Rep. Jim Durkin

Filed: 5/22/2019

 

 


 

 


 
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1
AMENDMENT TO SENATE BILL 1852

2    AMENDMENT NO. ______. Amend Senate Bill 1852 by replacing
3everything after the enacting clause with the following:
 
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

 

 

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1pathogens.
2    "Ethylene oxide sterilization source" means any stationary
3source with ethylene oxide usage that would subject it to the
4emissions standards in 40 CFR 63.362. "Ethylene oxide
5sterilization source" does not include beehive fumigators,
6research or laboratory facilities, hospitals, doctors'
7offices, clinics, or other stationary sources for which the
8primary purpose is to provide medical services to humans or
9animals.
10    "Exhaust point" means any point through which ethylene
11oxide-laden air exits an ethylene oxide sterilization source.
12    "Stationary source" has the meaning set forth in subsection
131 of Section 39.5.
14    (b) Beginning 180 days after the effective date of this
15amendatory Act of the 101st General Assembly, no person shall
16conduct ethylene oxide sterilization operations, unless the
17ethylene oxide sterilization source captures, and demonstrates
18that it captures, 100% of all ethylene oxide emissions and
19reduces ethylene oxide emissions to the atmosphere from each
20exhaust point at the ethylene oxide sterilization source by at
21least 99.9% or to 0.2 parts per million.
22        (1) Within 180 days after the effective date of this
23    amendatory Act of the 101st General Assembly for any
24    existing ethylene oxide sterilization source, or prior to
25    any ethylene oxide sterilization operation for any source
26    that first becomes subject to regulation after the

 

 

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1    effective date of this amendatory Act of the 101st General
2    Assembly as an ethylene oxide sterilization source under
3    this Section, the owner or operator of the ethylene oxide
4    sterilization source shall conduct an initial emissions
5    test in accordance with all of the requirements set forth
6    in this paragraph (1) to verify that ethylene oxide
7    emissions to the atmosphere from each exhaust point at the
8    ethylene oxide sterilization source have been reduced by at
9    least 99.9% or to 0.2 parts per million:
10            (A) At least 30 days prior to the scheduled
11        emissions test date, the owner or operator of the
12        ethylene oxide sterilization source shall submit a
13        notification of the scheduled emissions test date and a
14        copy of the proposed emissions test protocol to the
15        Agency for review and written approval. Emissions test
16        protocols submitted to the Agency shall address the
17        manner in which testing will be conducted, including,
18        but not limited to:
19                (i) the name of the independent third party
20            company that will be performing sampling and
21            analysis and the company's experience with similar
22            emissions tests;
23                (ii) the methodologies to be used;
24                (iii) the conditions under which emissions
25            tests will be performed, including a discussion of
26            why these conditions will be representative of

 

 

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

 

 

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

 

 

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1            calculations, and equipment calibration.
2            (E) Within 30 days of receipt, the Agency shall
3        accept, accept with conditions, or decline to accept a
4        stack testing protocol and the testing results
5        submitted to demonstrate compliance with paragraph (1)
6        of this subsection (b). If the Agency accepts with
7        conditions or declines to accept the results
8        submitted, the owner or operator of the ethylene oxide
9        sterilization source shall submit revised results of
10        the emissions testing or conduct emissions testing
11        again. If the owner or operator revises the results,
12        the revised results shall be submitted within 15 days
13        after the owner or operator of the ethylene oxide
14        sterilization source receives written notice of the
15        Agency's conditional acceptance or rejection of the
16        emissions testing results. If the owner or operator
17        conducts emissions testing again, such new emissions
18        testing shall conform to the requirements of this
19        subsection (b).
20        (2) The owner or operator of the ethylene oxide
21    sterilization source shall conduct emissions testing on
22    all exhaust points at the ethylene oxide sterilization
23    source at least once each calendar year to demonstrate
24    compliance with the requirements of this Section and any
25    applicable requirements concerning ethylene oxide that are
26    set forth in either United States Environmental Protection

 

 

