UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: March 3, 2016 

SUBJECT: Fluometuron: Tier I (Scoping) Review of Human Incidents and Epidemiology 

PC Code: 035503 DP Barcode: 0431967 

Decision No.: 51 1228 

Petition No.: NA 

Risk Assessment Type: NA 

TXR No.: NA 

MRID No.: NA 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 2164-17-2 

40 CFR: NA 

Ver.Apr.OS 

FROM: li z~beth Evans, iro~m ntal Protection Specialist / 

Toxicology and Ep1dem1ology Branch C {, , c.,h-lf'r\ ~ 

THROUGH: 

TO: 

Health Effects Division (7509P) -i ~ 

and 

Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

David Miller, Acting Branch Chief 1( 

Toxicology and Epidemiology Branc 

Health Effects Division (7509P) 

Julie Yan Alstine, Risk Assessor 

Risk Assessment Branch VI 

Health Effects Division (7509P) 

and 

L. Walsh, Chemical Review Manager 

Risk Management & Implementation Branch 3 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

~ 

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

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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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, 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 

Fluometuron is an herbicide used to control broadleaf weeds on cotton. 

1 

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 fluometuron (pc code: 035503). The purpose 

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

effects attributed to fluometuron exposure. Fluometuron is not included in the AHS, and therefore 

this study does not provide information for this report. 

Ill. RESULTS/DISCUSSlON 

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 (FJFRA) 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 of two modules: Main IDS and Aggregate IDS: 

1 Fluometuron RED (2005) found online at: 

http://www.epa.gov/pesticides/chem search/reg actions/reregistration/red PC-035503 1-Sep-05.pdf 

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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. 

For the Main IDS, from January 1, 20 l 0 to September 25, 20 15, there were no incidents reported 

for fluometuron in the database. 

Aggregate IDS, from January I, 20 l 0 to September 25, 2015, there was one incident reported 

involvi ng fluometuron. This incident was classified as minor severity. Overall, there are few 

incidents reported to IDS involving fluometuron. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-2011 , 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 12 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 review of SENSOR-Pesticides 1998-2011 identifies no cases involving fluometuron. 

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 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. Fluometuron is not included in the AHS, and 

therefore this study does not provide information for this report. 

IV. CONCLUSION 

Based on the low frequency and severity of incident cases reported for fluometuron in both lDS 

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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