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1    AN ACT concerning safety.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 1. Short Title. This Act may be referred to as the
5Matt Haller Act.
 
6    Section 5. The Environmental Protection Act is amended by
7adding Section 9.16 as follows:
 
8    (415 ILCS 5/9.16 new)
9    Sec. 9.16. Control of ethylene oxide sterilization
10sources.
11    (a) As used in this Section:
12    "Ethylene oxide sterilization operations" means the
13process of using ethylene oxide at an ethylene oxide
14sterilization source to make one or more items free from
15microorganisms, pathogens, or both microorganisms and
16pathogens.
17    "Ethylene oxide sterilization source" means any stationary
18source with ethylene oxide usage that would subject it to the
19emissions standards in 40 CFR 63.362. "Ethylene oxide
20sterilization source" does not include beehive fumigators,
21research or laboratory facilities, hospitals, doctors'
22offices, clinics, or other stationary sources for which the

 

 

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1primary purpose is to provide medical services to humans or
2animals.
3    "Exhaust point" means any point through which ethylene
4oxide-laden air exits an ethylene oxide sterilization source.
5    "Stationary source" has the meaning set forth in subsection
61 of Section 39.5.
7    (b) Beginning 180 days after the effective date of this
8amendatory Act of the 101st General Assembly, no person shall
9conduct ethylene oxide sterilization operations, unless the
10ethylene oxide sterilization source captures, and demonstrates
11that it captures, 100% of all ethylene oxide emissions and
12reduces ethylene oxide emissions to the atmosphere from each
13exhaust point at the ethylene oxide sterilization source by at
14least 99.9% or to 0.2 parts per million.
15        (1) Within 180 days after the effective date of this
16    amendatory Act of the 101st General Assembly for any
17    existing ethylene oxide sterilization source, or prior to
18    any ethylene oxide sterilization operation for any source
19    that first becomes subject to regulation after the
20    effective date of this amendatory Act of the 101st General
21    Assembly as an ethylene oxide sterilization source under
22    this Section, the owner or operator of the ethylene oxide
23    sterilization source shall conduct an initial emissions
24    test in accordance with all of the requirements set forth
25    in this paragraph (1) to verify that ethylene oxide
26    emissions to the atmosphere from each exhaust point at the

 

 

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1    ethylene oxide sterilization source have been reduced by at
2    least 99.9% or to 0.2 parts per million:
3            (A) At least 30 days prior to the scheduled
4        emissions test date, the owner or operator of the
5        ethylene oxide sterilization source shall submit a
6        notification of the scheduled emissions test date and a
7        copy of the proposed emissions test protocol to the
8        Agency for review and written approval. Emissions test
9        protocols submitted to the Agency shall address the
10        manner in which testing will be conducted, including,
11        but not limited to:
12                (i) the name of the independent third party
13            company that will be performing sampling and
14            analysis and the company's experience with similar
15            emissions tests;
16                (ii) the methodologies to be used;
17                (iii) the conditions under which emissions
18            tests will be performed, including a discussion of
19            why these conditions will be representative of
20            maximum emissions from each of the 3 cycles of
21            operation (chamber evacuation, back vent, and
22            aeration) and the means by which the operating
23            parameters for the emission unit and any control
24            equipment will be determined;
25                (iv) the specific determinations of emissions
26            and operations that are intended to be made,

 

 

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1            including sampling and monitoring locations; and
2                (v) any changes to the test method or methods
3            proposed to accommodate the specific circumstances
4            of testing, with justification.
5            (B) The owner or operator of the ethylene oxide
6        sterilization source shall perform emissions testing
7        in accordance with an Agency-approved test protocol
8        and at representative conditions to verify that
9        ethylene oxide emissions to the atmosphere from each
10        exhaust point at the ethylene oxide sterilization
11        source have been reduced by at least 99.9% or to 0.2
12        parts per million. The duration of the test must
13        incorporate all 3 cycles of operation for
14        determination of the emission reduction efficiency.
15            (C) Upon Agency approval of the test protocol, any
16        source that first becomes subject to regulation after
17        the effective date of this amendatory Act of the 101st
18        General Assembly as an ethylene oxide sterilization
19        source under this Section may undertake ethylene oxide
20        sterilization operations in accordance with the
21        Agency-approved test protocol for the sole purpose of
22        demonstrating compliance with this subsection (b).
23            (D) The owner or operator of the ethylene oxide
24        sterilization source shall submit to the Agency the
25        results of any and all emissions testing conducted
26        after the effective date of this amendatory Act of the

