Public Act 101-0022
 
SB1852 EnrolledLRB101 09550 CPF 54648 b

    AN ACT concerning safety.
 
    Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
 
    Section 1. Short Title. This Act may be referred to as the
Matt Haller Act.
 
    Section 5. The Environmental Protection Act is amended by
adding Section 9.16 as follows:
 
    (415 ILCS 5/9.16 new)
    Sec. 9.16. Control of ethylene oxide sterilization
sources.
    (a) As used in this Section:
    "Ethylene oxide sterilization operations" means the
process of using ethylene oxide at an ethylene oxide
sterilization source to make one or more items free from
microorganisms, pathogens, or both microorganisms and
pathogens.
    "Ethylene oxide sterilization source" means any stationary
source with ethylene oxide usage that would subject it to the
emissions standards in 40 CFR 63.362. "Ethylene oxide
sterilization source" does not include beehive fumigators,
research or laboratory facilities, hospitals, doctors'
offices, clinics, or other stationary sources for which the
primary purpose is to provide medical services to humans or
animals.
    "Exhaust point" means any point through which ethylene
oxide-laden air exits an ethylene oxide sterilization source.
    "Stationary source" has the meaning set forth in subsection
1 of Section 39.5.
    (b) Beginning 180 days after the effective date of this
amendatory Act of the 101st General Assembly, no person shall
conduct ethylene oxide sterilization operations, unless the
ethylene oxide sterilization source captures, and demonstrates
that it captures, 100% of all ethylene oxide emissions and
reduces ethylene oxide emissions to the atmosphere from each
exhaust point at the ethylene oxide sterilization source by at
least 99.9% or to 0.2 parts per million.
        (1) Within 180 days after the effective date of this
    amendatory Act of the 101st General Assembly for any
    existing ethylene oxide sterilization source, or prior to
    any ethylene oxide sterilization operation for any source
    that first becomes subject to regulation after the
    effective date of this amendatory Act of the 101st General
    Assembly as an ethylene oxide sterilization source under
    this Section, the owner or operator of the ethylene oxide
    sterilization source shall conduct an initial emissions
    test in accordance with all of the requirements set forth
    in this paragraph (1) to verify that ethylene oxide
    emissions to the atmosphere from each exhaust point at the
    ethylene oxide sterilization source have been reduced by at
    least 99.9% or to 0.2 parts per million:
            (A) At least 30 days prior to the scheduled
        emissions test date, the owner or operator of the
        ethylene oxide sterilization source shall submit a
        notification of the scheduled emissions test date and a
        copy of the proposed emissions test protocol to the
        Agency for review and written approval. Emissions test
        protocols submitted to the Agency shall address the
        manner in which testing will be conducted, including,
        but not limited to:
                (i) the name of the independent third party
            company that will be performing sampling and
            analysis and the company's experience with similar
            emissions tests;
                (ii) the methodologies to be used;
                (iii) the conditions under which emissions
            tests will be performed, including a discussion of
            why these conditions will be representative of
            maximum emissions from each of the 3 cycles of
            operation (chamber evacuation, back vent, and
            aeration) and the means by which the operating
            parameters for the emission unit and any control
            equipment will be determined;
                (iv) the specific determinations of emissions
            and operations that are intended to be made,
            including sampling and monitoring locations; and
                (v) any changes to the test method or methods
            proposed to accommodate the specific circumstances
            of testing, with justification.
            (B) The owner or operator of the ethylene oxide
        sterilization source shall perform emissions testing
        in accordance with an Agency-approved test protocol
        and at representative conditions to verify that
        ethylene oxide emissions to the atmosphere from each
        exhaust point at the ethylene oxide sterilization
        source have been reduced by at least 99.9% or to 0.2
        parts per million. The duration of the test must
        incorporate all 3 cycles of operation for
        determination of the emission reduction efficiency.
