Illinois General Assembly - Full Text of HB0349
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Full Text of HB0349  101st General Assembly

HB0349 101ST GENERAL ASSEMBLY

  
  

 


 
101ST GENERAL ASSEMBLY
State of Illinois
2019 and 2020
HB0349

 

Introduced , by Rep. Kelly M. Cassidy

 

SYNOPSIS AS INTRODUCED:
 
New Act

    Creates the Drug and Sharps Waste Stewardship Act. Directs the Environmental Protection Agency to administer a drug and sharps waste stewardship program. Provides that the State Board of Pharmacy is to guide and advise the Agency in its administration of the program. Requires covered entities to provide lists of covered and not covered products to the State Board and to implement stewardship plans. Requires stewardship plans to be submitted to the Agency for review and acceptance. Requires that all counties have at least one collection site for unused drugs and sharps per 50,000 people, and no fewer than 5 such collection sites. Requires counties that do not have the necessary number of collection sites to establish a mail-back program, or alternative collection program for covered products, or both. Imposes an administrative fee on covered entities. Provides penalties for covered entities that fail to comply with the provisions of the Act. Creates the Drug and Sharps Stewardship Fund and the Drug and Sharps Stewardship Penalty Account within the Fund. Directs the Agency to post lists of compliant covered entities on its website. Exempts stewardship programs already in existence under local ordinances at the time the Act takes effect from the Act's provisions, but provides that those entities with programs that are not within the Act's purview are not to receive any monetary support from the Drug and Sharps Stewardship Fund or the Drug and Sharps Stewardship Penalty Account. Exempts confidential proprietary information from public disclosure by the Agency.


LRB101 00244 CPF 45248 b

FISCAL NOTE ACT MAY APPLY
HOME RULE NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB0349LRB101 00244 CPF 45248 b

1    AN ACT concerning safety.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4
Article 1. Short Title; Definitions

 
5    Section 1-1. Short title. This Act may be cited as the Drug
6and Sharps Waste Stewardship Act.
 
7    Section 1-5. Definitions. In this Act:
8    "Agency" means the Illinois Environmental Protection
9Agency.
10    "Authorized collection site" means a location where an
11authorized collector operates a secure collection receptacle
12for collecting covered products.
13    "Authorized collector" means a person or entity that has
14entered into an agreement with a program operator to collect
15covered drugs, including, but not limited to, any of the
16following:
17        (1) A person or entity that is registered with the
18    United States Drug Enforcement Administration and that
19    qualifies under federal law to modify that registration to
20    collect controlled substances for the purpose of
21    destruction.
22        (2) A law enforcement agency.

 

 

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1        (3) A retail pharmacy that offers drug take-back
2    services in compliance with subpart 205 of part 889 of
3    title 35 of the Illinois Administrative Code.
4    "Controlled substance" means a substance listed under the
5Illinois Controlled Substances Act or Section 812 or 813 of
6Title 21 of the United States Code.
7    "Cosmetic" has the meaning provided in Section 2 of the
8Illinois Food, Drug and Cosmetic Act.
9    "Covered drug" means a drug, including a brand name or
10generic drug, sold, offered for sale, or dispensed in the State
11of Illinois in any form, including, but not limited to, any of
12the following:
13        (1) Prescription and nonprescription drugs approved by
14    the United States Food and Drug Administration under
15    Section 505 of the Federal Food, Drug, and Cosmetic Act (21
16    U.S.C. 355) or Section 351 of the federal Public Health
17    Service Act (42 U.S.C. 262).
18        (2) A drug marketed pursuant to an over-the-counter
19    drug monograph.
20        (3) A drug in a medical device, or a combination
21    product containing a drug and a medical device.
22    "Covered drug" does not include any of the following:
23        (1) Vitamins or supplements.
24        (2) Herbal-based remedies and homeopathic drugs,
25    products, or remedies.
26        (3) Cosmetics, soap with or without germicidal agents,

 

 

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1    laundry detergent, bleach, household cleaning products,
2    shampoos, sunscreens, toothpaste, lip balm,
3    antiperspirants, or any other personal care product that is
4    regulated as both a cosmetic and a nonprescription drug
5    under the Federal Food, Drug, and Cosmetic Act.
6        (4) A drug for which a pharmaceutical product
7    stewardship program or drug take-back program is provided
8    in the State as part of a United States Food and Drug
9    Administration managed risk evaluation and mitigation
10    strategy under 21 U.S.C. 355-1.
11        (5) Biological drug products, as defined by 42 U.S.C.
12    262(i)(1), including those products currently approved in
13    the State under a new drug application that will be deemed
14    to be licensed under Section 351 of the Public Health
15    Service Act (42 U.S.C. 262) pursuant to Section 7002(e) of
16    the federal Biologics Price Competition and Innovation Act
17    of 2009 (Public Law 111-148).
18        (6) A medical device, or a component part or accessory
19    of a medical device, if it does not contain a covered drug.
20        (7) Drugs that are used for animal medicines,
21    including, but not limited to, parasiticide products for
22    animals.
23        (8) Dialysate drugs or other saline solutions required
24    to perform kidney dialysis.
25    "Covered entity" means:
26        (1) The manufacturer of covered products that are sold

 

 

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1    in or into the State.
2        (2) If no entity that meets the definition in paragraph
3    (1) is located in the State, "covered entity" means the
4    distributor of covered products that are sold in or into
5    the State that is licensed as a wholesale drug distributor,
6    as defined in the Wholesale Drug Distribution Licensing
7    Act, but does not include a warehouse of a retail pharmacy
8    chain that is licensed as a wholesale drug distributor if
9    it engages only in intracompany transfers between any
10    division, affiliate, subsidiary, parent, or other entity
11    under complete common ownership and control.
12        (3) If no entity that meets the definitions in
13    paragraphs (1) or (2) is located in the State, "covered
14    entity" means any person or entity who repackages, as
15    defined in the Wholesale Drug Distribution Licensing Act,
16    covered products that are sold in or into the State.
17        (4) If no entity that meets the definitions in
18    paragraphs (1), (2), or (3) is located in the State,
19    "covered entity" means the owner or licensee of a trademark
20    or brand under which covered products are sold in or into
21    the State, regardless of whether the trademark is
22    registered.
23        (5) If no entity that meets the definitions in
24    paragraphs (1), (2), (3), or (4) is located in the State,
25    "covered entity" means the importer of the covered products
26    that are sold in or into the State.

