UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: March 17, 2016 

SUBJECT: Ethalfluralin: Tier I Update Review of Human Incidents for Draft Risk 

Assessment 

PC Code: 11 3101 

Decision No.: 510535 

Petition No.: NA 

OP Barcode: 0432322 

Registration No.: NA 

Regulatory Action: NA 

Risk Assessment Type: NA Case No.: NA 

TXR No.: NA CAS No.: 80844-07-1 

MRID No.: NA 40CFR: NA 

FROM: 

THROUGH: 

TO: 

Yer.Apr.08 

Elizabeth Evans, Environmental Protection Specialist c--

Tox

Health 

icol

Effects 

ogy and 

Divi

Epid

sion 

em

(7509P) 

iology Branch c

l 

; ?J' ·, ~n 

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and 

Shanna Recore, Industrial Hygienist l ~ A - • j, II. , n a f\1. n / 

Toxicology and Epidemiology Branch vbJtJJJ~ μ.cv'V---" 

Health Effects Division (7509P) /) 

I r ll!/j/ ·'7-::J 

David J. Miller, Acting Branch Chief .{At!,} #/JV'( .'1'1 ·/l/)/. Z,.J' c 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Julie Van Alstine, Risk Assessor 

Risk Assessment Branch VI 

Health Effects Division (7509P) 

and 

Kelly Ballard, Chemical Review Manager 

Risk Management & Implementation Branch 1 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Ethalfluralin was previously reviewed in 2010 (S. Recore, 0 383687, 11130/2010). At the time, 

there was one moderate severity incident reported for ethalfluralin to Main IDS and seven minor 

severity cases reported to Aggregate IDS from January 1, 2002 to May 27, 2010. Upon review of 

these incidents, it was concluded that "Based on the low frequency and severity of incident 

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cases, there does not appear to be a concern at this time that would warrant further 

investigation." 

The current IDS analysis from January I, 2010 through December 3, 2015, shows no incidents 

reported for ethalfluralin in Main or Aggregate IDS. 

A query of SENSOR-Pesticides 1998-2011 identifies two cases involving ethalfluralin (pc code 

113101). One case was moderate in severity and one case was low in severity. 

Based on the low frequency and severity of incidents reported to both IDS and SENSORPesticides, there does not appear to be a concern at this time. The Agency will continue to 

monitor the incident data and if a concern is triggered, additional analysis will be conducted. 

Detailed Review 

l. ACTION REQUESTED 

Ethalfluralin is 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. 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 

Ethalfluralin is a selective herbicide for the preemergence control of certain annual grasses and 

broad leaf weeds. It is registered for use on a variety of food and feed crops; including beans, 

peanuts, canola, soybeans, and cucurbits. 

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

and Prevention/National [nstitute 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 Ethalfluralin (PC Code: 113101). 

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

of the health effects attributed to ethalfluralin exposure. 

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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 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 infonnation 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 l , 2011 to January 12, 20 16, there were no incidents reported to either Main IDS 

or Aggregate IDS involving the active ingredient, ethalfluralin. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-2012, 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 focuses on occupational 

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 surrounding 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. 

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A query of SENSOR-Pesticides 1998-2012 identifies two cases involving ethalfluralin. Both 

cases involve a single a.i. One case was moderate in severity and one case was low in severity. 

The moderate severity case was a livestock production worker who was spraying the product and 

was exposed to the mist. This case experienced dermal and ocular symptoms including: 

swelling, corneal abrasion, eye pain and conjunctivitis. The low severity case was an agricultural 

researcher who developed mild eye irritation after entering a treated field 4 hours post 

application of a granular herbicide with a 24 hour re-entry. The researcher needed to seed the 

field before rainstorms. She wore PPE but wasn't sure that goggles fit properly. She consulted an 

eye doctor. 

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. Ethalfluralin is not included in the AHS, and 

therefore this study does not provide information for this report. 

CONCLUSION 

Based on the low frequency and severity of incidents reported to both IDS and SENSORPesticides, there does not appear to be a concern at this time. The Agency will continue to 

monitor the incident data and if a concern is triggered, additional analysis will be conducted. 

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