### UN ITE D STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFI CE OF CHEMICAL SAFETY AND POLLUTION PREVENTIO N



### MEMORANDUM Date: March 3, 2015 

### SUBJECT: Orthosulfamuron: Updated Tier I Review of Human Inc idents

PC Code: I 08209 OP Barcode: 04258 15 Decision No.: 499854 Petition No.: NA Risk Assessment Type: NA TXR No.: NA MRID No.: NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 213464-77-8 40 CFR: NA Ver.Apr.08 

### FROM: Shanna Recore, Industrial Hygi eni st

# ~4....-/"-.0-**~** Elizab eth Evans, Envirorunental Protection Specialist

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### ~**~** Tox icology and Epide miology Branch 

### C)**~.IJ~ ~**  Health Effects Division (7509 P ) v- 

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### THROUGH: David Miller, Acting Branch Chiefr.t:!J 

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# ~ '14!J Toxicology and Epidemiology Branch Health Effects Division (7509P) 

### TO: Karlyn Middleton, Risk Assessor Ri sk Assessment Branch II He a lth Effe cts Division (7509P) and Khue Nguyen, Chemical Review Manager Risk Management & Implementation Branch 1 Pesticide Re- evalu atio n Division (7508P)

Page 1 of4Summary and Co nclu s ion s Orthosulfamuron was previo usly reviewed in 201 1 (S. Winfield , 08/3 /20 11, 0390658) covering 2006 to June 2011. It was concluded that "because there are no incid ent cases reported for ort ho sulfamuron in either the Main or Aggregate IDS mo dul e, there doe s not appear to be a concern at this time that wo ul d war rant further investigation." The current updated IDS analysis from June 2011 to February 25, 2015, shows no incidents reported for orthos ul farn uron. In addition, there were no incidents reported to SENSOR-Pesticides from 1998-2011. Because there continue t o be no incident cases reported for orthosulfamuron to either IDS or NIOS H SENSOR-Pe st icides, there does not appear to be a concern at this time th at wou ld warrant further in vestigation

. The Agency will continue to monitor th e incident information and if a concern i s triggered, additional analysis will be included in the risk assessme nt. I. ACTION REQUESTED Orthosulfamuron was previously rev iewed in 20 1 1 (S. Winfield , 08 / 3/ 2 011 , D 390658) from 2006 to Jun e 2011. It was concluded th at " b ecause there are no incident cases rep orted for orthosulfamuron in either the Main or Aggregate IDS module, there does not appear to be a concern at this time that would warrant further inve s tigation." An incident report was reque sted to update the previou s analysis for the Preliminary Ri sk Assessment. II. BACKGROUND Orthosulfamuron is a postemergence herbicide that is registered for control of vario us weeds on rice. Orthosulfarnuron is not currently regist ere d for residential use. For this evaluation , both the OPP Incident Data System (IDS) and the Centers for Disease Control and Pre vention/Nationa l Institute for Occupationa l Safet y and Health (C DC/NIOSH ) Sentinel Event Notification Syst em for Occupational Risk-Pesticides (SENSO R) database were co nsulted for pesticide incident data on th e activ e ingre dient orthosulfamuron (PC Code 1 08209). The purp ose of the database searc h is to identify potential patterns in the frequency and severity of the health effects att ributed to orthosulfarnuron exposure. In addition, we sought information from the Agricultural Health Study ( AHS ). The AH S is a high quality prosp ective epidem i ology study evaluating th e link between pesticide use and various he alth outcomes, including canc er. Orthosulfarnuron is not included in the AHS, and therefore thi s study does not provide information for this report. III. RESULTS/DISCUSS I ON

a. IDS (Incident Data System) OPP ' s IDS inc lu des reports of all eged human health incidents f rom various sources, including mandatory Federal Insectic ide, Fungicide and Rodenticide Act (FIFRA ) S ec tion 6(a)(2) report s from registrants, other federal and state health and environmental agencie s, and individual consumer s. Since 1 992 , OPP has compiled the se reports in ID S. ID S contains reports from Page 

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### 4across 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 module s : Main IDS and Aggregate ID S:

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 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 ID S contains incidents resulting in les s severe human incidents (minor, unknown , or no effects outcomes). These are reported by registrants only as counts in what are aggregate summaries. From June 1 , 2011 to February 25 , 2015, there were no incidents reported involving orthosulfamuron in either Main or Aggregate IDS database. b. SENSOR-Pesticides The SENS OR-Pesticides database covers 11 states from 1998-2010, a lthough 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 phys ic ian reports to state Departments of Health. Although both occupational and non - occupational incidents are included in the database, SENSOR-Pesticides focuses on occupa ti onal pesticide incidents, and is of particular valu e in provid in g that information. The state coordina tor at each of the 11 respective state Departments of Hea lth conducts case foll owup ac tiviti es such as obtaining medical records to verify symptoms and severity

. Us ing sta ndardized protocol and case definitions derived from poison center reporting, the state SENSOR-Pe sticide coordinator enters the incident information into the state-based system which is sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides from 1 998

- 20 l l identifies no cases involving orthosulfamuron.

c. Agricultural Health Study (AHS) The AI-IS is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. The AHS incl udes private and commercial pesticide applicators and their spouses . If there are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem formulation/scoping phase ofthe process and , if appropriate, fully reviewed in the risk assessment phase of the process . The AHS includes information on use of 80 different pesticide
Page 3 of4active ingredients commonly used in agriculture. Orthosulfamuron is not included in the AHS , and therefo re this study does not p rovide information for this report. 

### IV. CONCLUSION Because th ere were no incident cases reported for orthosulfamuron to either lOS or NIOSH 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 ana lysis will be included in the ri sk assessment.

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