In our earlier post, Public and Regulatory Attention to Forever Chemicals is at an All-Time High, we discussed the expected and upcoming regulation of per- and polyfluoroalkyl substances (“PFAS”). Another chemical expected to see further federal regulation and enforcement action that should be on the radar of many companies is ethylene oxide (EtO).
EtO is a flammable, colorless gas that is used to sterilize equipment and products that cannot be otherwise sterilized using steam or extreme heat, such as medical components, food products (herbs and spices), and cosmetics. EtO is also used in manufacturing a vast number of products, including antifreeze, fabrics, textiles, plastics, cleaners, detergents, adhesives, and many other chemicals such as glycol and polyglycol ethers, emulsifiers, and solvents. According to the U.S. Environmental Protection Agency (EPA) website, EtO is critical for sterilizing medical equipment and thus necessary to protect public health.
The agency has prioritized efforts to reduce EtO emissions and their impact on human health and the environment. For many health advocates, however, the agency hasn’t moved fast enough or done enough. This is mainly because, in December 2016, EPA classified EtO as a human carcinogen after the agency released an updated Integrated Risk Information System unit risk estimate for EtO. The risk estimate indicated that cancer risks from EtO were significantly higher than the agency previously understood. Further, many of the facilities that use and emit EtO are located in and around lower income and minority communities and the Biden Administration and EPA Director Regan have identified this issue as an environmental justice concern.
The agency’s current efforts to reduce EtO’s impact on human health and the environment fall into two main areas: air emissions and use as an antimicrobial pesticide, in this case, a sterilant. The following post will walk through some of the regulatory history of emissions regulation and examine what is on the horizon.
An Overview of Federal EtO Emissions Regulation
The federal regulation of EtO emissions dates back further than 2016. In December 1994, EPA established the National Emission Standards for Hazardous Air Pollutants (NESHAP) for EtO Commercial Sterilization and Fumigation Operations. EtO is now one of the hazardous air pollutants listed under the 1990 amendments to the Clean Air Act.
According to the rule and fact sheet, the NESHAP established emission standards for both major sources and area sources. The standards require existing and new major sources that use at least 1 ton of EtO in sterilization or fumigation operations in any 12-month period to control emissions to the level achievable by the maximum achievable control technology and require existing and new area sources at the same utilization level to control emissions using generally available control technology. Recordkeeping and monitoring requirements are also imposed.
EPA completed a residual risk and technology review for the NESHAP in 2006. The agency concluded that the risk under existing standards was acceptable and provided an ample margin of safety.
After the carcinogen classification in 2016, the National Air Toxics Assessment (NATA) was released in August 2018. The assessment identified EtO emissions as an important risk driver in several areas across the nation. EPA decided to evaluate potential options to reduce emissions of EtO from several source categories, including the commercial sterilization sector. Throughout 2019-2021, EPA exercised its regulatory authority under Section 114 of the Clean Air Act to request information from sterilization operators and those that use the compound in manufacturing operations. According to the agency, this information gathering exercise was to better understand the emissions sources, measurement and monitoring techniques, and available control technologies and their associated efficiencies and to evaluate opportunities to reduce EtO emissions through potential rule revisions.
In December 27, 2021, the agency expanded its Toxics Release Inventory (TRI) reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA) to include 29 contract sterilization facilities that were not currently obligated to report on EtO releases. EPA included these facilities because “they use the highest amounts of EtO in the contract sterilization sector.” In addition, EPA also “considered additional factors, including these facilities’ proximity to population centers and their history of releases of EtO emissions.” Companies should ensure compliance with these new TRI reporting obligations under Section 313 of EPCRA.
States and Private Citizens Have Taken Action in the Absence of Further Federal Regulation
As EPA conducts additional studies and data gathering efforts, states have taken action on several fronts. First, legislatures in many states have enacted laws to restrict EtO emissions within their borders. Second, there has been a significant uptick in state Attorney Generals filing actions against private companies that emit EtO and working to shutter many facilities. Lastly, on October 11, 2019, Maryland Attorney General Brian E. Frosh joined a coalition of 14 states urging the U.S. EPA to propose and finalize stricter standards for EtO emissions. A similar letter was circulated in February 2020. As EPA continues to study EtO in greater depth, we expect more legislative, regulatory, and enforcement action at the state and local level.
In addition, hundreds of private lawsuits have been filed against EtO emitters. Many of these lawsuits are brought by local communities located near emitting facilities to curb releases to the environment and to remedy personal injury claims based on alleged environmental or occupational exposure. One of the largest of these lawsuits was filed by 30+ plaintiffs, both workers and community members, against B. Braun Medical Company in Allentown, Pennsylvania. This case in pending.
Companies Should Be Thinking about Regulatory and Litigation Risk Mitigation
Due to the 2016 classification of EtO as a human carcinogen and the regulatory attention that has resulted under the Biden Administration and U.S. EPA Administrator Regan, the new NESHAP will most likely be revised to include stricter emission reductions and require more sources to reduce emissions. The final rule is expected in late 2022 or early 2023 and will be circulated for public comment. Companies that use and emit EtO should be mindful of the governmental regulatory issues and litigation risks that may be coming.
There are several ways to begin minimizing future regulatory enforcement and litigation risk.
Compliance: The first way to minimize future regulatory enforcement and litigation risk is to ensure compliance with any existing permits or regulations. According to some agency guidance documents, EtO sterilizers and users may require an air quality operating permit from a state agency such as the Maryland Department of the Environment. Further, companies should ensure compliance with any new TRI reporting obligations under EPCRA. Proactively working with EPA and the state or local agency to understand compliance is crucial to meeting obligations and to reducing risk from enforcement and third-party litigation from workers and the community.
Process Assessment: To prepare for any upcoming emissions reduction obligations and reporting requirements, companies should consider conducting a technical and operational assessment that includes a review of all compliance monitoring data, a review of current potential emission points, assessing options for readily available equipment upgrades to prevent and reduce emissions, and addressing community engagement. Having this information will be critical to quickly meeting new obligations.
Public Comments: When the proposed rule is published for public comment later this year or next, companies should consider submitting public comments on the revised standards and rule implementation and address any operational or compliance risks they see.
Opinions and conclusions in this post are solely those of the author unless otherwise indicated. The information contained in this blog is general in nature and is not offered and cannot be considered as legal advice for any particular situation. The author has provided the links referenced above for information purposes only and by doing so, does not adopt or incorporate the contents. Any federal tax advice provided in this communication is not intended or written by the author to be used, and cannot be used by the recipient, for the purpose of avoiding penalties which may be imposed on the recipient by the IRS. Please contact the author if you would like to receive written advice in a format which complies with IRS rules and may be relied upon to avoid penalties.
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