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Congressionally Requested Report:
Improving air quaiity
EPA Delayed Risk Communication
and Issued Instructions Hindering
Region 5's Ability to Address
Ethylene Oxide Emissions
Report No. 21-P-0123
April 15, 2021

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Report Contributors:
Bao Chuong
Gaida Mahgoub
Andrew Lavenburg
Renee McGhee-Lenart
Julie Narimatsu
Abbreviations
ATSDR	Agency for Toxic Substances and Disease Registry
CMS	Clean Air Act Stationary Source Compliance Monitoring Strategy
EPA	U.S. Environmental Protection Agency
FCE	Full Compliance Evaluation
NATA	National Air Toxics Assessment
OAQPS	Office of Air Quality Planning and Standards
OAR	Office of Air and Radiation
OIG	Office of Inspector General
Cover Image:	A 2014 National Air Toxics Assessment map of part of Lake County,
Illinois, that includes Gurnee and Waukegan. The colors on the map
represent the different levels of cancer risk. For example, the dark blue
color indicates that the cancer risk is greater than 100 in one million.
(EPA image)
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Learn more about our OIG Hotline.
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www.epa.aov/oia
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151 U.S. Environmental Protection Agency	April 15,2021
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At a Glance
s viv *
Why We Did This Audit
We received four congressional
requests regarding actions by
Regions 5 and 6 to address
ethylene oxide emissions. In
response, we conducted this
audit to address:
•	Whether the U.S.
Environmental Protection
Agency complied with all
statutory, regulatory, and
policy requirements and
protocols in disclosing
public health information
about ethylene oxide
emissions from three
facilities in Illinois.
•	Whether EPA senior
political appointees
instructed EPA inspectors to
avoid conducting
inspections at ethylene
oxide-emitting facilities
across Regions 5 and 6.
•	Whether the EPA has
conducted inspections at
ethylene oxide-emitting
facilities in Regions 5 and 6.
In December 2016, the EPA
revised its characterization of
ethylene oxide to "carcinogenic
to humans."
This audit addresses the
following:
•	Improving air quality.
This audit addresses a top EPA
management challenge:
•	Communicating risks.
Address inquiries to our public
affairs office at (202) 566-2391 or
OIG WEBCOMMENTS@epa.gov.
List of OIG reports.
EPA Delayed Risk Communication and Issued
Instructions Hindering Region 5's Ability to Address
Ethylene Oxide Emissions
The EPA did not achieve its
mission when senior leaders
issued instructions to Region 5
that impacted the region's
ability to address ethylene
oxide emissions and when the
EPA delayed communicating
health risks regarding ethylene
oxide.
What We Found
The EPA delayed communicating health
risks to community residents in Illinois, which
is part of EPA Region 5, who lived near
ethylene oxide-emitting facilities. Specifically,
Office of Air and Radiation leadership
delayed informing the Willowbrook, Illinois,
community about the results of the EPA's
May 2018 short-term monitoring around the
Sterigenics facility and did not conduct public
meetings with residents either near the Medline facility in Waukegan, Illinois, or
the Vantage facility in Gurnee, Illinois. Outside of the residual risk review
process, the Office of Inspector General did not identify any statutory, regulatory,
or specific policy requirements or protocols to disclose public health information
about ethylene oxide emissions. The EPA's mission statement and risk
communication guidance state, however, that communities should have accurate
information to participate in decision-making processes.
According to two Region 5 managers, a then-senior leader in the Office of Air and
Radiation, who was a political appointee, instructed Region 5 to not conduct
inspections at ethylene oxide-emitting facilities unless invited by the state to
conduct a joint inspection. Region 6 managers and inspectors stated that they did
not receive such policy instructions. Office of Air and Radiation senior leaders
also issued additional instructions that hindered Region 5's ability to effectively
address ethylene oxide emissions, according to Region 5 personnel.
The EPA delegates authority to state, local, and tribal agencies to implement
federal environmental programs. The states in Regions 5 and 6 generally
inspected major and synthetic minor facilities that emit ethylene oxide from fiscal
years 2018 through 2020, according to the frequencies outlined in the EPA's
2016 Clean Air Act Stationary Source Compliance Monitoring Strategy or a
state's alternative Clean Air Act CMS plan.
Recommendations and Planned Agency Corrective Actions
We recommend that the assistant administrator for Air and Radiation develop
standard operating procedures describing the roles and responsibilities of the
Office of Air and Radiation and EPA regional offices in assessing and addressing
air toxics emissions and how the Office of Air and Radiation will work with regional
offices to communicate preliminary air toxics risk information to the public. The
Agency's response to the draft report stated that its air toxics strategy would
address these recommendations. We reviewed the draft air toxics strategy, and it
did not address our concerns. We consider the two recommendations unresolved.

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
April 15, 2021
MEMORANDUM
SUBJECT: EPA Delayed Risk Communication and Issued Instructions Hindering Region 5's Ability
to Address Ethylene Oxide Emissions
Report No. 21-P-0123
This is our report on the subject audit conducted by the Office of Inspector General of the
U.S. Environmental Protection Agency. The project number for this audit was OA&E-FY19-0091. This
report contains findings that describe the problems the OIG has identified and corrective actions the OIG
recommends. Final determinations on matters in this report will be made by EPA managers in accordance
with established audit resolution procedures.
The Office of Air and Radiation is responsible for the issues discussed in the report.
Action Required
This report contains unresolved recommendations. The resolution process, as described in the EPA's
Audit Management Procedures, begins immediately with the issuance of this report. Furthermore, we
request a written response to the final report within 60 days of this memorandum. Your response will be
posted on the OIG's website, along with our memorandum commenting on your response. Your response
should be provided as an Adobe PDF file that complies with the accessibility requirements of Section 508
of the Rehabilitation Act of 1973, as amended. The final response should not contain data that you do not
want to be released to the public; if your response contains such data, you should identify the data for
redaction or removal along with corresponding justification.
FROM:
TO:
Joseph Goffman, Acting Assistant Administrator
Office of Air and Radiation
We will post this report to our website at www.epa.gov/oig.

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EPA Delayed Risk Communication and
Issued Instructions Hindering Region 5's
Ability to Address Ethylene Oxide Emissions
21-P-0123
Table of C
Chapters
1	Introduction		1
Purpose		1
Background		1
Responsible Offices		3
Scope and Methodology		4
Prior Report		5
2	EPA Delayed Risk Communication Concerning Health Risks from Ethylene
Oxide-Emitting Facilities in Illinois		6
Communities Should Have Access to Information to Help Manage
Health Risks		6
OAR Leadership Delayed Informing Willowbrook Community About
Results from Short-Term Monitoring of Sterigenics		7
State and Local Agencies Communicated Risks to Residents Near
Medline and Vantage Facilities		11
Conclusion		12
Recommendation		12
Agency Response and OIG Assessment		12
3	OAR Senior Management Hindered Region 5's Ability to Address
Ethylene Oxide Emissions and Achieve EPA's Mission		14
OAR Senior Political Leader Instructed Region 5 Not to Conduct
Inspections Unless Invited by the State		14
OAR Issued Additional Instructions that Restricted Region 5's Ability
to Fulfill EPA's Mission		16
Impact of OAR's Instructions on Region 5 and Public Health		18
Conclusion		19
Recommendation		19
Agency Response and OIG Assessment		19
4	States in Regions 5 and 6 Have Generally Conducted Inspections
of Ethylene Oxide-Emitting Facilities as Specified in Their CMS		21
FCE Frequencies for Stationary Sources Are Outlined in CMS		21
States in Regions 5 and 6 Have Generally Conducted FCEs for Major
and Synthetic Minor Ethylene Oxide-Emitting Facilities		22
Conclusion		22
Status of Recommendations and Potential Monetary Benefits		23
--continued-

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EPA Delayed Risk Communication and
Issued Instructions Hindering Region 5's
Ability to Address Ethylene Oxide Emissions
21-P-0123
Appendices
A Congressional Requests to the OIG		24
B Agency Response to Draft Report		28
C Distribution		31

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Chapter 1
Introduction
Purpose
Top Management Challenge
This audit addresses the following top
management challenge for the Agency, as
identified in OIG Report No. 20-N-0231,
EPA's FYs 2020-2021 Top Management
Challenges, issued July 21, 2020:
• Communicating risks,
congressional requests, we conducted this audit to determine:
•	Whether the EPA complied with all statutory, regulatory, and policy
requirements and protocols in disclosing public health information about
ethylene oxide emissions from the Sterigenics facility in Willowbrook,
Illinois (DuPage County); the Medline Industries facility in Waukegan,
Illinois (Lake County); and the Vantage Specialty Chemicals facility in
Gurnee, Illinois (Lake County).
