### UNIT E D STATE S ENVIRONMENTAL PROTECT I O N AGE N CV WASHINGTON , D

. C. 2 0460 OFF I C E O F C HEMI C A L SAF E TY AND POL L UT I O N P RE VE N TIO N



### MEM O RAN D UM D ate: April 29, 20 1 5 

### SU B .JEC T : Flufenacet: Tier 

### I Update Rev iew of Human In c ident s/Ep idem i ology for 

### Draft Risk A ssess m e nt PC Co d e : 121 903 DP B arco d e: 0427013 Dec is io n No. : 485585 P et it ion N o.: NA R is k A ssess me n t T ype: A T XR No.: A MR I D No.: A Reg istrat io n No.: NA Reg u la t ory Action: 1 A C a s e No.: 1 A CAS No .: 1 4 2459-58-3 .$ 0CF R : NA Ver.Apr.08 

### F ROM : Shanna Recore , I ndust ria l Hy g i enist Toxicol ogy and Ep idem iology

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# Protection**Specia' ~**  /v Toxicolog y and Epidemiolog y Branch 

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# J H ealth Effec ts Di v i s ion ( 7509P)**d/J~** 

### T HROUGH: Dav id J
. Miller , Act ing Branch C h ief 

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# Branch**~** Heal th Effects D ivis ion (7509P) 

### T O : Kri s tin Rury . Ri sk Assessor Ri sk Assessme nt Branch III H ea lth E ff ec t s Di v i s ion (7509 P ) and M. H a thaw ay, Chemical Revi ew Manager Risk Management & Impleme ntation Branch 2 Pe s tic i de R e -evaluation Di v i s ion (7508 P ) Su mmary and Conclusions Flufenacet was pre v iou s ly re v iewed in 20 10 ( S. R ecore, 11 / 30 /2 010. 0383691). A t the time , th ere we re no flufenacct incidents found in Main 

### I OS and e ig ht incid ents reported to Aggregate 

### ID S

. Upon re view of the se incidents , it was conc lud ed that '·Based on the low frequenc y and

P age I of 4severity of incident cases , there does not appear to be a concern at thi s time that woul d wanant further investi ga tion. " Th e current ID S analysi s from January 1 , 20 10 throu g h Apr il 15. 2015 , s how s n o incide nt s reported involving flufenacet in Main or Agg r ega te ID S. A query of SENS OR-P est icides from 1998-2011 id en tifies five cases involving flufenace t. These incident s involve multip le active in g redients and are classified as low sever ity. Ba sed on th e low frequenc y and low seve rit y of in c ide nt cases repo rted for flufenacet in both IDS and JOSH SENSOR-Pesticides, there does not appear to be a concern at this time that wou ld warrant further in ves ti gat ion . The Age ncy will conti nu e to m o nitor th e inciden t informat ion and if a concern is tri gge red, a dditi o n a l a nal ys is w ill be cond u cted

. The Agricultu ral H ealth Study (A HS ) i s a lso a potential so urc e of infonnation assoc iated with human health effec ts assoc iated with certain pesticid es . Flufe n acet is not included in the AHS. and therefore thi s s tudy does not provide in format ion for this report. D e tai l ed Rev iew I. 

### ACT ION REQ UES TED Flufenacet are b e ing con si d e red und e r th e F QPA-m a ndated R eg i s tra ti o n R eview pro gram estab li s hed to r ev iew, on a 15 year cyc le, pesticid es fo r which a R e- reg i stration E li g ibility D ecision ha s bee n made. One component of the Age ncy's R egistrat io n R eview Program is cons iderati on of human incident data

. In co njuncti o n w ith a human hea lth ri s k assessment ba sed on other dat a so urc es, suc h human in cident data can ass is t the Agency in b e tte r defi nin g a nd c h arac t erizing th e risk of p es ticides/ pe s ticide produ cts. R epo rts of adverse health effects allege dly d ue to a spec ific pesticide ex p osure 

### (i.e., an ' ·incide nt ") are large ly se l f- reporte d a nd th e refo re , ge nera lly s p eak in g, neither ex po su re to a pe s ticide or repo rted sy mpt om (o r th e con nection between the two) is valid ated or o th e r w ise confirmed. Typically, causati on cannot be determined ba se d on incident data. I l owever, incident information can be a n imp or tant so urce of feedback to the Age nc y : incidents of severe o utcome, o r a s u ggested pat1 e rn o r trend among less severe in cide nts, can s ig n al the Agency to f urth e r in ves ti gate a parti cu l a r chemical o r product. Ob serva tional epidemiology stu die s relate th e ri s k of di sease, 

### e.g., ca ncer, and exposu r e to an agent suc h as a pesticide product in the genera l populatio n o r specific s ub-group s like pe s ticide appl i cators. 

