07-23-2025

Regulatory Relief for Certain Stationary Sources To Promote American Security With Respect to Sterile Medical Equipment

ProclamationView the Original .pdf
View the Original .pdf

The 1-Minute Brief

What: A presidential proclamation that exempts 22 named commercial medical device sterilization companies from complying with a new Environmental Protection Agency (EPA) rule on ethylene oxide (EtO) emissions for a period of two years beyond the rule's original compliance dates.

Money: There is no direct Congressional Budget Office (CBO) score for this proclamation. However, it delays the costs of compliance with the EPA's EtO Rule for the exempted facilities. The EPA estimated its rule would reduce EtO emissions by 21 tons annually. The financial impact of the delay will be on the exempted companies, which will save on compliance costs in the short term, and on the communities near these facilities, which will not see the benefits of reduced emissions.

Your Impact: If you live near one of the 22 exempted facilities, you will not see the reduction in ethylene oxide emissions that the new EPA rule was intended to provide for at least another two years. For other Americans, the proclamation is intended to prevent disruptions in the supply of sterile medical devices.

Status: This proclamation was issued by the President on July 17, 2025, and is in effect.

What's Actually in the Bill

This proclamation, titled "Regulatory Relief for Certain Stationary Sources to Promote American Security with Respect to Sterile Medical Equipment," uses presidential authority under the Clean Air Act to pause a specific environmental regulation for a list of companies. It argues that the technology to comply with the new EPA rule for sterilizing medical equipment is not yet commercially available and that enforcing the rule on its original timeline would threaten national security by causing shortages of sterile medical devices.

Core Provisions:

  • Exemption Granted: 22 specific stationary sources (companies and their facilities) are exempt from the EPA's "National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities" (EtO Rule).
  • Duration: The exemption lasts for 2 years beyond the original compliance deadlines set in the EtO Rule.
  • Justification: The President determined that the technology to meet the new standards is "not available" in a commercially viable form.
  • National Security: The proclamation states it is in the "national security interests" of the United States to grant the exemption to avoid disruption of the medical equipment supply chain.

Stated Purpose (from the Sponsors):

  1. To prevent the closure of commercial sterilization facilities, which are deemed essential for sterilizing about 50% of all sterile medical devices in the United States.
  2. To avoid a "serious disruption" in the supply of medical equipment needed to treat patients in both civilian and military healthcare systems.
  3. To provide regulatory relief based on the assertion that the compliance timeline of the EtO Rule is unfeasible due to a lack of commercially viable emissions-control technologies.

Key Facts:

Affected Sectors: Healthcare, Medical Device Manufacturing, and Environmental Regulation.
Timeline: The exemption took effect on July 17, 2025, and extends the compliance deadlines of the April 5, 2024, EtO Rule for the listed facilities by two years.
Scope: The exemption is specific to the 22 facilities listed in Annex I of the proclamation, located across the United States, including in Florida, Georgia, Utah, Nebraska, Puerto Rico, Oklahoma, Montana, Massachusetts, Texas, California, New York, New Mexico, New Jersey, Pennsylvania, Indiana, West Virginia, Tennessee, Maryland, Colorado, Connecticut, and Alabama.

The Backstory: How We Got Here

Timeline of Events:

The Long Road to Regulating a Known Carcinogen:

The EPA has regulated ethylene oxide emissions from sterilization facilities since 1994. However, the science on its toxicity has evolved significantly.

  • 2016: The EPA updated its risk assessment, classifying ethylene oxide as a "human carcinogen" and concluding it was up to 60 times more toxic than previously understood.
  • 2018-2019: Public awareness grew, particularly in communities near sterilization facilities like Willowbrook, Illinois, and in Georgia, leading to protests and local action. A bipartisan congressional task force was formed to pressure the EPA to update its regulations.
  • April 5, 2024: After years of pressure and lawsuits from environmental groups demanding action, the EPA finalized its new, stricter EtO Rule. The rule aims to cut EtO emissions by 90% by requiring facilities to install advanced pollution-control equipment and conduct continuous monitoring.
  • June 2024: The new rule faced immediate legal challenges from two sides: environmental and health groups argued it wasn't strong enough and gave too long for compliance, while an industry trade group, the Ethylene Oxide Sterilization Association, argued the rule was too strict, used flawed risk estimates, and had an unrealistic compliance timeline.

Why Now? The Political Calculus:

  • Industry Pushback: The medical device and sterilization industries have consistently argued that overly stringent regulations on EtO could jeopardize the supply of essential medical equipment, as for many devices, EtO is the only effective sterilization method.
  • Regulatory Relief Initiative: The proclamation is part of a broader administration effort to provide "regulatory relief." In March 2025, the EPA announced it would reconsider the EtO rule and invited companies to apply for presidential exemptions under the Clean Air Act.
  • Presidential Authority: The administration is utilizing a specific, and rarely used, provision of the Clean Air Act that allows the President to grant temporary exemptions from air pollution standards if the technology is unavailable and it serves the national security interest.

Your Real-World Impact

The Direct Answer: This directly affects people living in communities near the 22 exempted facilities and has an indirect, though significant, impact on the healthcare industry and its patients.

What Could Change for You:

Potential Benefits:

  • Stable Medical Supply: The action is intended to prevent shortages of critical medical devices like catheters, stents, and surgical kits that require EtO sterilization. This ensures that hospitals and medical facilities have the necessary sterile equipment for procedures.
  • Industry Viability: For the exempted companies, this provides financial relief and more time to develop or acquire the technology needed to comply with the new EPA standards.

