UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### MEMORANDUM Date: January 21, 20tS OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### SUBJECT: Propoxycarbazone

- sodium: Tier I Review of Human Inci dents

PC Code: 1 22019 DP Barcode: 0425154 Decision No.: 496089 Petition No.: NA Registration No.: NA Regulatory Action: NA Case No.: NA Risk Assessment Type: N A TXR No.: NA MRIDNo.:NA CAS No.: 181274-15-7 40CFR: NA 

### FROM: Elizabeth Evans , Environmental Protect i on Specialist Toxicology and Epidemi ology Branch 

### C · .. Health Effects Division (7509P) 

# / J
and ' Shanna Recore , Industrial Hygienist 

# £ ·**~** Toxicology and Epidemip logy Branch Health Effect Division (7509P)


### THROUGH: David Miller, Acting Branch Chief Toxico logy and Epidemiology Branch Health Effect s Division (7509P) 

### TO: Sarah Levy , Risk Assessor Risk Assessment Branch I Heal th Effects Division (7509P) and Lata Venkateshwara, Chemical Review Manager Risk Management & Implementation Branch 3 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the low frequency and low severity of case s involving propoxycarbazone-sodium reported in both IDS and SENSOR-Pesticides, 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
Page 1 of 4informati on and if a concern is triggered , additional analys i s will be included in the risk assessment. Deta il ed Rev iew I. 

### ACTION REQUESTED This review is intended to fulfill our requirement to docket summaries of inc ident data that were reported to the Agency, as we ll as to ens ure human incident data an d the Agricu ltural Health Study (AHS) are part of the problem formulation phase of registration 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, n either exposure to a pesticide or reported symptom (or th e connection between the two) is validated or otherwise confirmed
. Typ ically, causation canno t be determined based on inc i dent data. However, incident informa t ion 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 signa l the Agency to further investiga te a particular ch emical or product. Observational epidemi ology studies relate the risk of disease , 

### e. g., cancer, and exposure to an agent such as a pesticide produc t in the general population or spec ific sub

- groups like pes ticide applicators. 

### II. BACKGROUND Propoxycarbazone-sodium is applied post-emergence through ground or aerial app li cation equipment to wheat. Propoxycarbazone-sodiurn has herb icidal activity agains t certain grasses and broadleaf weeds. Its efficacy is the resu lt of the inhib ition of the enzyme acetolactate synthase (ALS) enzyme in target plants. Fo r this evaluati on, both the OPP Inc i dent Data System (IDS) and the Centers for Disease Control and Prevention/Nationa l Institute for Occupationa l Safety an d H ealth (CDC/NIOS H ) Sentinel Event Notification System for Occupational Risk-Pes ticides (SENSOR) databases were consulted for pesticide incident data on the active in gredient propoxycarbazo n e-sodiurn (pc code: 122019)
. The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to fo r propoxycarbazone-sodium exposure. For propoxycarbazone

-sodium is not included 

### in the AHS, and therefore this study does not provide info rma t i on for th i s report. 

### III. RESULTS/DISCUSSION
a. IDS (Inci de nt Data System) OPP 's IDS includes reports of alleged human health incidents from various so u rces, incl u ding mandatory Federa l Insectici de , Fungicide an d Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants , other federal and state health and environmental agenc ies, and indiv i dual consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from across the U.S. and most in ci dents have all relevant product information recorded. Reports

Page 2 of4submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS records incidents in one of two module s : Main IDS and Aggregate IDS:

o Main IDS contains incidents resulting in higher sever ity outcomes and provides more detail with regard to case specifics. This system stores incident data for death, major and moderate incidents, and it include s information about t he location, date and nature of the incident. Main IDS incidents invo lving only one active ingredient (as opposed to pesticide products with multiple active ingred ients) 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 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 invo lving propoxycarbazone-sodium in the database. In Aggregate IDS, from Januar y 1, 2009 to August 12 , 2014, there was 1 incident reported involving propoxycarbazone-sodium in the database. This incident was classified as minor severi ty . Overall, there are few incident s involving propoxycarbazone-sodium reported to IDS. 

### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2010 , although reporting varies from state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources, including: report s from local Poison Control Centers, state Department of Labor workers' compensation claims when reported by physicians, reports from State Departments of Ag ricu lture , 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 of particular value in providing that information. The state coordinator at each of th e 1 1 r espec t ive state Departments of Health conducts case followup activities such as obtaining medical record s to verify symptoms and severi ty . Using standardized protocol and case definitions derived from poison center reporting, the state SENSOR-Pesticide coordinator enters the incident information into th e state-based system which is sent to N IOSH annually to be aggregated. A query of SENSOR-Pesticides from 1998-2010 identifies one case involving propoxycarbazone-sodium which involved multiple active in gredients. 

### c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemiology stud y evaluating the link between pesticide use and various heal th 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 formulation/scoping phase of the process and, if appropriate, fully reviewed in th e risk Page 3 of 4assessment phase of the process. The AHS includes information on use of 80 different pesticide active ingredients commonly used in agriculture. Propoxycarbazone-sodium is not included in the AHS, and th erefore this study does not provide information for thi s report. IV. CONCL U S I ON Based on the low frequency and low severity of cases invo lving propoxycarbazone-sodium reported in both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time that wo uld warrant further investigation. The Age n cy will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the ri sk assessment.

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