 

 

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1    The Agency shall adopt regulations on the process for
2determining what entity is a covered entity following the
3priority order set forth in paragraphs (1) through (5).
4    "Covered product" means a covered drug or home-generated
5sharps waste.
6    "Distributor" means a wholesale drug distributor, as that
7term is defined in Wholesale Drug Distribution Licensing Act.
8    "Drug" means any of the following:
9        (1) An article recognized in the United States
10    Pharmacopoeia or the National Formulary published by the
11    United States Pharmacopoeia Convention, or the Homeopathic
12    Pharmacopoeia of the United States published by the
13    Homeopathic Pharmacopoeia Convention of the United States,
14    or any supplement of the Formulary or those Pharmacopoeiae.
15        (2) A substance intended for use in the diagnosis,
16    cure, mitigation, treatment, or prevention of disease in
17    humans or other animals.
18        (3) A substance, other than food, intended to affect
19    the structure or any function of the body of humans or
20    other animals.
21        (4) A substance intended for use as a component of any
22    substance specified in this subsection.
23    "Generic drug" means a drug that is chemically identical or
24bioequivalent to a brand name drug in dosage form, safety,
25strengths, route of administration, quality, performance,
26characteristics, and intended use, though inactive ingredients

 

 

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1may vary.
2    "Home-generated sharps waste" means hypodermic needles,
3pen needles, intravenous needles, lancets, and other devices
4that are used to penetrate the skin for the delivery of
5medications derived from a household, including a multifamily
6residence or household. "Home-generated sharps waste" does not
7include either of the following:
8        (1) Components manufactured for use with external
9    ambulatory insulin pump therapy systems or continuous
10    glucose monitoring systems, including, but not limited to,
11    insulin infusion sets, glucose sensors that are sterile
12    goods indicated for single subcutaneous use, sterile drug
13    delivery channels indicated for single subcutaneous use,
14    and injection ports.
15        (2) A biological product, as defined in Section
16    262(i)(1) of Title 42 of the United States Code, including
17    a combination product, as defined in Section 3.2(e) of
18    Title 21 of the Code of Federal Regulations.
19    "Mail-back program" means a method of collecting covered
20products from ultimate users by using prepaid, preaddressed
21mailing envelopes.
22    "Medical waste generator" means any person whose act or
23process produces medical waste and includes, but is not limited
24to, a provider of health care. All of the following are
25examples of businesses that generate medical waste:
26        (1) Medical and dental offices, clinics, hospitals,

 

 

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1    surgery centers, laboratories, research laboratories,
2    unlicensed health facilities, those facilities required to
3    be licensed, chronic dialysis clinics, and education and
4    research facilities.
5        (2) Veterinary offices, veterinary clinics, and
6    veterinary hospitals.
7        (3) Pet shops.
8        (4) Trauma scene waste management practitioners.
9    "Nonprescription drug" means any drug that may be lawfully
10sold without a prescription.
11    "Pharmacy" has the meaning provided in the Pharmacy
12Practice Act.
13    "Prescription drug" means a drug, including, but not
14limited to, a controlled substance, that is required under
15State or federal law to be dispensed with a prescription, or is
16restricted to use by practitioners only.
17    "Program operator" means a covered entity, or stewardship
18organization on behalf of a group of covered entities, that is
19responsible for operating a stewardship program in accordance
20with this Act.
21    "Proprietary information" means information that is all of
22the following:
23        (1) Submitted under this Act.
24        (2) A trade secret, or commercial or financial
25    information, that is privileged or confidential, and is
26    identified as such by the entity providing the information

 

 

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1    to the Agency.
2        (3) Not required to be disclosed under any other law or
3    any regulation affecting a covered product or covered
4    entity.
5    "Retail pharmacy" has the meaning provided for "pharmacy"
6in the Pharmacy Practice Act.
7    "Retail pharmacy chain" means a retail pharmacy with 5 or
8more stores in the State.
9    "Sharps" means hypodermic needles, pen needles,
10intravenous needles, lancets, and other devices that are used
11to penetrate the skin for the delivery of medications.
12    "State Board" means the Illinois State Board of Pharmacy.
13    "Stewardship organization" means an organization exempt
14from taxation under Section 501(c)(3) of the federal Internal
15Revenue Code of 1986 that is established by a group of covered
16entities in accordance with this Act to develop, implement, and
17administer a stewardship program established under this Act.
18    "Stewardship plan," or "plan" means the plan that is
19developed by a covered entity or stewardship organization under
20this Act for collecting and properly managing covered products.
21    "Stewardship program" means a stewardship program for the
22collection, transportation, and disposal of covered products.
23    "Ultimate user" means a State resident or other nonbusiness
24entity and includes a person who has lawfully obtained, and who
25possesses, a covered product, including a controlled
26substance, for his or her own use or for the use of a member of

 

 

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1his or her household. "Ultimate user" does not include a needle
2exchange program, or a medical waste generator as defined in
3this Act.
 
4
Article 5. Covered Entities and Stewardship Organizations

 
5    Section 5-1. Covered and noncovered products.
6    (a) No later than 90 days after the effective date of this
7Act, a covered entity shall provide to the State Board a list
8of covered products and a list and description of any drugs or
9sharps that are not covered products that it sells or offers
10for sale in the State.
11    A covered entity, or a stewardship organization on behalf
12of a group of covered entities, shall update the lists
13described in this subsection and provide the updated lists to
14the State Board on or before January 15 of each year or upon
15request by the Agency.
16    (b) No later than 90 days after the effective date of this
17Section, a retail pharmacy that sells a covered product under
18its own label shall provide written notification to the State
19Board identifying the covered entity from which the retail
20pharmacy obtains a covered product that the retail pharmacy
21sells under its store label.
22    (c) The State Board shall verify the information received
23under subsections (a) and (b) and make it available to the
24Agency upon request.

