By Ed Stuber, CIH, ROH, FAIHA

Recently, I conducted an informative AIHA webinar on ethylene oxide (EtO). Considering the growing concern surrounding the safeguarding of individuals enduring prolonged exposure to EtO or its derivatives, I shared the latest from the Interstate Technology and Regulatory Council (ITRC), as well as proposed regulation updates from the EPA.
Ethylene oxide is used to produce ethylene glycol and other chemicals for a range of products, including antifreeze, textiles, plastics, detergents, and adhesives. It also represents about 50% of single-use medical device sterilization globally, as steam or radiation is not always effective.

In 2008, the International Agency for Research on Cancer (IARC) of the World Health Organization classified EtO as a Class 1 carcinogen, as did the EPA in 2018, lowering safe limits 30X to 0.2 ppb – 1 in 1,000,000.

The ITRC, a state-led environmental coalition, studies issues such as EtO, with a goal of creating innovative solutions and best management practices. Their reporting is used by the EPA to revise and develop new legislation. The EPA is presently proposing the following new pieces of legislation related to EtO:

  • Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA has proposed increased protections for workers and community members exposed to EtO when it is used to sterilize products.
  • Under FIFRA, the EPA has also proposed a new requirement that all workers in a facility workers wear personal protective equipment when EtO concentrations exceed 10 parts per billion (ppb) based on real-time monitoring. This also includes employees that aren’t directly working with EtO.
  • The EPA has also proposed National Emission Standards for Hazardous Air Pollutants (NESHAP) as an interim proposal for EtO emissions from commercial sterilizers into ambient air.

SGS Galson has provided quality routine EtO analytical services for years, and our innovations in EtO analysis are unmatched. We answered the call when our clients requested an evacuated canister method at the extremely low levels for ambient air analysis with the development of validated GCMS analysis by EPA TO-15 SIM. Click here to learn more about our EtO services.

As with all our analysis and monitoring solutions, we’ll continue to innovate, provide quality services, and answer all your questions. If you’d like the full details of my AIHA webinar, “Ethylene Oxide: Update from the ITRC and EPA”, please click on the link below for a video of the entire session.

Click here to watch a recording of the webinar.

We are SGS – the world’s leading testing, inspection and certification company.

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