UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: August 5, 2014 

SUBJECT: Fluazifop-Butyl & Fluazifop-P-butyl: Tier I Review of Human Incidents 

PC Code: 122805,122809 

Decision No.: 492472 

DP Barcode: D421768 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

Petition No.: NA 

Risk Assessment Type: NA 

TXR No.: NA CAS No.: 69806-50-4, 7924 1-46-6 

MRID No.: NA 40CFR: NA 

FROM: 

THROUGH: 

TO: 

Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

and 

Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) {J 

David Miller, Acting Branch ChieV' :! 4~ Toxicology and Epidemiology ~ " 

Health Effects Division (7509P) 

Alexandra LaMay, Risk Assessor 

Risk Assessment Branch V 

Health Effects Division (7509P) 

and 

Jill Bloom, Chemical Review Manager 

Risk Management & Implementation Branch 5 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Ver.Apr.08 

Based on the low frequency and low severity of incident cases reported for fluazifop-butyl and 

fluazifop-p-butyl 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 

Fluazifop-P-butyl is a selective, post-emergent herbicide registered for the control of perennial 

and annual grass weeds. 1 Fluazifop-P-butyl's registered uses include food/feed use on asparagus, 

carrot, coffee, cotton, endive (escarole), garlic, macadamia nut, onion, pecan, pepper, rhubarb, 

soybeans, stone fruits, sweet potato, bananas, citrus, grapes, sugar beets, and yams. It is also 

registered for use on lawns/turf. Fluazifop-butyl has been cancelled and is no longer used in the 

U.S. 

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 ingredients fluazifop-butyl and fluazifop-pbutyl (pc codes: 122805, 122809). The purpose of the database search is to identify potential 

patterns in the frequency and severity of the health effects attributed to fluazifop and fluazifop-pbutyl exposure. Fluazifop-butyl and fluazifop-p-butyl are included in the AHS, but are only in 

phase III and the data is not currently available. 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 

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

1 http://www .epa.gov/oppsrrd l/REDs/fluazifop _ tred.pdf 

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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. 

Fluazifop-butyl: 

For the Main IDS, from January 1, 2009 to May 28, 2014, there were no incidents reported for 

fluazifop. 

In Aggregate IDS, fmm January I, 2009 to May 28, 2014, there were no incidents reported for 

fluazifop. 

Fluazifop-P-butyl: 

For the Main IDS, from January 1, 2009 to May 28,2014, there were 10 incidents reported for 

the single chemical only in the database. There were 26 additional incidents reported involving 

more than one chemical. These incidents were classified as moderate severity. 

In Aggregate IDS, from January 1, 2009 to May 28,2014, there were 439 incidents reported 

involving fluazifop-p-butyl. These incidents were classified as minor severity. 

The product implicated most often is Chemsico Herbicide RTU DFC (Registration No. 9688-

208). This product was implicated in 48% of the fluazifop-p-butyl incidents reviewed in 

Aggregate IDS and 25% of the incidents reviewed in Main IDS. This product is a non-selective 

herbicide that is used to control common weeds and grasses. It can be used on driveways, 

walkways, curbs, along fences and foundations, and in flower and mulch beds. It can be applied 

with sprinkler cap applicator or trigger sprayer applicator. 

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 

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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 1998-2010 identifies a total of two cases involving fluazifopbutyl (pc code 122805); both cases involved multiple active ingredients and were low in severity. 

A query of SENSOR-Pesticides 1998-2010 identifies a total of33 cases, stemming from 24 

events, involving fluazifop-P-butyl, isomers (pc code 122809). Three of these cases involves a 

single active ingredient which will be analyzed for this memo. These three cases were low in 

severity. One case (TX05717) involved the accidental ingestion of a root killer product that was 

transferred into a Gatorade bottle. This case experienced nervous system and gastrointestinal 

symptoms. Another case was splashed in the eye when inspecting the product packaging and 

experienced ocular and nervous system symptoms. The third case was a homeowner who 

experienced minor dermal symptoms (red, itchy hand) following the use of the product. 

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 50 different pesticide 

active ingredients commonly used in agriculture. Fluazifop-butyl and fluazifop-p-butyl are 

included in the AHS, but are only in phase III and the data is not currently available. Therefore 

this study does not provide information for this report. 

IV. CONCLUSION 

Based on the low frequency and/or low severity of incident cases reported for fluazifop-butyl and 

fluazifop-P-butyl 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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