EPA Ethylene Oxide Emissions Regulations for Medical Device Sterilization: 2026 Proposed Rollback, Compliance, and Supply Chain Impact

How the EPA's 2026 proposed rollback of ethylene oxide emissions standards affects medical device manufacturers, sterilization facilities, and supply chains — the 2024 rule, proposed changes, compliance timelines, and alternative sterilization strategies.

The regulatory landscape for ethylene oxide (EtO) sterilization of medical devices is in upheaval. In March 2026, the U.S. Environmental Protection Agency (EPA) proposed rolling back significant portions of a 2024 rule that would have cut EtO emissions from commercial sterilization facilities by roughly 90%. The proposal has ignited a fierce debate pitting medical device supply chain stability against community health protections -- with roughly 20 billion devices and millions of nearby residents in the balance.

This article provides a comprehensive guide to the EPA's EtO emissions regulations as they stand in 2026, the proposed rollback, what it means for medical device manufacturers, and practical steps the industry should take now.

Why EtO Emissions Regulation Matters for Medical Devices

Ethylene oxide is a colorless, flammable gas that has been used to sterilize medical devices for approximately 80 years. It is the dominant sterilization method in the industry for a simple reason: material compatibility. EtO sterilizes at low temperatures and does not damage the polymers, electronics, and complex geometries found in modern medical devices. Alternatives like steam, gamma radiation, and electron beam are effective for some products but degrade or destroy many others.

The scale of dependence is staggering:

EtO sterilizes approximately 50% of all medical devices worldwide -- roughly 20 billion devices per year.
An estimated nearly 90% of surgical kits rely on EtO sterilization.
Devices that depend exclusively on EtO include pacemakers, heart valves, stents, catheters, ventilators, syringes, surgical kits, wound dressings, and continuous glucose monitors.

The FDA has stated plainly: "Without EtO, there would be a significant sterilization shortfall with no commensurate sterilization alternative available." For medical device manufacturers, any disruption to EtO sterilization capacity is not an inconvenience -- it is an existential supply chain threat.

At the same time, EtO is classified as a known human carcinogen by both the EPA and the U.S. National Toxicology Program. Long-term inhalation exposure is linked to lymphoid cancers and breast cancer. Approximately 14 million people in the United States and Puerto Rico live within five miles of a commercial sterilizer facility, according to a 2023 Union of Concerned Scientists report. Roughly 2.3 million live within two miles. Communities near these facilities are disproportionately low-income and communities of color, compounding existing health disparities from other pollution sources.

This is the fundamental tension: EtO is irreplaceable for sterilizing a vast array of medical devices, yet its emissions pose a real cancer risk to nearby populations. Regulating it responsibly requires balancing these realities.

Background: EPA Regulation of EtO (1994-2024 Timeline)

Understanding the current regulatory conflict requires tracing the history of EPA EtO regulation. The standards at issue fall under 40 CFR Part 63, specifically the National Emission Standards for Hazardous Air Pollutants (NESHAP) for commercial sterilization facilities, issued under Section 112 of the Clean Air Act.

