UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: ovember 24, 20 15 

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

PC Code: 122 10 1 OP Barcode: 0429078 

Decision o.: 508972 

Petition No.: N/\ 

Risk Assessment Type: 1 A 

TXR No.: 'A 

!RID No.: NA 

Registratio n o.: N/\ 

Regulatory Action: A 

Case o.: 1 A 

CA No.: 60207-90-1 

40 CFR: N/\ 

FROM: Elizabeth !:vans, Environmental Protectio n Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

and 

Va./\pr.08 

~ 

~ ~ 

Shanna Recore. Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

jJ_0;/1}-P-~ ~ 

THROUGH: 

TO: 

David Mi ll er, Acting Branch Chi cf/J/ J ,#tlf 

Toxicology and Epidemiology Branch 

Hea lth Effects Division (7509P) 

Thurston Morton, Risk Assessor 

Risk Assessment Branch IV 

Health Effects Division (7509P) 

and 

Christina Scheltema, Chemical Revievv Manager 

Risk Management & Implementation Branch 3 

Pestic ide Re-evaluation Division (7508 P) 

Summary and Conclusio ns 

Based on the relati vely low frequency and severity of incident cases reported for propiconazole 

in both IDS and SEN OR-Pesticides there docs not appear to be a concern at this time that 

would warrnnt further investi gation. The Agency will continue to monitor the incident 

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infonnation and if a concern is triggered. additional analysis \Viii be included in the risk 

assessment. 

Detailed Review 

I. ACTION REQUESTED 

This review is intended to fulfill o ur requirement to docket summaries of incident data that v.iere 

reported to the Agency. as well as to ensure human incident data and the Agricultural Health 

tudy (AHS) are part of the problem formulation phase of registration review. Reports of 

adverse health effects allegedl y due to a spec ific pesticide exposure (i.e .. an " inc ident'") are 

largely self-reported and therefore, generally speaking, neither exposure to a pesticide or 

reported symptom (or the connection between the two) is va lidated or otherwise confirmed. 

Typicall y, causation canno t be determined based on incident data. However, incident 

information can be an impor1ant source of feedback to the Agency: inc idents of severe outcome. 

o r a suggested pattern o r trend amo ng less severe inc idents, 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 

Propiconazole is a systemic broad spectrum fungicide used for control of disease in a variety of 

field and orchard crops. 1 

For this evaluation. both the OPP Incident Data ystem (IDS) and the Centers for Disease 

Control and Prevention/National Institute for Occupationa l Safety and Hea lth (CDC TOSH) 

entinel Event otifi cation System for Occupational Risk-Pesticides ( ENSOR) databases were 

consulted for pesticide incident data on the acti ve ingredient propiconazole (pc code: 122 101 ). 

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

of the health effects attributed to propiconazole exposure. Propiconazole is not incl uded in the 

AHS. and therefore this study does not provide informati on 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 Insecti cide, 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. O PP 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 o r all egatio ns only, unless o therwise stated in 

the report. 

1 EPA factsheet. found on line at: http://www.epa.gov/oppOOOO I/chem search/cleared revicws/csr PC-12210 I IOMar-05 a.pdf 

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ID records incidents in one of two modules: Main JDS and Aggregate IDS: 

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 ID incidents involving only one 

active ingredient (as opposed to pesticide products with multiple active 

ingredients) are considered to provide more certai n 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 are aggregate summaries. 

For the Main IDS. from January 1, 2010 to May 27. 20 15, there were 6 incidents reported for the 

single chemical propiconazole only in the database. These incidents were classified as moderate 

severity. There were 26 additional incidents reported involving than o ne chemical. 

In Aggregate ID . from January 1, 2010 to May 27. 2015. therc were 68 incidents reported 

involving propiconazole. These incidents were classified as minor severity. 

b. SENSOR-Pesticides 

The EN OR-Pesticides database covers 12 states from 1998-201 I. although reporting varies 

from state to state. Cases of pesticide-related illnesses arc 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 

Agri culture, 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 information. The 

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

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

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

is sent to 10 H annually to be aggregated. 

A query of ENSOR-Pesticides 1998-2011 identifies a total of 66 cases involving propiconazole. 

Of these seven cases involve a single ai. Six cases were low in severity and one case was 

moderate in severity. The moderate severity case involved a farmworker in a field who was 

exposed and experienced respiratory and gastrointestinal symptoms. The moderate severity case 

occurred in California in 1999 and no case narrative is provided. Of the seven single ai cases. 5 

cases were occupational agricultural (occurred on farms) and two cases were residential use 

cases. Of the seven cases. four experienced dermal symptoms. three had ocular symptoms, two 

had gastrointestinal symptoms and one case reported respiratory symptoms. 

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c. Agricultural Health Study (AHS) 

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

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

pesticide applicators and their spouses. If there are J\FIS findings rel evant to a pm1icular 

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. Propiconazolc is not included in the AHS. and 

therefore this study does not provide infonnation for this report. 

IV. CONCLUSION 

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

in both IDS and SENSOR-Pesticides 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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