UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Date: April 17, 20 13 

### SUBJECT: Propylene Oxide: ReviewofHuman Incidents PC Code: 042501 Decision No.: 476419 Petition No.: NA RiskAssessmentType: NA TXRNo.:NA MRIDNo.:NA DPBarCilde: 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: DavidJ. 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 reasonthere does not appear to be a concern atthis time that would warrant further investigation. The Agency will continue to monitor the incident infonnation and ifa concern is triggered, additional analysis will be included inthe risk assessment. Page 

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### •The Agricultural Health Study (AHS) is also a potential source ofinformation associated with human health effects associated with certain pesticides. Propylene oxide is not incl

. uded in the AHS, andtherefore this study does provide information for this report.

Detailed Review 

### I. ACTION REQUESTED Thisreview is intended to fulfill ourrequirement to docket summaries ofincidentdatathat were reportedto the Agency, as well asto ensure human incidentdataandthe Agricultural Health Study (AHS) are 

## part oftheproblem formulation phase ofregistration review. Reports of adverse health effects allegedly due to a specific pesticide exposure 

### (i.e., an "incident") are largely self-reported andtherefore, generally speaking, neither exposure to a pesticide or reported symptom (or the connectionbetweenthe two) is validated orotherwise confirmed. Typically, causation cannotbe determined based on incidentdata. However, incident information can be animportant source offeedback to the Agency: incidents ofsevere outcome, or a suggested patternortrend among less severe incidents, can signal the Agency to further investigate a particular chemical orproduct. Observational epidemiology studies relate the risk ofdisease, 

### e.g., cancer, and exposure to an agent suchas a pesticide product inthe general population or specific sub-groups like pesticide applicators. 

### II. BACKGROUND Propylene oxide (PPO) is aninsecticidal fumigant and sterilant used both to control bacterial contamination, mold contamination, insect infestations, and microbial spoilage offood products as well asto control insects in nonfood products. PPO is formulated as a pressurized liquid and/or gas.**End~**use products containing PPO canbe applied indoors oroutdoors as a gas in vacuum-sealed pressurized changers. PPO can also be applied outdoors as a gas in other types of chambers andin/underloose-fitting structures suchastrailers, rail cars, tents ortarps where gas is confined and entry is restricted during fumigation. PPO is registered for use on several food items suchas dried herbs and spices, dried onions, dried garlic, cacao beans, cocoapowder and in-shell and processed nutmeats (except peanuts). 1 Forthis 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 ofthe database search is toidentify potential patterns in the frequency and severity ofthe 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

12006 Reregistration Eligibility Decision (RED) Docwnent for Propylene Oxide: http://www.epa.gov/oppsrrdl!REDs/propylene oxide red.pdf Page2 of4various 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 DataSystem) OPP's IDS includes reports ofalleged 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 statehealth and environmental agencies, and individual consumers. Since I992, 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:

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, andit includes information aboutthe location, date and nature ofthe 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 ofexposure from the pesticide.

o Aggregate IDS contains incidents resulting in less severe human incidents (minor, unknown, orno effects outcomes). These are reported by registrants only as counts inwhat are aggregate summaries. For the Main IDS, from January 1, 2008 to February 19, 2013, there were no incidents reported inthe database involving propylene oxide. InAggregate 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 ofpesticide-related illnesses are ascertained from a variety ofsources, including: reports from local Poison Control Centers, state Department ofLabor workers' compensationclaims when reported byphysicians, reports from State Departments of Agriculture, and physician reports to state Departments ofHealth. Although both occupational and non-occupational incidents are included inthe database, SENSOR-Pesticides focuses on occupational pesticide incidents, andis ofparticular value in providing that information. The state coordinator at each ofthe 1 I respective state Departments ofHealth conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using Page3 of4standardizedprotocol and case definitions derived from poison center reporting, the state SENSOR-Pesticide coordinatorenters the incident information into the state-based system which is sent to NIOSH annually to be aggregated. A query ofSENSOR-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. Ifthere are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem formulationlscoping phase ofthe process and, ifappropriate, fully reviewed inthe risk assessment phase ofthe process. The AHS includes informationonuse of

### 50 different pesticide active ingredients commonly used in agriculture. Propylene oxide is not included in the AHS. 

### IV. CONCLUSION Nocases involving propylene oxide were identified in IDS orSENSOR-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 monitorthe incident information and ifa concern is triggered, additional analysis will be included in the risk assessment.

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