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 Eli zabeth Evans , Environmental Protection Specialist

### ~ Toxicology and Epidemiology Branch /"':**iJ.~~** 

### FROM:

THROUGH:

TO: Heal th Effects Division (7509P) 

### 'V , · and Shanna Recore, Industrial Hygienist 

## p ", , T\. 1 Toxicology and Epidemiology Branch

### ~**~** Health Effect Division (7509P) 

# /) .,. , $tft-1..... ,nc; /1 ur '1 David Miller, Acting Branch

### Chief~ , , Toxicology and Epidemiology Branch Health Effects Division (7509P)
Ivan 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 oxyfluorf en reported to IDS and SENSOR

Pesticides. The Agency will continue to monitor the incident information and if a concern is
Page 1 ofStriggered, 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 ofregistration review. Reports of adverse health effects all egedly due to a specific pesticide exposure (i.e., an " incident") are largely self-reported and therefo re, 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 broadleaf 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 Federa l Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants , other federal and state health and environmenta l agencies , and individual consumers . Since 1992 , OPP has compiled these reports in IDS. IDS contains reports from
Page 2 of5across 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 ID S and Aggregate ID S:



### 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 informati on about the potential effects ofexposure 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 28,20 14 , there were 2 incidents reported for the single chemical only in the database. One was classified as major severity and involved a 42 year o ld 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 inc ident. 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 ofexposure. 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, f r om 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%). T hi s product is used fo r weed control. It s hould be appli ed only where no vegetation is desired, such as driveways, landsca ped areas around trees and s hrubs , along fences, sidewalks , walkways , patios, curbs , gutters, and sidewalks. It is sold with a sprinkle pour spout, a pull and spray applicato r and a trigger sprayer.
Page 

### 3 ofS

### b. SENSOR-Pesticides The SENS OR-Pesticides database covers 11 states from 1998-2010, although reporting varies fro m state to state. Cases ofpesticide-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 occupat ional 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 wi ll 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 Ca rdiovascular 1 3 Renal 0 

### * Cases may report mu ltip l e 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 ofthe moderate cases reported hypertension and one low s ever ity case reported chest pain. Page 4 of5problem formulation/scoping phase of the process and, if appropriate, fully reviewed in the ri sk assessment phase ofthe process. The AHS includes informat ion on use of 50 different pesticide active ingredients commonly used 

### in agriculture. Oxyfluorfen is not included in the AHS , and therefore th i s 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 proporti on ofOrtho Fence & Grass Edger Formula II (Registration No. 239-2516) incidents the Agency may evaluate this product further during in the Preliminary Risk Assessment.

Page 5 of5