 

 

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1    (d) The State Board may issue a letter of inquiry to any
2covered entity, requesting a list of all drugs and sharps it
3distributes in Illinois, regardless of whether the drugs or
4sharps are covered under this Act, the name of the manufacturer
5of such products, and any additional information necessary to
6carry out this Act. An entity that is issued a letter of
7inquiry under this subsection shall respond in writing no later
8than 60 days after receipt of the letter. Responses to those
9inquiries may be shared with the Agency, but are otherwise
10deemed proprietary and exempt from disclosure. If the entity
11does not believe it is a covered entity for purposes of this
12Act, it shall submit all of the following to the State Board in
13response to the letter of inquiry:
14        (1) the basis for the claim that it is not a covered
15    entity;
16        (2) a list of any drugs and sharps it sells,
17    distributes, repackages, or otherwise offers for sale
18    within the State; and
19        (3) if applicable, the name and contact information of
20    the person or entity from which it obtains a drug or sharp
21    identified under paragraph (2).
22    (e) The State Board shall obtain and verify and, within 30
23days of receipt or upon request by the Agency, submit to the
24Agency a list of drugs and sharps sold or offered for sale in
25the State excluded from the definition of covered drugs or from
26the definition of home-generated sharps waste.

 

 

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1    (f) Notwithstanding Section 30-10, information submitted
2by the State Board to the Agency under this Act may include
3proprietary information.
4    (g) The State Board shall notify the Agency if any covered
5entity or stewardship organization is in violation of this
6Section for purposes of enforcement by the Agency.
 
7    Section 5-5. Implementation and administration.
8    (a) The Agency shall adopt regulations for the
9implementation of this Act with an effective date of no later
10than January 1, 2021.
11    (b) The State Board may adopt rules for the administration
12of the portions of this Act for which it has been given
13responsibility.
 
14    Section 5-10. Compliance.
15    (a) Except as specified in subsection (d) of Section 25-1,
16a covered entity is not in compliance with this Act and is
17subject to penalties under Article 25 if, commencing one year
18after the adoption of rules under Section 5-5, a covered
19product sold or offered for sale by the covered entity is not
20subject to an approved stewardship plan, which is submitted by
21the covered entity or by a stewardship organization that
22includes the covered entity, that has been approved by the
23Agency under Section 10-1.
24    (b) In order to comply with the requirements of this Act, a

 

 

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1covered entity may establish and implement a stewardship
2program independently, or as part of a group of covered
3entities through membership in a stewardship organization
4exempt from taxation under Section 501(c)(3) of the federal
5Internal Revenue Code of 1986.
 
6    Section 5-15. Education and outreach program.
7    (a) A program operator shall conduct a comprehensive
8education and outreach program intended to promote
9participation in the stewardship program. At a minimum, the
10education and outreach program shall do all of the following:
11        (1) promote its stewardship program to ultimate users
12    by providing signage for hospitals, pharmacies, and other
13    locations, as necessary;
14        (2) provide educational and outreach materials for
15    persons authorized to prescribe drugs, pharmacies,
16    pharmacists, ultimate users, and others, as necessary;
17        (3) establish a website that publicizes the location of
18    authorized collectors and provides other information
19    intended to promote the use of the stewardship program;
20        (4) prepare and provide additional outreach materials
21    not specified in this Section, as needed, to promote the
22    collection and proper management of covered drugs and
23    home-generated sharps waste; and
24        (5) encourage ultimate users to separate products that
25    are not covered products from covered products, when

 

 

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1    appropriate, before submitting the covered products to an
2    authorized collection site or mail-back program.
3    (b) A program operator shall not, as part of the education
4and outreach program, promote the disposal of a covered product
5in a manner inconsistent with the services offered to ultimate
6users by the stewardship program.
 
7
Article 10. Stewardship Plans

 
8    Section 10-1. Stewardship plan; submission; Agency review.
9    (a) Within 6 months after the adoption of regulations by
10the Agency under Section 5-5, a program operator shall submit
11to the Agency for approval a complete stewardship plan that
12meets the requirements of Section 10-5 for the establishment
13and implementation of a stewardship program, in a format
14determined by the Agency. The Agency shall approve a proposed
15stewardship program if the program operator submits a completed
16plan that meets the requirements of this Section.
17    (b) Before submitting a stewardship plan to the Agency
18under this Section, a program operator shall submit its
19proposed stewardship plan to the State Board for review, and to
20any other applicable State agencies with areas of authority
21relative to the stewardship plan. The duration of time that the
22State Board takes to review a stewardship plan under this
23subsection shall not count toward the time limit specified in
24subsection (a).

 

 

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1    A State agency that receives a plan shall review the plan
2for compliance with State and federal laws and regulations
3related to that agency's respective authority. The agency shall
4determine compliance or noncompliance with those laws and
5regulations, and provide to the program operator that
6determination and an explanation for any finding of
7noncompliance, within 90 days of receipt of the plan.
8    A program operator may submit an updated proposed plan to a
9State agency that issued a determination of noncompliance to
10attempt to obtain a determination of compliance. A program
11operator shall submit any determination received from an agency
12when it submits its stewardship plan to the Agency.
13    If, 90 days after submitting a plan to an applicable State
14agency, a program operator has not received a response from the
15applicable agency, the program operator may submit a
16certification to the Agency that the stewardship plan is
17consistent with all other applicable laws and regulations.
18    (c) The Agency shall determine if a stewardship plan is
19complete, including the determinations required under
20subsection (b), and notify the submitting program operator
21within 30 days of receipt.
22    If the Agency finds that the stewardship plan is complete,
23the Agency's 90-day review period for consideration of approval
24of the plan set forth in subsection (d) shall commence upon the
25original date of receipt.
26    If the Agency determines the stewardship plan is

