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U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
20-N-0128
March 31, 2020
Why We Did This Project
While conducting an audit of
the U.S. Environmental
Protection Agency's actions to
address air toxics emissions
through its residual risk and
technology review program, the
EPA's Office of Inspector
General identified an urgent
matter related to whether the
EPA had informed the public
about health risks from
exposure to ethylene oxide
emissions. Therefore, we are
issuing this management alert
so that the EPA can address
this matter while our overall
audit work continues.
Ethylene oxide is a gas used to
make other chemicals that are
needed to manufacture a
variety of products and to
sterilize medical equipment.
Studies show that breathing in
elevated ethylene oxide levels
over many years can lead to
lymphoid cancers in males and
females and breast cancer in
females. In December 2016,
the EPA revised its
characterization of the chemical
to "carcinogenic to humans."
This report addresses the
following:
• Improving air quality.
Address inquiries to our public
affairs office at (202) 566-2391 or
OIG WEBCOMMENTS@epa.gov.
List of OIG reports.
Management Alert: Prompt Action Needed to Inform
Residents Living Near Ethylene Oxide-Emitting
Facilities About Health Concerns and Actions to
Address Those Concerns
What We Found
Through its National Air Toxics Assessment,
the EPA identified areas where exposure to
ethylene oxide emissions could contribute to
an elevated estimated lifetime cancer risk
equal to or greater than 100 in one million, a
risk level that the EPA generally considers not
sufficiently protective of health. These
emissions primarily come from chemical manufacturing plants and commercial
sterilizers that sterilize medical equipment.
The EPA needs to inform
residents who live near
facilities with significant
ethylene oxide emissions
about their elevated estimated
cancer risks so they can
manage their health risks.
The EPA has prioritized activities to more fully assess ethylene oxide emissions
and the associated health risks to the public near 25 high-priority facilities. These
activities include communicating with facilities and states about gathering
emissions information and communicating with elected officials about the
National Air Toxics Assessment results. While the EPA or state personnel, or
both, have met with residents living near nine of the 25 high-priority facilities,
communities near 16 facilities have yet to be afforded public meetings or other
direct outreach to learn about the health risks and actions being taken to address
those risks.
The OIG did not identify any specific statutory, regulatory, or policy requirements
for the EPA to provide the public additional information regarding its preliminary
determination that certain ethylene oxide-emitting facilities may present health
risks to surrounding communities. However, the EPA's mission statement
includes working to ensure that "[a]ll parts of society ... have access to accurate
information sufficient to effectively participate in managing human health and
environmental risks." Thus, the Agency should work to ensure that the health
risks and actions that the EPA is taking to address those risks are directly and
promptly communicated to residents living near all the high-priority facilities.
Recommendations and Planned Agency Corrective Actions
We recommend that the Agency provide residents in all communities near the 25
high-priority ethylene oxide-emitting facilities with a forum for an interactive
exchange of information with EPA or state personnel regarding health concerns
related to exposure to ethylene oxide. In its response to our draft report, the
Agency proposed an alternative recommendation with corrective actions that
focused on completing more refined investigations of risk prior to conducting
significant public outreach. We do not believe that the Agency should delay
providing forums for interactive outreach with residents in these communities.
Therefore, our recommendation is unresolved pending receipt of an acceptable
corrective action plan with milestones from the EPA.

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