UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: February 5, 2013 

SUBJECT: Pymetrozine: Review of Human 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 Branch II 

Health Effects Division (7509P) 

and 

Molly Clayton, Chemical Review Manager 

Risk Management & Implementation Branch 3 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Based on the low frequency and severity of incident cases reported for pymetrozine in both IDS 

and NIOSH 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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The Agricultural Health Study (AHS) is also a potential source of information associated with 

human health effects associated with certain pesticides. Pymetrozine is not included in the AHS, 

and therefore this study does not provide information for this report. 

Detailed 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 of the 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 

Pymetrozine is a pyridine azomethine insecticide used on fruiting vegetables, cucurbits, potatoes, 

tobacco, ornamentals and non-bearing fruit, nut and Christmas trees. 

For this 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 

Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were 

consulted for pesticide incident data on the active ingredient pymetrozine (PC Code: 101103). 

The purpose of the database search is to identify potential patterns in the frequency and severity 

of the 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 between pesticide use and 

various health outcomes including cancer. Pymetrozine 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 

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.• 

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 specific. 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 

pesticide 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, 2007 to December 11, 2012, there was 1 incident reported for 

single chemical only in the database. There was 1 additional incident reported involving more 

than one chemical. These incidents were classified as moderate severity. Overall, there are few 

incidents involving pymetrozine reported 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 SENSOR database covers 11 states from 1998-2009, although reporting varies from 

state to state. Cases of pesticide-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 focuses on occupational 

pesticide incidents, and is of particular value in providing that information. 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, SENSOR coordinators at 

State Departments of Health enter the incident interview description provided by the case, 

medical report, physician and patient into the SENSOR data system. The SENSOR data system 

is accessible to participating states and EPA. 

A query of SENSOR-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 low in severity and symptoms reported were dermal, ocular, and gastrointestinal 

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for 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 between pesticide 

use and various health outcomes including cancer. The AHS 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 50 different pesticide 

active ingredients commonly used in agriculture. 

Pymetrozine 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 pymetrozine in both IDS 

and NIOSH 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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