•	Whether EPA senior political appointees instructed EPA inspectors to
avoid conducting inspections at ethylene oxide-emitting facilities across
Regions 5 and 6.
•	Whether the EPA has conducted inspections at ethylene oxide-emitting
facilities in Regions 5 and 6.
Background
Ethylene oxide is a flammable and colorless gas
used to make chemicals that are needed to
manufacture a variety of products, including
antifreeze, textiles, plastics, detergents, and
adhesives. It is also used to sterilize medical
equipment and other items that cannot be
sterilized by methods such as steam. A variety of
sources emit ethylene oxide, including chemical
manufacturing facilities and medical equipment
sterilization facilities. The Sterigenics facility and
the Medline facility are medical equipment sterilization facilities. The Vantage
facility is a chemical manufacturing facility that uses ethylene oxide to produce
The Office of Inspector General for
the U.S. Environmental Protection
Agency received four congressional
requests (Appendix A) between
November 2018 and January 2019
regarding the actions of EPA
Regions 5 and 6 to address ethylene
oxide emissions. In response to the
The EPA classifies ethylene
oxide as carcinogenic to
humans, meaning it can cause
cancer. Studies show that
breathing air containing
elevated ethylene oxide levels
over many years increases the
risk of developing lymphoid
cancers in males and females
and breast cancer in females.
21-P-0123
1

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ingredients for personal care, food, and consumer products, as well as other uses.
Ethylene oxide is one of 187 hazardous air pollutants regulated by the EPA.1 Also
known as air toxics, hazardous air pollutants are known or suspected to cause
cancer or other serious health effects.
The EPA increased the cancer risk value for ethylene oxide in December 2016
based on studies from the National Institute for Occupational Safety and Health.
The EPA estimated the chemical to be 30 times more carcinogenic to adults than
previously thought, and the Agency revised ethylene oxide's carcinogenic
description from "probably carcinogenic to humans" to "carcinogenic to humans."
Studies show that breathing air containing elevated ethylene oxide levels over
many years increases the risk of developing lymphoid cancers in males and
females and breast cancer in females. For a single year of exposure to ethylene
oxide, the risk of developing cancer is greater for children than for adults. This is
because ethylene oxide can damage deoxyribonucleic acid, which is hereditary
material in humans.
Residual Risk Reviews
The 1990 amendments to the Clean Air Act require the EPA to establish
technology-based standards for sources of air toxics and to, within eight years
thereafter, review the remaining health risks to the public and establish additional
standards to reduce the public's health risk to acceptable levels, if necessary. This
regulatory review is known as the residual risk review. Through the residual risk
review, the EPA can communicate risks to the public through its regulatory public
notice and comment process.
Ethylene Oxide Identified as Significant Health Risk
The EPA periodically conducts the National Air Toxics Assessment, known as
NATA, to assess the public health risk from exposure to air toxics. NATA is not
required by regulation and is not part of the EPA's regulatory program that
addresses air toxics emissions. NATA is a screening tool that can assist the EPA
and state, local, and tribal air agencies in identifying geographic areas, pollutants,
or emission sources for further examination. Based on the updated cancer risk
value for ethylene oxide, the EPA's 2014 NATA identified ethylene oxide as a
new and significant driver of cancer risk. The 2014 NATA was released on
August 22, 2018, but is based on emission inventories reported for calendar
year 2014. The EPA began working on the 2014 NATA in 2016 and used the
most recent emission inventories at the time, which were for the calendar
year 2014.
1 On June 18, 2020, the EPA granted petitions to add 1-bromopropane to the list of air toxics contained in the Clean
Air Act. The EPA stated in the petition grant that it will take a separate regulatory action to add 1-bromopropane to
the list of air toxics under Clean Air Act Section 112(b)(1). Once this separate regulatory action is completed, the
number of listed air toxics will be 188.
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The EPA identified census tracts with elevated estimated cancer risks primarily
driven by ethylene oxide emissions in 17 metropolitan areas. Census tracts are
small, relatively permanent statistical subdivisions of a county with boundaries
that normally follow visible features, such as roads and rivers. The U.S. Census
Bureau designs census tracts with a goal that each tract contain about
4,000 people and 1,600 housing units.
NAT A presents cancer risk estimates based on a cumulative 70-year lifetime
exposure. For example, a cancer risk of one in one million implies that if
one million people are exposed to the same concentration of a pollutant
continuously for 70 years, one person would likely develop cancer from this
exposure. This risk would be in addition to any baseline cancer risk of a person
not exposed to these air toxics. The EPA generally considers a risk of 100 in one
million, or one in 10,000, as not sufficiently protective of public health.
Of the 17 metropolitan areas containing census tracts with cancer risks equal to or
greater than 100 in one million, two are in Region 5, while seven are in Region 6
(Figure l).2 The EPA identified three facilities that contributed to elevated
estimated cancer risks in Illinois: Sterigenics, Medline, and Vantage.3
Figure 1: Metropolitan areas in Regions 5 and 6 where there is at least
one census tract in which ethylene oxide is a main driver of cancer risk
Source: Developed by EPA OIG based on 2014 NATA and information from the EPA.
(EPA OIG graphic)
Note: According to the EPA, a facility in New Mexico installed a control device that reduced
ethylene oxide emissions priorto the 2014 NATA release.
The EPA's Office of Air Quality Planning and Standards, within the Office of Air
and Radiation, conducts the NATA. OAQPS works with regional offices and
states to ensure the accuracy of the emissions data used in conducting the NATA.
EPA regional offices and delegated state and local agencies inspect ethylene
oxide-emitting facilities.
2	Region 5 states include Illinois, Indiana. Minnesota, Michigan, Ohio, and Wisconsin. Region 6 states include
Arkansas, Louisiana. Oklahoma, New Mexico, and Texas.
3	The Vantage facility was not modeled as part of the 2014 NATA because of an error in the National Emissions
Inventory.
Responsible Offices
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Scope and Methodology
We conducted our work from March 2019 to February 2021. We conducted this
performance audit in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our findings and
conclusions based on our audit objectives. We believe that the evidence obtained
provides a reasonable basis for our findings and conclusions based on our audit
objectives.
To address congressional concerns related to risk communication and inspections
of ethylene oxide-emitting facilities, we:
•	Interviewed staff and managers in OAQPS; Regions 5 and 6, including
Clean Air Act inspectors or their supervisors; and the Agency for Toxic
Substances and Disease Registry, known as ATSDR.
•	Interviewed staff in the Office of Enforcement and Compliance
Assurance.
•	Reviewed the EPA's Clean Air Act Stationary Source Compliance
Monitoring Strategy, known as CMS, issued October 4, 2016.
•	Reviewed the EPA's FY2020 - FY2023 National Compliance Initiatives,
issued June 7, 2019.
•	Searched the Toxics Release Inventory, Enforcement and Compliance
History Online, and Integrated Compliance Information System databases
to determine the universe of ethylene oxide-emitting facilities and
confirmed the information with regional and state personnel.
•	Obtained information from states in Regions 5 and 6 about the most recent
full compliance evaluations, or FCEs, conducted at major and synthetic
minor facilities when incomplete information was found in the
Enforcement and Compliance History Online database.
•	Reviewed the Clean Air Act, the EPA's mission statement, the Agency's
guidance on risk communication, and regional communications plans.
•	Reviewed news media reports related to public concerns about ethylene
oxide emissions from the Sterigenics, Medline, and Vantage facilities in
Illinois.
