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

MEMORANDUM Date: July 10,2013 SUBJECT: Flumetsulam : Review of Human Incidents for Preliminary Risk Assessment PC Code: 1290 16 Decision No.: 477891 Petition No .: NA Risk Assessme nt T ype: NA TXRNo.: NA MRIDNo.: NA DP Barcode: 0412985 Registration No.: NA Regulatory Acti o n: NA Case No.: NA CAS No. : 98967-40-9 40CFR:NA Ver. Apr.08 F ROM: Shanna Recore, Industrial Hygienist 

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## V Toxicology and Epidemio logy Branch Health Effects Division (7509P) TO: Mohsen Sahafeyan, Risk Assessor Risk Assessment Branch VI Health E f fec ts Division (7509P) and Katherine St. C lair, Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re-evaluation Di vis ion (7508P) Summary and Conclusions TEB has been asked to review the incidents in IDS and NIO S H SENSOR-Pesticides and review the findings in the AHS for t he flumetsulam preliminary risk assess ment due August 2013. Based on the low frequency and severity of incident cases rep orted for flumetsu lam in both ID S and NIOSH SENS OR-Pestic ide s, there does not appear to be a concern at thi s time that would

Page 1 of 4warrant further investigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be conducted. The Agricultural Health Study (AHS) is also a potential source of information associated with human health effects associated with certain pesticides. Flumetsulam is not included in the AHS, and therefore this study does not provide information for this report. Detailed Review 

### I. ACTION REQUESTED Flumetsulam is a pesticide being considered under the FQP A-mandated Registration Review program established to review, on a 15 year cycle, pesticides for which a Re-registration Eligibility Decision has been made. One component of the Agency ' s Registration Review Program is consideration of human incident data. In conjunction with a human health risk assessment based on other data sources, such human incident data can assist the Agency in better defining and characterizing the risk of pesticides/pesticide products. 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 valida ted 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 s tudies 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 Flurnetsulam is an herbicide used to control broadleaf weeds in field corn, soybeans and dry beans. Flurnetsulam currently has no residential uses. For this evaluation, both 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 (S ENSOR) databases were consulted for pesticide incident data on the active ingredient flumetsulam (PC Code: 129016). The purpose ofthe database search is to identify potential patterns in the freq uency and severity of the health effects attributed to flumetsulam exposure. In addition, findings from the Agricultural Health Study (AHS) were reviewed. The AHS is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. Flurnetsulam is included in the AHS, but it is only in phase III and there are no studies available yet to consider.

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### 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 informa tion recorded. Reports submitted 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 specific. This system stores incident data for death , major and moderate incidents , and it includes information about the location, date and nature of the incident. Main ID S incidents involving only one pesticide 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 r eported by registrants only as counts in what are aggregate summaries. For the Main ID S, from January 1, 2008 to May 8 , 2013, there were no incidents reported for single chemical only in the database involving flumetsulam. There were 5 additional incidents reported involving more than one chemical. However, they were all foreign incidents, one incident occurred in Australia and four incidents occurred in China. Foreign incidents are not reviewed in detail because ofthe potential differences in the exposure patterns, u se practices, and product formulation. All of these incidents were classified as moderate severity. In Aggregate ID S, from January 1, 2008 to May 8 , 2013, there were nine reported incidents involving flumetsulam. These i ncidents were classified as minor severity. Overall , there are few incidents involving tlumetsulam reported to IDS.


### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2009 , 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 Departme nt of Labor workers' compensation claims w hen 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 focuses on occupational pesticide incidents, and is of particular value in providing that information. A state SENSOR
Page 3 of4contact specialist attempts to follow-up with cases and obtains medical records to verify symptoms, circumstances surrounding the exposure, severity, and outcome. Using standardized protocol and case definitions derived from poison center reporting , SENSOR coordinators at State Departments of Health enter the incident interview description provided by the case, medical report, physician and patient into the SENSOR data system. The SENSOR data system is accessible to participating states and EPA. A query of SENSOR-Pesticides 1998 -2009 identifies no cases involving flumetsulam.



### 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. 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 of the 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. Flumetsulam is included in the AHS, but it is only in phase III and there are no studies available yet to consider.



### IV. CONCLUSION Based on the low frequency and severity of incident cases reported for flumetsu lam in both IDS and NIOSH 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 conducted.

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