            (C) Upon Agency approval of the test protocol, any
        source that first becomes subject to regulation after
        the effective date of this amendatory Act of the 101st
        General Assembly as an ethylene oxide sterilization
        source under this Section may undertake ethylene oxide
        sterilization operations in accordance with the
        Agency-approved test protocol for the sole purpose of
        demonstrating compliance with this subsection (b).
            (D) The owner or operator of the ethylene oxide
        sterilization source shall submit to the Agency the
        results of any and all emissions testing conducted
        after the effective date of this amendatory Act of the
        101st General Assembly, until the Agency accepts
        testing results under subparagraph (E) of paragraph
        (1) of this subsection (b), for any existing source or
        prior to any ethylene oxide sterilization operation
        for any source that first becomes subject to regulation
        after the effective date of this amendatory Act of the
        101st General Assembly as an ethylene oxide
        sterilization source under this Section. The results
        documentation shall include at a minimum:
                (i) a summary of results;
                (ii) a description of test method or methods,
            including description of sample points, sampling
            train, analysis equipment, and test schedule;
                (iii) a detailed description of test
            conditions, including process information and
            control equipment information; and
                (iv) data and calculations, including copies
            of all raw data sheets, opacity observation
            records and records of laboratory analyses, sample
            calculations, and equipment calibration.
            (E) Within 30 days of receipt, the Agency shall
        accept, accept with conditions, or decline to accept a
        stack testing protocol and the testing results
        submitted to demonstrate compliance with paragraph (1)
        of this subsection (b). If the Agency accepts with
        conditions or declines to accept the results
        submitted, the owner or operator of the ethylene oxide
        sterilization source shall submit revised results of
        the emissions testing or conduct emissions testing
        again. If the owner or operator revises the results,
        the revised results shall be submitted within 15 days
        after the owner or operator of the ethylene oxide
        sterilization source receives written notice of the
        Agency's conditional acceptance or rejection of the
        emissions testing results. If the owner or operator
        conducts emissions testing again, such new emissions
        testing shall conform to the requirements of this
        subsection (b).
        (2) The owner or operator of the ethylene oxide
    sterilization source shall conduct emissions testing on
    all exhaust points at the ethylene oxide sterilization
    source at least once each calendar year to demonstrate
    compliance with the requirements of this Section and any
    applicable requirements concerning ethylene oxide that are
    set forth in either United States Environmental Protection
    Agency rules or Board rules. Annual emissions tests
    required under this paragraph (2) shall take place at least
    6 months apart. An initial emissions test conducted under
    paragraph (1) of this subsection (b) satisfies the testing
    requirement of this paragraph (2) for the calendar year in
    which the initial emissions test is conducted.
        (3) At least 30 days before conducting the annual
    emissions test required under paragraph (2) of this
    subsection (b), the owner or operator shall submit a
    notification of the scheduled emissions test date and a
    copy of the proposed emissions test protocol to the Agency
    for review and written approval. Emissions test protocols
    submitted to the Agency under this paragraph (3) must
    address each item listed in subparagraph (A) of paragraph
    (1) of this subsection (b). Emissions testing shall be
    performed in accordance with an Agency-approved test
    protocol and at representative conditions. In addition, as
    soon as practicable, but no later than 30 days after the
    emissions test date, the owner or operator shall submit to
    the Agency the results of the emissions testing required
    under paragraph (2) of this subsection (b). Such results
    must include each item listed in subparagraph (D) of
    paragraph (1) of this subsection (b).
        (4) If the owner or operator of an ethylene oxide
    sterilization source conducts any emissions testing in
    addition to tests required by this amendatory Act of the
    101st General Assembly, the owner or operator shall submit
    to the Agency the results of such emissions testing within
    30 days after the emissions test date.
