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

MEMORANDUM Date: October 23, 2014 SUBJECT: Spirodiclofen: TierI Review ofHuman Incidents

PC Code: 124871 DP Barcode: 0422435 Decision No.: 494556 Petition No.: NA Risk Assessment Type: N A TXRNo.:NA MRIDNo.:NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 148477-71-8 40CFR:NA Ver.Apr.08 ElizabethEvans, Environmental Protection Specialist 

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### THROUGH: David Miller, Acting BranchChief

# .eJ:.1'f!5-.ll'v Toxicology and Epidemiology Branch HealthEffects Division (7509P) TO: Kelly Lowe, Risk Assessor Risk Assessment Branch V Health Effects Division (7509P) and Julia Stokes, Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the low frequency and low severity ofcases involving spirodiclofenreported inboth IDS and SENSOR-Pesticides, there does not appearto be a concern atthis 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. Page 1 of4

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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 andtherefore, generally speaking, neither exposure to a pesticide or reported symptom (or the connectionbetweenthe two) is validated or otherwise confirmed. Typically, causation cannot be determined based on incident data. However, incident information canbe an important source offeedback to the Agency: incidents ofsevere outcome, or a suggestedpattern or trend among less severe incidents, can signal the Agency to further investigate a particular chemical orproduct. 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 Spirodiclofen is an insecticide/miticide in the tetronic acid chemical class. The mode ofaction is inhibition oflipid synthesis. It controls mites and San Jose scale in citrus, grapes, pome fruit, stone fruit, and tree nut crops. The method ofapplication is ground boom. Forthis 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 onthe active ingredient spirodiclofen (pc code: 124871). The purpose ofthe database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to carboxin exposure. Spirodiclofen is not included in the AHS, and therefore this study does notprovide information for this report. 

### III. RESULTS/DISCUSSION

a. IDS (IncidentData System) OPP's IDS includes reports ofalleged 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 relevantproduct 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 inhigher severity outcomes andprovides 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 human incidents (minor, unknown, orno effects outcomes). These are reportedby registrants only as counts in what are aggregate summaries. Forthe Main IDS, from January 1, 2009 to August 12, 2014, there were 0 incidents reported for the single chemical only inthe database. There was 1 incident reported involving more than one chemical. In Aggregate IDS, from January 1, 2009 to August 12,2014,there were 2 incidents reported involving spirodiclofen inthe database. These incidents were classified as minor severity. Overall, there are few incidents involving spirodiclofen reported to IDS.



### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2010, althoughreporting 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 whenreported by physicians, reports from State Departments of Agriculture, and physician reports to state Departments ofHealth. Although both occupational and non-occupational incidents are included inthe database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is ofparticularvalue inproviding 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 standardized protocol and case definitions derived from poison centerreporting, the state SENSOR-Pesticide coordinator enters the incident information into the state-based system which is sentto NIOSH annually to be aggregated. A query ofSENSOR-Pesticides from 1998-2010 identifies three cases involving spirodiclofen (pc code 124871); two cases involved a single active ingredient and will be analyzed for this memo. Both cases were low in severity and related to agricultural work. Both cases involved Envidor 2 SC, EPA regulation # 264-831. The label requires waterproofgloves for handlers/mixers/loaders; the label does notrequire eye protection. One case was exposed via splash from a 

### tank loading accident and experienced ocular symptoms. The second case was an orchard worker who was drifted on while packing apples, the case description and symptoms are provided: "A 29year-old female waspackingapples in the fieldwhen a sprayerpassedby in the next row. She felt moisture droplets on her face andsmelleda chemical odor. Within 5 minutes she had

Page 3 of4gastrointestinalandneurologicalsymptoms. She reportsphoningher local clinic on day of exposure andthe next, butthat she was unable to getan appointment. Her GIsymptoms continuedandbecame worse over the nextsix days. She soughtmedicalcare on sixthday atER"



### c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemiology study evaluatingthe linkbetweenpesticide 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 inthe problem formulation/scoping phase ofthe process and, ifappropriate, fully reviewed in the risk assessment phase ofthe process. The AHS includes information on use of80 different pesticide active ingredients commonly used inagriculture. Spirodiclofen is not included inthe AHS, and therefore this study does not provide information for this report. 

### IV. CONCLUSION Based onthe low frequency and low severity ofcases involving spirodiclofen reported inboth 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 inthe risk assessment.

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