 

 

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1incomplete, the Agency shall identify for the program operator
2the required additional information, and the program operator
3shall resubmit the plan within 30 days.
4    If the Agency determines upon resubmission that the
5stewardship plan is complete, the Agency's 90-day review period
6for consideration of approval of the plan shall commence upon
7the date of receipt of the resubmitted plan.
8    (d) The Agency shall review a complete submitted
9stewardship plan and shall approve, disapprove, or
10conditionally approve the plan within 90 days of receipt of the
11complete plan. The Agency may consult with, or submit a
12stewardship plan for review to, the State Board or another
13State agency it determines is necessary to determine the
14completeness of the stewardship plan or for making a
15determination on the approval of the stewardship plan or an
16amendment to the stewardship plan. The duration of time that
17the Agency takes to review a stewardship plan shall not count
18toward the 90-day time limit specified in this subsection.
19    (e) A program operator shall submit any significant changes
20to a stewardship plan in writing for approval by the Agency,
21and shall not implement the changes prior to that approval.
22    (f) If the Agency disapproves a submitted stewardship plan
23under subsection (d), the Agency shall explain, in writing
24within 30 days, how the plan does not comply with this Act, and
25the program operator shall resubmit a revised plan to the
26Agency.

 

 

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1    If the Agency finds that the revised stewardship plan
2submitted by the program operator does not comply with the
3requirements of this Act and disapproves the plan, the covered
4entity operating its own stewardship program, or the
5stewardship organization and the covered entities that are
6members of the stewardship organization, are not in compliance
7with this Act until the program operator submits a plan that
8the Agency approves.
9    (g) A program operator shall fully implement an approved
10stewardship program no later than 270 days after approval by
11the Agency of the stewardship plan.
12    (h) If a stewardship plan is revoked under subsection (a)
13of Section 25-10 or terminated by the program operator that
14submitted the plan, a covered entity no longer subject to that
15plan may, without being subject to penalties under Article 25,
16sell or offer for sale covered products in the State for a
17period of up to one year after the plan terminated or was
18revoked if the covered entity continues to operate under the
19most recent approved stewardship plan to which the covered
20entity was subject.
21    (i) The Agency shall make all stewardship plans submitted
22under this Section available to the public, except proprietary
23information in the plans protected under Section 30-10.
 
24    Section 10-5. Stewardship plan requirements.
25    (a) To be complete, a stewardship plan for covered drugs

 

 

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1shall do all of the following:
2        (1) Identify and provide contact information for the
3    stewardship organization, if applicable, and each
4    participating covered entity, and identify each covered
5    drug sold or offered for sale by each participating covered
6    entity.
7        (2) Identify and provide contact information for the
8    authorized collectors for the stewardship program, as well
9    as the reasons for excluding any potential authorized
10    collectors from participation in the program.
11        (3) Include any determinations provided by a State
12    agency under subsection (b) of Section 10-1. Any
13    determination of noncompliance shall be accompanied by a
14    superseding determination of compliance.
15        (4) Demonstrate adequate funding for all
16    administrative and operational costs of the stewardship
17    program, to be borne by participating covered entities.
18        (5) Provide for a handling, transport, and disposal
19    system that complies with applicable State and federal
20    laws, including, but not limited to, regulations adopted by
21    the United States Drug Enforcement Administration.
22        (6) Provide for a collection system that complies with
23    the requirements of this Act and meets all of the following
24    requirements for authorized collection sites in each
25    county in which the plan will be implemented:
26            (A) Provides for a minimum of 5 authorized

 

 

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1        collection sites or one authorized collection site per
2        50,000 people, whichever is greater.
3            (B) Provides for a reasonable geographic spread of
4        authorized collection sites and an explanation for the
5        geographic spread.
6            (C) Provides for a mail-back program covering any
7        counties where there is not an authorized retail
8        pharmacy operating as an authorized collection site.
9        (7) Require a program operator to do all of the
10    following:
11            (A) Permit an ultimate user who is a homeless,
12        homebound, or disabled individual to request prepaid,
13        preaddressed mailing envelopes, or an alternative form
14        of a collection and disposal system, as described in
15        paragraph (2) of subsection (c), that would render the
16        covered drug inert. A program operator shall accept
17        that request through a website and toll-free telephone
18        number that it shall maintain to comply with the
19        requests.
20            (B) Provide alternative methods of collection from
21        ultimate users for any covered drugs, other than
22        controlled substances, that cannot be accepted or
23        commingled with other covered drugs in secure
24        collection receptacles or through a mail-back program,
25        to the extent technically feasible and permissible
26        under applicable State and federal law, including, but

 

 

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1        not limited to, United States Drug Enforcement
2        Administration regulations.
3            (C) Provide a service schedule that meets the needs
4        of each authorized collection site to ensure that each
5        secure collection receptacle is serviced as often as
6        necessary to avoid reaching capacity and that
7        collected covered drugs are transported to final
8        disposal in a timely manner. A receipt or collection
9        manifest shall be left with the authorized collection
10        site to support verification of the service. The
11        authorized collection site shall maintain and make
12        available to the Agency this documentation. An
13        authorized collector shall comply with applicable
14        State and federal laws regarding collection and
15        transportation standards, and the handling of covered
16        drugs, including United States Drug Enforcement
17        Administration regulations.
18        (8) Provide the policies and procedures for the safe
19    and secure collection, transportation, and disposal of the
20    covered drug, describe how and where records will be
21    maintained, describe how, at a minimum, instances of
22    security problems that occur will be addressed, and explain
23    the processes that will be taken to change the policies,
24    procedures, and tracking mechanisms to alleviate the
25    problems and to improve safety and security.
26    (b) At least 120 days before submitting a stewardship plan