•	Accessed and reviewed email accounts of key officials in OAR and
Region 5 that were pertinent to our audit objectives. The email accounts
that the OIG reviewed included content that was in the accounts at the
21-P-0123
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time the Office of Environmental Information, now the Office of Mission
Support, received the OIG's email access request, including deleted and
sent/received items from December 2017 to June 2019.
While interviewing staff and managers in Region 5, we learned that OAR senior
leaders issued instructions that impacted the region's role in addressing ethylene
oxide emissions. We reviewed documents provided to us by Region 5. We
discussed these instructions with managers and staff in Region 6 and OAQPS to
determine whether they also received these instructions.
Prior Report
EPA OIG Report No. 20-N-0128. Management Alert: Prompt Action Needed to
Inform Residents Living Near Ethylene Oxide-Emitting Facilities About Health
Concerns and Actions to Address Those Concerns, issued March 31, 2020, found
that while the EPA or state personnel, or both, met with residents living near nine
of the 25 high-priority ethylene oxide-emitting facilities, communities near
16 facilities have yet to be afforded public meetings or other direct outreach to
learn about the health risks of ethylene oxide and actions being taken to address
those risks.
We recommended that the EPA promptly provide 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. The EPA provided an alternative
recommendation and corrective actions that did not meet the intent of the OIG
recommendation. Subsequently, the recommendation went into audit dispute
resolution, and then-EPA Administrator Andrew Wheeler sided with OAR's
proposed corrective action plan, which committed the EPA to, among other
things, conduct additional, more refined risk assessments and outreach to affected
communities by May 31, 2021.
21-P-0123
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Chapter 2
EPA Delayed Risk Communication Concerning
Health Risks from Ethylene Oxide-Emitting
Facilities in Illinois
The EPA delayed communicating preliminary findings of health risks from
ethylene oxide-emitting facilities to community residents in Illinois. Moreover,
we did not identify any statutory, regulatory, or specific policy requirements or
protocols for disclosing public health information related to health risks posed by
ethylene oxide-emitting facilities outside of the residual risk review process.
The EPA's mission statement asserts that the Agency works to ensure that "[a]ll
parts of society—communities, individuals, businesses, and state, local and tribal
governments—have access to accurate information sufficient to effectively
participate in managing human health and environmental risks." The EPA's risk
communication guidance also states that communities have the right to participate
in decision-making processes that affect their lives and livelihoods.4
The EPA's actions have not been consistent with its mission or guidance on risk
communication. Data from the short-term monitoring that the EPA conducted in
May 2018 around the Sterigenics facility indicated elevated risks to people
exposed to ethylene oxide for a lifetime, which is assumed to be 70 years, but the
Agency chose to delay informing the community. In addition, the Agency did not
conduct public meetings with residents near the Medline and the Vantage
facilities.
Communities Should Have Access to Information to Help Manage
Health Risks
Outside of the residual risk review process, we did not identify any statutory,
regulatory, or specific policy requirements or protocols for disclosing public
health information related to health risks posed by ethylene oxide-emitting
facilities. The EPA has a regulatory process in place to conduct residual risk
reviews to assess the health and environmental risks that remain after the
implementation of technology-based standards limiting air toxics emissions.
Employing this regulatory process, the EPA can communicate risks to the public
through its regulatory public notice and comment process.
Commercial sterilizers, such as the Sterigenics and Medline facilities, are among
the 119 types of industrial sources, referred to as source categories, that require
residual risk reviews. The EPA finalized its residual risk review of commercial
4 EPA, Risk Communication in Action—the Tools of Message Mapping, EPA/625/R-06/012, August 2007.
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sterilizers in April 2006. In 2016, the EPA's Office of Research and Development
found that ethylene oxide was more toxic than previously known and determined
it was carcinogenic to humans. An EPA manager stated that while the Agency is
required to conduct a review of technology-based standards every eight years, it is
not required to conduct additional residual risk reviews. Therefore, the public may
not have updated risk information in cases where residual risk reviews for a
source category were conducted before the EPA discovered that the risk level of a
pollutant increased.
The EPA's mission is to protect human health and the environment. The EPA
achieves its mission in part by ensuring that all parts of society, such as
communities and individuals, have "access to accurate information sufficient to
effectively participate in managing human health and environmental risks."5 In
our EPA's FYs 2020-2021 Top Management Challenges report, we noted that one
of the EPA's management challenges is communicating risk to allow the public to
make informed decisions about its health and environment. Then-Acting
Administrator Wheeler identified risk communication as one of his top priorities
in his July 2018 speech to EPA employees, stating:
Risk communication goes to the heart of EPA's mission of
protecting public health and the environment. ... We must be able
to speak with one voice and clearly explain to the American people
the relevant environmental and health risks that they face, that their
families face and that their children face.
Further, the EPA's risk communication guidance states that one of the seven
"cardinal rules" of risk communication is to accept and involve the public as a
legitimate partner.6 The guidance also states that communities have the right to
participate in decision-making processes that affect their lives and livelihoods.
To adhere to its mission statement and risk communication principles, the EPA
should assure that all impacted communities are provided an opportunity to
engage in an interactive exchange of information with the EPA and state agencies
to more fully understand the health concerns related to ethylene oxide exposure
and the actions that the EPA is taking to address those concerns.
OAR Leadership Delayed Informing Willowbrook Community About
Results from Short-Term Monitoring of Sterigenics
After learning about the elevated estimated cancer risks from ethylene oxide
emissions from point sources, which are generally large stationary sources, in the
draft 2014 NATA, Region 5 wanted to confirm the emissions data used in the
5	EPA website. Our Mission and What We Do, last updated on February 7, 2018.
6	EPA, Risk Communication in Action-the Risk Communication Workbook, EPA/625/R-05/003, August 2007;
EPA, Risk Communication in Action-the Tools of Message Mapping, EPA/625/R-06/012, August 2007.
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draft 2014 NATA. Because OAQPS did not allow regions to disclose the draft
2014 NATA data to external stakeholders except states, Region 5 conducted its
own internal modeling of Sterigenics and Ele, a chemical plant in McCook,
Illinois, in November 2017. According to Region 5 staff, these two facilities were
chosen, in part, because they represent two types of ethylene oxide-emitting
sources—commercial sterilizers and chemical plants. The internal modeling
confirmed that the two facilities had the potential to contribute to elevated cancer
risks.
In December 2017, Region 5 sent letters to Sterigenics and Ele requesting their
review of the modeling results and their suggestions for improvements for
modeling accuracy. The Illinois Environmental Protection Agency received
copies of the letters. From January to March 2018, Region 5 communicated with
Sterigenics until Sterigenics stopped communicating with the region. Region 5
also communicated with Ele during this time period, and it took Ele until
June 2018 to provide corrections to the modeling parameters.
Without information from Sterigenics to verify that the inputs for the Region 5
internal modeling were accurate, Region 5, with funding assistance from OAQPS,
conducted monitoring for ethylene oxide near the Sterigenics facility May 16-18,
2018. Region 5 chose to monitor around the Sterigenics facility because:
•	Region 5 has a warehouse next to the facility and would not have any
issues with access rights to the property. This allowed the region to install
monitors around the warehouse and the meteorological station on the
warehouse's rooftop.
•	It would allow the region to determine whether ethylene oxide could be
detected using an EPA monitoring method and identify the levels of
ethylene oxide, if any, present in the outdoor air.
After the monitoring data were received and reviewed, Region 5 provided the
monitoring and modeling data to the ATSDR, which is another federal agency,
and requested that it review the data.
Table 1 is a timeline of key events regarding the short-term monitoring around the
Sterigenics facility.
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Table 1: Timeline of key events preceding and following the May 16-18, 2018
short-term monitoring around the Sterigenics facility
Date
Event
November 2017
Region 5 conducted internal modeling of the Sterigenics and Ele facilities.
12/22/17
Region 5 sent letters to Sterigenics and Ele requesting information and
copied the Illinois Environmental Protection Agency on the letters.
January-March 2018
Region 5 communicated with the Sterigenics facility until the facility
stopped communicating with the region.
February-March 2018
Region 5 and OAQPS jointly designed a monitoring plan.
5/16/18-5/18/18
Region 5 conducted monitoring around the Sterigenics facility.
