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Ethylene oxide (EtO) is produced in large volumes and is primarily used as an intermediate in the production of several industrial chemicals, the most notable of which is ethylene glycol. It is also used as a fumigant in certain agricultural products and as a sterilant for medical equipment and supplies. Unfortunately, EtO possesses several physical and health hazards that merit special attention. EtO is both flammable and highly reactive. Acute exposures to EtO gas may result in respiratory irritation and lung injury, headache, nausea, vomiting, diarrhea, shortness of breath, and cyanosis. Chronic exposure has been associated with the occurrence of cancer, reproductive effects, mutagenic changes, neurotoxicity, and sensitization.
Scope
OSHA’s EtO requirement applies to all occupational exposures EXCEPT the following:
- The processing, use, or handling of products containing EtO where objective data are reasonably relied upon that demonstrate that the product is not capable of releasing EtO in airborne concentrations at or above the action level under the expected conditions of processing, use, or handling that will cause the greatest possible release.
Regulatory citations
- 29 CFR 1910.1047 — Ethylene oxide
Key definitions
- Action level: A concentration of airborne EtO of 0.5 ppm calculated as an eight (8)-hour time-weighted average.
- Authorized person: Any person specifically authorized by the employer whose duties require the person to enter a regulated area, or any person entering such an area as a designated representative of employees for the purpose of exercising the right to observe monitoring and measuring procedures under paragraph (l) of this section, or any other person authorized by the Act or regulations issued under the Act.
- Emergency: Any occurrence such as, but not limited to, equipment failure, rupture of containers, or failure of control equipment that is likely to or does result in an unexpected significant release of EtO.
- Employee exposure: Exposure to airborne EtO which would occur if the employee were not using respiratory protective equipment.
- Ethylene oxide or EtO: The three-membered ring organic compound with chemical formula C(2)H(4)O.
- Permissible Exposure Limit or PEL: One (1) part EtO per million parts of air (1 ppm) as an (8)-hour time-weighted average (8-hour TWA). Also note the “Excursion limit,” of 5 parts of EtO per million parts of air (5 ppm) as averaged over a sampling period of fifteen (15) minutes.
Summary of requirements
If employee exposures exceed either the PEL or the excursion limit, employers must take the following actions:
- Use engineering controls and work practices to control employee exposure.
- Establish and implement a written compliance program to reduce exposures to or below the TWA and exposure limit.
- Establish personal air monitoring as well as information and training programs for employees exposed to EtO at or above the action level or above the excursion limit. Conduct training upon initial job assignment and annually.
- Establish a regulated area wherever airborne concentrations of EtO are expected to exceed the 8-hour TWA or the excursion limit.
- Establish a medical surveillance program for employees exposed to EtO at concentrations above the action level of 0.5 ppm, measured as an 8-hour TWA, for more than 30 days per year.
- Place warning labels on all containers that might cause employee exposures at or above the action level or excursion limit.
- Remember that employee rotation is prohibited as a means of compliance with the 8-hour TWA or exposure limit.
- Select, provide, and maintain appropriate personal protective equipment and ensure that employees use it to prevent skin and eye contact.