 

 

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1to the Agency, the operator of a stewardship program for
2covered drugs shall notify potential authorized collectors in
3the county or counties in which it operates of the opportunity
4to serve as an authorized collector for the proposed
5stewardship program. If a potential authorized collector
6expresses interest in participating in a stewardship program,
7the program operator shall commence good faith negotiations
8with the potential authorized collector within 30 days.
9    A retail pharmacy shall make a reasonable effort to serve
10as an authorized collector as part of a stewardship program in
11the county in which it is located. If the minimum threshold
12described in subparagraph (A) of paragraph (6) of subsection
13(a) is not met in each county in which a retail pharmacy chain
14has store locations, the retail pharmacy chain shall have at
15least one location or 15 percent of its store locations,
16whichever is greater, in that county serve as authorized
17collectors in a stewardship program.
18    A program operator shall include as an authorized collector
19under its stewardship program any entity that meets the
20definition of an authorized collector and offers to participate
21in the stewardship program, in writing and without
22compensation, even if the minimum threshold described in
23subparagraph (A) of paragraph (6) of subsection (a) has been
24achieved. The program operator shall include the offering
25entity as an authorized collector in the program within 90 days
26of receiving the written offer to participate. A program

 

 

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1operator shall not be required to respond to offers under this
2subsection until the program operator's stewardship plan has
3been approved by the Agency.
4    (c) After a stewardship plan for covered drugs has been
5approved, the program operator may supplement service, if
6approved by the Agency, for a county in which it operates that
7does not have the minimum number of authorized collection sites
8due to circumstances beyond the program operator's control, by
9establishing one or both of the following:
10        (1) A mail-back program. The mail-back program may
11    include providing information on where and how to receive
12    mail-back materials or providing the locations at which it
13    distributes prepaid, preaddressed mailing envelopes. The
14    program operator shall propose the locations of those
15    envelope distribution locations as part of the stewardship
16    plan. Prepaid mailing envelopes may be mailed to an
17    ultimate user upon request.
18        (2) An alternative form of collection and disposal of
19    covered drugs that complies with applicable State and
20    federal law, including, but not limited to, United States
21    Drug Enforcement Administration regulations.
22    (d) To be complete, a stewardship plan for home-generated
23sharps waste shall do all of the following:
24        (1) Identify and provide contact information for the
25    stewardship organization, if applicable, and each
26    participating covered entity, and identify each covered

 

 

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1    product sold or offered for sale by each participating
2    covered entity.
3        (2) Include any determinations provided by a State
4    agency under subsection (b) of Section 10-1. Any
5    determination of noncompliance shall be accompanied by a
6    superseding determination of compliance.
7        (3) Demonstrate adequate funding for all
8    administrative and operational costs of the stewardship
9    program, to be borne by participating covered entities.
10        (4) Provide for a handling, transport, and disposal
11    system, at no cost to the ultimate user, that complies with
12    applicable State and federal laws.
13        (5) Maintain a website and toll-free telephone number
14    for purposes of providing information on the program,
15    including disposal options, and to receive requests for
16    sharps waste containers from ultimate users.
17        (6) Provide that a stewardship program for
18    home-generated sharps waste shall be a mail-back program
19    for home-generated sharps waste that complies with this Act
20    and that meets all the following requirements:
21            (A) The program provides or initiates distribution
22        of a sharps waste container and mail-back materials at
23        the point of sale, to the extent allowable by law.
24        Containers and mail-back materials shall be provided
25        at no cost to the ultimate user. The program operator
26        shall select and distribute a container and mail-back

 

 

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1        materials sufficient to accommodate the volume of
2        sharps purchased by an ultimate user over a selected
3        time period. Containers and mail-back materials shall
4        include:
5                (i) for any sharps, on the packaging, inserts,
6            instructions, or separate information provided to
7            the ultimate user, information on proper sharps
8            waste disposal;
9                (ii) on a label affixed to the container or
10            packaging or on a separate insert included in the
11            container or packaging, the program operator's
12            website and toll-free telephone number; and
13                (iii) prepaid postage affixed to the container
14            or to the mail-back packaging.
15            (B) Upon request, the program provides for
16        reimbursement to local agencies for disposal costs
17        related to home-generated sharps waste, unless the
18        program operator provides for the removal of the
19        home-generated sharps waste from the local household
20        hazardous waste facility.
21                (i) A local agency shall not knowingly request
22            reimbursement for disposal expenses under this
23            subparagraph for disposal costs resulting from a
24            municipal needle exchange program or a medical
25            waste generator.
26                (ii) Reimbursement costs shall be limited to

 

 

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1            the actual costs of transportation from the
2            household hazardous waste facility and for the
3            actual costs of disposal.
4                (iii) A request for reimbursement under this
5            subparagraph shall be submitted with a declaration
6            under penalty of perjury that the local agency has
7            not knowingly requested reimbursement for expenses
8            prohibited by this Section.
9                (iv) A cost is eligible for reimbursement
10            under this subparagraph if the cost is incurred 270
11            days or more after the approval of a stewardship
12            plan for home-generated sharps waste.
13    (e) A stewardship plan shall include provisions to expand
14into jurisdictions not included in the stewardship plan under
15Section 30-5, in the event a jurisdiction repeals its local
16stewardship program ordinance.
17    (f) A stewardship plan shall include educational and
18outreach provisions to meet the requirements under Section
195-15.
 
20
Article 15. Budgets, Reports, and Records

 
21    Section 15-1. Stewardship plan program budget. With the
22submission of a stewardship plan, a program operator shall
23submit to the Agency an initial stewardship program budget for
24the first 5 calendar years of operation of its stewardship

 

 

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1program that includes both of the following:
2    (a) the total anticipated revenues and costs of
3implementing the stewardship program; and
4    (b) a total recommended funding level sufficient to cover
5the plan's budgeted costs and to operate the stewardship
6program over a multiyear period.
 
