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

MEMORANDUM Date: November 20, 2014 SUBJECT: Carboxin and Oxycarboxin: Tier I Review ofHuman Incidents

PC Code: 09020I, 090202 Decision No.: 497186 Petition No.: NA DP Barcode: 0424015 Registration No. : NA Regulatory Action: NA Case No.: NA Risk Assessment Type: NA TXRNo.: NA CAS No.: 5234

-68-4 40CFR: NA MRID No.: 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) 

# ,{7. ;;**~** David Miller, Acting Branch

# Chie**~.J'**//ff:; Toxicology and Epidemiology Branch Health Effects Division (7509P) Jessica Kidwell, Risk Assessor Risk Assessment Branch IV Health Effects Division (7509P) and Dana Friedman, Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Ver.Apr.08

Based on the low frequency and low severity ofincident cases reported for carboxin and oxycarboxin 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 incident information and if a 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 ourrequirement 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 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 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 offeedback to the Agency: incidents ofsevere outcome, or a suggested pattern or trend among less severe incidents, can signal the Agency to further investigate a particular chemica l 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 Carboxin is a systemic fungicide used to control seed and seedling diseases (smut, rot, blight) on barley, beans, canola, corn, cotton, oats, onions, peanuts, rice, rye, safflower, sorghum, soybeans, triticale, and wheat. 1 There are no registered residential uses for carboxin. Oxycarboxin is a wettable powder fungicide to be used as a foliar spray for control ofrust diseases ofornamentals grown in enclosed commercial structures such as greenhouses, shadehouses and interiorscapes. It can only be applied by commercial applicators utilizing hand held equipment. For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/Nationa l 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 carboxin (pc codes: 090201, 090202). The purpose ofthe da tabase search is to identify potential patterns in the frequency and severity ofthe health effects attributed to carboxin exposure. Carboxin 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 ofalleged 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

1 http://www.epa.gov/oppsrrd 1/REDs/factsheets/0012fact

_carboxin.pdf Page 2 of4submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS records incidents in one oftwo 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 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 carboxin or oxycarboxin. In Aggregate IDS, from January 1, 2009 to August 12,2014, there were 6 incidents reported involving carboxin. These incidents were classified as minor severity. There were 0 incidents involving oxycarboxin. Overall, there are few incidents involving carboxin 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 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 pesticide incidents, and is ofparticular value in providing 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 standardized protocol and case definitions derived from poison center reporting, the state**SENSOR-Pesti~ide** 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 a total of5 cases involving carboxin (pc code 090201) all ofwhich involve multiple active ingredients. No cases involving oxycarboxin (pc code 090202) were identified.
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 Page 3 of4problem formulation/scoping phase ofthe process and, ifappropriate, fully reviewed in the risk assessmentphase ofthe process. The AHS includes information on use of80 different pesticide active ingredients commonly used in agriculture. Carboxin is not included in the AHS, and therefore this study does not provide information for this report. 

### IV. CONCLUSION Based on the low frequency and low severity ofincident cases reported for carboxin and oxycarboxin 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 incident information and ifa concern is triggered, additional analysis will be included in the risk assessment.

Page 4 of4