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12-Person(A,B,C,D,E,F,H,R,X,Z)
Law Division Motion Section Initial Case Management Dates for CALENDARS Jury will be heard In Person.
All other Law Division Initial Case Management Dates will be heard via Zoom
For more information and Zoom Meeting IDs go to https.//www.cookcountycourt,org/HOME?Zoom-Links?Agg4906_SelectTab/12
Court Date: 7/17/2024 10:30 AM FILED
5/15/2024 1:07 PM
STATE OF ILLINOIS ) IRIS Y. MARTINEZ
CIRCUIT CLERK
) SS.
COOK COUNTY, IL
COUNTY OF COOK )
FILED DATE: 5/15/2024 1:07 PM 2024L005399
2024L005399
Calendar, B
IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 27704134
COUNTY DEPARTMENT, LAW DIVISION
THOMAS R. WILHELMI, JR., as Independent
Administrator of the Estate of ROSARIA A.
WILHELMI, Deceased,
Plaintiffs, 2024L005399
Case No. ________________
versus
Plaintiff Demands a 12 Person Jury
STERIGENICS U.S., LLC; SOTERA Trial
HEALTH, LLC; GTCR, LLC; GRIFFITH
FOODS INTERNATIONAL, INC., BOB
NOVAK, and ROGER CLARK,
Defendants.
COMPLAINT
The Plaintiff, THOMAS R. WILHELMI, JR., as Independent Administrator of the
Estate of ROSARIA A. WILHELMI, Deceased, through his attorneys, DUNN
HARRINGTON, LLC and PASSEN & POWELL, complains against the Defendants,
STERIGENICS U.S., LLC; SOTERA HEALTH, LLC; GTCR, LLC; GRIFFITH FOODS
INTERNATIONAL, INC., BOB NOVAK, and ROGER CLARK, as follows:
PARTIES, JURISDICTION and VENUE
1. This Complaint is brought by THOMAS R. WILHELMI, JR., as Independent
Administrator of the Estate of ROSARIA A. WILHELMI, Deceased 1, who is a citizen of
Illinois, for injuries that occurred in Illinois, due to Ethylene Oxide [“EtO”] emissions in Illinois,
that were caused by Defendants’ negligence and other wrongful conduct, all of which took
place in the State of Illinois. This court is a proper venue pursuant to 735 ILCS 5/2-101.
2. The Plaintiff, THOMAS R. WILHELMI, JR., as Independent Administrator
of the Estate of ROSARIA A. WILHELMI, Deceased, did not have notice that the injuries and
damages at issue were wrongfully caused or that they were caused by Defendants’ emissions of
EtO until he learned of the possible connection between EtO exposure and the development of
Pancreatic Cancer.
1
Thomas R. Wilhelmi, Jr. has been appointed to serve as the Independent Administrator of the Estate of Rosaria a.
Wilhelmi, Deceased, who died on April 15, 2022, by the Circuit Court of Will County, Probate Division, Case No.
2024 PR 283.
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3. The Defendant, Sterigenics U.S., LLC [“Sterigenics”] is a wholly owned subsidiary
of Sotera Health, LLC and is a limited liability company organized under the laws of Delaware with
FILED DATE: 5/15/2024 1:07 PM 2024L005399
its headquarters and principal place of business at 2015 Spring Road, Suite 650, Oak Brook, Illinois
60523.
4. The Defendant, Sterigenics U.S., LLC, under its current name and previously under
other names, operated EtO sterilization facilities at 7775 Quincy Street in Willowbrook, Illinois
[the “Willowbrook facility”] and 830 Midway Drive in Willowbrook, Illinois, continuously and
at all relevant times. [The two facilities are referred to collectively herein as “the Willowbrook
facilities” or “the facilities”]
5. The Defendant, Sterigenics U.S., LLC’s, predecessors who operated the
Willowbrook facilities include: Micro-Biotrol Company; Micro-Biotrol, Inc.; Griffith Micro
Science, Inc.; IBA S&I, Inc.; and Sterigenics EO, Inc. Through a series of acquisitions, mergers,
and name changes, Sterigenics U.S. LLC has assumed the liabilities of these predecessor entities
for their respective involvement in the operation of the Willowbrook facilities. [Sterigenics U.S.
and its predecessors are referred to collectively herein as “Sterigenics U.S.”]
6. The Defendant, Griffith Foods International, Inc., was previously known as Griffith
Laboratories U.S.A, Inc. [“Griffith Labs”]. During certain times prior to May 14, 1999, which are
detailed below, Griffith Labs operated the Willowbrook facilities.
7. At all times prior to May 14, 1999, Griffith Labs directed and controlled the
sterilization operations at the Willowbrook facilities. Further, at all times prior to May 14, 1999,
Griffith Labs directly participated in the operation of the Willowbrook facilities. The Defendant,
Griffith Foods International, Inc., is responsible for all acts and omissions of Griffith Labs as alleged
herein. At all relevant times, Griffith Labs, now Griffith Foods International, Inc., had its
headquarters and principal place of business in Alsip, Illinois, which is in Cook County. The
Plaintiffs allege that Griffith Labs committed independent injurious acts and omissions separate
and apart from and alongside of, the acts or omissions of Sterigenics.
8. The Defendant, Sotera Health, LLC [“Sotera Health”], under its current name and
previously under other names (first as Sterigenics International, Inc. and then as Sterigenics
International, LLC), as the sole owner, member, and “manager” of Sterigenics U.S., operated,
managed, maintained, and otherwise participated directly in Sterigenics U.S.’s operation of the
Willowbrook facilities. [Defendant Sotera Health, LLC and its predecessors are referred to
collectively herein as “Sotera”]
9. Rosaria Wilhelmi brings these personal injury claims against Sterigenics, Sotera
Health, Griffith Labs, two plant managers (Bob Novak and Roger Clark) and a private equity firm
GTCR, LLC [“GTCR”].
FACTS COMMON TO ALL COUNTS
10. For decades, tens of thousands of people have lived in the quiet but densely
populated suburbs of Cook and DuPage Counties—Willowbrook, Burr Ridge, Darien, and
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Hinsdale—believing that their neighborhoods were safe and their air free from dangerous toxins.
However, the Defendants’ Willowbrook sterilization facilities were emitting massive and
unnecessary amounts of ethylene oxide [“EtO”]—an invisible, odorless carcinogen—into their air.
