UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORAN D UM Date: March 17 , 20 16 SU BJEC T: Eth alfluralin: Tier I Update Rev iew of Human Incident s fo r Draft Ri sk Assessment

P C Co de: 11 310 1 De c i sio n No.: 510535 Petition No.: NA OP B arco d e: 0432322 Re g ist rati on No.: NA Regulatory Action: NA Case N o .: NA Risk Assess m ent Type: NA TXR No.: NA CAS No. : 80844-07- 1 40CFR: NA MRID No.: NA

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THROUGH:

T O: Ye r.Apr.08 E li zabeth Evans, Environmental Protection Speciali st 

### c-- Tox ico logy and Epidem iology Branch 

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### '1 and Shanna Recore, Ind u str i a l Hyg ienist 

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## c Toxicology and Epidem iology Branch Health Effects Division (7509P) Jul ie Van A l stine , Risk Assessor Risk Assess m e nt Branch VI Health Effects Divi s ion (7509P) and Ke ll y Ballard , Chem ical Rev iew Manager Ri sk Management & Imp le mentation Branch 1 Pestic ide Re-evaluation Divi sio n (7508 P) Summary and Conclus i ons Ethalflurali n was previously reviewed in 2010 (S. Recore, 0 383687 , 111 30/2010). At the time , th ere was one moderate sever ity in cident reported for ethalfluralin to Main ID S and seven minor severity cases reporte d to Aggregate ID S from Janu ary 1, 2002 to May 27 , 2010. Upon review of these incide nts, it was concl ud ed that " Based on the low frequency and severity of incident Page l of 4cases, there does not appear to be a concern at this time that would warrant further investigation. " The current IDS analysis from January I , 2010 through December 3, 2015, shows no incidents reported for ethalfluralin in Main or Aggregate IDS. A query of SENSOR-Pesticides 1998-2011 identifies two cases involving ethalfluralin (pc code 113101). One case was moderate in severity and one case was low in severity. Based on the low frequency and severity of incident s reported to both IDS and SENSORPes ticid es, there does not appear to be a concern at this time. The Agency will continue to monitor the incident data and if a concern is triggered, additional analysis will be conducted. Detailed Review 

### l. ACTION REQUESTED Ethalfluralin i s being considered under the FQPA-mandated Registration Review program estab lished to review , on a 15 year cycle, pesticides for which a Re-registration Eligibility Decision has been made. One component of the Agency's Registration Review Program i s consideration of human incident data. In conjunction with a human hea lth risk assessment based on other data sources, such human incident data can assist the Agency in better defining and characterizing the risk of pesticides/ pesticide products. Reports of adverse health effects allegedly due to a specific pesticide ex posure (i.e., an " incident ") are largely self-reported and th erefore , generally speaking, ne ither exposure to a pesticide or reported symptom (or the connection between the two) is validated or otherwise confirmed. Typically, causation cannot be determined based on incident data. However, incident information can be an important source of feedback to the Agency: incidents of severe outcome, or a suggested pattern or trend among less severe incidents , can signal the Agency to further investigate a particular chemical or product. Observational epidemiology studies relate the risk of dis ease, 

### e.g., cancer, and exposure to an agent such as a pesticide product in the general population or specific sub-groups like pesticide applicators. II. BACKGROUND Ethalfluralin i s a selective herbicide for the preemergence control of certain annual grasses and broad leaf weeds. 

### It is registered for use on a variety of food and feed crops; including beans , peanuts , canola, soybeans, and cucurbits. For this evaluation, both OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National [nstitute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient Ethalfluralin (PC Code: 113101). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to ethalfluralin exposure. Page 2of4III. RESULTS/DISCUSSION a. IDS (Incident Data System) OPP's IDS includes reports of a ll eged hum an h ealth incidents from various sources, includin g mandatory Federal Insecticide, Fungicide and Rode nticide Act (FIFRA) Sectio n 6(a)(2) reports from registrants , ot h er federa l and state health and environmental agencies, and individual consumers. S i nce 1992 , OPP has compiled these reports in I DS. IDS contains repo rts from ac ross the U.S. and most incidents have all relevant produ c t information recorded. Reports submitted to the IDS represe nt anecdotal reports or allegation s only, unless otherwise stated in the report. ID S record s in cidents in one of two modules: Main IDS and Aggregate IDS:

o Main ID S contains incide n ts resulting in higher severity outcomes and provide s more detail w ith regard to case specifics. This system stores i ncident data for death, major and moderate incidents , and it in c ludes infonn ation about the locati on , date and nature of the incident. Main IDS incidents involving only o ne pes ticide are co nsidered to provide more certain in formation about the potential effects of expos ure from the pesticide.

o Aggregate ID S contains in cidents resulting in less severe hum an in cidents (minor , unknown, or no effects outcomes). These are reported by registrants only as counts in w hat are aggre gate summaries. From Janu a ry l , 20 1 1 to J anuary 12 , 20 16, the re were no i ncidents reported to e ither Main ID S or Aggregate IDS invol vi ng the active ingredient , et ha lfluralin. b. SENSOR-Pesticides The SENSOR-Pestic ides database covers 12 s tates from 1998-2012 , although reporting varies from state to state. Cases of pes ti cide-related ill nesses are ascertained from a variety of sources , includin g: repo rts from local Poison Control Centers, state D e partment of Labor workers ' compe n sation claims when reported by phy s icians , reports from State Departments of Agriculture , and physician reports to state Departments of Health. Although both occupational and non-occupational incidents are included in the datab ase , SENSOR focuses on occ upati onal pesticide i ncidents, and is of particular value in providing that information. A sta te SENSOR contact s peciali st attempts to follow-up with cases and obtain s medical records to verify symptoms, ci rcumstances s urrounding the exposure, severity , and outcome. Using standardized protocol and case definition s derived from poison center reporting , SENSOR coord in ators at State D ep artments of Health e nter the incident interview description provided by the case , medical report, physician and patient into th e SENSOR data syste m. The SENSOR data system i s accessib le to participating states and EPA.

Page 3 of 4A query of SENSO R-Pesticides 1998-2012 identifi es two cases involving ethalflura lin. Both cases involve a s in gle a. i

. One case was moderate in seve ri ty and one case was low in severity. The moderate severity case was a li ves to ck production wo rker who was sprayi ng the product a nd was expose d to th e mist. This case experienced dermal and oc ular sy mptom s including: swe llin g, corneal abras io n , eye pain and co njun cti v i tis. The low sever ity case was an agricultural researcher who developed mild eye irritation after e ntering a treated field 4 hours post app li catio n of a g ranu lar herbicide with a 24 hour re-entry. The researcher needed to seed the fie ld before r ainsto rm s. She wore PPE but wasn ' t sure that goggles fit properly. She consulted an eye doctor.

c. Agricultural Health Stud y (AHS) T h e AHS i s a hi g h quali ty, prospective epidemiology study evaluatin g the link betwee n pesticide use and variou s h ealth outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. If there a re AHS findings relevant to a particular pesticide going through registration review, the Agency w ill ens ure they are considered in the problem formulat ion/scop i ng phase of the process and , if appropriate , fully reviewed in the ri sk assessment phase of the process. The AH S includes information on use of 50 different pesticide active ingredients commonly used in agriculture. Ethalfluralin is not included in the AHS, and therefore this study does not provide information for this report. CONCLUS IO N Based on the low frequency and severity of incidents reported to both IDS and SENSORPesticides , there does not appear to be a concern at this time. The Agency will co ntinue to monitor the incident data and if a concern i s triggered , additional analysis wi ll be conducted.

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