        (5) The Agency shall accept, accept with conditions, or
    decline to accept testing results submitted to demonstrate
    compliance with paragraph (2) of this subsection (b). If
    the Agency accepts with conditions or declines to accept
    the results submitted, the owner or operator of the
    ethylene oxide sterilization source shall submit revised
    results of the emissions testing or conduct emissions
    testing again. If the owner or operator revises the
    results, the revised results shall be submitted within 15
    days after the owner or operator of the ethylene oxide
    sterilization source receives written notice of the
    Agency's conditional acceptance or rejection of the
    emissions testing results. If the owner or operator
    conducts emissions testing again, such new emissions
    testing shall conform to the requirements of this
    subsection (b).
    (c) If any emissions test conducted more than 180 days
after the effective date of this amendatory Act of the 101st
General Assembly fails to demonstrate that ethylene oxide
emissions to the atmosphere from each exhaust point at the
ethylene oxide sterilization source have been reduced by at
least 99.9% or to 0.2 parts per million, the owner or operator
of the ethylene oxide sterilization source shall immediately
cease ethylene oxide sterilization operations and notify the
Agency within 24 hours of becoming aware of the failed
emissions test. Within 60 days after the date of the test, the
owner or operator of the ethylene oxide sterilization source
shall:
        (1) complete an analysis to determine the root cause of
    the failed emissions test;
        (2) take any actions necessary to address that root
    cause;
        (3) submit a report to the Agency describing the
    findings of the root cause analysis, any work undertaken to
    address findings of the root cause analysis, and
    identifying any feasible best management practices to
    enhance capture and further reduce ethylene oxide levels
    within the ethylene oxide sterilization source, including
    a schedule for implementing such practices; and
        (4) upon approval by the Agency of the report required
    by paragraph (3) of this subsection, restart ethylene oxide
    sterilization operations only to the extent necessary to
    conduct additional emissions test or tests. The ethylene
    oxide sterilization source shall conduct such emissions
    test or tests under the same requirements as the annual
    test described in paragraphs (2) and (3) of subsection (b).
    The ethylene oxide sterilization source may restart
    operations once an emissions test successfully
    demonstrates that ethylene oxide emissions to the
    atmosphere from each exhaust point at the ethylene oxide
    sterilization source have been reduced by at least 99.9% or
    to 0.2 parts per million, the source has submitted the
    results of all emissions testing conducted under this
    subsection to the Agency, and the Agency has approved the
    results demonstrating compliance.
    (d) Beginning 180 days after the effective date of this
amendatory Act of the 101st General Assembly for any existing
source or prior to any ethylene oxide sterilization operation
for any source that first becomes subject to regulation after
the effective date of this amendatory Act of the 101st General
Assembly as an ethylene oxide sterilization source under this
Section, no person shall conduct ethylene oxide sterilization
operations unless the owner or operator of the ethylene oxide
sterilization source submits for review and approval by the
Agency a plan describing how the owner or operator will
continuously collect emissions information at the ethylene
oxide sterilization source. This plan must also specify
locations at the ethylene oxide sterilization source from which
emissions will be collected and identify equipment used for
collection and analysis, including the individual system
components.
        (1) The owner or operator of the ethylene oxide
    sterilization source must provide a notice of acceptance of
    any conditions added by the Agency to the plan, or correct
    any deficiencies identified by the Agency in the plan,
    within 3 business days after receiving the Agency's
    conditional acceptance or denial of the plan.
        (2) Upon the Agency's approval of the plan, the owner
    or operator of the ethylene oxide sterilization source
    shall implement the plan in accordance with its approved
    terms.
    (e) Beginning 180 days after the effective date of this
amendatory Act of the 101st General Assembly for any existing
source or prior to any ethylene oxide sterilization operation
for any source that first becomes subject to regulation after
the effective date of this amendatory Act of the 101st General
Assembly as an ethylene oxide sterilization source under this
Section, no person shall conduct ethylene oxide sterilization
operations unless the owner or operator of the ethylene oxide
sterilization source submits for review and approval by the
Agency an Ambient Air Monitoring Plan.
