UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: May 8, 2014 

SUBJECT: Noviflumuron: Tier I Review of Human Incidents 

PC Code: 118204 

Decision No.: 489301 

Petition No.: NA 

Risk Assessment Type: NA 

TXRNo.:NA 

MRIDNo.:NA 

DP Barcode: 0420119 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 121451-02-3 

40CFR: NA 

Ver.Apr.08 

FROM: 

Toxicology 

Elizabeth Evans, 

and Epidemiology 

Environmental 

Branch 

Protection Specialist 

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Health Effects Division (7509P) (./"" "QLU ~ ' 

and 

Shanna Recore, Industrial Hygienist /l-11 d 

Toxicology and Epidemiology Branch At~~ Health Effect Division (7509P) 

THROUGH: David Miller, Acting Branch ChierrdJ fJ!i~ Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: Kristin Rury, Risk Assessor 

Risk Assessment Branch III 

Health Effects Division (7509P) 

and 

Dana Friedman, Chemical Review Manager 

Risk Management & Implementation Branch 2 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

There does not appear to be a concern at this time that would warrant further investigation, since 

there was a low frequency of incidents involving noviflumuron reported to IDS and SENSOR-
Pesticides. The Agency will continue to monitor the incident information and if a concern is 

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

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 

Noviflumuron is an insect growth regulator (IGR) that prevents the successful molting 

and development of subterranean termites. This disruption in termite growth and activity 

results in the decline of the colony to the point where the colony can no longer sustain 

itself and dies. Before using noviflumuron, subterranean termite activity is first 

determined through monitoring in and around the target site. When activity is detected, 

the 0.5% noviflumuron bait can be placed directly in the monitoring stations or applied in 

separate baitube devices or bait blocks. Termites can be collected from the monitoring 

device and added directly to the noviflumuron bait to hasten bait detection and feeding. 

The baitubes and bait stations are monitored and new bait is added as needed until 

feeding ceases. Under optimum conditions, termite colonies can be eliminated in three to 

three and one half months. When termite activity is no longer detected, monitoring only 

is resumed at the site to determine that the site remains free of new termite infestations. 

The termite control program designed by Dow AgroSciences LLC virtually eliminates 

exposure to noviflumuron for the applicator and persons living at the treatment site. 

Since treatments are made only after termite activity is detected, the amount of pesticide 

used is greatly reduced compared to chemical barrier treatment programs. The 

application of noviflumuron with baitube and bait station devices protects wildlife from 

exposure. 1 

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 noviflumuron (pc code: 118204). 

1 Found online at: http://www .cdpr.ca.gov/docs/registration/ais/publicreports/5816.pdf 
The purpose of the database search is to identify potential patterns in the frequency and severity 

of the health effects attributed to noviflumuron exposure. Noviflumuron 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 

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 March 5, 2014, there were 0 incidents reported 

involving noviflumuron in the database. 

In Aggregate IDS, from January 1, 2009 to March 5, 2014, there was 1 incident reported 

involving noviflumuron in the database. This incident was classified as minor severity. 

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 follow-
up 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 1998-2010 identifies no cases involving noviflumuron (pc code 

118204). 

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. Noviflumuron is not included in the AHS, and 

therefore this study does not provide information for this report. 

IV. CONCLUSION 

There does not appear to be a concern at this time that would warrant further investigation, since 

there was a low frequency of incidents involving noviflumuron reported to IDS and SENSORPesticides. The Agency will continue to monitor the incident information and if a concern is 

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