### ll. BACKGROUND Flufenacet i s an an ilide herbicide registered for use on wheat ( including tritical e), perennial g rasses grow n for see d. com (fie ld and swee t)

. soybeans and fir trees (F IFRA 24(c) in WA a nd OR o nl y)

. There are n o reg is te re d re s id en ti a l us es or fluf e nac e t. For this evaluation, both OPP In cident Data System ( ID S) a nd th e Ce nte rs for Di sease Con tro l and Prevention/National In s titute for Occ upat i onal afety and H ea lth (C D C IOSH) Sentinel

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### Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient flufenacet (PC Code: 121903). The purpose of the database search is to ide ntify potential patterns in the frequency and severity of the health effects att r ibuted to flufenacet exposure. l n addition, findings from the Agricultural Health Study (AHS) were rev iewed

. The AHS is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes i nclud ing cancer. F lufenacet is not included i n the AHS, and t herefore this study does not provide information for th is report.


### III. RESULTS/DISCUSS IO N a. ID S ( In cid e nt Da t a Syste m ) OPP 's IDS includes reports of alleged human health incidents from various sources , includ ing mandatory Federa l Insecticide, Fungicide and R odentic ide Act (F IFRA) Section 6(a)(2) reports from registrants , other federal and state health and env ironmental agencies , and individual consumers. Since 1992 , OPP has compiled these repo11s in IDS. IDS contains repo11s from across the U.S. and most incident s have all re levant product information reco rded . R eports submitted to the JDS represent anecdotal reports or allegations on ly , unless otherwise stated in the report . IDS records incidents in one of two modules: Main IDS and Aggregate IDS:

o 

### Main IDS contains incidents resulting in higher severity outcomes an d provides more detail with regard to case specific. T h is system stores incident data for death , major and moderate inc idents, 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 certain information about the potential e ff e cts of exposure from the pesticide.



### o Aggregate IDS contains incidents resulting in less severe human incidents (minor , unknown , or no effects outcomes). These are reported by registrants only as counts in what are aggregate summar ies. From January 1, 20 I 0 to April 15 , 2015 , there were no incidents reported to Main IDS o r Aggregate IDS involving flufenacet. 

### b. SENS OR- Pes ticid es The SENSOR-Pesticides database covers 12 states from 1998

-2011 , although reporting varies from state to state. Case s of pesticide-related illnes s es are ascertained from a variety of sources , including: reports from local Po ison Control Centers, state Oepai1ment of Labor wo rkers ' compensation claims when reported by physic i ans, reports from State D epartments of Agriculture, and physician reports to state Departments of Health. Although both occupationa l and non-occupational incidents are included in the database, S ENSOR focuses on occupati onal
Page 3 of 4pesticide incidents. a nd is of particular value in providing that information. A state SENSOR contact specialist attempts to follow-up with cases and obtains medical records to verify sy mptoms , circumstances s unounding the exposure, seve rity , and outcome. Us ing standardized protocol and case definitions der ived from poi so n center reporting. SENSOR coo rdin ators at State Department s of Hea lth enter the incident interview description provided by the case, medical report , physician and patient into the SENSO R data system. Th e SENSO R data system is accessible to participating states and EPA. A query of SENSOR-Pesticides from 1998-2011 identifies five cases. stemming from three events. involving nufenacet. 

### All five cases involve multiple active in gredients (each of these cases involve four or more products) and all cases are low in severity.

c . Ag ri c ultural Health St ud y (A H S) The AHS is a hi gh quality , prospective epidemiology study evaluating the link between pesticide use and various health outcomes includin g cancer. The AHS includes private and commercial pesticide applicators and their spouses . The AHS includes information on use of 

### 50 different pesticide active ingredients commonly used in agriculture. Flufenacet is not included in the A HS. and therefore this study does not provide information for this report. 

### IV. CONCLUS ION Based on the low frequency and low severity of incident cases reported 

### for flufenacet in both IDS and IOSH SENSOR-Pes ticides , 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 if a concern is triggered. addit ional analysis will be conducted.

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