§ 18973.2. Stewardship Plan for Covered Drugs.
14 CA ADC § 18973.2Barclays Official California Code of Regulations
14 CCR § 18973.2
§ 18973.2. Stewardship Plan for Covered Drugs.
Within six months of the adoption date of the regulations in this Article by the department, a program operator shall submit a stewardship plan to the department. To be complete, the stewardship plan shall include the following:
(2) Pursuant to Section 42032.2(b)(1) of the Public Resources Code, list of potential authorized collectors, in the counties in which the program will operate, that were notified of the opportunity to serve as an authorized collector for the proposed stewardship program, and the method(s) by which each potential authorized collector was notified. The notification shall occur at least 120 days before the stewardship plan is submitted to the department.
(3) Pursuant to Section 42032.2(b)(1) of the Public Resources Code, description of the process by which good faith negotiations with potential authorized collectors were and, if applicable, continue to be conducted. 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.
(5) Description of the process to incorporate potential authorized collectors that submit a written offer to join the stewardship program, in accordance with section 42032.2(b)(3) of the Public Resources Code. A program operator shall include under its stewardship program any entity listed in subdivision (b) of section 42030 of the Public Resources Code that offers to participate in the stewardship program, in writing and without compensation, even if the minimum convenience standards set in clause (i) of subsection (1)(F) of subdivision (a) of section 42032.2 of the Public Resources Code have been achieved. The program operator shall include the offering entity as an authorized collector in the stewardship program within 90 days of receiving the written offer to participate. A program operator shall not be required to respond to offers pursuant to this subsection until the program operator's stewardship plan has been approved by the department.
(1) State agency determinations, pursuant to section 42032.2(a)(1)(C) of the Public Resources Code. If a determination of noncompliance was initially issued, the stewardship plan shall include both the initial determination of noncompliance and the superseding determination of compliance. If any state agency failed to respond to a request for review within 90 days of receipt of the stewardship plan, the program operator shall include documentation of this request along with a written certification, signed by an authorized representative of the program operator, that, at the time of submission to the department, the stewardship plan is consistent with all laws and regulations relevant to that agency's authority, and the applicable state agency failed to respond within 90 days of receipt of the stewardship plan.
(2) Written certification by an authorized representative of the program operator that, at the time of submission to the department, the stewardship plan, including all aspects of the plan related to the collection, transportation, and disposal of covered drugs, is in compliance with all applicable local, state, and federal laws and regulations, including, but not limited to United States Drug Enforcement Administration regulations.
(B) Pursuant to section 42032.2(a)(1)(G)(i) of the Public Resources Code, mechanism to provide preaddressed, prepaid mail-back materials or an alternative form of collection and disposal system requested by ultimate users who are homeless, homebound, or disabled through the program operator's internet website and toll-free telephone number.
(C) Pursuant to section 42032.2(c)(2) of the Public Resources Code, description of any mail-back program or alternative form of collection and disposal system that complies with applicable local, state, and federal laws and regulations including, but not limited to, United States Drug Enforcement Administration regulations that will be used as a supplemental service for any county that does not have the minimum number of authorized collection sites due to circumstances beyond the program operator's control.
(D) Pursuant to section 42032.2(a)(1)(G)(ii) of the Public Resources Code, any alternative methods of collection for 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.
(7) Description of a service schedule that meets the needs of each authorized collection site. Process by which collection receptacles will be monitored, explanation of how service schedules are determined to ensure that collection receptacles do not reach capacity, and procedures to be followed if capacity is reached. The service schedule must meet the needs of each authorized collection site to ensure that collected covered drugs are transported to final disposal in a timely manner.
(10) Standard operating procedures that will address incidents related to safety and security, including processes to ensure that the department and applicable local, state, and federal agencies are notified of the incident. This description shall also explain the actions that will be taken to change policies, procedures, and tracking mechanisms to alleviate the problems with safety and security and improve safety and security.
(h) Collection, Transportation, and Disposal System Records. Description of how and where the records generated during the collection, transportation, and disposal of collected covered drugs will be maintained. These records include, but are not limited to: collection manifests, mailer distributions, receipts of returned covered drugs, return mailings, and final disposal of covered drugs, as applicable.
(i) Ordinance Repeals. Pursuant to subdivision (e) of section 42032.2 of the Public Resources Code, description of processes, logistics, and timing of implementation that will be necessary for the stewardship program to expand into jurisdictions not previously included in the stewardship plan, in the event of the repeal of a local stewardship program ordinance. The description shall include an explanation of how the stewardship program will meet the convenience standards, pursuant to subsection (1)(F) of subdivision (a) of section 42032.2 of the Public Resources Code.
(2) Materials to be utilized that are distributed in languages suited to local demographics, consistent with section 7295 of the Government Code. These materials shall include, but are not limited to, signage for hospitals, pharmacies, and other locations, as necessary. Signage or labeling for secure collection receptacles shall be designed with explanatory graphics which are readily understandable by all ultimate users.
(3) Establishment of an internet website designed with functionality for mobile platforms, provided with language options suited to local demographics, consistent with section 7295 of the Government Code, and maintained to ensure all information is up to date and accurate. The internet website's digital content and navigability must be accessible to disabled individuals. The internet website shall include, but is not limited to, the following:
(4) Establishment of a toll-free telephone number to accept requests for mail-back materials from ultimate users who are homeless, homebound, or disabled, and to provide disposal options and other program information to ultimate users without access to the internet. The toll-free telephone number shall offer language options suited to local demographics, accept calls via human representative, and provide services for hearing-impaired and speech-impaired individuals.
(k) Coordination Efforts. Description of how the program operator will coordinate with other program operators to avoid confusion to the public and all program participants in the event that multiple stewardship programs for covered drugs are in operation concurrently or new stewardship programs begin operating.
Note: Authority cited: Sections 40401, 42031.2 and 40502, Public Resources Code. Reference: Sections 42030, 42031, 42031.6, 42032, 42032.2, 42033, 42035.8, 42036.2 and 42036.4, Public Resources Code; and Section 17041, California Code of Regulations.
1. New section filed 1-7-2021; operative 1-7-2021 (Register 2021, No. 2). Filing deadline specified in Government Code section 11349.3(a) extended 60 calendar days pursuant to Executive Order N-40-20 and an additional 60 calendar days pursuant to Executive Order N-71-20.
This database is current through 5/26/23 Register 2023, No. 21.
Cal. Admin. Code tit. 14, § 18973.2, 14 CA ADC § 18973.2
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