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



### MEMORANDUM Date: February 5, 2013 SUBJECT: Pymetrozine: Review ofHuman Incidents
PC Code: 101103 DP Barcode: D408569 Decision No.: 474077 Petition No.: NA Risk Assessment Type: NA TXRNo.:NA MRIDNo.:NA Registration No.: NA Regulatory Action: NA Case No.: 7474 CAS No.: 123312-89-0 40 CFR: §180.556 Ver.Apr.08 

### FROM: Elizabeth Evans, Environmental Protection Specialist

# ~ / Toxicology and Epidemiology Branch 

# 0 0.**~ 1~** **JJ1'1~** Health Effect Division (7509P)**c./'()~** 

### " and Shanna Recore, Industrial Hygienist Toxicology and Epidemiology Branch Health Effect Division (7509P) THROUGH: David J. Miller, Acting Branch Chief 1 Toxicology and Epidemiology Branch Health Effects

.Division (7509P) TO: Douglas Dotson, Risk Assessor Risk Assessment BranchII Health Effects Division (7509P) and Molly Clayton, Chemical ReviewManager Risk Management & Implementation Branch 3 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the lowfrequency and severity ofincident cases reported for pymetrozine inboth IDS and NIOSH SENSOR-Pesticides, there does not appearto be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and ifa concern is triggered, additional analysis will be included in the risk assessment.
Page 1of4The Agricultural Health Study (AHS) is also a potential source ofinformation associated with humanhealth effects associated with certainpesticides. Pymetrozine is not included inthe AHS, and therefore this study does notprovide information for this report.
Detailed Review 

### I. ACTION REQUESTED This review is intended to fulfill ourrequirementto docket summaries ofincident 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 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 connectionbetweenthe two) is validated or otherwise confirmed. Typically, causation cannotbe determined based on incident data. However, incident information can be an important source offeedback to the Agency: incidents ofsevere outcome, ora suggestedpattern ortrend among less severe incidents, can signal the Agency to further investigate a particular chemical orproduct. Observational epidemiology studies relate the risk ofdisease, 

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

### II. BACKGROUND Pymetrozine is a pyridine azomethine insecticide used on fruiting vegetables, cucurbits, potatoes, tobacco, ornamentals and non-bearing fruit, nut and Christmas trees
. Forthis evaluation, both OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel EventNotification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data onthe active ingredientpymetrozine (PC Code: 101103). The purpose ofthe database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to pymetrozine exposure. In addition, findings from the Agricultural Health Study (AHS) were reviewed. The AHS is a high quality, prospective epidemiology study evaluating the link betweenpesticide use and various health outcomes including cancer. Pymetrozine is not included inthe AHS, and therefore this study does notprovide information for this report.


### III. RESULTS/DISCUSSION a. IDS (Incident Data System) OPP's IDS includes reports ofalleged humanhealth 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
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consumers. Since 1992, OPP has compiledthese reports in IDS. IDS contains reports from across the U.S. and most incidents have all relevantproduct informationrecorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS records incidents in one oftwo modules: Main IDS and Aggregate IDS:



### o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specific. This system stores incident data for death, major and moderate incidents, and it includes information aboutthe location, date and nature ofthe incident. Main IDS incidents involving only one pesticide are considered to provide more certain information aboutthe potential effects ofexposure 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. Forthe Main IDS, from January 1, 2007 to December 11, 2012, there was 1 incidentreported for single chemical only inthe database. There was 1additional incident reported involving more than one chemical. These incidents were classified as moderate severity. Overall, there are few incidents involving pymetrozinereported to IDS. In Aggregate IDS, from January 1, 2007 to December 11, 2012, there was one reported incident involving pymetrozine. This incident was classified as minor severity.


### b. NIOSH SENSOR The NIOSH SENSORdatabase covers 11 states from 1998-2009, althoughreporting varies from state to state. Cases ofpesticide-related illnesses are ascertained from a variety ofsources, including: reports from local Poison Control Centers, state Department ofLabor workers' compensation claims whenreported byphysicians, reports from State Departments of Agriculture, and physicianreports to state Departments ofHealth. Although both occupational and non-occupational incidents are included inthe database, SENSORfocuses onoccupational pesticide incidents, and is ofparticularvalue inprovidingthatinformation. A state SENSOR contact specialist attempts to follow-up with cases and obtains medical records to verify symptoms, circumstances surrounding the exposure, severity, and outcome. Using standardized protocol and case definitions derived from poison center reporting, SENSORcoordinators at State Departments ofHealth enterthe incident interview descriptionprovided bythe case, medical report, physician and patientinto the SENSORdata system. The SENSORdata system is accessible to participating states and EPA. A query ofSENSOR-Pesticides 1998-2009 identifies 2 cases stemming from one event. This event involved exposure to multiple active ingredients. The event occurred in Oregon in 2001; both cases were lowin severity and symptoms reported were dermal, ocular, and gastrointestinal
Page 3 of4for both cases and also nervous system symptoms for one case. No further case details are provided.


### c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemiology study evaluating the link betweenpesticide 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 registration review, the Agency will ensure they are considered inthe problem formulation/scoping phase ofthe process and, ifappropriate, fully reviewed inthe risk assessmentphase ofthe process. The AHS includes information on use of50 different pesticide active ingredients commonly used in agriculture. Pymetrozine is not included inthe AHS, and therefore this study does not provide information for this report. 

### IV. CONCLUSION Based onthe lowfrequency and severity ofincident cases reported for pymetrozine in both IDS andNIOSH SENSOR-Pesticides, there does not appear to be a concern at this timethat would warrant further investigation. TheAgency will continue to monitorthe incident information and ifa concern is triggered, additional analysis will be included inthe risk assessment.

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