FILED DATE: 5/15/2024 1:07 PM 2024L005399
11. There is no safe level of EtO, and its carcinogenic effects have been widely known
since the 1940s and known to Defendants since at least 1984. Notwithstanding, Defendants chose
to operate their business and emit EtO in a densely populated area full of children, houses,
parks, schools, and businesses.
12. Further, although technologies to control EtO have been available—and widely
used—since the 1980s, Defendants operated for years in Willowbrook without using the best
practices and control technologies available to reduce their emissions; and as a direct and
proximate result, the Willowbrook area has become one of the most toxic in the U.S. The people
who have lived and worked in the area have inhaled EtO on a routine and continuous basis for
years, unknowingly. Defendants never warned them about the danger it posed.
13. In August 2018, the U.S. Department of Health and Human Services, Agency for
Toxic Substances and Disease Registry [“ATSDR”] released to the public a report titled
“Evaluation of Potential Health Impacts for Ethylene Oxide Emissions.” That report,
documenting the public health impacts of Defendants’ emissions on the Willowbrook area,
revealed the area’s staggering and disproportionate risks of cancer.
14. In February 2019, the Illinois Environmental Protection Agency [“IEPA”] ordered
Defendants’ Willowbrook facilities to stop using EtO. In the months that followed, Sterigenics
announced a plan to install equipment to reduce emissions of EtO to 85 lbs. per year — a drastic
reduction from the thousands of pounds of EtO emitted in the years prior. Before implementing
the plan, however, Sterigenics announced the permanent closure of its Willowbrook facilities
effective September 30, 2019.
15. The Decedent, Rosaria Wilhelmi, lived, worked, and recreated near Defendants’
Willowbrook facilities, and unknowingly breathed the excessive and dangerous amounts of EtO
emitted from the facilities on a routine and continuous basis for years. As a result, she has been
diagnosed with serious — sometimes fatal — diseases or conditions and has sustained severe
personal injuries causing him to incur and endure medical bills, lost wages, pain and suffering,
emotional distress, disability, disfigurement, a reduced life expectancy, and loss of a normal life.
16. Since 2016, Sterigenics and Sotera, and their corporate investors and parents,
including GTCR, have pursued a plan to escape accountability to those who have been sickened
or have lost their lives, and thereby to cynically render this Court proceeding a sham. That is, they
have funneled nearly $1.3 billion in cash out of the Sterigenics/Sotera companies in just the last
few years for distribution to wealthy venture-capitalist investors, such that the funds could never
be used to compensate the victims who have come to this Court to seek justice. And they have
made certain that even those assets not siphoned away would never be available to those victims,
by pledging the assets to banks to guarantee repayment of billions in corporate borrowings, so that
even if the companies failed, they would be used to pay the banks, not the plaintiffs who had
proven their cases.
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17. At all times relevant hereto, Sotera took responsibility for, and participated directly
in, the following functions in connection with the facilities’ operations:
FILED DATE: 5/15/2024 1:07 PM 2024L005399
a. Preparing and implementing risk management plans regarding health, safety, and
other risks posed by the facilities’ use and storage of EtO to human health and the
environment;
b. Conducting hazard reviews at the facilities;
c. Developing written operating procedures for training and guiding the work of
operators;
d. Training operations employees;
e. Evaluating whether the facilities’ systems and equipment were in proper working
condition;
f. Implementing a program to monitor the physical condition of process equipment;
g. Investigating incidents;
h. Conducting safety audits;
i. Determining potential impacts on the surrounding community from worst-case and
alternative-case releases of EtO;
j. Evaluating the facilities’ accident history;
k. Developing procedures for notifying local, state and federal emergency planning and
response agencies about chemical spills;
l. Developing an incident prevention program that includes the following:
i. Process Safety Information;
ii. Process Hazard Analysis;
iii. Employee Training;
iv. Mechanical Integrity;
v. Pre-Startup Review;
vi. Compliance Audits;
vii. Employee Participation; and
viii. Hot Work Permit.
m. Developing plans to address accidental release that includes the following:
i. Computer controls;
ii. Door interlock system;
iii. EtO leak detection monitors;
iv. Emission Control Systems to destroy residual EtO;
v. Pressure Relief Valves;
vi. Process Safety Information for employees;
vii. Written SOPs for training and instructions to employees; and
viii. New hire and annual refresher training.
n. Applying for IEPA construction permits to allow structural modifications at the
facilities, including modifications impacting the volume of EtO emitted;
o. Holding the facilities’ construction permit, as permittee, authorizing it to:
i. Modify EtO emissions controls including sterilization chamber exhaust
vents;
ii. Operate the sterilization chamber exhaust vents without any EtO
emissions controls; and
iii. Modify the operation of its sterilization equipment, such as aeration
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rooms, by allowing EtO emissions controls to be bypassed.
p. Holding the facilities’ construction permit, as permittee, requiring it to:
i. Operate EtO emission controls in a manner that complies with local, state
FILED DATE: 5/15/2024 1:07 PM 2024L005399
and federal law;
ii. Conduct operational monitoring for the EtO emissions controls to ensure
compliance with plans previously submitted to EPA;
iii. Enhance operational monitoring to address the effects of modification of
EtO emissions controls;
iv. Keeping records for operational monitoring for the EtO emissions
controls affecting certain aeration rooms; and
v. Notifying IEPA promptly of permit deviations including identifying the
date, time, duration, description of the deviation, its probable cause,
corrective actions, if taken, and preventative measures, if taken.
q. Certifying the facilities’ permit compliance (or non- compliance) to the IEPA;
r. Communicating with IEPA regarding permit violations and uncontrolled emissions
events;
s. Communicating with IEPA about its emission control equipment, including its
plans to exhaust EtO from its chamber back vents to the atmosphere;
t. Monitoring and reviewing of the facilities’ emission data to analyze the duration and
quantity of EtO emissions released, including any excess emissions;
u. Reporting to IEPA on the volume of the facilities’ EtO emissions;
v. Monitoring the facilities’ emissions control equipment;
w. Assessing the capacity of the EtO sterilization chambers at the Willowbrook
facilities as compared to customer demand for its sterilization services;
x. Deciding to add EtO sterilization chambers at the facilities to meet customers’
demand;
y. Inventorying hazardous chemicals stored at the facilities, including EtO; and
z. Communicating with state and local emergency response groups about such
hazardous chemicals, including EtO.
18. Sotera undertook these responsibilities and functions even though, as alleged
elsewhere in this complaint, it failed to ensure implementation adequate to keep the community
safe.
