States Temporarily Relax EtO Restrictions

In light of the need for effectively sterilized personal protection equipment (PPE) due to the COVID-19 outbreak, state and federal regulatory signs indicate support for increased sterilization operations.

In 2019, officials in Illinois and Georgia raised questions regarding medical device manufacturing facilities using ethylene oxide (EtO) for sterilization, leading to separate U.S. FDA and EPA hearings (1,2). In particular, environmental protection agencies in those states were concerned about exposure to EtO in communities surrounding these plants. In response, representatives from medical device manufacturers and patient groups argued closures of these facilities could lead to device shortages (1).

In the midst of the COVID-19 outbreak, these same state regulators have, in some cases, postponed expanded EtO restrictions.

On March 27, the Illinois EPA announced that device manufacturer Medline Industries could resume sterilization at the company’s Waukegan, Ill. plant as environmental testing indicated the plant had complied with state caps on EtO release (3). Medline implemented new emissions systems to comply with state testing (3).

Also in late March, the EPA announced that an agreement between the Georgia Environmental Protection Division and Becton Dickinson (BD) had been reached to temporarily increase the number of medical devices sterilized at BD facilities in two locations within the state (4). The announcement directly pointed to the “increased need for sterile medical equipment during the COVID-19 response” (4).

Following this, a U.S. District Court issued a restraining order temporarily allowing Sterigenics, a company that conducts sterilization for a number of industries including medical devices, to reopen a site in Cobb County, Ga. that had been closed since August (5). In turn, Cobb County agreed to allow the site to continue operations past the temporary deadline set by the U.S. District Court, citing the COVID-19 crisis (5).

A proposed EPA rule would require chemical plants using EtO to reduce emissions by ten tons per year and implement stricter controls on leaks (6). Comments on this rule change closed Jan. 31. At this time, EPA has made no further announcements regarding the rule change.

References

1. Stauffer, R. “FDA Panel Addresses EtO Sterilization.” PDA Letter (Dec. 2, 2019)
2. Stauffer, R. “EPA Hearing on EtO Draws Debate.” PDA Letter (Jan. 21, 2020)
3. “Illinois EPA Announces the Successful Completion of Compliance Testing at Medline Industries, Inc.” ILLINOIS.gov (March 27, 2020) https://www2.illinois.gov/Pages/news-item.aspx?ReleaseID=21315
4. “Efforts Underway to Increase Sterilization Capacity in Response to the COVID-19 Pandemic.” U.S. EPA (March 25, 2020) https://www.epa.gov/newsreleases/efforts-underway-increase-sterilization-capacity-response-covid-19-pandemic
5. “Latest on Sterigenics Plant situation.” Cobb County Government (April 8, 2020) https://www.cobbcounty.org/communications/news/latest-sterigenics-plant-situation
6. “National Emission Standards for Hazardous Air Pollutants: Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review,” U.S. EPA, Dec. 17, 2019 https://www.federalregister.gov/documents/2019/12/17/2019-24573/national-emission-standards-for-hazardous-air-pollutants-miscellaneous-organic-chemical