        (1) The Ambient Air Monitoring Plan shall include, at a
    minimum, the following:
            (A) Detailed plans to collect and analyze air
        samples for ethylene oxide on at least a quarterly
        basis near the property boundaries of the ethylene
        oxide sterilization source and at community locations
        with the highest modeled impact pursuant to the
        modeling conducted under subsection (f). Each
        quarterly sampling under this subsection shall be
        conducted over a multiple-day sampling period.
            (B) A schedule for implementation.
            (C) The name of the independent third party company
        that will be performing sampling and analysis and the
        company's experience with similar testing.
        (2) The owner or operator of the ethylene oxide
    sterilization source must provide a notice of acceptance of
    any conditions added by the Agency to the Ambient Air
    Monitoring Plan, or correct any deficiencies identified by
    the Agency in the Ambient Air Monitoring Plan, within 3
    business days after receiving the Agency's conditional
    acceptance or denial of the plan.
        (3) Upon the Agency's approval of the plan, the owner
    or operator of the ethylene oxide sterilization source
    shall implement the Ambient Air Monitoring Plan in
    accordance with its approved terms.
    (f) Beginning 180 days after the effective date of this
amendatory Act of the 101st General Assembly for any existing
source or prior to any ethylene oxide sterilization operation
for any source that first becomes subject to regulation after
the effective date of this amendatory Act of the 101st General
Assembly as an ethylene oxide sterilization source under this
Section, no person shall conduct ethylene oxide sterilization
operations unless the owner or operator of the ethylene oxide
sterilization source has performed dispersion modeling and the
Agency approves such modeling.
        (1) Dispersion modeling must:
            (A) be conducted using accepted United States
        Environmental Protection Agency methodologies,
        including 40 CFR Part 51, Appendix W, except that no
        background ambient levels of ethylene oxide shall be
        used;
            (B) use emissions and stack parameter data from the
        emissions test conducted in accordance with paragraph
        (1) of subsection (b), and use 5 years of hourly
        meteorological data that is representative of the
        source's location; and
            (C) use a receptor grid that extends to at least
        one kilometer around the source and ensure the modeling
        domain includes the area of maximum impact, with
        receptor spacing no greater than every 50 meters
        starting from the building walls of the source
        extending out to a distance of at least one-half
        kilometer, then every 100 meters extending out to a
        distance of at least one kilometer.
        (2) The owner or operator of the ethylene oxide
    sterilization source shall submit revised results of all
    modeling if the Agency accepts with conditions or declines
    to accept the results submitted.
    (g) A facility permitted to emit ethylene oxide that has
been subject to a seal order under Section 34 is prohibited
from using ethylene oxide for sterilization or fumigation
purposes, unless (i) the facility can provide a certification
to the Agency by the supplier of a product to be sterilized or
fumigated that ethylene oxide sterilization or fumigation is
the only available method to completely sterilize or fumigate
the product and (ii) the Agency has certified that the
facility's emission control system uses technology that
produces the greatest reduction in ethylene oxide emissions
currently available. The certification shall be made by a
company representative with knowledge of the sterilization
requirements of the product. The certification requirements of
this Section shall apply to any group of products packaged
together and sterilized as a single product if sterilization or
fumigation is the only available method to completely sterilize
or fumigate more than half of the individual products contained
in the package.
    A facility is not subject to the requirements of this
subsection if the supporting findings of the seal order under
Section 34 are found to be without merit by a court of
competent jurisdiction.
    (h) If an entity, or any parent or subsidiary of an entity,
that owns or operates a facility permitted by the Agency to
emit ethylene oxide acquires by purchase, license, or any other
method of acquisition any intellectual property right in a
sterilization technology that does not involve the use of
ethylene oxide, or by purchase, merger, or any other method of
acquisition of any entity that holds an intellectual property
right in a sterilization technology that does not involve the
use of ethylene oxide, that entity, parent, or subsidiary shall
notify the Agency of the acquisition within 30 days of
acquiring it. If that entity, parent, or subsidiary has not
used the sterilization technology within 3 years of its
acquisition, the entity shall notify the Agency within 30 days
of the 3-year period elapsing.
