### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D . C . 20460 O FFICE O F C H E M I C AL SAFET Y A N D P O LL U TI O N PRE VE NT IO N

ME MORA ND U M D ate : Sep tember 15 , 20 1 5 SU BJ EC T : Metconazole: Revised Tie r I (Scoping) Revi ew of Hu m a n I nc i d e n t s and Epidemio logy PC Co de : 125619 DP B a r codc: 042890 0 Deci s i o n o.: 5 07 195 Petiti o n No.: /\ R egis t ra t io n No .: A Regulator y Act ion: N/\ Case No.: NA R is k A ssess m e nt Ty p e: N/\ T X R No. : NA CAS No.: 125 1 16-23

- 6 4 0 C FR : N/\ M RID o. : N/\


### F ROM : E lizab e th Evans , E nviro nm e nt a l Protecti o n Specia list ');?._

# -~**~** Toxicology a nd E pidemi o logy Branch

- 

# 0 -- Health Effects Di v i s ion (7509 P ) and

## ~ Shanna Re co re , Indust r ial I l ygienist 

# J g /)f 11 1 

## IA 11 Toxic o logy a nd Ep idemi o logy Branch**~V'-fl\...JI""-'** Health Effect Di vis io n (7509P) ,. . 

### THRO UG H: David Miller , Acting Bran c h C hief

# ~**l"f/,J:V ;~** **fl .1l** **1~** Tox ico logy a n d Ep idem io logy Bra n c h 

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# u Health Effec t s Division (7509 P) TO : Barry O'Keefc, Ri sk Assessor Ri sk Assessment Br an c h )[) I lcalth Effec t s Division (7509 P ) and Bonnie Ad le r , Chemica l R ev iew Manage r Ri s k Management & Impl e me nt a tion Bran c h 5 Pesticide Re-evaluation Di vision (7508 P ) Sum m a ry a nd Conclusions This memorandum was rev i se d to con-eel th e DP Barcode only. No other changes were mad e t o th i s assessment. Ba sed on th e low frequ e n cy a nd seve rit y of in c id e nt cases r eporte d for metconaz o le in both ID S and SENSO R-P es ticid es th e r e d oes n o t a ppear to be a concern at thi s ti m e that wou ld wa rrant fu rth e r in ves ti ga ti on. The Agency wi ll co ntinu e t o m o nitor the incid e nt
Pa ge I of 5information a n d if a co n cern i s tri gge red , add iti onal anal ys i s w ill be in cluded in th e ri sk assessment. Detail ed R eview 

### I. ACT IO N REQ UES TED This review i s intended to fulfill our requ i rement to docket summaries of incident data that were reported to the Agency, as we ll as t o ensure human incid e nt data and the Agricul tural Health Study (A HS) a r e par t of th e prob lem form ulati on phase of reg i stration review. R epo rt s of adverse health effects alleged ly due to a specific pesticide exposu r e 

### (i.e., an "inc id ent") arc largely self-reported and therefore. generally speaking, neither exposure t o a pesticide o r report e d symptom (or th e co nn ect ion between th e two) i s va lid a ted or otherw i se confirmed. Typ ically , cau s ation cannot be determined based on in cident data. Ho wever , incident information can be an important sou rc e of feedback to the Agency: incidents of severe outcome, or a s u gges ted pa tte rn o r trend among less seve re incident s, can sig nal th e Agency to fu11her inve s tigate a particular chemica l or product. Ob se rvational epidemiology stud ies relate the risk of di sease, 

### e.g. , cancer , a nd exposure to a n agent such as a pesticide produc t in the general popu la tion or spec ific s ub-group s lik e pe s ticide app li cators. 

