EPA Hearing on EtO Draws Debate
The U.S. Environmental Protection Agency held a public hearing in Washington, D.C., Jan. 16, to allow stakeholders to speak directly to the Agency about proposed changes to the regulation of ethylene oxide (EtO).
Specifically, EPA is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Miscellaneous Organic Chemical Manufacturing category, often called MON. These amendments would require risk reviews to address EtO emissions from storage tanks, process vents and equipment leaks. In addition, EPA would require additional start/stop monitoring by manufacturers of EtO.

A number of stakeholders representing EtO manufacturers and environmental organizations addressed a panel of EPA representatives.
Epidemiologist Kenneth Mundt, MD, suggested EPA’s data showing increased rates of breast cancer among workers exposed to EtO “grossly inflated the risk,” citing a research paper his team published in December (1). Bill Gulledge, Senior Director of the Chemical Products and Technology Division with the American Chemistry Council and head of ACC’s EtO Committee expressed concern that these proposed MON amendments could result in shortages in a number of industries, including healthcare.
Other stakeholders represented environmental concerns regarding EtO manufacturing plants and the impact on nearby communities. Genna Reed of the Union of Concerned Scientists, Kathleen Riley of Earthjustice, Stephanie Herron of the Environmental Justice Health Alliance for Chemical Policy Reform, and Jennifer Sass of the Natural Resources Defense Council, all urged EPA to implement the proposed amendments. Another speaker, representing citizens living near EtO manufacturing facilities, Jennifer Burton, urged those industries that rely on EtO to consider using these more stringent regulations as “an opportunity to innovate” and look to new technologies to replace or reduce EtO.
Reference
- Vincent, M., et al. “Ethylene Oxide: Cancer Evidence Integration and Dose–Response Implications.” Dose Response 17 (2019) https://www. ncbi.nlm.nih.gov/pmc/articles/PMC6906442/