### 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 C ode: 111901, 111 902 Decision No.: 478862 Petition No.: NA Risk Assessment Type: N A TXRNo.:NA MRIDNo.: N A DP Barcode: 0412205 Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 35554-44-0, 585 94-72-2 40CFR: N A Ver

. Apr.08 Shanna Recore, Industrial Hygi enist 

# 11. n

# ~~ ., A

# ~ Toxicology and Epidemiology Branch**_AIJ'U./fA..I~** FROM:

THROUGH:

TO: and Health Effects Division (7509P )**~** Elizabeth Evans , E nvironmental Protection Sp#· Toxicology and Epidemiolo gy Branch Health Effects Di vision (7509 P) /) 

## / If D avid J. Miller, Ac ting Branch

# Chie**~;}**J)/f Ct___ Toxicology and Epidemiology BraneR Health Effec ts Division (7509P) Karlyn Middleton, Risk Assessor Risk Assessment Branch II Health Effects Di vision (7509 P) and M. Hathaway , Chemical Review Manager Ri sk Management & Implementatio n Branch 2 P esticide 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 N IO S H SENSOR-Pesticides , there does not appear to be a concern at thi s time that would warrant further investigation. The Agency wi ll continue to monitor the incident information and if a concern is triggered , additional analysis will be included 

### in the risk assessment. Page 1 of 4

### The Agricultural Health Study (AHS) is also a potential source of information associated with human health effects associated with certain pestic i des. Imazalil and imazalil sulfate is not included in the AHS, and therefore this study does not provide information for this report.

Detailed Re view 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 Healt h Study (AHS) are part of the problem formulation phase of registration review. Reports of adverse health effects allegedly due to a specific pesticide expo sure 

### (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. Howe ver, inciden t 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 th e Agency to further investigate a particular chemical or product. Observational epidemiology studies rela te 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 pub lic health uses. For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease Contro l 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 sulf ate (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 effec ts attributed to imazalil and imazalil sulfate exposure. Imazalil and imazalil sulfate are not included in the AHS, and therefore this study do es no t 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 otherwi se stated in Page 2 of 4the r eport. It should b e no ted there are two incidents reported as lawsuits to ID S that are not considere d in this r ep ort. IDS records incidents in one of t w o modules : M ain ID S and Aggregate IDS:

Im azal il o Main ID S contains incidents resulting in higher severity ou tcomes and provides more detail with regard to case specifics. This system stores incident data for death, major and moderate inci de nts, and it includes information abo ut the location , date and n ature of the i ncident. Main IDS incide nt s involving only o ne active ingredient (as opposed to pesticide products with multiple active ingredients) are considered to provide more certain information about the po tenti al effect s of exposure from the pe sticide.

o Aggregate IDS co ntains incide nt s r es ulting in less severe human i ncidents (minor, unknown , or no effects outcomes). These are reported by registrants only a s counts i n wha t are aggregate summaries.

For the Mai n IDS , from January 1 , 2008 to Jun e 11 ,2 013, there were 0 incidents reported for s ing l e chemical onl y i n the database. There was 1 in cident reported in vo l v ing more than one chemical. Thi s inciden t was classified a s mod e rate severi ty. In Aggregate IDS , f rom January 1 , 2008 to Jun e 11 ,2 013, t here were 2 rep orte d incidents invo lving imazali l. These incidents were classified as minor severi ty. lmazalil S u lfate There we re no incidents reported to either Main IDS or Aggre gat e ID S for imazalil s ul fate from January 1 , 2008 to June 11,20 1 3. 

### b. SENSOR-Pesticides Th e SENSOR-Pesticide s database covers 11 states fro m 1 998

- 2009 , although r epo rting varies from state to state. Cases of pest ici de-related illnesses are ascertained from a var iety of sources , incl uding: reports from local P oiso n Control Centers, state Department of Labo r worker s' compensation claims when reported b y physicians, rep orts from State Dep artments o f Ag riculture, and physician reports to state Departments o f Health. A lth o u gh bot h occupational and n on-occ up ati onal incidents are included in the database, SENSOR-Pe st icides focuses on occupational pe stici d e incidents, and is of particul a r value in providing that inf ormation. The sta te coordinator at eac h of th e 11 respectiv e state Departments of Health conducts case followup activities such as obtaining medical r eco rds to verify symptoms and severi ty. Us i ng standardized pro toco l and case definitions derived from poison center reporting , t he state SENSO R-Pestic ide coordinator enter s the incident information into the state

- based system which is sent to NIOSH annu a ll y to be aggregated. A query of SENSOR-Pesticide s 1 99 8-2009 find s a total of two cases, ste mmi ng from two events, invol ving imazalil. Of the two, one case involved a s ing l e active ingredi e nt (ai). This case was

Page 

### 3 

### of 4

### 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 li sted in this case are: bifenthrin> imazalil> and chlorpyrifos-methyl. Followin g 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 bananapeel and the bananapulp. 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 ep i demio l ogy study evaluating the link between pesticide use and various health outcomes including cancer . The AHS includes private and commercial pesti cide applicators and their spouses. If there are AHS fmdings re levant to a particular pesticide going through registration review> the Agency wi ll 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 AH S includes informat ion on use of 50 different pesticide active ingredients commonl y used in agriculture. Im azalil and imazalil sulfa t e 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. Th e Agency will continue to monitor the inc i dent information and if a concern is trig gered, additional analys i s w ill 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. 

### Page 

### 4 of 4