19. With respect to the Willowbrook facilities, the activities of Sterigenics and Sotera
have been intertwined. Sterigenics and Sotera have routinely and publicly held themselves out as
a single entity – “Sterigenics” – engaged in operating EtO sterilization facilities throughout the
country, including the Willowbrook facilities; and others, including Moody’s Investor Services,
for example, has always treated the Sterigenics entities as a single entity and issued them a single
“Corporate Family Rating.”
20. Sterigenics and Sotera have shared the same Chairman and CEO, the same Vice
President, the same General Counsel & Secretary, the same President and COO, and the same Vice
President for Environmental, Health & Safety. And they have shared a complete unity of
interest, with Sterigenics acting as an instrumentality of Sotera to accomplish Sotera’s business
mission.
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21. In 2011, a private equity fund or funds created, maintained and managed by GTCR
acquired Sterigenics International, LLC (now Sotera), along with its subsidiaries (including
Sterigenics) and parent companies, for $675 million.
FILED DATE: 5/15/2024 1:07 PM 2024L005399
22. The Defendants Sterigenics, Griffith Labs, Sotera, and GTCR do regular and
substantial business in Cook County, Illinois.
Griffith Labs decided to locate an EtO Sterilization facility in Willowbrook
notwithstanding its knowledge that exposure to EtO is harmful to human health and can
cause cancer.
23. Griffith Labs claims to have pioneered the development and use of EtO as a sterilant
in the 1930s. In the 1940s, Griffith Labs received patents for the EtO sterilization of hospital and
medical supplies. Beginning in the 1950s, Griffith Labs began offering contract EtO sterilization
to third-party customers. Griffith Labs continued its contract sterilization business for decades,
and in or around 1984, it opened and operated an EtO sterilization facility in the Village of
Willowbrook –– a suburban community located roughly 20 miles southwest of Chicago with a
population of approximately 8,500.
24. Before 1984, Griffith Labs knew or should have known that it was too dangerous
to locate an EtO sterilization facility in or near a residential community, and indeed that any
sterilization facility anywhere should be equipped with emission control equipment adequate to
ensure that no one outside the facility was exposed to EtO.
25. Griffith Labs’ decision to locate its EtO sterilization facility in Willowbrook
was driven by logistical and financial self-interest, such as Griffith Labs’ belief that Willowbrook
would be an optimal location because it is centrally located in the Midwest near highways and
railroads and because it was able to secure favorable lease terms. Griffith Labs’ decision was also
driven by a desire to expand its ethylene oxide sterilization services to the commercial sterilization
of medical supplies. In making its decision, Griffith Labs ignored its knowledge that placing an
EtO sterilization facility in or near a residential community would cause significant risk to human
health. Griffith Labs could have secured a facility far enough away from a residential population
to drastically reduce and/or minimize the danger to residents, but consciously chose not to.
26. On or about April 12, 1984, Griffith Labs, through its unincorporated division,
Micro-Biotrol, Co., leased a 44,939 square foot facility at 7775 Quincy Street in Willowbrook for
the stated purpose of: “Sterilization process of various products.” The lease terms were originally
for five years, with multiple options to renew for another five years thereafter. In this way, Griffith
Labs ensured that a dangerous EtO sterilization facility would operate next to a residential
neighborhood in Willowbrook for many years to come.
Griffith Labs’ dealings with IEPA in securing a permit to operate an EtO sterilization
facility in Willowbrook.
27. On or about May 31, 1984, in anticipation of constructing and operating the
sterilization facility in Willowbrook, Griffith Labs marked off the distances from its EtO facility
in Willowbrook to various schools, and therefore knew its facility would be located within ½
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mile of Gower Elementary; one mile of Hinsdale South High School; two miles of Gower West
Elementary; ¼ mile of the nearest residence to the west; ½ mile of the nearest residence to the south;
and otherwise in the immediate proximity of many homes, parks, schools, and small businesses.
FILED DATE: 5/15/2024 1:07 PM 2024L005399
28. Griffith Labs further knew that EtO emissions from its Willowbrook facility could
and would migrate to parts of the community in concentrations that would endanger human health.
29. Notwithstanding this knowledge, Griffith Labs elected to move forward with its
plans to open an EtO sterilization facility in Willowbrook and, on or about June 1, 1984, applied
for a construction and operating permit from IEPA.
30. Griffith Labs’ permit application to IEPA included the above plot and also included
a representation to IEPA that its maximum emissions of EtO would be 40 tons (80,000 lbs.) per
year.
31. On or about July 6, 1984, Griffith Labs received the following letter from IEPA
concerning the environmental impact of its proposed EtO emissions (highlighting added):
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FILED DATE: 5/15/2024 1:07 PM 2024L005399
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32. By way of this July 6, 1984 letter, Griffith Labs was expressly advised by the state
regulatory authority that its EtO sterilization operation posed significant adverse health risks to
humans in that: (i) EtO exposure is associated with human cancers; and (ii) EtO has carcinogenic,
FILED DATE: 5/15/2024 1:07 PM 2024L005399
mutagenic, leukemogenic, and teratogenic effects. Griffith Labs thus had knowledge that its EtO
emissions would cause harm to humans in neighboring communities long before it exposed
Plaintiffs to EtO emissions.
33. IEPA’s letter further informed Griffith Labs that at least two of the schools and two
residential areas on the plot were within the area where IEPA had determined that EtO
concentrations from the Willowbrook facility would be “several magnitudes higher than desirable.”
34. Indeed, Griffith Labs was already aware of the toxic and deadly effects of EtO when
it received the July 6, 1984 letter from IEPA. Even before that date, and before Plaintiffs were
exposed to EtO emissions, Griffith Labs knew that:
a. there was “no safe level” of EtO, i.e., there was no concentration of EtO that could
be safely breathed without risk of serious damage to health;
b. “ethylene oxide has also been found to pose a serious health risk;”
c. the very attribute which made EtO so lethally effective as a sterilant—e.g., its
ability to inactivate DNA—also made EtO very dangerous for human beings
exposed to it;
d. the state of Illinois recognized EtO as one of the 19 most dangerous chemicals (a
“priority” pollutant);
e. EtO was suspected to cause cancer in humans, and threaten reproductive harm;
f. “the highly toxic nature of ethylene oxide and its classification as a suspect
carcinogen;”
g. any exposure to EtO that threatened to cause even one additional cancer in a
population of 1,000,000 was unacceptable;
h. those exposed to EtO emitted from a sterilization facility were significantly more
likely to contract cancer and other serious illnesses;
i. EtO was a “mutagen,” i.e., that it damaged human DNA in a way that promoted the
development of cancer;
j. “[t]here has been widespread recognition of the mutagenic potential of ethylene
oxide;”
k. once emitted from a sterilization facility, EtO would be breathed by those living,
working, and attending school near the facility; and
l. “human receptors outside of the building may unknowingly come into contact with
ethylene oxide before it has been sufficiently dispersed in the ambient atmosphere.”
