UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: May 21, 2015 

SUB.JECT: Tetraconazole: Tier I (Scoping) Review of Human Incidents 

PC Cod e: 120603 

Decisio n No.: 503204 

Pet ition No.: NA 

Ris k Assessment Type: NA 

TX R No.: NA 

MRIO No.: NA 

DP Barcocle: ()4274 19 

Registration No.: NA 

Regu latory Action: NA 

Case No.: NA 

CAS No.: 1 12281-77-3 

.tO CFR: NA 

FROM: /6f Elizabeth Evans, Environmental Protection Specioqt 

Toxicology and Epidemiology Branch 

1 Health Effects Division (7509P) 

and 

Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) /) / _ Ii!{ 

THROUGH: David Miller, Acting Branch Chief kjf;;,/ ;f!A'l 

Toxicology and Epidemiology Branch 

TO: 

Health Effects Division (7509P) 

Anwar Dunbar, Risk Assessor 

Risk Assessment Branch I 

Health Effects Division (7509P) 

and 

Veronica Dutch, Chemical Review Manager 

Risk Management & Implementation Branch 5 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Ver.Apr.08 

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

Tetraconazole is a fungicide. The end-use product, Eminent l 25SL, contains 11 .6% 

tetraconazole by weight and is a liquid fungicide for control of Cercospora leaf spot and powdery 

mildew on sugar beets. 

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 tetraconazole (pc code: 120603). 

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

of the health effects attributed to tetraconazole exposure. Tetraconazole is not included in the 

AHS, and therefore this study does not provide information for thjs 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 summari es. 

For the Ma in IDS, from January 1, 2010 to February 4, 20 15, there were no inc idents reported 

involving tetraconazolc. 

In Aggregate lDS. from January 1, 2010 to February 4, 2015, there were 3 incidents reported 

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

incidents reported to IDS involving tetraconazole. 

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 I lealth. Although both occupational 

and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on 

occupational pesticide incidents, and is of particular val ue 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 

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

is sent to N IO 1-l annually to be aggregated. 

A review of SENSOR-Pesticides 1998-2011 identifies two cases, stemming from one event, 

involving tetraconazole. The two cases involve multiple active ingredients. These two cases 

occurred in North Carolina in 2010. Both cases were low in severity. The cases were residential 

bystanders in their home. A certified applicator was making an aerial application to soybeans in 

a nearby field and the product drifted to their home; as they were walking outside of the home 

"the mist hit them as they were running out of the way'·. They both experienced cough/choke 

and one also had gastrointestinal symptoms. Products used in this aerial application include 

Headline Fungicide. Domark 230 ME Fungicide and Declare. The applicator did receive 

citations for violating FIFRA. including '·use not in accordance with label. operating unlicensed 

equipment, the department of pesticides was in a no deposit zone. and depositing in a hannful 

manner. 

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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 health outcomes including cancer. The AI-IS 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 80 different pesticide 

active ingredients conunonly used in agriculture. Tetraconazole is not included in the AI-IS, and 

therefore this study does not provide infonnation for this report. 

IV. CONCLUSION 

Based on the low frequency an~ severity of incident cases reported for tetraconazole 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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