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1    Agency rules or Board rules. Annual emissions tests
2    required under this paragraph (2) shall take place at least
3    6 months apart. An initial emissions test conducted under
4    paragraph (1) of this subsection (b) satisfies the testing
5    requirement of this paragraph (2) for the calendar year in
6    which the initial emissions test is conducted.
7        (3) At least 30 days before conducting the annual
8    emissions test required under paragraph (2) of this
9    subsection (b), the owner or operator shall submit a
10    notification of the scheduled emissions test date and a
11    copy of the proposed emissions test protocol to the Agency
12    for review and written approval. Emissions test protocols
13    submitted to the Agency under this paragraph (3) must
14    address each item listed in subparagraph (A) of paragraph
15    (1) of this subsection (b). Emissions testing shall be
16    performed in accordance with an Agency-approved test
17    protocol and at representative conditions. In addition, as
18    soon as practicable, but no later than 30 days after the
19    emissions test date, the owner or operator shall submit to
20    the Agency the results of the emissions testing required
21    under paragraph (2) of this subsection (b). Such results
22    must include each item listed in subparagraph (D) of
23    paragraph (1) of this subsection (b).
24        (4) If the owner or operator of an ethylene oxide
25    sterilization source conducts any emissions testing in
26    addition to tests required by this amendatory Act of the

 

 

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1    101st General Assembly, the owner or operator shall submit
2    to the Agency the results of such emissions testing within
3    30 days after the emissions test date.
4        (5) The Agency shall accept, accept with conditions, or
5    decline to accept testing results submitted to demonstrate
6    compliance with paragraph (2) of this subsection (b). If
7    the Agency accepts with conditions or declines to accept
8    the results submitted, the owner or operator of the
9    ethylene oxide sterilization source shall submit revised
10    results of the emissions testing or conduct emissions
11    testing again. If the owner or operator revises the
12    results, the revised results shall be submitted within 15
13    days after the owner or operator of the ethylene oxide
14    sterilization source receives written notice of the
15    Agency's conditional acceptance or rejection of the
16    emissions testing results. If the owner or operator
17    conducts emissions testing again, such new emissions
18    testing shall conform to the requirements of this
19    subsection (b).
20    (c) If any emissions test conducted more than 180 days
21after the effective date of this amendatory Act of the 101st
22General Assembly fails to demonstrate that ethylene oxide
23emissions to the atmosphere from each exhaust point at the
24ethylene oxide sterilization source have been reduced by at
25least 99.9% or to 0.2 parts per million, the owner or operator
26of the ethylene oxide sterilization source shall immediately

 

 

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1cease ethylene oxide sterilization operations and notify the
2Agency within 24 hours of becoming aware of the failed
3emissions test. Within 60 days after the date of the test, the
4owner or operator of the ethylene oxide sterilization source
5shall:
6        (1) complete an analysis to determine the root cause of
7    the failed emissions test;
8        (2) take any actions necessary to address that root
9    cause;
10        (3) submit a report to the Agency describing the
11    findings of the root cause analysis, any work undertaken to
12    address findings of the root cause analysis, and
13    identifying any feasible best management practices to
14    enhance capture and further reduce ethylene oxide levels
15    within the ethylene oxide sterilization source, including
16    a schedule for implementing such practices; and
17        (4) upon approval by the Agency of the report required
18    by paragraph (3) of this subsection, restart ethylene oxide
19    sterilization operations only to the extent necessary to
20    conduct additional emissions test or tests. The ethylene
21    oxide sterilization source shall conduct such emissions
22    test or tests under the same requirements as the annual
23    test described in paragraphs (2) and (3) of subsection (b).
24    The ethylene oxide sterilization source may restart
25    operations once an emissions test successfully
26    demonstrates that ethylene oxide emissions to the

 

 

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1    atmosphere from each exhaust point at the ethylene oxide
2    sterilization source have been reduced by at least 99.9% or
3    to 0.2 parts per million, the source has submitted the
4    results of all emissions testing conducted under this
5    subsection to the Agency, and the Agency has approved the
6    results demonstrating compliance.
7    (d) Beginning 180 days after the effective date of this
8amendatory Act of the 101st General Assembly for any existing
9source or prior to any ethylene oxide sterilization operation
10for any source that first becomes subject to regulation after
11the effective date of this amendatory Act of the 101st General
12Assembly as an ethylene oxide sterilization source under this
13Section, no person shall conduct ethylene oxide sterilization
14operations unless the owner or operator of the ethylene oxide
15sterilization source submits for review and approval by the
16Agency a plan describing how the owner or operator will
17continuously collect emissions information at the ethylene
18oxide sterilization source. This plan must also specify
19locations at the ethylene oxide sterilization source from which
20emissions will be collected and identify equipment used for
21collection and analysis, including the individual system
22components.
23        (1) The owner or operator of the ethylene oxide
24    sterilization source must provide a notice of acceptance of
25    any conditions added by the Agency to the plan, or correct
26    any deficiencies identified by the Agency in the plan,

