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

MEMORANDUM Date: March 31, 2015 

### SUBJECT: Cycloate: Tier I Review of Human Incidents

PC Code: 04130 I DP Barcode: 0424437 Decision No .: 498103 Petition No.: NA Risk Assessment Ty p e: NA TXR No.: NA MRIDNo.:NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 1134-23-2 40CFR: NA Ver.Apr.OS
FROM: Elizabeth Evans, Environmental Protection Specialist

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# CJ Toxicology and Epidemio log y Branch

# ~ Health Effec ts Division (7509P) and Shanna Recore, Industrial Hygienis t 

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### ~ Toxicology and Epidemiology Branch**~** Health Effect Division (7509P) 

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### D THROUGH: David Miller, Acting Branch Chief

### vh Toxicology and Epidemiology Branch Health Effects Division (7509P) 

### TO: Barry O'Keefe, Risk Assessor Risk Assessment Branch III Health Effects Division (7509P) and M. Manupell, Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the low frequency and low severity of incident cases reported for cycloate in both IDS and SENSOR-Pesticides, there does no t appear to be a concern at this time that would warrant
Page 1 of 4further 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. Detailed 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 largely self-reported and therefore, generally speaking, ne ither 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: incident s 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 of disease, 

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

### II
. BACKGROUND Cycloate is a broad-spectrum, pre-emergent herbicide registered for the control of annual grasses, certain perennial grasses and many broadleaf weeds on garden beets, spinach and sugarbeets. Cycloate is not for homeowner/garden use. Sugarbeets account for more than 90% of cycloate usage. 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 cycloate (pc code: 041301). The purpose of the
. database search is to identify potential patterns in the frequency and severity of the health effects attributed to cycloate exposure. Cycloate is not included in the AHS, and therefore this study does not provide information for this report. 

### III. RESULTS/D I SCUSSION
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 environmenta l 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 relevant product information recorded. Reports submitted to the ID S represent anecdotal reports or allegations only, unless otherwise stated in the report.
Page 2of4IDS records incidents in one of two modules: Main IDS and Aggregate I DS:

o Main I DS contains incidents resulting in higher severity outcomes and provides more de tail with regard to case specifics. This system stores incident data for death, major and moderate incidents, and it includes information abo u t the location, date and nature ofthe incident. Main IDS incidents involving only one active ingredient (as opposed to pestic ide product s w ith 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**n~idents** (minor, unknown, or no effects outcomes). These are reported by regis trants only as counts in what are aggregate summaries. For the Main IDS, from January 1, 2010 to December 30, 20 14, there were no incidents reported involving cycloate. In Aggregate IDS, from January 1, 2010 to December 30, 20 14, there were no inc idents reported involving cycloate. 

### b . SENSOR -Pesticides The SENSOR-Pesticides database covers 12 states from 1 998

- 201 1 , although reporting varies from state to state. Cases of pesticide

-related illnesses are ascertained from a variety of sources, in cluding : 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 H ealth. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide inc idents, an d i s of part icular value in providing that information. The state coordinator at each of the 12 respective state Departments of Health conducts case followup activ ities such as obtaining medical records to verify symptoms and severity. Using standardized protocol and case definitions deri ved from poison center reporting, the state SENSOR-Pesticide coordinator enters the incident information into the sta te-based system which is sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides from 1998-20 1 1 identifies A review of SENSOR

- Pesticides 1998

- 2011 identifies nine cases invo lving cycloate (pc code 041301); one case was a s ing le ai. Thi s case occurred in California in 2000, was work-related and low in sever ity with dermal symptoms reported
. 

### c. Agricultural Health Study (AHS) The AHS is a high quality, prospective ep idemio logy study evaluating the link between pesticide use and various health outcomes including cancer. The AHS includes private and commerc i al pesticide applicators and their spouses. 

### Ifthere are AHS findings relevant to a particular 

### pesticide going through registratio n r eview, the Agency will ensure they are considered in the prob lem formulation/scoping phase of the process and, if appropriate, fully reviewed in the risk
Page 3of4assessment phase of the process. The AHS includes information on use of 80 different pesti cide active ingredients commonly used in agriculture. Cycloate is not includ ed in the AHS, and therefore this study doe s not provide information for this report. 

### IV. CONCLUSION B ase d on the low frequency and low severity of incident cases reported for cycloate 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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