
(AGENPARL) – mar 14 gennaio 2025 Issued: Jan 14, 2025 (3:00pm EST)
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EPA Finalizes Protections for Workers and Communities from Cancer-Causing
Ethylene Oxide Pollution
WASHINGTON – Today, Jan. 14, the U.S. Environmental Protection Agency
released the Interim Decision for Ethylene Oxide (EtO) – a pesticide used on
50 percent of all sterilized medical devices in the United States and on
approximately 30 percent of dried herbs and spices. EtO is known to cause
cancer, including lymphocytic leukemia, breast cancer, non-Hodgkin lymphoma
and myeloma in people. Workers who use EtO and people who work, live, or go
to school or daycare near facilities that use EtO may breathe in emissions at
levels that can increase cancer risk. The greatest risk is for people who work
for their entire careers at facilities directly handling EtO with insufficient
worker protections in place.
The Interim Decision includes mitigation measures that, in addition to the
measures included in the 2024 EtO National Emissions Standards for Hazardous
Air Pollutants (NESHAP), will reduce exposure to workers and nearby
communities. Together, these two EPA actions provide a comprehensive approach
to addressing EtO pollution concerns, including cancer risk, that will
increase safety in communities and for workers while supporting ongoing supply
chain needs for sterilized medical equipment. This decision advances President
Biden’s commitment to ending cancer as we know it as part of the Cancer
Moonshot, as well as the Administration’s commitment to securing
environmental justice and protecting public health, including for communities
that are most exposed to toxic chemicals.
“EPA continues to make important strides to protect people from dangerous
chemicals like ethylene oxide,” said Assistant Administrator for the Office
of Chemical Safety and Pollution Prevention Michal Freedhoff. “These
protections will reduce EtO exposures to workers and communities, while also
ensuring that the chemical remains available to provide sterile life-saving
medical supplies.”
Ethylene Oxide
EPA regulates EtO’s use as a pesticide under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). EtO has both antimicrobial uses, such
as sterilization of medical devices, and conventional uses, such as fumigation
of dried herbs and spices. In some instances, such as with sterilization of
medical devices like surgical kits, EtO is the only available option, making
it essential for protecting human health. Every 15 years, EPA evaluates
potential human health and environmental effects associated with the use of a
pesticide through the registration review process. As part of EtO’s
registration review, the agency assessed cancer risk from working in
sterilization and health care facilities that use EtO, living in communities
near EtO facilities, and consuming dried herbs and spices treated with EtO.
After a 75-day public comment period with over 60 stakeholder meetings with
industry, other federal agencies, unions, and nonprofit organizations, EPA
identified a broad set of protections under FIFRA that aim to reduce exposure
to all EtO sterilization facility workers and to others who work, live, or go
to school near sterilization facilities. Specifically, the Decision includes a
reduced EtO concentration rate limit for new medical device sterilization
cycles to reduce levels of exposure for workers; a lowered worker exposure
limit of 0.5 ppm after three years, 0.25 ppm after five years, and 0.1 ppm
after 10 years (compared to the current Occupational Safety and Health
Administration standard of 1 ppm); phased cancellation of the use of EtO on
specific dried herbs and spices; and cancellation of the use of EtO when safer
and effective alternatives are available.
Interim Decision
Some of the highlights of the Interim Decision include:
Commercial Sterilizers
Lowered worker exposure limit of 0.5 ppm by 2028, 0.25 ppm by 2030, and 0.1
ppm by 2035, as compared to the 1984 OSHA limit of 1 ppm. Any workers who
could be exposed to concentrations of EtO above these limits would need to
wear additional respiratory protection.
Finalizing the ban of use for museum, library and archival materials;
cosmetics; musical instruments; and beekeeping equipment.
Immediate cancellation of the use of EtO for specific dried herbs and spices
for which its use is not considered critical for food safety, and phased
cancellation for specific dried herbs and spices for which EtO use is
considered critical for food safety but have potential alternatives to EtO.
Establishing a concentration limit of 600 mg/L for new medical device
sterilization cycles within 10 years. If a device requires a concentration of
EtO greater than 600 mg/L due to the device design, the facility must maintain
records to justify the increased application rate.
Separation of HVAC systems for areas where EtO is used and areas where EtO is
not used, to reduce EtO exposure in areas such as offices.
Requiring respirators to protect workers involved in certain high EtO exposure
tasks, such as connecting and disconnecting EtO containers from sterilization
process equipment.
Continuous EtO concentration monitoring throughout sterilization facilities,
including on-site storage facilities.
Data requirements to monitor breathing zone worker exposure to EtO within
commercial sterilization facilities and warehouses that store sterilized
materials, both on and off-site.
Healthcare Facilities
Require abatement devices for healthcare facilities that use more than 10 lbs.
of EtO/year by comparison – c commercial sterilizers typically release tons
of EtO annually.
Ventilation of EtO through exterior ventilation stacks to reduce exposure to
healthcare facility workers. Exposure to communities from EtO used in
healthcare facilities is expected to be minimal because the amount of EtO used
at healthcare facilities is orders of magnitude lower than at commercial
sterilization facilities.
Next Steps
EPA expects that registrants will submit label amendments that include the
changes outlined in the Interim Decision within 60 days after publication. The
agency plans to quickly review the label amendments so that products sold and
distributed by registrants will include the changes outlined in the Interim
Decision. The timing for implementation for individual mitigation measures
ranges from two years to 10 years, taking into consideration the costs,
technology availability, potential impacts to the medical device supply chain
and other logistical elements. Additionally, EPA will issue a Data Call-In
(DCI) to gather information on worker exposure. Specifically, the DCI will
require submission of worker exposure data for commercial sterilizers and
warehouses in order to understand the worker exposure impacts of complying
with EPA’s Clean Air Act EtO commercial sterilization NESHAP and
implementing the mitigation measures identified in this Interim Decision. EPA
will reevaluate this Interim Decision within eight years, earlier than the
typical 15-year cycle, based on the submitted worker exposure data, in order
to identify further opportunities to reduce EtO exposures.
To view all documents related to EtO’s registration review, visit docket
EPA-HQ-OPP-2013-0244.
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