UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFF I CE OF CHEMICAL SAFETY AND POLLUTION PREVENT I ON



### MEMORANDUM Date: November 5, 2014 

### SUBJECT : Oxadiazon: Tier I Review of Human Incidents

PC Code : I0900 l Decision No. : 491700 Petition No.: NA DP Barcode: 0421632 Registration No.: NA Regulatory Action: NA Case No.: NA Risk Assessment Type: NA TXR No.: NA CAS No. : MRID No.: NA 40CFR: NA
Elizabeth Evans, Environmental**Protection ~**  Sec' list Toxicology and Epidemiology Branch**~** Health Effects Division (7509P) and · 

### FROM:

Shanna Recore, Industrial Hygieni st Toxicology and Epidemiology Branch Health Effect Division (7509P) 

# /) / ;Jt,/P. (ff.JI/vV , 1-ol 

## tt THROUGH: David Miller, Acting Branch

### Chie~J / 1 

### /'YIA... Toxicology and Epidemiology Branch Health Effects Division (7509P) 

### TO: Linnea Hansen, Risk Assessor Risk Assessment Branch II Health Effects Division (7509P) and Joel Wolf, Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re-evaluation Division (7508P) Summary and Conclusio ns Yet
.Apr.08

There does not appear to be a concern at this time that woul d warrant further investigation, since there was a low frequency of incidents involving oxadiazon reported to IDS and SENSORPage 

### 1 of 4Pesticides. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment. Detailed Review I
. ACTION REQUESTED This review is intended to fulfill our requirement to docket summaries of incident data that were reported to the Agency, as well as to ensure human incident data and the Agricultural Health Study (AHS) are part of the 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 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 studies 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 Oxadiazon is a pre-emergent or early post-emergent oxadiazole herbicide registered for commercial use on turf grown on golf courses**(~77%** of total use) and in partment/condominium complexes, parks, athletic fields, playgrounds, and cemeteries (**~** 12% of total use). In addition, oxadiazon is used on sod farms and on conifer nurseries and landscapes (i.e. industrial sites, ornamental, roadside plantings, woody, ornamental shrubs, vines and trees, and herbaceous ornamentals). Annual usage is approximately 249,000 pounds on 52,000 acres. For this evaluation, both the 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 (SENSOR) databases were consulted for pesticide incident data on the active ingredient oxadiazon (pc code: 109001 ). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to oxadiazon exposure. Oxadiazon 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 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 information recorded. Reports Page 2 of 4submitted to the IDS represent a n ecdotal reports or allegations only , unless ot herwise stated in the report. IDS records incidents in one of two modules: Main IDS and Aggregate ID S:

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 wit h 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 registrants only as counts in what are aggregate summaries. For th e Main IDS, from January 1 , 2006 to May 28,2014, there were 0 incidents reported for the sing le chemical only in the database. There was 1 incident r epor ted involving more than one chemica l that was reported as a lawsuit to IDS that was not considered in this report. In Aggregate IDS , from January 1, 2009 to May 28 , 2014 , there were 18 incident reported involving oxadiazon in the database
. These incidents were classified as mino r severity
. 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: 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 D epartments of Health. Although both occupa tional and non-occupationall incidents are included in the database, SENSOR-Pesticides focuses on occupat ional pesticide incidents, and is of particular value in providing that information. The state coordinator at each ofthe 11 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using standardized protoco l and case definitions derived from poison center reporting, the stat e SENSOR-Pesticide coordinator enters the incident information into the state-based system which is sent to NIOSH annually to be aggregated. A query of S ENSOR-Pesticides 1998

-2010 ident ifies a total of three cases, stemming from 3 events, involving oxadiazon (pc code 109001) and two of these cases involves a single active ingredient for analys is in this memo. One case was low in severity and one case was moderate in severi ty
. The low severity case occurr ed after the individual applied the her bicide and then rubbed his eye and experienced ocu lar irritation. The moderate severity case reported dermal and respiratory symptom s, no further case details were provided.
Page 3 of 4c. 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 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 the risk assessment phase of the process. The AHS includes information on use of 

### 50 different pesticide active ingredients commonly used in agriculture. Oxadiazon is not included in the AHS , and therefore this study does not provide information for this report. 

### IV
. CONCLUSION There does not appear to be a concern at this time that would warrant further investigation, since there was a low frequency ofreported incidents involving oxadiazon reported to IDS and SENSOR-Pest icides. 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.

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