### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D . C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM D a t e: A u g u s t 6, 2 01 5 

### SU BJEC T: Diuron: T ie r 

### I ( S coping) Revi e w of Human Incident s/ Ep id e miology
P C Co d e : 03 5 505 D P Bar coclc: 0 428534 Deci s ion N o .: 496087 Pet iti o n No.: NA Ri s k A ss e ss ment T y p e : A T X R No .: J\**lRID** No .: A Regi s tr at io n No.: NA Re g ul a t o r y Action: NA C a s e N o.: NA C A S N o.: 330

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### FROM: Sh a nn a R eco re, Industrial H yg ie ni s t 

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. ,,., Toxicolo g y and Ep ide mi o lo g y Bra n c h

# ~**~** Health E ff ec t Divi s ion (750 9 P ) a n d E li zabe th Evan s, En v ironme nt a l Pro tec tion S p e ciali s t Tox ico logy a nd E pid e mi o logy B ra n c h H e alth Effects Di v i s io n (7509 P ) 

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### ~,;101S THROUGH: D av id Mill e r , Acting Branch C hi ef 

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TO: To x ico logy a nd E pidemiol ogy Bran c h Health E ff e cts Division (7509P) Karl y n Middl eto n , Ri s k A ssesso r Ri s k Assess m e nt Branch 

### II H ea lth Effec ts D iv i s io n (7509 P ) a n d Kath e rin e S tC l a ir , C h e mi ca l R ev i ew M a n ag er Ri s k M a nage m e nt 

### & Impl e m e nt a ti o n Bra nch 

### 2 Pe s ticid e R e - ev alu a t ion D ivi s ion ( 7 5 08P) S umm ar y a nd Con c lu s io n s Based o n th e l ow fre qu e n cy a nd lo w s everity o f in c id e nt c as es reporte d fo r diuron in IDS , SENS OR-P es ticid es , a n d N PI C th e re d o e s n o t ap pea r to b e 

### a c o n c ern a t thi s t ime that wo uld warra nt furth e r in ves ti ga ti o n. T he Age n cy w ill co ntinu e to m o nit o r th e in c id e nt in fo rmati o n a nd if a co n ce rn i s tri gge re d , a d d it i o n a l a nal ys i s will b e in cl uded in th e ri s k assess m e nt.

P ag e 

### I o f 5Detailed Review 

### I. 

### AC TIO N RE Q UES T ED This review is int e nd ed to fulfill o ur req uirem e nt to docket s ummari es of incident data th at were reported to the Agency, as well as to ensure huma n incident data and th e Agricu ltural He a lth Study (AHS) are part of the prob l em fo rmul a ti on phase of r eg istration review. Reports of adverse health effects alleged l y due to a specific pesticide exposur e 

### (i .e., an " incidenC) arc largely se l f-reported and the refo re , genera l ly speaking, neither ex po s ure to a p est icid e or r e po11 ed sy mpto m (o r the connection between th e two) is validated o r o th e rwi se co nfirmed. Ty pic a ll y , ca u sation ca nn ot be determined based o n incident data. H owever, incident in fo rmati on can be an imp o rt a nt sou rce of feedback to the Age nc y: incidents of severe outcome, o r a suggested patte rn or trend among less severe in c ident s, can signa l the Agency to further in vest igate a particular chemical o r product. Observational ep id e mi o logy s tudi es re la te the ri sk of disease, 

### e.g. , cance r and exposure to an age nt suc h as a pest icide product in the ge neral population o r speci fie s ub- groups like pesticide ap plicator s. 

### II
. B ACKG RO UN D Diuron is a pre- and post-emergent he rb icide that controls a wide variety of a nnu a l an d perennial broad leafed and grassy weeds o n both crop and non-crop s it es. Th e mechanism of herbicidal act ion is the inhibiti on o f photosynthesis. Produ c t s contai nin g diuron are intended for both occu pati o n a l and resi d e ntial u ses. Occupational uses include agricultural food and non-food cro ps ; ornamental trees, flow e rs, and shrubs; p a int s and coatin gs; orn a m e ntal fi s h a nd catfish product ion ; rights-of-way and indu stria l s ites. R es identi al uses includ e ponds , aquar ium s , and paints. For this eval uati o n , both the OPP Incid e nt Data Syste m (ID S) , the Cen te rs for Di sease Co ntro l an d Prevention/Nati onal In stitu te for Occ up ationa l Safety and H ea lth (CDC/N IOSH) Sentinel Eve nt No tifi cati o n Syste m fo r Occupational Ri sk- Pesticides (SENSO R), and the Nat ion al Pes t icide Information Ce nt e r (N P I C) d a ta b ases were consulted for pesticide incid e nt data o n the act i ve ingredient diuron (pc code : 035505). Th e purpose of the database searc h is to id entify pote nti a l patterns in the frequency and severity of the health effects attributed to d iu ron ex po s ure. Diuron is not includ ed in the /\HS, and th e re fo re thi s stud y does n o t provide information for thi s report. 

