12- 12 and Tree Nut Crop Group 14-12. IR-4 subseque n tly submi tted an addit ional request associated w ith PP # 4E8319 on be h a l f of Hawaii, Montana , and Oregon , to estab li sh a tolerance in or on quinoa g rain at 3.0 parts per million (ppm). IR-4 a l so requested that quinoa be added to two r egis te red en d use products contain in g azoxystrob in : Quilt Xcel ® Fu ng i cide (EPA Reg. No. 100-1178; Sy n genta Crop Protection) a nd Quilt ® Fu ngicide (EPA R eg. No. I 00-1178; Syngenta Crop Protection) to contro l downy mildew 

### (Peronospora variabilis)

. A second petition, PP # 3E8228 , was submitted by Sy ngen ta Crop Protection and included a proposal to add import tolerances without domestic regis trations to the AmistarZtra SC label (Columb ia) on coffee, to the Azoxystrob in Am istar WP 10% l abe l (So uth Korea) on Asian pear , and to the Am istar 20 SC label (J apan) on tea. IR-4 has proposed label directions for quinoa that are nearly identical to those registered fo r bar ley gra in , except th at the reference to the Feekes growth stage 10.5 has been removed because quinoa is a pseudocereal rather than a grass . For both Quilt®a nd Quilt Xce l ®, azoxystrobin may be applied to quinoa via ground o r ae r ial equ ipment and at a maximum single app li cation rate of 14 

### fl. oz . product/ A , w ith no more than 2 applications per acre per season. Appl icat io n s may be made no closer th an a 14 -d ay interval , and the r est ri cted entry inte rval (REI) listed on both products is 12 hours. No quinoa residue data ha ve been sub mitted w ith this petition ; rather , IR -4 has proposed to translate the data used to establish a tol erance on barley grain at 3.0 ppm in order to suppo r t a tolerance and registration for use on quinoa grain. The IR-4 proposal is suppo rted by a recent recommendation of the Chemistry Science Advisory Council (ChemSAC). 

### Chemistry Science Advisory Council (ChemSAC) Recommendations The HED Chem SAC rece ntl y impl eme nted a po li cy to allow the trans lat ion of wheat or bar ley data to establis h a tolerance in or on quinoa (ChemSAC Meetings , 5/ 27/ 2015 and 7 / 29/ 2015). ChemSAC recommended that data may be translated from cerea l grains to quinoa , allowing for a quinoa registration without additional qui noa-spec ific residue data, i f the following cr iteria are met:

• There are established tolerances for residues in or on wheat , barley (in cases where a barley tolerance has been established at a higher tolerance than a wheat tolerance) or Cereal Grain Crop Group 15; and Page 2of3Revised A ddendum to Azoxys trobin Hum a n Health Risk Assessment DP No. 428619

• The proposed use pattern for quinoa is the same as the regi ste red u se pattern on wheat , barley , or Cerea l Gra in Crop Group 15. For azoxys trobin , th e u se patterns , treatment timin g and l abe l rates will be sa me as those for th e r egistere d use of azoxystrobin on barley gra in. Therefore, translation from th e existing data fo r the azoxystrobin use in or o n barley grain to quinoa is appropriate, based o n th e s imilarity of cultura l practices fo r quinoa and barley (as we ll as ot her cereal grains). 

### Expos ur e and Risk Co n s iderations There is no consumption of quinoa reported in the 2003-2008 data from th e U.S. D e partme nt of Ag riculture 's (US DA 's) Nationa l Health and Nutrition Examination S urvey, What We Eat in A m e rica , (NHANES / WWE IA). Notwithstand in g, b ec ause quinoa ca n be prepared li ke other w hol e grains , suc h as ri ce a nd barley , and b eca u se it may be used to mak e flour in a manner s imilar to w heat and o th e r ce r ea l g rain s, the Agency co nclude s that quinoa w ill likely substitute in the diet for cereal grain foods, wh ic h , as discussed above , w ill co nt ai n similar re s idues of azoxys trobin. Consequently, a signifi cant increase in dietary exposure to residues of azoxystrobi n from co n su mpti on of quinoa-containing foods is not antici p ated. S inc e the use pattern for quinoa is consiste nt with that for w heat and barley, in c reased expos ure s to indi v idu als through drinking water is not expected. Therefore , estab lishing toleran ces o n quinoa will not result in add iti onal di e tary ex posure to azoxystrobin from food or drink in g wate r so urces . No c h a n ges to re side nti a l expos ures will occ ur as a r es ult of proposed u se o n quinoa. Based on the in formation provided above , HED co nc lud es that the agg regate exposure and ri sks as a result of the proposed use o n quinoa wi ll not increase and w ill be the same as those estimated in previous H E D risk assessme nt s. S in ce the agronomi c practices for quinoa are known to be similar to those of wheat and barle y, and ex i sting occupationa l ex posure assessment s on wheat and barley are not of concern, these assess ments are pro tec tiv e of the proposed u se o f azoxystrobin on quinoa. 

### HED Re co mm end atio n s In the most recently-completed comprehensive ri sk assessment for azoxys trobin (042369 1 and 0418374 , Kristin Rury , 4/7/20 15) , the toxic ity database was cons idered co mpl e t e. Adequate residue data are avai lab le to s upport th e proposed use on quinoa grai n , tran s lated from barley grain, w hich h ave nea rl y identical use p atte rn s (excep t that the ref ere nce to th e Feekes growth s tage ha s been removed because quinoa is a p se udoc e real rather than a g rass)

. HED conclude s th at the aggregate expos ures and risks wi ll not in c rease for azoxystrob in as a re s ult of the proposed u se and w ill be th e sa m e as those es tim a ted in the recentl y - co mpl e ted H ED risk assessment. No risks of concern we r e identified in th ose previous assessmen ts . Occupational exposures and risks are also not of concern. Th erefo re, HED recommends es tablis hin g a permanent tolerance fo r residues of azoxystrobin in or on quinoa , grain at 3.0 ppm . Further, H ED recommends gran tin g the proposed regis tr at io n of Qui lt Xcel ® Fungicide and Quilt® Fungicide on quinoa grain.
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