### II
. BACKGROUND Metconazole i s a sterol bios y nthesis inhibitor (DM l- Fung icide). It can be app li ed to turf and ornamentals but it can on ly be app li ed by ground spray . 1 For thi s eva lu ation, both the OPP Incid en t Data System ( IDS) and the Centers fo r Disease Cont r o l and Prevention/National I nstitute for Occupatio nal Safe t y and Health (C DC JOSH ) Sentinel Event Notification System fo r Occ up a ti o nal Ri sk- Pesticid es (SENSO R ) databases we re consulted for p es ticid e incident data on the active in g redi ent metconazole (pc code: 

### 125619 ). The purpose of th e database searc h is to identify potential patterns in the frequency and seve r ity of the health effect s attr ibut ed to m e t conazole ex po s ure. Metconazol e i s not in cluded in the AHS , and th e refo re this s tud y doc s n ot provide information for this report.


### lll. R ESU LTS / DISCU SS ION

a. IDS ( Incident Data System) OPP 's I DS in c lude s repo rts or alleged human h ealth in cidents from various sou rces, includ i ng mandatory F edera l ln sec ticide , Fung ic ide and Rodenticide Act 

### (FlFRA) Section 

### 6(a)(2) repo rts from registrant s, othe r federal and state health and e n viro1m1ental age nci es, and individual consumers. S inc e 

### 19 92 , OPP has compiled these reports in IDS
. IDS contains reports from across the U.S. a nd m ost incid en t s h ave a ll relevant product in fo rm a ti on reco rd ed. Repo r ts

1 EPA Factsheet , found on lin c at: http: // www.epa.gov/ pe s ticidc s /chcm sea rch / r eg action slre gistralion/ fs PC

125619 O l- Sep-07.pdf
Pa ge 

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### s ubmitt ed to th e IDS repr ese nt anec dot a l report s o r a ll ega ti o ns o nl y, unl ess o th e rw ise s tated in the repo rt. IDS records in c id e nt s in one of two modules: Main ID S and Agg regate ID S:

o Ma in IDS co ntain s incident s res ulting in hi ghe r se verity o ut comes and pro v id es more detail with regard to case s pecifics. Thi s sys tem stores incid e nt data for d eath , m ajo r and moderate in c idents , and it in c lud es inform at io n about the loca ti o n , date a nd nat ure of th e inc id e nt. Main IO S incident s involv in g only o ne act ive in g redien t (as opposed to pe st icid e produc t s with multipl e act ive in g redient s) a re co ns id e red lo provide more ce rt a in informati o n a bout the pote n t ia l effects of exposure fro m the p es ticid e.


### o Aggregate ID S conta in s incid e nt s resulting in less seve re human incidents (minor, unknown. o r n o effec t s outco mes). These a r e r epo rt ed by re gis tran ts o nl y as cou nt s in what are aggregate sum marie s. Fo r the Ma in ID S, from J a nu a ry 1 , 20 1 0 t o May 2 7 , 2015, th ere we r e no in c id e nts reported fo r the s in g le c hemical metconazole o nl y in th e database. Th ere w e r e three in c id e nt s reported in vo l v in g me t co nazol e and pyraclostrobin. T hese incident s were c lass ifi ed as mo derate seve rit y> Description s for the se in c id e nt s are pro vided in Appendix A. Agg regate ID S, from January I , 20 l 0 to May 27, 20 1 5, there we re 17 incid e nt s r epo rted in vo lv in g me t co nazole. These incident s were classified as minor s everity. Overall , there are few incid en ts re ported to ID S involving mc t conazo le .
b. SENSOR-Pes tici d es 

