UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WAS H I N GTON, D.C. 2 0460 OFFI C E OF CHEMICAL SAFETY AND POLL UTION PREVENTION



### MEMORANDUM Date: February 4, 2014 

### SUBJECT : Ter razole: Tier I Revi ew of Human Incidents PC Code: 08470 1 DP B arcode: 0417574 Decision No.: 487060 Petiti on No. : NA Registr atio n No. : NA Reg ul atory Action: NA Case No.: NA Ris k Assess ment Type: NA TXRNo.: NA CAS No.: 2593- 15-9 40 CFR : NA MRIDNo.: NA 

### FROM:

THROUGH: Shanna Recore, Industrial Hygienist Toxico logy and Epidemiology Bra nch H ealth Effect Division (7509P) and Elizabeth Evans, Environmental Protection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509P) 

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Davi d Mi ll er, Acting Branch Chief

# f~:'}#(}, Toxicology and Epide miology Branch Healt h Effects D ivi sion (7509P) 

### TO: Danette Drew, Risk Assessor Risk Assessment Branch V Healt h Effects Division (7509P) and Catherine Britton, Chemical Review Manager Risk Management & Implementation Branch 2/4 Pesticide Re-evaluation Di vision (7508P) Summary and Conclusions Ver.Apr.08

Based on the low frequency and sever ity of incident cases reported for terrazole, 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 1 of 4Detailed 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 ofthe 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
Terrazole is a fungicide used to control damping-off, root rot and stem rot caused by Pythium and Phytophthora. It is u sed on golf course turf, cotton and nursery ornamentals, non-bearing citrus, non-bearing coffee, and mixed with potting soil for greenhous e use. It is also used as a seed treatment on barley, beans, com, cotton, peanuts, peas, sorghum, soybeans, safflower and wheat. 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 Terrazole (PC codes: 084701). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to Terrazo le exposure. Terrazole is 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 f rom 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 ID S. 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:
Page 2 of4o 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, 2009 to January 15,2014, there was 1 incident reported for terrazole in the database. It is classified as moderate severity. In Aggregate IDS, from January 1, 2009 to January 15, 2014, there was 1 reported incident involving terrazole. Overall, there are few incidents involving terrazole reported to IDS. 

### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2009, although reporting varies from state to state. Cases ofpesticide-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 coordina tor 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 coordina tor enters the incident information into the state-based system which is sent to NIOSH annually to be aggregated. A query of SENSOR

-Pesticides 1998-2010 identifies a total of 11 cases involving terrazole (pc code 084701); stemming from five events. Eight cases involved the single active ingredient which will be analyzed here. Five cases were low in severity and three cases were moderate in severity. All eight cases were work-related. Seven cases stem from one event which occurred in Texas in 1999. The event was obtained from a Texas Poison Control Network report. The cases were exposed while standing at table cutting and soaking strawberry plants." The symptoms reported are included in Table 1.

Page 3 of 4Table 1. SENSOR-Pesticides 1998-2010: Reported Health Effects for single ai Terrazole Cases N=8

Health Effect # ofTimes Reported Dermal 7 Ocular 7 Respiratory 6 Gastrointestinal 2 Nervous System 5 Cardiovascular 0 

### * Cases may report multiple health effects

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 . Ifthere are AHS findings relevant to a particular pesticide going through regi st ration review, the Agency will ensure they are considered in the problem formulationlscoping 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

. Terrazole 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 for terrazole 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 tr

iggered, additional analysis will be included in the risk assessment.

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