Year	Event	Significance
1994	EPA issues original NESHAP for commercial sterilizers	First federal EtO emission standards, covering chamber exhaust vents, aeration room vents (ARVs), and catalytic oxidizer vents (CEVs). Established baseline emission limits.
2001	EPA revises NESHAP	Removes requirements for catalytic oxidizer vents due to equipment failure issues.
2006	EPA completes residual risk and technology review	Required under CAA Sections 112(f)(2) and 112(d)(6). EPA concludes no further tightening is warranted.
2016	EPA's IRIS assessment published	The Integrated Risk Information System concludes EtO is "carcinogenic to humans" and far more dangerous than previously understood -- 30 times more carcinogenic for adults exposed since birth, and 50 times more for those exposed since birth. This finding triggers new regulatory action.
2017-2018	Community outrage at Sterigenics Willowbrook	U.S. EPA monitoring reveals elevated EtO levels near the Sterigenics facility in Willowbrook, IL. Cancer risk in surrounding areas found to be nine times the national average.
February 2019	Illinois EPA shuts down Sterigenics Willowbrook	Seal order issued after air monitoring finds "the highest levels of EtO recorded in the area to date." Facility permanently closes in September 2019. Sterigenics later pays $408 million to settle 870+ lawsuits.
2019-2023	Community activism spreads	Protests and lawsuits emerge near facilities in Cobb County and Covington, GA (BD plant), Waukegan, IL (Medline), Laredo, TX, and elsewhere.
2023	EPA proposes major EtO rule update	Proposes sweeping reductions in EtO emissions from ~90 commercial sterilization facilities. Industry groups warn of 30-50% capacity reductions.
April 5, 2024	EPA finalizes 2024 rule	Biden-era rule mandates 90% emissions reduction, continuous monitoring, fugitive emissions controls, and building enclosures. Published at 89 Fed. Reg. 24090.
March 2025	Trump EPA invites exemption requests	Opens electronic mailbox for facilities to request exemptions from the 2024 rule.
July 2025	Presidential exemptions granted	40-41 facilities receive two-year renewable exemptions via presidential proclamation, citing CAA Section 112(i)(4).
March 17, 2026	EPA proposes permanent rollback	Published at 91 FR 12700. Proposes rescinding key provisions of the 2024 rule.
May 1, 2026	Comment period extended	EPA extends public comment period to May 15, 2026, after receiving multiple requests for additional time.

The 2024 Rule: What It Required

The 2024 final rule (89 Fed. Reg. 24090) was the most significant update to EtO emission standards in three decades. It addressed approximately 90 commercial sterilization facilities owned by roughly 50 companies. The rule had five principal components:

1. Fugitive Emissions Regulation (First Time)

The 1994 and 2006 standards regulated only process vents -- chamber exhaust, aeration room vents, and similar point sources. They did not address fugitive emissions, also called "room air emissions," which escape through building leaks, door seals, and other uncontrolled pathways. The 2024 rule regulated fugitive emissions for the first time, requiring facilities to capture and control these releases.

2. Stricter Emission Limits

The rule imposed more stringent emissions standards for larger facilities, expanded the sources of emissions covered, and set risk-based standards under CAA Section 112(f)(2) to ensure that no individual faced a lifetime cancer risk greater than 100-in-1 million from EtO exposure.

3. Permanent Total Enclosures (PTE)

Facilities were required to install permanent total enclosures -- physical structures designed to ensure complete capture of EtO so that all emissions are routed through control devices rather than escaping into the environment.

4. Continuous Emissions Monitoring Systems (CEMS)

The rule mandated that most commercial sterilizers install and operate continuous emissions monitoring systems (CEMS) with quarterly reporting. This was a major shift from periodic stack testing to real-time, continuous oversight of emissions.

5. Startup, Shutdown, and Malfunction Provisions

Emissions standards were required to apply during startup, shutdown, and malfunction events -- periods when emissions had previously been unregulated.

Projected Impact of the 2024 Rule

EPA projected that full implementation would:

Reduce annual EtO emissions from commercial sterilizers by over 90%
Reduce the number of people exposed to unacceptable cancer risks from EtO by 92%
Reduce the number of children facing lifetime cancer risks of greater than 100-in-1 million from 4,300 to zero
Reduce children facing risks of greater than 1-in-1 million from 1.25 million to 162,300

Compliance Timelines

The original rule set compliance deadlines beginning in 2026, with phased implementation. However, the Biden administration was forced to establish a presidential exemption process in January 2025 -- before leaving office -- because facilities could not meet the required standards before the compliance deadlines, and closures posed an immediate risk to medical device supply.

The 2026 Proposed Rollback: What Changes

On March 17, 2026, EPA published its proposed reconsideration at 91 FR 12700, titled "National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review Reconsideration." The rule asserts that the 2024 standards relied on misinterpretations of the Clean Air Act, unreliable data, and faulty analyses.