35. As a result, and well before it began operations in Willowbrook, Griffith Labs was
acutely aware of the catastrophic risk to human health that inhalation exposure to EtO would
create.
36. In addition to warning Griffith Labs about the health risks of EtO, the IEPA letter
expressly told Griffith Labs that IEPA’s air modeling raised substantial concerns that the
surrounding Willowbrook community would be adversely impacted by Griffith Labs’ EtO
emissions. In particular, it informed Griffith Labs that: (i) emissions from the Willowbrook facility
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appear to be “several magnitudes higher than desirable;” and (ii) steps should be taken to
“minimize emissions in order to reduce the ambient impacts to an acceptable level.”
FILED DATE: 5/15/2024 1:07 PM 2024L005399
37. Moreover, Griffith Labs knew or should have known when it received IPEA’s letter
that IEPA’s modeling results vastly understated the risk to Griffith Labs’ neighbors that the
Willowbrook emissions would pose. According to the letter, IEPA had based its EtO modeling in
part on Griffith Labs’ representation that its maximum emissions would be 40 tons (80,000 lbs.)
per year. Upon information and belief, Griffith Labs knew that its emissions going forward would
be significantly more than 80,000 pounds per year. In fact, in 1985, the Willowbrook facility
emitted more than 125,000 pounds of EtO. In each of 1986 and 1987, it emitted more than 160,000
pounds of EtO.
38. Further, Griffith Labs’ representation to IEPA that it had emitted 40 tons of EtO
during the year of 1983 was itself understated. In an internal memorandum dated May 3, 1984,
Griffith Labs discloses that it had actually emitted approximately 50 tons in 1983. Griffith Labs
never corrected its misrepresentation to IEPA:
39. The same internal memo also predicted that Griffith Labs would grow to emit 65
tons per year. Griffith Labs did not disclose this fact to IEPA either.
40. As a result, Griffith Labs knew or should have known that IEPA’s opinion that its
emissions would be “several magnitudes higher than desirable” was based on modeling that only
accounted for about half of what Griffith Labs actually intended to emit. Griffith Labs never
corrected IEPA’s modeling assumptions at any point prior to receiving its permit.
41. Separately, upon information and belief, Griffith Labs misinformed IEPA about
the height of the stack it would use at Willowbrook to release EtO emissions. The height of
the stack is important because, in general, the higher the stack, the greater the EtO concentrations
will be diminished before they descend to the zone in which they are breathed by, e.g., residents,
workers, and schoolchildren. In connection with its 1984 permit application, Griffith Labs told
IEPA that the stack exhaust point would be 40-50 feet above grade. However, upon information and
belief, the actual exhaust point was only 28 feet above grade.
42. As a result, Griffith Labs knew or should have known that IEPA’s opinion that its
emissions would be “several magnitudes higher than desirable” was based upon modeling that
used a falsely inflated stack height. Griffith Labs never corrected IEPA’s modeling assumptions
at any point prior to receiving its permit.
43. Further, Griffith Labs took essentially no action in connection with IEPA’s stated
concerns about its “minimiz[ing] emissions in order to reduce the ambient impacts to an
acceptable level.” Instead, once Griffith Labs received its permit, it operated without any
emission controls designed to remove or eliminate EtO from emissions and thereby caused massive
unfiltered emissions of EtO into the Willowbrook community 24 hours a day, 7 days a week, 365
days a year. Griffith Labs did so notwithstanding its knowledge that: (a) toxicity data showed that
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EtO exposure was associated with human cancers and other harms; (b) the facility was located
within the immediate proximity of homes, parks, schools, and small businesses; and (c) IEPA’s
(understated) modeling predicted emissions “several magnitudes higher than desirable.”
FILED DATE: 5/15/2024 1:07 PM 2024L005399
44. Indeed, by no later than 1982, Griffith Labs knew that emission control technology
was available that could remove up to 99% of EtO from the Willowbrook facility’s exhaust before
it was allowed to enter Willowbrook’s air. Despite knowing of the availability of this technology
before operating in Willowbrook, Griffith Labs specifically declined to use it for essentially the
first four years of Willowbrook operations.
Griffith Labs received an operating permit for the Willowbrook facility that was subject to
special conditions with which Griffith Labs failed to comply.
45. On July 30, 1984, IEPA issued Griffith Labs a Joint Construction and Operating
Permit to construct and operate sterilization chambers 1, 3, 4, 5, 9, and 10 at the Willowbrook
facility.
46. The permit was issued to “Griffith Laboratories, U.S.A., Inc.” (i.e., Griffith
Labs) for its operation of the Willowbrook facility. The permit had a two-year term, expiring on
July 31, 1986. Griffith Labs never attempted to amend or correct this permit in any way, including
to substitute any other entity as the permit holder.
47. The 1984 permit, as well as all permits relating to the Willowbrook facility issued
thereafter, expressly warned Griffith Labs the permit did not release it from liability for harm to
its neighbors. They stated:
a. the permit “does not release the permittee from any liability for any loss due to
damage to person or property caused by, resulting from, or arising out of, the
design, installation, maintenance, or operation of” the Willowbrook facility.
b. the permit “in no manner implies or suggests that the [IEPA] . . . assumes any
liability, directly or indirectly, for any loss due to damage, installation, maintenance
or operation” of the Willowbrook facility.
c. the Willowbrook facility could not be operated in such a manner as to “cause a
violation of the Environmental Protection Act or Regulations promulgated
thereunder,” all of which forbid air pollution in the State of Illinois.
