Final Amendments to Air Toxics Standards for Ethylene Oxide

Final Amendments to Air Toxics Standards for

Ethylene Oxide Commercial Sterilization Facilities

FACT SHEET

• On March 14, 2024, the U.S. Environmental Protection Agency

(EPA) announced final amendments to Clean Air Act standards

for ethylene oxide (EtO) emitted from commercial sterilization

facilities, also called commercial sterilizers.

o Commercial sterilizers are one of the nation’s leading

sources of EtO, a potent cancer-causing air pollutant.

o Commercial sterilizers that use EtO must follow the

National Emission Standards for Hazardous Air

Pollutants (NESHAP). EPA is significantly strengthening

this regulation based on our updated understanding of

risk from EtO exposure, as well as available technologies

to control emissions.

o This rule will reduce EtO emissions by over 90 percent,

reducing cancer risk in dozens of communities

nationwide. It will enable cost-effective compliance,

mitigating and managing any potential risks to the

supply chain.

Key Information:

• Slashes emissions of toxic air pollution: Based on feedback

and public comment, EPA strengthened the standards from

proposal to final resulting in reduced EtO emissions to the

outdoor air. Using proven and achievable air pollution

controls, the result is an over 90 percent reduction in EtO

emissions from commercial sterilizers nationwide.

• Significantly reduces cancer risks: Finalizing this rule is one of

the most important measures EPA is taking to reduce

emissions of EtO. Once implemented, this rule will reduce the

lifetime cancer risk from EtO exposure for people living near

commercial sterilization facilities.

• Requires accountability and transparency: Continuous

emissions monitoring and quarterly reporting for most

commercial sterilizers will provide EPA and communities with

data to ensure EtO emissions are controlled and not entering

the outdoor air before being captured and controlled.

Quick Facts

• This action will result in

an over 90 percent

reduction in EtO

emissions nationwide

from commercial

sterilizers.

• These reductions in EtO

are critical for

communities that have

suffered

disproportionately

from toxic air pollution

for far too long.

• Once the rule is in full

effect, no individual will

be exposed to EtO at

levels that correspond

to a lifetime cancer risk

of greater than 100-in-

1 million.

• The number of people

with a potential risk of

greater than or equal

to 1-in-1 million will be

reduced by

approximately 92

percent.

• There are currently 88

commercial sterilizers

in the U.S., with two

facilities under

construction.

• Ensures a safe supply of medical devices for patients and hospitals: Building on extensive

engagement with communities, as well as industry and federal partners with expertise in medical

supply chain issues, the rule lays out a process that safeguards our nation’s critical supply of

sterilized medical equipment.

Ensuring a Safe Supply of Sterilized Medical Devices:

• In developing this final rule, EPA was mindful of the vital role that commercial sterilizers play in

supplying the nation with sterile medical devices. The Agency carefully evaluated the feasibility and

cost of compliance and any potential implications for the medical supply chain.

• This final rule provides sufficient time and flexibility for facilities to come into compliance,

simultaneously providing strong public health protection for nearby communities while minimizing

any potential impacts to the medical device supply chain.

• A number of facilities covered by this final rule have already implemented one or more of the

controls that will be needed for compliance.

• The final rule provides a timeline for compliance that ensures that facilities using larger amounts of

EtO must comply sooner than other facilities because they pose the greater risk:

Facility EtO Use

Compliance

Timeframe

Number of Facilities

Over 60 tons per year

Two years

1-60 tons per year

Two to three years

Less than 1 ton per year

Three years

• EPA’s own experience working with facility owners, as well as state and local agencies that have

regulated EtO emissions from these facilities, confirms that it is feasible for individual facilities to

install the required controls within the deadlines provided in this rule. This rule offers cost-

effective compliance options and mitigates and manages any potential risks to the supply chain.

It ensures that these standards reduce cancer risks for communities exposed to EtO emissions.

• Among other things, the final rule extends the compliance deadlines to provide the maximum

compliance time allowed by law. It provides sufficient compliance time to enable facilities to

continue sterilizing essential products while installing and testing new control systems and

associated equipment that will provide ample protection for nearby communities.

Details:

Facilities will have an additional 180 days to demonstrate compliance. Also, the Clean Air Act provides that

under certain standards (i.e., those established under section 112(d)), facilities can apply for a 1-yr extension. The 1-

year extension is not available for standards issued under section 112(f)to reduce risk.

• This final rule requires facilities to install available and proven technologies, practices, and

procedures which have been demonstrated to significantly reduce EtO emissions.

• Ethylene oxide is a significant contributor to air toxics risk, and reducing the cancer risk posed by

this chemical is a major priority for EPA.

• EPA’s analysis for this rule examined the risks posed by commercial sterilizers to those living around

the facilities. Once the rule is in full effect, no person will be exposed to EtO at levels that

correspond to a lifetime cancer risk of greater than 100-in-1 million, which is an important Clean Air

Act metric for elevated cancer risk. The number of people with a potential risk of greater than or

equal to 1-in-1 million will be reduced by approximately 92 percent.