### III
. RE SULTS /DI SCUSS IO N
a. ID S ( Incid e nt Data Sys t em ) OPP's ID S includ es reports of a ll eged human hea lth incid en t s from various sou rces , including mandato r y Federa l I n sec ticid e , Fun g icid e and Rodent i cide Act (F IFRA ) Se ction 6(a)(2) repo rt s from registrant s , o th er fede ral and state health and e n v ironmental age ncies , and individual cons um ers . S inc e 1 992 , OPP h as compiled these reports in ID S. IDS contain s reports from across the U.S
. and mo s t in c id e nts ha ve a ll rele va nt produ c t informati o n record e d
. Report s

Page 2of5s ubmitted to the ID S represent anecd otal reports o r a ll egat io n s on ly , unless o th e r w i se s tate d in the report. ID S reco rd s incid e nt s in o n e of two modul es: Main ID S a nd Aggregate ID S :


### o Ma in ID S co nt ai n s incident s res ultin g in hi g her seve rit y outco me s and provide s more detail with regard to case speci fi cs. This sys tem s to res in c ident dat a for death , major and m o d erate i ncidents , and it includes info r mation about the location , date and nature of the in cident. Main ID S incide nt s involving o nl y o n e active in gre di ent (as opposed to pesticide products wit h multiple act i ve in g redien ts) are considered to provide m o r e certain inform a ti o n a bout the potential effects of exposure fr o m th e p est icide.



### o Aggregate ID S contains in c ident s r es ulting in less seve r e hum a n incidents ( minor , unknown , o r no effec t s o ut co m es). Th ese are rep o rt ed by reg istrant s o nl y as counts in what are aggregate su mm aries. Por the Main IDS , from January 1 , 2009 to Augus t 1 2 , 20 14, there we re 3 in cidents re ported involving diuron. They were classified as moderate sever ity. In Agg re gate IDS , from January 1 , 2009 to August 1 2, 20 14 , there were 49 incide nt s r e ported in vo lving d iu ron. T hirt y s ix of these incid ents were c lass ifi e d as minor seve rit y. Thirteen incidents were c la ss ifi ed having no or unkn ow n effec t s . Overall, th e r e are few inciden t s involving diuron reported to lDS
. 

### b. SENSOR-Pest icid es The SENSO R-P est icide s database covers 11 s t ates from 1998

- 20 1 0 , a lth ough reporting v arie s from state to state. Cases of pest i cide-r elated illnesses a r e asce rtain ed from a va ri e ty of sou r ces , including: reports from loca l Po i so n Control Ce nte rs , s tate Department of Labo r workers' co mp e n sation cla im s when reported by ph ysic ia n s , re p o rt s from State D e p a rtm e nt s of Ag ri c ulture, and ph ys ici a n reports to state D e partm e nt s of H ea lth
. A lthough both occupational and non-occupational i ncidents are include d in th e database, SENSOR-P es ti ci d es focuses on occupat i ona l pesticide incidents, a nd is of particu la r va lu e in providin g that information. The s tate coord inato r at each of the 11 respective s t a te Departments of H ea l th cond u cts case followup activities suc h as obtaining m ed ica l records to ve rif y symp tom s and severi ty. Using s tandardized protocol and case definitions derived from poison center reporting, th e state S E NSOR

- Pesticide coo rdin ator enters the in c ide nt information into the state -b ase d syste m w hi ch i s se nt to N TO S H a1mually to be agg re ga ted
. A query of SENSOR-Pestic id es from 1998- 2 0 I 0 identifies 92 cases in volv in g diuron (pc code 035505) ste mmin g f rom 49 eve nt s . Of th ese 92 cases , nin e cases s te mmin g from fi ve events involve a s in g le ac ti ve ingredient and we re ana ly z ed fo r thi s memo. All nine cases we re low i n sev erity. Two cases were occupationa l and seven cases were n on-occupational. Five o f the nonoc cupational cases (all five cases resulted from one eve n t) occurr ed afte r one Ri gh t- of

- way applicati on was made to a railroad track in Oregon in 2000
. These five cases each individually crossed railroad tra cks that had been treated wi th Dircx 80 OF , EPA re g # 181 2