5/30/18
Region 5 received preliminary monitoring data.
6/15/18
Region 5 completed quality assurance and quality control of the monitoring
data.
6/20/18
The then-Region 5 regional administrator was briefed on the monitoring
data and directed staff to prepare a website to post the monitoring data and
a press release.
6/22/18
The then-assistant administrator for Air and Radiation directed the
then-Region 5 regional administrator to not release monitoring results to
the public. The then-regional administrator complied with this direction. The
then-Region 5 acting deputy regional administrator sent an email regarding
the monitoring results to staff working at the Region 5 Willowbrook site.
7/26/18
The ATSDR submitted a Letter Health Consultation of the Sterigenics
facility's ethylene oxide emissions to a Region 5 manager, indicating that
the facility would present a public health hazard to people living and
working in Willowbrook "if measured and modeled data represent typical
[ethylene oxidel ambient concentrations in ambient air."3
8/21/18
The ATSDR posted a Letter Health Consultation of Sterigenics facility's
ethylene oxide emissions on its website.
8/22/18
The EPA released the 2014 NATA, posting the data on its website. The
Region 5's webpage on Sterigenics facility monitoring was online for about
an hour before the then-deputy assistant administrator for Air and
Radiation directed Region 5 to take the webpage down.
8/29/18
The EPA, the Illinois Environmental Protection Agency, the ATSDR, and
Sterigenics met with the Willowbrook community.
10/2/18
A revised webpage with less information on the Sterigenics facility was
posted.
Source: Developed by EPA OIG based on information from the EPA and OIG analysis of EPA
information. (EPA OIG table)
a An ATSDR Letter Health Consultation is a verbal or written response from ATSDR to a specific
request for information about health risks related to a specific site, a chemical release, or the
presence of hazardous material.
OAR Senior Leader Delayed Public Release of May 2018 Sterigenics
Willowbrook Facility Monitoring Results
On June 20, 2018, the then-Region 5 regional administrator was briefed on the
monitoring results. These monitoring results showed ambient ethylene oxide
concentrations that would lead to increased cancer risk if people were exposed for
a lifetime. According to a Region 5 manager who attended the briefing, the
then-Region 5 regional administrator expressed concern about the monitoring
results and wanted to immediately release them to the public to avoid another
public health emergency like the Flint, Michigan drinking water crisis.
Region 5 staff were directed to prepare a public webpage to post the monitoring
results and develop a press release. Region 5 planned to release the monitoring
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results to the public on June 22, 2018. The then-assistant administrator for Air and
Radiation delayed Region 5 from releasing the monitoring results because,
according to Region 5 staff, the 2014 NATA had not been released, and the
then-assistant administrator for Air and Radiation wanted to release both sets of
data at the same time.
Despite not being allowed to release the monitoring results to the public, the
then-acting deputy regional administrator for Region 5 informed staff working at
its Willowbrook site of the monitoring results on June 22, 2018, stating that the
measured ethylene oxide concentrations "do not pose an immediate health risk"
and that the "EPA plans to conduct additional work to ensure that it understands
the source and long-term exposure of [ethylene oxide] in the area, including any
effects on indoor air quality." According to the ATSDR, if the measured ethylene
oxide concentrations persisted long-term, then the ethylene oxide emissions from
the Sterigenics facility would present a public health hazard to people living and
working in Willowbrook.
OAR Senior Leader Directed Region 5 to Take Down Its Sterigenics
Webpage, and Key Information Was Removed Before Webpage Was
Reposted
OAR senior leaders wanted to release the 2014 NATA and the ATSDR's
Sterigenics facility Letter Health Consultation around the same time because the
Letter Health Consultation discussed the NATA data. The ATSDR released the
Sterigenics facility Letter Health Consultation on August 21, 2018. The next day,
the EPA released the 2014 NATA results to the public. At the same time, Region 5
posted the following information on its Sterigenics facility webpage:
•	Background information on ethylene oxide, what the facility is, the
facility's history, and why the EPA is involved.
•	The May 2018 monitoring results showing high ethylene oxide
concentrations and the health impacts from exposure to ethylene oxide.
•	Details on how the EPA was responding, including efforts with the State of
Illinois on working with the Sterigenics facility to reduce ethylene oxide
emissions.
•	Documents related to the Sterigenics facility, including a link to the
ATSDR's Letter Health Consultation.
About an hour after the information was posted, the then-deputy assistant
administrator for Air and Radiation directed Region 5 to take down the webpage
because, according to an OAQPS manager, it was not similar to the Region 6
webpage on the Denka facility. The Denka facility is the only facility in the
United States that produces a class of synthetic rubber called "neoprene," which is
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made from chloroprene, a likely human carcinogen. Region 6 developed a
webpage on the Denka facility to communicate elevated cancer risks from the
facility found in the 2011 NATA. According to Region 5 staff, the Sterigenics
webpage was modeled after the Denka facility webpage. We reviewed the
webpage that was taken down and determined that it was similar to the current
Denka facility webpage.
According to Region 5 staff, after the webpage was taken down, all that remained
on the Region 5 website concerning the Sterigenics facility were the May 2018
monitoring results and the link to the ATSDR Letter Health Consultation. Without
the background information on the Sterigenics facility, the public did not have any
context regarding monitoring results or the ATSDR Letter Health Consultation. In
September 2018, OAQPS took over communicating with the Sterigenics facility
from Region 5. Region 5 revised the Sterigenics facility webpage based on input
from OAR and posted it on October 2, 2018. We determined that the webpage as of
January 15, 2021, did not include all the details that were in the original webpage,
including the statement that the EPA has determined ethylene oxide to be
carcinogenic to humans.
State and Local Agencies Communicated Risks to Residents Near
Medline and Vantage Facilities
On August 29, 2018, the EPA, the Illinois Environmental Protection Agency, the
ATSDR, and Sterigenics attended a public meeting with residents living near the
Sterigenics facility in Willowbrook. The EPA, however, did not hold similar
meetings in Lake County, which is the location of the Medline and Vantage
facilities. The EPA's then-assistant administrator for Air and Radiation explained
in a May 29, 2019 public meeting in Burr Ridge, Illinois, that Medline had taken
concrete steps to address its ethylene oxide emissions, including agreeing to install
additional controls. Questions regarding the Vantage facility were deferred to the
state.
Although the EPA did not hold meetings with residents near the Medline or
Vantage facilities, the following public meetings were held in Lake County:
•	On May 23, 2019, the Illinois Environmental Protection Agency held a
public meeting with residents living near the Medline facility. The meeting
focused on the state's draft construction permit for Medline that required
the facility to install controls and emissions monitors and limited total
ethylene oxide emissions to 150 pounds annually.
•	On October 2, 2019, Illinois State Senator Melinda Bush held a meeting
with Lake County residents to discuss ethylene oxide emissions from the
Vantage and Medline facilities. ATSDR staff also attended.
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• On November 14, 2019, the Illinois Environmental Protection Agency held
a public meeting with residents living near the Vantage facility. The
meeting focused on the state's draft construction permit for Vantage that
required enhanced leak detection and repair and limited total facility
ethylene oxide emissions to 110 pounds annually.
Region 5 staff said that its Office of Regional Counsel and Office of External
Communications staff attended these three meetings but did not participate or
provide information. The 2019 fall meetings occurred more than a year after the
NATA was released and the EPA first met with the residents near the Sterigenics
facility. According to the news media, residents near the Medline and Vantage
facilities were concerned that they first learned of their risks from ethylene oxide
emissions six months after the August 29, 2018 public meeting for residents near
the Sterigenics facility in Willowbrook. They were also concerned that they
learned about the risks from news media and not from government officials.
Although the first public meetings with residents in Lake County did not occur
until 2019, the EPA met with Lake County public officials on November 28,
2018. The EPA also met with the organization "Stop EtO in Lake County" on
July 8, 2019, and April 2, 2020.
Conclusion
The EPA did not act consistently with its mission or guidance on risk
communication because it delayed informing the Willowbrook community about
the results from the May 2018 short-term monitoring around the Sterigenics
facility. Further, the Agency did not actively conduct outreach with residents
living near the Medline and Vantage facilities. Instead, state and local agencies
communicated risks to these communities.
