### UNITED STATES ENVIRONMENTAL PROTE C TION AGENC Y WASHINGTON , 

### D.C. 20460 OFFICE OF C HEMI CAL S AF E TY A N D POLLUT I ON PREVENTIO N

MEMORAN D UM Date: August 25, 2015 SUBJECT: Prothioconazol e: Tier 1 (Scoping) Review of Hum an Incid e nt s and E pidemiology

PC Co de : 113961 OP Barcodc: Dn881 l Deci s ion No.:**1** Petiti o n No.: NA Ri s k Assess m e nt T ype: N/\ TXR N o.: NA MRIO o .: A Registration No.: N/\ Reg ul ator y Ac ti o n : NA Case No.: NA CAS No.: 17 8928- 7 0 -6 40 CFR: NA Ver.Apr.OS FROM: E li zabeth Evan s , E n v ironmental Protection Specialist**~** Tox ic o logy and Ep idemi o logy Bra nch H ea lth Effec ts Di v i s ion (7509 P ) and Sha nn a Recore , Industri a l H yg ie ni s t T ox icol ogy and Epidemi o lo gy Branch Health Effec t Di v is ion (7509 P)

THRO U GH: David Miller, Acting Bran ch Chief Tox ic ology and E pidemiology Branch Health Effec t s Di v i s ion (7509 P )

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TO: Nancy Keller, Ri s k Asse ss or Risk Assessmen t Branch X Health Effec t s Di v is ion (7509 P ) a nd Margare t Hathaw ay, Chemical R eview Manager Ri sk Management 

### & Impl e mentation Branch 2 Pesticide Re-eva luation Division ( 7508P) Summar y and Co nclu s io n s Based on the low frequency a nd seve rit y of incid e nt cases report e d fo r prot hiocona zo le in both IDS a nd SE SO R-Pe s ti c ides ther e doc s n o t appea r to be a concern at thi s time th a t would warrant further in vest iga tion. The Agenc y w ill co ntinu e to monit o r the in c id e nt information a nd if a conce rn is tri gge red , ad diti o n al an alysis w ill be includ ed in th e risk assessment.

Page I of 4Detailed Revi ew I. 

### AC TIO N REQ UES T E D Thi s re v iew i s intended to fulfill our re quirement l o d oc ket s ummaries o f in cide nt data that were reported to the Agency , as well as to e nsure human i ncident data a nd th e Agricultural H ea lth Study (A HS ) a re part of th e problem fo mrnl ation pha se of reg istration rev iew

. Rep o rts o f adverse health effects a ll ege dl y due to a specific pesticide expos ure 

### (i.e., an ' ·incid e nt ' ") are large ly se lf-repo rted and therefore , gene rally speaking, neither exposure to a pesticide or r epo rted s ymp tom (o r the connection betw ee n th e two) is va lidate d or othe r wise confirmed. T yp icall y, causation cannot be determ ined based on in c ident data

. However , incid ent information can be an im porta nt so urc e of feedb a ck to the Age n cy : in c ident s of severe o utcome , or a s ug gested patt e rn or tre nd among les s seve r e incidents , c an s i g n al the Age n cy to further invest i ga te a pa rti cula r che mi cal or prod u ct. Ob se r vat io nal epidemio logy studies re late th e ri sk of disease , 

### e.g. . cance r , and exposu re to an agent s uch as a p es ticide product in th e ge neral population or s pec i fic s u b-groups like pes ti cide app licator s. 

### II
. BA C KGROUND P roth ioco n azo le i s a broad-spectrum syste mic fungicide u sed on barley , wheat and o th e r crops. (E PA fac1shee1, found online ar: hllp :// www.epa.gov/ pes t icides/c h em search/ r eg acrions /registrati on/ fs PC

11 396 1 1 4- Mar -07.pdO For thi s evaluation , both th e OPP In c ident Data Sys tem ( ID S) and the Ce nter s for Disease Con trol and Prevention / N a tional In sti tute fo r Occupational Safe ty and Health (C D C/N IO SH) Sentinel Eve nt No tificati o n System for Occupatio n a l Risk-Pesticides (SENSO R ) databases we re con s ulted for pe s ticide in c ident data on the acti ve in g r ed ient prot hi oconazo le (pc code: I 139 6 l )

. The purp os e of the databa se search is to id e ntif y potential p a ttern s in th e freque nc y and severit y of th e health effects attributed to prothioconazol e expos ure . Prothioconazole is n o t included in the AH S, and therefore thi s study do es not provide in formation for this report. 

