### UNITED STATES ENVIRONMENTAL PROTECTION AGENC Y WASHINGTON , D . C. 20460 O F FI C E OF C H E M ICA L SAFET Y AND P O LLU T I O N PREVENTION



### M EM OR AN D U M D ate : September 2, 2015 SU BJE C T : Pinoxaden: T ier I (S coping) Revi ew of Human Inc i d e nts
P C Code : 14 7500 OP B a r code: D-128933 D ecis i on No.: 508570 P eti t i o n No.: NA Ri s k Asse ss me n t T ype: 1A TXR N o. : A MRIO No.: NA Reg is trati o n No.: NA R eg u l a t o r y Ac ti o n : NA Case N o.: A CAS No.: 243973-20

- 8. 99607

- 70-2 40 C FR : NA Vcr.Apr .0 8 

### FROM: E li z abeth Ev ans , E nviro nme . ntal Protection**Spccia~ ,** **LL~** 

# Toxicology and Epide mi o logy Branch ___;,,,**~**

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T HRO UG H: H ea lth Eff ec t Di v i s ion (7509 P) 

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# ?.Cc/ -/. Z:J '-.) David M ill e r , Acting Branch Chi e f Toxicology and Ep idemi o logy Branch He a lth Effects Div is ion (7509P) 

### TO : William Wassell. Ri s k Assesso r Ri s k Assessment Branc h 

### J H ea lth Effec t s Di vis io n (7509P) and Linsey W als h , Chemical Rev ie w Manager III Ri sk Man age m e nt & Impl e ment a tion Branch Pesticide Re -eva luation Div i sion (7508 P) Summary a nd Conclus ions Ba sed on th e lo w frequency and severi ty of cases rep o rt e d for pinoxaden in both ID S and SENSOR-Pesticides, t here does not app ear to be a concern at this time that would warrant further investigat io n. The Age n cy will continue to m oni to r the incid ent in fo r mation and if a co n cern i s triggered , additional anal ysis will be included in the r is k assessment.

Page I of 4Detailed Review I. A C TION RE Q UESTED This review is intended to fulfi l l our requirement to docket summaries of inc i dent data that were repo r ted to the Agency , as we ll as to ensure human incident data and the Agricultura l Health Study (AHS) are part of the problem formula t ion phase ofregistration review. Reports of adverse hea lth effects alleged l y d ue to a specific pes ticide exposur e 

### (i.e., an "i nc ide n t") are largely self-reported and therefore , generally speaking. neither exposure to a pestic ide or reported symptom (or the connection between the two) is va l idated or o th erw ise confirmed. T ypica ll y. cau sat ion cannot be determ ined based on inc ident data. However, incident information can be an important source of feedback to the Agency: inc idents of severe outcome , or a suggested pattern or trend among less severe inc iden t s , can signa l th e Age n cy to f u

rthe r investigate a particular chemical or product. Observational epidemiology studies relate the r isk of disease , 

### e.g. , cancer, and exposure to an agent such as a pest icide product in the ge neral population or specific sub-groups like pestic ide applicators. II. B AC KGRO UND Pinoxaden was registered in 2005 as an herbicide for post emergence control of grass weeds in wheat and barl ey. O ne app li cation per crop season can be made using either open - cab ground boom equipment or via aerial application. For this eva luation , both the OPP Incident Data System (IDS) and the Centers for Disease Control and P revention/National Institute for Occupational Safety and Health (CDC/N I OSH) Sentinel Even t Notification System for Occupa ti onal Ris k-P esticides (SENSOR) databases were con s ulted for pesticide incident data on the active i ngredient pinoxaden (pc code: 147500). The purpose of the database search is to identify potenti a l patterns in the frequency and seve rit y of the health effects attri buted to pinoxaden exposure. Pinoxaden is not included in the AHS. and therefore this study does not provide information for this report. 