What the Proposed Rollback Does

The 2026 proposal makes four primary changes:

2024 Rule Requirement	2026 Proposed Change
Risk-based standards under CAA 112(f)(2)	Rescinded entirely. EPA argues it lacked statutory authority for the discretionary risk review.
Permanent total enclosures (PTE)	Requirement rescinded. Facilities no longer required to install building enclosures to capture fugitive EtO.
Continuous emissions monitoring systems (CEMS)	No longer mandatory. Facilities may choose between CEMS and parametric monitoring (which measures operational parameters rather than directly measuring EtO concentrations).
Technology review standards for new ARVs	Revised for facilities using at least 10 tons per year of EtO, scaling back stringency.
Applicability threshold	Emissions requirements would no longer apply to facilities using 30 or fewer tons of EtO per year.

EPA's Stated Rationale

EPA Administrator Lee Zeldin framed the proposal as necessary to protect the medical device supply chain: "The Trump EPA is committed to ensuring lifesaving medical devices remain available for the critical care of America's children, elderly and all patients without unnecessary exposure to communities."

The agency's core legal argument is that the 2024 rule improperly conducted a "discretionary" residual risk review under CAA Section 112(f)(2), rather than the statutory review that was actually required. EPA now contends that its 2006 review satisfied the statutory obligation and that the 2024 rule exceeded its Clean Air Act authority.

Quantified Impact

EPA's own analysis projects the following consequences if the rollback is finalized:

7.8 additional tons of EtO released annually -- approximately a one-third increase compared to the 2024 rule's projected emissions levels
At least 85,000 more people subjected to unacceptable cancer risks compared to the 2024 rule
Cost savings of $43 million per year (at 3% discount rate) to $48 million per year (at 7% discount rate) over the 2026-2046 period, totaling approximately $630 million over 20 years
EPA did not calculate the health impact costs to the public, a departure from previous regulatory practice

Comment Period and Process

The original comment period was set to close on May 1, 2026. After multiple requests for additional time, EPA extended the deadline to May 15, 2026. A public hearing was held on April 1, 2026. As of the date of this article, EPA has received more than 6,000 public comments.

Impact on Medical Device Manufacturers and Supply Chain

The regulatory whiplash on EtO has profound implications for the medical device supply chain, which operates with razor-thin sterilization capacity margins.

The Capacity Problem

Even before the 2024 rule was finalized, EtO sterilization facilities were operating at or near full capacity. Industry estimates provided by AdvaMed indicated that taking even a few facilities offline for retrofitting would reduce overall sterilization capacity by 30-50%, and as much as 70% in some cases. The FDA warned that "shortfalls of a variety of critical medical devices would likely be imminent" if EtO sterilization capacity were disrupted.

When the Biden administration finalized the 2024 rule, it acknowledged that facilities would need to temporarily slow operations while completing upgrades. EPA's own regulatory impact analysis noted: "EtO sterilization services are a critical input in the provision of safe medical devices and there is uncertainty in how the proposal could potentially affect the medical device supply chain."

The Waiver Phase (2025)

In March 2025, the Trump EPA opened an electronic mailbox inviting facilities to request exemptions. By July 2025, a presidential proclamation under CAA Section 112(i)(4) granted two-year waivers to approximately 40 of the roughly 90 commercial sterilization facilities. Exempted facilities included operations owned by B. Braun, DeRoyal Industries, Sterigenics, Sterilization Services of Virginia, and Kendall Patient Recovery (KPR).

These waivers were renewable, meaning they could potentially extend the exemption indefinitely. Environmental groups including Earthjustice, the Natural Resources Defense Council (NRDC), and the Southern Environmental Law Center filed lawsuits challenging the legality of the presidential exemptions.

What the 2026 Rollback Means for Manufacturers

If the proposed rollback is finalized, the near-term practical effects include:

Reduced compliance costs. Facilities that invested in CEMS, permanent total enclosures, or other controls to meet the 2024 rule may be able to reduce or decommission that equipment. New compliance costs are avoided entirely.

Regulatory uncertainty. The pendulum swing from strict regulation to rollback -- and the near-certainty of legal challenges -- means manufacturers cannot plan with confidence. A court could reinstate the 2024 rule, or a future administration could reverse the rollback.

