UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D
. C

. 20460 O FFI C E OF CHEMICA L SAFETY A N D POLLUTION PREVENTION

MEMORANDUM D ate : July30 , 2015 

### SUBJECT : Topramezone: Tier I Review of Human Incidents

PC Code : I 23009 DP Barcode: 0428433 Decision No.: 49992 I Pet itio n No.: 1 A Risk Asses s ment T y pe: A TXR No.: NA MRJD No.: NA Registra ti on No.: NA Regulato r y Action: A Case No. : 1 A CAS No.: 210631

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- 8 40CFR: NA
FROM: Elizabeth Evans , Environmental Protection Specialist Toxicology and Epidemio logy Branch 

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Shanna Recore , Industrial Hygienjst 

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# l/J;(.**:t ~**  Z,o • f David Miller, Acting Branch Cruef ((

- / ./, ' , Toxicology and Epidemiolo gy Branch Health Effects Division (7509P) Cassi Walls , Risk Assessor Risk Assessment Branch I Health Effects Division (7509 P) and Jose Gayoso , Chemjcal Review Manager Risk Management & Impleme ntation Branch 2 Pesticide R e-evaluation Divi s ion ( 7508P) Summary and Co nclusion s Based on low severity and frequency of incident cases reporte d for topramezone to both IDS and SENSOR-Pesticides there does not appear to be a concern at this time that would warrant furth er investigation. The Agency will continue to monitor the incident i nformation and if a concern i s triggered , additi ona l anal ysis w ill be includ ed in the risk assessment.

Page I of 4Detailed Review I. 

### AC TIO N RE Q UESTE D This review is intended to fulfi ll our req uireme nt to docket summari es of incid ent data that we re reported to the Agency, a s well as to e n s ure human incident data and th e Agricultural H ea lth Stu dy (AHS) are part of the problem formula ti on phase of registration review. R epo rts of ad ve rse health effects allegedly due to a speci fi c pesticide exposure 

### (i.e. , an " incident") are largely se lf-reported and th erefore, ge ne r a ll y speaking , ne ith er exposure to a pesticide or reporte d sy mptom (or the connection betwe en th e two) is validated or otherwise confirmed. Typica ll y , causat io n cannot be d e termin ed based o n incident data. However, in ci d e nt information can be an imp ortant so urce of feedback to the Agency: incidents of sever e outcome, or a suggested pattern or tre nd amon g less severe incident s, can signal the Agen cy to further investigate a parti cula r chemical or product. Ob servational ep idemiol ogy studi es relate the ri sk of disease , 

### e.g. , cance r, and exposure to an agent such as a pes ticid e product in the ge n era l population o r sp ec ific s ub- gro up s like pesticide appl icators. 

### II
. BAC KGRO UN D To pram ezo ne is an herbicid e app lied p os t-emer ge nce to field com, sweet corn and popcorn applied v ia ground o r aerial ap plication equipment. Topramezo ne ha s he rbicidal activity aga inst broadleaf weeds and grasses. Fo r thi s evaluation , both th e OPP Incid e nt Data Sys tem (IDS) and the Center s for Disease Control and Pre vent ion/Nationa l In st itu te fo r Occupational Safet y and Health (C D C/N IO S H ) Se ntin el Eve nt Notifi cati on System for Occ up atio na l Ri sk-P esticides (SENS OR ) databases were co nsulted fo r p esticide incident data on th e acti ve ingredi ent to pram ezone (pc code: 12 3009)

. The purp ose of the database searc h i s to id e ntif y potential patterns in th e frequency and severity of the health effects attributed to topramezone exposure. T op ram ezone i s n ot included in the AHS, and therefore this stud y does not provide informatio n for thi s report
. 

### III. RE S ULTS/DI SCUSS IO N

a . ID S (I ncid en t D a ta Syste m) OPP ' s IDS includes reports of alle ged human health incidents from variou s sources , including mand ato ry Federal In secticide , Fungicide and R odenticid e Act (FIFRA ) Section 6(a)(2) reports from re g is trant s, ot h er federa l and state health and environmental ag e ncies , and individu al co nsum ers . S inc e 1992 , OPP has compiled these reports in IDS. IDS co ntain s repo rts from across the U.S. and most inc ide nts have a ll relevant product informat ion r ecorded. Reports submitted to th e ID S repre sent anecdotal reports or allegations only, unle ss otherwise stated in the rep o rt. IDS r ecords incidents in one of two modules: Main IDS and Aggregate IDS :

Page 2of4o Main IDS contains in cidents resulting in higher severity outcomes and provides more detail with regard to case specifics. This system sto res inc ident data for death, major and moderate incidents, and it includes information about the location, date and nature of the incident. Main IDS incidents invo lving only one active ingredient (as oppo sed to pesticide products with multiple active ingredients) are considered to provide more certain information about the potential effects of exposure from the pesticide.



### o Aggregate ID S conta in s incidents resulti ng in less severe hum an in c id ents (m in or, unknown, or no effects outcomes)

. These are reported by registrants onJy as counts 

### in what are aggregate summaries

. For the Main IDS, from January 1, 2010 to February 4, 2015, there were no in cidents reported involving topramezone
. In Aggregate ID S, from January 1 , 2010 to February 4 , 20 15 , there we re 3 incidents reported involving topramezone. These incidents were classified as minor severity. Overall , there are few incidents reported to IDS involving topram ezone. b. SENS OR-Pes ticides The SENSOR-Pesticides database covers 12 states from 1998-2011 , although reporting varies from state to state
. Cases of pesticide-re l ated illn esses are asce rtained fro m a varie ty of sources, including : report s from local Po i son Control Ce nters, state Departme nt of Labor workers' compensation claims when reported by physicians , reports from State Departm ents of Agriculture, and physician reports to state Departments of Health. Although both occ upation al and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents , and i s of particular value in providing that in formation. The state coordinator at each of the 12 respective state Dep artments of Health conducts case followup activit ies such as obtaining medical records to verify symptoms and severity. Using standardized protocol and case definitions derived from poison center reporting , the state SENSOR-Pesticide coordinator e nters the incident information into th e sta te -b ased system w hi ch is sent to N IO SH annually to be aggregated. A review of SENSOR-Pesticides 1998

- 2011 identifies no cases invo lving topram ezone.

c . Agricultura l Health Study (AHS) Th e AHS is a high quality , prospective ep id emio log y study evaluating the link between pesticide use and various health outcomes includin g cancer. The AHS includes private and commercial pesticide applicators and their s pouses. If there are AHS findings relevant to a particular pesticide going through registration review , the Agency wi ll ensure they are co n si dered in th e problem formulation/scoping phase of the process and , if appropriate , fu ll y reviewed in the risk assessme nt phase of the process. The AHS includes information on use of 80 different pesticide active ingredients commonly used in agriculture. Topramezone is not included in the AHS, and therefore this study does not prov ide informati on for this report. IV. CO NC LUSION
Page 3of4Based on . low severity and frequency of incident cases reported for topramezone to both IDS and SENSOR- Pesticides there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and i f a concern is triggered , additional analysis will be included in the risk assessment.

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