### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFF I CE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Date: December 2, 2015 

### SUBJECT: Azoxystrobjn: Tier 

### I Review of Human In cidents for Draft Risk Assessment

PC Co d e: 12881 0 DP Barcode: 0430445 Deci s i on No.: 5 11 551 Petition No.: NA Ri s k Assess m e nt Type : NA TXR No.: NJ\ MRID No.: NJ\ R eg i stration No. : NA Re g ulator y Action: NJ\ Case No. : NA CAS No.: 1 3 186 0-33 -8 40 CFR: NA


### FROM: Elizabeth Evans, Env ironm ental Protection Specialist Tox ico logy and Epidemiology Branch Health Effects Division (7509P) and Ver.Apr.08



### Shanna Recore , Indu stri al Hygienist 

### l\**~** A •• ' · n 

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. n . Toxicology and Epidemiology Branch**~ ~**  

### Health Effects Division (7509P)


### THROUGH:

TO: David J. 

### Miller , Acting Branch Chief

# /),,J ,($ Toxicology and Epidemio logy Branch Health Effects Di vis ion (7509P) Kri s tin Rury , Risk Assessor Risk Assessment Branch JI 

### Health Effects Division (75 09P) and Veronica Dutch , Chem ica l Review Manager Ri s k Management & 

### Impl eme ntation Branch 5 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Azoxystrobin was previously reviewed in 2009 (M. Hawkins , 6/4/ 09). At the time , there we re nine incidents reported for azoxystrob in IDS from 2002 to Jun e 2009. Upon review of these incid e nt s, it was concluded that " there are no remarkable case reports w hi ch suggest a plausible assoc iation between a moderate or severe health outcome a nd exposure to pesticide azoxystrobin Page 1 of 5nor can we discern any s uggestion of a trend or pattern regarding the h ea lth effec ts due to the alleged exposure to pesticide azoxystrobin
. The current review of th e incid e nt data does not warrant further in vest igations at this time. " The current IDS a n a lysis from January I , 2010 through May 27, 2015, s how s 4 moderate severity incidents re ported involving the single ac tive ingredient , azoxystrobin , a nd 

### 29 additional incidents involving multiple chemicals in Main ID S. Th e re were 40 minor severity incidents reported to Aggregate IDS. The query of SENSOR-Pesticides 1998-201 1 id ent ifie s 51 total cases involving azoxystrobin and 

### 13 cases involve a s in g le ai. Twelve of the se were low in severity and one was moderate in seve rity. Detailed Review I. 

### ACTION REQUESTED Azoxys trobin is being considered under the FQPA-mandated Re gis trati o n Review program established to revie w, on a 15 year cycle , pesticides for which a Re-re g i strat ion Eligibility Deci s ion has been mad e. One component of th e Agency's Registration Review Program is consideration of human incident data. In conjunction with a human health ri sk assessment based on other data sources, s uch human incid ent data can assist the Agency in b e tter defining and characte ri z in g the ri sk of pesticides /pesticide products. Reports of adverse he a lth effects allegedly due to a spec ific pesticide exposure 

### (i.e., an
" in c ident " ) are largel y se lf-reported and therefore , generally speak i ng , neither exposure to a pesticide or reported symptom (or the connection between the two) is va lidated o r otherwise confirmed. Typically , causation cannot be determined based on incid ent data. H oweve r, incident infornrntion can be an important sou rc e of feedback to the Agency: in c idents of severe outcome, or a s u ggested pattern or trend among less severe incidents , can s ig nal the Agency to further investigate a particu lar chemical or product. Observational ep id emiology stud ies relate th e risk of disease , 

### e.g., cancer , and exposure to an agent such as a pesticide product in the ge ne ral population or s p ec ific sub-groups lik e pesticide applicators. 

