UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460
OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM Date: April 9, 2014 SUBJECT: Propargite : Tier I Review of Human Incidents
PC Code: 09760 I DP Barcode: 04 19224 Decision No.: 485493 Petition No.: NA Risk Assessment Type: NA TXR No.: NA MRID No.: NA Registration No.: NA Regulatory Action: NA Case No .: NA CAS No. : 2312-35-8 40CFR: NA Ver.Apr.08 Shanna Recore, Industrial Hygienist 

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# :/_;jli /rf Elizabeth Evans, Environmental Protection

# Specia**li stUf..~l(_lfjfv**  / /' Toxicology and Epidemio logy Branch Health Effects Division (7509P) /) 1 THROUGH: David Miller, Acting Branch Chief 

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# rtf/'/! 7tH { Toxicology and Epidemiology Branch Health Effects Division (7509P) TO: Marquea King, Risk Assessor Risk Assessment Branch IV Health Effects Division (7509P) and Wilhelmena Livingston, Chemical Review Manager Risk Management & Implementation Branch 2/4 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the low frequency and severity ofincident cases reported for propargite, there does not appear to be a concern at this 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 of4Detailed Review 

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. 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 ofregistration 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 Propargite is an insecticide used to control mites on a variety offield, fruit, and vegetable crops, as well as ornamenta ls. It is sold in both liquid and wettable powder formulations

. Propargite is applied by aerial application, chemigation, airblast sprayer, and high pressure handwand. 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 Occupationa l Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient Propargite (PC codes: 097601). The purpose of the database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to Propargite exposure. Propargite 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 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:

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 Page 2 of4death, major and moderate incidents, and it includes informati on 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 propargite in the database. 

### It is classified as moderate severity. In Aggregate IDS, from January 1, 2009 to January 15,2014 , there were no reported incidents involving propargite. Overall , there are few incidents involving propargite reported to IDS. 

### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2010, 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 ofparticular value in providing that information. The state coordinator at each ofthe 11 respective state Depar tments 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 SENS OR-Pesticides 1998-2010 identifi es a total of 63 cases involving propargite (pc code 097601), stemming from 31 events. There was a spike in reports in 2000 (n=30), including 24 cases in one multiple exposure agricultural drift event in California; all were occupational and all but one (moderate) were low in severity. The products implicated in this event were Omite30W and Backlash 4E) invo lved multiple active ingredients. After this spike of reports in 2000 , case reports drop to an annual average of 1.5 case reports. It is noted that a total of 58 cases were reported by California. Of the 63 cases, 35 involved a single ai (pc code 097601). Ofthe single ai cases , 33 were workrelated and two were not work-related ; 29 occurred in an agricultural setting. Seven cases were moderate in severity and 28 were low in severity. Unfortunately 6 ofthe 7 moderate severity cases did not include the case narratives (California cases 1999-2002) therefore a moderate severity case description table will not be provided here. In 2004 a moderate severity case report from California states, Case used the restroom after refilling a machine with the pesticide,· did not thoroughly wash thepes ticide off his hand sfirst.

Page 3 of4f In terms o symptoms, 71% 

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. o o smg :e at cases reported a dermal symptom (Table 1 ).

Table I. SENSOR-Pesticides I998 -20 I0: Reported Health Effects for single ai Propargite Cases N=35

Health Effect # ofTimes Reported Dermal 25 Ocular 13 Respiratory 17 Gastrointestinal 9 Nervous System 9 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 priva te 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 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. Propargite 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 repo rted for propargite 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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