UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: February 11, 2014 

SUBJECT: Revised: Pyraclostrobin: Tier I Review of Human Incidents 

PC Code: 099 1 00 

Decision No.: 487330 

Petition No.: NA 

DP Barcode: 0417740 

Registration No.: NA 

Regulatory Action: NA 

Risk Assessment Type: NA Case No.: NA 

TXR No.: NA CAS No.: 175013- 18-0 

MRID No.: NA 40CFR: NA 

FROM: 

THROUGH: 

TO: 

Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

and 

Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

David Miller, Acting Branch Chief aJ/ life 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Barry O'Keefe, Risk Assessor 

Risk Assessment Branch III 

Health Effects Division (7509P) 

and 

Jill Bloom, Chemical Review Manager 

Risk Management & Implementation Branch 2/4 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Ver.Apr.08 

This assessment was modified to reflect a revised DB Barcode. Based on the low frequency and 

severity of incident cases reported for pyraclostrobin, 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 cormection 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 

Pyraclostrobin is an agricultural pesticide product used to kill fungi (e.g., blights, mildews, 

molds, and rusts). The agricultural use sites include com, peanuts, almonds, potatoes soybeans, 

wheat, Brassica, legumes, sugar beets, small grains, fruit trees (including citrus and nut trees), 

berries, tomatoes, peppers, and eggplant. Non-agricultural use sites include ornamental shrubs 

and bushes, and turf. 

For this evaluation, both the 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 pyraclostrobin (PC codes: 0991 00). 

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

of the health effects attributed to Pyraclostrobin exposure. Pyraclostrobin 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 

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: 

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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, 2009 to January 15, 2014, there were 5 incidents reported for 

single chemical only in the database. There were 9 additional incidents reported involving more 

than one chemicaL One incident was classified as no or unknown effects, one incident was 

classified as minor severity and the rest were classified as moderate severity. 

In Aggregate IDS, from January 1, 2009 to January 15,2014, there were 36 reported incidents 

involving pyraclostrobin. These incidents were classified as minor severity. Overall, there are 

few incidents involving pyraclostrobin reported to IDS. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 11 states from 1998-2009, 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. The 

state coordinator at each of the 11 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using 

standardized protocol and case defmitions derived from poison center reporting, the state 

SENSOR-Pesticide coordinator enters the incident information into the state-based system which 

is sent to NIOSH annually to be aggregated. 

A query of SENSOR-Pesticides 1998-2010 identifies a total of 65 cases involving pyraclostrobin 

(pc code 0991 00), stemming from 28 events. Of these, 52 cases involved a single ai, which will 

be analyzed here. Forty three cases (83%) were work-related. Forty one of the 52 cases (79%) 

resulted from aerial applications. Headline Fungicide (EPA reg # 00796900 186) is the product 

implicated in 42 of the 52 cases, including one multiple exposure agricultural drift event that 

occurred in Iowa in 2007 and led to 27 cases of pesticide illness. This event was documented in 

the CDC's Morbidity and Mortality Weekly Report 1

• This event is documented in the MMWR 

as foiJows, 

1 MMWR January 4, 2008/ 56 (5 1); 1343-1345 

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On July 23, 2007, the Iowa Department of Public Health (IDPH) received media reports that migrant 

workers in afield had been inadvertently exposed to pyracfostrobinfungicide by a crop-duster plane on 

July 22. An IDPH investigation identified 27 cases of acute illness among the potentially exposed workers; 

all illnesses were associated with off-target drift of the pyracfostrobin to an adjacent field, owned by a 

different grower, where workers were detasselingfield corn. IDPH learned that the pilot had seen the 

nearby workers yet proceeded to apply the fungicide. Some workers reported feeling wet droplets on their 

skin and seeing mist coming from the aircraft. All 27 persons with acute illness were Hispanic and 

residents ofTexas ... A/1 received skin decontamination on-site by a hazardous materials team before being 

transported to an emergency department for observation until their symptoms resolved. All cases were 

categorized as being of low severity. The most common symptom was upper respiratory tract pain or 

irritation (26 patients), followed by chest pain (20 patients). 

Another multiple exposure event occurred in Iowa in 2010 that resulted in four case reports 

(Headline again was the product implicated). The event narrative states, " 18 people were [over] 

sprayed by a crop-duster while detasseling. 4 people went to the ER, the rest were 

decontaminated on-site. Headline was the chemical used."2 

Of the 52 single ai pyraclostrobin cases, four were moderate in severity and 48 were low in 

severity (see Table 2 for descriptions of the moderate severity cases). Respiratory symptoms 

were the most frequently reported (63%) health effects involving pyraclostrobin cases (Table 1). 

Table l. SENSOR-Pesticides 1998-2010: Reported 

Health Effects for single ai Pyraclostrobin Cases 

N=52 

Health Effect # of Times Reported 

Dermal 13 

Ocular 13 

Respiratory 33 

Gastrointestinal 9 

Renal l 

Nervous System 14 

Cardiovascular 4 

* Cases may report multiple health effects 

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 

2 The other 14 cases may not have met the SENSOR case definition (two or more symptoms) and are therefore not 

included as cases. 

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active ingredients commonly used in agriculture. Pyraclostrobin are 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 both pyraclostrobin in 

both IDS and 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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