UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: April 17, 20 13 

SUBJECT: Propylene Oxide: Review of Human Incidents 

PC Code: 042501 

Decision No.: 476419 

Petition No.: NA 

Risk Assessment Type: NA 

TXRNo.:NA 

MRIDNo.:NA 

DP BarCilde: 410806 

Registration No.: NA 

Regulatory Action: NA 

CaseNo.:NA 

CAS No.: 75-56-9 

40CFR:NA 

Ver.Apr.08 

Elizabeth Evans, Environmental Protection Specialist Q 

Toxicology and Epidemiology Branch e>c.fZ_v1't~V! ~ 

Health Effects Division (7509P) d ·- - -' t-> ~ 

FROM: 

and 

Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

;Health Effects Division (7509P) 

/) )' lf'/fl. !'l.oy'/;/!1-0t:J 

THROUGH: David J. Miller, Acting Branch Chief (.{4/ '1/Ef/1 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: Thurston Morton, Risk Assessor 

Risk Assessment Branch IV 

Health Effects Division (7509P) 

and 

Andrea Mojica, Chemical Review Manager 

Risk Management & Implementation Branch IV 

Pesticide Reevaluation Division (7508P) 

Summary and Conclusions 

No cases involving propylene oxide were identified in IDS or SENSOR-Pesticides. For this 

reason there does not appear to be a concern at this time that would warrant further investigation. 

The Agency will continue to monitor the incident infonnation and if a concern is triggered, 

additional analysis will be included in the risk assessment. 

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

human health effects associated with certain pesticides. Propylene oxide is not incl.uded in the 

AHS, and therefore this study does provide information for this report. 

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 

Propylene oxide (PPO) is an insecticidal fumigant and sterilant used both to control bacterial 

contamination, mold contamination, insect infestations, and microbial spoilage of food products 

as well as to control insects in nonfood products. PPO is formulated as a pressurized liquid 

and/or gas. End~ use products containing PPO can be applied indoors or outdoors as a gas in 

vacuum-sealed pressurized changers. PPO can also be applied outdoors as a gas in other types of 

chambers and in/under loose-fitting structures such as trailers, rail cars, tents or tarps where gas 

is confined and entry is restricted during fumigation. PPO is registered for use on several food 

items such as dried herbs and spices, dried onions, dried garlic, cacao beans, cocoa powder and 

in-shell and processed nutmeats (except peanuts).1 

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 propylene oxide (PC Code: 

042501 ). The purpose of the database search is to identify potential patterns in the frequency 

and severity of the health effects attributed to Propylene oxide exposure. 

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

high quality, prospective epidemiology study evaluating the link between pesticide use and 

1 2006 Reregistration Eligibility Decision (RED) Docwnent for Propylene Oxide: 

http://www.epa.gov/oppsrrd l!REDs/propylene oxide red. pdf 

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various health outcomes including cancer. Propylene oxide is not included in the AHS and 

provides no 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 I 992, 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. Tills 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, 2008 to February 19, 2013, there were no incidents reported 

in the database involving propylene oxide. 

In Aggregate IDS, from January 1, 2008 to February 19, 2013, there were no reported incidents 

involving propylene oxide. 

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 of Health. 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 1 I respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using 

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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 1998-2009 finds no cases involving propylene oxide. 

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 formulationlscoping 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. 

Propylene oxide is not included in the AHS. 

IV. CONCLUSION 

No cases involving propylene oxide were identified in IDS or SENSOR-Pesticides. For this 

reason 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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