UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: September I 0, 20 l 5 

SUBJECT: Bcnsulide: Tier I Update Revi ew of Human Incidents and Epidemiology for Draft 

Risk Assessment 

PC Code: 009801 OP Barcode: 0428879 

Decision No.: 507866 

Pelition o.: NA 

Registration No.: NA 

Regulatory Action: NJ\ 

Risk Assessment Type: NA Case No.: NA 

TXR o.: NA CAS No.: 7.J 1-58-2 

MRID No.: J\ 40 CFR: J\ 

FROM: 

THROUGH: 

Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

and 

Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) /.) rj, 

David J. Miller, Acting Branch Chief fl.fa )!'tf/t. 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: ldeli z Encarnacion, Risk Assessor 

Risk Assessment Branch V 

Health Effects Division (7509P) 

and 

Margaret Hathaway, Chemical Review Manager 

Risk Management & Implementation Branch 2 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Ver.Apr.OS 

Bensulide was previously reviewed in 1998 (J. Blondell and M. Spann, 2/911998, D239353). Al 

the time, there were two incidents reported for bensulide in IDS from 1992- February 1998. Upon 

review of these incidents, no recommendations were made and it was concluded that, "Very few 

illness cases have been reported due to bensulide and none have been confirmed." 

Page I of 5 
The current IDS analysis from January l , 20 10 through August 25, 2015, shows 2 moderate 

severity incident repo11ed involving bensulide in Main IDS and 5 minor severi ty incidents 

repo11ed to Aggregate IDS. 

The query of SENSOR-Pesticides 1998-2011 identified a total of 38 cases involving (pc code 

009801). Of these 38 cases, 17 cases, stemming from seven events, involve a single ai and were 

reviewed further. 

The Agricultural Health Study (AHS) is also a potential source of information associated with 

human health effects associated with certain pesticides. Bensulide is not included in the AHS, 

therefore no AHS information is available for this chemical. 

Based on the low frequency of incidents involving bensulide 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 information and if a concern is triggered, additional analysis will be 

conducted. 

Detailed Review 

I. ACTION REQUESTED 

Bensulide 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. On~ 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 clue 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 cormection 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 

Bensulide is an organophosphate herbicide used for weed control in agricultural, residential and 

occupational settings. 

Page 2of5 
For this evaluation, both 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 bensulide (PC Code: 00980 1 ). The 

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

the health effects attributed to bensulide exposure. 

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 (FJFRA) 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 infomrntion 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 specific. 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 

pesticide are considered to provide more certain infonnation 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 1, 2010 to August 25, 2015, there was one incident reported to Main IDS 

involving the single active ingredient, bensulide. This incident was classified as moderate 

severity. It involved nine farm employees who were exposed during a product (EPA Reg. No. 

10163-200) application being made by a licensed pest control business to a nearby field. One 

worker was moving irrigation pipe when he was exposed. He complained of symptoms of 

burning eyes, numbness of tongue, extreme nausea, abdominal pain, headache and pain to his 

arms and legs. He was seen at a hospital emergency room and was treated with atropine, 

admitted to the hospital, and released after twelve hours. The other eight fieldworkers were 

harvesting leafy greens at the time of exposure. They reported various symptoms including: 

burning eyes, headache, sore throat, nausea, vomiting, heavy legs, and numbness in tongue. Two 

of the workers sought medical attention and six workers did not. 

There was one additional incident reported to Main IDS, involving multiple active ingredients. 

This incident was classified as moderate severity. 

Page 3 of 5 
From January I, 20 I 0 to March 18, 2015, there were 5 incidents reported to Aggregate IDS 

involving bensulide. These incidents were c lassified as minor severity. Overall, there were few 

incidents reported to IDS involving bensulide. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-201 I, 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 obta ins 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. 

A query of SENSOR-Pesticides 1998-201 1 identifies a total of 38 cases involving (pc code 

00980 I). Of these 38 cases, 17 cases, stemming from seven events, involve a single ai and will 

be reviewed here. Fourteen cases were low in severity and three cases were moderate in 

severity. Sixteen cases were occupational exposure. A total of 14 of the single ai cases reports 

were caused by drift. 1 One drift event whi ch occurred in Cali fornia in 2008, resulted in eight 

symptomatic cases, including all three of the three moderate severity case reports. This event 

was investigated by CDPR and resulted in violations that cited, in particular, the applicator 

failing to notify workers in the adjacent field that an application was taking place. A second dri ft 

event whi ch aJso occurred in California in 2008, resulted in four symptomatic cases. Eleven 

cases reported gastrointestinal symptoms including nausea (n=9) and vomiting (n=6) and eleven 

cases reported nervous system symptoms, primarily headache (n=9). 

c. Agricultural Health Study (AHS) 

The AI-IS is a high quality, prospective epidemiology study evaluating the link between pesticide 

use and various health outcomes including cancer. The AI-IS 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. Bensulicle is not included in the AHS, and 

therefore this study does not provide information for this report. 

1 SENSOR-Pesticides defines drift as "off-target movement of pesticide" which includes cases of volatilization. 

Page 4 of 5 
IV. CONCLUSION 

Based on the low frequency of incidents, involving bensulide reported to both IDS and 

SENSOR-Pesticides, there does not appear to be a concern at this time. The Agency will 

continue to monitor the incident information and if a concern is triggered, additional analysis 

wi ll be conducted. 

Page 5 of 5