7    Section 15-5. Program operator reports.
8    (a) On or before March 31, 2022, and each year thereafter,
9a program operator shall prepare and submit to the Agency both
10of the following:
11        (1) a written report describing the stewardship
12    program activities during the previous reporting period of
13    one calendar year; and
14        (2) a written program budget for stewardship program
15    implementation for the upcoming calendar year.
16    (b) An annual report submitted under paragraph (1) of
17subsection (a) shall include, at a minimum, all of the
18following for the prior year:
19        (1) A list of covered entities participating in the
20    stewardship organization.
21        (2) The updated and reverified list provided under
22    subsection (a) of Section 5-1 of covered products that each
23    covered entity subject to the stewardship plan sells or
24    offers for sale.
25        (3) The amount, by weight, of covered products

 

 

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1    collected from ultimate users at each authorized
2    collection site that is part of the stewardship program.
3        (4) For a stewardship plan for covered drugs, the name
4    and location of authorized collection sites at which
5    covered drugs were collected.
6        (5) For a stewardship plan for home-generated sharps
7    waste, information on the mail-back program.
8        (6) Whether policies and procedures for collecting,
9    transporting, and disposing of covered products, as
10    established in the stewardship plan, were followed during
11    the reporting period and a description of each instance of
12    noncompliance, if any occurred.
13        (7) Whether any safety or security problems occurred
14    during collection, transportation, or disposal of
15    collected covered products during the reporting period
16    and, if so, what changes have been or will be made to
17    policies, procedures, or tracking mechanisms to alleviate
18    the problem and to improve safety and security.
19        (8) How the program operator complied with all elements
20    in its stewardship plan.
21        (9) Any other information the Agency reasonably
22    requires.
23    (c) An annual program budget submitted under paragraph (2)
24of subsection (a) shall include, at a minimum, both of the
25following for the upcoming calendar year:
26        (1) an independent financial audit of the stewardship

 

 

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1    program, as required under subsection (b) of Section 15-10,
2    funded by the stewardship organization from the charge paid
3    from its member covered entities under Section 20-1 or by a
4    covered entity if it operates its own stewardship program;
5    and
6        (2) anticipated costs and the recommended funding
7    level necessary to implement the stewardship program,
8    including, but not limited to, costs to cover the
9    stewardship plan's budgeted costs and to operate the
10    stewardship program over a multiyear period in a prudent
11    and responsible manner.
12    (d) The Agency shall determine if a submitted annual report
13and program budget are complete and notify the submitting
14stewardship organization or covered entity within 30 days.
15    If the Agency finds that an annual report and program
16budget are complete, the Agency's 90-day review period for
17consideration of approval of the annual report and program
18budget, set forth in subsection (e), shall commence upon the
19original date of receipt.
20    If the Agency determines either an annual report or a
21program budget is incomplete, the Agency shall identify for the
22program operator within 30 days the required additional
23information, and the program operator shall submit a revised
24annual report or program budget, as applicable, within 30 days.
25    If the Agency determines upon resubmission that the annual
26report or program budget is complete, the Agency's 90-day

 

 

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1review period for consideration of approval of the annual
2report or program budget shall commence upon the date of
3receipt of the resubmitted report or program budget.
4    (e) The Agency shall review the annual report and program
5budget required under subsection (a) and within 90 days of
6receipt shall approve, disapprove, or conditionally approve
7the annual report and program budget.
8    If the Agency conditionally approves an annual report or
9program budget, the Agency shall identify the deficiencies in
10the annual report or program budget and the program operator
11shall comply with the conditions of the conditional approval
12within 60 days of the notice date, unless the Director of the
13Agency determines that additional time is needed.
14    If the Agency conditionally approves an annual report or
15program budget and the conditions are not met within 60 days of
16the notice date, unless additional time is granted under this
17subsection, the Agency shall disapprove the annual report or
18program budget.
19    If the Agency disapproves an annual report or program
20budget, the Agency shall identify the deficiencies in the
21annual report or program budget and the program operator shall
22submit a revised annual report or program budget and provide
23any supplemental information requested within 60 days of the
24notice date.
 
25    Section 15-10. Keeping minutes, books, and records;

 

 

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1audits.
2    (a) A program operator shall keep minutes, books, and
3records that clearly reflect the activities and transactions of
4the program operator's stewardship program.
5    (b) The minutes, books, and records of a program operator
6shall be audited at the program operator's expense by an
7independent certified public accountant retained by the
8program operator at least once each calendar year.
9    A program operator shall arrange for the independent
10certified public accountant audit to be delivered to the
11Agency, along with the annual report and program budget
12submitted under subsection (a) of Section 15-5.
13    The Agency may conduct its own audit of a program operator.
14The Agency shall review the independent certified public
15accountant audit for compliance with this Act and consistency
16with the program operator's stewardship plan, annual report,
17and program budget submitted under this Act. The Agency shall
18notify the program operator of any conduct or practice that
19does not comply with this Act or of any inconsistencies
20identified in the Agency's audit. The program operator may
21obtain copies of the Agency's audit, including proprietary
22information contained in the Agency's audit, upon request. The
23Agency shall not disclose any confidential proprietary
24information protected under Section 30-10 that is included in
25the Agency's audit.
 

 

 

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1    Section 15-15. Local jurisdiction reimbursement;
2requirements. For a local jurisdiction that requests removal of
3home-generated sharps waste or cost recovery or reimbursement
4for removal under Section 10-5, the local jurisdiction shall
5provide information on home-generated sharps waste to the
6covered entity or program operator, within a reasonable time,
7upon request by the covered entity or program operator.
 
8    Section 15-20. Adequate access report. As part of the
9administration of this Act, within 12 months of a program
10operator's submission of 3 consecutive complete annual reports
11submitted under Section 15-5, the Agency shall develop, and
12post on its website, a report analyzing whether the program
13operator's stewardship program provides adequate access to
14safe disposal of home-generated sharps waste or covered drugs,
15as applicable, to the ultimate user.
 