• EPA estimates that the capital costs for the final rule would be $313 million and would reduce

emissions by 21 tons per year, which will lower the risk of adverse health effects, including cancer,

for individuals in communities near commercial sterilization facilities.

• Commercial sterilizers use EtO to sterilize devices that cannot be sterilized using steam or radiation,

such as some medical and dental equipment. According to the Food and Drug Administration (FDA),

approximately 50 percent of sterile medical devices in the United States - approximately 20 billion

devices each year -- are sterilized with EtO.

• Medical sterilization is a critical function that ensures a safe supply of medical devices for patients

and hospitals. This final rule reflects robust engagement with the public, industry, and our federal

partners.

• Based on extensive input and our review, EPA is finalizing the following amendments to the

NESHAP:

o Establish standards for currently unregulated emissions, such as building leaks (“room air

emissions”) and chamber exhaust vents, to reduce risk and account for technological

developments.

o Strengthen standards that are on the books for sources such as sterilization chamber vents and

aeration room vents.

o Strengthen compliance by requiring the use of continuous emissions monitoring systems, which

will provide much-needed assurance to nearby communities.

o Include definitions for affected sources.

o Ensure that sterilizers are subject to emission standards during periods of startup, shutdown,

and malfunction.

o Other clarifying items including electronic reporting and technical revisions.

• The final rule will address emissions at nearly 90 commercial sterilization facilities that are owned

and operated by approximately 50 companies.

• In this final rule, EPA is addressing the second Risk and Technology Review for the EtO NESHAP,

which was initially promulgated in 1994 and last amended in 2001. EPA last reviewed the rule in

2006.

• In the coming weeks, EPA will also finalize an action that will reduce outdoor emissions of EtO from

the chemical sector under the Clean Air Act. The chemical sector rule is expected to reduce EtO-

related cancer risks in communities surrounding the facilities it covers.

• EPA’s Office of Pesticide Programs (OPP) is also working on a comprehensive set of new mitigation

measures for workers who use EtO to sterilize products and for other people in communities near

sterilization facilities.

TECHNOLOGY AND RESIDUAL RISK REVIEW:

• The Clean Air Act requires EPA to assess, review, and revise air toxics standards, as necessary, taking

into account developments in practices, processes, and control technologies, every eight years.

• Although risk review is a one-time obligation, which EPA completed along with a

technology review (RTR) in 2006, the Clean Air Act does not limit EPA’s discretion or

authority to conduct another risk review should EPA consider that such review is

warranted.

• Due to changes in our understanding of the health effects of ethylene oxide, EPA has

conducted a second residual risk review for commercial sterilization facilities using

ethylene oxide in order to ensure that the standards provide an ample margin of safety to

protect public health.

BACKGROUND:

• The Clean Air Act requires EPA to regulate hazardous air pollutants, also known as air toxics, from

categories of industrial facilities in two phases.

• The first phase is “technology-based,” where EPA develops standards for controlling the emissions

of air toxics from processes and equipment in an industry group or “source category.” These

standards reflect application of the maximum achievable control technology (MACT) and are based

on emissions levels that are already being achieved by the best-controlled and lower-emitting

sources in an industry. For commercial sterilizers that emit smaller amounts of air toxics, also known

as area sources, EPA has the option of setting standards based on generally available control

technology (GACT).

• Within eight years of setting the MACT standards, the Clean Air Act directs EPA to assess the

remaining health risks from each source category to determine whether the MACT standards

protect public health with an ample margin of safety and protect against adverse environmental

effects. This second phase is a risk-based approach called “residual risk review.” Here, EPA must

determine whether more health-protective standards are necessary.

• Every eight years after setting technology-based standards, the Act requires EPA to review and

revise the standards, if necessary, to account for improvements in air pollution controls and/or

prevention.

FOR MORE INFORMATION:

• To read a copy of the final rule, visit:

https://www.epa.gov/stationary-sources-air-

pollution/ethylene-oxide-emissions-standards-sterilization-facilities

• Today’s action and other background information are also available either electronically at

https://www.regulations.gov/

, EPA’s electronic public docket and comment system, or in hardcopy

at the EPA Docket Center’s Public Reading Room.

o The Public Reading Room is located at EPA Headquarters Library, room number 3334 in the

WJC West Building, 1301 Constitution Ave., NW, Washington, DC. Hours of operation are 8:30

a.m. to 4:30 p.m. Eastern Standard Time, Monday through Friday, excluding federal holidays.

o Visitors are required to show photographic identification, pass through a metal detector, and

sign the EPA visitor log. All visitor materials will be processed through an X-ray machine as

well. Visitors will be provided a badge that must be visible at all times.

o Materials for this final action can be accessed at https://www.regulations.gov/

using Docket

ID No. EPA-HQ-OAR-2019-0178.