101ST GENERAL ASSEMBLY
State of Illinois
2019 and 2020
SB2264

 

Introduced 10/28/2019, by Sen. John F. Curran

 

SYNOPSIS AS INTRODUCED:
 
415 ILCS 5/9.18 new

    Amends the Environmental Protection Act. Provides that by January 1, 2021 ethylene oxide shall only be used to sterilize medical products, and only if the Environmental Protection Agency determines that there is no substitute sterilization technology available for sterilizing a particular medical product. Prohibits the Agency from accepting permit applications for the use of ethylene oxide unless the application is for the use of ethylene oxide for the sterilization of medical products. Requires the Agency to prohibit all uses of ethylene oxide that require a CAAPP permit by January 1, 2022. Effective immediately.


LRB101 13323 CPF 62165 b

 

 

A BILL FOR

 

SB2264LRB101 13323 CPF 62165 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
5adding Section 9.18 as follows:
 
6    (415 ILCS 5/9.18 new)
7    Sec. 9.18. Emissions standards, regulations, and notice
8for facilities emitting ethylene oxide.
9    (a) The General Assembly finds that the emission of
10ethylene oxide constitutes a threat to public health and
11welfare, depresses property values, and diminishes quality of
12life. It is the purpose of this Section to restore, maintain,
13and enhance the purity of the air of this State in order to
14protect health, welfare, and quality of life and to assure that
15no air contaminants are discharged into the atmosphere without
16being given the degree of treatment or control necessary.
17    (b) Except as otherwise provided in this subsection, on and
18after January 1, 2021 the use of ethylene oxide requiring a
19CAAPP permit shall be limited to the sterilization of medical
20products. If the Agency determines, based on the best
21scientific evidence, that there is no substitute sterilization
22technology available for sterilizing a particular medical
23product, then ethylene oxide may be used for that medical

 

 

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1product. This subsection shall apply to any group of products
2packaged together and sterilized as a single product if
3sterilization or fumigation is the only available method to
4completely sterilize or fumigate more than half of the
5individual products contained in the package. Cost shall not be
6considered in this determination. If the Agency determines
7there is a substitute technology for a particular medical
8product or half or more of the individual products in a
9package, then the Agency shall prohibit all use of ethylene
10oxide for that medical product or package of medical products.
11        (1) "Substitute sterilization technology" means a
12    method of sterilization for a particular medical product
13    that does not use ethylene oxide and is capable of
14    sterilizing that medical product.
15        (2) In determining whether a substitute sterilization
16    technology exists, the Agency shall make the determination
17    based upon a review of the products for which CAAPP permit
18    applicants have applied to use ethylene oxide. The Agency
19    may consider factors such as whether a potential substitute
20    sterilization technology adequately eliminates, removes,
21    kills, or deactivates all forms of life and other
22    biological agents from a medical product and whether a
23    potential substitute sterilization technology is able to
24    adequately sterilize a medical product without damaging
25    the product. The Agency may rely on federal Food and Drug
26    Administration guidance in making its determination under

 

 

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1    this subsection.
2        (3) The Agency may issue regulations, emissions
3    standards, or permit conditions that state which medical
4    products or classes of medical products have substitute
5    sterilization technologies.
6        (4) If the Agency determines a substitute
7    sterilization technology exists for every use of ethylene
8    oxide, the Agency shall prohibit all uses of ethylene
9    oxide.
10    On and after the effective date of this amendatory Act of
11the 101st General Assembly, the Agency shall not accept permit
12applications for the use of ethylene oxide unless the
13application is for the use of ethylene oxide for the
14sterilization of medical products as provided under this
15subsection.
16    The Agency shall prohibit all uses of ethylene oxide that
17require a CAAPP permit by January 1, 2022.
18    (c) On and after January 1, 2021, the use of ethylene oxide
19requiring a CAAPP permit in a manner that results in the
20emission of ethylene oxide for purposes other than
21sterilization of medical products is a violation of this Act.
22The Agency shall immediately notify all CAAPP permit holders
23permitted to use ethylene oxide of this deadline. The Agency
24shall have the authority to adopt rules, in accordance with the
25Illinois Administrative Procedure Act, as the Agency deems
26necessary, to implement this subsection.
 

 

 

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1    Section 99. Effective date. This Act takes effect upon
2becoming law.