Supply chain stability (short-term). Facilities that might have shut down or curtailed operations to install controls can continue operating. This reduces the near-term risk of device shortages.

Liability risk. Manufacturers and sterilization facilities continue to face tort liability from communities. Sterigenics' $408 million settlement over the Willowbrook facility illustrates the financial exposure from community health claims.

International competitiveness concerns. AdvaMed has warned that disruption in domestic sterilization capacity "could shift critical medical supplies overseas, threatening our national sterile infrastructure." If U.S. capacity is compromised -- whether by overly strict regulation or by loss of community license to operate -- manufacturers may need to move sterilization offshore.

Stakeholder Positions: Industry vs. Communities vs. Regulators

The EtO debate has produced sharply divergent stakeholder positions.

Industry: AdvaMed and Sterilization Companies

AdvaMed, representing more than 450 medical technology companies, has been the most prominent industry voice. The organization has consistently argued that:

EtO is irreplaceable for sterilizing half of all medical devices, and no alternative exists at scale
The 2024 rule as written would cause a 30-50% reduction in sterilization capacity
Stricter regulations must be phased in over sufficient time to avoid supply disruptions
The industry supports updated regulations but insists on realistic timelines and technology-neutral approaches

Khatereh Calleja, AdvaMed's senior vice president of technology and regulatory affairs, testified before EPA: "The use of EtO for the sterilization of medical equipment has been and will continue to be safe and is subject to stringent regulations. We place the highest priority on the safety of our communities, employees, and the millions of patients we serve." AdvaMed has also warned that disruption in domestic sterilization capacity could shift critical medical supplies overseas.

The SBA Office of Advocacy supported the industry position, warning that the 2024 rule "would lead to a significant number of small entities leaving the market for commercial sterilization, harming small medical device manufacturers, causing significant supply chain disruptions, and hurting patients needing sterilized medical devices."

Environmental and Community Groups

Organizations including Earthjustice, the Union of Concerned Scientists, the Natural Resources Defense Council, and community groups like Stop Sterigenics have argued that:

EtO is one of the most toxic air pollutants EPA regulates, capable of damaging DNA even in small doses
The 2024 rule was based on the best available science, including the 2016 IRIS assessment that survived rigorous peer review
Communities near sterilization plants have been exposed to elevated cancer risks for decades without adequate protection
The rollback would subject at least 85,000 more people to unacceptable cancer risks
Many facilities were already in compliance with portions of the 2024 rule, and the rollback would allow them to reduce existing controls
A recent National Academies review rejected an alternative risk assessment promoted by Texas regulators, effectively reaffirming EPA's IRIS assessment

Darya Minovi, senior analyst at the Union of Concerned Scientists, stated: "EPA's decision to roll back commercial sterilizer safeguards is an affront to countless families and workers who were unknowingly exposed to ethylene oxide -- a cancer-causing gas -- for years, even decades. The rule was based on a growing and robust body of evidence showing the toxicity of long-term exposure to ethylene oxide, which EPA, international institutions, and the National Academies have affirmed."

EPA (Current Administration)

The Trump EPA's position is that the 2024 rule exceeded the agency's statutory authority under the Clean Air Act, was based on faulty legal interpretations, and threatened the domestic supply of sterile medical equipment. EPA notes that even the Biden administration was forced to create an exemption process for its own rule because facilities could not comply in time.

EPA has also removed several web pages about EtO health risks from its public website concurrent with the rollback proposal, replacing them with pages emphasizing the utility of EtO for medical device sterilization -- a move criticized by environmental data transparency advocates.

Public Health and Scientific Community

Scientists testifying during the April 2026 public hearings noted that EPA's 2026 proposal did not calculate the health impact costs of increased emissions, a significant departure from standard regulatory practice. The American Lung Association and other public health organizations have urged EPA to maintain the 2024 standards.