### The SENSO R-P esticides database co ve rs 12 s ta te s from 1998-20 11 , although repo rting va ri es from s t a t

e t o s tate. Ca ses of pes ticide-relate d illne sses are ascertai ned from a va ri ety of sources , includin g : re port s from lo ca l Poi so n Control Ce nt ers, s tate D e partment of Labo r workers ' compensati o n c la im s w h e n r epo rted by physicians, report s from State Departm e nt s of Ag ri culture. and ph ysician reports to sta t e Departments of H ea lth. A lthough both occ upati ona l and non-occupational inciden ts a r e in cluded in the datab ase, SENS OR-P esticides focuses on occupationa l pesticide in cide nt s, and is of par ti c ular value in providing that information. T he state coord inato r at eac h of th e 12 res pecti ve s t ate Departm e nt s of He a lth cond uc ts case followup activities s uc h as obtai nin g me dic a l reco rd s to verify symp t oms and sever ity. Using standardized protocol and case d e finition s derived from poison ce nter reportin g, th e s tate SE SOR-Pes ti c id e coordina tor ente rs th e in c ide nt in format ion into the s tate
- based sys tem which is sent to IOS H a nnu ally to be agg re gated. A rev iew o f SENS OR-P es ti c id es 1998

- 20 11 identifies no cases involving met co nazole.

c . Ag ri cu l tu ra l Hea l th Stu dy (A H S) 

### The A HS is a high quality , prospec ti ve ep id em io logy study eva lu at in g th e link be tween pesticide use and va rious hea l th o ut comes includi ng cance r. The AHS includes private and co mm ercia l

Page 3 of 5pesticide app li cato r s a nd their s pouses. I f there a re AHS finding s re leva nt to a particular pesticide going through regist ration review, the Agency will ensu r e they are con s idered in the probl e m formulation/ sco pin g phase of the proc ess and, if appropr i ate , fully re viewed in th e risk asses s ment phase of th e process. The AHS in cl ud es in forma ti o n on u se of 80 diff e rent pe s ticide active ingredi e n ts commonly u se d in ag ri culture. Metconazole i s not included in the AHS, and therefore this s tud y does not provide information for this report. 

### IV. 

### CONCLUS ION Based on the low frequency and severit y of in cide nt cases reported fo r m etconazo le in both IDS and SENSO R-Pesticides there does not appear to be a concern at this tim e that would warrant further inve s tigation. The Agency will continue to monit or the incident information and if a co n ce rn i s tri gge red , ad dition a l analysis w ill be includ ed in the ri s k assessme nt.

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### Appendix A. In cidents Report e d lo 

### Main ID S from 20 10 to 

### M ay 2 7 , 20 15 Involvin g Mctconazo lc Incid e nt Package In c id e n t P C Report D a t e Locatio n Re g Number Product Na me Code s In ci de n t D esc ri pt io n The caller's dau g hter was hos pitali ze d with panc ytopenia. 023168

- IND EPENDENC E, 00 796 9- HEADLINE AMP 125619 Ca ll e r believe s it i s due to fungicide reaching drinkin g 00001 8 /2/20 11 IL 00291 FUNG I C ID E 099100 wate r. Doctors ha ve no t d ete nnin ed cause of pan cytop enia. A 61 y r o ld ma le exposed to produ ct durin g an ae ri a l app lic atio n . H e s how ered sho rtl y afle r th e exposure. Three 024 27 9

- 007969- HEADLINE AMP 099100 ho urs late r he reported pain a nd a burnin g se nsa ti o n in hi s 00001 7/14 / 20 1 2 OXFORD , NE 00291 FUNG I C IDE 1256 19 lun gs , s ho rtne ss o f brea th , and irrit ated eye so ck et. Two teenage fe m a le s ( 13 years old a nd 16 yea r s old) a long with seve ral do ze n other adolescenls and adu l ts we r e detasse lin g com and were s pra ye d 1- 2 times b y a n ae ri al applicator with product. Fix ed win g a irpl a n e apparently spraye d the wr o ng li e ld. Th e thirt een yea r o ld deve lop ed n

a usea, s kin irrit ati o n, per s is t e nt hea dach e, and nausea. The s ixl ee n yea r o ld ex peri e nced difficu lt y breathing. BAS 556 SC s hortn es s of brea th and had an e pi so de of l oss of 025 5 90

- 007969- FVNG I C IDE /l I EADLI N E 125619 co nsciou s ness for so me period of time while a nd was taken 00001 7 / 29/ 2013 HAMMOND, IL 00291 AMP 099100 10 a local E R where s h e rec ove red
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