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Beginning 60 days after the effective date of this Division I, each Drug Wholesaler that sells any Covered Drug in the City must provide a list of the Producers of those Covered Drugs to the Director in a form prescribed by the Director. Wholesalers must update and resubmit the list in response to a request from the Director, within 15 days of receiving such request.
(a) By one year after the effective date of this Division I each Producer, group of Producers or Stewardship Organization shall submit its proposed Stewardship Plan to the Director for review, accompanied by the plan review fee in accordance with Section 2215 of this Division I. The Director may upon request provide information, counseling, and technical assistance about the requirements of this Division I to assist with the development of a proposed Stewardship Plan.
(b) The Director shall review the proposed Stewardship Plan and determine whether it meets the requirements of this Division I. In reviewing a proposed Stewardship Plan, the Director shall provide an opportunity tor written public comment on the proposed Stewardship Plan and consider any comments received.
(c) After the review under subsection (b) of this Section 2211 and within 90 days after receipt of the proposed Stewardship Plan, the Director shall either approve or reject the proposed Stewardship Plan in writing and, if rejected, provide reasons for the rejection.
(d) If the Director rejects a proposed Stewardship Plan, a Producer, group of Producers, or Stewardship Organization must submit a revised Stewardship Plan to the Director within 60 days after receiving written notice of the rejection. The Director shall review and approve or reject a revised Stewardship Plan as provided under subsections (b) and (c) of this Section 2211.
(e) If the Director rejects a revised Stewardship Plan, or any subsequently revised plan, the Director may deem the Producer or group of Producers out of compliance with this Division I and subject to the enforcement provisions in this Division I.
(f) In approving a proposed Stewardship Plan, the Director may exercise reasonable discretion to waive strict compliance with the requirements of this Division I that apply to Producers in order to achieve the objectives of this Division I.
(g) The Director shall make all Stewardship Plans and proposed plans submitted under this Section 2211 available to the public.
(a) Proposed changes to an approved Stewardship Plan that substantively alter plan operations, including, but not limited to, changes to disposal facilities, collection methods, achievement of the service convenience goal, policies and procedures for handling Unwanted Covered Drugs, or education and promotion methods or disposal facilities, must be approved in writing by the Director before the changes are implemented.
(b) A Producer or group of Producers participating in a Stewardship Plan shall submit to the Director any proposed change to a Stewardship Plan as described under subsection (a) of this Section 2212 in writing at least 30 days before the change is scheduled to occur and accompanied by the review fee in accordance with Section 2215 of this Division I.
(c) The plan operator of an approved Stewardship Plan shall notify the Director at least 15 days before implementing any changes to drop-off site locations, methods for scheduling and locating periodic collection events, or methods for distributing prepaid, pre-addressed mailers, that do not substantively alter achievement of the service convenience goal under Section 2205(c) of this Division I, or other changes that do not substantively alter plan operations under subsection (a) of this Section 2212.
(d) The plan operator may request an advance determination from the Director whether a proposed change would be deemed to substantively alter plan operations.
(a) The Director shall administer the penalty provisions of this Division I.
(b) If the Director determines that any Person has violated this Division I or a regulation adopted pursuant to this Division I the Director shall send a written warning, as well as a copy of this Division I and any regulations adopted pursuant to this Division I, to the Person or Persons who violated it. The Person or Persons shall have 30 days after receipt of the warning to come into compliance and correct all violations.
(c) If the Person or Persons fail to come into compliance or correct all violations, the Director may impose administrative fines for violations of this Division I or of any regulation adopted pursuant to this Division I. San Francisco Administrative Code Chapter 100, "Procedures Governing the Imposition of Administrative Fines," as amended, is hereby incorporated in its entirety and shall govern the imposition, enforcement, collection, and review of administrative citations issued to enforce this Division I or any rule or regulation adopted pursuant to this Division I. Each day shall constitute a separate violation for these purposes.
