SB 212 Informal Rulemaking Public Workshop #1: Articles 1-3 CalRecycle Public Workshop January 30, 2019
Introduction By Howard Levenson, Ph.D. Deputy Director, Materials Management & Local Assistance Division 2
Purpose of Rulemaking • Clarify statute • Establish administrative procedures • Provide a level playing field by establishing consistent standards 3
SB 212 Implementation Timeline Informal CR to Adopt Rulemaking Begins Regulations 1/1/ 1/1/2019 2019 1/1/2021 1/1/ 2021 2021 2019 2020 Stewardship Plans Industry to Provide Lists Due to CR of MFRS and Brands to 7/1/ 7/1/2021 2021 BOP 4/1/ 4/1/2019 2019 CR – CalRecycle SO – Stewardship Organization BOP – Board of Pharmacy 4
SB 212 Implementation Timeline SO to provide CR 1 st Annual Report 3/31/ 3/31/2022 2022 2023 2022 2021 Stewardship Plans CR Sets Administrative Due to CR Fee for Agencies’ 7/1/ 7/1/2021 2021 Costs by FY 2022/23 FY 2022/23 CR – CalRecycle SO – Stewardship Organization BOP – Board of Pharmacy 5
Key Components of SB 212 • Industry-operated and funded collection & disposal programs • Stewardship Plans • Minimum Convenience Standards • Annual Budgets • Annual Reports 6
Outline of Draft Regulatory Concepts I. Article 1. Definitions II. Article 2. Covered Entities and Stewardship Organizations III. Article 3. Stewardship Plans IV. Article 4. Reports, Budgets, and Records V. Article 5. Financial Provisions VI. Article 6. Enforcement VII. Article 7. Miscellaneous Provisions 7
Outline of Draft Regulatory Concepts I. Article 1. Definitions II. Article 2. Covered Entities and Stewardship Organizations • Submittal of Manufacturer Product Lists • Criteria for Determining Covered Entity • Education and Outreach III. Article 3. Stewardship Plans • Plan Submittal to Board, Department, et al • Requirements and Process for Plan Approval 8
Article 1. Definitions • Covered entity – § 42030.(f)(1)(A)-(E) • Administrative and Operational Costs – § 42032.2.(a)(1)(D) • Significant change – § 42032.(e) • Homebound – § 42032.2.(a)(1)(G)(i) • Technically feasible – § 42032.2.(a)(1)(G)(ii) • Good faith negotiations – § 42032.2.(b)(1) • Reasonable effort – § 42032.2.(b)(2) 9
Covered Entity Definition – § 42030.(f)(1)(A)-(E) § 42030(f)(1)(A) Examples? Manufacturer § 42030(f)(1)(B) Examples? Distributor § 42030(f)(1)(C) Examples? Repackager Owner/Licensee § 42030(f)(1)(D) Examples? Importer § 42030(f)(1)(E) Examples? 10
§ 42030(f)(1)(A) –(E) “Covered entity” means the manufacturer of covered products that are sold in or into the state. (B) If no entity that meets the definition in subparagraph (A) is in the state, “covered entity” means the distributor of covered products that are sold in or into the state that is licensed as a wholesaler, as defined in Section 4043 of the Business and Professions Code, but does not include a warehouse of a retail pharmacy chain that is licensed as a wholesaler if it engages only in intracompany transfers between any division, affiliate, subsidiary, parent, or other entity under complete common ownership and control. (C) If no entity that meets the definition in subparagraph (A) or (B) is in the state, “covered entity” means a repackager, as defined in Section 4044 of the Business and Professions Code, of covered products that are sold in or into the state. (D) If no entity that meets the definition in subparagraph (A), (B), or (C) is in the state, “covered entity” means the owner or licensee of a trademark or brand under which covered products are sold in or into the state, regardless of whether the trademark is registered. (E) If no entity that meets the definition in subparagraph (A), (B), (C), or (D) is in the state, “covered entity” means the importer of the covered products that are sold in or into the state. 11
Administrative and Operational Costs § 42032.2.(a)(1)(D) Demonstrate adequate funding for all administrative and operational costs of the stewardship program, to be borne by participating covered entities. 12
Administrative and Operational Costs: Examples Used Mattress Recovery and Recycling Program 14 CCR § 18960(d): “ Operational costs ” means costs to operate a mattress recycling organization's mattress recycling program, including, but not limited to, collection, transportation, processing, disposal, and education and outreach costs. Architectural Paint Recovery Program 14 CCR § 18951(b) : “Administrative fee” means the fee imposed by the department on the architectural paint manufacturer or stewardship organization in order to cover the costs of administering and enforcing the statute. Product Stewardship for Carpets 14 CCR § 18941(b): “ Administrative fee ” means payments from the carpet assessment to the department that cover the costs of its administrative, oversight, and enforcement services necessary for manufacturers or stewardship organizations to effectively implement carpet stewardship plans. The administrative fee will be paid by the individual manufacturer or stewardship organizations submitting a stewardship plan. 13
