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

MEMORANDUM Date: October 28, 2014 SUBJECT: Famoxadone: Tier I Review ofHuman Incidents

PC Code: 113202 DP Barcode: D423541 Decision No.: 496180 Petition No.: NA Registration No.: NA Regulatory Action: NA Case No.: NA RiskAssessment Type: NA TXRNo.:NA MRIDNo.:NA CAS No.: 131807-57-3 40CFR:NA FROM:

THROUGH:

TO: Shanna Recore, Industrial Hygienist Toxicology and Epidemiology Branch Health Effect Division (7509P) and Elizabeth Evans, Environmental Protection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509P) 

## LJ

# j

# J!J;Jt,**Uj~** ti}t'( David Miller, Acting Branch Chief

### ~J Toxicology and Epidemiology Branch Health Effects Division (7509P) Ideliz Encarnacion, RiskAssessor Risk Assessment Branch V Health Effects Division (7509P) and Christina Scheltema, Chemical Review Manager Risk Management & Implementation Branch 3 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Ver.Apr.08

Based onthe low frequency and low severity ofincident cases reported for famoxadone in both 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 in the risk assessment.
Page 1 of4Detailed Review 

### I. ACTION REQUESTED This review is intended to fulfill ourrequirementto docket summaries ofincident datathat 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 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 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, ora suggested pattern 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 Famoxadone belongs to the oxazolidinedione class ofchemicals and is highly active against spore germination and mycelial growth ofsensitive fungi. Famoxadone is used inthe U.S. in combination with cymoxanil inthe formulated productTanos DF for the control of 1various fungal diseases on fruiting vegetables, tomatoes, potatoes, curcurbits, head lettuce and imported grapes, including raisins. 1 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 Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data onthe active ingredient famoxadone (pc code: 113202). The purpose ofthe database search is to identifypotential patterns inthe frequency and severity ofthe health effects attributed to famoxadone exposure. Famoxadone is not included inthe AHS, and therefore this study does notprovide information for this report. 

### III. RESULTS/DISCUSSION
a. IDS (IncidentData 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, other federal 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 information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report.

1http://www.epa.gov/pesticides/chem _search/reg_actions/registrationlfs_PC-113202
_01-Jul-03.pdf Page 2 of4IDS records incidents in one oftwo modules: Main IDS and Aggregate IDS:
o Main IDS contains incidents resulting in higher severity outcomes andprovides 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 ofthe incident. Main IDS incidents involving only one active ingredient (as opposed to pesticide products withmultiple active ingredients) are consideredto provide more certain information aboutthe potential effects ofexposure from the pesticide.
o Aggregate IDS contains incidents resulting inless 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 famoxadone. In Aggregate IDS, from January 1, 2009 to August 12, 2014, there were 2 incidents reported involving famoxadone. These incidents were classified as minor severity. Overall, there are few incidents involving famoxadone 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 whenreported byphysicians, reports from State Departments of Agriculture, and physicianreports to state Departments ofHealth. Although both occupational and non-occupational incidents are included inthe database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is ofparticular value 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 incident information into the state-based system which is sent to NIOSH annually to be aggregated. A query ofSENSOR-Pesticides from 1998-2010 identifies no cases involving famoxadone (pc code 113202).


### 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 relevantto 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 assessmentphase ofthe process. The AHS includes information onuse of80 differentpesticide

Page 3 of4active ingredients commonly used in agriculture. Famoxadone is notincluded 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 famoxadone 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 incidentinformation and ifa concern is triggered, additional analysis will beincluded in the risk assessment.

Page4 of4