### UNITED STA T ES ENVIRO N MENTAL PROTE C TION AGENCY W ASHINGTON , D. C

. 204 60 OFFICE OF CHEMICAL SA F ETY AND POLLU T ION PREV E NTION

MEMORANDUM Dat e : May 21, 2015 

### SUB.JECT: Tetraconazo le: T ier 

### I (Scoping) Review of Human Incidents

PC Co d e: 1 20603 D ec is io n No.: 503204 P et iti o n No.: NA Ri s k A ss e ss m e nt T y p e: NA T X R No.: NA MRIO No.: NA DP Barcocle: ()4274 19 R eg i s trati o n No
. : NA R eg u latory Actio n : NA Case No.: NA CAS No.: 1 12281-77-3 .t O C FR: NA FROM: 

# / 6f E li zabeth Evans, E nvironmental Protec tion Speci oq t Toxicology and Ep idemiol ogy Branch 1 Health Effects Di v ision (7 509P) and S hanna Re core , Industrial H yg ien is t Toxico logy and Epidemiology Branch Health Effec t Di vision (7509 P) /) /
_ 

# Ii!{ THRO UG H: David Miller , Acting Bra nch Ch ief 

# kjf;;,/ 

# ;f!A'l Tox icology and Epi demiolo gy Bran c h


### TO: Hea lth Effects Di v i sio n (7509P) Anwar Dunbar, Risk Assessor Ri s k Assessment Branc h I H

ealth Effects Division (7509 P) and Ve ronica Dutch , Chemical Revi ew Manager Ri s k Management & Implementation Branch 5 P es ticide Re-evaluation Divi s ion (750 8P) Summary a nd Co nclu s io ns Ver.Apr.08

Based o n the low frequ e nc y and severity of incident cases repo rted fo r tetraconazole in both ID S a nd SENSO R-P es ticid es, there does not appear to b e a concern a t thi s time that would warrant further in ves ti gat ion. The Age nc y will continue to monitor th e incident in format ion and if a concern is tri gge red , additiona l analysis will be included in th e ri s k assessme nt.

Page 1 of 4Detailed Review 

### I. ACTION REQUESTED Thi s review is intended to fulfill our requirement to docket summar ie s of incident data that were reported to the Agency, as well as to ensure human incide nt data and the Agricultural H ealth Study (AHS ) are part of th e problem fo rmul at ion phase of regi stration review. Reports of adverse health effects a ll egedly due to a s pecific pesticide exposure 

### (i.e., an " incident ") are largel y se lf-reported and therefore , genera ll y speak ing , neither exposure to a pesticide or reported sym ptom (or th e connect i on between the two ) is vali dated or otherwise confirmed
. Typically , causation cannot be determined based on incid ent data. However, incident information can be an important source of feedback to the Agency: incidents of severe outcome, or a sugges ted pattern or trend among less severe incid ents, can s ignal the Agency to further inves ti gate a part icu l ar chemica l or product. Ob servat ional epidemiology stu die s re late the risk of disease, 

### e. g., cancer, and exposure to an agent such as a pesticide product in the general population or spec ific sub-groups like pesticide applicators. 

### II. BA C KGROUND Tetraconazo le is a fungicide
. The end-use product, Eminent l 25SL, co ntains 11 .6 % tetraconazole by weight and i s a liquid fung icide for contro l of Cercospora leaf spot and powder y m il dew on sugar beets. For this eva lu at ion, 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 co nsulted for pe sticide incident data on the active ingredient tetraconazole (pc code : 120603)
. The purpose of the database search is to ident ify potent ial patterns in the frequency and seve ri ty of the health effects attributed to tetraconazole exposure. T etraconazo le is not included in the AHS , and therefore th is stu dy doe s not prov ide informat io n for thjs report . 

### III. RESULTS /DISCUSS ION
a. IDS (Incident Data Syste m) O PP 's IDS includes report s of alleged hum an hea lth incidents from various sources, including mandatory Federal In secticide , Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants , other federa l and state health and environmental agencies, and individual consumers. Since 1992 , OPP has compiled these reports in IDS. IDS contains report s from across the U
. S. and most incidents have all re levant product information recorded. Repo rt s s ubmitted to the IDS r epresent anecdotal reports or a ll egations only, unl ess otherwise state d in the report . IDS records inc idents in one of two module s : Ma in ID S and Agg regate IDS:

Pag e 2 of 4o Main ID S 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 i nformation about the location, date and nature of the incident. Main IDS incidents involving only one ac tive in gredient (as opposed to pesticide products with multip le act ive ingredients) are considered to provide more certa in info rmation about the potential effects of exposure from the pesticide.


### o Aggregate IDS contains incidents resulting in less severe human incidents (m inor , unknown , or no effects outcomes)
. These are r eported by registrants only as counts in what are aggregate su mmari es. For the Ma in IDS , from J anua ry 1, 2010 to February 4, 20 1 5 , th e re were no inc ide nt s reported involving tetraco nazolc. In Aggregate lDS. from January 1 , 2010 to Februar y 4, 2015 , there were 3 incidents reported involving tctraconazole
. The se incidents were c la ss ifi ed as minor severity
. Overa ll , there are few incidents reported to IDS invo lving tetraconazole. 

### b. SENS OR-Pes ticides The SENSOR-Pesticides database covers 12 states from 1998-2011 , although reporting varies from state to state. Cases of pesticide-related illnesses are ascertai ned from a variety of sources , including: report s 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 l ealth. A lthou gh both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupatio n al pesticide incidents, and is of particular val ue in providing that information. The state coordinator at each of the 12 resp ect ive state Departments of H ea lth conducts case fo ll owup activities suc h as obtaining medical records to verif y symptoms and severity. Using sta ndardi zed protocol and case definitions derived from poison center reporting, the state SENSOR-Pestic ide coord inator ente rs the incident in formation into the s tate-base d system w hi ch is sent to N IO 1-l an nually to be aggregated. A review of SENSOR-Pesticides 1998-2011 identifi es two cases, stemming from one event, involving tetraconazole. The two cases involve multiple active ingredients. These two cases occurred in North Carolina in 2010. B oth cases wer e low in severity. The cases were residential bystanders in their home. A certified applicator was making an aeri al app lication to soybeans in a nearby field and the product drifted to their home; as they were walking outs ide of the home "the mist hit them as they were running out of the way'·. They both experi enced cough/choke and one also had gastrointestinal symptoms. Products used in this aerial application include Headline Fungicide. Domark 230 ME Fungicide and D eclare. The applicato r did receive citations for violating FIFRA. including ' · use not in accordance with label. operat ing unlicensed equipment, the department of pesticides was in a no deposit zone. and depositing in a hannful manner.

Page 

### 3 of 4c . Ag ri cul tural Hea lth S tud y (A H S) 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 . CONC L US IO N 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 inc ident information and if a concern is triggered , additional analysis w ill be included in the risk assessment.

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