UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHING TON , D.C. 20460 OFFICE O F CH EMI CAL SAFETY AND PO LLUT IO N PREVENTION

MEMORANDUM Date: July I6, 2014 SUBJECT : Ethoxyquin: Tier I Review of Human Incidents ·

PC Co d e : 05550 I DP Barcode : 0420799 Decision No.: 491210 Petition No
. : NA Registration No.: NA Regu latory Actio n : NA Case No.: NA Risk Assessme n t Type : NA TXRNo.:NA CAS No.: 91-53-2 MRID No.: NA FROM:

THROUGH :

TO: 40 CFR: N A Shanna Recore, Industrial Hygienist Toxi co logy and Epidemio logy Branch Health Effect Division (7509P) and Elizabeth Evans, Envirorunental Protection Specialist Toxicolo gy and Epidemiology Branch Health E ffect s Division (7509P) 

# Jl Davi d Miller, Acting Branch Chief 

# ((_fo;j;(//{ Jc{ Toxicology and Epidemio l ogy Branch Health Effec ts Divis ion (7509P) Bonnie Cropp-Kohlligian, Risk Assessor Risk Assessment Branch IV Health Effects Division (7509P) and Khue Nguyen, Chemical Review Manager Risk Management & I mplementation Branch I Pesticide Re-evaluation Division (7508P) Summa rv and Conclus ions Ver.Apr.08

There does not appear to be a concern at this time that would warrant further investigation , s ince there were no incide nts involving ethoxyquin reported to either IDS or SENSOR-Pesticides. The Agency will continue to monitor the incident information and if a concern is triggered , additi ona l analysis will be included in the risk assessment.
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### 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, generall y 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 chemica l or product. Observational epidemiology studies rela te 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 applicators. 

### II . BACKGROUND Ethoxyquin is registered for use as an antioxidant to control scald (browning) iin pears. It is applied post-harvest by spraying/drenching, paper wrapping , or a combination thereof. Currently only two formulation types are registered for this chemical, which includes an emul sifiable concentrate (1 product) and an impregnated wrap (3 products). 1 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 N otification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient ethoxyquin (pc code: 05550 l ). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to ethoxyquin exposure. Ethoxyquin 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 a ll eged 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 mo st incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. ID S records incidents in one oftwo modules: Main IDS and Aggregate IDS:

1 http:/ /www .epa.gov /oppsrrd 1/REDs/factshee ts/0003 fact. pdf Page 2 of4o Main ID S 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 invol ving 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 M ay 28, 2014, there were 0 incidents reported involving ethoxyquin in the database. In Aggregate IDS, from January 1, 2009 to May 28, 2014, there were 0 incidents reported involving ethoxyquin in the database. b. SENSOR-Pesticides The SENSOR-Pe sticides 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 of La bor workers ' compensation claims when reported by physicians, reports from State Departments of Agriculture , and physician reports to state Departments of Health. 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 of Health conducts case follow

up activities such as obtaining medical records to veri fy 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 state-based system which i s sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides 1998-2010 identifies no cases invo lving ethoxyquin (pc code: 055501).
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 go ing 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. Etho xyquin is not included in the AHS, and therefore this study does not provide information for this report.

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### IV. CONCLUSION There does not appear to be a concern at th is time that would warrant further investigation, since there were no incidents invo lving ethoxyquin reported to either IDS or SENSOR-Pesticides. The Agency will continue to monitor the incident information and if a concern is triggered, add itional analysis will be included in the risk assessment.

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