### II. BACKGRO UN D Azoxystrobin is a broad-spectrum fungicide u sed to control fo li ar and soi l-b o rn e diseases including downy and powdery mildew , early and late blight , and seve ral pathogens on man y crops. For this evaluation, both O PP Incident Data System (IDS) and the Centers for Disease Control and Prevention/Nation a l In s titute for Occupati o nal Safety and Health (CDC/N IOSH ) Sentinel Event Notification Sys tem for Occupational Ri sk- Pest icides (SENSO R) databases were co n su lted for pesticide incident data on the active in gredie nt Azoxystrobin (PC Code : 12881 0). The purpose of the database sea rch is to identify potential pattern s in th e frequency and severity of the health effects attributed to azoxystrobin expos ure. Pag e 

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### III. RES U L 

### TS/D I SCUSS ION a . IDS (Incident Data S yste m) OPP's IDS includes reports of alleged human health incidents from various sou rces , includin g mandatory Federal I nsec ticide , Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants , other federal and state health and environmental agencies, and individual co nsu mers. Since 1992 , O PP has compiled these reports in IDS. IDS contains reports from across the 

### U

. S. and most incidents have all relevant product information recorded. Reports s ubmitted to the ID S represent anecdotal reports o r a ll egat ions only , unless o th erw ise stated in the report. IDS records incidents in one of two modules: Main IDS and Agg rega t e IDS:


### o Main IDS conta in s in cidents resulting in higher severity ou tcomes and provides more detail with regard to case spec ifi c. This system stores incident data fo r death , major and moderate incidents , and it includes information about the location , date and nature of the incident. Main IDS incidents involving only one pesticide are considered to provide more certa in infom1ation about the potentia l effects of ex po s ure from the pes ticide
.
o Aggregate I D S co ntain s incidents r es ultin g in less seve r e human in c idents (minor , unknown , or no effects outcomes). These are reported by registrants only as counts in what are aggregate summaries. 17rom January I , 

### 2010 to May 27, 2015, there were 4 incidents reported to Main IDS invo lving the s ingle active ingredient , azoxystrobin. These incidents were c la ssified as moderate severity (Tab le I). 

### D ermal symptoms were reported most o ft en which includ ed redness, ra s h and burning. There 29 addit io nal in cident r eported to Main ID S, in vo lving azoxystrob in and other act ive in gre di ents. From January I , 

### 2010 to May 27 , 2015, there were 40 incidents r eport ed to Aggregate ID S involving azoxystrobin. These incidents were classified as min or severity.

Ta bl e I
. Azoxys tr o bin Moderate Seve ri ty S in g le Active In 'red ie nt In cid e nt s R e porte d to ID S I ncident P ac ka ge In c id en t Reg P roduct Reoor t Da t e Locat io n Number Na me In c id e nt Ocsc riotion An adu lt female mail ca 1Tier was drifted on by an ae ri al app li cat ion. She immediatel y developed a headache , nasal inflammation , dizzine ss, and nausea. She went 10 the 022281

- 000100- emergency department. Her headach e 00030 8/9/ 2010 MO 01098 OUADRJS persisted for the next two weeks. Sixteen field workers had poscapplicaci o n 023187- INDIANAPOLIS , 000100- QUADRJS exposure due 10 reentry into a treated fi e ld. 000 16 7/ 29/ 20 11 IN 0 1098 FLOW ABLE The reentry lime had been observed. The y all 

### Page 3 of 5experienced dermal redness and burning on their arms. A 72 year old male field inspector was exposed to spray drift. H e experienced scratchy eyes, cough
. chest pain. short11ess of breath. elevated blood pressure. stomach QUADRJS ache. sweat s, skin rash , left arm pain, leg 025458

- 000 100- F LOW ABLE cramps, difficult breathing. puffy face, and 000 16 6/27 /20 1 3 I N 0 1098 FUNGICIDE tooth pain
. An ad ult male app lied the granular fungicide to hi s lawn and his ne ighbor, who was using a le af blower at th e tim e, acc id enta ll y blew th e granule s on him
. He was wearing gogg l es and a long s l eeved s hirt , but he had hi s mouth ope n at th e tim e and accide ntall y in ges t ed so me of th e g ranu l es. H e experi enced nausea, 02660 I

- 000 100- HERITAGE vomitin g, diarrhea , watering eyes , hea dac he, 00084 5/ 11 / 20 14 NC 01093 FUNG I C ID E fatigue and a rash on hi s sca lp , face and arms.