Possible Disruptions or Costs:

Short-term (The next two years):

  • Continued Emissions: Communities near the listed facilities will continue to be exposed to ethylene oxide levels that the EPA has determined pose an elevated cancer risk. The proclamation delays the 90% reduction in emissions the new rule was designed to achieve.
  • Uncertainty: The two-year exemption creates uncertainty for residents and local officials about if and when the stricter environmental standards will be implemented.

Long-term:

  • Delayed Health Protections: The delay postpones the long-term public health benefits that the EPA projected from its rule.
  • Precedent for Exemptions: The use of this presidential authority could set a precedent for other industries seeking to delay compliance with environmental regulations.

Who's Most Affected:

Primary Groups: Residents in communities with the exempted sterilization facilities, particularly in states like Georgia, Texas, California, and Puerto Rico, where multiple facilities are listed. These communities are often disproportionately low-income and communities of color.
Secondary Groups: Patients and healthcare providers who rely on a steady supply of sterile medical devices. Medical device manufacturers and the sterilization industry also are directly affected.
Regional Impact: The impact is concentrated in the specific locations listed in the proclamation's annex, spanning numerous states and Puerto Rico.

Bottom Line: The proclamation prioritizes the stability of the medical device supply chain over the immediate implementation of stricter environmental protections for communities near specific industrial facilities.

Where the Parties Stand

Republican Position: "Protecting Patient Access and American Industry"

Core Stance: Generally supports the proclamation, viewing the EPA's EtO rule as an example of regulatory overreach that threatens national security and economic stability.

Their Arguments:

  • ✓ The exemption is necessary to prevent medical device shortages and protect patient lives.
  • ✓ The EPA's compliance deadlines are unrealistic because the required technology is not widely available.
  • ✗ They often contest the EPA's risk assessment for ethylene oxide, arguing it overstates the cancer risk.

Legislative Strategy: Supporting the President's use of exemption authority and advocating for the reconsideration or weakening of the underlying EPA rule.

Democratic Position: "Protecting Communities and Public Health"

Core Stance: Generally opposes the proclamation, prioritizing the enforcement of environmental regulations to protect communities from known carcinogens.

Their Arguments:

  • ✓ Stricter EtO regulations are essential to protect public health, especially in vulnerable communities located near these facilities.
  • ⚠️ While acknowledging the need for a stable medical device supply, they argue for a balance that doesn't sacrifice community health and that industry has had years to prepare for stricter controls.
  • ✗ The "national security" justification is an overreach and a way to circumvent critical environmental protections.

Legislative Strategy: Criticizing the use of the exemption, supporting legal challenges against it, and pushing the EPA to enforce the original rule vigorously.

Constitutional Check

The Verdict: ⚠️ Questionable

Basis of Authority:

The proclamation cites Section 112(i)(4) of the Clean Air Act as its legal basis.

Relevant Portion of the Constitution: This is a statutory authority granted by Congress to the President, not a direct constitutional power. The underlying authority for the Clean Air Act itself stems from the Commerce Clause (Article I, Section 8, Clause 3), which gives Congress the power to regulate interstate commerce.

Constitutional Implications:

[Statutory Authority]: Section 112(i)(4) explicitly allows the President to grant an exemption for up to two years if "(1) ‘the technology to implement such standard is not available’ and (2) ‘it is in the national security interest of the U.S. to do so.’" The key legal questions revolve around the interpretation of "not available" and "national security interest."
[Presidential Discretion]: Courts typically grant the President significant deference on matters of national security, which could make a legal challenge difficult.
[Federalism]: This action does not directly raise federalism concerns, as it is an exemption from a federal rule, not an imposition on state power.

Potential Legal Challenges:

The proclamation is highly likely to be challenged in court by environmental and community advocacy groups.

  • The Core Argument: Lawsuits will likely argue that the President's determination that the technology is "not available" is factually incorrect. Opponents may contend that the necessary pollution controls do exist, even if they are costly or require time to install.
  • National Security Claim: Challengers will also likely argue that the "national security" claim is a pretext to benefit industry and that potential supply chain issues do not rise to the level of a national security threat as intended by the statute.
  • Judicial Review: While presidential exemptions are not reviewable under the Administrative Procedure Act, courts could still examine whether the President acted outside the authority granted by the Clean Air Act.

Your Action Options

TO SUPPORT THIS BILL

5-Minute Actions:

  • Call Your Rep/Senators: Capitol Switchboard: (202) 224-3121 "I'm a constituent from [Your City/Town] and I support the President's proclamation (Proclamation 10959) to provide regulatory relief for medical sterilizers to ensure a stable supply of medical equipment."

30-Minute Deep Dive:

  • Write a Detailed Email: Contact your elected officials and the White House to express support, emphasizing the importance of an uninterrupted medical supply chain.
  • Join an Organization: Groups like the Ethylene Oxide Sterilization Association (EOSA) and the Medical Device Manufacturers Association (MDMA) advocate for risk-based regulations that consider the industry's role in healthcare.

TO OPPOSE THIS BILL

5-Minute Actions:

  • Call Your Rep/Senators: Capitol Switchboard: (202) 224-3121 "I'm a constituent from [Your City/Town] and I urge [Rep./Sen. Name] to oppose Proclamation 10959 and demand the EPA enforce its rule on ethylene oxide emissions to protect public health."

30-Minute Deep Dive:

  • Write a Letter to the Editor: Submit a letter to your local newspaper arguing that public health should not be delayed for industry profits and that companies should be held to the standards set by the EPA.
  • Join an Organization: Environmental and health advocacy groups like Earthjustice, the Sierra Club, and the Union of Concerned Scientists have been actively litigating to force stronger regulations on ethylene oxide.