    An entity, or any parent or subsidiary of an entity, that
owns or operates a facility permitted by the Agency to emit
ethylene oxide that has any intellectual property right in any
sterilization technology that does not involve the use of
ethylene oxide shall notify the Agency of any offers that it
makes to license or otherwise allow the technology to be used
by third parties within 30 days of making the offer.
    An entity, or any parent or subsidiary of an entity, that
owns or operates a facility permitted by the Agency to emit
ethylene oxide shall provide the Agency with a list of all U.S.
patent registrations for sterilization technology that the
entity, parent, or subsidiary has any property right in. The
list shall include the following:
        (1) The patent number assigned by the United States
    Patent and Trademark Office for each patent.
        (2) The date each patent was filed.
        (3) The names and addresses of all owners or assignees
    of each patent.
        (4) The names and addresses of all inventors of each
    patent.
    (i) If a CAAPP permit applicant applies to use ethylene
oxide as a sterilant or fumigant at a facility not in existence
prior to January 1, 2020, the Agency shall issue a CAAPP permit
for emission of ethylene oxide only if:
        (1) the nearest school or park is at least 10 miles
    from the permit applicant in counties with populations
    greater than 50,000;
        (2) the nearest school or park is at least 15 miles
    from the permit applicant in counties with populations less
    than or equal to 50,000; and
        (3) within 7 days after the application for a CAAPP
    permit, the permit applicant has published its permit
    request on its website, published notice in a local
    newspaper of general circulation, and provided notice to:
            (A) the State Representative for the
        representative district in which the facility is
        located;
            (B) the State Senator for the legislative district
        in which the facility is located;
            (C) the members of the county board for the county
        in which the facility is located; and
            (D) the local municipal board members and
        executives.
    (j) The owner or operator of an ethylene oxide
sterilization source must apply for and obtain a construction
permit from the Agency for any modifications made to the source
to comply with the requirements of this amendatory Act of the
101st General Assembly, including, but not limited to,
installation of a permanent total enclosure, modification of
airflow to create negative pressure within the source, and
addition of one or more control devices. Additionally, the
owner or operator of the ethylene oxide sterilization source
must apply for and obtain from the Agency a modification of the
source's operating permit to incorporate such modifications
made to the source. Both the construction permit and operating
permit must include a limit on ethylene oxide usage at the
source.
    (k) Nothing in this Section shall be interpreted to excuse
the ethylene oxide sterilization source from complying with any
applicable local requirements.
    (l) The owner or operator of an ethylene oxide
sterilization source must notify the Agency within 5 days after
discovering any deviation from any of the requirements in this
Section or deviations from any applicable requirements
concerning ethylene oxide that are set forth in this Act,
United States Environmental Protection Agency rules, or Board
rules. As soon as practicable, but no later than 5 business
days, after the Agency receives such notification, the Agency
must post a notice on its website and notify the members of the
General Assembly from the Legislative and Representative
Districts in which the source in question is located, the
county board members of the county in which the source in
question is located, the corporate authorities of the
municipality in which the source in question is located, and
the Illinois Department of Public Health.
    (m) The Agency must conduct at least one unannounced
inspection of all ethylene oxide sterilization sources subject
to this Section per year. Nothing in this Section shall limit
the Agency's authority under other provisions of this Act to
conduct inspections of ethylene oxide sterilization sources.
    (n) The Agency shall conduct air testing to determine the
ambient levels of ethylene oxide throughout the State. The
Agency shall, within 180 days after the effective date of this
amendatory Act of the 101st General Assembly, submit rules for
ambient air testing of ethylene oxide to the Board.
 
    Section 99. Effective date. This Act takes effect upon
becoming law.