Significant Change § 42032.(e) A program operator shall submit any significant changes to a stewardship plan in writing for approval by the department, and shall not implement the changes prior to that approval. 14
Significant Change § 42032.(e) Example: Used Mattress Recovery and Recycling Program 14 CCR § 18960(e): “Significant or material change” includes a change in a required element of the used mattress recovery and recycling plan that affects the organization's costs or revenues, such as a change that results in a modification of the recycling charge, a change that requires a party other than the mattress recycling organization to make a major change in how it participates in the program, or a change that reduces the goals set for the organization in the existing approved recycling plan. 15
Homebound § 42032.2.(a)(1)(G)(i) Permit an ultimate user who is a homeless, homebound, or disabled individual to request prepaid, preaddressed mailing envelopes, or an alternative form of a collection and disposal system, as described in paragraph (2) of subdivision (c), that would render the covered drug inert. A program operator shall accept that request through an Internet Web site and toll-free telephone number that it shall maintain to comply with the requests. 16
Homebound § 42032.2.(a)(1)(G)(i) Example of an existing definition: Medicare Definition of Homebound : Normally unable to leave home unassisted. To be homebound means that leaving home takes considerable and taxing effort. A person may leave home for medical treatment or short, infrequent absences for non-medical reasons, such as a trip to the barber or to attend religious service. A need for adult day care doesn't keep you from getting home health care. 17
Technically feasible § 42032.2.(a)(1)(G)(ii) Provide alternative methods of collection from ultimate users for any covered drugs, other than controlled substances, that cannot be accepted or commingled with other covered drugs in secure collection receptacles or through a mail-back program, to the extent technically feasible and permissible under applicable state and federal law, including, but not limited to, United States Drug Enforcement Administration regulations. 18
Good faith negotiations § 42032.2.(b)(1) At least 120 days before submitting a stewardship plan to the department, the operator of a stewardship program for covered drugs shall notify potential authorized collectors in the county or counties in which it operates of the opportunity to serve as an authorized collector for the proposed stewardship program. If a potential authorized collector expresses interest in participating in a stewardship program, the program operator shall commence good faith negotiations with the potential authorized collector within 30 days. 19
Reasonable effort: § 42032.2.(b)(2) A retail pharmacy shall make a reasonable effort to serve as an authorized collector as part of a stewardship program in the county in which it is located. If the minimum threshold described in clause (i) of subparagraph (F) of paragraph (1) of subdivision (a) is not met in each county in which a retail pharmacy chain has store locations, the retail pharmacy chain shall have at least one location or 15 percent of its store locations, whichever is greater, in that county serve as authorized collectors in a stewardship program. 20
Questions for Stakeholders 1. Are there other terms from Articles 1-3 that will need to be clarified and/or defined? 2. Regarding “covered entity,” are there terms within the tiered definition that should be clarified? 3. Are any of the examples provided here sufficient? Do you have revisions that would make any of the examples sufficient? 4. Do you have suggested example definitions? 21
Article 2. Covered Entities and Stewardship Organizations 1. Submittal of Manufacturer Product Lists 2. Criteria for Determining Covered Entity 3. Education and Outreach 22
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