48. As the permittee for the Willowbrook facility, Griffith Labs was responsible for the
following operations:
a. sterilization processes for the six chambers for which it received a permit;
b. emissions of EtO and other volatile organic materials from the facility;
c. the acquisition, installation, and operation of pollution controls at the facility;
d. testing and monitoring for levels of EtO both in the facility and the environment;
e. monitoring, testing, maintenance, and repair of all equipment involved in the
sterilization processes at the facility;
f. maintaining emission records and reporting to IEPA and as otherwise required by
law;
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g. ensuring that its emissions and emission controls were compliant with local, state,
and federal law;
h. monitoring and reviewing the facility’s emission data to analyze the duration and
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quantity of EtO emissions released, including any excess emissions;
i. assessing the capacity of the EtO sterilization chambe
Preview
12-Person(A,B,C,D,E,F,H,R,X,Z) Law Division Motion Section Initial Case Management Dates for CALENDARS Jury will be heard In Person. All other Law Division Initial Case Management Dates will be heard via Zoom For more information and Zoom Meeting IDs go to https.//www.cookcountycourt,org/HOME?Zoom-Links?Agg4906_SelectTab/12 Court Date: 7/17/2024 10:30 AM FILED 5/15/2024 1:07 PM STATE OF ILLINOIS ) IRIS Y. MARTINEZ CIRCUIT CLERK ) SS. COOK COUNTY, IL COUNTY OF COOK ) FILED DATE: 5/15/2024 1:07 PM 2024L005399 2024L005399 Calendar, B IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 27704134 COUNTY DEPARTMENT, LAW DIVISION THOMAS R. WILHELMI, JR., as Independent Administrator of the Estate of ROSARIA A. WILHELMI, Deceased, Plaintiffs, 2024L005399 Case No. ________________ versus Plaintiff Demands a 12 Person Jury STERIGENICS U.S., LLC; SOTERA Trial HEALTH, LLC; GTCR, LLC; GRIFFITH FOODS INTERNATIONAL, INC., BOB NOVAK, and ROGER CLARK, Defendants. COMPLAINT The Plaintiff, THOMAS R. WILHELMI, JR., as Independent Administrator of the Estate of ROSARIA A. WILHELMI, Deceased, through his attorneys, DUNN HARRINGTON, LLC and PASSEN & POWELL, complains against the Defendants, STERIGENICS U.S., LLC; SOTERA HEALTH, LLC; GTCR, LLC; GRIFFITH FOODS INTERNATIONAL, INC., BOB NOVAK, and ROGER CLARK, as follows: PARTIES, JURISDICTION and VENUE 1. This Complaint is brought by THOMAS R. WILHELMI, JR., as Independent Administrator of the Estate of ROSARIA A. WILHELMI, Deceased 1, who is a citizen of Illinois, for injuries that occurred in Illinois, due to Ethylene Oxide [“EtO”] emissions in Illinois, that were caused by Defendants’ negligence and other wrongful conduct, all of which took place in the State of Illinois. This court is a proper venue pursuant to 735 ILCS 5/2-101. 2. The Plaintiff, THOMAS R. WILHELMI, JR., as Independent Administrator of the Estate of ROSARIA A. WILHELMI, Deceased, did not have notice that the injuries and damages at issue were wrongfully caused or that they were caused by Defendants’ emissions of EtO until he learned of the possible connection between EtO exposure and the development of Pancreatic Cancer. 1 Thomas R. Wilhelmi, Jr. has been appointed to serve as the Independent Administrator of the Estate of Rosaria a. Wilhelmi, Deceased, who died on April 15, 2022, by the Circuit Court of Will County, Probate Division, Case No. 2024 PR 283. 1 of 62 3. The Defendant, Sterigenics U.S., LLC [“Sterigenics”] is a wholly owned subsidiary of Sotera Health, LLC and is a limited liability company organized under the laws of Delaware with FILED DATE: 5/15/2024 1:07 PM 2024L005399 its headquarters and principal place of business at 2015 Spring Road, Suite 650, Oak Brook, Illinois 60523. 4. The Defendant, Sterigenics U.S., LLC, under its current name and previously under other names, operated EtO sterilization facilities at 7775 Quincy Street in Willowbrook, Illinois [the “Willowbrook facility”] and 830 Midway Drive in Willowbrook, Illinois, continuously and at all relevant times. [The two facilities are referred to collectively herein as “the Willowbrook facilities” or “the facilities”] 5. The Defendant, Sterigenics U.S., LLC’s, predecessors who operated the Willowbrook facilities include: Micro-Biotrol Company; Micro-Biotrol, Inc.; Griffith Micro Science, Inc.; IBA S&I, Inc.; and Sterigenics EO, Inc. Through a series of acquisitions, mergers, and name changes, Sterigenics U.S. LLC has assumed the liabilities of these predecessor entities for their respective involvement in the operation of the Willowbrook facilities. [Sterigenics U.S. and its predecessors are referred to collectively herein as “Sterigenics U.S.”] 6. The Defendant, Griffith Foods International, Inc., was previously known as Griffith Laboratories U.S.A, Inc. [“Griffith Labs”]. During certain times prior to May 14, 1999, which are detailed below, Griffith Labs operated the Willowbrook facilities. 7. At all times prior to May 14, 1999, Griffith Labs directed and controlled the sterilization operations at the Willowbrook facilities. Further, at all times prior to May 14, 1999, Griffith Labs directly participated in the operation of the Willowbrook facilities. The Defendant, Griffith Foods International, Inc., is responsible for all acts and omissions of Griffith Labs as alleged herein. At all relevant times, Griffith Labs, now Griffith Foods International, Inc., had its headquarters and principal place of business in Alsip, Illinois, which is in Cook County. The Plaintiffs allege that Griffith Labs committed independent injurious acts and omissions separate and apart from and alongside of, the acts or omissions of Sterigenics. 8. The Defendant, Sotera Health, LLC [“Sotera Health”], under its current name and previously under other names (first as Sterigenics International, Inc. and then as Sterigenics International, LLC), as the sole owner, member, and “manager” of Sterigenics U.S., operated, managed, maintained, and otherwise participated directly in Sterigenics U.S.’s operation of the Willowbrook facilities. [Defendant Sotera Health, LLC and its predecessors are referred to collectively herein as “Sotera”] 9. Rosaria Wilhelmi brings these personal injury claims against Sterigenics, Sotera Health, Griffith Labs, two plant managers (Bob Novak and Roger Clark) and a private equity firm GTCR, LLC [“GTCR”]. FACTS COMMON TO ALL COUNTS 10. For decades, tens of thousands of people have lived in the quiet but densely populated suburbs of Cook and DuPage Counties—Willowbrook, Burr Ridge, Darien, and 2 of 62 Hinsdale—believing that their neighborhoods were safe and their air free from dangerous toxins. However, the Defendants’ Willowbrook sterilization facilities were emitting massive and unnecessary amounts of ethylene oxide [“EtO”]—an invisible, odorless carcinogen—into their air. FILED DATE: 5/15/2024 1:07 PM 2024L005399 11. There is no safe level of EtO, and its carcinogenic effects have been widely known since the 1940s and known to Defendants since at least 1984. Notwithstanding, Defendants chose to operate their business and emit EtO in a densely populated area full of children, houses, parks, schools, and businesses. 