101ST GENERAL ASSEMBLY
State of Illinois
2019 and 2020
HB3885

 

Introduced , by Rep. Jim Durkin

 

SYNOPSIS AS INTRODUCED:
 
415 ILCS 5/9.16

    Amends the Environmental Protection Act. Provides that nothing within provisions regarding the control of ethylene oxide sterilization sources shall limit the ability of a home rule unit of local government to adopt an ordinance that imposes additional operating restrictions upon or prohibits ethylene oxide sterilization operations of a facility that is located within the boundaries of the home rule unit of local government and is permitted to emit ethylene oxide. Effective immediately.


LRB101 13376 CPF 63059 b

 

 

A BILL FOR

 

HB3885LRB101 13376 CPF 63059 b

1    AN ACT concerning safety.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Environmental Protection Act is amended by
5changing Section 9.16, as added by Public Act 101-22, as
6follows:
 
7    (415 ILCS 5/9.16)
8    Sec. 9.16. Control of ethylene oxide sterilization
9sources.
10    (a) As used in this Section:
11    "Ethylene oxide sterilization operations" means the
12process of using ethylene oxide at an ethylene oxide
13sterilization source to make one or more items free from
14microorganisms, pathogens, or both microorganisms and
15pathogens.
16    "Ethylene oxide sterilization source" means any stationary
17source with ethylene oxide usage that would subject it to the
18emissions standards in 40 CFR 63.362. "Ethylene oxide
19sterilization source" does not include beehive fumigators,
20research or laboratory facilities, hospitals, doctors'
21offices, clinics, or other stationary sources for which the
22primary purpose is to provide medical services to humans or
23animals.

 

 

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1    "Exhaust point" means any point through which ethylene
2oxide-laden air exits an ethylene oxide sterilization source.
3    "Stationary source" has the meaning set forth in subsection
41 of Section 39.5.
5    (b) Beginning 180 days after the effective date of this
6amendatory Act of the 101st General Assembly, no person shall
7conduct ethylene oxide sterilization operations, unless the
8ethylene oxide sterilization source captures, and demonstrates
9that it captures, 100% of all ethylene oxide emissions and
10reduces ethylene oxide emissions to the atmosphere from each
11exhaust point at the ethylene oxide sterilization source by at
12least 99.9% or to 0.2 parts per million.
13        (1) Within 180 days after the effective date of this
14    amendatory Act of the 101st General Assembly for any
15    existing ethylene oxide sterilization source, or prior to
16    any ethylene oxide sterilization operation for any source
17    that first becomes subject to regulation after the
18    effective date of this amendatory Act of the 101st General
19    Assembly as an ethylene oxide sterilization source under
20    this Section, the owner or operator of the ethylene oxide
21    sterilization source shall conduct an initial emissions
22    test in accordance with all of the requirements set forth
23    in this paragraph (1) to verify that ethylene oxide
24    emissions to the atmosphere from each exhaust point at the
25    ethylene oxide sterilization source have been reduced by at
26    least 99.9% or to 0.2 parts per million:

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1        (3) submit a report to the Agency describing the
2    findings of the root cause analysis, any work undertaken to
3    address findings of the root cause analysis, and
4    identifying any feasible best management practices to
5    enhance capture and further reduce ethylene oxide levels
6    within the ethylene oxide sterilization source, including
7    a schedule for implementing such practices; and
8        (4) upon approval by the Agency of the report required
9    by paragraph (3) of this subsection, restart ethylene oxide
10    sterilization operations only to the extent necessary to
11    conduct additional emissions test or tests. The ethylene
12    oxide sterilization source shall conduct such emissions
13    test or tests under the same requirements as the annual
14    test described in paragraphs (2) and (3) of subsection (b).
15    The ethylene oxide sterilization source may restart
16    operations once an emissions test successfully
17    demonstrates that ethylene oxide emissions to the
18    atmosphere from each exhaust point at the ethylene oxide
19    sterilization source have been reduced by at least 99.9% or
20    to 0.2 parts per million, the source has submitted the
21    results of all emissions testing conducted under this
22    subsection to the Agency, and the Agency has approved the
23    results demonstrating compliance.
24    (d) Beginning 180 days after the effective date of this
25amendatory Act of the 101st General Assembly for any existing
26source or prior to any ethylene oxide sterilization operation

 

 

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

 

 

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

 

 

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1    business days after receiving the Agency's conditional
2    acceptance or denial of the plan.
3        (3) Upon the Agency's approval of the plan, the owner
4    or operator of the ethylene oxide sterilization source
5    shall implement the Ambient Air Monitoring Plan in
6    accordance with its approved terms.
7    (f) 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 has performed dispersion modeling and the
16Agency approves such modeling.
17        (1) Dispersion modeling must:
18            (A) be conducted using accepted United States
19        Environmental Protection Agency methodologies,
20        including 40 CFR Part 51, Appendix W, except that no
21        background ambient levels of ethylene oxide shall be
22        used;
23            (B) use emissions and stack parameter data from the
24        emissions test conducted in accordance with paragraph
25        (1) of subsection (b), and use 5 years of hourly
26        meteorological data that is representative of the

 

 

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

 

 

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

 

 

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

 

 

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1    than or equal to 50,000; and
2        (3) within 7 days after the application for a CAAPP
3    permit, the permit applicant has published its permit
4    request on its website, published notice in a local
5    newspaper of general circulation, and provided notice to:
6            (A) the State Representative for the
7        representative district in which the facility is
8        located;
9            (B) the State Senator for the legislative district
10        in which the facility is located;
11            (C) the members of the county board for the county
12        in which the facility is located; and
13            (D) the local municipal board members and
14        executives.
15    (j) The owner or operator of an ethylene oxide
16sterilization source must apply for and obtain a construction
17permit from the Agency for any modifications made to the source
18to comply with the requirements of this amendatory Act of the
19101st General Assembly, including, but not limited to,
20installation of a permanent total enclosure, modification of
21airflow to create negative pressure within the source, and
22addition of one or more control devices. Additionally, the
23owner or operator of the ethylene oxide sterilization source
24must apply for and obtain from the Agency a modification of the
25source's operating permit to incorporate such modifications
26made to the source. Both the construction permit and operating

 

 

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

 

 

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1ambient levels of ethylene oxide throughout the State. The
2Agency shall, within 180 days after the effective date of this
3amendatory Act of the 101st General Assembly, submit rules for
4ambient air testing of ethylene oxide to the Board.
5    (o) Nothing in this Section shall limit the ability of a
6home rule unit of local government to adopt an ordinance that
7imposes additional operating restrictions upon or prohibits
8ethylene oxide sterilization operations of a facility that is
9located within the boundaries of the home rule unit of local
10government and is permitted to emit ethylene oxide.
11(Source: P.A. 101-22, eff. 6-21-19.)
 
12    Section 99. Effective date. This Act takes effect upon
13becoming law.