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



### MEMORANDUM Date: February 21,20 13 

### SUBJECT: Fenhexamid: Review of Human Incident s P C Code: 090209 DP Barcode: 0407943 Decision No.: 473334 Petition No.: NA Ri s k Assessment Type: NA TXRNo.: NA MRID No.: NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 126833-17-8 40 CF R : NA Ver.Apr

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### FROM: E li za beth Evans, Environmental Protection Special!st
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### ~ Toxicology and Epidemiology Branch G 

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## ,a t2- Toxico logy and Ep idemiol ogy Branch**\J£.N'-'--** Health Effects Division (7509P) 

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## ;:<t,,feb...-'l.dt3 David J. Miller , Acting Branch Chief 

## ;)J/If(!rJ! Toxicology and Epidemiology Branch Health Effects Division (7509P) Monica Hawkins, Risk Asses sor Risk Assessment Branch VI Health Effects Di v ision (7509P) and Joel Wolf, Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the low frequency and severity of incident cases reported for fenhexamid in both ID S and N T OSH SENSOR-Pesticides, there does not appear to be a concern at this time that would warrant further investigation. The Agency will conti nu e to mon itor the incident info rmation and if a co nce rn is triggered, additional analysis will be included in the ri sk assessment.
Page 1 of 5The Agricultural Health Study (AHS) is also a potential source of information associated with human health effects assoc iated with certain pesticides. Fenhexamid is not included in the AHS, and therefore this study does not provide information for this repo rt.
Detailed Review 

### I. ACTION REQUESTED This review is intended to fulfill our requirement to docket summaries of incident data that were reported to the Agency, as well as to ensure human incident data and the Agricultural Health Study (AHS) are part of the problem formu lation phase of registration rev iew . Reports of adverse health effects allegedly due to a specific pesticide exposure 

### (i.e., an "incident") are largely self

-reported and therefore, generally speaking, neither exposure to a pesticide or reported symptom (or the connection between the two) is validated or ot herwise 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 particul ar chemical or product. Observational epidemiology studies relate the risk of disease, 

### 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 Fenhexamid is a fungicide registered for use on grapes, strawb erries and ornamentals. The enduse product is a water dispersible granule formulation containing 50% active ingredient. The product is applied as a fo liar spray by ground equipment only. T he product is for commercial use only. For this evaluation, both OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and He alth (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR-Pe sticides) databases were consulted for pesticide incident data on the active ingredient fenhexamid (PC Code: 090209). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to fenhexamid exposure. In addition, findings from the AHS were reviewed. The Agricultural Health Study (AHS) is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. Fenhexamid is not included in the AHS, and therefore this study does not provide information for thi s repo rt.


### III. RESULTS/DISCUSSION a. IDS (Incident Data System)

Page 2 of 5OPP's ID S includes reports of alleged human health incidents from various sources, including mandatory Federal Insectic ide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants, other federal and state health and environmental agencies, and indivi dual consumers. Since 1992 , OPP has compiled these reports in IDS
. IDS contains reports from across the U.S. and most incid ents have all relevant product information recorded
. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report . IDS records incidents in one of two modules: Main IDS and Aggregate IDS:
o Main IDS conta ins incidents re sulting in higher severity outcomes and provides more detail with regard to case specifics. This system stores incident data for death, major and moderate incidents, and it includes information about the location, date and nature of the incident. Main IDS incidents involving only one active ingredient (as opposed to pesticide products with multiple active ingredients) are considered to provide more certain information about the potential ef fects of exposure from the pesticide. o Aggregate IDS contains incidents resulting in less severe human incidents (minor, unknown, or no effects outcomes). These are reported by registrants only as counts in what are aggregate summaries. For the Main IDS, fro m January 1, 2007 to December 11,2012, there was 1 incident reported for single chemical only in the database. This incident was classified as major severity. However; it is not clear that t his incident is related to fenhexamid or the implicated product (Elevate 50 WDG Fungicide). Additionally, the case wore more PPE than is required by the label for Elevate 50 WDG Fungicide (long-sleeved shirt, long pants, shoes, and chemical resistant gloves). This incident is described further in Table 1. There was 1 additional incident reported involving more than one chemical. Overall, there are few incidents invo lving fenhexamid reported to IDS. In Aggregate IDS , from January 1, 2007 to December 11, 2012, there were no reported incidents involving fenhexamid. T bl 1 M
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. lflnh em1ca e exam1 Human Incident Chemical: F enhexamid 

## I PC Code: 090209 Incident E x posure Package Incide nt Reg Severity Report Date L ocation Number Product Name Codes I ncident Description A 63 year old male used the product with PPE (gl asses , gloves , suit, and respirator) and notes no exposure at the time of the accident. Since th e application he has 021815 3/ 1 /2009 066330- ELEVATE 50 experienced interm ittent rashes, burning -00001 FL 00035 WDG HB sensations to his skin, periodic elevated FUNGICIDE blood pressure and racing heart rate, and sensitivity to chlorides and chloridecontaining compounds. Also his step daughter has noticed erratic thought patterns. Page 3 of5*HB-Human Majo r (if the person alleged or exhibited symptoms which may have been life

- threatenin g, or resulted in adv erse reproductiv e effects or in re sidual disability)



### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 199 9-200 8 , although repo rting varies from state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources, including: reports f rom local P o ison Control Centers, state Department of Labor workers' compensation claims when reported by physicians, reports from State Departments of Agriculture , and physician reports to state Departments of Health. A lthough both occupati onal and non-occupational incidents are included in the database , SENSOR-Pesticides focuses on occupational pesticide incidents, and i s ofparticular value in providing that information. A state SENSOR contact specia list attempts to fo ll ow-up w ith cases and obta ins medical records to verify symptoms, ci rcumstances surrounding the exposure, severity, and outcome. Using standardized protocol and case definitions derived from poison center reporting , SENS OR coordinators at Stat e Departments of He alth enter the incident intervie w description provided by the case, medical report , physician and patient into the SENSOR data system. The SENSORPesticides data system is accessible to participating states and EPA. A query of SENSOR-P esticides from 1998-2009 identifie s fou r cases, stemmi n g from one event, involving fenhexamid. All four cases were coded as low in severity. T his event occurred in Oregon in 200 1 and was a bystander drift event that occurred after a pes t icide application was made at an adjacent vineyard. Multiple pesticide products with 6 different active ingredients were used for this application that led to the drift event. One of the cases , age 10 , experienced symptoms related to asthma following the drift exposure.
c. Agricultural Health Study (AHS) The AHS is a hi gh qualit y, prospective epidemiology study evalua ting the link between pesticide use and various health outcomes including cancer. The AH S includes private and commercial pesticide app licators and their spouses. If there are AHS find ings relevant to a particula r pesticide go ing through registration re v iew , the Agency wi ll ensure they are considered in the p robl em formu l ation!scoping phase of the process and, if appropriate, fully reviewed in the ri sk as sessment phase of the process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture
. Fenhexamid is not included in the AHS , and therefore this study does not prov ide information for this report. 

### IV. CONCLUSION Based on the low frequency and severity of incident cases reported for fenh examid in both IDS and SENSOR-Pesticides , there does not appear to be a concern at this t ime that would warrant
Page 4 of5further investigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional analys i s will be included in the risk assessment.

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