UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORAN DUM 

Date: August 25, 2015 

SUBJECT: Prothioconazole: Tier 1 (Scoping) Review of Human Incidents and Epidemiology 

PC Code: 113961 OP Barcodc: Dn881 l 

Decision No.: 1 

Petition No.: NA 

Risk Assessment Type: N/\ 

TXR No.: NA 

MRIO o.: A 

Registration No.: N/\ 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 178928-70-6 

40 CFR: NA 

Ver.Apr.OS 

FROM: 

Tox

Eli zabeth 

icology 

Eva

and 

ns, 

Ep

En

idemi

vironmental 

ology Br

Protection 

anch 

Specialist ~ 

Health Effects Division (7509P) 

and 

Shanna Recore, Industri al Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

THROUGH: David Miller, Acting Branch Chief 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

~~ 

/2J4'/t lb.ij-'-"') 

TO: Nancy Keller, Risk Assessor 

Risk Assessment Branch X 

Health Effects Division (7509P) 

and 

Margaret Hathaway, 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 prothioconazole in both 

IDS and SE SOR-Pestic ides there docs 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 lo 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 fomrnlation phase of registration review. Reports of 

adverse health effects allegedl y 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 inc ident 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 

Prothioconazole is a broad-spectrum systemic fungicide used on barley, wheat and other crops. 

(EPA fac1shee1, found online ar: hllp://www.epa.gov/pesticides/chem search/reg acrions/registration/fs PC11 396 1 14-Mar-07.pdO 

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 prothioconazole (pc code: I 1396 l ). 

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

of the health effects attributed to prothioconazole exposure. Prothioconazole 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 a ll egations 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 arc reported by registrants only as 

counts in what arc aggregate summaries. 

For the Main IDS, from January I, 20 I 0 to May 27, 20 15, there were 0 incidents reported for the 

single chemical prothioconazole only in the database. There was 1 incidents reported involving 

than one chemical. This incident was classified as moderate severity and involved a 50 year old 

male who got diluted product, containing prothioconazole and penflufen, on his hands. He 

developed burning sensation, redness, and weeping sores. He was evaluated by doctor, treated 

with a steroid injection and prescribed a topical cream to apply to the area. 

In Aggregate IDS, from January 1, 20 10 to May 27, 201 5, there were 12 incidents reported 

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

few incidents reported to IDS involving prothioconazole. 

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-Pesticides focuses on 

occupational pesticide incidents, and is of parti cular value in providing that in formation. The 

state coordinator at each of the 12 respecti ve state Departments of Health 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 annually to be aggregated. 

A query of SENSOR-Pesticides 1998-20 11 identifies one case involving prothioconazole. This 

case involves multiple active ingredients. The case is low in severity. The case was exposed to 

drift from an aeri al application made to a nearby wheat field. The case experienced nausea, 

burning eyes and nose, dizziness and headache. 

c. Agricultural Health Study (AHS) 

The AHS is a high quality, prospective epidemiology study evaluating the li nk between pesticide 

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

pesticide applicators and their spouses. If there are AHS find ings relevant to a particular 

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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 80 different pesticide 

active ingredients commonly used in agriculture. Prothioconazolc is not included in the AHS, 

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

IV. CONCLUSION 

Based on the low frequency and severity of incident cases reported for prothioconazole 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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