### b . SENSOR - Pesticides The SENSO R-P es ticides d atabase co v er s 1 2 s tates fro m 1998 -2 0 11 , a lth o u g h reportin g va rie s fro m s ta te to sta te. Cases of p esti c id e - relate d ill nesses are asce rtain ed from a varie ty of sou rces, includin g : r e p or t s from local P oison Contro l Cen te rs, s ta te D epartm e nt of Labor wo rkers · compensat ion claims w he n reported b y ph ys ician s, reports from State Departments of Ag ri cu lture, and p hys ician reports to state Dep artme nt s of H ealth
. Alth ough both occupat ional a nd n o n- occ upational incidents are included in the databa se, SENSOR foc u ses on occ up at io nal pe s ti c id e incid e nt s, and is of p art icular val u e in p rov idin g th a t information
. A s tate SENSO R con tac t s p ec iali s t a tte mpt s to follow-up w ith cases a nd obta in s m e dical record s to verify sy mpto m s, c ircum s tance s s urro undin g the expos ure, seve rity , a nd outcome. Using stan dardiz ed protoc o l and case definitions deri ve d from p o iso n ce nte r re p o rtin g, SENS OR coo rdinator s at S ta te D e partm e nts of Health e nter the incid e nt inte rvi ew d esc ripti o n provided by the case , m ed ic a l r epo 11 , physician and patient into th e SENSOR d ata sys te m. T he SENS OR data sys te m is access ibl e to pa11icipating sta te s and E PA
. A qu e ry of SENSOR- P es ticid es 1998-2011 identifi es a tota l of 5 1 cases involving azoxystrobin (pc code 1 28810). Of the se, 1 3 cases , stemm in g from 9 eve nt s, are si n g le ai cases . Twe l ve cases we re low in severity a nd one ca se i s m oderate in severity. One eve nt invol ve d fo ur cases, ag ri c ul tura l wo rke rs in a field that became ill after being direc tl y sprayed by an aer ial applicato r w h o was mak i n g an applicati on to a nearby field a nd th e n failed to tu rn of the s pray whi le m akin g a turn
. Another event in v ol ve d a fathe r and yo un g dau g hte r w h o were made ill from drift 1 fo ll ow in g a n aerial applicati on to a nearb y pot a to fie ld. Of th e 1 3 s in g l e a i cases, eight cases expe ri enced ne urol og ic a l sy mpto m s, primarily headache ; e ig ht cases experi enced gas trointes tinal sy mpto m s, in c lu di n g abdom in a l pai n a nd nausea. F i ve

1 SENSOR-Pes ti c id es defin es drift as " off target move me nt ofa p es ti c id e'' whi c h in c lud es vo latili zation. Page 

### 4 of 5cases ex peri e n ced d erma l sy mptoms such as rash/irritation , three reported resp iratory symptoms and two reported oc ul a r sy mptoms.



### c . Agricu ltur a l Hea lth Study {AHS) T he AHS is a hi g h qu a lit y, prospective e pid e miolo gy study evalua tin g th e link between pe s ti c id e use and vari o u s hea lth o utco m es includin g ca ncer . The AHS includes pri va te and commercial pestic id e a ppli cators a nd thei r spo use s . 

### If there are AHS findings re leva nt to a partic ul ar pest icide go in g throu gh registration revi ew, th e Agency wi ll ensure they a re co n s idered in th e problem formulation/scoping phase of th e process an d , if appropriate, f ull y rev iewe d in the ri sk assess ment pha se of the proc ess . The AHS in cludes information o n u se of 50 different pesticid e act i ve in g redi e nt s commo nl y used in agricu lture . Azoxystrob in i s not included in the AHS.


### CONCLUSION Based on the relatively low fre quenc y of in c id en t s reported to both ID S and SENSO R-P es ti c id es , th ere does not appea r to be a concern at this time. T he Age nc y will con tinu e to monitor the incident data a nd if a conce rn is triggered, addi ti o n a l analysis will b e conducted.

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