 

 

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1        101st General Assembly, until the Agency accepts
2        testing results under subparagraph (E) of paragraph
3        (1) of this subsection (b), for any existing source or
4        prior to any ethylene oxide sterilization operation
5        for any source that first becomes subject to regulation
6        after the effective date of this amendatory Act of the
7        101st General Assembly as an ethylene oxide
8        sterilization source under this Section. The results
9        documentation shall include at a minimum:
10                (i) a summary of results;
11                (ii) a description of test method or methods,
12            including description of sample points, sampling
13            train, analysis equipment, and test schedule;
14                (iii) a detailed description of test
15            conditions, including process information and
16            control equipment information; and
17                (iv) data and calculations, including copies
18            of all raw data sheets, opacity observation
19            records and records of laboratory analyses, sample
20            calculations, and equipment calibration.
21            (E) Within 30 days of receipt, the Agency shall
22        accept, accept with conditions, or decline to accept a
23        stack testing protocol and the testing results
24        submitted to demonstrate compliance with paragraph (1)
25        of this subsection (b). If the Agency accepts with
26        conditions or declines to accept the results

 

 

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1        submitted, the owner or operator of the ethylene oxide
2        sterilization source shall submit revised results of
3        the emissions testing or conduct emissions testing
4        again. If the owner or operator revises the results,
5        the revised results shall be submitted within 15 days
6        after the owner or operator of the ethylene oxide
7        sterilization source receives written notice of the
8        Agency's conditional acceptance or rejection of the
9        emissions testing results. If the owner or operator
10        conducts emissions testing again, such new emissions
11        testing shall conform to the requirements of this
12        subsection (b).
13        (2) The owner or operator of the ethylene oxide
14    sterilization source shall conduct emissions testing on
15    all exhaust points at the ethylene oxide sterilization
16    source at least once each calendar year to demonstrate
17    compliance with the requirements of this Section and any
18    applicable requirements concerning ethylene oxide that are
19    set forth in either United States Environmental Protection
20    Agency rules or Board rules. Annual emissions tests
21    required under this paragraph (2) shall take place at least
22    6 months apart. An initial emissions test conducted under
23    paragraph (1) of this subsection (b) satisfies the testing
24    requirement of this paragraph (2) for the calendar year in
25    which the initial emissions test is conducted.
26        (3) At least 30 days before conducting the annual

 

 

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1    emissions test required under paragraph (2) of this
2    subsection (b), the owner or operator shall submit a
3    notification of the scheduled emissions test date and a
4    copy of the proposed emissions test protocol to the Agency
5    for review and written approval. Emissions test protocols
6    submitted to the Agency under this paragraph (3) must
7    address each item listed in subparagraph (A) of paragraph
8    (1) of this subsection (b). Emissions testing shall be
9    performed in accordance with an Agency-approved test
10    protocol and at representative conditions. In addition, as
11    soon as practicable, but no later than 30 days after the
12    emissions test date, the owner or operator shall submit to
13    the Agency the results of the emissions testing required
14    under paragraph (2) of this subsection (b). Such results
15    must include each item listed in subparagraph (D) of
16    paragraph (1) of this subsection (b).
17        (4) If the owner or operator of an ethylene oxide
18    sterilization source conducts any emissions testing in
19    addition to tests required by this amendatory Act of the
20    101st General Assembly, the owner or operator shall submit
21    to the Agency the results of such emissions testing within
22    30 days after the emissions test date.
23        (5) The Agency shall accept, accept with conditions, or
24    decline to accept testing results submitted to demonstrate
25    compliance with paragraph (2) of this subsection (b). If
26    the Agency accepts with conditions or declines to accept

 

 

