After years of delays – largely due to the COVID-19 pandemic – on April 11, 2023, the U.S. Environmental Protection Agency finally issued two proposals that would reduce ethylene oxide (EtO) emissions affecting fence-line communities neighboring EtO sterilization facilities and establish direct protections for facility employees likely to be regularly exposed to this sterilizing chemical. The proposals, which fall under the Clean Air Act (CAA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), are expected to dramatically reduce EtO emissions by a whopping 80% annually and strengthen worker protections. Among the industries that will be impacted by the proposals are medical device and instrument manufacturing, pharmaceutical preparation, spice and extract purifying, and packaging and labeling services.
The long-awaited proposals come on the heels of a separate action announced by the EPA last week, a proposal to strengthen standards for synthetic organic chemical plants as well as polymers and resins plants, projected to reduce EtO-emissions risks to people who live near these facilities, which make and use EtO in their manufacturing processes.
Clean Air Act Proposal
The EPA has proposed a revision to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Commercial Sterilization Facilities, which are stationary source standards for hazardous air pollutants pursuant to the CAA, by amending existing standards and establishing additional standards in order to tighten EtO protections. Among the industries impacted by the proposals are medical devices and instrument manufacturing, pharmaceutical preparation, spice and extract purifying, and packaging and labeling services.
The revision aims to accomplish a few things. First, the EPA is proposing emission standards for a number of currently underregulated emission sources of EtO. Second, the EPA is proposing risk-based standards to protect public health. Finally, the EPA is proposing emission standards based on the EPA’s review of developments in practices, processes, and control technologies for commercial sterilization facilities. EPA’s proposed rule states that there are “86 commercial sterilization facilities in this source category, many of which are located near residences, schools, and other public facilities.” EPA further explained that it “has determined that approximately 23 of these facilities pose elevated lifetime cancer risks to the surrounding communities, some of which are exceptionally high.”
The EPA believes that this proposed rule reflects the EtO toxicological assessment the agency undertook in December 2016, which concluded that EtO, when breathed in for extended periods of time, is a far more potent carcinogen than previously understood. Indeed, the EPA updated EtO’s toxicity value in 2016, finding that the chemical was 60 times more toxic than previously estimated. However, the EPA has acknowledged the difficulty of crafting the new subject standards. As we have conveyed in prior ELM posts related to EtO, “commercial sterilization facilities play a vital role in maintaining an adequate supply of medical devices,” a fact learned the hard way during COVID when widely available sterilized equipment and supplies – 20 billion are sterilized per year in the U.S. alone – was literally a matter of life or death.
If enacted, these proposed amendments would reduce EtO emissions from this source category by 19 tons per year. They would also reduce EtO-emissions risks to public health to levels deemed acceptable by the EPA, which has emphasized throughout recent EtO community outreach meetings held in communities most severely at risk from facility emissions (previously reported by ELM here) its reliance on modeling that errs on the side of caution.
FIFRA Proposal
The EPA also issued a Proposed Interim Registration Review Decision for EtO under FIFRA. By way of background, all pesticides distributed or sold in the U.S. must be registered by the EPA, with scientific data showing that they will not cause unreasonable adverse effects to human health or to the environment when used as directed on product labeling. FIFRA mandates the continuous review of existing pesticides every 15 years to ensure that risk assessments and decisions reflect the best available science. As such, the EPA has also been evaluating EtO as part of its registration review process.
Through this registration review of EtO, the EPA will determine whether EtO continues to meet the standard for registration under FIFRA. EPA has determined that mitigation of inhalation risk concerns is necessary to meet that standard for continued registration. The EPA says, “The registered pesticidal uses of EtO pose inhalation risks to workers inside commercial sterilization facilities, healthcare facilities, and has the potential to pose inhalation risks to communities near facilities where EtO is used.” Mitigating the inhalation risk concerns will come in the form of a number of regulations relating to:
- Proposing use-rate reductions through reduced concentrations;
- Series of engineering controls within commercial sterilization facilities and healthcare facilities;
- Respiratory protection requirements for commercial sterilization facilities;
- Monitoring, training, and recordkeeping requirements; and
- Establishing an action limit based on the current lowest technologically measurable limit.
The EPA has also proposed to terminate the use of EtO for certain niche sterilization purposes involving museum and library materials, archival materials, cosmetics, musical instruments, and beekeeping equipment.
Continued EPA Outreach and Public Participation in the EtO Rulemaking Process
As for the public’s role in the rulemaking process, the EPA is encouraging all affected stakeholders to participate in the public comment process for the proposed rules, which can be found in the Federal Register. The EPA will also host a public webinar the evening of May 1, 2023. Public hearings on the proposal to reduce EtO emissions from Commercial Sterilization Facilities will be held on May 2, and May 3, 2023. The public has until June 12, 2023, to submit its comments on publicly accessible dockets.
In its April 11 announcement, the EPA emphasized that the draft EtO rules were not the end of the road for the agency’s reinvigorated oversight of and outreaching concerning EtO emissions. Indeed, the EPA promised it would continue to:
- Work with state and local partners to reduce EtO emissions during the Clean Air Act rulemaking process;
- Identify sterilization alternatives to EtO in coordination with the FDA;
- Review and revise air emissions standards for EtO-emitting facilities;
- Expand environmental reporting requirements for sterilization facilities;
- Enforce existing regulations; and
- Conduct research to increase our knowledge and monitoring accuracy of EtO.
Public Reaction to the New Draft EtO Rules
Interested entities long expecting the EtO rule changes have already reacted over the past couple of days since the EPA’s announcement – some with tentative relief and others with skepticism and concern. For instance, on the very day the EPA disclosed the proposed changes, the American Chemistry Council (ACC) issued a public statement reiterating its support for science-based EtO regulations, but asserted that it “oppose[s] the use of EPA’s flawed IRIS value [established during the pivotal December 2016 assessment mentioned above] as a benchmark in any rulemaking.” The ACC suggested that the benchmark, rather, should be the less conservative measurement assessment previously used by the Texas Commission on Environmental Quality (TCEQ), an EtO facility hot-spot state dealing with its own EtO toxicological TCEQ data access drama (previously covered by ELM here).
Conversely, Earthjustice, which litigates environmental issues, announced that although the proposed new standards are a good first step, it does not think that the rules go far enough. A public statement issued by the nonprofit argued that the NESHAP revision should have required monitoring for fence-line communities and that it also creates a potential loophole for sterilized-product warehouses. The Earthjustice statement went on to say that the FIFRA Review Decision should have also phased out the use of EtO in food products – a move similar to the one made by the European Union, whose June 2021 “zero-tolerance” policy resulted in thousands of food recalls. Although the EPA and other federal, state, and local agency partners have invested significant time, efforts, and resources in researching and proposing new EtO standards that aim to maximize public health and safety, at this time it does not seem even remotely likely that the U.S. will cease using EtO as a pesticide entirely.
Indeed, as the draft rules show, the EPA’s main goal related to the oversight of EtO use in the U.S. is to minimize direct, extended exposure to people most directly affected by emissions while still providing a highly effective, efficient sterilizing product that exponentially increases our quality of life and contributes to society’s overall health and wellness. Whether the long-awaited proposed rules will ultimately achieve this goal after they are finalized will require – yes – more waiting.