Recommendation
We recommend that the assistant administrator for Air and Radiation:
1. Develop standard operating procedures describing how the Office of Air
and Radiation will work with EPA regional offices to communicate
preliminary air toxics risk information, including elevated risks found in
the National Air Toxics Assessment, to the public so that communities are
promptly informed of potential health concerns.
Agency Response and OIG Assessment
The Agency provided corrective actions and a milestone for Recommendation 1.
OAQPS is establishing an air toxics strategy that will discuss how it will address
emerging air toxics issues and how those issues will be elevated and handled
within OAQPS, EPA regions, and external stakeholders. The strategy will also
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include a framework to improve internal and external communication,
coordination, and collaboration on air toxics. After reviewing and being briefed
on the draft strategy, we determined that it does not address our concerns about
how OAR will work with EPA regional offices to communicate preliminary air
toxics risk information to the public so that communities are promptly informed
of potential health concerns. The recommendation is unresolved.
Appendix B contains OAR's response to the draft report. OAR and Region 5 also
submitted technical comments on the draft report. We have considered those
comments and updated the report as appropriate.
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Chapter 3
OAR Senior Management Hindered Region 5's Ability
to Address Ethylene Oxide Emissions
and Achieve EPA's Mission
An OAQPS manager relayed policy instructions from an OAR senior political
appointee to Region 5 to not conduct inspections at ethylene oxide facilities
unless invited by the state, according to two Region 5 managers. These policy
instructions were relayed after one Region 5 manager asked whether the region
could inspect or send out Clean Air Act Section 114 letters to ethylene oxide
facilities.7 According to one Region 5 manager, an OAR senior political
appointee wanted the region to address ethylene oxide emissions through
regulatory or voluntary control efforts and not enforcement tools, such as on-site
inspections or Clean Air Act Section 114 letters.
While interviewing staff and managers in Region 5, we learned that OAR senior
leaders issued other instructions that impacted Region 5's role in addressing
ethylene oxide emissions. These oral instructions were for Region 5 to:
•	Not send Clean Air Act Section 114 letters to facilities.
•	Limit ambient air monitoring for ethylene oxide to the Sterigenics facility.
•	Not seek the ATSDR's assistance for toxicological or health assessments
and risk communication.
•	Coordinate with OAQPS before starting any modeling of facility emissions.
OAR Senior Political Leader Instructed Region 5 Not to Conduct
Inspections Unless Invited by the State
After the then-assistant administrator for Air and Radiation delayed Region 5
from informing the Willowbrook community about the results of the May 2018
short-term monitoring around the Sterigenics facility and OAQPS took over
communicating with the Sterigenics facility on ethylene oxide issues in
September 2018, Region 5 staff started asking OAR headquarters for permission
before conducting ethylene oxide-related activities. For example, in
September 2018, a Region 5 manager asked an OAQPS manager whether the
region could conduct inspections at ethylene oxide-emitting facilities. According
to Region 5, the OAQPS manager asked the then-deputy assistant administrator
for Air and Radiation and then orally relayed instructions to two Region 5
managers to not conduct any inspections at ethylene oxide-emitting facilities
7 To inform the development of National Emission Standards for Hazardous Air Pollutants and for other Clean Air
Act purposes. Section 114 of the Clean Air Act authorizes the EPA to require regulated entities to develop and
submit a broad range of information, as well as to install monitoring equipment and sample emissions.
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unless invited by the state. Figure 2 shows the dissemination of the inspection
instruction from OAR to Region 5.
Figure 2: Dissemination of the inspection instruction from OAR to Region 5
Region 5 Air	Office of Air Quality
and Radiation	Planning and
Division	Standards
Source: Developed by OIG based on information from the EPA. (EPA OIG image)
Note: Red line shows how the inspection instruction went from OAR to Region 5.
The Region 5 manager orally relayed this information to other Region 5 managers,
who were responsible for relaying the information to the inspectors. According to
Region 5 personnel, OAQPS personnel had
directed Region 5 to not conduct inspections at
ethylene oxide facilities because the region did
not follow EPA headquarters two-pronged
approach, which includes reviewing regulations
pertaining to facilities that emit ethylene oxide
and collecting information from facilities.
Region 5 personnel orally communicated to one
state agency and one local agency that OAR
headquarters directed Region 5 to not inspect
ethylene oxide facilities unless invited by a
state. Within one day, these agencies emailed
Region 5 requesting the region's presence and
assistance with on-site inspections at ethylene
oxide-emitting facilities because of the region's
expertise.
By contrast, Region 6 managers and inspectors stated that they did not receive
instructions to not inspect ethylene oxide facilities unless invited by a state. While
Region 6 had its states take the lead in assessing ethylene oxide emissions from
facilities, Region 5 had conducted modeling of the Sterigenics and Ele facilities,
communicated with the two facilities to ensure modeling accuracy, and conducted
ambient monitoring at the Sterigenics facility. OAQPS personnel were aware of
Region 5's actions, and Region 5 personnel believed that it was up to OAQPS
personnel to decide which issues OAR senior political appointees were briefed
on.
Atmospheric
Programs
Office ofRadiation
and IndoorAir
Transportation and
Air Quality
EPA's Two-Pronged Approach
to Address Ethylene Oxide
Emissions
Regulatory review. The first prong
of the EPA's approach is to review
existing air emissions regulations
pertaining to facilities that emit
ethylene oxide.
Information gathering. The
second prong of the EPA's
approach is to work closely with
state and local air agencies to
gather additional information on
facility emissions to determine
whether more immediate
emission reduction steps are
needed.
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The instructions from OAR leadership prevented Region 5 personnel from
initiating inspections at ethylene oxide facilities to address potential noncompliance
with emission standards unless the state invited them. For example, Region 5
informed the Michigan Department of Environmental Quality—now the Michigan
Department of Environment, Great Lakes, and Energy—about the instructions and
was invited by the department to participate in an inspection at a Michigan facility.
Region 5 participated in the inspection on October 12, 2018.
OAR Issued Additional Instructions that Restricted Region 5's Ability
to Fulfill EPA's Mission
While collecting information to address our
objective, we learned that OAR senior
political appointees orally issued other
instructions that impacted Region 5's role in
addressing ethylene oxide emissions, some
of which impacted other regions as well. We
deemed this information relevant to the
scope of our work and have included it in
this report. These instructions included:
•	Not to send Clean Air Act Section
114 letters to facilities.
•	Limit ambient air monitoring for
ethylene oxide to the Sterigenics
facility.
•	Not to seek the ATSDR's assistance for toxicological or health assessments
and risk communication.
•	Coordinate with OAQPS before starting any modeling of facility emissions.
The EPA's mission is "to protect human
health and the environment." The
Agency achieves its mission by
ensuring, among other things, that:
•	"Americans have clean air, land
and water."
•	"All parts of society-communities,
individuals, businesses, and state,
local and tribal governments-have
access to accurate information
sufficient to effectively participate
in managing human health and
environmental risks."
These instructions hindered Region 5's ability to effectively address ethylene oxide
emissions in a timely manner.
OAR Senior Leaders Prevented OAQPS and Region 5 from Sending
Clean Air Act Section 114 Letters to Facilities
OAR senior political appointees did not allow OAQPS and Region 5 to obtain
information from ethylene oxide-emitting facilities through Clean Air Act
Section 114 letters. Instead, those senior
political appointees instructed Region 5 to
obtain information voluntarily from ethylene
oxide-emitting facilities through phone calls,
emails, and letters delivered through the
postal service or another delivery service.
The Sterigenics and Ele facilities were
unresponsive to these informal information
OAR's denial of Region 5's request to
send Clean Air Act Section 114 letters
to ethylene oxide-emitting facilities
led to delays in the EPA obtaining
critical information to further
evaluate the cancer risks attributed
to ethylene oxide emissions from
these facilities.
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requests, so Region 5 asked OAR headquarters whether the region could send out
Clean Air Act Section 114 letters requiring the information. OAR headquarters
did not approve the request.