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1    the results submitted, the owner or operator of the
2    ethylene oxide sterilization source shall submit revised
3    results of the emissions testing or conduct emissions
4    testing again. If the owner or operator revises the
5    results, the revised results shall be submitted within 15
6    days after the owner or operator of the ethylene oxide
7    sterilization source receives written notice of the
8    Agency's conditional acceptance or rejection of the
9    emissions testing results. If the owner or operator
10    conducts emissions testing again, such new emissions
11    testing shall conform to the requirements of this
12    subsection (b).
13    (c) If any emissions test conducted more than 180 days
14after the effective date of this amendatory Act of the 101st
15General Assembly fails to demonstrate that ethylene oxide
16emissions to the atmosphere from each exhaust point at the
17ethylene oxide sterilization source have been reduced by at
18least 99.9% or to 0.2 parts per million, the owner or operator
19of the ethylene oxide sterilization source shall immediately
20cease ethylene oxide sterilization operations and notify the
21Agency within 24 hours of becoming aware of the failed
22emissions test. Within 60 days after the date of the test, the
23owner or operator of the ethylene oxide sterilization source
24shall:
25        (1) complete an analysis to determine the root cause of
26    the failed emissions test;

 

 

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1        (2) take any actions necessary to address that root
2    cause;
3        (3) submit a report to the Agency describing the
4    findings of the root cause analysis, any work undertaken to
5    address findings of the root cause analysis, and
6    identifying any feasible best management practices to
7    enhance capture and further reduce ethylene oxide levels
8    within the ethylene oxide sterilization source, including
9    a schedule for implementing such practices; and
10        (4) upon approval by the Agency of the report required
11    by paragraph (3) of this subsection, restart ethylene oxide
12    sterilization operations only to the extent necessary to
13    conduct additional emissions test or tests. The ethylene
14    oxide sterilization source shall conduct such emissions
15    test or tests under the same requirements as the annual
16    test described in paragraphs (2) and (3) of subsection (b).
17    The ethylene oxide sterilization source may restart
18    operations once an emissions test successfully
19    demonstrates that ethylene oxide emissions to the
20    atmosphere from each exhaust point at the ethylene oxide
21    sterilization source have been reduced by at least 99.9% or
22    to 0.2 parts per million, the source has submitted the
23    results of all emissions testing conducted under this
24    subsection to the Agency, and the Agency has approved the
25    results demonstrating compliance.
26    (d) Beginning 180 days after the effective date of this

 

 

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1amendatory Act of the 101st General Assembly for any existing
2source or prior to any ethylene oxide sterilization operation
3for any source that first becomes subject to regulation after
4the effective date of this amendatory Act of the 101st General
5Assembly as an ethylene oxide sterilization source under this
6Section, no person shall conduct ethylene oxide sterilization
7operations unless the owner or operator of the ethylene oxide
8sterilization source submits for review and approval by the
9Agency a plan describing how the owner or operator will
10continuously collect emissions information at the ethylene
11oxide sterilization source. This plan must also specify
12locations at the ethylene oxide sterilization source from which
13emissions will be collected and identify equipment used for
14collection and analysis, including the individual system
15components.
16        (1) The owner or operator of the ethylene oxide
17    sterilization source must provide a notice of acceptance of
18    any conditions added by the Agency to the plan, or correct
19    any deficiencies identified by the Agency in the plan,
20    within 3 business days after receiving the Agency's
21    conditional acceptance or denial of the plan.
22        (2) Upon the Agency's approval of the plan, the owner
23    or operator of the ethylene oxide sterilization source
24    shall implement the plan in accordance with its approved
25    terms.
26    (e) Beginning 180 days after the effective date of this

 

 