### III. R ESU LTS/D ISCUSS IO N

a. ID S ( Incid ent Data Sys t e m ) OPP ' s IDS include s reports of a lleged human he a lth incident s fr o m various so urce s, includin g mandatory Federa l I nsecticide , Fungicide an d R ode nti cide Act ( F IFRA) Sect ion 6(a)(2 ) r eports from re g i s trant s, other federal a nd s ta te health and en v ironme ntal agencies, a nd indi v idu a l con s umers. Since 1 992, OPP h as compiled these r eports in IDS. ID S contains rep orts from across th e U.S

. and most incid e nts h ave all rele va nt pro duct information recorded

. R eports submitted to the IDS repr ese nt anecdo t a l reports o r a ll egations only , unless o therw i se state d in th e report. ID S records in cide nt s in o ne of two module s : Main ID S and Agg regate IDS:

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### o Main ID S conta in s in c id ents resultin g in higher seve rity outcomes and provide s more d e tail with regard to case specifics. This sys te m sto res in c id ent data for d eath , major and moderate inc idents , and it include s information about the lo cation , date and nature of the in c id e nt. Mai n ID S incide nt s invo lving only one act i ve in gredient (as opposed to pesticide products with multipl e active in g redients) a r e conside red to provide more cer t ain in format ion abo ut th e potential effects of exposu r e from th e pesticide.

o Aggregate I DS contains in c id ents resulting in le ss seve r e hum an i ncident s (m inor , un known, o r no effec ts outcomes). Th ese arc reported by registrant s only as cou nt s in what arc aggregate s ummari es . For the Ma in IDS , from J a nu ary I , 20 I0 to May 27, 20 1 5, there were 0 incidents reported for the sing le chemica l prothioconazole o nly in th e database. There was 1 incide nts r eported involving than one chem ica l. This incident was c l assified as modera te severity and invo lved a 50 year old male who got diluted product, containi ng prothioconazole and pe n flufe n , on his h ands. He deve loped burning sensation , rednes s, and weeping so res . He was eva luated by doctor , treated with a stero id inj ec tion and prescribed a top i ca l c ream to apply t o th e area. In Aggregate ID S, from January 1, 20 10 t o May 27, 2 01 5, th e r e we re 12 incid e nts r epo rted involving prothioconazo le. These in cidents we re classified as minor sever ity. Overa ll , there a re few incident s reported to ID S invo lvi ng pro thi oco nazo le. b. SENSOR-Pes ticid es 

### The S EN SOR-Pest icides database cove r s 12 states fro m 1998

- 20 11 , a lth o ug h reporting varies from state to state. Cases of pesticide-related ill nesses are asce rt a ined fr om a variety of so urc es, including: r e port s from loca l Poi so n Con trol Ce nters , state Depa rtm e nt of Labo r worker s' compensat io n claims when reported by physicians, reports from State D e partment s o f Agriculture, a nd phys ician report s to s tate Departmen ts of Heal th. A lthou g h both occ u pat ion a l and non-occupationa l incidents are included in the database , SENSOR-P esticides foc use s o n occupatio nal pesticide incid e nt s, and i s of pa rti cul ar va lue in provid ing that in formation. Th e state coordinator at each of the 12 re spec ti ve state D epar tment s of Health conducts case fo ll owup ac tivitie s s uch as obtaining me dical rec o rds to verify symptoms and severi ty. Using standard ized protocol a nd case defi niti o ns derived from p oiso n cente r reportin g, th e s t ate SENSOR-Pesticide coord in ato r e nter s the incident inform ation into the state-based syste m which is sen t to N IOSH a nnu a ll y to be agg r egated

. A query of SENSO R -Pest ic id es 1 998-20 11 iden tifie s o ne case involv ing prothiocon azo le. This case involves multiple ac ti ve ingred ien ts. The case is low in severity. Th e case was exposed to drift fr o m an ae ri a l app li cation made t o a n earb y wheat fie ld

. The case experie nced nau sea, burning eyes and nose , dizziness and head ac he.

c . Agr i cu ltu ra l Health S tudy (A H S) 

### The AHS is a high quality , prospective epide mi ology study eva luatin g th e li nk betwee n pesticide use and vari ous h ea lth outcomes including can cer. The AHS in cludes private and commerc ial pe s ticide applicators and their spouses. If there are A HS find in gs relevant to a particular
Page 3o f4pesticide go in g through re gis tr at ion review, the Agency will ensure they are considered in the problem formulatio n / scoping phase of the process and , if appropriate , fully reviewed in the ri sk

. assessment phase of th e process. The AHS includes informati o n on u se of 80 different pesticide active in g re dients co mmonl y u sed in agriculture. Prothioconazolc is not included in the AHS , and therefore this study does n ot prov id e infonnation for this report. 

### IV. CONCLUS ION B ased on the low frequency and severity of incid e nt cases rep o rted fo r prothioconazole in both IDS and SENSOR-Pesticides th e re does not appear to be a concern at this time that would warrant further investigation. The Age n cy will continue to monitor the in cident in formation and if a concern is triggered , additional ana l ysis will be included in the ri sk assessme nt.

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