OAQPS staff told us that they asked the then-assistant administrator for Air and
Radiation for permission to send Clean Air Act Section 114 letters to multiple
miscellaneous organic chemical manufacturing facilities with ethylene oxide
emissions to obtain information for the miscellaneous organic chemical
manufacturing risk and technology review proposed rule, which was in
development. According to OAQPS staff, the then-assistant administrator for Air
and Radiation allowed OAQPS to send one Clean Air Act Section 114 letter in
November 2018 to the Lanxess facility in South Carolina that had one of the
highest source category risk driven by ethylene oxide emissions. This Clean Air
Act Section 114 letter included requirements for stack testing to quantify ethylene
oxide emissions from certain emission points but did not include an OAQPS-
requested requirement to monitor for fugitive emissions.
Region 5 Instructed to Not Conduct Monitoring for Ethylene Oxide
With the exception of the Sterigenics facility, where Region 5 conducted
monitoring from November 2018 to March 2019, OAR instructed Region 5 not to
conduct any new air monitoring for ethylene oxide. According to notes from a
March 13, 2019 meeting, OAQPS managers and staff told a Region 5 manager
that the then-assistant administrator for Air and Radiation said that:
•	Modeling is a better tool for assessing risk.
•	Monitoring would slow down the regulatory process.
According to Agency personnel, modeling is preferred over monitoring because
of the detection limits associated with ethylene oxide monitoring. The detection
limit of the EPA's contract laboratory performing this method, during the time of
the Sterigenics monitoring, would have equated to a cancer risk well in excess of
100 in one million. According to an OAQPS manager, the EPA is working to
improve the method detection limit because a non-detect does not mean that the
risk is equal to or lower than 100 in one million. In the meantime, modeling
would provide a more complete spatial and temporal assessment compared to
monitoring, according to Agency personnel.
According to Region 5 staff, in August 2018, the EPA committed to conducting
ambient monitoring around the Sterigenics facility. The EPA conducted
monitoring from November 2018 through March 2019 despite the detection
limitations. The monitoring results demonstrated that the facility's emissions were
above the detection limit and higher than expected based on the September 2018
stack test data.
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The Illinois Environmental Protection Agency found that the measured ambient
ethylene oxide levels at the Sterigenics facility were an imminent and substantial
endangerment to public health or welfare and issued a "seal order" in
February 2019, which "sealed" the facility's ethylene oxide storage containers,
restricting access to them. This access restriction prevented facility personnel
from introducing ethylene oxide into the sterilization process.
The monitoring results suggested that fugitive emissions were likely the source of
the high ambient concentrations given that the September 2018 stack test had
shown that chamber back vent emissions had been controlled after being routed to
existing control equipment. According to the EPA, the likely source of the
majority of fugitive emissions at the Sterigenics facility was the off-gassing of
sterilized products in uncontrolled areas of the facility. Fugitive emissions are
generally not captured by emission control equipment or detected through normal
equipment monitoring processes. Leaks are one source of fugitive emissions and
are most often associated with equipment used for the movement of fluids and
gases, such as pumps, valves, and connectors.
OAR Instructed Region 5 to Not Seek ATSDR's Assistance
Region 5 commonly sought the ATSDR's assistance for various risk assessment
needs. Among a number of statutory mandates, the ATSDR also has
responsibilities in the areas of public health assessments, the establishment and
maintenance of toxicologic databases, and information dissemination. According
to Region 5 personnel, an OAR senior leader instructed Region 5's Air and
Radiation Division to no longer consult with the ATSDR and said that OAQPS
would handle risk communication because the office is fully staffed with
toxicologists. An OAQPS manager was not aware of who gave those instructions
and stated that federal agencies should not be "providing different voices to the
public."
Region 5 Was Instructed to Coordinate with OAQPS Before Starting
Any Modeling of Facility Emissions
According to Region 5 personnel, an OAQPS manager told Region 5 to
coordinate with OAQPS before conducting any modeling of ethylene oxide
emissions.
Impact of OAR's Instructions on Region 5 and Public Health
The instructions from OAR ultimately hindered Region 5's ability to protect
human health from ethylene oxide emissions in a timely manner. Region 5 could
not assess potential noncompliance of emission standards with inspections.
Furthermore, Region 5's inability to send Clean Air Act Section 114 letters to
facilities allowed Sterigenics and Ele to delay providing critical information to the
EPA that was needed to assess their ethylene oxide emissions and determine the
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current cancer risk attributed to these emissions. While the Sterigenics facility is
no longer in operation as of November 2020, the EPA was still assessing Ele's
emissions nearly three years after Region 5 first communicated with Ele about the
internal modeling results. According to Region 5, Region 5 and the Illinois
Environmental Protection Agency will continue to investigate Ele, and additional
follow-up is planned for 2021.
According to a Region 5 manager, the OAR instructions impacted Region 5's
relationship with the Illinois Environmental Protection Agency, companies, and
the ATSDR. For example, Region 5 personnel did not know that Illinois planned
to issue a seal order to the Sterigenics facility until the order was reported by the
news. The relationship with companies was likely impacted because companies
understood that the EPA would not require them to provide additional information
about their emissions since OAR would not allow Region 5 to issue Clean Air Act
Section 114 letters. Further engagement, however, with companies and the state
was necessary to fully address risks. Without effective relationships with
companies or the state, the EPA lacked timely, accurate information about these
facilities.
Conclusion
OAR senior leaders issued instructions that hindered Region 5's efforts to address
ethylene oxide in a timely manner. OAR senior leaders' intervention to prevent
Region 5 from gathering information and communicating with ethylene oxide-
emitting facilities delayed the public from receiving timely, accurate information
about health risks from ethylene oxide emissions.
Recommendation
We recommend that the assistant administrator for Air and Radiation:
2. Develop standard operating procedures describing the roles and
responsibilities of the Office of Air and Radiation and regional offices in
assessing and addressing air toxics emissions contributing to health risks,
as found in the National Air Toxics Assessment or other studies.
Agency Response and OIG Assessment
The Agency provided corrective actions and a milestone to address
Recommendation 2. As part of its air toxics strategy, OAQPS has already
established three teams and an Air Toxics Council to improve its methods of
communication, coordination, and collaboration around air toxics issues, both
within OAQPS and with regional offices. One team under the strategy includes
regional representatives, but the others only include cross-divisional OAQPS
staff. After reviewing and being briefed on the draft strategy, we determined that
the draft strategy does not provide specific information about roles and
responsibilities, and the recommendation remains unresolved.
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The Agency's response to our draft report is in Appendix B. The Agency also
provided specific technical suggestions for our consideration, and we revised the
report as appropriate.
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Chapter 4
States in Regions 5 and 6 Have Generally
Conducted Inspections of Ethylene Oxide-Emitting
Facilities as Specified in Their CMS
The states in Regions 5 and 6 generally inspected major and synthetic minor
facilities that emit ethylene oxide from fiscal years 2018 through 2020, according
to the frequencies outlined in the EPA's CMS or a state's alternative Clean Air
Act CMS plan. The states in Regions 5 and 6 conducted FCEs at 75 ethylene
oxide-emitting facilities from fiscal years 2018 through 2020. The EPA conducted
12 on-site partial compliance evaluations of ethylene oxide-emitting facilities in
Region 5 and 6 states during the same time
period. Partial compliance evaluations are more
targeted evaluations and generally less
time-consuming and resource-intensive than
FCEs.
An FCE is a comprehensive
evaluation that assesses facility
compliance as a whole,
resulting in a compliance
determination. An FCE
addresses all regulated
pollutants at all regulated
emission units.
Title V of the Clean Air Act requires all major
sources and a limited number of minor sources to
have approved operating permits that outline what
facilities must do to control air pollution. States delegated with implementing and
enforcing the Title V operating permit program, which include all Region 5 and 6
states, are responsible for issuing permits and enforcing their requirements.
FCE Frequencies for Stationary Sources Are Outlined in CMS
The EPA's CMS focuses on federally enforceable requirements for Title V major
sources and synthetic minor sources that emit or have the potential to emit at or
above 80 percent of the Title V major source threshold. Major source thresholds
for air toxics are emissions of ten tons per year for a single hazardous air pollutant
or 25 tons per year of any combination of hazardous air pollutants.
