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

MEMORANDUM Date: August 20, 2013 S UBJECT: Acibenzolar: Tier I Review ofHuman Incidents PC Code: 061402 DP Barcode : 0413833 Decision No.: 481700 Petition No.: NA Registration No.: NA Regulatory Action: NA Case No.: NA Risk Assessment Type: NA TXRNo.:NA MRIDNo.:NA CAS No.: 135158-54-2 40CFR:NA FROM: Elizabeth Evans, Environmental Protec t ion Specia li st Toxicology and Epidemiology Branch Health Effects Division (7509P) and

## ~ Shanna Recore, Industrial Hygienist Toxicology and Epidemiology Branch

# ~ Health Effect Division (7509P) 

# /..f7J A 

## : -#c

## 1'1~**,./;; L**  THRO UGJt,JDavid Miller, Acting Branch Chief 

## LNWWl[ WQ Toxicology and Epidemiology Brancl1 Health Effects Division (7509P) TO: Thurston Morton, Risk Assessor Ri sk Assessment Branch IV Health Effects Division (7509P) and Dana Friedman, Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the low frequency and severity of incident cases reported for acibenzolar, 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 1 of 4Detailed Review 

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. ACTION REQUESTED Thi s 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. Typicall y, causation cannot be determined based on incident data. Ho wever, incident information can be an important source of feedback to the Agency: incidents of severe outcome, or a suggested pattern o r 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 Acibenzolar is a selective, systemic compound which induces host plant resistance. This is a unique mode of action which mimics the natural systemic activated resi stance (SAR) response found in most plant species. It has no direct effect on the target pests. It is used for the control of downy mildew on leafy vegetables (including Brassica (cole) leafy vegetables, bacterial spot and bacterial speck on tomatoes, and blue mold on tobacco. Acibenzolar is also used on bananas for importation only. 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 Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient Acibenzolar (PC code: 06 I 402). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to Acibenzolar exposure. Acibenzo la r is no t 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 environmen tal agencies, and individual consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from across the U.S. and most incidents ha ve all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in

1 Excerpt from Acibenzolar Factsheet, found online at: h ttp : //www .epa . gov / o pp OOOO 1/cbem search/ re g actio ns/re gi st ratio n / fs PC -0 61402 1 1

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. pdf Page 2 of 4the report. It should be noted there are three incidents reported as lawsuits to ID S that are not considered in thi s report. IDS records incidents in one of two 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 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, 2008 to June 11, 2013, there were no incidents reported in the database involving acibenzolar. In Aggregate IDS, from January 1, 2008 to June 11, 2013, there was one reported incident involving acibenzolar.


### b. SENSOR-Pesticides The SENSOR

-Pesticides database covers 11 states from 1998-2009, al though 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 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 state 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 state-based system which is sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides 1998-2009 finds no cases involving acibenzolar.


### 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 inc ludes private and commercial pesticide applicators and their spouses. If there are AHS findings relevant to a particular pestic ide going through registration review, the Agency will ensure they are considered in the problem formulation/seeping phase of the process and, if appropriate, fu ll y reviewed in the risk
Page 3 of4assessment phase of the process. T he AHS includes informat ion on use of 50 different pesticide active ingredients commonly used in agriculture. Acibenzolar 

### is not included in the AHS, and therefore thi s study does not provide information for this report.


### IV. CONCLUSION Based on the low frequency and severity of incident cases reported for acibenzo lar in both IDS and SENSOR-Pest icides, there does not appear to be a concern at this time that would warrant further investigation. The Agenc y 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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