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| Public Act 101-0022
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| SB1852 Enrolled | LRB101 09550 CPF 54648 b |
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AN ACT concerning safety.
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Be it enacted by the People of the State of Illinois,
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represented in the General Assembly:
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Section 1. Short Title. This Act may be referred to as the |
Matt Haller Act.
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Section 5. The Environmental Protection Act is amended by |
adding Section 9.16 as follows:
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(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 |
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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 |
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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, |
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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 |
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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 |
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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 |
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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 |
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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; |
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(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 |
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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 |
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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 |
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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 |
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(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 |
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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 |
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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; |
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(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 |
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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 |
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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.
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Section 99. Effective date. This Act takes effect upon |
becoming law.
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