According to the EPA's CMS guidance, states and local agencies should conduct
an FCE, at a minimum:


Once every two fiscal years at all Title V major sources, except those
classified as mega-sites.
Once every three fiscal years for mega-sites.
Once every five fiscal years at synthetic minor sources, which are sources
that emit or have the potential to emit at or above 80 percent of the Title V
major source threshold.
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These recommended FCE frequencies apply to EPA regions that directly
implement the Clean Air Act in Indian Country or U.S. territories. The CMS only
recommends FCE frequencies for major and synthetic minor facilities and not for
minor facilities. Some ethylene oxide-emitting facilities are minor facilities,
including Sterigenics, Vantage, Medline, and Ele.
According to the EPA's CMS guidance, each state submits a plan, known as a
CMS plan, every two years at a minimum to implement its CMS. States may
request and receive approval from their respective EPA region for alternative time
frames to conduct FCEs for their major and synthetic minor facilities, which are
incorporated into a state's CMS plan.
States in Regions 5 and 6 Have Generally Conducted FCEs for Major
and Synthetic Minor Ethylene Oxide-Emitting Facilities
The states in Regions 5 and 6 generally conducted FCEs of ethylene oxide-
emitting facilities according to the frequencies outlined in the EPA's CMS or
alternative monitoring strategies approved by the regions from fiscal years 2018
to 2020. These states conducted FCEs at 75 ethylene oxide-emitting facilities
from fiscal years 2018 to 2020. The EPA conducted 12 on-site partial compliance
evaluations at ethylene-oxide emitting facilities during that same time period.
Conclusion
States in Regions 5 and 6 conducted FCEs of major and synthetic minor ethylene
oxide-emitting facilities according to the frequencies outlined in the EPA's CMS or
states' alternative Clean Air Act CMS from fiscal years 2018 through 2020.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
Page
Rec. No. No.
Subject
Status1
Action Official
Planned
Completion
Date
Potential
Monetary
Benefits
(in $000s)
1 12
Develop standard operating procedures describing how the
Office of Air and Radiation will work with EPA regional offices to
communicate preliminary air toxics risk information, including
elevated risks found in the National Air Toxics Assessment, to
the public so that communities are promptly informed of potential
health concerns.
U
Assistant Administrator for
Air and Radiation


2 19
Develop standard operating procedures describing the roles and
responsibilities of the Office of Air and Radiation and regional
offices in assessing and addressing air toxics emissions
contributing to health risks, as found in the National Air Toxics
Assessment, other studies, or public complaints.
U
Assistant Administrator for
Air and Radiation


1 C = Corrective action completed.
R = Recommendation resolved with corrective action pending.
U = Recommendation unresolved with resolution efforts in progress.
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Appendix A
Congressional Requests to the OIG
November 1, 2018 Request from Senators Durbin and Duckworth and
Congressman Foster
The Honorable Charles Sheehan
Acting Inspector General
U.S. iiin iromnental Protection Agency
1200 Penn.sv Ivania Avenue, NW
Washington. DC 20460
Dear Acting Inspector General Sheehan,
We officially request the Office of the Inspector General of the U.S. Environmental
Protection Agency (EPA) investigate if L-'PA complied with all statutory, regulatory, and policy
requirements and protocols when it intentionally withheld critical health information from the
public about carcinogenic air pollution from the Sterigenics facility in DuPage County. Illinois.
We are concerned that the agency failed to take swift action to protect the health of a community
thai suffers from some of the highest cancer risks in the nation.
The 2016 Integrated Risk Information System report found ethylene oxide (EtO) to be
much more carcinogenic at lower concentrations than previously thought. As a result, the 2014
National Air foxies Assessment showed that DuPage County residents have an increased cancer
risk from HtO exposure. In December 2017. FPA sent a letter to Sterigenics linking high cancer
risks in the area to ht() emissions from the facility. 1 lowencr, f-.PA decided to withhold this vital
information from the public for eight months.
An investigation is necessary to determine whether proper measures were taken to protect
the lives of those affected bv I-'tO emissions from the facility, to hold officials accountable, and
to assure that proper protocol is followed in the future if any similar situation arises.
The EPA is responsible for protecting human health with safeguards to assure our nation
has clean and safe air, water, and environment for all Americans. Making certain that proper
action is taken when it is discovered that a community is facing a public health risk, is essential
for the public to have confidence that the EPA is doing its job.
We look forward to your prompt response to this urgent request for a comprehensive
investigation.
Congress of tljr itnitctj States
tMlislliiisilOi), iX 20olC
November 1. 2018
Sincerely.
RICHARD.!. DURBIN
I hiitcd States Senator
BILL I OS II R
United States Representative
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November 7, 2018 Request from Senator Durbin
RIO-
RBIN
C(
DEMOCRATIC WHIP
Unitel Sdi'cs Seiim
cc
a h
liiiiilioii BC :ono hoi
November 7, 2018
The Honorable Charles Sheehan
Acting Inspector General
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Dear Acting Inspector General Sheehan,
I write to follow up on a request from November 1 and ask the Office of the Inspector
General of the U.S. Environmental Protection Agency (RPA) to investigate if statutory authority
and proper protocols were followed when critical health informalion about carcinogenic ethylene
oxide pollution from two additional facilities—Medline Industries. Inc. in Waukegan and
Vantage Specialty Chemicals, Inc. in Guraee—was intentionally withheld from residents in Lake
County, Illinois.
After the findings of the 2016 Integrated Risk Information System report that indicated
ethylene oxide (F.tO) is much more carcinogenic at lower concentrations than previously
thought, IT'A acknowledged the increased risks but did not inform residents in DuPage and Lake
counties of facilities near them that use and emit EtO and how those emission could cause long-
term health concerns. This news is especially concerning as Vantage Specialty Chemicals has
not reported its most recent BtO emissions, as it is required to do, and previous reports show that
Vantage released more EtO than both Sterigenics and Medline.
Withholding this vital public health information front the communities with potentially
high EtO exposure is unacceptable. The residents need reassurance that the EPA has their best
interests in mind and is taking the proper steps to ensure the air they breathe is clean.
For this reason, I ask you expand the scope of my previously requested investigation to
include the facilities in Lake County. I look forward to your prompt response.
Sincerely,
RICHARD J. DURBIN
United States Senator
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January 17, 2019 Request from Senators Duckworth, Carper, and Durbin
VIA ELECTRONIC DELIVERY
Mr. Charles J, Sheehan
Acting Inspector General
Office of the Inspector General
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue NW
Washington, DC 20460
Dear Acting Inspector General Sheehan:
We write to request that the U.S. Environmental Protection Agency (EPA) Office of Inspector
General (GIG) immediately initiate an independent investigation into a serious allegation of
misconduct involving failure to protect public health. Senator Duckworth's staff recently
received information alleging that EPA senior political appointees instructed career civil servants
to avoid conducting inspections in Region 5 of facilities that emit Ethylene Oxide (EtO), a
known carcinogen,
A review of public source reporting from EPA's official website appears to confirm EPA has
tailed to conduct inspections of EtO emitting facilities over the past six months across Region 5
and the Country, despite recent incidents involving dangerous exposure to this carcinogenic
chemical. This fact pattern is concerning in and of itself. However, if the lax inspection and
enforcement activity is a result of politically-motivated interference overriding recommendations
of career staff, that would elevate our concerns from simple poor performance to potential
outright misconduct by political appointees.
According])', we urge the EPA OIG to swiftly begin a thorough independent investigation into
allegations that senior EPA political appointees instructed or impeded investigations of facilities
that emit KtO, Americans rely on EPA to protect them from public threats posed by
contaminated air and water. The allegation that EPA may be preventing its personnel from
carrying out this critical mission is disturbing and must be investigated to determine the truth,
and if necessary, identify corrective actions.
