UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: March 3, 2015 

SUBJECT: Novaluron: Tier I Review of Human Incidents 

PC Code: 124002 DP Barcode: 0425887 

Decision No.: 494066 

Petition No.: A 

Registration No.: NA 

Regulatory Action: NA 

Risk Assessment Type: NA Case No.: NA 

TXR No.: NA CAS No.: 116714-46-6 

MRID No.: NA 40CFR: NA 

FROM: 

THROUGH: 

TO: 

Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

and 

Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) {I? 

David Miller, Acting Branch Chie / ' r /1/A. oJfo~ ~cr Toxicology and Epidemiology Bra li 

Health Effects Division (7509P) 

Anwar Dunbar, Risk Assessor 

Risk Assessment Branch I 

Health Effects Division (7509P) 

and 

Margaret Hathaway, Chemical Review Manager 

Risk Management & Implementation Branch 2 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Based on the low frequency and low severity of cases involving novaluron 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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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 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 

Novaluron is an insect growth regulators (IGR). IGRs slowly kill the insects over a period of few 

days by disrupting the normal growth and development of immature insects. Novaluron acts as 

an insecticide mainly by ingestion, but has some contact activity. 

Rimon® Technical is sold for formulating other end-use-product formulations. Rim on® I 0 EC is 

an emulsifiable concentrate recommended for the control of whiteflies, thrips, leafminers and 

armyworms on containerized ornamentals grown in greenhouses. The Rimon® I 0 EC is mixed 

with water and applied as a foliage spray using conventional spray equipment. To prevent 

buildup of resistance, rotation with other insecticides having dissimilar mode of action is 

recommended between successive applications. 

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 novaluron (pc code: I24002). The 

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

the health effects attributed to novaluron exposure. Novaluron is not included in the AHS, and 

therefore this study does not provide information for this report. 

III. RESULTS/DISCUSSION 

a. IDS (lnc~dent 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 

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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 

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 August 12,2014, there were 0 incidents reported for 

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

chemical. This incident was classified as moderate severity. 

In Aggregate IDS, from January 1, 2009 to August 12, 2014, there were 17 incidents reported 

involving novaluron in the database. These incidents were classified as minor severity. Overall, 

there are few incidents involving novaluron reported to IDS. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 11 states from 1998-2010, 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-Pesticides focuses on 

occupational pesticide incidents, and is of particular value in providing that information. The 

state coordinator 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 coordinator enters the incident information into the state-based system which 

is sent to NIOSH annually to be aggregated. 

A query of SENSOR-Pesticides from 1998-2010 identifies five cases involving novaluron (pc 

code 124002); one case involves a single active ingredient and will be analyzed for this memo. 

This case was low in severity. The case was occupational and exposure was coded as 

agricultural "drift" by the state SENSOR coordinator. SENSOR-Pesticides defines drift to be 

"off-target movement of pesticide" and this definition includes both spray drift and 

volatilization. The case was in a truck checking tarps in a field with the windows rolled down 

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and he smelled the chemical. This case reported experiencing symptoms including dermal and 

ocular irritation. 

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 80 different pesticide 

active ingredients commonly used in agriculture. Novaluron 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 low severity of cases involving novaluron 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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