12. Further, although technologies to control EtO have been available—and widely used—since the 1980s, Defendants operated for years in Willowbrook without using the best practices and control technologies available to reduce their emissions; and as a direct and proximate result, the Willowbrook area has become one of the most toxic in the U.S. The people who have lived and worked in the area have inhaled EtO on a routine and continuous basis for years, unknowingly. Defendants never warned them about the danger it posed. 13. In August 2018, the U.S. Department of Health and Human Services, Agency for Toxic Substances and Disease Registry [“ATSDR”] released to the public a report titled “Evaluation of Potential Health Impacts for Ethylene Oxide Emissions.” That report, documenting the public health impacts of Defendants’ emissions on the Willowbrook area, revealed the area’s staggering and disproportionate risks of cancer. 14. In February 2019, the Illinois Environmental Protection Agency [“IEPA”] ordered Defendants’ Willowbrook facilities to stop using EtO. In the months that followed, Sterigenics announced a plan to install equipment to reduce emissions of EtO to 85 lbs. per year — a drastic reduction from the thousands of pounds of EtO emitted in the years prior. Before implementing the plan, however, Sterigenics announced the permanent closure of its Willowbrook facilities effective September 30, 2019. 15. The Decedent, Rosaria Wilhelmi, lived, worked, and recreated near Defendants’ Willowbrook facilities, and unknowingly breathed the excessive and dangerous amounts of EtO emitted from the facilities on a routine and continuous basis for years. As a result, she has been diagnosed with serious — sometimes fatal — diseases or conditions and has sustained severe personal injuries causing him to incur and endure medical bills, lost wages, pain and suffering, emotional distress, disability, disfigurement, a reduced life expectancy, and loss of a normal life. 16. Since 2016, Sterigenics and Sotera, and their corporate investors and parents, including GTCR, have pursued a plan to escape accountability to those who have been sickened or have lost their lives, and thereby to cynically render this Court proceeding a sham. That is, they have funneled nearly $1.3 billion in cash out of the Sterigenics/Sotera companies in just the last few years for distribution to wealthy venture-capitalist investors, such that the funds could never be used to compensate the victims who have come to this Court to seek justice. And they have made certain that even those assets not siphoned away would never be available to those victims, by pledging the assets to banks to guarantee repayment of billions in corporate borrowings, so that even if the companies failed, they would be used to pay the banks, not the plaintiffs who had proven their cases. 3 of 62 17. At all times relevant hereto, Sotera took responsibility for, and participated directly in, the following functions in connection with the facilities’ operations: FILED DATE: 5/15/2024 1:07 PM 2024L005399 a. Preparing and implementing risk management plans regarding health, safety, and other risks posed by the facilities’ use and storage of EtO to human health and the environment; b. Conducting hazard reviews at the facilities; c. Developing written operating procedures for training and guiding the work of operators; d. Training operations employees; e. Evaluating whether the facilities’ systems and equipment were in proper working condition; f. Implementing a program to monitor the physical condition of process equipment; g. Investigating incidents; h. Conducting safety audits; i. Determining potential impacts on the surrounding community from worst-case and alternative-case releases of EtO; j. Evaluating the facilities’ accident history; k. Developing procedures for notifying local, state and federal emergency planning and response agencies about chemical spills; l. Developing an incident prevention program that includes the following: i. Process Safety Information; ii. Process Hazard Analysis; iii. Employee Training; iv. Mechanical Integrity; v. Pre-Startup Review; vi. Compliance Audits; vii. Employee Participation; and viii. Hot Work Permit. m. Developing plans to address accidental release that includes the following: i. Computer controls; ii. Door interlock system; iii. EtO leak detection monitors; iv. Emission Control Systems to destroy residual EtO; v. Pressure Relief Valves; vi. Process Safety Information for employees; vii. Written SOPs for training and instructions to employees; and viii. New hire and annual refresher training. n. Applying for IEPA construction permits to allow structural modifications at the facilities, including modifications impacting the volume of EtO emitted; o. Holding the facilities’ construction permit, as permittee, authorizing it to: i. Modify EtO emissions controls including sterilization chamber exhaust vents; ii. Operate the sterilization chamber exhaust vents without any EtO emissions controls; and iii. Modify the operation of its sterilization equipment, such as aeration 4 of 62 rooms, by allowing EtO emissions controls to be bypassed. p. Holding the facilities’ construction permit, as permittee, requiring it to: i. Operate EtO emission controls in a manner that complies with local, state FILED DATE: 5/15/2024 1:07 PM 2024L005399 and federal law; ii. Conduct operational monitoring for the EtO emissions controls to ensure compliance with plans previously submitted to EPA; iii. Enhance operational monitoring to address the effects of modification of EtO emissions controls; iv. Keeping records for operational monitoring for the EtO emissions controls affecting certain aeration rooms; and v. Notifying IEPA promptly of permit deviations including identifying the date, time, duration, description of the deviation, its probable cause, corrective actions, if taken, and preventative measures, if taken. q. Certifying the facilities’ permit compliance (or non- compliance) to the IEPA; r. Communicating with IEPA regarding permit violations and uncontrolled emissions events; s. Communicating with IEPA about its emission control equipment, including its plans to exhaust EtO from its chamber back vents to the atmosphere; t. Monitoring and reviewing of the facilities’ emission data to analyze the duration and quantity of EtO emissions released, including any excess emissions; u. Reporting to IEPA on the volume of the facilities’ EtO emissions; v. Monitoring the facilities’ emissions control equipment; w. Assessing the capacity of the EtO sterilization chambers at the Willowbrook facilities as compared to customer demand for its sterilization services; x. Deciding to add EtO sterilization chambers at the facilities to meet customers’ demand; y. Inventorying hazardous chemicals stored at the facilities, including EtO; and z. Communicating with state and local emergency response groups about such hazardous chemicals, including EtO. 18. Sotera undertook these responsibilities and functions even though, as alleged elsewhere in this complaint, it failed to ensure implementation adequate to keep the community safe. 19. With respect to the Willowbrook facilities, the activities of Sterigenics and Sotera have been intertwined. Sterigenics and Sotera have routinely and publicly held themselves out as a single entity – “Sterigenics” – engaged in operating EtO sterilization facilities throughout the country, including the Willowbrook facilities; and others, including Moody’s Investor Services, for example, has always treated the Sterigenics entities as a single entity and issued them a single “Corporate Family Rating.” 