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

MEMORANDUM Date: August 7, 2013 SUBJECT : Fluthiacet-methyl: Tier I Review of Human Incidents PC Code: I 08803 Decision No.: 480370 Petition No.: NA Risk Assessment Type: NA TXRNo.:NA MRIDNo.:NA DP Barcode: 0413851 Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 117337

- 19-6 40CFR:NA FROM: 

# {l' Shanna Recore, Industrial Hygienist

# ~~J.t, Toxicology and Epidemiology Branch 'v 

# l Health Effects Division (7509P) and Elizabeth Evans, Environmental Protection Specialis t Toxicology and Epidemiology Branch Health Effects Division (7509P) 

# a

THROUGH: David 

### J
. Miller, Acting Branch Chierl' )

# ~ 

# et:1, Toxicology and Epidemiology Branch Health Effects Division (7509P) TO: Kristin Rury, Risk Assessor Risk Assessment Branch III Health Effects Divisio n (7509 P) and R. Jone s, Chemical Review Manager Risk Management & Implementation Branch 5 Pesticide Reevaluation Division (7508P) Summary and Conclusions Ver.Apr.08

Based on the low frequency and severity of incident cases reported for fluthiacet-methyl in bo th 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 included in the risk assessment. Page 1 

### of 4The Agricultural Health Study (AHS) is also a potential source of inform ation associated with human health effects associated with certain pesticides. Fluthi acet-met hyl is not included in the AHS, and therefore this study does not provide information for this report.
Detai led Review 

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. ACTION REQUESTED This review is intended to fulfill our requirement to docket summaries of inc ident data that were reported to the Agency , as well as to ensure human in cident data and the Agricu ltural Health Study (AHS) a re pa rt of the problem formulation phase ofregistration review. Reports of adverse health efiects allegedly due to a specific pesticide exposure (i.e. , an " incident") are largely self-reported and therefore , generally speaki n g, neither exposure to a pesticide or reported symptom (or the connectio n between th e two) is validated o r o therwi se confirmed. Typica lly , causation cannot be determined based on incident data
. However, incident information can be an imp o rtant source of feedback to the Agency: incidents of severe outcome , or a s u ggested pattern or trend among les s severe incidents, can signal the Agency to further investigate a particular chemical or product. Observational ep idemiology s tudies relate the risk of disease, 

### e.g., cance r, and exposure to an agent such as a pesticide product in the general popula tion or specific sub-g roups like p esticide applicators. 

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. BACKGROUND Fluthiacet-methyl i s an herbi c ide registered for application to cotton , soybea n s and corn to control broad leaf weeds and as a harvest a id for cotto n defoliatin g. For this evalua t ion, both the OPP Incident Data System (IDS) and the Centers for Disease Contro l and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentine l Event Notification System for Occupationa l Ri sk-Pesticides (SENSOR) databases were consulted for p es ticide incident data on the active ingredient fluthiacet-methyl (pc code: 108803). The purpose of the database search i s to identify potential patterns in the fre quency and severity of the health effects attributed to fluthiacet-methyl exposure. Fluthiacet-methyl is not included in the AHS , and therefore this study does not provide information fo r this report . 

### Ill. RESULTS/DISC US SION a. IDS (Incident Data System) OPP's IDS in cl udes reports of alleged human health incidents from various sources, includin g mandatory Federal Insecticide, Fungicide and Rodenticide Act (F IF RA) Section 6(a)(2) reports from registrants , other federal and state health and environmental agencies , and individual consumers. Since 1 992, OPP has compiled these reports in IDS. IDS contains reports from across the U.S. and most incidents have all relevant product information recorded. R eports submitted to the IDS represent anecdotal reports or allegat i ons only , unless otherwise stated in Page 2 of 4the report. 

### It should be noted there are two incidents reported as lawsuits to IDS that are not considered in th is report. IDS records incidents in one of two modules: Main IDS and Aggregate IDS :
o Main IDS conta ins incidents resulting in higher severity outcomes and provides more detail with regard to case specifics. This system sto res incident data for death, major and moderate incidents, and it includes informa tion about the location, date and nature of the 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 of exposure from the pesticide.
o Aggregate IDS contains incidents resulting in less severe human incidents (minor, unknown, or no effects outcomes). These are reported by reg is trant s only as counts in what are aggregate summaries. For the Main IDS, from January 1 , 2008 to June 11, 2013, there were 0 incidents reported for fluthiacet-methyl in the database involving either single ai or multiple ai incidents. In Aggregate IDS, from January 1, 2008 to June 11, 2013, there were 2 reported incidents invo lving fluthiacet-methyl. These incidents were classified as minor severity. 

### b . SENSOR-Pesticides The SENSOR-Pesticides database covers 1 1 states from 1998

-2009, although reporting varies from state to state. Cases ofpesticide-related illnesses are ascertained from a variety of source s , including: reports from local Poi son Control Centers, s tate Department of Labor 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 of the 11 respective state Departments of Health conducts case follow

up activities such as obtaining medical record s to verify sym ptoms and severity. U sing standardized protocol and case definitions derived from poi so n center reporting, t he 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 1998-2009 finds no cases involving fluthiacet-methyl.


### 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 include s private and commercial pesticide applicators and their spo uses. If there are AHS findings rele vant to a particular pestic ide going through registration review, the Agency will ensure they are considered in the Page 

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### of4problem formulation/scoping 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. Fluthiacet-methyl i s not included in the AHS , and therefore this study does not provide information fo r this report.


### IV. CONCLUS ION Based on the low frequency and severity of incident cases reported for fluthiacet

- methyl 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 co nc ern is triggered, additional analysis will be included in the risk assessment.

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