UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: September 15, 2015 

SUBJECT: Cyproconazole: Tier I (Scoping) Review of Human Incidents and Epidemiology 

PC Code: 128993 DP Barcode: 0429119 

Decision No.: 508975 

Petition No.: NA 

Registration No.: NJ\ 

Regulatory Action: NA 

Risk Assessment Type: NA Case No.: NJ\ 

TXR No.: NJ\ CAS No.: 94361-06-5 

MRID No.: NJ\ 40 CFR: NA 

FROM: Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

and 

El izabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Yer.Apr.08 

Health Effects Division (7509P) 

THROUGH: David Miller, Acting Branch hief~i!Ldv();J1- 1tt-r!tn Toxicology and Epidemiology Branch (~ {) fJ 

TO: 

Health Effects Division (7509P) 

George Kramer, Risk Assessor 

Risk Assessment Branch I 

Health Effects Division (7509P) 

and 

Kelly Ballard, Chemical Review Manager 

Risk Management & Implementation Branch l 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

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

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

warrant furthe r 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 fulfi ll 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 impo11ant 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 fu11her 

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 

Cyproconazole is a broad-spectrum tri azole (Group 3) fungicide that is a mixture of two 

distereoisomers (2RS,3RS:2RS,3SR; - 1: I). Cyproconazole is currently registered for use on 

greenhouse- and field-grown roses, as a wood preservative, and on sod farms, golf courses, as 

well as a number of crops. There are no proposed or registered uses for cyproconaozle in the 

residential setting. 

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 IOSH) 

Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were 

consulted for pesti cide incident data on the active ingredient cyproconazole (pc code: 128993). 

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

of the health effects attributed to cyproconazole exposure. Cyproconazole is not included in the 

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

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 (FlFRA) 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. JDS 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 

acti ve 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 JDS, from January I, 20 I 0 to May 27, 20 15, there were no incidents reported 

involving cyproconazole. 

In Aggregate IDS, from January 1, 20 10 to May 27, 20 15, there were 2 incidents reported 

involving cyproconazole. One incident was classified as minor severi ty and the other was 

classified as having no or unknown effects. Overall, there are few incidents reported to IDS 

involving cyproconazole. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-2011 , 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, SE SOR-Pesticides focuses on 

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

state coordinator at each of the 12 respective state Depar1ments of Hea lth conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using 

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

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

is sent to NIOSH annuall y to be aggregated. 

A query of SENSOR-Pestic ides 1998-2011 identifies three cases involving cyproconazole (pc 

code 128993). All three cases involved multiple active ingredients. All three cases were low in 

severity. 

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. Ifthere are AHS findings relevant to a particul ar 

pesticide going through registration review, the Agency will ensure they are considered in the 

problem formu lation/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 80 different pesticide 

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active ingredients commonly used in agriculture. Cyproconazole 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 cyproconazole 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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