20. Sterigenics and Sotera have shared the same Chairman and CEO, the same Vice President, the same General Counsel & Secretary, the same President and COO, and the same Vice President for Environmental, Health & Safety. And they have shared a complete unity of interest, with Sterigenics acting as an instrumentality of Sotera to accomplish Sotera’s business mission. 5 of 62 21. In 2011, a private equity fund or funds created, maintained and managed by GTCR acquired Sterigenics International, LLC (now Sotera), along with its subsidiaries (including Sterigenics) and parent companies, for $675 million. FILED DATE: 5/15/2024 1:07 PM 2024L005399 22. The Defendants Sterigenics, Griffith Labs, Sotera, and GTCR do regular and substantial business in Cook County, Illinois. Griffith Labs decided to locate an EtO Sterilization facility in Willowbrook notwithstanding its knowledge that exposure to EtO is harmful to human health and can cause cancer. 23. Griffith Labs claims to have pioneered the development and use of EtO as a sterilant in the 1930s. In the 1940s, Griffith Labs received patents for the EtO sterilization of hospital and medical supplies. Beginning in the 1950s, Griffith Labs began offering contract EtO sterilization to third-party customers. Griffith Labs continued its contract sterilization business for decades, and in or around 1984, it opened and operated an EtO sterilization facility in the Village of Willowbrook –– a suburban community located roughly 20 miles southwest of Chicago with a population of approximately 8,500. 24. Before 1984, Griffith Labs knew or should have known that it was too dangerous to locate an EtO sterilization facility in or near a residential community, and indeed that any sterilization facility anywhere should be equipped with emission control equipment adequate to ensure that no one outside the facility was exposed to EtO. 25. Griffith Labs’ decision to locate its EtO sterilization facility in Willowbrook was driven by logistical and financial self-interest, such as Griffith Labs’ belief that Willowbrook would be an optimal location because it is centrally located in the Midwest near highways and railroads and because it was able to secure favorable lease terms. Griffith Labs’ decision was also driven by a desire to expand its ethylene oxide sterilization services to the commercial sterilization of medical supplies. In making its decision, Griffith Labs ignored its knowledge that placing an EtO sterilization facility in or near a residential community would cause significant risk to human health. Griffith Labs could have secured a facility far enough away from a residential population to drastically reduce and/or minimize the danger to residents, but consciously chose not to. 26. On or about April 12, 1984, Griffith Labs, through its unincorporated division, Micro-Biotrol, Co., leased a 44,939 square foot facility at 7775 Quincy Street in Willowbrook for the stated purpose of: “Sterilization process of various products.” The lease terms were originally for five years, with multiple options to renew for another five years thereafter. In this way, Griffith Labs ensured that a dangerous EtO sterilization facility would operate next to a residential neighborhood in Willowbrook for many years to come. Griffith Labs’ dealings with IEPA in securing a permit to operate an EtO sterilization facility in Willowbrook. 27. On or about May 31, 1984, in anticipation of constructing and operating the sterilization facility in Willowbrook, Griffith Labs marked off the distances from its EtO facility in Willowbrook to various schools, and therefore knew its facility would be located within ½ 6 of 62 mile of Gower Elementary; one mile of Hinsdale South High School; two miles of Gower West Elementary; ¼ mile of the nearest residence to the west; ½ mile of the nearest residence to the south; and otherwise in the immediate proximity of many homes, parks, schools, and small businesses. FILED DATE: 5/15/2024 1:07 PM 2024L005399 28. Griffith Labs further knew that EtO emissions from its Willowbrook facility could and would migrate to parts of the community in concentrations that would endanger human health. 29. Notwithstanding this knowledge, Griffith Labs elected to move forward with its plans to open an EtO sterilization facility in Willowbrook and, on or about June 1, 1984, applied for a construction and operating permit from IEPA. 30. Griffith Labs’ permit application to IEPA included the above plot and also included a representation to IEPA that its maximum emissions of EtO would be 40 tons (80,000 lbs.) per year. 31. On or about July 6, 1984, Griffith Labs received the following letter from IEPA concerning the environmental impact of its proposed EtO emissions (highlighting added): 7 of 62 FILED DATE: 5/15/2024 1:07 PM 2024L005399 8 of 62 32. By way of this July 6, 1984 letter, Griffith Labs was expressly advised by the state regulatory authority that its EtO sterilization operation posed significant adverse health risks to humans in that: (i) EtO exposure is associated with human cancers; and (ii) EtO has carcinogenic, FILED DATE: 5/15/2024 1:07 PM 2024L005399 mutagenic, leukemogenic, and teratogenic effects. Griffith Labs thus had knowledge that its EtO emissions would cause harm to humans in neighboring communities long before it exposed Plaintiffs to EtO emissions. 33. IEPA’s letter further informed Griffith Labs that at least two of the schools and two residential areas on the plot were within the area where IEPA had determined that EtO concentrations from the Willowbrook facility would be “several magnitudes higher than desirable.” 34. Indeed, Griffith Labs was already aware of the toxic and deadly effects of EtO when it received the July 6, 1984 letter from IEPA. Even before that date, and before Plaintiffs were exposed to EtO emissions, Griffith Labs knew that: a. there was “no safe level” of EtO, i.e., there was no concentration of EtO that could be safely breathed without risk of serious damage to health; b. “ethylene oxide has also been found to pose a serious health risk;” c. the very attribute which made EtO so lethally effective as a sterilant—e.g., its ability to inactivate DNA—also made EtO very dangerous for human beings exposed to it; d. the state of Illinois recognized EtO as one of the 19 most dangerous chemicals (a “priority” pollutant); e. EtO was suspected to cause cancer in humans, and threaten reproductive harm; f. “the highly toxic nature of ethylene oxide and its classification as a suspect carcinogen;” g. any exposure to EtO that threatened to cause even one additional cancer in a population of 1,000,000 was unacceptable; h. those exposed to EtO emitted from a sterilization facility were significantly more likely to contract cancer and other serious illnesses; i. EtO was a “mutagen,” i.e., that it damaged human DNA in a way that promoted the development of cancer; j. “[t]here has been widespread recognition of the mutagenic potential of ethylene oxide;” k. once emitted from a sterilization facility, EtO would be breathed by those living, working, and attending school near the facility; and l. “human receptors outside of the building may unknowingly come into contact with ethylene oxide before it has been sufficiently dispersed in the ambient atmosphere.” 