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

MEMORANDUM Date: September 30, 2014 SUBJECT: Flonicamid: Tier I Review ofHuman Incidents

PC Code: 128016 DP Barcode: 0423122 Decision No.: 493129 Petition No.: NA Risk Assessment Type: NA TXRNo.:NA MRIDNo.:NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 158062-67-0 40CFR:NA Ver.Apr.08 FROM: ShannaRecore, Industrial Hygienist 

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### 'I THROUGH: David Miller, Acting Branch Chief Toxicology and Epidemiology Branch Health Effects Division (7509P) TO: Barry O'Keefe, Risk Assessor Risk Assessment Branch III Health Effects Division (7509P) and R. Jones, Chemical Review Manager Risk Management & Implementation Branch 1 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the low frequency and low severity ofincident cases reported for flonicamid inboth IDS and SENSOR-Pesticides, there does not appearto be a concern at this time that would warrant further investigation. The Agency will continue to monitorthe incident information and ifa concern is triggered, additional analysis will be included inthe risk assessment.
Page 1of4Detailed Review 

### I. ACTION REQUESTED This reviewis intended to fulfill ourrequirementto docket summaries ofincident datathat were reported to the Agency, as well as to ensure humanincident data and the Agricultural Health Study (AHS) are part ofthe problem formulation phase ofregistrationreview. Reports of adverse health effects allegedly due to a specificpesticide exposure (i.e

., an "incident") are largely self-reported and therefore, generally speaking, neither exposure to a pesticide or reported symptom (or the connectionbetween the two) is validated or otherwise confirmed. Typically, causation cannotbe determined based on incident data. However, incident information canbe an important source offeedback to the Agency: incidents ofsevere outcome, or a suggestedpattern ortrend among less severe incidents, can signal the Agency to further investigate a particular chemical orproduct. Observational epidemiology studies relate the risk ofdisease, 

### 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 Flonicamid is a systemic insecticide that immediately suppresses the feeding ofsucking insects onplants. Flonicamid is registered for use on a variety ofagricultural crops, including: cotton, cucurbits, fruiting vegetables, greenhouse grown cucumbers, hops, leafyBrassicagreens, leafy vegetables, okra, pome fruits, potatoes, root vegetables, stone fruits, tuberous and corm vegetables, and turnip greens. Flonicamid is also registered for use on commercial ornamentals, interiorscapes, and nurseries; butthese labels do notallow use inhome gardens, greenhouses, or in any residential settings. Forthis 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 EventNotification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data onthe active ingredient flonicamid (pc code: 128016). The purpose ofthe database search is to identify potential patterns inthe frequency and severity of the health effects attributed to flonicamid exposure. Flonicamid are 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 ofalleged humanhealth incidents from various sources, including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants, otherfederal and state health and environmental agencies, and individual consumers. Since 1992, OPP has compiledthese reports in IDS. IDS contains reports from across the U.S. and most incidents have all relevantproduct informationrecorded. Reports submittedto the IDS represent anecdotal reports orallegations only, unless otherwise stated in the report.
Page 2 of4IDS records incidents in one oftwo modules: MainIDS and Aggregate IDS:

o Main IDS contains incidents resulting inhigher severity outcomes and provides more detail withregard to case specifics. This system stores incident data for death, major and moderate incidents, and it includes information aboutthe location, date and nature ofthe incident. Main IDS incidents involving only one active ingredient (as opposed topesticideproducts 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. Forthe Main IDS, from January 1, 2009 to May 28, 2014, there were 0 incidents reported involving flonicamid in the database. · In Aggregate IDS, from January 1, 2009 to May 28, 2014, there was 1incidents reported involving flonicamid in the database. Itwas classified as minor severity. Overall, there are few incidents involving flonicamid reported to IDS.


### 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 ofsources, including: reports from local Poison Control Centers, state Department ofLabor workers' compensation claims when reported byphysicians, reports from State Departments of Agriculture, and physicianreports to state Departments ofHealth. Althoughboth occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupationalpesticide incidents, and is ofparticularvalue inproviding that information. The state coordinator at each ofthe 11 respective state Departments ofHealth conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using standardizedprotocol and case definitions derived from poison centerreporting, the state SENSOR-Pesticide coordinator enters the incidentinformation into the state-based system which is sent to NIOSH annually to be aggregated. A query ofSENSOR-Pesticides 1998-2010 identifies no cases involving flonicamid (pc code: 128016).


### c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemiology study evaluating the link betweenpesticide 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, ifappropriate, fully reviewed inthe risk
Page 3 of4assessmentphase ofthe process. The AHS includes information onuse of50 different pesticide active ingredients commonly used in agriculture. Flonicamid is not included in the AHS, and therefore this study does notprovide information for this report. 

### IV. CONCLUSION Based onthe lowfrequency and low severity ofincident cases reported for flonicamid inboth 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 ifa concern is triggered, additional analysis will be included inthe risk assessment.

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