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1amendatory Act of the 101st General Assembly for any existing
2source or prior to any ethylene oxide sterilization operation
3for any source that first becomes subject to regulation after
4the effective date of this amendatory Act of the 101st General
5Assembly as an ethylene oxide sterilization source under this
6Section, no person shall conduct ethylene oxide sterilization
7operations unless the owner or operator of the ethylene oxide
8sterilization source submits for review and approval by the
9Agency an Ambient Air Monitoring Plan.
10        (1) The Ambient Air Monitoring Plan shall include, at a
11    minimum, the following:
12            (A) Detailed plans to collect and analyze air
13        samples for ethylene oxide on at least a quarterly
14        basis near the property boundaries of the ethylene
15        oxide sterilization source and at community locations
16        with the highest modeled impact pursuant to the
17        modeling conducted under subsection (f). Each
18        quarterly sampling under this subsection shall be
19        conducted over a multiple-day sampling period.
20            (B) A schedule for implementation.
21            (C) The name of the independent third party company
22        that will be performing sampling and analysis and the
23        company's experience with similar testing.
24        (2) The owner or operator of the ethylene oxide
25    sterilization source must provide a notice of acceptance of
26    any conditions added by the Agency to the Ambient Air

 

 

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1    Monitoring Plan, or correct any deficiencies identified by
2    the Agency in the Ambient Air Monitoring Plan, within 3
3    business days after receiving the Agency's conditional
4    acceptance or denial of the plan.
5        (3) Upon the Agency's approval of the plan, the owner
6    or operator of the ethylene oxide sterilization source
7    shall implement the Ambient Air Monitoring Plan in
8    accordance with its approved terms.
9    (f) Beginning 180 days after the effective date of this
10amendatory Act of the 101st General Assembly for any existing
11source or prior to any ethylene oxide sterilization operation
12for any source that first becomes subject to regulation after
13the effective date of this amendatory Act of the 101st General
14Assembly as an ethylene oxide sterilization source under this
15Section, no person shall conduct ethylene oxide sterilization
16operations unless the owner or operator of the ethylene oxide
17sterilization source has performed dispersion modeling and the
18Agency approves such modeling.
19        (1) Dispersion modeling must:
20            (A) be conducted using accepted United States
21        Environmental Protection Agency methodologies,
22        including 40 CFR Part 51, Appendix W, except that no
23        background ambient levels of ethylene oxide shall be
24        used;
25            (B) use emissions and stack parameter data from the
26        emissions test conducted in accordance with paragraph

 

 

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1        (1) of subsection (b), and use 5 years of hourly
2        meteorological data that is representative of the
3        source's location; and
4            (C) use a receptor grid that extends to at least
5        one kilometer around the source and ensure the modeling
6        domain includes the area of maximum impact, with
7        receptor spacing no greater than every 50 meters
8        starting from the building walls of the source
9        extending out to a distance of at least one-half
10        kilometer, then every 100 meters extending out to a
11        distance of at least one kilometer.
12        (2) The owner or operator of the ethylene oxide
13    sterilization source shall submit revised results of all
14    modeling if the Agency accepts with conditions or declines
15    to accept the results submitted.
16    (g) A facility permitted to emit ethylene oxide that has
17been subject to a seal order under Section 34 is prohibited
18from using ethylene oxide for sterilization or fumigation
19purposes, unless (i) the facility can provide a certification
20to the Agency by the supplier of a product to be sterilized or
21fumigated that ethylene oxide sterilization or fumigation is
22the only available method to completely sterilize or fumigate
23the product and (ii) the Agency has certified that the
24facility's emission control system uses technology that
25produces the greatest reduction in ethylene oxide emissions
26currently available. The certification shall be made by a

 

 

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1company representative with knowledge of the sterilization
2requirements of the product. The certification requirements of
3this Section shall apply to any group of products packaged
4together and sterilized as a single product if sterilization or
5fumigation is the only available method to completely sterilize
6or fumigate more than half of the individual products contained
7in the package.
8    A facility is not subject to the requirements of this
9subsection if the supporting findings of the seal order under
10Section 34 are found to be without merit by a court of
11competent jurisdiction.
12    (h) If an entity, or any parent or subsidiary of an entity,
13that owns or operates a facility permitted by the Agency to
14emit ethylene oxide acquires by purchase, license, or any other
15method of acquisition any intellectual property right in a
16sterilization technology that does not involve the use of
17ethylene oxide, or by purchase, merger, or any other method of
18acquisition of any entity that holds an intellectual property
19right in a sterilization technology that does not involve the
20use of ethylene oxide, that entity, parent, or subsidiary shall
21notify the Agency of the acquisition within 30 days of
22acquiring it. If that entity, parent, or subsidiary has not
23used the sterilization technology within 3 years of its
24acquisition, the entity shall notify the Agency within 30 days
25of the 3-year period elapsing.
26    An entity, or any parent or subsidiary of an entity, that

