UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

/ OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Date: March 25, 2015 

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

PC Code: 129122 DP Barcode: 0426369 Decision No.: 498469 Petition No.: NA R isk Assessment Type : NA TXRNo.:NA MRIDNo .: NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 14570 1 -21-9 40CFR: NA 

### FROM: Shanna Recore, Industrial Hygienist Toxicology and Epidemiology Branch Health Effect Division (7509P) and Elizabeth Evans, Envirorunental Protection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509P) 

### THROUGH: David Miller, Acting Branch

# Chie~**&J** jf ,(L Toxicology and Epidemiology Branch Heal th Effects Division (7509P) 

### TO: Kristin Rury, Risk Assessor Risk Assessment Branch III Health Effects Division (7509P) and Bonnie Adler, Chemical Review Manager Risk Management & Implementation Branch 5 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Ver.Apr.08

Because there were no incident cases reported for diclosulam to either IDS or SENSORPesticides, 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 1of4Detailed 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, 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 chemical or product. Observational epidemiology s tudies relate the risk of disease , 

### e.g., cancer, and exposure to an agent such as a pesticide product i n the general population or specific sub -groups like pesticide applicators. 

### II. BACKGROUND Diclosulam belongs to the triazolopyrimidine sulfonamide class of herbicides. It is registered for use on peanuts and cottonwood. Diclosulam has no residential uses. For thi s 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 Notific ation System for Occupational Ri sk-Pesticide s (SENSOR) databases were consulted for pesticide incident data on the active ingredient diclosulam (pc code: 129122). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to diclosulam exposure. D iclosulam is 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 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 the se reports in IDS. IDS contains reports from across the U.S
. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the 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 detai l with regard to case specifics. This system stores incident data for
Page 2 of4death, 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 of exposure from the pesticide.

o Aggre gate IDS contains incidents resulting in less severe human incidents (minor, unknown, or no effects outcomes). These are reported by re gistrants only as counts in what are aggregate summaries. For the Main ID S, from January 1, 2010 to December 30 , 2014, there were no incidents reported involving diclosulam. In Aggregate IDS, from January 1, 2010 to December 30, 2014, there were no incidents reported involving diclosulam. 

### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 12 s tates from 1998

- 201 1 , although reporting varies from state to state. Cases ofpesticide-related illne sses 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 occupational 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 12 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and sever ity. Using standardized protocol and case definitions derived from poison center reporting, the state SENSOR-Pesticide coordinator enters the incident informat ion into the state-based system which is sent to NIOSH annually to be aggregated. A review of SENSOR-Pesticides 1998-2011 identifies no cases involving diclosulam (pc code 129 122)
. 

### c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemio logy study evaluating the link between pesticide 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 Agenc y 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 us e of 80 different pesticide active ing redients commonly used in agriculture
. Diclosulam is not included in the AHS, and therefore this study does not provide information for this report. 

### IV. CONCLUSION

Page 3 of4Because there were no incident cases reported for diclosulam to either IDS or SENSORPesticides, there does not appear to be a concern at this time that would warrant further investigat ion
. The Agency will cont inue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.

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