35. As a result, and well before it began operations in Willowbrook, Griffith Labs was acutely aware of the catastrophic risk to human health that inhalation exposure to EtO would create. 36. In addition to warning Griffith Labs about the health risks of EtO, the IEPA letter expressly told Griffith Labs that IEPA’s air modeling raised substantial concerns that the surrounding Willowbrook community would be adversely impacted by Griffith Labs’ EtO emissions. In particular, it informed Griffith Labs that: (i) emissions from the Willowbrook facility 9 of 62 appear to be “several magnitudes higher than desirable;” and (ii) steps should be taken to “minimize emissions in order to reduce the ambient impacts to an acceptable level.” FILED DATE: 5/15/2024 1:07 PM 2024L005399 37. Moreover, Griffith Labs knew or should have known when it received IPEA’s letter that IEPA’s modeling results vastly understated the risk to Griffith Labs’ neighbors that the Willowbrook emissions would pose. According to the letter, IEPA had based its EtO modeling in part on Griffith Labs’ representation that its maximum emissions would be 40 tons (80,000 lbs.) per year. Upon information and belief, Griffith Labs knew that its emissions going forward would be significantly more than 80,000 pounds per year. In fact, in 1985, the Willowbrook facility emitted more than 125,000 pounds of EtO. In each of 1986 and 1987, it emitted more than 160,000 pounds of EtO. 38. Further, Griffith Labs’ representation to IEPA that it had emitted 40 tons of EtO during the year of 1983 was itself understated. In an internal memorandum dated May 3, 1984, Griffith Labs discloses that it had actually emitted approximately 50 tons in 1983. Griffith Labs never corrected its misrepresentation to IEPA: 39. The same internal memo also predicted that Griffith Labs would grow to emit 65 tons per year. Griffith Labs did not disclose this fact to IEPA either. 40. As a result, Griffith Labs knew or should have known that IEPA’s opinion that its emissions would be “several magnitudes higher than desirable” was based on modeling that only accounted for about half of what Griffith Labs actually intended to emit. Griffith Labs never corrected IEPA’s modeling assumptions at any point prior to receiving its permit. 41. Separately, upon information and belief, Griffith Labs misinformed IEPA about the height of the stack it would use at Willowbrook to release EtO emissions. The height of the stack is important because, in general, the higher the stack, the greater the EtO concentrations will be diminished before they descend to the zone in which they are breathed by, e.g., residents, workers, and schoolchildren. In connection with its 1984 permit application, Griffith Labs told IEPA that the stack exhaust point would be 40-50 feet above grade. However, upon information and belief, the actual exhaust point was only 28 feet above grade. 42. As a result, Griffith Labs knew or should have known that IEPA’s opinion that its emissions would be “several magnitudes higher than desirable” was based upon modeling that used a falsely inflated stack height. Griffith Labs never corrected IEPA’s modeling assumptions at any point prior to receiving its permit. 43. Further, Griffith Labs took essentially no action in connection with IEPA’s stated concerns about its “minimiz[ing] emissions in order to reduce the ambient impacts to an acceptable level.” Instead, once Griffith Labs received its permit, it operated without any emission controls designed to remove or eliminate EtO from emissions and thereby caused massive unfiltered emissions of EtO into the Willowbrook community 24 hours a day, 7 days a week, 365 days a year. Griffith Labs did so notwithstanding its knowledge that: (a) toxicity data showed that 10 of 62 EtO exposure was associated with human cancers and other harms; (b) the facility was located within the immediate proximity of homes, parks, schools, and small businesses; and (c) IEPA’s (understated) modeling predicted emissions “several magnitudes higher than desirable.” FILED DATE: 5/15/2024 1:07 PM 2024L005399 44. Indeed, by no later than 1982, Griffith Labs knew that emission control technology was available that could remove up to 99% of EtO from the Willowbrook facility’s exhaust before it was allowed to enter Willowbrook’s air. Despite knowing of the availability of this technology before operating in Willowbrook, Griffith Labs specifically declined to use it for essentially the first four years of Willowbrook operations. Griffith Labs received an operating permit for the Willowbrook facility that was subject to special conditions with which Griffith Labs failed to comply. 45. On July 30, 1984, IEPA issued Griffith Labs a Joint Construction and Operating Permit to construct and operate sterilization chambers 1, 3, 4, 5, 9, and 10 at the Willowbrook facility. 46. The permit was issued to “Griffith Laboratories, U.S.A., Inc.” (i.e., Griffith Labs) for its operation of the Willowbrook facility. The permit had a two-year term, expiring on July 31, 1986. Griffith Labs never attempted to amend or correct this permit in any way, including to substitute any other entity as the permit holder. 47. The 1984 permit, as well as all permits relating to the Willowbrook facility issued thereafter, expressly warned Griffith Labs the permit did not release it from liability for harm to its neighbors. They stated: a. the permit “does not release the permittee from any liability for any loss due to damage to person or property caused by, resulting from, or arising out of, the design, installation, maintenance, or operation of” the Willowbrook facility. b. the permit “in no manner implies or suggests that the [IEPA] . . . assumes any liability, directly or indirectly, for any loss due to damage, installation, maintenance or operation” of the Willowbrook facility. c. the Willowbrook facility could not be operated in such a manner as to “cause a violation of the Environmental Protection Act or Regulations promulgated thereunder,” all of which forbid air pollution in the State of Illinois. 48. As the permittee for the Willowbrook facility, Griffith Labs was responsible for the following operations: a. sterilization processes for the six chambers for which it received a permit; b. emissions of EtO and other volatile organic materials from the facility; c. the acquisition, installation, and operation of pollution controls at the facility; d. testing and monitoring for levels of EtO both in the facility and the environment; e. monitoring, testing, maintenance, and repair of all equipment involved in the sterilization processes at the facility; f. maintaining emission records and reporting to IEPA and as otherwise required by law; 11 of 62 g. ensuring that its emissions and emission controls were compliant with local, state, and federal law; h. monitoring and reviewing the facility’s emission data to analyze the duration and FILED DATE: 5/15/2024 1:07 PM 2024L005399 quantity of EtO emissions released, including any excess emissions; i. assessing the capacity of the EtO sterilization chambe