UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: December 2, 2015 

SUBJECT: Azoxystrobjn: Tier I Review of Human Incidents for Draft Risk Assessment 

PC Code: 12881 0 DP Barcode: 0430445 

Decision No.: 5 11 551 

Petition No.: NA 

Risk Assessment Type: NA 

TXR No.: NJ\ 

MRID No.: NJ\ 

Registration No.: NA 

Regulatory Action: NJ\ 

Case No.: NA 

CAS No.: 13 1860-33-8 

40 CFR: NA 

FROM: Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

and 

Ver.Apr.08 

Shanna Recore, Industrial Hygienist l\ ~ A •• ' · n D _ /\. n . Toxicology 

Health Effects 

and 

Division 

Epidemiology 

(7509P) 

Branch ~ ~ 

THROUGH: 

TO: 

David J. Miller, Acting Branch Chief /),,J ,($ 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Kristin Rury, Risk Assessor 

Risk Assessment Branch JI 

Health Effects Division (7509P) 

and 

Veronica Dutch, Chemical Review Manager 

Risk Management & Implementation Branch 5 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Azoxystrobin was previously reviewed in 2009 (M. Hawkins, 6/4/09). At the time, there were 

nine incidents reported for azoxystrobin IDS from 2002 to June 2009. Upon review of these 

incidents, it was concluded that "there are no remarkable case reports which suggest a plausible 

association between a moderate or severe health outcome and exposure to pesticide azoxystrobin 

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nor can we discern any suggestion of a trend or pattern regarding the health effects due to the 

alleged exposure to pesticide azoxystrobin. The current review of the incident data does not 

warrant further investigations at this time." 

The current IDS analysis from January I, 2010 through May 27, 2015, shows 4 moderate 

severity incidents reported involving the single active ingredient, azoxystrobin, and 29 additional 

incidents involving multiple chemicals in Main IDS. There were 40 minor severity incidents 

reported to Aggregate IDS. 

The query of SENSOR-Pesticides 1998-201 1 identifies 51 total cases involving azoxystrobin and 

13 cases involve a single ai. Twelve of these were low in severity and one was moderate in 

severity. 

Detailed Review 

I. ACTION REQUESTED 

Azoxystrobin is being considered under the FQPA-mandated Registration Review program 

established 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 is 

consideration of human incident data. In conjunction with a human health risk assessment based 

on other data sources, such human incident data can assist the Agency in better defining and 

characteriz ing the risk of pesticides/pesticide products. 

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 infornrntion 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 

Azoxystrobin is a broad-spectrum fungicide used to control foliar and soil-borne diseases 

including downy and powdery mildew, early and late blight, and several pathogens on many 

crops. 

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) databases were 

consulted for pesticide incident data on the active ingredient Azoxystrobin (PC Code: 12881 0). 

The purpose of the database search is to identify potential patterns in the frequency and severity 

of the health effects attributed to azoxystrobin exposure. 

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III. RES UL TS/DISCUSSION 

a. IDS (Incident Data System) 

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 specific. 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 

pesticide are considered to provide more certain infom1ation 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. 

17rom January I , 2010 to May 27, 2015, there were 4 incidents reported to Main IDS involving 

the single active ingredient, azoxystrobin. These incidents were classified as moderate severity 

(Table I). Dermal symptoms were reported most often which included redness, rash and 

burning. There 29 additional incident reported to Main IDS, involving azoxystrobin and other 

active ingredients. 

From January I , 2010 to May 27, 2015, there were 40 incidents reported to Aggregate IDS 

involving azoxystrobin. These incidents were classified as minor severity. 

Table I. Azoxystrobin Moderate Severity Single Active In 'redient Incidents Reported to IDS 

Incident 

Package Inciden t Reg Product 

Reoort Date Location Number Name Incident Ocscriotion 

An adult female mail ca1Tier was drifted on 

by an aerial application. She immediately 

developed a headache, nasal inflammation, 

dizziness, and nausea. She went 10 the 

022281 - 000100- emergency department. Her headache 

00030 8/9/2010 MO 01098 OUADRJS persisted for the next two weeks. 

Sixteen field workers had poscapplicacion 

023187- INDIANAPOLIS, 000100- QUADRJS exposure due 10 reentry into a treated fi eld. 

000 16 7/29/20 11 IN 0 1098 FLOW ABLE The reentry lime had been observed. They all 

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experienced dermal redness and burning on 

their arms. 

A 72 year old male field inspector was 

exposed to spray drift. He experienced 

scratchy eyes, cough. chest pain. short11ess of 

breath. elevated blood pressure. stomach 

QUADRJS ache. sweats, skin rash, left arm pain, leg 

025458 - 000 100- FLOW ABLE cramps, difficult breathing. puffy face, and 

000 16 6/27/20 13 IN 0 1098 FUNGICIDE tooth pain. 

An adult male applied the granular fungicide 

to his lawn and his neighbor, who was using 

a leaf blower at the time, accidentally blew 

the granules on him. He was wearing goggles 

and a long sleeved shirt, but he had his mouth 

open at the time and accidentally ingested 

some of the granu les. He experienced nausea, 

02660 I - 000 100- HERITAGE vomiting, diarrhea, watering eyes, headache, 

00084 5/ 11 /20 14 NC 01093 FUNGICIDE fatigue and a rash on his scalp, face and arms. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-20 11 , 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 focuses on occupational 

pesticide incidents, and is of particular val ue 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 repo11, physician and patient into the SENSOR data system. The SENSOR data system 

is accessible to pa11icipating states and EPA. 

A query of SENSOR-Pesticides 1998-2011 identifies a tota l of 5 1 cases involving azoxystrobin 

(pc code 128810). Of these, 13 cases, stemming from 9 events, are single ai cases. Twelve cases 

were low in severity and one case is moderate in severity. One event involved four cases, 

agricultural workers in a field that became ill after being directly sprayed by an aerial applicator 

who was making an application to a nearby field and then failed to turn of the spray while 

making a turn. Another event involved a father and young daughter who were made ill from 

drift 1 following an aerial application to a nearby potato field. 

Of the 13 single ai cases, eight cases experienced neurological symptoms, primarily headache; 

eight cases experienced gastrointestinal symptoms, including abdominal pain and nausea. Five 

1 SENSOR-Pesticides defines drift as "off target movement ofa pesticide'' which includes volatilization. 

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cases experienced dermal symptoms such as rash/irritation, three reported respiratory symptoms 

and two reported ocular symptoms. 

c. Agricultural Health Study {AHS) 

The AHS is a high quality, prospective epidemiology study evaluating the link between pestic ide 

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, full y 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. Azoxystrobin is not included in the AHS. 

CONCLUSION 

Based on the relatively low frequency of incidents reported to both IDS and SENSOR-Pesticides, 

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. 

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