- 362. Another

P age 3 of 5non-oc c upational case occurred w hen an individual swam in a pond that had be e n treated w ith diuron, which is an ill egal u se of the pesticide. No furth e r informati o n was provided re ga rdin g this case. Th e seven th non-occupational case in vo l ved a c hil d near hi s fathe r w he n app ly ing the pesticide an d th e dust got into the c hil d 's eye . Th e two occupational cases in vo l ved pesticid e app lic at io n s , one of which wa s a Right-of-Way app licator, th e se cond occ upati onal case did n o t include a case descrip tion
. In s um , a to ta l o f six ou t o f th e nin e s in g le a i cases were exposed as a res ult of R ig ht
- of-way applicatio n s. T he lead i ng hea lth sys te m effec ted in vo l ved th e nervou s sys te m ; th e chief sy mptom re ported a m ong cases headache. Tab le 2 pre se nts a s umm ary of hea l th effects reported for the nine sin g le active in g r e dient cases.

Table 2. SENSOR-Pest i c ide s 1998-2009 : R eported H

ealth Effects fo r Cases (N = 9)

H

ealth Effect # of Time s R eported Denna I 4 Oc ul ar 5 Respirat o ry 4 Gastroin tes tinal 6 Renal 0 Nervou s Sys tem 7 Cardi ovascular 0 "'Cases may report multiple hea lth effects
c. Na ti o nal P es ti c id e In fo rm ati o n Cente r (N PI C) The Nat io nal P es ti c ide Inform a tion Center or NP I C is a cooperative effo rt betwe e n Oregon State Uni versi t y a nd E P A w hich is funded by E PA to serve as a so urce of objective , sc ie nce-ba se d pe s ticid e informati o n and r es p o nd to inquiries fro m the public a nd to incident s . N PIC fun c tion s nationa ll y durin g w ee kday bu s ine ss h o ur s through a toll

- free te l e ph o ne number in add iti on to the inte rn et (www .npi c.orst.ed u ) a nd e mail. S imil a r to Poiso n Co ntro l Cente rs, N PI C's pri mary purpose is not to collect in cident data , but rather to prov i de information to inquirers o n a wi d e range of pest ic ide topics, and direct calle rs fo r p es ti ci d e in cident in vest iga ti on and eme rgency treatmen t. Neve rth e less NPI C does co ll ec t in fo rm a ti on about incidents (approx im a te l y 4000 i ncidents p e r ye ar) from i nquirers and reco rds that informati o n in a database. N P IC is a source of nation a l incident informati o n but ge nerall y re ce ives fewer r eports than ID S. Regardle ss, if a hi g h frequency is observe d in I D S, NP IC pro v id es a n additional so urce of inform a tion to see w hether th e re i s ev id e nce of consistency across n a t io nal dat a se ts or po ss ibly duplication and addit io n al in fon n a ti o n about th e same in cident (s).

Page 4 of 5From 2009 to June 30, 20 14, 6 in cidents we r e r e ported to N P.I C in vo lvin g diuron. NPIC estim ates a ce rt a inty index as to w heth e r an incident ( includin g r epo rted sy mpt o m s) was either definitely , probably, possibly, o r unlikely to have been caused by the rep orted exposu re to a pesticide, or whe th e r the incident was unrelated to pesticides or if the incid ent was unclass i fiable. Of the 6 reported incid en ts , 3 we re reported as sy mptom at i c a nd classified as probably r e lated to the diur o n ex po s ure , 2 cases were classifi ed as unlikely and 

### I case was uncla ss ifiable. T h e three probable in c id ents we re c l assi fi ed as minor severity. d. Ag ricultura l Health S tud y (A HS) T h e AHS is a hi g h quality , prospect ive e pid em iology study eva lu at ing th e link between pe st icide u se a nd vari o u s h ealth outcomes inc l udin g ca nc e r. The A l-IS in c ludes private and com m e rcial pesticide app li cato rs and th e ir s pou ses . I f th e r e a r e AHS findin gs relevant to a particular pesticide going through registration rev iew. the Age nc y w il l e n sure they are considered in the problem formulat ion/scop in g phase of the process and, if appropriate, fully reviewed in the ri sk assessment phase of the process. The A I-I S includes information o n use of 80 d iff e ren t pe st ic id e active in g r edien ts common ly used in agriculture. Diuron i s n o t included in the A HS , and therefore thi s s tud y do es n ot provide inform a ti o n for this repo rt. 

### IV. C ONCLUSION Based on the low frequency and low severity of incident cases reported for diu ro n in ID S, SENSO R -Pes ticide s, a nd NP J C th e re d oes not appear to be a co n ce rn at thi s tim e that would warrant furth er investigation. The Age n cy will co ntinu e to monitor the incid e nt information and if a concern is triggered , addi tiona l ana lys i s wi ll be included in th e ri s k assessment.

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