### II I. RES U LTS / D IS CUSS I O N

a . ID S ( In c i d e nt Data Sys te m ) OP P's ID S includes repo rts of a ll eged h um a n hea l th inc idents from va ri o u s sou rces , in cl ud i ng mandatory Federal Insecticide , Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants , other federal and state health and environmental agencies , and i nd ividua l consumers. Since 1992. O P P has comp il ed these reports in IDS. IDS contains reports from across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the I DS represent a necdotal repo rts o r a ll ega tions o nl y, un less othe rw ise stated i n the report. IDS records i ncidents 1 n one of two modu les: Main IDS and Aggregate IDS:



### o Mai n ID S contai ns incide n ts res u l ting i n h i g h er seve r ity outcomes a nd provides more detail with regard to case specifics. This system stores incident data for Page 2of4death, major and moderate incidents , and it includes information about the location , date and nature of the incident. Main IDS incidents involving o nl y one active in g redient (as opposed to pesticide products with mu ltiple active ingredients) are co n s id ered to provide more certain information about the potential effects of expos ure from the pesticide.

o Aggregate IDS conta in s incidents resulting in less severe human incidents (minor, unknown, or no effec t s outco m es). Th ese are r epo rted by re g i strant s only as coun t s in what are aggregate summaries. For th e Main ID S, from January l , 2010 to February 4, 20 1 5 , there were no incid e nt s reported involving pinoxaden

. In Aggregate ID S. from January 

### I. 20 I 0 to February 4. 2015. there were 3 incidents reported involving pinoxaden. These in c id en t s were classified as min or seve rit y . Overall, th e re are few in cide nt s reported to IDS in vo l v in g pin oxade n. 

### b. SENS OR -Pesticid es The SENSOR -P esticides database covers 12 states from 1998-2011. although repo11ing varies from state to state. Cases of pesticide-related illnesses are ascertained from a vari ety of sources , in clud in g : reports from local P o i son Contro l Cen ter s , state D epa rtm ent of Labor worke r s· compensation claims when reported by physicians, reports from State Dep artments of Agricu lture , and physician reports to state D e p a 1tments of H eal th. Although both occupational and non-occupational incidents are included in the database , SENSOR- P esticides focuses on occupational pesticide incidents , and is of particular va lue in providing that information. The state coordinator a t each of the 1 2 resp ec tive state D epar tm ents of H ea lth conducts case fo llo wup activities such as obtaining medical records to verify symptoms and severity

. Using standardized protoco l and case definitions derived from poi son center reporting, the state SENSOR-Pesticide coo rd in ator enters the incident information in to the s t a te-based system which is s ent to N IOSH annually to be aggrega ted

. A review of SENSOR-Pe s ticide s 1998-2011 identifie s two cases . stemming from one event. involving pinoxaden (pc code 147500). B oth of these cases in vo l ve a s in gle ac ti ve ingredient. The cases we re both low in seve ri ty
. In 20 l 0, the cases we re exposed to spray drift from an aerial pesticide appl ication taking place in an adjacent field about 900 feet away. After the two cases developed res piratory sy mptom s includin g cough , the fami ly left th e ir h o m e to avoid further exposure. The In s pecto r from the Texas Department of Agricu lture took clothing and vegetation samples, the results of the TOA inspection we re n ot inclu ded in SENSO R

.


### c. Ag ri c ultura l H ea lth St udy (A H S) The AHS is a hi g h quality , prospective e p idemio logy s tud y eva luatin g the link between pesticide use and various health outcomes inclu ding cancer. The A.HS includes private and commercial pesticide applicators and their spouses. 

### If there are A H S findin gs re levant to a parti cular pesticide go in g through reg i strat ion review, the Age n cy will ensure they are conside red in the problem formulation/scoping phase of the process and. if approp ri ate , fully reviewed in the ri sk ass e ssment phase of th e process. The A H S includ es in formatio n on u se of 80 d ifferent pesticide

Page 3of4active ingredients commonly u se d in agriculture. Pinoxaden is not included in the A HS , and there fo re this stud y does not prov ide in fom1ation for thi s re port. 

### IV. CONC LUSION Based o n the low freq uency and severit y of cases reported for pinoxaden in both ID S and SENSO R-P est icid es, there does not appear to be a conce rn at thi s time that wou ld warrant furth e r investigation. The Agency wi ll con tinu e to monitor th e incident information and if a concern is triggered , additiona l anal ys i s wi ll be in c lud e d in th e ri sk assessme nt.

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