### UN ITED STATES ENVIRONMENTAL PROTEC T ION AGENCY WASHINGTON, D.C. 20460 OF F ICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM Date : July 29,2014 SUBJECT : Fenpyrox imate: Tier I R eview of Human Incid ents

PC Co de : 129131 DP Barcode: 0421242 Dec isio n No.: 492677 Petitio n No.: NA Risk Assess ment T y p e: NA TXR No.: NA MRID No.: NA Registration No.: NA Regulatory Actio n: NA Case No.: NA CAS No.: 111812-58-9 , 134098-61-6 40 CFR: NA
FROM:

# ~t" Shanna Recore, Indus tria l Hyg ieni"

...

# /]./1£) /u Toxicology and Epidemio logy

## Bra~**?t** ( Hea lth Effect Division (7509P) and Ver.Apr.08

Elizabeth Evans, Environmental Protection Specialist**~~** 

## C ' Toxicology and Epidemiology Branch "'

-**~** Health Effects Division (7509 P ) /) 

### THROUGH: David Miller, Acting Branch Chief 

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- 2i!l' i Toxicolo gy and Epidemiology Branch " Health Effects Division (7509P) TO: Jennifer Tyler, Risk Assessor Ri s k Assessment Branch I He alth Effects Div ision (7509P) and Miguel Zavala, Chemical Re view Manager Risk Management & Implementation Branch 3 Pes ti cide Re- eval uation D ivis ion (7508P) Summary and Conclu sio n s Based on the low f requ ency and low severity of incident cases reported for Fenpyroximate 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 if a concern is triggered, additional analysis will be included in the risk assessment.

Pag e l 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 large ly se lf-reported and therefore, generally speaki ng, 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 informati on can be an important source of feedback to the Agency: incidents of severe outcome, or a suggested pattern or trend amo n g le ss severe incidents, can s ignal the Agency to furthe r investigate a particular chemical or product. Observation a l epidemiology s tudies relate the risk of di sease , 

### e.g., cancer, and exposure to an agent such as a pesticide product in the general population or specific sub-groups like pesticide app li cators. 

### II. BACKGROUND Fenpyroximate is a contact insecticide /miticide used for the control of leafhoppers, mealybugs, and mites. Fenpyroximate is a mitochondrial electron-transport inhibitor (METI) which acts by targe ting proton-translocating NADH:Q oxidoreductase and blocking ubiquinone reduction. Fenp yroximate is registered for use on pome fruit , citrus fruit , fruiting vegetables , greenhouse

grown cucumbers, and mint. 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 ingred ient Fenpyroximate (pc code: 129131 ). The purpose of the database search is to identify po tential patterns in the frequency and severity of th e healt h effects attributed to Fenpyroximate exposure. Fenpyroxi mate is not included in the AHS, and therefore this study does no t provide information for this report. 

### III. RESULTS/DISCUSSION

a. IDS (Incident Data System) OPP ' s ID S 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. ID S contains reports from acro s s the U .S. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal report s or allegations only , unless otherwise stated in the report.

· ID S records incidents in one of two modules: Main IDS and Aggregate ID S:
Page2of4o Main IDS contains incidents resu lting in higher severity outcomes and provides more detail w ith 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 ingred ients) are cons idered 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 sum maries. For the Main IDS, from Janu a ry 1, 2009 to May 28, 2014, there was 1 incident reported for the single chemical only in the database. There were 3 additional incidents reported involving more than one chem ical. T hese incidents were classified as moderate severity. In Aggregate IDS, from January 1, 2009 to May 28, 2014, there were 9 incidents reported involving Fenpyroximate. These incident s were classified as minor severity. Overall, there are few incidents involving Fenpyroximate reported to IDS. b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2010, although reporting varies from state to s tate. Cases of pesticide-related illnesses are ascertained from a variety of sources, including: reports from loc a l 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 occupation a l and non-occupationa l incidents are included in the database , SENSOR-Pe sticides focuses on occupational pesticide incidents, and is of particular value in providing that information. The s tate coordinato r at each of the 11 respective state Departments of Health conducts case follo wup activitie s such as obtaining medical record s to verify symptoms and severity. Using standardized protoco l and case definitions derived from poison center reportin g, the state SENSOR-Pesticide coordinator enters the incident information into the state-based system which is sent to N IOS H annually to be aggregated. A query of SENS OR-Pesticides 1998-2010 identifies two cases involving fenpyroximate (pc code 129131 ). Both cases were work-r elated, low in severity , involved the same product, and occurred in Washington State. One case occurred in Washington State in 2006. The case description states, "A 28 y /o male sp raying apples sought medical care for ocula r symptoms. The product (FUJI SEC) splashed up while mixing/ loading the sprayer. He reported wearing protective eye wear but said the splash came over the top of his goggles." This case reported ocular symptoms includin g lacrimation, pain and conjunctivitis. The second case occurred in Washington State in 2009. The case description states,
Page 3 of4"A 26 year old female farmworker was thinning grapevines approximately 200 feet from ground**spraye~** applying miticide to grapes. She could smell the spray and developed neurological and gastrointestinal health effects. She left the spraying area but did no t feel better and was t aken to the ER three hours after notifying supervisor." The neurological symptoms this case experienced include headache and dizziness. The gastrointestinal symptom this case experienced was nausea.
c. Agricultural Health Study (AHS) The AHS is a high quality , prospective epidemiology study evaluating the link between pesticide use and vari ous health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spo us es. If there are AHS findings relev ant to a particular pesticide going throu gh registration review , the Agency will ensure they are considered in the problem forrnulation/scoping phase of the process and , if appropriate, fu ll y reviewed in the risk as s essment phase of the process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture. Fenpyroximate is not included in the AHS, and therefore this study doe s not provide information for this report. IV. CONCLUSION Based on the low frequency and low severity of incident cases reported for Fenpyroximate in both ID S 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 if a concern is triggered , additional analysis will be included in the risk assessment.

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