16
Article 20. Financial Provisions

 
17    Section 20-1. Administrative and operational costs. In
18order to further the objective that covered entities establish
19and implement stewardship programs that comply with the
20requirements of this Act, each covered entity, either
21individually or through a stewardship organization, shall pay
22all administrative and operational costs associated with
23establishing and implementing the stewardship program in which

 

 

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1it participates, including the cost of collecting,
2transporting, and disposing of covered products.
 
3    Section 20-5. Administrative fee.
4    (a) On or before the end of State Fiscal Year 2023, and
5once every 3 months thereafter, a program operator shall pay to
6the Agency an administrative fee. The Agency shall set the fee
7at an amount that, when paid by every covered entity, is
8adequate to cover the Agency's and any other State agency's
9full costs of administering and enforcing this Act. The total
10amount of fees collected shall not exceed the State's actual
11and reasonable regulatory costs to implement and enforce this
12Act. These costs may include the actual and reasonable costs
13associated with regulatory activities under this Act before
14submission of stewardship plans under Section 10-1.
15    For a stewardship organization, the administrative fee
16paid under this subsection shall be funded by the covered
17entities that make up the stewardship organization. This
18administrative fee shall be in addition to the charge paid
19under Section 20-1. A stewardship organization may require its
20participating covered entities to pay the administrative fee
21and the charge paid under Section 20-1 at the same time.
22    (b) The fees received by the Agency under this Section
23shall be deposited into the Drug and Sharps Stewardship Fund,
24which is hereby created as a special fund in the State
25treasury. Upon appropriation by the General Assembly, moneys in

 

 

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1the fund may be expended by the Agency, the State Board, and
2any other agency that assists in the regulatory activities of
3administering and enforcing this Act. Upon appropriation by the
4General Assembly, moneys in the fund may be used for those
5regulatory activities and to reimburse any outstanding loans
6made from other funds used to finance the startup costs of the
7Agency's activities under this Act. Moneys in the fund shall
8not be expended for any purpose not enumerated in this Act.
9    (c) The penalties received by the Agency under Section 25-5
10shall be deposited into the Pharmaceutical and Sharps
11Stewardship Penalty Account, which is hereby created as an
12account within the Pharmaceutical and Sharps Stewardship Fund.
13Upon appropriation by the General Assembly, moneys in the
14account may be expended by the Agency on activities including,
15but not limited to, the promotion of safe handling and disposal
16of covered products, grants for related purposes, and the
17administration and enforcement this Act.
 
18    Section 20-10. Audits.
19    (a) A stewardship organization may conduct an audit of
20covered entities that are required to remit a charge or
21administrative fee to the stewardship organization under
22Sections 20-1 and 20-5 to verify that the administrative fees
23and charges paid are proper and accurate. A stewardship
24organization may conduct an audit of authorized collectors to
25verify the charges submitted are proper and accurate.

 

 

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1    The purpose of the audits described in this subsection is
2to ensure parties required by this Act to pay or collect an
3administrative fee or charge are paying or collecting the
4proper amount to implement the program.
5    (b) If a stewardship organization conducts an audit under
6subsection (a), it shall do each of the following:
7        (1) conduct the audit in accordance with generally
8    accepted auditing practices;
9        (2) limit the scope of the audit of covered entities to
10    confirming whether a charge or administrative fee has been
11    properly paid by the covered entities;
12        (3) hire an independent third-party auditor to conduct
13    the audit; and
14        (4) provide a copy of the audit to the Agency.
 
15
Article 25. Enforcement

 
16    Section 25-1. Posting listed stewardship organizations.
17    (a) On or before June 30, 2022, and at least annually
18thereafter, the Agency shall post on its website a list of
19stewardship organizations, including entities with an approved
20stewardship plan, and covered entities, authorized collection
21sites, retail pharmacies, and retail pharmacy chains provided
22in the stewardship plans that are in compliance with this Act.
23    The State Board shall coordinate with the Agency to verify
24that the list posted under this subsection is consistent with

 

 

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1the information submitted to each agency under Section 5-1.
2    (b) A covered entity or stewardship organization that is
3not listed on the Agency's website under subsection (a), but
4demonstrates compliance with this Act before the Agency is
5required to post the following year's list under subsection
6(a), may request a certification letter from the Agency stating
7that the covered entity or stewardship organization is in
8compliance with this Act. A covered entity or stewardship
9organization that receives a certification letter shall be
10deemed to be in compliance with this Act.
11    (c) A distributor or wholesale drug distributor of covered
12products, and a pharmacy or other retailer that sells or offers
13for sale a covered product, shall monitor the Agency's website
14to determine which covered entities and stewardship
15organizations are in compliance with this Act. The distributor
16or wholesale drug distributor and the pharmacy or other
17retailer shall notify the Agency if it determines that a
18covered product that it sells or offers for sale is from a
19covered entity that is not listed on the Agency's website.
20    (d) The sale, distribution, or offering for sale of any
21inventory that was in stock before the commencement of a
22stewardship program is exempt from this Act and not required to
23be subject to a stewardship plan.
24    (e) If the Act determines a covered entity or stewardship
25organization is not in compliance with this Act, the Agency
26shall remove the entity from the list maintained on the

 

 

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1Agency's website under subsection (a).
 
2    Section 25-5. Administrative penalties.
3    (a) The Agency may impose an administrative penalty on any
4covered entity, program operator, stewardship organization, or
5authorized collector that sells, offers for sale, or provides a
6covered product in violation of this Act.
7    The amount of the administrative penalty imposed under this
8subsection shall not exceed $10,000 per day per violation
9unless the violation is intentional, knowing, or reckless, in
10which case the administrative penalty shall not exceed $50,000
11per day per violation.
12    (b) The Agency shall not impose a penalty on a program
13operator under this Section for failure to comply with this Act
14if the program operator demonstrates it received false or
15misleading information that contributed to its failure to
16comply, including, for a stewardship organization, from a
17participating covered entity.
 
