UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: July 10,2013 

SUBJECT: Flumetsulam: Review of Human Incidents for Preliminary Risk Assessment 

PC Code: 129016 

Decision No.: 477891 

Petition No.: NA 

Risk Assessment Type: NA 

TXRNo.: NA 

MRIDNo.: NA 

DP Barcode: 0412985 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 98967-40-9 

40CFR:NA 

Ver.Apr.08 

FROM: Shanna Recore, Industrial Hygienist fJ _ ..... <C:\ ~ Toxicology 

Health Effects 

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and 'vf Elizabeth Evans, Environmental Protection Specialis 

. Toxicology and Epidemiology Branch 

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THROUGH: David J. Miller, Acting Branch Chief . ,tJ ///~!/\ V 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: Mohsen Sahafeyan, Risk Assessor 

Risk Assessment Branch VI 

Health Effects Division (7509P) 

and 

Katherine St. Clair, Chemical Review Manager 

Risk Management & Implementation Branch 2 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

TEB has been asked to review the incidents in IDS and NIOSH SENSOR-Pesticides and review 

the findings in the AHS for the flumetsulam preliminary risk assessment due August 2013. 

Based on the low frequency and severity of incident cases reported for flumetsulam in both IDS 

and NIOSH SENSOR-Pesticides, there does not appear to be a concern at this time that would 

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warrant further investigation. The Agency will continue to monitor the incident information and 

if a concern is triggered, additional analysis will be conducted. 

The Agricultural Health Study (AHS) is also a potential source of information associated with 

human health effects associated with certain pesticides. Flumetsulam is not included in the AHS, 

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

Detailed Review 

I. ACTION REQUESTED 

Flumetsulam is a pesticide being considered under the FQP A-mandated Registration Review 

program established to review, on a 15 year cycle, pesticides for which a Re-registration 

Eligibility Decision has been made. One component of the Agency's Registration Review 

Program is consideration of human incident data. In conjunction with a human health risk 

assessment based on other data sources, such human incident data can assist the Agency in better 

defining and characterizing the risk of pesticides/pesticide products. 

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 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-groups like pesticide applicators. 

II. BACKGROUND 

Flurnetsulam is an herbicide used to control broadleaf weeds in field corn, soybeans and dry 

beans. Flurnetsulam currently has no residential uses. 

For this evaluation, both 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 flumetsulam (PC Code: 129016). 

The purpose of the database search is to identify potential patterns in the frequency and severity 

of the health effects attributed to flumetsulam exposure. 

In addition, findings from the Agricultural Health Study (AHS) were reviewed. The AHS is a 

high quality, prospective epidemiology study evaluating the link between pesticide use and 

various health outcomes including cancer. Flurnetsulam is included in the AHS, but it is only in 

phase III and there are no studies available yet to consider. 

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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 

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 oftwo modules: Main IDS and Aggregate IDS: 

o Main IDS contains incidents resulting in higher severity outcomes and provides 

more detail with regard to case specific. 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 

pesticide 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. 

For the Main IDS, from January 1, 2008 to May 8, 2013, there were no incidents reported for 

single chemical only in the database involving flumetsulam. There were 5 additional incidents 

reported involving more than one chemical. However, they were all foreign incidents, one 

incident occurred in Australia and four incidents occurred in China. Foreign incidents are not 

reviewed in detail because of the potential differences in the exposure patterns, use practices, and 

product formulation. All of these incidents were classified as moderate severity. 

In Aggregate IDS, from January 1, 2008 to May 8, 2013, there were nine reported incidents 

involving flumetsulam. These incidents were classified as minor severity. Overall, there are few 

incidents involving tlumetsulam reported to IDS. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 11 states from 1998-2009, 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 focuses on occupational 

pesticide incidents, and is of particular value in providing that information. A state SENSOR 

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contact specialist attempts to follow-up with cases and obtains medical records to verify 

symptoms, circumstances surrounding the exposure, severity, and outcome. Using standardized 

protocol and case definitions derived from poison center reporting, SENSOR coordinators at 

State Departments of Health enter the incident interview description provided by the case, 

medical report, physician and patient into the SENSOR data system. The SENSOR data system 

is accessible to participating states and EPA. 

A query of SENSOR-Pesticides 1998-2009 identifies no cases involving flumetsulam. 

c. 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. 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 formulationlscoping phase of the process and, if appropriate, fully reviewed in the risk 

assessment phase of the process. The AHS includes information on use of 50 different pesticide 

active ingredients commonly used in agriculture. 

Flumetsulam is included in the AHS, but it is only in phase III and there are no studies available 

yet to consider. 

IV. CONCLUSION 

Based on the low frequency and severity of incident cases reported for flumetsulam in both IDS 

and 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 conducted. 

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