UNITED STATES ENVIRONMENTAL PROTECTION AGENC Y WASHINGTON , D . C
. 20460
OF F I CE OF CHE MI C AL SA FET Y A N D PO LL U TI O N PRE V EN T I O N

M E MORA N DU M Da t e: December 8, 2015 

### SUB J ECT: Eth of um esate : Ti e r 

### I (Sco ping) Review of Hum an In ciden t s and Epi d e mi o logy
PC Code: 1 1 0601 DP Bar co d e: 0430503 Dec i s i o n No.: 508006 P eti t io n No.: NA Ri s k Assessme n t T y p e: /\ T X R No.: NA M R ID No. : NA R eg i str a ti o n No

. : NJ\ R eg u lat ory Act i o n : NA Case No.: A CAS No.: 26225-79-6 4 0 CF R : NA Vcr.Apr.08 F R OM : E li zabet h Eva n s, E n vironme nt a l Pro t ec t ion S pecia lis t**~** Tox ico logy and E p ide mi ology B ranc h**~** · Hea lt h Effects Di vis ion (7509 P) 

### W

T H ROUGH:

TO: and Shanna Reco re , Industria l Hy g ieni s t Toxicolo gy and Epidem iology Branc h

### ~**~LQ_** Health Effec t D ivision (7509 P ) Dav i d Miller , Acting Branch Chief 

### r 

# 014/tt AJdo.--Lo<:> Tox ico logy and Ep idemio logy

# an**G~ ·**  Hea lth E f fec ts Div ision (7509 P) William Ir w in , Risk Assessor Ri sk Assessment Branch V Health Effec ts Div ision (7509 P) and J. Trujillo, C hemical Review Manag e r R isk Management & Imp lementation Branc h 5 Pest ic ide Re-eva luati on D i v is io n (7 508 P) Summary a nd Co nc l u s ions Ba sed on the low frequ e ncy and severity of incid e nt cases reported for ethofumesate in bot h IDS and SENSOR-Pesticides th e re does not appear to be a concern at thi s tim e that would warrant furcher in ves ti gat i on. The Age ncy will contin u e to monitor the i ncident information and if a co ncern is triggered , additional analysis will be inc luded in the risk assessment.

P age I of 4Detail e d R ev iew I. AC TIO N REQUES T E D This r eview is intend ed to fulfill our require ment to docket s ummaries of incident data that were reported to th e Agency , as we ll as to ensure human incident data and the Agricultural Health Study (A H S) a re part of the problem formulation phase of reg i s tration rev iew. R epo rt s of adverse health effects all ege dly due to a spec ific pestic ide exp os ure (i.e., an " in c id ent") are largely se lf-re ported and th e refore , genera ll y s peaking , neither exposu r e to a p es ticid e o r reported sy mptom (o r th e co nn ection between the t w o ) is validated or otherwi se confirmed. Typicall y, causation cannot be determined ba se d o n incid ent data. Howev e r , in cide nt inform at ion can be an important sou rc e of feedback to th e Age n cy: incid e nt s of seve r e outcom e , or a suggested pattern or tre nd among le ss seve re inc ident s, ca n s i g nal the Agency t o further inve s ti gate a particular chemical or product. Ob se rva tion a l ep id e miolog y s tudi es relate th e risk of dis ease, 

### e.g., cancer, and expos ure to an age n t suc h as a p es ticide product in th e ge neral populati o n o r spe cific s ub- gro up s like p es ti cide a pplicato r s. II

. BAC K GROUN D Ethofum esa t e is a se lecti ve herbicide r eg i s te re d for pre-plant , pre-emergence and post-em e rge n ce use to contro l broad leaf and g ra ss weed s . E thofumesate i s r eg ist e red for u se o n s u gar beets , ga rd e n bee t s, tabl e beets, carrot s, and turf uses. It i s a l so registered for use in seed production for Swiss chard a n d s pinach. 1 For this eva lu at ion , bo t h the OPP Incident D a t a Sys tem (IDS ) a nd the Centers fo r Di sease Control and Preve nti on/National In st itute for Occup a ti o n a l Safety a nd H ealth (C D C/ N IOSH ) Se ntin e l Event No tifi catio n Sy s tem fo r Occ upati onal Ri sk -P est icid es (SENS OR) databa ses we re con s ult e d for pes ti cide incide nt data o n the active ingr ed ient ethofumesate (pc code: 11 060 I ). The purp ose of the databa se sea rch i s to id e nti fy potential patterns in th e frequency a nd seve rit y of the health effects attributed to ethofumesate exp osu re. Ethofum esate is not included in the AHS , a nd therefore thi s st ud y do es n o t provide inform a ti o n fo r th i s rep o rt.
III. RESU L TS/D I SCUSS IO N