Compliance Strategy: What Manufacturers Should Do Now

Regardless of whether the 2026 rollback is finalized, medical device manufacturers and sterilization facilities face a period of sustained regulatory uncertainty. The following strategic actions are recommended:

1. Do Not Abandon Compliance Investments

Many facilities have already installed or begun installing emissions controls to comply with the 2024 rule. Even if the rollback removes the federal mandate, several considerations argue against rolling back those investments:

State regulations may remain or tighten. Illinois enacted the nation's strictest EtO law following the Sterigenics closure. Other states may follow.
Legal challenges could reinstate the 2024 rule. Multiple lawsuits are pending. A court victory for environmental groups could restore the stricter standards with compressed compliance timelines.
Future administrations may re-tighten standards. The regulatory pendulum swings both ways.
Community license to operate. Facilities that reduce existing controls in the current political climate face community backlash, negative publicity, and tort liability risk. The Sterigenics precedent is instructive.

2. Map Your EtO Supply Chain Dependencies

Manufacturers should conduct a thorough risk assessment:

Identify which products in your portfolio require EtO sterilization and whether any alternatives exist
Map your contract sterilization facilities and determine their regulatory status (exempt, compliant, or at risk)
Assess single-point-of-failure risks in your sterilization supply chain
Quantify the impact of losing access to each sterilization facility

3. Engage in the Regulatory Process

The comment period closes May 15, 2026. Manufacturers should:

Submit detailed comments to EPA (Docket ID EPA-HQ-OAR-2019-0178) explaining the specific operational and supply chain impacts of both the 2024 rule and the proposed rollback
Participate in SBA Office of Advocacy roundtables and industry working groups
Coordinate with AdvaMed and trade associations to present unified industry positions

4. Monitor State-Level Actions

Federal rollbacks do not preclude state action. Illinois, Georgia, and other states with significant sterilization facilities have active community advocacy movements and may enact state-level EtO restrictions that exceed federal standards. Manufacturers should monitor state legislatures and environmental agencies in states where their contract sterilizers operate.

5. Document Everything

In a litigious environment, documentation of compliance efforts, emissions data, community engagement, and supply chain contingency plans provides critical legal protection. The Sterigenics litigation demonstrates that facilities face substantial tort exposure regardless of federal regulatory status.

Alternative Sterilization Methods and Risk Mitigation

The FDA has been actively encouraging the development and adoption of alternative sterilization methods through innovation challenges and guidance updates. However, no single alternative can replace EtO across its full range of applications. Here is the current state of play:

Established Alternatives

Method	Status	Strengths	Limitations
Gamma radiation	Established (Category A)	High penetration, high throughput, no residues	Damages semiconductors, degrades certain polymers, discolors clear materials. Cobalt-60 supply concerns.
Electron beam (E-beam)	Established (Category A)	No radioactive source, rapid processing	Limited penetration depth, not suitable for dense or large packages
Steam/moist heat	Established (Category A)	Gold standard for heat-stable instruments	Only works for heat-stable, moisture-resistant materials. Not viable for most single-use devices.
Dry heat	Established (Category A)	No moisture, no residues	High temperatures limit material compatibility

Emerging Alternatives

Method	Status	Strengths	Limitations
Vaporized hydrogen peroxide (VHP)	Elevated to Category A (January 2024)	Low temperature, broad material compatibility, ISO 22441:2022 recognized	Limited penetration compared to EtO; challenges with lumened devices and permeable packaging (e.g., Tyvek)
Nitrogen dioxide (NO2)	Emerging (510(k) cleared for some devices)	Effective for pre-filled syringes and drug-delivery systems	Limited commercial availability, narrow validation base
Supercritical carbon dioxide (scCO2)	Emerging (FDA innovation challenge)	Gentle on materials	Limited to specific device types; not yet scalable
Chlorine dioxide (ClO2)	Emerging	Gas-phase sterilization	Lacks broad industry data and long-term experience for medical devices
X-ray irradiation	Emerging	Similar to gamma but no radioactive source	Very limited commercial experience; not suitable for permeable packaging

The Hard Truth

The FDA has stated that there are "no viable alternatives to EtO for the sterilization of certain medical devices and equipment" at scale. While VHP has been elevated to Category A status and radiation methods continue to expand, the material compatibility, penetration, and validation requirements for the majority of EtO-sterilized devices mean that EtO will remain essential for the foreseeable future.