United States Senate
WAS^NOION, DC 20510
January 17, 2019
Sincerely,
7
Taini#( Duckworth	Tom Carper <
Ranging Member	Ranking Member
U.S. Senate Subcommittee on U.S. Senate Comr
U.S. Senate Committee on
Environment and Public Works
Richard J. Durbin
Democratic Whip
United States Senate
Fisheries, Water and Wildlife
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January 31, 2019 Request from Congressman Richmond
CEDRiC L, RICHMOND	SOB Cannon
2nd Pismicr, t.oufSi&^A.		
Contpresw of tfie Hm'trt States
lihmu n( Iac p r r<3 rntaftti cs
lilasliiiniloii, ,OC 'JO.'lo -ItJOto
January 31,2019
Mr, Charles J, Sheehan
Acting Inspector General
Office of the Inspector General
U.S. Environmental Protection Agency
1200 Pennsylvania Ave NW
Washington, D.C. 20460
Dear Acting Inspector General Sheehan;
It has come to my attention that Senators Duckworth, Carper, and Durbin recently
sent you a letter requesting an investigation into whether senior political appointees at the
Environmental Protection Agency [EPA] instructed career civil servants to avoid inspecting
facilities that emit Ethylene Oxide (EtO), While their letter concerned inspections in Region
5,	these reports are disturbing to all of us who represent areas with facili ties that emit EtO.
I am requesting that you extend any investigation related to this issue to actions in Region
6,	as well.
Acting EPA Secretary Andrew Wheeler was questioned by Senator Duckworth on
the lack of inspection of EtO at his confirmation hearing where he stated, "We are
monitoring a number of facilities that release ethylene oxide," but failed to mention any
specifics surrounding that issue, such as where, how often, and the type of inspections
being conducted.
In light of recent reports on this issue, my office examined information on the EPA's
website and found no inspections of EtO facilities in Region 6 within the last six months.
This has prompted me to write to you today. 1 ask that you conduct a thorough
investigation to determine the truth. Have inspections by the EPA been conducted on these
facilities in Region 6? If not, why? Have political appointees inappropriately interfered with
the work of career civil servants on this matter?
I hope that you take action quickly to investigate this matter. The people of
Louisiana's 2nd Congressional District and the nation, deserve the truth and assurance that
the EPA is transparently and effectively conducting its critical missions.
Sincerely,
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Appendix B
Agency Response to Draft Report
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
March 5, 2021
OFFICE OF
AIR AND RADIATION
MEMORANDUM
SUBJECT: EPA Response to OIG Draft Reports titled: "EPA Should Conduct New Residual
Risk and Technology Reviews for Chloroprene- and Ethylene Oxide-Emitting
Source Categories to Protect Human Health" - Project No. OA&E-FY19-0091,
January 14, 2021; and "EPA Delayed Risk Communication and Issued Instructions
Hindering Region 5's Ability to Address Ethylene Oxide Emissions" - Project No.
OA&E-FY19-0091, February 4, 2021
The Office of Air and Radiation (OAR) welcomes the opportunity to provide comment on the
following two draft reports and their recommendations: EPA Should Conduct New Residual Risk
and Technology Reviews for Chloroprene- and Ethylene Oxide-Emitting Source Categories to
Protect Raman Health and EPA Delayed Risk Communication and Issued Instructions Hindering
Region 5's Ability to Address Ethylene Oxide Emissions. We have provided our comments in the
attachments to this memorandum and provide our initial thoughts on the recommendations in each
of the two reports below, along with other information requested in the reports.
OIG Comment: For the purpose of this appendix, we only included the Agency's response
to this report. We will include the section removed herein in the relevant report.
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FROM:	Joseph Goffman
Acting Assistant Administrator
Office of Air and Radiation
TO:
Renee McGhee-Lenart
Acting Air Director
Office of the Inspector General

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Section 2: EPA Response to Draft Report "EPA Delayed Risk Communication and Issued
Instructions Hindering Region 5's Ability to Address Ethylene Oxide Emissions"
OIG Recommendation 1: Develop standard operating procedures describing how the Office of
Air and Radiation will work with EPA regional offices to communicate preliminary air toxics risk
information, including elevated risks found in the National Air Toxics Assessment, to the public
so that communities are promptly informed of potential health concerns.
Response 1: We recognize the public as key users of the air toxics analyses done by OAQPS. As
noted above, OAQPS is establishing a strategy to improve internal and external communication,
coordination, and collaboration around air toxics. The Air Toxics Strategy establishes a standard
operating procedure that realigns OAQPS to address air toxic issues more effectively and
proactively. The strategy positions OAQPS to apply a systematic approach to air toxics
management and mitigation, data and analytics, and new and emerging issues. Further, an outreach
and implementation component embedded throughout the strategy ensures the office is focused
not only on how to address air toxics issues, but how to more effectively understand the concerns
of coregulators and the public, and to improve the ways in which findings are shared. Consistent
with the Agency's mission statement, it is fundamental that we provide accurate information in
communicating risks. As such, any preliminary air toxics risk information needs to be verified and
quality assured prior to communicating with the public to avoid confusion and to build trust.
Finally, we have collected a lot of information regarding regional needs and uses for NATA over
time and look forward to continued engagement as new products/tools are developed.
Planned Completion Date: Quarter 4, FY 2021
OIG Recommendation 2: Develop standard operating procedures describing the roles and
responsibilities of the Office of Air and Radiation and regional offices in assessing and addressing
air toxics emissions contributing to potential health risks as found in the National Air Toxics
Assessment, other studies, or public complaints.
Response 2: As part of the Air Toxics Strategy, OAQPS has established three teams and an Air
Toxics Council to improve our methods of communication, coordination, and collaboration around
air toxics issues - both within our office and with our Regional offices. The Air Toxics Evaluation
and Screening Team, specifically, comprises a diverse group of OAQPS staff and includes regional
participants. This group screens new and emerging air toxics issues that come to OAQPS through
our interactions with a diverse set of internal and external stakeholders. Once preliminary
assessments are conducted this team engages a newly formed Air Toxics Council, which includes
OAQPS senior managers, to determine if further evaluation is needed, whether project teams need
to be established for more substantive work, whether or not issues are national in scope, or whether
issues are for OAQPS awareness and should be transferred to another office or EPA region for
further action. The Management and Mitigation Team primarily includes OAQPS first-line
managers; the team will recommend priorities and steer efforts to address management and
mitigation of air toxics through collaborative regulatory and non-regulatory efforts and streamlined
approaches. The Data and Analytics Team will recommend priorities and steer efforts to ensure
that the range of air toxics data collection, infrastructure, and analysis efforts across OAQPS
support short-term and long-term air toxics program priorities. The Management and Mitigation
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and Data and Analytics Teams also brief the Air Toxics Council to engage in a substantive
discourse about their short- and long-term assessments and recommendations. Outreach and
implementation are key components of the strategy. As such, each team under the strategy includes
OAQPS staff that specialize in outreach to states, locals, communities, and tribes.
Planned Completion Date: Quarter 4, FY 2021
If you have any questions regarding this response, please contact JoLynn Collins, OAQPS/OAR
Audit Liaison, at (919) 541-0528.
cc: James Hatfield
Betsy Shaw
Peter Tsirigotis
Mike Koerber
Marc Vincent
Penny Lassiter
Brian Shrager
Erika Sasser
Kelly Rimer
Chet Way land
Ned Shappley
JoLynn Collins
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Appendix C
Distribution
The Administrator
Assistant Deputy Administrator
Associate Deputy Administrator
Chief of Staff
Deputy Chief of Staff
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
Director, Office of Continuous Improvement, Office of the Chief Financial Officer
Regional Administrator for Region 5
Regional Administrator for Region 6
Regional Deputy Administrator for Region 5
Regional Deputy Administrator for Region 6
Assistant Administrator for Air and Radiation
Principal Deputy Assistant Administrator for Air and Radiation
Deputy Assistant Administrators for Air and Radiation
Director, Office of Air Quality Planning and Standards, Office of Air and Radiation
Audit Follow-Up Coordinator, Office of the Administrator
Audit Follow-Up Coordinator, Office of Air and Radiation
Audit Follow-Up Coordinator, Office of Air Quality Planning and Standards, Office of
Air and Radiation
Audit Follow-Up Coordinator, Region 5
Audit Follow-Up Coordinator, Region 6
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