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



### M E MORAND U M Date: March 3, 2016 

### SUBJECT: Fluometuron : Tier I (Scoping) R ev iew of Human In c id e nt s a n d E pid emio logy

PC Co d e: 035503 DP Bar co d e: 0431967 Deci s i o n N o .: 51 1 228 Petition No.: NA Ri s k Assess ment T ype: N A TXR No.: NA MRID No.: NA R eg is tratio n N o .: NA Regu l atory Action: NA C a se No.: NA CAS No.: 2164-17-2 40 C FR: NA Ver.Apr.OS 

### FROM :**li z~bet** **h** Evans,**iro~m ntal**  Protec ti o n Spec ia l ist / Tox ico logy and Ep 1 dem1olo gy Branch C {, , 

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### THROUGH:

T O: Health Effec t s Di v i sion (7509P)



### - i**~** a n d S h anna R eco re , Industr i a l H yg ienist Tox icology and Ep idemio logy Branch H ealt h Effect Division (7509P) D av id Mill e r , Acting Branch C hi ef 

# 1( Tox ico logy and Epidemiology Branc Health Effects Division (7509P) Ju li e Yan A l sti ne , Ri sk Assessor Risk Assessment Branch VI Health Effects Di vis ion (7509 P ) and L. Wa l s h , C h emical R ev i ew Mana ger Ri sk Management & Impl ementation Branch 3 Pesticide Re-evaluation Di v i s i o n (7508 P) S ummary and Conclusions

# ~

Based on th e low frequency and severity of incident cases reported for fluometuron in b oth IDS and SENSOR-Pesticides there does not appear t o be a co n cern at this time th at wo ul d warrant furthe r i nvest igation. T h e Agency will conti n ue to monitor the incident i nformatio n and i f a co nc ern is triggered , additional analys i s wi ll be included in the risk assessme n t.

Page 1 of 4Detailed Review 

### I. ACTION REQUESTED Th i s revi ew i s int ended to fulfill our requirem ent to docket s ummari es of incident data that were report e d to th e Agency, as we ll as to ensure human incident data and the Agricultural Health Study (A HS) are part of th e problem formulation phase of reg i s tration rev i ew . Reports of adve r se h ea lth effec ts allegedly due to a specific pesticide exposure 

### (i .e . , an " in cident") are larg e ly se l f-reported and therefore , generally speaking, neith e r exposure to a pesticide or reported sy mptom (or the connection between the two) i s va lid a ted or otherwise confirmed

. Typically , causation can n ot be determined based on incid e nt data. However, in cident in format i on can b e an imp ortant source of feedback to th e Age n cy: incidents of severe outcome , o r a s u ggested pattern or trend among less severe inc id e nt s , ca n s ignal the Agency to further in vest igate a particular c hemica l or product. Observational ep id em io logy s tudies re late the risk of di sease, 

### e .g. , cancer , and expos ur e to an agent suc h as a p es ticid e product in the general population or spec ific sub-groups like pesticide app li cators. II. BACKGROUND Flu omet uron i s an herb icide used to control broadleaf weeds on cotto n . 1 For this eval u at ion , both the OPP Incident D ata System ( ID S) and th e Centers for Disease Control and Prevention/National Institute for Occupational Safety and H ea lth (C DC/NIOSH) Se n tinel Eve nt Notificat ion System for Occupational Ri sk- Pe st ic id es (SENSOR) databases were consu l ted for p est ic id e incident data on the active ingredient fluometuron (pc code: 035503). The purpo se of the database searc h i s to identify potentia l patterns in the frequency and severi ty of the health effects attributed to fluometuron exposure. Fluometuron is n o t included in the AHS , and th e refore this s tudy doe s not p rovide information for this report.
Ill. RESULTS/DISCUSSlON



### a. IDS (Incident Data System) OPP 's ID S include s reports of alleged human health incidents from various sources , including mandatory Federal In secticide , Fu ng icide and Rodenticid e Ac t (FJFRA) Sectio n 6(a)(2) reports from reg i s trants , other federal and state health and env ironm e ntal agencies , and individual consumers. Since 1992 , OPP has compiled these reports in IDS. I DS contai n s reports from acro ss the U.S. and mos t incidents h ave all re levant produ c t information recorded. Reports subm itt ed to the ID S rep rese nt anecdotal report s or allegation s only , unless otherwi se stated i n the report. ID S records incident s in one of two modules: Main IDS and Aggregate ID S:

1 Fluometuron RED (2005) found online at: http :// www.epa .go v / pesticides/ chem sea rch/reg action s/ re regi s tration/ red P C-035503 1-Sep-05.p df
Page2of4o Main ID S co nta in s incid e nt s res ultin g in high e r seve ri ty outcomes a nd provides more detail wi th regard to case speci fic s. T hi s syste m s tores in c ident data for death , major and moderat e incidents, and it includes informat io n abou t the location , date and nature of the inc ident. Main I DS in c id e nt s in vo l vin g only one act i ve in g re di e nt (as oppo se d to pe s ti cide product s wit h multipl e act ive in gred ients) are considered to pro v id e more ce rt a in inform a ti o n abo ut th e poten ti al effects of exp osu re from the pe s ticid e.

o Aggr egate ID S co nta in s i nc id e nts re s ulting in less seve re hum an i ncidents ( min or, unknown , o r no effec t s outcomes). These are reporte d b y reg i st rant s on ly as co unt s in w h at are aggregate s umm ar ies. Fo r the Ma in ID S, from J anua ry 1 , 20 l 0 to Sep te mb e r 25 , 20 1 5 , there were no in c id e nt s reported for fluometuron in th e d a t abase. Aggregate I D S , from Janu a r y I , 20 l 0 to September 25, 2015 , the re was one in c id en t reported in vo l vi n g flu o m eturon. Thi s inc ident wa s cla ss ifi ed as minor seve rity. Overall , ther e ar e few incid ents re ported to ID S in vo l v in g flu o m e turon. b . SENSOR-Pest icide s Th e SENSO R

- Pes ticide s datab ase covers 12 s tates from 19 98-2 011 , a lthou g h re porting var ies fro m sta te t o s tate. Cas es of p es ticide-re late d illn esses are ascerta in ed from a vari e ty of so urces , including: reports from l oca l Poi s on Co nt ro l Ce nt e r s, sta te D epa rtment of Labor workers ' compensation claim s w h e n re ported b y ph ys ici a n s, re port s from State D epartments of Agricu lture , a nd phys ic i an reports to state Departme nts of Hea lth. A l though both occu pati ona l a nd non-occ up a tiona l in c id e n ts a r e includ ed in the databa se , SENS OR-Pe s ti c id es focuses o n occupational p esticide in c id e nt s , and i s of parti c ul ar va lu e i n prov idin g th at information

. Th e s tate coord in a tor at eac h of the 1 2 respective s ta te D e p artments of Hea lth co ndu cts case followup activ iti es s u c h as obtaining medic al records to ve rif y sy mptom s and sever it y . U s in g s tand ardi z ed protocol and case defi niti ons derived from p oiso n ce nter r ep ort i ng , th e state SENSOR-Pestic id e coordinator en ter s the incide n t informatio n into the state- b ased system w hi c h i s se nt to N I OS H annuall y t o be aggreg ated. A review of SENS OR

- Pe s ticide s 1 998-2011 id e ntifie s no cases involving flu o m et uro n .
c. Agricu ltura l Health Study (AHS) Th e A H S i s a hi g h qu ality , prospective e pid e mi o logy study eva lu at in g the link between pesticide u se and va ri o u s health o utco m es i ncl udin g cancer. Th e AHS in cludes privat e a nd commerc ia l pesticide ap pl icators and th e ir spo u ses. If there a re AHS findin gs re l ev ant to a particular pe stic id e go in g throu gh reg i s tration rev iew , th e Agency w ill e n s ure they are conside re d in the probl e m formulation/scoping phase of the pro cess and , if approp ri ate , fu ll y rev iewe d in th e r i sk assessment phase o f the process. T he AH S includ es inf ormation o n use of 80 diff e rent p es ti cide

P age 3of4active in gredi e nt s common ly used in ag ri culture. Fluometuron is n ot included in th e AHS, and therefore thi s s tud y d oes not provide information for thi s report
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### C O NC L US IO N Base d on th e low frequency and seve r ity of incid e nt cases reporte d for fluom e turon in both l DS and SENS OR

- Pestic id es th ere d oes no t appear to be a concern at this tim e that wo u ld warran t further invest i gation. The Age nc y will co ntinu e to m o nit o r the inc id e nt informat io n and if a co n ce rn is tri ggered , addit ional analysis w i ll be included in the r i sk assess m ent.

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