California Code of Regulations
Title 14 - Natural Resources
Division 7 - Department of Resources Recycling and Recovery
Chapter 11 - Product Stewardship
Article 4 - Pharmaceutical and Sharps Waste Stewardship Program
Section 18973.1 - Document Approvals: Stewardship Plan, Initial Program Budget, Annual Report, and Annual Budget

(a) A program operator submitting a stewardship plan, initial program budget, annual report, or annual budget shall provide to the department, upon request and by the requested deadline, clarifying information that is necessary to assist the department in its consideration of completeness and/or approval.

(b) Within 30 days of the department's receipt of a document, the department shall determine if a document is complete or incomplete and notify the submitting program operator. The department shall consider a document to be complete if it contains provisions intended to meet each requirement in sections 18973, 18973.1, 18973.2, 18973.3, 18973.4, 18973.5, 18973.6, 18974, 18974.1, 18974.2, and 18974.3 of this Article, as applicable to each document, and if it contains sufficient detail for the department to determine if the requirements in the referenced sections have been met.

(c) Should it be necessary for the department to consult with or submit a stewardship plan to the State Board of Pharmacy or other agencies for review of completeness or approval, the duration of time this takes the department shall not count toward the 30-day review to determine completeness or 90-day review to determine approval, conditional approval, or disapproval.

(d) The department shall approve a document if it determines that the documents meets all material requirements in sections 18973, 18973.1, 18973.2, 18973.3, 18973.4, 18973.5, 18973.6, 18974, 18974.1, 18974.2, and 18974.3 of this Article, as applicable to each document.

(e) The department shall conditionally approve a document if it determines that the document is substantially compliant with all material requirements in sections 18973, 18973.1, 18973.2, 18973.3, 18973.4, 18973.5, 18973.6, 18974, 18974.1, 18974.2, and 18974.3 of this Article, as applicable to each document, but additional information from and/or additional actions by the program operator are necessary.

(f) The department shall disapprove a document if it determines that the document is not substantially compliant with all material requirements in sections 18973, 18973.1, 18973.2, 18973.3, 18973.4, 18973.5, 18973.6, 18974, 18974.1, 18974.2, and 18974.3 of this Article, as applicable to each document.

(g) If the department conditionally approves a stewardship plan, the department shall identify the condition(s) to be met for approval and provide written notice to the program operator within 30 days of conditional approval. The program operator shall comply with the conditions in that notice as specified. If the conditions are not met, the department shall notify the program operator that the plan is deemed disapproved and the covered entities operating under the stewardship plan are not in compliance until the program operator submits a stewardship plan the department approves.

(h) If the department disapproves a stewardship plan, the department shall explain how the stewardship plan does not comply and provide written notice to the program operator within 30 days of disapproval. The program operator shall resubmit a revised stewardship plan within 60 days of the disapproval date the written notice was issued, and the department will review the revised stewardship plan within 90 days of resubmittal. If a revised stewardship plan is disapproved by the department, the covered entities operating under the stewardship plan are not in compliance until the program operator submits a stewardship plan that the department approves.

(i) 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. Any significant changes to an approved stewardship plan shall be submitted to the department in accordance with the requirements of section 18973. The program operator shall also include a re-certification that the stewardship plan containing the significant changes is compliant with all applicable laws and regulations, in accordance with section 18973.2(e)(2) or 18973.3(d)(2), as applicable.

(j) If the department conditionally approves an annual report or program budget, the department shall identify the condition(s) to be met for approval and provide written notice to the program operator within 30 days of conditional approval. The program operator shall comply with the conditions in that written notice within 60 days of the date the written notice was issued, unless the Director of the Department of Resources Recycling and Recovery determines that additional time is needed. If the program operator does not comply and the conditions are not met within 60 days of the date the written notice was issued for a conditional approval, the department shall disapprove the annual report or program budget.

(k) If the department disapproves an annual report or program budget, the department shall identify how the annual report or program budget does not comply and provide written notice to the program operator within 30 days of disapproval. The program operator shall resubmit a revised annual report or program budget and provide any supplemental information requested within 60 days of the date the written notice was issued.

(l) The department's review of any resubmitted documents shall follow the process outlined in subdivisions (a) through (k) above.

(m) A program operator shall fully implement operation of an approved stewardship program no later than 270 days after approval by the department of the stewardship plan that establishes the stewardship program.