UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: March 3, 2015 

SUBJECT: Orthosulfamuron: Updated Tier I Review of Human Incidents 

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 

Elizabeth 

Recore, 

Evans, 

Industrial 

Envirorunental 

Hygieni

Prot

st 

ection 

~4....-/"-.0- Specialist ~ _ ~ ~ Tox

Health 

icology 

Effects 

and 

Division 

Epidemiolog

(7509

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P

Branch 

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THROUGH: David Miller, Acting Branch Chiefr.t:!J ,.($ ~ '14!J 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: Karlyn Middleton, Risk Assessor 

Risk Assessment Branch II 

Health Effects Division (7509P) 

and 

Khue Nguyen, Chemical Review Manager 

Risk Management & Implementation Branch 1 

Pesticide Re-evaluation Division (7508P) 

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Summary and Conclusions 

Orthosulfamuron was previously reviewed in 201 1 (S. Winfield, 08/3/20 11, 0390658) covering 

2006 to June 2011. It was concluded that "because there are no incident cases reported 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 investigation." The current updated IDS analysis 

from June 2011 to February 25, 2015, shows no incidents reported for orthosulfarnuron. In 

addition, there were no incidents reported to SENSOR-Pesticides from 1998-2011. 

Because there continue to be no incident cases reported for orthosulfamuron to either IDS 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 analysis will be included in the risk assessment. 

I. ACTION REQUESTED 

Orthosulfamuron was previously reviewed in 20 11 (S. Winfield, 08/3/2011 , D390658) from 

2006 to June 2011. It was concluded that "because there are no incident cases reported 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 investigation." An incident report was requested 

to update the previous analysis for the Preliminary Risk Assessment. 

II. BACKGROUND 

Orthosulfamuron is a postemergence herbicide that is registered for control of various weeds on 

rice. Orthosulfarnuron is not currently registered for residential use. 

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) database were 

consulted for pesticide incident data on the active ingredient orthosulfamuron (PC Code 

1 08209). The purpose of the database search is to identify potential patterns in the frequency and 

severity of the health effects attributed to orthosulfarnuron exposure. 

In addition, we sought information from the 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. Orthosulfarnuron 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 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 environmental agencies, and individual 

consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from 

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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 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. 

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 SENSOR-Pesticides database covers 11 states from 1998-2010, although 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 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 11 respective state Departments of Health conducts case followup activities such as obtaining 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 from 1998-20 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 includes 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 of the process and, if appropriate, fully reviewed in the risk 

assessment phase of the process. The AHS includes information on use of 80 different pesticide 

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active ingredients commonly used in agriculture. Orthosulfamuron is not included in the AHS, 

and therefore this study does not provide information for this report. 

IV. CONCLUSION 

Because there 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 analysis will be included in the risk assessment. 

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