UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASH IN GTON, D.C . 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM Date: Apri l 8 , 2014 S UBJECT : Eto xazo l e: Ti er I Review of Human In cidents
P C C od e : 107091 DP Barcode: 04 1 8223 De c is ion No.: 487997 Petition No.: NA Risk Assessm ent T ype: NA TXR N o.: NA MRID No.: NA R eg i str at i on No.: NA R eg ul a t ory Actio n: NA C a se No.: NA CAS No.: 153233-9 1 -1 40CFR: NA V e r .A pr .08' FROM : Shanna Recor e, Industrial Hygienist {} , ,**~** r.. , 0 Toxicology a nd E pidemiolo gy Branch**~~** H ealth Effect Division (7509P)

-- and E lizabeth Evans, Env ironmental Protectio n Specialist Toxicology and Epidemiology Branch H ealth E ff ects Division (7509P) /)
. THROUGH: David Miller , Acti n g Bran ch C hief 

# J_J;;) Toxico logy and Epidemiolo gy Branch H ealth Effects Di v i s ion (7509P) TO : J ennifer Ty ler, Risk Assessor Risk Assessment Branch I Health Effects Division (7509P) and J
. Stokes, Chem ical Review Manager Ri sk Managemen t & Impl eme ntation Branch 5 Pesticide Re-evaluation Divisio n (7508P) Summary and Conclusions Ba sed o n the low frequency and low severity of incident cases rep orted for etoxazole in both IDS and SENSO R-P esticides, t h er e does not appear to be a concern at this time th at would warrant furth er investigation. Th e Agency w ill contin ue to monitor the in cide nt inform ation and if a concern is triggered , additional analysis will be included in the risk assess ment.

Page 1 of 4Detailed Review 

### I. ACTION REQUESTED This review i s i nten ded to fu lfi ll our requirement to docket summaries of incident data that were reported to t he Agency , as we ll as to ensure human incident data and the Agricultural Health Study (AHS) are part of the problem formulation phase of registrati on rev i ew. Reports o f ad verse health effects allegedly due to a specific pesticide exposure (i.e. , an "inc i dent " ) are l arge l y self-reported and therefore, generally speaking , neither exposure to a pesticide or reported symptom (o r the connection between the two) is validated or otherwise confirmed. Typically, causation cannot be determined based on incident data

. However, incident i nformation can be an important source of feedback to
. the Agency: incidents of severe outcome, or a suggested pattern or trend among l ess severe incidents , can signal the Agency to further i nvesti gate a particular chemical or product. Observa t ional epidemiology studies relate the risk of disease, 

### e . g., cancer, and exposure to an agent such as a pesticide product in the general popula t ion or specific sub-gro ups like pesticide applicators. 

### II. BACKGROUND Etoxazole is a contact acaricide/ ovicide that is currently reg i stered in the U.S
. fo r the control of m i tes on various raw ag ricultural commodities (RACs). There are currently no registered or proposed residential uses of e toxazo l e . For this evalua t ion, bo th the OPP Inc id en t Data System (IDS) and the Centers for Disease Contro l and Prevention/National Institute for Occupational Safety and H eal th (C D C/N IO S H) Senti nel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient etoxazole (pc code : 107091 )
. The purpose of the database searc h is to identify potenti al patterns in the frequency and seve rity of th e health effects attributed to etoxazole exposure. Etoxazole is no t i ncluded in the A H S, and therefore this study does no t p rov id e inf ormation for this report. 

### III. RESULTS/DISCUSSION
a. IDS (Incident Data System) OPP's ID S includes reports of a ll eged human heal th inc idents from various sources , including mandatory Federal Insec t icide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from reg i strants, other federal and state h ealth and environmenta l agencies, and individual consumers. Since 1 992, OPP has compiled these reports in IDS
. ID S contains reports from across the U.S. and most incidents have all relevant product information recorded. Reports subm itted to th e IDS represent anecdotal reports or allegations only, unless ot h erwise stated in the report. IDS records incidents in one of two modules: Main ID S and Aggregate IDS:

Page 2 of 4o Main ID S contain s incidents res ultin g in higher severity outcomes and pro vides more d etail with regard to case spec ific s . This system sto res incident data for death , ma jor and moderate incid ents, and it incl udes information about the location , d ate and nature of the incident. Main IDS incid e nt s involving only on e active in gredien t (as oppos e d to pesticide products with multip l e active ingredi e nt s) are considered to provide more certain information about t he potential effects of exposure from the pesticide.

o Aggregate ID S co ntains in c id ents resulting in less severe human incidents (mi nor, unknown, or no effects ou tcomes). These are reported by registrants only as counts in what are aggregate summa ri es . For the Main ID S, from J anuary 1 , 2009 to March 5, 20 14 , there were 2 incid e nts reported for the si ngle chemical only in th e database. These incid e n ts were classified as moderate severity. T here were no add i tio n al incidents reported involving more than one chemical. In Aggregate IDS, from January 1, 2009 to March 5, 20 14, there was 1 inc ident rep orted i nvolvi ng eto xazole. This incident was classified as minor severi ty. O vera ll , there are few i nc idents in volving e t oxa z ole reported to ID S. 

### b. SENSOR-Pesticides The SENSOR-P esticides database covers 11 s tate s from 1998 -20 10 , although reporting varies from state to state. Cases of p esticide-related illne sses are ascertaine d from a variety of source s, including: reports from local Poison Control Centers, s tate Department of La bor workers' compens ation claims when reported by ph ysic ians , reports from State Departments of Agriculture, and physician reports to state D epartme nt s of Health. Althoug h both occupational and non-occupational inc idents are incl uded i n the database, SENSOR-Pesticides focuses on occupatio nal pe st ic id e inc id e nts, and is of particular val ue in pro vi d ing that information. T h e state coordinator at eac h of the 11 respective state Departments of Health conducts case followup activ i ti es such as obtaining m e dical records to v erify sym ptoms and seve ri ty. Us ing s ta ndardized protocol a nd case definitions deriv e d from poison center reporting, the state SENSO R-Pesticide coo rdinator enters the in c id en t information into th e s tate-based system whi ch is sent to NIOSH an nually to be aggregated. A query of SENSOR-Pesticides 1998

- 20 1 0 identifies four cases, stem min g from three events , in volv in g etoxazole (pc code 107 09 1 )
. On e case involved a si ngle active ingredients and three in volved multiple active ingred ients. All four cases were work-re lated . All four cases were lo w in severi ty
. Three cases reported ocular symptoms, tw o r eported respirato ry sy mp to ms , one reported gast rointestinal sy mptoms, and two reported nervous system sy mptom s . One e ven t i nvolvin g two cases occurred in Mi chi ga n in 200 8. T wo U SDA in spec tors were deliberately sprayed whi l e in a n orchard; th ese inspectors received inhalation and dermal exposure. A vio lation was cited because the applicator "applied products in a way that contacted workers or othe r persons."

Pa ge 3 of4c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pestici de applicators and their spouses. If there are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem formulation/scoping phase of the process and , if appropriate , fully reviewed in the risk assessment phase of the process. The AHS includes information on use of 50 different pesticide active ingredients commonly used 

### in agriculture. Etoxazole is not included in the AHS, and therefore this study does not provide information for this report. 

### IV
. CONCLUSION Based on the low frequency and low severity of incident cases reported for etoxazole in both IDS and SENSOR-Pesticides, 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 , additional analysis will be included in the risk assessment.

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