UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: May 28, 2014 

SUBJECT: Fluroxypyr, 1-methylheptylester: Tier I Review of Human Incidents 

PC Code: 128968 DP Barcode: D420478 

Decision No.: 488688 

Petition No.: NA 

Registration No.: NA 

Regulatory Action: NA 

Risk Assessment Type: NA Case No.: NA 

TXRNo.: NA CAS No.: 81406-37-3 

MRlDNo.: NA 40CFR: NA 

FROM: Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

and 

Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

THROUGH: David Miller, Acting Branch Chief ,;} ;f/tij, 

Health Effects Division (7509P) () 

Toxicology and Epidemiology Branc 

Health Effects Division (7509P) 

TO: Seyed Tadayon, Risk Assessor 

Risk Assessment Branch V 

Health Effects Division (7509P) 

and 

K.hue Nguyen, Chemical Review Manager 

Risk Management & Implementation Branch 1 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Ver.Apr.08 

Based on the low frequency and severity of incident cases reported for Fluroxypyr, 1-

methylheptylester (Fluroxypyr-MHE), 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 

Fluroxypyr-MHE is an herbicide intended for post-emergent selective control of broadleaf 

weeds. It is currently registered for wheat, barley, oats, com, sorghum, fallow cropland, 

rangefield, pome fruit, millet, and others. Fluroxypyr-MHE is formulated as an emulsifiable 

concentrate that is mixed with water and applied as ground or aerial spray, although spot 

application by hand is also possible. 

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 Fluroxypyr-MHE (PC codes: 

128968). The purpose of the database search is to identify potential patterns in the frequency 

and severity of the health effects attributed to Fluroxypyr-MHE exposure. Fluroxypyr-MHE 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 

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 oftwo modules: Main IDS and Aggregate IDS: 

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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, 2009 to January 15,2014, there was 1 incident reported for 

single chemical only in the database. This incident was classified as moderate severity. There 

were 7 additional incidents reported involving more than one chemical. 

In Aggregate IDS, from January l, 2009 to January 15,2014, there were 50 incidents reported 

involving Fluroxypyr-MHE. Forty five of these incidents were classified as minor severity and 

five were classified as having no/unknown severity. Overall, there are few incidents involving 

Fluroxypyr-MHE reported to IDS. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 11 states from 1998-2009, 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 ofHealth. 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 11 cases, stemming from ten 

events, involving fluroxypyr, 1-methylhelptylester (pc code 128968). One case involved a single 

ai and ten involved multiple ais. All cases were low in severity. Seven cases were work-related 

and all seven involved the application of a product. The other four cases involved bystander 

exposures. Three of the 11 cases occurred in windy conditions, two cases involved an equipment 

malfunction (hose clamp broke). 

The most commonly reported symptoms were respiratory (n=8) and nervous system (n=8) 

followed by ocular (n=7). 

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Table X. SENSOR-Pesticides 1998-20 I 0: Reported 

Health Effects for Fluroxypyr, 1-methylhelptylester 

N= l l 

Health Effect # of Times Reported 

Dermal 2 

Ocular 7 

Respiratory 8 

Gastrointestinal 6 

Renal 0 

Nervous System 8 

Cardiovascular 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 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 ofthe process. The AHS includes information on use of 50 different pesticide 

active ingredients commonly used in agriculture. Fluroxypyr-MHE 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 both Fluroxypyr-MHE 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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