 

 

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1owns or operates a facility permitted by the Agency to emit
2ethylene oxide that has any intellectual property right in any
3sterilization technology that does not involve the use of
4ethylene oxide shall notify the Agency of any offers that it
5makes to license or otherwise allow the technology to be used
6by third parties within 30 days of making the offer.
7    An entity, or any parent or subsidiary of an entity, that
8owns or operates a facility permitted by the Agency to emit
9ethylene oxide shall provide the Agency with a list of all U.S.
10patent registrations for sterilization technology that the
11entity, parent, or subsidiary has any property right in. The
12list shall include the following:
13        (1) The patent number assigned by the United States
14    Patent and Trademark Office for each patent.
15        (2) The date each patent was filed.
16        (3) The names and addresses of all owners or assignees
17    of each patent.
18        (4) The names and addresses of all inventors of each
19    patent.
20    (i) If a CAAPP permit applicant applies to use ethylene
21oxide as a sterilant or fumigant at a facility not in existence
22prior to January 1, 2020, the Agency shall issue a CAAPP permit
23for emission of ethylene oxide only if:
24        (1) the nearest school or park is at least 10 miles
25    from the permit applicant in counties with populations
26    greater than 50,000;

 

 

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1        (2) the nearest school or park is at least 15 miles
2    from the permit applicant in counties with populations less
3    than or equal to 50,000; and
4        (3) within 7 days after the application for a CAAPP
5    permit, the permit applicant has published its permit
6    request on its website, published notice in a local
7    newspaper of general circulation, and provided notice to:
8            (A) the State Representative for the
9        representative district in which the facility is
10        located;
11            (B) the State Senator for the legislative district
12        in which the facility is located;
13            (C) the members of the county board for the county
14        in which the facility is located; and
15            (D) the local municipal board members and
16        executives.
17    (j) The owner or operator of an ethylene oxide
18sterilization source must apply for and obtain a construction
19permit from the Agency for any modifications made to the source
20to comply with the requirements of this amendatory Act of the
21101st General Assembly, including, but not limited to,
22installation of a permanent total enclosure, modification of
23airflow to create negative pressure within the source, and
24addition of one or more control devices. Additionally, the
25owner or operator of the ethylene oxide sterilization source
26must apply for and obtain from the Agency a modification of the

 

 

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1source's operating permit to incorporate such modifications
2made to the source. Both the construction permit and operating
3permit must include a limit on ethylene oxide usage at the
4source.
5    (k) Nothing in this Section shall be interpreted to excuse
6the ethylene oxide sterilization source from complying with any
7applicable local requirements.
8    (l) The owner or operator of an ethylene oxide
9sterilization source must notify the Agency within 5 days after
10discovering any deviation from any of the requirements in this
11Section or deviations from any applicable requirements
12concerning ethylene oxide that are set forth in this Act,
13United States Environmental Protection Agency rules, or Board
14rules. As soon as practicable, but no later than 5 business
15days, after the Agency receives such notification, the Agency
16must post a notice on its website and notify the members of the
17General Assembly from the Legislative and Representative
18Districts in which the source in question is located, the
19county board members of the county in which the source in
20question is located, the corporate authorities of the
21municipality in which the source in question is located, and
22the Illinois Department of Public Health.
23    (m) The Agency must conduct at least one unannounced
24inspection of all ethylene oxide sterilization sources subject
25to this Section per year. Nothing in this Section shall limit
26the Agency's authority under other provisions of this Act to

 

 

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1conduct inspections of ethylene oxide sterilization sources.
2    (n) The Agency shall conduct air testing to determine the
3ambient levels of ethylene oxide throughout the State. The
4Agency shall, within 180 days after the effective date of this
5amendatory Act of the 101st General Assembly, submit rules for
6ambient air testing of ethylene oxide to the Board.
 
7    Section 99. Effective date. This Act takes effect upon
8becoming law.