UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: July 17, 2014 

SUBJECT: Oxyfluorfen: Tier I Review of Human Incidents 

PC Code: 11160 I 

Decision No.: 489869 

Petition No.: NA 

Risk Assessment Type: NA 

TXRNo.: NA 

MRIDNo.: NA 

DP Barcode: 0419420 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 42874-03-3 

40CFR:NA 

Ver.Apr.08 

FROM: 

Toxicology 

Elizabeth Eva

and 

ns, 

Epidemiology 

Environmental 

Branch 

Protection Specialist 

/"': iJ.~~ 

~ 

THROUGH: 

TO: 

Health Effects Division (7509P) 'V, · 

and 

Shanna Recore, Industrial Hygienist p " ,, T\. 

1 Toxicology 

Health Effect 

and 

Division 

Epidemiology 

(7509P) 

Branch ~ ~ 

/) .,. , $tft-1..... ,nc;/1 ur '1 

David Miller, Acting Branch Chief~ , , 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

I van Nieves, Risk Assessor 

Risk Assessment Branch IV 

Health Effects Division (7509P) 

and 

Russell Wasem, Chemical Review Manager 

Risk Management & Implementation Branch I 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

There does not appear to be a concern at this time that would warrant further investigation, since 

there was a low frequency of incidents involving oxyfluorfen reported to IDS and SENSORPesticides. The Agency will continue to monitor the incident information and if a concern is 

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triggered, additional analysis will be included in the risk assessment. However; due to the large 

proportion of Ortho Fence & Grass Edger Formula II (Registration No. 239-25 16) incidents the 

Agency may evaluate this product further during in the Preliminary Risk Assessment. 

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 

Oxyfluorfen is a diphenyl-ether herbicide used for broad spectrum pre- and post-emergent 

control of annual broad leaf and grassy weeds in a variety of tree fruit, nut, vine, and field crops. 

The largest agricultural markets in terms of total pounds active ingredient are wine grapes and 

almonds. There are also non-agricultural ornamental and forestry uses. Oxyfluorfen is also used 

for weed control in landscapes, patios, driveways, and similar areas in residential sites. 

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 oxyfluorfen (pc code: 111601 ). The 

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

the health effects attributed to oxyfluorfen exposure. Oxyfluorfen 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. 

For the Main IDS, from January 1, 2006 to May 28,2014, there were 2 incidents reported for the 

single chemical only in the database. One was classified as major severity and involved a 42 

year old female suicide attempt. The other incident was classified as moderate severity and is 

described below: 

Three field workers harvesting flower seed sought medical attention due to an alleged pesticide drift 

incident. Two additional field workers also suffered symptoms due to this incident, but they did not seek 

medical attention. The five field workers reported symptoms ranging from eye irritation, headache, nausea 

and vomiting. A grower in the adjacent field was applying an Oxyfluorfen product to a pre-emergent 

cabbage field using ground equipment during the onset of symptoms. The field workers that sought medical 

attention reported wind blowing in their direction at the time of exposure. The field workers were 

approximately 150 feet away from the application site. 

There were 24 additional incident reported involving more than one chemical. Twenty three of 

these incidents were classified as moderate severity and one incident was classified as minor 

severity. It should be noted there was one incident reported as a lawsuit to IDS that was not 

considered in this report. 

In Aggregate IDS, from January 1, 2009 to May 28, 2014, there were 316. incidents reported 

involving oxyfluorfen in the database. One incident was classified as no or unknown symptoms 

and 315 were classified as minor severity. 

Ortho Fence & Grass Edger Formula II (Registration No. 239-2516) appears to be implicated in 

a large number of incidents in both Aggregate (77%) and Main IDS (71 %). In addition to 

oxyfluorfen (0.25%), this product contains the active ingredient glyphosate, isopropylamine salt 

(0.25%). This product is used for weed control. It should be applied only where no vegetation is 

desired, such as driveways, landscaped areas around trees and shrubs, along fences, sidewalks, 

walkways, patios, curbs, gutters, and sidewalks. It is sold with a sprinkle pour spout, a pull and 

spray applicator and a trigger sprayer. 

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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 1998-2010 identifies a total of 57 cases, stemming from 49 

events, involving oxyfluorfen (pc code 111601 ). Sixteen of these cases involve a single active 

ingredient and will analyzed in this memo. Three cases were moderate in severity and 13 cases 

were low in severity. Fifteen cases were work-related and one case was not work-related. 

Twelve ofthe single ai cases involved the product named "Goal 2XL". One event that occurred 

in Oregon in 2000 involved 4 cases. A truck with the herbicide was on fire and three first 

responder and one volunteer were exposed and made ill while responding to the incident. 

Nervous system symptoms, primarily a headache, was most frequently reported. 

Table 2. SENSOR-Pesticides 1998-2010 

Health Effects Reported for Oxyfluorfen Cases 

Health Effect Frequency 

Dermal 5 

Ocular 5 

Nervous System 9 

Gastrointestinal 5 

Respiratory 6 

Miscellaneous I 

Cardiovascular1 3 

Renal 0 

* Cases may report multiple health effects 

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 fmdings relevant to a particular 

pesticide going through registration review, the Agency will ensure they are considered in the 

1 Two of the moderate cases reported hypertension and one low severity case reported chest pain. 

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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. Oxyfluorfen is not included in the AHS, and 

therefore this study does not provide information for this report. 

IV. CONCLUSION 

There does not appear to be a concern at this time that would warrant further investigation, since 

there was a low frequency of incidents involving oxyfluorfen reported to IDS and SENSORPesticides. The Agency will continue to monitor the incident information and if a concern is 

triggered, additional analysis will be included in the risk assessment. However; due to the large 

proportion ofOrtho Fence & Grass Edger Formula II (Registration No. 239-2516) incidents the 

Agency may evaluate this product further during in the Preliminary Risk Assessment. 

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