 

 

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1    within 3 business days after receiving the Agency's
2    conditional acceptance or denial of the plan.
3        (2) Upon the Agency's approval of the plan, the owner
4    or operator of the ethylene oxide sterilization source
5    shall implement the plan in accordance with its approved
6    terms.
7    (e) Beginning 180 days after the effective date of this
8amendatory Act of the 101st General Assembly for any existing
9source or prior to any ethylene oxide sterilization operation
10for any source that first becomes subject to regulation after
11the effective date of this amendatory Act of the 101st General
12Assembly as an ethylene oxide sterilization source under this
13Section, no person shall conduct ethylene oxide sterilization
14operations unless the owner or operator of the ethylene oxide
15sterilization source submits for review and approval by the
16Agency an Ambient Air Monitoring Plan.
17        (1) The Ambient Air Monitoring Plan shall include, at a
18    minimum, the following:
19            (A) Detailed plans to collect and analyze air
20        samples for ethylene oxide on at least a quarterly
21        basis near the property boundaries of the ethylene
22        oxide sterilization source and at community locations
23        with the highest modeled impact pursuant to the
24        modeling conducted under subsection (f). Each
25        quarterly sampling under this subsection shall be
26        conducted over a multiple-day sampling period.

 

 

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1            (B) A schedule for implementation.
2            (C) The name of the independent third party company
3        that will be performing sampling and analysis and the
4        company's experience with similar testing.
5        (2) The owner or operator of the ethylene oxide
6    sterilization source must provide a notice of acceptance of
7    any conditions added by the Agency to the Ambient Air
8    Monitoring Plan, or correct any deficiencies identified by
9    the Agency in the Ambient Air Monitoring Plan, within 3
10    business days after receiving the Agency's conditional
11    acceptance or denial of the plan.
12        (3) Upon the Agency's approval of the plan, the owner
13    or operator of the ethylene oxide sterilization source
14    shall implement the Ambient Air Monitoring Plan in
15    accordance with its approved terms.
16    (f) Beginning 180 days after the effective date of this
17amendatory Act of the 101st General Assembly for any existing
18source or prior to any ethylene oxide sterilization operation
19for any source that first becomes subject to regulation after
20the effective date of this amendatory Act of the 101st General
21Assembly as an ethylene oxide sterilization source under this
22Section, no person shall conduct ethylene oxide sterilization
23operations unless the owner or operator of the ethylene oxide
24sterilization source has performed dispersion modeling and the
25Agency approves such modeling.
26        (1) Dispersion modeling must:

 

 

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1            (A) be conducted using accepted United States
2        Environmental Protection Agency methodologies,
3        including 40 CFR Part 51, Appendix W, except that no
4        background ambient levels of ethylene oxide shall be
5        used;
6            (B) use emissions and stack parameter data from the
7        emissions test conducted in accordance with paragraph
8        (1) of subsection (b), and use 5 years of hourly
9        meteorological data that is representative of the
10        source's location; and
11            (C) use a receptor grid that extends to at least
12        one kilometer around the source and ensure the modeling
13        domain includes the area of maximum impact, with
14        receptor spacing no greater than every 50 meters
15        starting from the building walls of the source
16        extending out to a distance of at least one-half
17        kilometer, then every 100 meters extending out to a
18        distance of at least one kilometer.
19        (2) The owner or operator of the ethylene oxide
20    sterilization source shall submit revised results of all
21    modeling if the Agency accepts with conditions or declines
22    to accept the results submitted.
23    (g) A facility permitted to emit ethylene oxide that has
24been subject to a seal order under Section 34 is prohibited
25from using ethylene oxide for sterilization or fumigation
26purposes, unless (i) the facility can provide a certification

