UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: June 9, 2015 

SUBJECT: Profenofos: Tier I Update Review of Human Incidents/Epidemiology for Draft 

Risk Assessment 

PC Code: 111401 

Decision No.: 482022 

Petition No.: 1 /\ 

Risk Assessment Type: , /\ 

TXR No.: NA 

i\IRID No.: NA 

DP Barcode: 0427690 

Registration No.: NA 

Regu latory Action: A 

Case No.: NA 

CAS No.: .ti 198-08-7 

.tO CFR: N/\ 

FROM: ¥ ( 

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Shann

ico

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logy 

Recore, 

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Epidem

dustrial 

iology 

Hygi

Branch 

enist 1 ~ ~ ' 

Health Effects Division (7509P) 

and 

Elizabeth Evans. Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Ver.Apr.OS 

T HROUGH: David J. Miller, Acting Branch Chief fil~ r;/<f/ /<;;; .f rToxicology and Epidemiology Branch / -

TO: 

Health Effects Division (7509P) 

Monique Perron, Risk Assessor 

Risk Assessment Branch I 

Health Effects Division (7509P) 

and 

Christina Scheltema, Chemical Review Manager 

Risk Management & Implementation Branch 3 

Pesticide Re-evaluation Division (7508P) 

ummary and Conclusions 

Profenofos was previously reviewed in 1996 (V. Dobozy. 02/29/1996. Pro.feno.fos - Re\·iell' of 

Pesticide Poisoning Incident Dara). At the time. three human incidents were found in Main IDS. 

Upon review of these incidents. it was concluded that ··The low number of cases of poisoning due 

to this chemical prevents recommendations on specific use practices or labeling changes." 

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The current IDS analysis from January I, 2010 through January 13, 20 15, shows no incidents 

reported involving profenofos in either Main IDS or Aggregate IDS. Further, a query of 

SE SOR-Pesticides 1998-2011 identifies 13 single ai incidents for profenofos. 12 of which were 

low in severity. 

Based on the low frequency and mostly low severity of incident cases reported for profenofos in 

both IDS and NIOSH SENSOR-Pesticides. there does not appear to be a concern at this time that 

would warrant fu11her investigation. The Agency will continue to monitor the incident 

information and if a concern is triggered. additional analysis will be conducted. 

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

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

and therefore this study does not provide information for this report. 

Detailed Review 

I. ACTION REQUESTED 

Profenofos arc 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 

confim1ed. Typicall y, causation cannot be detennined based on incident data. r Iowever, 

incident in formation 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 

Profenofos is a restricted use pesticide. It is an insecticide/miticide used solely on canon. to 

control the tobacco budworm. cotton bollwom1. armyworm. cotton aphid. whitetlies. spider 

mites, plant bugs. and flea hoppers. 

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

and Prevention/National Institute for Occupational Safety and I lealth (CDC/NIOSH) Sentinel 

Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were 

consulted for pesticide incident data on the active ingredient profenofos (PC Code: 111401). 

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

of the health effects attributed to profenofos exposure. 

In addition, findings from the Agricultural Health Study (AHS) were reviewed. The AHS is a 

high quality, prospecti ve epidemiology stud y eva luating the li nk between pesticide use and 

various health outcomes including cancer. Profenofos 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 TDS includes reports of alleged human health inc idents from various sources, including 

mandatory Federal Insecti cide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports 

from registrants, other fede ral 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 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 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 summari es. 

From January I, 20 10 to January 13. 2015. there were no incidents reported to either Main or 

Aggregate IDS involving profenofos. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-20 I 1, although reporting varies 

from state to state. Cases of pesticide-related illnesses are ascertained from a vari ety 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 SE SOR 

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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 lo participating slates and EPA. 

A query or SENSOR-Pesticides from 1998-20 11 identifies a total of 20 cases involving 

profenofos (pc code 11140 I): 13 of these cases are single ai and \Viii be analyzed for the memo. 

These 13 single ai cases stem from 3 events: one of these event resulted in 11 cases. details of the 

case are included in the next paragraph. Of the 13 single ai cases. 12 were low in severity and 

one case was moderate in severity. The moderate severity cases occurred in California in 1998 

and there is no detail provided on the circumstances. Of the 13 single ai cases. 11 cases 

experi enced gastrointestinal symptoms, including abdominal pain, nausea. and diarrhea. Eight 

cases experienced respiratory symptoms including respiratory pain and cough. Some cases a lso 

reported headaches and eye irritation. Also. 12 of the 13 cases resulted from aeri al applications. 

Specifically 11 cases were made ill from spray drift (all 11 narrati ves indicate spray drift from 

aerial application and not volatilization) and one case was directl y sprayed overhead by the aeria l 

appl icalor. 

One event in Texas in 2005 led to I I cases made ill. This event occurred when an aerial 

application as made to a cotton field that was adjacent to a school and residential area. Five 

young children and six adults at the school or in their homes were made ill by this event. 

SENSOR-Pesticides 1998-2011 

Profenofos Cases (single ai) 

N=13 

Case ID Severity Case Descriptions -

CA03698 moderate Description not provided 

LA00989 low Working on train and as crop duster fl ew overhead subject reported fee ling a mist. 

TX04630 low Exposed to drift from aerial application made to nearby cotton field. case lives in 

school property. 

TX04713 low Exposed to residue from aerial application to cotton field next to school, where case 

works. 

TX04714 low Outside when crop duster made application to nearby cotton field, felt mist and smelled 

product 

TX04715 low Outside their residence playing during aerial application to nearby cotton field, exposed 

to drift. 

TX047 16 IO\.V 

Kids were outside their residence playing during aerial application to nearby cotton 

field. went outside to get them in 

TX04717 low Kids were outside their residence playing during aerial application to nearby cotton 

field, went outside to get them in 

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TX04718 low Outside their residence playing during aerial application to nearby cotton field, exposed 

to drift. 

TX047 19 low Inside home w/window down during aerial application to nearby cotton field. Went 

outside shortly after application 

TX04720 low Inside home w/window down during aerial application to nearby cotton field. Went 

outside shortly after application 

TX0472 1 low 

Inside home w/window down during aerial application to nearby con·on field. Went 

outside shortly after application 

TX04722 low Inside home w/window down during aerial application to nearby cotton field. Went 

outside shortly after application 

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. The AHS includes information on use of 50 different 

pesticide active ingredients commonly used in agriculture. Profcnofos 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 mostly low severity of incident cases reported for profenofos in 

both IDS and N IOSH 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 conducted. 

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