(d) The City Attorney, a Producer, or any organization with tax exempt status under 26 United States Code Section 501(c)(3) or 501(c)(4) and with a primary mission of protecting the environment in the San Francisco Bay Area may bring a civil action to enjoin violations of or compel compliance with any requirement of this Division I or any rule or regulation adopted pursuant to this Division I, as well as for payment of civil penalties and any other appropriate remedy. The court shall award reasonable attorney's fees and costs to the City Attorney, Producer, or a nonprofit organization that is the prevailing party in a civil action brought under this subsection (d). A Producer or nonprofit organization may institute a civil action under this subsection (d) only if:
(1) The Producer or nonprofit organization has filed a Complaint with the Director;
(2) 90 days have passed since the filing of the Complaint;
(3) After such 90-day period has passed, the Producer or nonprofit organization provides 30-day written notice to the Director and the City Attorney's Office of its intent to initiate civil proceedings; and
(4) The City Attorney's Office has not provided notice to the Producer or nonprofit organization of the City's intent to initiate civil proceedings by the end of the 30-day period.
(e) Any Person who knowingly and willfully violates the requirements of this Division I or any rule or regulation adopted pursuant to this Division I is guilty of a misdemeanor and upon conviction thereof is punishable by a fine of not less than fifty dollars ($50) and not more than five hundred ($500) for each day per violation, or by imprisonment in the County Jail for a period not to exceed six months, or by both such fine and imprisonment.
(f) Any Person in violation of this Division I or any rule or regulation adopted pursuant to this Division I shall be liable to the City for a civil penalty in an amount not to exceed one thousand dollars ($1,000) per day per violation. Each day in which the violation continues shall constitute a separate violation. Civil penalties shall not be assessed pursuant to this subsection (f) for the same violations for which the Director assessed an administrative penalty pursuant to subsection (c) of this Section 2213.
(g) In determining the appropriate penalties, the court or the Director shall consider the extent of harm caused by the violation, the nature and persistence of the violation, the frequency of past violations, any action taken to mitigate the violation, and the financial burden to the violator.
(h) No criminal, civil or administrative action under this Section 2213 may be brought more than four years after the date of the alleged violation.
(a) The Director, following public notice and a hearing, may adopt rules necessary to implement, administer, and enforce this Division I.
(b) The Director may work with the Stewardship Plan operator to define goals for collection amounts, education, and promotion for a Stewardship Plan.
(c) The Director shall report biennially to the Board of Supervisors concerning the status of all Stewardship Plans and recommendations for changes to this Division I. The biennial report may also include a summary of available data on indicators and trends of abuse, poisonings and overdoses from prescription and nonprescription drugs and a review of comprehensive prevention strategies to reduce risks of drug abuse, overdoses, and preventable poisonings. The first report shall be due two years from the effective date of this Division I.
(a) The Board of Supervisors authorizes the Director to charge the fees identified in this Division I. A Producer or group of Producers participating in a Stewardship Plan shall pay to the Director plan review fees to be established under subsection (d) of this Section 2215 for:
(1) Review of a proposed Stewardship Plan;
(2) Resubmittal of a proposed Stewardship Plan;
(3) Review of changes to an approved Stewardship Plan;
(4) Submittal of an updated Stewardship Plan at least every four years under Section 2203(d)(5) of this Division I; or
(5) Review of any petition for approval to use alternative final disposal technologies under Section 2207(c) of this Division I.
(b) In addition to plan review fees, a Producer or group of Producers participating in a Stewardship Plan shall pay to the Director annual operating fees to be established under subsection (d) of this Section 2215.
(c) A plan operator or a Stewardship Organization may remit the plan review fee on behalf of participating Producers.
(d) As soon as practicable, the Director shall propose to the Commission on the Environment a schedule of fees charged to a Producer or group of Producers to cover costs of administering and enforcing this Division I. The Director shall set the fees to recover but not exceed actual costs to the City. The Commission of the Environment must approve the schedule of fees for it to become effective. The Controller shall confirm that the fees set by the Director do not exceed the actual costs to the City.
In adopting and implementing this Division I, the City is assuming an undertaking only to promote the general welfare. It is not assuming, nor is it imposing on its officers and employees, an obligation for breach of which it is liable in money damages to any Person who claims that such breach proximately caused injury.
This Division I shall be construed so as not to conflict with applicable federal or State laws, rules or regulations. Nothing in this Division I shall authorize any City agency or department to impose any duties or obligations in conflict with limitations on municipal authority established by State or federal law at the time such agency or department action is taken. The City shall suspend enforcement of this Division I to the extent that said enforcement would conflict with any preemptive State or federal legislation subsequently adopted. Nothing in this Division I is intended or shall be construed to protect anti-competitive or collusive conduct, or to modify, impair, or supersede the operation of any of the antitrust or unfair competition laws of the State of California or the Unites States.
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