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



### MEMORANDUM Date: February 18, 2014 

### SUBJECT: Revised: Pyra:flufen-ethyl: Tier I Review ofHuman Incidents PC Code: 030090 Decision No.: 487210 Petition No.: NA DP Barcode: 0418062 Registration No.: NA Regulatory Action: NA Case No. : NA Risk Assessment Type: NA TXR No.: NA CAS No.: 129630-19-9 40CFR: NA MRIDNo.: NA 

### FROM:

THROUGH:

TO: Shanna Recore, Industrial Hygienist Toxicology and Epidemiology Branch Health Effect Division (7509P) and Elizabeth Evans, Environmental Protection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509P) /) 

## /, I

. ; 

# f) I' David Miller, Acting Branch Chief 

# &u;,/ $(f.t,1 Toxicology and Epidemiology Branch Health Effects Division (7509P) Kristin Rury, Risk Assessor Risk Assessment Branch III Health Effects Division (7509P) and S. Snyderman, Chemical Review Manager Risk Management & Implemen tation Branch 3 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Ver

.Apr

.08

[ This assessment was modified from an earlier version dated 2112/14 to reflect a revision to the SENSOR-Pesticides section to include a second product implicated in the case, "This case involved multiple active ingredients (the twoproducts implicated are Vanquish Herbicide and ETHerbicide/Defoliant)
. ]
Page 1 of4Based on the low frequency and severity ofincident cases reported for pyraflufen-ethyl, 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 ifa 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 ofincident data that were reported to the Agency, as well as to ensure human incident data and the Agricultural Health Study (AHS) are part ofthe 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 offeedback 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 ofdisease, 

### 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 Pyraflufen-ethyl is an herbicide which belongs to the phenyl pyrazole class ofchemicals called protox inhibitors. The chemical works by inhibiting an enzyme in a plant's chloroplasts, causing subsequent cell membrane destruction. Pyraflufen-ethyl is currently registered as a defoliant in cotton, a dessicant in potatoes, and to control broad-leafweeds in field corn, cotton, potatoes, soybeans, wheat, nonbearing crops (tree fruit, tree nut, and vine crops), and non-crop areas (airports, commercial plants, nurseries, and ornamental turf). 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 Pyraflufen-ethyl (PC codes: 030090). The purpose ofthe database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to Pyraflufen

-ethyl exposure. Pyraflufen-ethyl is not included in the AHS, and therefore this study does not provide information for this report. III. RES U LTS/DISCUSSION
a. IDS (Incident Data System) OPP's IDS includes reports ofalleged human health inciden ts 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
Page 2 of4across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, u nless otherwise stated in the report. IDS records incidents in one oftwo 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. 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 with multiple active ingredients) are considered to provide more certain information about the potential effects ofexposure from the pesticide.
o Aggregate IDS contains incidents resulting in less severe huma n 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 January 15,2014, there were no incidents reported for pyraflufen-ethyl in the database. In Aggregate IDS, from January 1, 2009 to January 15,2014, there were 8 reported incidents involving pyraflufen-ethyl. Overall, there are few incidents involving pyraflufen-ethyl reported to IDS.


### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2009, although reporting varies from state to state. Cases ofpesticide

-related illnesses are ascertained from a variety ofsources, 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 Departments ofHealth. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is ofparticular value in providing that information. The state coordinator at each ofthe 11 respective state Departments ofHealth conducts case followup activities such as · Obtaining medical records to verify symptoms and severity. Using standa rdized protocol and case definitions derived from poison center reporting, the state SENSOR-Pesticide coordinator enters the incident information into the state-based system which is sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides 1998-2010 identifies one case involving pyraflufen-ethyl (pc code 030090) which occurred in Washington State in 2005. This case involved multiple active ingredients (the two products implicated are Vanquish Herbicide and ET Herbicide/Defoliant). The case description provided states, "A 58 year-old female homeowner was sitting on her porch when she observed a truck spraying weeds. She could smell the products and then had GI,

Page 3 of4respiratory, ocular and dermal symptoms. She sought medical care that day. WSDA took samples one week after the application was made. They were negative."


### 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. Ifthere 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 ofthe process and, ifappropriate, fully reviewed in the risk assessment phase ofthe process. The AHS includes informa tion on use of 50 different pesticide active ingredients commonly used in agriculture. Pyraflufen-ethyl is not included in the AHS, and therefore this study does not provide information for this report.


### IV. CONCLUSION Based on the low frequency and severity ofincident cases reported for pyraflufen-ethyl in both IDS and SENSOR-Pesticides, 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 ifa concern is triggered, additional analysis will be included in the risk assessment.

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