UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORA NDUM 

Date: September 15, 20 15 

SUBJECT : Metconazole: Revised Tier I (Scoping) Review of Human Inc idents and 

Epidemiology 

PC Code: 125619 DP Bar codc: 0428900 

Decision o.: 507 195 

Petition No.: /\ 

Registration No.: A 

Regulatory Act ion: N/\ 

Ris k Assessment Type: N/\ Case No.: NA 

TXR No.: NA CAS No.: 125 116-23-6 

M RID o.: N/\ 40 CFR: N/\ 

FROM : 

Toxicology 

Elizabeth Evans

and 

, 

E

E

pidemi

nvironm

ology 

enta

Branch 

l Protection Specialist ');?._ 

- 0

-~-- ~ Health Effects Division (7509P) 

Toxic

Shanna 

ol

and 

ogy 

Reco

a

re

nd 

, 

Ep

Indust

idemi

rial 

ol

I l

ogy 

ygienist 

Branch ~V'-fl\...JI""-' 

Jg /)f 

111 

IA 

11 

~ 

Health Effect Division (7509P) ,. . 

THROUGH: David Miller, Acting Branch Chief ~ l"f/,J:V;~ fl.1l 1~ Toxicology and Epidemiology Branch t .. ~"'{/( u 

Health Effects Division (7509P) 

TO: Barry O'Keefc, Risk Assessor 

Risk Assessment Branch )[) 

I lcalth Effects Division (7509P) 

and 

Bonnie Adler, Chemical Review Manager 

Risk Management & Implementation Branch 5 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

This memorandum was revised to con-eel the DP Barcode only. No other changes were made to 

this assessment. Based on the low frequency and severity of incident cases reported for 

metconazole in both IDS and SENSOR-Pesticides there does not appear to be a concern at this 

ti me that would warrant further investigation. The Agency will continue to monitor the incident 

Page I of 5 
information and if a concern is triggered, additional anal ysis will be included in the risk 

assessment. 

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") arc 

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 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 

Metconazole is a sterol biosynthesis inhibitor (DMl-Fungicide). It can be applied to turf and 

ornamentals but it can only be applied by ground spray.

1 

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 JOSH) Sentinel 

Event Notification System for Occupati onal Risk-Pesticides (SENSOR) databases were consulted 

for pesticide incident data on the active ingredient metconazole (pc code: 125619). The purpose 

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

effects attributed to metconazole exposure. Metconazole is not included in the AHS, and therefore 

this study docs not provide information for this report. 

lll. RESULTS/DISCUSSION 

a. IDS (Incident Data System) 

OPP's IDS includes reports or alleged human health incidents from various sources, including 

mandatory Federal lnsecticide, Fungic ide and Rodenticide Act (FlFRA) Section 6(a)(2) reports 

from registrants, other federal and state health and enviro1m1ental 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 

1 EPA Factsheet, found on linc at: http://www.epa.gov/pesticidcs/chcm search/reg actionslregistralion/fs PC125619 Ol-Sep-07.pdf 

Page 2 of 5 
submitted to the IDS represent anecdotal reports or all egations onl y, 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 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 I OS incidents involving only one 

active ingredient (as opposed to pesticide products with multiple active 

ingredients) are considered lo 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, 2010 to May 27, 2015, there were no incidents reported for 

the single chemical metconazole only in the database. There were three incidents reported 

involving metconazole and pyraclostrobin. These incidents were classified as moderate severity> 

Descriptions for these incidents are provided in Appendix A. 

Aggregate IDS, from January I, 20 l 0 to May 27, 2015, there were 17 incidents reported 

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

incidents reported to IDS involving mctconazole. 

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 

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 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 

SE SOR-Pesti cide coordinator enters the incident information into the state-based system which 

is sent to IOSH annually to be aggregated. 

A review of SENSOR-Pesticides 1998-20 11 identifies no cases involving metconazole. 

c. Agricultural Health Study (AHS) 

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

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

Page 3 of 5 
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 80 different pesticide 

active ingredients commonly used in agriculture. Metconazole 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 fo r metconazole 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. 

Page 4 of 5 
Appendix A. 

Incidents Reported lo Main IDS from 2010 to May 27, 2015 Involving Mctconazolc 

Incident 

Package Incident PC 

Report Date Locatio n Reg Number Product Name Codes Incident Descri ption 

The caller's daughter was hospitalized with pancytopenia. 

023168 - INDEPENDENCE, 007969- HEADLINE AMP 125619 Caller believes it is due to fungicide reaching drinking 

00001 8/2/20 11 IL 00291 FUNGICIDE 099100 water. Doctors have not detennined cause of pancytopenia. 

A 61 yr old male exposed to product during an aerial 

application. He showered shortly afler the exposure. Three 

024279 - 007969- HEADLINE AMP 099100 hours later he reported pain and a burning sensation in his 

00001 7/14/20 12 OXFORD, NE 00291 FUNGICIDE 125619 lungs, shortness of breath, and irritated eye socket. 

Two teenage females ( 13 years old and 16 years old) along 

with several dozen other adolescenls and adu lts were 

detasseling com and were sprayed 1-2 times by an aerial 

applicator with product. Fixed wing airplane apparently 

sprayed the wrong lield. The thirteen year old developed 

nausea, skin irritation, persistent headache, and nausea. 

The sixleen year old experienced difficulty breathing. 

BAS 556 SC shortness of breath and had an episode of loss of 

025590 - 007969- FVNGICIDE/l IEADLINE 125619 consciousness for some period of time while and was taken 

00001 7/29/2013 HAMMOND, IL 00291 AMP 099100 10 a local ER where she recovered. 

Page 5 of 5