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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

Date: November 27, 2012

SUBJECT: Trifloxystrobin: Review of Human Incidents

PC Code: 129112 DP Barcode: D407067

Decision No.: 469960 Registration No.: NA

Petition No.: NA Regulatory Action: NA

Risk Assessment Type: NA Case No.: NA

TXR No.: NA CAS No.: 141517-21-7

MRID No.: NA 40 CFR: NA

 Ver.Apr.08

 

FROM: Shanna Recore, Industrial Hygienist

Toxicology and Epidemiology Branch

Health Effect Division (7509P)

and

Elizabeth Evans, Environmental Protection Specialist

Toxicology and Epidemiology Branch

Health Effect Division (7509P)

THROUGH: David Miller, Acting Branch Chief

Toxicology and Epidemiology Branch

Health Effects Division (7509P)

TO: Nancy Tsaur, Risk Assessor

Risk Assessment Branch III

Health Effects Division (7509P)

and

Moana Appleyard, Chemical Review Manager

Risk Management & Implementation Branch V

Pesticide Re-evaluation Division (7508P)

Summary and Conclusions

Based on the low frequency and severity of incident cases reported for trifloxystrobin in both 

IDS and NIOSH SENSOR, 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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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

Trifloxystrobin is a strobilurin-class fungicide that controls foliar fungal diseases and 

soilborne/seedling fungal diseases. It works by interrupting mitochondrial respiration in plantpathogenic fungi, thus inhibiting spore germination and mycelial growth. It is a broad-spectrum 

preventative fungicide used for control of many plant diseases in various fruit, nut, vegetable, 

and field crops, including corn and soybean.

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 trifloxystrobin (PC Code 129112). 

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

of the health effects attributed to trifloxystrobin 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. Trifloxystrobin 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)

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 
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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 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 September 13, 2012, there was 1 incidents reported 

for single chemical only in the database and 10 additional incidents reported involving more than 

one chemical. These incidents were classified as moderate severity. In the single chemical 

incident, an adult male became ill after blowing into a hose to clear the product causing the 

product to blow into his face. He went to the emergency room and was admitted. No further 

information is available (Table 1).

In Aggregate IDS, from January 1, 2007 to September 13, 2012, there were 20 reported incidents 

involving trifloxystrobin. 

b. NIOSH SENSOR

The NIOSH-led SENSOR-Pesticides database covers 11 states from 1998-2008, 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-Pesticides coordinators at State Departments of Health enter the incident interview 

description provided by the case, medical report, physician into the data system. In order to be 

included in the database, all SENSOR-Pesticides cases, including low severity cases, must have 

at least two adverse health effects.

In SENSOR-Pesticides from 1998 to 2008, 11 cases, stemming from 10 exposure events,

involving trifloxystrobin were identified. Two cases were exposed to a single active ingredient 
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whereas the other 9 involve exposure to multiple active ingredients. Two cases are moderate in 

severity and 9 cases are low severity. 

Of the 11 cases, six reported respiratory symptoms, four reported dermal symptoms, four

reported gastrointestinal symptoms, and three reported ocular symptoms. It is noted that two of

reported ocular symptoms despite wearing the label-required eye protection; however, both of 

these cases involved the application of multiple active ingredients.1 One case narrative states 

“Patient was spraying on hop field, wearing full protection: half face respirator, rubber boots, 

rubber gloves, raingear and goggles. But next day around 11:00 am he experienced ocular 

symptoms. He doesn't know how he got exposed.” The second case narrative states “A 33 y/o 

male developed ocular symptoms after applying pesticides and fertilizers in a tank mix. He was 

wearing eye protection.” Both cases were classified as low severity.

Eight of the 11 cases are coded as “work-related”. Of these, seven cases resulted from 

occupational pesticide exposure. Specifically, five of these cases are pesticide applicator 

exposures, one involved a farmworker thinning apples, and one case was coded “work-related”

but no further detail provided.

One of the two moderate severity cases involved a single active ingredient. This case occurred 

in California in 2008 and involved application of Flint Fungicide (EPA reg # 00026400777). 

This case was spraying Flint Fungicide from a tractor, reported wearing all required PPE, but he 

blew into a hose to clear it, and the product contacted him. He experienced gastrointestinal 

symptoms and was hospitalized for one day and reported missing at least one day of work. The 

second moderate severity case occurred in Washington in 2005 and involved a 33 year old male 

applicator who went to a clinic complaining of neurological and gastrointestinal symptoms after 

applying Flint Fungicide. This case, however, was applying Axinphosmethyl 50W in addition to 

Flint Fungicide.

c. 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.

Trifloxystrobin is not included in the AHS, and therefore this study does not provide information 

for this report.

IV. CONCLUSION

 

1

In both cases where the applicator reported ocular symptoms despite wearing the label-required PPE; multiple 

products were implicated. Further investigation identifies an eye protection requirement on labels of the nontriflxoystrobin products. Both of these cases also used products containing sulfur which do have eye protection 

requirements on the labels.
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Based on the low frequency and severity of incident cases reported for trifloxystrobin in both 

IDS and NIOSH SENSOR, 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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Table 1. Main IDS Incident involving Trifloxystrobin as a single chemical

Human Incident Chemical: Trifloxystrobin PC Code: 129112

Incident 

Package 

Report

Incident 

Date Location Country

Reg 

Number

Product 

Name

Exposure 

Severity 

Codes Incident Description

020180 -

00059 5/24/2008 CA US

000264-

00777

FLINT 

FUNGICIDE HC

An adult male became ill after blowing into 

a hose to clear the product causing the 

product to blow into his face. He went to ER 

and was admitted.

*HC-Human Moderate (if the person alleged or exhibited symptoms more pronounced, more prolonged or of a more systemic nature than minor symptoms; and involved some form of treatment, 

even though symptoms were not life threatening and the person returned to his/her pre-exposure state of health with no additional residual disability)