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

MEMORANDUM Date: November 13, 2014 SUBJECT: Lufenuron: Tier I Review ofHuman Incidents

PC Code : 118205 OP Barcode: 0423832 Decision No.: 495971 Petition No.: NA Risk Assessment Type: NA TXRNo.:NA MRIDNo.: NA Registration No. : NA Regulatory Action: NA Case No.: NA CAS No.: 103055-07-8 40CFR: NA Ver.Apr.08 FROM: Shanna Recore, Industrial Hygienist 

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Elizabeth Evans , Environmental Protection Specialist**CJ~..vMY\** Toxicology and Epidemiology Branch v**~** 

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# J/t/1 /J.JlP(- VI t( THROUGH: David Miller, Acting Branch Chi Toxicology and Epidemiology Branch Health Effects Division (7509P) TO: Kristin Rury, Risk Assessor Risk Assessment Branch III Health Effects Division (7509P) and 

### B. Adler, Chemical Review Manager Risk Management & Implementation Branch 5 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Because there were no incident cases reported for lufenuron in either IDS or SENSORPesticides, 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.

Page I of4Detailed 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 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 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 Lufenuron is an insect growth regulator used in termite bait in inte grated management systems for protection of structures from termites. 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 lufenuron (pc code: 118205). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to lufenuron exposure. Lufenuron 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
Page 2 of4death, major and moderate incidents, and it includes information about the location, date and nature ofthe 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 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. For the Main IDS , from January 1, 2009 to August 12,2014, there were 0 incidents reported involving lufenuron. In Aggregate IDS, from January 1, 2009 to August 12, 2014, there were 0 incidents reported involving lufenuron

. 

### 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 ofLabor 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 ofparticular value in providing that information. The state coordinator at each ofthe 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 1998-20 10 identifies no cases involving lufenuron (pc code 118205).



### 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 appli cators 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 formulationlscoping phase ofthe 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. Lufenuron is not included in the AHS, and therefore this study does not provide information for this report.

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### IV. CONCLUSION B ecause there were no incident cases reported for lufenuron in either IDS or SENS OR

Pesticides , there does not appear to be a concern at thi s 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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