UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: February 21,2013 

SUBJECT: Fenhexamid: Review of Human Incidents 

PC Code: 090209 DP Barcode: 0407943 

Decision No.: 473334 

Petition No.: NA 

Risk Assessment Type: NA 

TXRNo.: NA 

MRID No.: NA 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 126833-17-8 

40 CFR: NA 

Ver.Apr.08 

FROM: 

T

E

oxicology 

lizabeth Evans, 

and Epidemiology 

Environmental 

Bran

Protection 

ch 

Special!st 

G t __ .. hl/'h ~ 

. ~ 

THROUGH: 

TO: 

Health Effects Division (7509P) VT " . 

and fMk_ Shanna Recore, Industrial Hygienist ~ ~J A 11 ,a t2-

Toxicology and Epidemiology Branch \J£.N'-'--

Health Effects Division (7509P) a .,../I M/JJ ;:<t ,,feb...-'l.dt3 

David J. Miller, Acting Branch Chief ;)J/If(!rJ! 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Monica Hawkins, Risk Assessor 

Risk Assessment Branch VI 

Health Effects Division (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 IDS 

and NTOSH 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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The Agricultural Health Study (AHS) is also a potential source of information associated with 

human health effects associated with certain pesticides. Fenhexamid is not included in the AHS, 

and therefore this study does not provide information for this report. 

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 formulation phase of registration review. 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 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 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, strawberries and ornamentals. The enduse product is a water dispersible granule formulation containing 50% active ingredient. The 

product is applied as a foliar spray by ground equipment only. The 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 Health (CDC/NIOSH) Sentinel 

Event Notification System for Occupational Risk-Pesticides (SENSOR-Pesticides) 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 this report. 

III. RESULTS/DISCUSSION 

a. IDS (Incident Data System) 

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OPP's IDS includes reports of alleged human health incidents from various sources, including 

mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports 

from registrants, other federal and state health and environmental agencies, and individual 

consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from 

across the U.S. and most incidents 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 contains incidents resulting 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 effects 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, from 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 this 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 involving 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 . IDS M . I . d a e am ~JOT nc1 ents fl or t e h smgJe c h em1ca . lflnh e exam1 

Human Incident Chemical: Fenhexamid I PC Code: 090209 

Incident Exposure 

Package Incident Reg Severity 

Report Date Location Number Product Name Codes Incident Description 

A 63 year old male used the product with 

PPE (glasses, gloves, suit, and respirator) 

and notes no exposure at the time of the 

accident. Since the application he has 

021815 3/ 1/2009 066330- ELEVATE 50 experienced intermittent 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 Major (if the person alleged or exhibited symptoms which may have been life-threatening, or resulted in adverse 

reproductive effects or in residual disability) 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 11 states from 1999-2008, although reporting varies 

from state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources, 

including: reports from local Poison 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. Although both occupational 

and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on 

occupational pesticide incidents, and is of particular value in providing that information. A state 

SENSOR contact specialist attempts to follow-up with cases and obtains medical records to 

verify symptoms, circumstances surrounding the exposure, severity, and outcome. Using 

standardized protocol and case definitions derived from poison center reporting, SENSOR 

coordinators at State Departments of Health enter the incident interview 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-Pesticides from 1998-2009 identifies four cases, stemming from one event, 

involving fenhexamid. All four cases were coded as low in severity. This event occurred in 

Oregon in 2001 and was a bystander drift event that occurred after a pesticide 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 high quality, prospective epidemiology study evaluating the link between pesticide 

use and various health outcomes including cancer. The AHS includes private and commercial 

pesticide 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. 

Fenhexamid 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 severity of incident cases reported for fenhexamid in both IDS 

and SENSOR-Pesticides, there does not appear to be a concern at this time that would warrant 

Page 4 of5 
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. 

Page 5 of 5