 

 

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

 

 

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1use of ethylene oxide, that entity, parent, or subsidiary shall
2notify the Agency of the acquisition within 30 days of
3acquiring it. If that entity, parent, or subsidiary has not
4used the sterilization technology within 3 years of its
5acquisition, the entity shall notify the Agency within 30 days
6of the 3-year period elapsing.
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 that has any intellectual property right in any
10sterilization technology that does not involve the use of
11ethylene oxide shall notify the Agency of any offers that it
12makes to license or otherwise allow the technology to be used
13by third parties within 30 days of making the offer.
14    An entity, or any parent or subsidiary of an entity, that
15owns or operates a facility permitted by the Agency to emit
16ethylene oxide shall provide the Agency with a list of all U.S.
17patent registrations for sterilization technology that the
18entity, parent, or subsidiary has any property right in. The
19list shall include the following:
20        (1) The patent number assigned by the United States
21    Patent and Trademark Office for each patent.
22        (2) The date each patent was filed.
23        (3) The names and addresses of all owners or assignees
24    of each patent.
25        (4) The names and addresses of all inventors of each
26    patent.

 

 

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1    (i) If a CAAPP permit applicant applies to use ethylene
2oxide as a sterilant or fumigant at a facility not in existence
3prior to January 1, 2020, the Agency shall issue a CAAPP permit
4for emission of ethylene oxide only if:
5        (1) the nearest school or park is at least 10 miles
6    from the permit applicant in counties with populations
7    greater than 50,000;
8        (2) the nearest school or park is at least 15 miles
9    from the permit applicant in counties with populations less
10    than or equal to 50,000; and
11        (3) within 7 days after the application for a CAAPP
12    permit, the permit applicant has published its permit
13    request on its website, published notice in a local
14    newspaper of general circulation, and provided notice to:
15            (A) the State Representative for the
16        representative district in which the facility is
17        located;
18            (B) the State Senator for the legislative district
19        in which the facility is located;
20            (C) the members of the county board for the county
21        in which the facility is located; and
22            (D) the local municipal board members and
23        executives.
24    (j) The owner or operator of an ethylene oxide
25sterilization source must apply for and obtain a construction
26permit from the Agency for any modifications made to the source

 

 

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1to comply with the requirements of this amendatory Act of the
2101st General Assembly, including, but not limited to,
3installation of a permanent total enclosure, modification of
4airflow to create negative pressure within the source, and
5addition of one or more control devices. Additionally, the
6owner or operator of the ethylene oxide sterilization source
7must apply for and obtain from the Agency a modification of the
8source's operating permit to incorporate such modifications
9made to the source. Both the construction permit and operating
10permit must include a limit on ethylene oxide usage at the
11source.
12    (k) Nothing in this Section shall be interpreted to excuse
13the ethylene oxide sterilization source from complying with any
14applicable local requirements.
15    (l) The owner or operator of an ethylene oxide
16sterilization source must notify the Agency within 5 days after
17discovering any deviation from any of the requirements in this
18Section or deviations from any applicable requirements
19concerning ethylene oxide that are set forth in this Act,
20United States Environmental Protection Agency rules, or Board
21rules. As soon as practicable, but no later than 5 business
22days, after the Agency receives such notification, the Agency
23must post a notice on its website and notify the members of the
24General Assembly from the Legislative and Representative
25Districts in which the source in question is located, the
26county board members of the county in which the source in

 

 

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1question is located, the corporate authorities of the
2municipality in which the source in question is located, and
3the Illinois Department of Public Health.
4    (m) The Agency must conduct at least one unannounced
5inspection of all ethylene oxide sterilization sources subject
6to this Section per year. Nothing in this Section shall limit
7the Agency's authority under other provisions of this Act to
8conduct inspections of ethylene oxide sterilization sources.
9    (n) The Agency shall conduct air testing to determine the
10ambient levels of ethylene oxide throughout the State. The
11Agency shall, within 180 days after the effective date of this
12amendatory Act of the 101st General Assembly, submit rules for
13ambient air testing of ethylene oxide to the Board.
 
14    Section 99. Effective date. This Act takes effect upon
15becoming law.".