Page 1 of 4Page 2 of 4

II. 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 of registration review. Reports of adverse health effects allegedly due to a specific pesticide exposur e ( 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. Typically, causation cannot
be determined based on incident data. H owever, incident information can be an important feedback loop 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. Observati onal 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.

III. BACKGROUND

For this evaluation, the OPP Incident Data System (IDS) w a s utilized for pesticide incident data on the active ingredient flumioxazin (PC Code 129034 ). The purpose of the database search is to identify potential patterns on the frequency and se verity of the health effects attributed to
flumi oxazin exposure. The 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 compiles these reports in IDS. IDS contain reports from across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal r eports or allegations only, unless otherwise stated in the report. 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 pe sticide 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, f ully 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

.

IV. RESULTS/DISCUSSION

IDS records incidents resulting in high er severity outcomes i n more detail, in a module called the
Main IDS module

. This system stores incident data for death, major and moderate incidents, and it includes more details about the location, date and nature of the incident. Main IDS incidents involving only one pesti cide are considered to provide more certain information about the potential effects of exposure from the pesticide , and therefore these incidents are listed in thePage 3 of 4

Table 1 at the end of this report. Additionally, since higher severity incidents are general ly of greater concern, incidents involving death and major outcomes include a narrative summary in
Table 1. The less severe human incidents (minor, unknown, or no effects outcomes) are reported by registrants as counts called aggregate summaries and are r ecorded in a separate module called Aggregate IDS

. In Aggregate IDS , from January 1, 200 2 to May 27 , 2010, there are nine case s reported for flumioxazin . Because it falls within the categories reported as counts (which
includes minor, unknown or no effe cts)

, there is no unique report that provides details about the incident and single chemical incidents are not distinguished from multiple chemical incidents ; however, a high frequency of incidents indicates there is a high potential for exposure and vice

versa

. For flumioxazin, there appears to be a low potential for exposure. For the M ain IDS, from January 1, 200 2 to November 30 , 2010

, there are four cases reported that involve the active in
flumioxazin. Of these four cases, there are three case s report ed for single chemical flumioxazin only in the database. They are all ranked moderate severity. Overall, there are few incidents involving flumioxazin reported to IDS and most of lower severity.

Flumioxazin is not included in the AHS, and therefore does not provide information for this
report.

Based on the low frequency and severity of incident cases, 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 4 of 4



# IDS Report Human
Incidents



### Chemical: Flumioxazin 

### PC code: 129034

Incident
Number Incident

Date Product

Name Registration Number City State Exposure Type*

014129 001 12

- May

- 03 VALOR WP 05963900098 AUGUSTA GA HC

019900 001 02

- Jun

- 08 CHATEAU

HERBICIDE

SW 05963900099 ALAMOSA CO HC

020257 001 18

- Aug

- 08 BROADSTAR

HERBICIDE 05963900128 SNELLVILLE GA HC

* Severity Categories

H Human

H

- A H uman Fatality

H

- B Human Major

H

- C Human Moderate

H

- D Human Minor

H

- E Human Unspecified