New Restrictions on Use of Ethylene Oxide Gas Proposed

EPA recently proposed stricter air emissions standards and new worker protections for ethylene oxide (EtO), a flammable, colorless gas used mainly to sterilize medical equipment. EPA estimates that the new, stricter regulations will cut EtO emissions from commercial sterilization facilities by 80% per year, significantly reducing potential cancer risk from exposure.  

EPA will accept stakeholder and public comments on both proposed actions until June 12, 2023.  

Ethylene Oxide Air Emissions Rules (Clean Air Act) 

EPA's proposed Clean Air Act rule covers 86 sterilization facilities in the US and aims to reduce EtO emissions. The regulation, if finalized, would require these facilities to:  

• Install/use stricter pollution control technology,
• Monitor air emissions using advanced methods, and
• Report to US EPA twice per year,

To achieve this, the rule revises the National Emissions Standards for Hazardous Air Pollutants (NESHAP) that cover commercial sterilization facilities. Covered facilities will have 18 months to achieve compliance with new and stricter provisions (if the rule becomes final) EPA says.

EPA will accept comments from stakeholders and the public on the new NESHAP Rule for commercial sterilization facilities until June 12, 2023. 

Ethylene Oxide Worker Protections (FIFRA)

A second proposal, authorized under FIFRA, increases control measures for certain uses of ethylene oxide: It restricts the amount of EtO that may be used to sterilize medical devices, for example, and prohibits some uses of the chemical in museums, document archives, beekeeping, some cosmetics, and musical instruments (when alternatives exist).

Engineering controls to reduce worker exposure to ethylene oxide would be required as well, if EPA's proposed "Interim Decision and Draft Risk Assessment" for ethylene oxide takes effect. The decision would also mandate personal protective equipment (PPE) in sterilization facilities with detectable levels of EtO (> 10 parts per billion). 

The public comment period for EPA's decision and risk assessment for ethylene oxide under FIFRA closes on June 12, 2023.   

Worker Protections …from EPA?

While “worker protection” is mostly OSHA’s bailiwick, several environmental laws authorize or direct US EPA to create regulations that protect workers from exposure to environmentally hazardous substances that pose health risks. 

FIFRA—the Federal Insecticide, Fungicide, and Rodenticide Act—is one of those laws. The regulations implementing FIFRA require pesticide manufacturers, distributors, and users to comply with extensive notification and reporting requirements, labeling standards for products/packages, use restrictions, and worker protections.  

Ethylene oxide (C₂H₄O) is regulated as a pesticide product under FIFRA because it’s used to kill bacteria, microorganisms, and pests on medical equipment and other surfaces. The chemical has been been used as a sterliant, disinfectant, and fumigant to protect or preserve items that are too heat- or moisture sensitive to be sterilize with steam or other common methods. 

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Tags: Chemical safety, Clean Air Act, ethylene oxide, FIFRA, NESHAP