UNITED STATES ENVIRONMENT AL PROTECTION AGENCV 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: April 29, 20 15 

SUB.JECT : Flufenacet: Tier I Update Review of Human Incidents/Epidemiology for Draft 

Risk Assessment 

PC Code: 121 903 DP Barcode: 0427013 

Decision No.: 485585 

Petition No.: NA 

Risk Assessment T ype: A 

TXR No.: A 

MRID No.: A 

Registration No.: NA 

Regulatory Action: 1 A 

Case No.: 1A 

CAS No.: 142459-58-3 

.$0CFR: NA 

Ver.Apr.08 

FROM: Shanna Recore, Industrial Hyg ienist 

Toxicology and Epidemiology Branch ~~ 

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Health Effects Division (7509P) d/J~ 

THROUGH: David J. Miller, Acting Branch Chief jJ} Q ~$11 ;lf djJ/, ioijToxicology and Epidemiology Branch~ Health Effects Division (7509P) 

TO: Kristin Rury. Risk Assessor 

Risk Assessment Branch III 

Health Effects Division (7509P) 

and 

M. Hathaway, Chemical Review Manager 

Risk Management & Implementation Branch 2 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Flufenacet was previously reviewed in 20 10 (S. Recore, 11 /30/2010. 0383691). At the time, 

there were no flufenacct incidents found in Main I OS and eight incidents reported to Aggregate 

IDS. Upon review of these incidents, it was concluded that '·Based on the low frequency and 

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severity of incident cases, there does not appear to be a concern at this time that would wanant 

further investigation." 

The current IDS analysis from January 1, 20 10 through April 15. 2015, shows no incidents 

reported involving flufenacet in Main or Aggregate IDS. A query of SENSOR-Pesticides from 

1998-2011 identifies five cases involving flufenacet. These incidents involve multiple active 

ingredients and are classified as low severity. 

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

IDS and JOSH 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 anal ysis will be conducted. 

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

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

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

Detai led Review 

I. ACTION REQUESTED 

Flufenacet are being considered under the FQPA-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. I lowever, 

incident information can be an important source of feedback to the Agency: incidents of severe 

outcome, or a suggested pat1ern 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. 

ll. BACKGROUND 

Flufenacet is an anilide herbicide registered for use on wheat (including triticale), perennial 

grasses grown for seed. com (field and sweet). soybeans and fir trees (FIFRA 24(c) in WA and 

OR onl y). There are no registered residenti al uses or flufenacet. 

For this evaluation, both OPP Incident Data System (IDS) and the Centers for Disease Control 

and Prevention/National Institute for Occupational afety and Health (CDC IOSH) Sentinel 

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Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were 

consulted for pesticide incident data on the active ingredient flufenacet (PC Code: 121903). The 

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

the health effects attributed to flufenacet exposure. 

ln 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. Flufenacet 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 repo11s in IDS. IDS contains repo11s from 

across the U.S. and most incidents have all relevant product information recorded. Reports 

submitted to the JDS 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 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. 

From January 1, 20 I 0 to April 15, 2015, there were no incidents reported to Main IDS or 

Aggregate IDS involving flufenacet. 

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 Oepai1ment 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 

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

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

symptoms, circumstances sunounding 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 from 1998-2011 identifies five cases. stemming from three 

events. involving nufenacet. All five cases involve multiple active ingredients (each of these 

cases involve four or more products) and all cases are low in severity. 

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. The AHS includes information on use of 50 different 

pesticide active ingredients commonly used in agriculture. Flufenacet 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 low severity of incident cases reported for flufenacet in both 

IDS and IOSH 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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