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

MEMORANDUM Date: August 29, 2013 SUBJECT: Flucarbazone -sodium: Tier I Review of Human Incidents PC Code: 114009 DP Barcode: 0414420 Decision No.: 477552 Petition No.: NA Risk Assessment Type: NA TXRNo.: NA MRIDNo.: NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 181274-17-9 40CFR: NA FROM:

# nna Recore , Industrial Hygienist c:, 

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# l-l~~ Toxicology and Epidemiology Branch 

# vo--- ' Health Effec ts Division (7509P) Ver.Apr.08

# lizab**e::~vans,** Env iron mental Protection Specialist 

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# Q Toxicology and Epidemiology Branch v 

## 0 - Health Effects Division (7509P) THROUGHK.vid J. Mille r, Acting Branch Chief

# ~ Toxicology and Epidemiology Branch /- Health Effects Division (7509P) TO: Charles Smith, Risk Assessor Risk Assessme nt Branch I Health Effec ts Division (7509P) and J. Trujillo, Chemical Re view Manager Risk Management & Implementation Branch 5 Pesticide Reevaluation Division (7508P) Summary and Concl usions Because there were no cases reported for flucarbazone-sodium to either IDS or SENSORPesticides, there does not appear to be a concern at this t ime 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 ri sk assessment. Page 

### 1 of 4The Agricultural Health Study (AHS ) i s also a potential source of information associated with human health effects associated with certain p es ticides . Flucarbazo n e-sod ium is not included in the AHS, and therefore this study do es not provide information for thi s report.
D eta iled Revi ew I. ACTION REQUESTED This re v iew i s intended to fulfill our requirement to docket summaries of incident data that were reported to the Agency , as well as to ensure hum an incident data and the Agricultura l Health Study (A HS ) are par t of the problem formulation phase of registration r evie w. Reports of adve rs e health effects a llegedly due to a spec ifi c pesticide exposure (i.e. , an " incident") are l arge ly self-reported and therefore, generally s p ea kin g, neither exposure t o a pe s ticide or rep orted symptom (or the co nn ection between the two) is validated o r otherwise confirmed. Typ icall y, causation can not be determin ed based on incident data. However , in cident in formation can be an important sour ce of feedback to the Agency: incidents of sever e outcome , or a sugge sted pattern or trend among le ss severe incidents, can sign a l the Age ncy to furth er investigate a parti cular chemica l o r produ ct. Observational epidemiology stu di es re lat e the risk of disease , 

### e. g. , cancer , a nd exposure to an age nt s uc h as a pesticide product in the general population or specific sub -grou ps like pe stic id e a pplicators. II. BACKGROUND Flucarbazone-sodium is a herb i cide re g istered for u se on spring wheat , including durum , and wi nter w heat. For thi s e valuation , both the OPP Incident Data Syste m (IDS) and the Cent e rs for Disease Co ntrol and Preventi on/Na tion al In st itute for Occupational Saf ety and Health (C DC/N IOSH) Se ntinel Event Not ification System for Occup at ional Risk-P esticide s (SENSOR) databases w ere consulted for pesti c id e in c ident data on the active ingredient flucarbaz on e-so dium (pc code: 1 14009). The purp ose o f the database se arch i s to identify potential p atterns in the frequenc y an d severity of the h ea lth effects attributed to flucarbazone

- sodium exposu re. Flucarbazonesod ium is not included in the AHS , and therefore th i s study do es not provide information for thi s report.
III. RES ULTS/DISCUS SION a. IDS (Incident Data System) OPP's IDS includes reports of all eged human health in cidents from vario u s sources, including mandatory Federal In sectic ide , Fun gicid e and R odenticide Act (FIFRA ) Section 6(a)(2) r eports from registrants , other fede ral and state health and environmental agenc ies , and individual consumers. Sin ce 1992, OPP has compiled these reports in IDS
. IDS contains rep orts from across the U
. S
. and most incidents have all relevant product informat ion rec orded. Reports s ubmitted to t h e IDS represent anecdotal reports or a llegations only , unless o therwise stated in Pag e 2 of 4the report. It s hou ld be noted there are two incidents reported as lawsuits to IDS that are not considered in th i s report. IDS records incidents in one of two 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. Thi s system stores incident data for death, major and moderate inc idents, and it includes information about th e l ocation, date and nature of the i ncident. Main IDS inc i dents involv i ng only one active ingredient (as opposed to pesticide products with multiple active ingredients) are considered to provide more certain information about th e potenti al effec ts of exposure from th e pesticide.
o Aggregate IDS conta i ns incidents resulting in les s severe human incidents (minor, unknown, or no effects outcomes). These are reported by registrants only as counts in what are aggregate s ummaries. For the Main IDS, from January 1, 2008 to June 11 , 20 13, there were 0 incidents reported for sing le chemical only in the database. There was 1 incident reported involving more than one chemical. This incident was classified as moderate sever ity. In Aggregate IDS, from January 1, 2008 to June 11, 2013, there were 0 reported inc i dents involving flucarbazone-sodium
. 

### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2009, although reporting varies from state to state. Cases of pesticide-related illnesses are ascertai n ed from a variety of sources, i nclud i ng: reports from local Poison Contro l Centers, state Department of Labor workers' compensation claims when reported by ph ysicians, reports from S tate Departments of Agriculture, and phys ic i an reports to state Departments of Health. Although both occupational and non-occupational incidents are incl uded in the database, S ENSOR-Pesticides focuses on occupational pesticide incident s, and is of particular value i n providing that in formation. The state coordinator at each of the 11 respective s tate Departments of H ealth conducts case followup activities such as obtaining medical records to verify symptoms and severity
. Us i ng standardized protocol and case defin itions derived from poison center reporting , the state SENSOR-Pesticide coordi n ator enters the inciden t information into the state
- based sys tem which is sent to NIOSH annually to be aggregated. A query of SENSOR

- Pesticides 1998-2009 finds no cases for fl ucarbazone -sodium.


### c. Agricultural Health Study (AHS) The AHS i s a high quali ty, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. The AHS includes priva te and commercia l pesticide applicators and the ir spouses. 

### If there are AHS findings relevant to a particular Page 

### 3 of4pesticide going through registration review , the Agency will ensure they are considered in the problem formulation/scop in g phase of the proc e ss and , if appropriate , 

### fully reviewed in the risk assessment phase of the process . The AHS includes information on use of 50 different pesticide active ingredient s commo nly used in agriculture. Flucarbazone -so dium is not included in the AHS, and therefore this study does not provide information for this report.
IV. CONCLUSION Because there were no cases reported for flucarbazone-sodium to either IDS or SENSORPesticides, there does not appear to be a concern at this time that would warrant further inve stig ation. The Agency w i ll continue to monitor the i ncident i nformation and if a concern i s triggered, additiona l analysis will be included in t he risk assessment.

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