UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: July 25, 2013 

SUBJECT: Imazalil and Imazalil Sulfate: Tier I Review of Human Incidents 

PC Code: 111901, 111 902 

Decision No.: 478862 

Petition No.: NA 

Risk Assessment Type: NA 

TXRNo.:NA 

MRIDNo.: NA 

DP Barcode: 0412205 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 35554-44-0, 58594-72-2 

40CFR: NA 

Ver.Apr.08 

FROM: 

Toxicology 

Shanna Recore, 

and 

Industrial 

Epidemiology 

Hygi

Branch 

enist 

_AIJ'U./fA..I~ 

11. n ~~ ., A ~ 

THROUGH: 

TO: 

and 

Health Effects Division (7509P) ~ 

Elizabeth Evans, Environmental Protection Sp#· 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) /) / If 

David J. Miller, Acting Branch Chie~;} J)/fCt___ 

Toxicology and Epidemiology BraneR 

Health Effects Division (7509P) 

Karlyn Middleton, Risk Assessor 

Risk Assessment Branch II 

Health Effects Division (7509P) 

and 

M. Hathaway, Chemical Review Manager 

Risk Management & Implementation Branch 2 

Pesticide Reevaluation Division (7508P) 

Summary and Conclusions 

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

sulfate in both IDS and NIOSH 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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The Agricultural Health Study (AHS) is also a potential source of information associated with 

human health effects associated with certain pesticides. Imazalil and imazalil sulfate is not 

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

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 

Imazalil is a systemic fungicide for post harvest use on bananas, citrus, and preplanting seed 

treatments of barley and wheat. Its only nonfood use is for chicken hatchery treatments. There 

are no residential or public health uses. 

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 ingredients imazalil and imazalil sulfate (pc 

code: 11190 I and 111902). The purpose of the database search is to identify potential patterns in 

the frequency and severity of the health effects attributed to imazalil and imazalil sulfate 

exposure. Imazalil and imazalil sulfate are 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 allegations only, unless otherwise stated in 

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the report. It should be noted there are two incidents reported as lawsuits to IDS that are not 

considered in this report. 

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

Imazalil 

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 summaries. 

For the Main IDS, from January 1, 2008 to June 11 ,2013, there were 0 incidents reported for 

single chemical only in the database. There was 1 incident reported involving more than one 

chemical. This incident was classified as moderate severity. 

In Aggregate IDS, from January 1, 2008 to June 11 ,2013, there were 2 reported incidents 

involving imazalil. These incidents were classified as minor severity. 

lmazalil Sulfate 

There were no incidents reported to either Main IDS or Aggregate IDS for imazalil sulfate from 

January 1, 2008 to June 11,2013. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 11 states from 1998-2009, 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 particular value in providing that information. The 

state coordinator at each of the 11 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 NIOSH annually to be aggregated. 

A query of SENSOR-Pesticides 1998-2009 finds a total of two cases, stemming from two events, 

involving imazalil. Of the two, one case involved a single active ingredient (ai). This case was 

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work-related and low in severity and included dermal and ocular symptoms. The multiple ai 

case was moderate in severity; the case ate a banana and immediately had a severe allergic 

reaction> the 3 ais listed in this case are: bifenthrin> imazalil> and chlorpyrifos-methyl. Following 

is the recorded case detail, 

"A 62 year old male ate a banana at home and developed a serious allergic reaction within 

minutes of eating the produce. One hour later he was treated at the ER He presented dermal 

and cardiovascular signs and complained of neurological and gastrointestinal symptoms. WSDA 

sampled the banana peel and the banana pulp. No pesticides were found the in the pulp. 

However, three pesticides were found in the peel. Concentrations of the pesticides were below 

the estimated tolerances for whole bananas. Nevertheless, symptoms experienced by the patient 

correlated well with an exposure with two of the pesticides used. Even though no pesticides were 

found in the pulp, he had contact with the peel before handling the pulp. "1 

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. If there are AHS fmdings 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 50 different pesticide 

active ingredients commonly used in agriculture. Imazalil and imazalil sulfate are 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 imazalil and irnazalil 

sulfate 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. 

1 The two chemicals correlating with symptoms are not specified in SENSOR; EPA is unable to determine which 

active ingredients may have contributed to the health effects reported. 

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