UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OF FICE O F CHEM I CA L SAF ETY AN D POLLUT I ON PREVENT I ON


### MEMORANDUM Date: August 20, 20 14 SUBJECT: Flufenpyr-ethyl: Tier I Review of Human Incidents

PC Code : I08853 DP Barcode: 0422322 Decision No.: 492594 Petition No.: NA Risk Assessment Type: NA TXR No.: NA MRID No
. : NA 

### FROM: Registrat ion No.: NA Regulatory Action: NA Case No.: NA CAS No.: 188489-07-8 40CFR: NA Ver.Apr.08 Shanna Recore, Industrial Hygienist 

# n_ /\ Toxicology and Epidemiology Branch

## JJ0/~~J-**.** Health Effect Division (7509P)**~**

THROUGH:

TO: and Elizabeth Evans, Environmenta l Protection Specialist 

# {j**~ ~DJ**  Toxicology and Epidemiology Branch 

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### · ' Health Effects Division (7509P) 

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## tt.h:JJ~ 1.0( II David Miller, Acting Branch Chie
. 1 

## /1fWL v· ( Toxicology and Epidemiology Bra Health Effects Division (7509P) Jenni fer Tyler, Risk Assessor Risk Assessment Branch I Health Effects D ivision (7509P) and Steven Snyderman, Chemical Review Manager Risk Management & Implementation Branch 3 Pesticide Re

-evaluation Division (7508P) Summary and Conclusions There does not appear to be a concern at this time that would warrant further investigation, since there were no incidents involving flufenpyr

- ethyl reported to either IDS or SENSOR-Pesticides. The Agency will continue to monitor the incident information and if a concern is triggered, additional analys is will be included in the risk assessment.
Page 1 of4Detailed 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 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, 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 sourc. e 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 Flufenpyr-ethyl is a contact pyridazinone herbicide that controls various broadleaf weeds through inhibition ofprotophyrinogen oxidase in the chlorophyll biosynthetic pathway, leading to phytotoxic buildup of intermediates and disruption of the cell membrane. It is registered for use on field corn, soybeans and sugarcane. 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 flufenpyr-ethyl (pc code : 1 08853)
. The purpose ofthe database search is to identify potential patterns in the frequency and severity of the health effects attributed to flufenpyr-ethyl exposure. Flufenpyr-ethyl are 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 submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS records incidents in one oftwo modules: Main IDS and Aggregate IDS:

Page 2 of4o 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 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 registrants only as counts in what are aggregate summaries
. For the Main IDS, from January 1, 2009 to May 28,2014 , there were 0 incidents reported involving flufenpyr-ethyl in the database. In Aggregate IDS , from January 1 , 2009 to May 28, 2014, there were 0 incidents reported involving flufenpyr-ethyl in the database. 

### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998

-2010, although reporting vari es from state to state. Cases ofpesticide-related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers, state 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 occupationa l 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 s tate coordinator at each of the 11 respective state Departments of Health conducts case followup activities such as obta ining medical records to verify symptoms and severity. Using standardized protocol and case definitions derived from poison center reporting, the state SENSOR-Pesticide coordinator enters the incident information into the sta te-b ased system which is sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides 1998-2010 identifies no cases involving flufenpyr-ethyl (pc code: 1 08853).


### 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 includes private and commercial pesticide applicators and their spouses. If there are AHS findings relevant to a particular pesticide going throu gh 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. Flufenpyr-ethyl is not included in the AHS, and therefore this study does not provide information for this report. 

### IV. CONCLUSION
Page 3 of 4There does not appear to be a concern at this time that would warrant further investigation, since there were no incidents involving flufenpyr-ethyl reported to either ID S or SENSOR-Pesticides. The Agency will continue to monitor the incident information and if a concern is triggered , additional analysis will be included in the risk assessment.

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