Manufacturers should adopt a multi-modal sterilization strategy where feasible:

Qualify alternative methods for products where material compatibility allows. This reduces EtO dependence incrementally.
Participate in FDA's Radiation Sterilization Master File Pilot Program if transitioning eligible products to radiation methods.
Invest in R&D for next-generation device designs that are compatible with non-EtO sterilization, where clinically appropriate.
Monitor ISO 10993-7:2026, which updates EO residual limits and may affect product design and sterilization cycle parameters.

What Happens Next: Timeline and Legal Outlook

The EtO regulatory saga is far from over. Here is what to expect:

Near-Term (May-December 2026)

May 15, 2026: Extended comment period closes. EPA received 6,000+ public comments, reflecting intense stakeholder interest on all sides.
Mid-to-late 2026: EPA reviews comments and prepares a final rule. The agency has indicated it intends to move quickly, but the volume of comments and complexity of the issues could extend the timeline.
Ongoing litigation: Multiple lawsuits are already challenging the presidential exemptions granted in 2025. A ruling in these cases could affect the legal landscape for the proposed rollback.

Medium-Term (2027-2028)

Final rule publication. EPA is expected to issue a final rule within approximately one year of the proposal, but this timeline is not certain.
Immediate legal challenges. Regardless of the outcome, the final rule will face lawsuits. Environmental groups will challenge any rollback. Industry groups may challenge if the rule does not go far enough. The legal arguments will center on whether EPA's 2024 discretionary review was lawful and whether the current administration's reversal is adequately supported by the record.
Court decisions on exemptions. The pending lawsuits over the 2025 presidential exemptions (Texas Environmental Justice Advocacy Services v. Trump, No. 25-03745; CleanAIRE NC v. Trump, No. 26-00233) could establish precedent on the scope of presidential exemption authority under CAA Section 112(i)(4).

Long-Term Considerations

Congressional action. Legislation could clarify the scope of EPA's authority to conduct discretionary risk reviews, provide explicit direction on EtO regulation, or establish a dedicated framework for medical device sterilization emissions. Given the current political dynamics, bipartisan legislation is unlikely in the near term but remains possible over a longer horizon.
State-level regulation. States are not waiting for federal action. Illinois has already enacted stringent state-level EtO standards. Other states may follow, creating a patchwork of regulations that complicates compliance for national sterilization operations.
Technology evolution. The FDA's continued investment in alternative sterilization methods through innovation challenges and master file programs will gradually expand the portfolio of available methods, but a wholesale replacement of EtO remains years or decades away.

Practical Action Items for Manufacturers

Immediate (next 30 days):

Submit public comments on the proposed rollback before the May 15, 2026 deadline (Docket EPA-HQ-OAR-2019-0178)
Audit your sterilization supply chain to identify exposure to regulatory changes
Review current compliance investments and assess the risk-benefit of maintaining vs. reducing controls

Short-term (next 6 months):

Develop contingency plans for loss of access to specific sterilization facilities
Begin qualification of alternative sterilization methods for products where material compatibility allows
Engage with contract sterilizers to understand their compliance posture and investment plans
Monitor state regulatory developments in jurisdictions where your sterilizers operate

Medium-term (next 12-24 months):

Invest in device design-for-sterilization initiatives that expand method options
Review ISO 10993-7:2026 residual limits and assess impact on current sterilization processes
Build internal expertise on EtO regulatory developments and participate in industry working groups

The EPA's EtO emissions regulations sit at the intersection of public health, industrial policy, and medical device supply chain security. The 2026 proposed rollback may provide short-term relief to sterilization facilities and device manufacturers, but it does not resolve the underlying tension. EtO is both indispensable and hazardous. The regulatory framework will continue to evolve -- through courts, through states, and through the slow but steady development of alternative technologies. Manufacturers that invest in supply chain resilience, regulatory engagement, and sterilization diversification will be best positioned to navigate whatever comes next.