Current through Register 2024 Notice Reg. No. 38, September 20, 2024
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, a stewardship plan for home-generated sharps waste shall include the following:
(a) Contact information of the corporate officer, or designee, responsible for submitting and overseeing the stewardship plan on behalf of the program operator, including, but not limited to:
(1) Contact name and title
(2) Name of program operator
(3) Mailing and physical address(es)
(4) Phone number
(5) Email address
(6) Internet website address
(b) Contact information for each covered entity participating in the stewardship plan, including, but not limited to:
(1) Contact name and title
(2) Name of covered entity
(3) Mailing and physical address(es)
(4) Covered entity email address
(5) Covered entity internet website address
(6) Covered entity phone number
(c) List of sharps sold or offered for sale by each participating covered entity covered by the stewardship plan.
(d) State Agency Determinations and Compliance Certifications.
(1) Agency determinations pursuant to 42032.2(d)(1)(B) 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 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 handling, transportation, and disposal of home-generated sharps waste is in compliance with all applicable local, state, and federal laws and regulations.
(e) Initial Program Budget and Program Funding. Demonstration of adequate funding for all administrative and operational costs of the stewardship program for the first five calendar years of operation, to be borne by participating covered entities pursuant to section 18973.6.
(f) Collection, Transportation, and Disposal System. Descriptions of the following:
(1) Processes and policies that will be used to safely and securely collect, track, and properly manage home-generated sharps waste from collection through final disposal.
(2) How stewardship plan implementation will provide or initiate distribution of sharps waste containers and mail-back materials, which include mail-back packaging and informational material, at no cost to ultimate users at the point of sale, to the extent allowable by law. In addition, how stewardship plan implementation will meet the following requirements:
(A) Containers and mail-back materials shall be distributed in amounts sufficient to accommodate the volume of sharps purchased by the ultimate user over a selected time period.
(B) For any sharps, the packaging, an insert or instructions, or separate information provided to the ultimate user shall include all necessary information on proper sharps waste disposal.
(C) All sharps waste containers shall include, on a label affixed to the container or packaging or on a separate insert included in the container or packaging, the program operator's internet website and toll-free telephone number.
(D) Prepaid postage shall be affixed to the container or mail-back packaging.
(3) Collection, Transportation, and Disposal System Records. Description of how and where the records generated during the collection, transportation, and disposal of collected home-generated sharps waste will be maintained. These records shall include, but are not limited to: collection manifests, mailer distributions, receipts of returned home-generated sharps waste return mailings, and final disposal of home-generated sharps waste, as applicable.
(4) Each service provider to be used to transport, process, or dispose of home-generated sharps waste collected through the stewardship program, including, but not limited to:
(A) Name of service provider
(B) Mailing and physical address(es) of service provider
(5) Supplemental collection method(s) for home-generated sharps waste that may be provided, in addition to, but not in lieu of, the mail-back program. These methods may include, but are not limited to:
(A) Secure receptacle collection. If a program operator proposes to implement a receptacle-based program using authorized and approved home-generated sharps consolidation points under the Medical Waste Management Act, then the following information, as applicable, shall be included, but not be limited to:
(i) Name and physical address of home-generated sharps consolidation point(s).
(ii) Process by which collection receptacles will be monitored, process by which service schedules will be determined to ensure that collection receptacles do not reach capacity, and the procedure to be followed if capacity is reached.
(iii) How each participating home-generated sharps consolidation point will be funded or reimbursed, if applicable.
(iv) 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.
(B) Take-back collection events shall be authorized and approved as a home-generated sharps consolidation point under the Medical Waste Management Act. Describe when take-back events are necessary and how they will be conducted, if applicable.
(6) Metrics that will be used to measure the amount of sharps waste containers and mail-back materials distributed and metrics that will be used to measure the amount of home-generated sharps waste returned.
(7) Metrics that will be used to measure the amount of home-generated sharps waste collected through supplemental collection method(s), if applicable.
(8) Metrics that will be used to measure the amount of home-generated sharps waste collected by household hazardous waste facilities operated by local agencies that request reimbursement or removal for disposal of home-generated sharps waste.
(9) Corrective actions that will be taken if a program operator discovers critical instances of noncompliance with stewardship plan policies and procedures.
(g) Local Agency Requests.
(1) Description of the process for coordinating with local agencies, or an agent on behalf of a local agency, for the removal of home-generated sharps waste from local household hazardous waste facilities, either by reimbursement for transportation and disposal costs or removal of the home-generated sharps waste.
(2) Requests by local agencies, or an agent on behalf of a local agency, shall include an invoice and shall be submitted to the program operator, as necessary. Such requests shall comply with the requirements in subsection (1)(F)(ii) of subdivision (d) of section 42032.2 of the Public Resources Code. Program operators shall respond to requests by local agencies within 14 days of receipt of the request and identify the method to resolve the request by selecting either reimbursement or removal from household hazardous waste facility(ies).
(A) A program operator that selects to resolve a request through reimbursement to a local agency shall issue payment within 45 days of receipt of the local agency's invoice.
(B) A program operator that provides for the removal of the home-generated sharps waste from the local household hazardous waste facilities shall do so as often as required according to section 117904 of the Health and Safety Code or by the local enforcement authority.
(h) 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.
(i) Education and Outreach. Description of a comprehensive education and outreach program shall include, but is not limited to, the following:
(1) Activities to promote awareness and maximize ultimate user participation in the stewardship program, including, but not limited to provision of educational and outreach materials for persons authorized to prescribe drugs, pharmacies, pharmacists, ultimate users, and others, as necessary.
(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:
(A) A mechanism to accept requests for sharps waste containers and mail-back materials.
(B) Information to promote the stewardship program including, but not limited to, instructions for safe handling and proper disposal of home-generated sharps waste and information on collection options for home-generated sharps waste.
(C) Home-generated sharps consolidation point addresses, if applicable.
(D) Home-generated sharps consolidation point site days and hours of operation, if applicable.
(E) Home-generated sharps consolidation point contact telephone numbers, if applicable.
(4) Establishment of a toll-free telephone number to serve as an option for ultimate users to request sharps waste containers and mail-back materials, and to obtain information about the program, including, but not limited to what is outlined in section 18973.3(i)(3)(A)-(E). 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.
(5) Metrics to evaluate performance of the comprehensive education and outreach program, including, but not limited to, ultimate user awareness, program usage, and accessibility.
(6) How ultimate users will be encouraged to separate products that are not covered products from covered products, when appropriate, before submitting the covered products to a home-generated sharps consolidation point or mail-back program.
(7) How the program operator will comply with the requirement in section 42031.6(b) of the Public Resources Code.
(j) 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 home-generated sharps waste are in operation concurrently or new stewardship programs begin operating.
(k) Process for providing grants, loans, sponsorships, reimbursements, or other incentives, as applicable.
(l) Process for selecting service providers, including a description of any competitive procedures used, if applicable.
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.
Note: Authority cited: Sections 40401, 42031.2 and 40502, Public Resources Code. Reference: Sections 42030, 42031, 42031.6, 42032, 42032.2, 42033, 42033.5, 42036.2 and 42036.4, Public Resources Code; Section 17041, California Code of Regulations; and Section 117904, Health and Safety Code.
