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 ofHuman 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: Elizabeth Evans, Environmental Protection Specialist

.**~** Toxicology and Epidemiology Branch 

# e**fA~ _**  f.i'>_;M.... 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 ofincidents involving noviflumuron reported to IDS and SENSOR-Pesticides. The Agency will continue to monitor t he 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 ofincident 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 speak ing, neither exposure to a pesticide or reported symptom (or the connection between th e two) is validated or otherwise confirmed. Typically, causation cannot be determined based on incident data. However, incident information can be an important source offeedback 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 itselfand 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 ba itube 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 halfmonths. When termite activity is no longer detected, monitoring only is resumed at the site to determine that the site remains free ofnew 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 ofpesticide 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 evalua tion, 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.pdfThe purpose of the database search is to identify potential patterns in the frequency and severity ofthe 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. ID S 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 loca tion, 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 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 ofHealth. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational p esticide incidents, and is ofparticular 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. Ifthere 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 ofthe 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 ofincidents involving noviflumuron reported to IDS and SENSORPesticides. The Agency will continue to monitor the incident information and ifa concern is triggered, additional analysis will be included in the risk assessment.