a . ID S ( In c id e n t Da ta Sys t e m ) OPP 's ID S in c lud es repor t s of alleged hum a n h ealth incid ents from variou s so urces, includin g mandat o ry Fed e ral In secticide , F un g icid e and Rodenticide Ac t ( FlFRA ) Sec ti o n 6(a)(2) rep o rt s from re g i s trants , oth er federal and state h ea lth a nd environme nt al agencies , a nd i ndi v idual consum e r s . S in ce 1 992, OPP h as co mpil ed th ese reports in ID S. IDS contain s report s from across the U.S. an d mo s t incid e nt s ha ve all re levant produ c t information r ecorded . R epo rt s

1 Revised Ethofum esa te RED (2007) found online at: file :///C: / Users /eevan s 4/ Downloads/ EPA- HQ-OPP-2004- 0346

-0036.pdf

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### submitted to the IDS repr ese nt a necdotal reports or allegations o nl y, unless otherwise stated in the report. IDS records incidents in one of two module s: Main ID S and Aggregate IDS:

o Main IDS contains incident s resulting in high er seve rity outcomes and provides more detail with regard to case spec ifics. This sys tem stores incident data for death , major and moderat e incidents , and it includes information about the location , date and natur e of th e incident. Main IDS incident s invol v ing only one active ingredient (as opposed to pesticide products w ith multipl e active in gred ie nt s) are co nsidered to provide more ce rta in informati o n abo ut the potential effects of exposure from the pesticid e.

o Aggregate ID S contains incid e nts resulting in less severe human incidents ( minor , unknown , o r no effects outcomes). These are repo rted by reg is trants only as counts in what are aggregate su mmaries. For th e Main IDS , from J anuary I , 20 l 0 to September 25, 2015, there were no incidents report ed for ethofumcsate in the database. Aggregate IDS , from January I , 20 I 0 to Septe mber 25 , 20 15, the re were no incidents reported involving ethofu me sate.

b. SENSO R-Pe sticide s 

### The SENSOR-Pesticides database covers 12 s tate s from 1998- 20 11 , although repo rting varies from state to s tate. Cases of pesticide-related illne sses are ascertained from a variet y of so ur ces, including: reports from loca l Poison Control Centers, state Department of Labor wo rker s' compensation claims when r epo rted by phy s icians, report s from State Departme nts of Agriculture , and physician reports to state D epartments of H ea lth. Althou gh both occupational and non-occupational in c id e nt s are included in the database , SENSOR -Pe stic id es focuses on occupational pesticide incidents , and is of particular va lu e in providing that information. Th e state coordinator at each of th e 12 respective state Departments of H ea lth conducts case followup activities suc h as obta inin g medical records t o verify symptoms and severity. Us ing standardized protocol and case definitions derived from poi so n center reportin g, the state SENSOR-Pest ic ide coordinator enters the incident information into the s t ate-based system which i s se nt to N IO SH annually to be agg r egated. A review of SENSOR -P es ti cides 1998-20 1 1 identifies three cases in vo l v in g e th ofu mesate
. One case involves a sing le ai. All three cases are c lass ified as low in seve rity and all three cases were occupational. The single a i case involv ed a g round maintenan ce worker on a go lf course who was exposed to Pro-Grass via inhalation from a cowo rker 's application. Th is case expe ri enced dizziness and gas trointe s tinal symptoms.

Pa ge 3 of 4c. Agricu l tura l Health Study (AHS) 

### The AHS i s a high quality , pro s pec tiv e e pidemi o logy s tud y eva luatin g the link between pesticide use and var io us h ea lth outcomes includin g cancer. T he AHS includ es private and co mm erc ia l pestic id e applicators and their spouses. I f there are AHS findings relevant to a particular pesticide go ing thro ugh registration review , th e Agency w ill ens ure th ey are considered in the problem formu l ation/scoping phase of th e proce ss and, if appropr iate, fully revi ewe d in th e ri s k assess men t phase of th e process. The AHS includ es inform ati on on use of 80 different pesticide active ingredients commonly used in agriculture. Eth ofumesate is not included in the AHS. and therefore thi s study does not provide information fo r thi s repor t. IV. CONCLUS I ON 

### B ase d on the l ow frequ ency and seve rit y o f incid e nt cases re po rt ed fo r e tbofum esa t e in both IOS a nd SENSO R-P es ti c id es there does not appear to be a concern at thi s tim e th a t woul d warrant furthe r investigation. The Agency w ill co ntinu e to monitor th e incident infomrntion and if a co nc e rn i s tri gge red , addition a l analys is w ill be in cl ud ed in the ri sk assessme nt.

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