18    Section 25-10. Additional penalties. Upon a written
19finding that a covered entity, program operator, stewardship
20organization, or authorized collector has not met a material
21requirement of this Act, in addition to any other penalties
22authorized under this Act, the Agency may take one or both of
23the following actions to ensure compliance with the
24requirements of this Act, after affording the covered entity,

 

 

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1stewardship organization, or authorized collector a reasonable
2opportunity to respond to, or rebut, the finding:
3    (a) Revoke the program operator's stewardship plan
4approval or require the program operator to resubmit the plan.
5    (b) Require additional reporting relating to compliance
6with the material requirement of this Act that was not met.
 
7    Section 25-15. Agency access and records; keeping records.
8    (a) A covered entity, stewardship organization, program
9operator, retail pharmacy, or retail pharmacy chain shall do
10both of the following:
11        (1) Upon request, provide the Agency with reasonable
12    and timely access, as determined by the Agency, to its
13    facilities and operations, as necessary to determine
14    compliance with this Act.
15        (2) Upon request, provide the Agency with relevant
16    records necessary to determine compliance with this Act.
17    (b) A covered entity, stewardship organization, program
18operator, retail pharmacy, or retail pharmacy chain shall
19maintain and keep accessible all records required to be kept or
20submitted under this Section for a minimum of 3 years.
21    (c) All reports and records provided to the Agency under
22this Section shall be provided under penalty of perjury.
23    (d) The Agency may take disciplinary action against a
24covered entity, stewardship organization, program operator,
25pharmacy, retail pharmacy, or retail pharmacy chain that fails

 

 

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1to provide the Agency with the access to information required
2under this Section, including one or both of the following:
3    (1) Imposing an administrative penalty under Section 25-5.
4    (2) Posting a notice on the Agency's website, in
5association with the list that the Agency maintains under
6subsection (a) of Section 25-1, that the covered entity,
7stewardship organization, program operator, pharmacy, retail
8pharmacy, or retail pharmacy chain is no longer in compliance
9with this Act.
10    (e) The Agency shall not prohibit as a disciplinary action
11a covered entity, stewardship organization, program operator,
12pharmacy, retail pharmacy, or retail pharmacy chain from
13selling a covered product.
 
14    Section 25-20. Handling, transport, and disposal. All
15handling, transport, and disposal undertaken as part of a
16stewardship program under this Act shall comply with applicable
17State and federal laws, including, but not limited to,
18regulations adopted by the United States Drug Enforcement
19Administration.
 
20
Article 30. Miscellaneous Provisions

 
21    Section 30-1. Violation exceptions.
22    (a) Except as provided in subsection (c), an action
23specified in subsection (b) that is taken by a stewardship

 

 

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1organization or a covered entity under this Act is not a
2violation of the Illinois Antitrust Act.
3    (b) Subsection (a) shall apply to all of the following
4actions taken by a stewardship organization or covered entity:
5        (1) The creation, implementation, or management of a
6    stewardship plan approved by the Agency under Article 10
7    and the determination of the types or quantities of covered
8    products collected or otherwise managed under a
9    stewardship plan.
10        (2) The determination of the cost and structure of an
11    approved stewardship plan.
12        (3) The establishment, administration, collection, or
13    disbursement of the charge or administrative fee imposed
14    under Section 20-1 or 20-5.
15    (c) Subsection (a) shall not apply to an agreement that
16does any of the following:
17        (1) Fixes a price of or for covered products, except
18    for an agreement related to costs, charges, or
19    administrative fees associated with participation in a
20    stewardship plan approved by the Agency and otherwise in
21    accordance with this Act.
22        (2) Fixes the output of production of covered products.
23        (3) Restricts the geographic area in which, or
24    customers to whom, covered products are sold.
 
25    Section 30-5. Ordinances affected; local stewardship

 

 

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1programs.
2    (a) This Act does not apply to a drug or sharp within a
3jurisdiction that is subject to a local stewardship program
4under an ordinance that took effect before January 1, 2020. If
5that ordinance is repealed, the drug or sharp program shall be
6subject to this Act in that jurisdiction within 270 days after
7the date on which the ordinance is repealed.
8    (b) This Act shall preempt a local stewardship program for
9drugs or sharps enacted by an ordinance with an effective date
10on or after January 1, 2020. The regulation of the collection,
11transportation, and disposal of drugs and sharps as described
12in this Act is an exclusive power and function of the State. A
13home rule unit may not regulate the collection, transportation,
14and disposal of drugs and sharps. This Section is a denial and
15limitation of home rule powers and functions under subsection
16(h) of Section 6 of Article VII of the Illinois Constitution.
17    (c) A local stewardship program for covered products
18enacted by an ordinance that has an effective date before
19January 1, 2020, may continue in operation, but the program and
20its participants shall not receive or benefit from moneys from
21the Pharmaceutical and Sharps Stewardship Fund or the
22Pharmaceutical and Sharps Stewardship Penalty Account,
23including, but not limited to, for administrative or
24enforcement costs. Participants of a local stewardship program
25for covered products enacted by an ordinance that has an
26effective date before January 1, 2020, shall be eligible to

 

 

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1participate in a stewardship program under this Act and thereby
2become eligible to receive funds from the Drug and Sharps
3Stewardship Fund or the Drug and Sharps Stewardship Penalty
4Account only if the local stewardship program is dissolved.
 
5    Section 30-10. Confidential proprietary information.
6Proprietary information submitted to the Agency under this Act
7shall be protected by all parties as confidential and shall be
8exempt from public disclosure under the State Records Act and
9the Freedom of Information Act. The Agency and other parties
10may only disclose proprietary information in an aggregated form
11that does not directly or indirectly identify financial,
12production, or sales data of an individual covered entity or
13stewardship organization. Proprietary information may be
14disclosed to the party that submitted the proprietary
15information.