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(a) This Division I does not require any Person to serve as a Collector in a Stewardship Plan. A Person may offer to serve as a Collector voluntarily, or may agree to serve as a Collector in exchange for incentives or payment offered by a Producer, group of Producers or Stewardship Organization. Collectors may include law enforcement agencies, Pharmacies, mail-back services or other entities, operating in accordance with state and federal laws and regulations for the handling of Covered Drugs, including but not limited to those of the United States Drug Enforcement Administration, and in compliance with this Division I. A Pharmacy collection site shall operate under applicable rules and guidelines of the State of California Board of Pharmacy.
(b) The collection system for each Stewardship Plan shall:
(1) Provide reasonably convenient and equitable access for all City residents in all Supervisorial Districts. The system of drop-off sites shall provide at least five drop-off sites in every Supervisorial District, geographically distributed to provide reasonably convenient and equitable access. If the service convenience goal in this subsection (b)(1) cannot be achieved due to a lack of drop-off sites at pharmacies, law enforcement agencies, or other qualified Collectors in each Supervisorial District, then those areas shall be served through periodic collection events and/or mail-back services;
(2) Be safe and secure, including providing for the prompt destruction of patient information on Drug packaging;
(3) Give preference to having Retail Pharmacies and law enforcement agencies serve as drop-off sites;
(4) Include, as Collectors, any Retail Pharmacy or any law enforcement agency willing to serve voluntarily as a drop-off site for Unwanted Covered Drugs and able to meet the requirements of this Division I within three months of their offer to participate, unless the Collector requests a longer time frame. A Stewardship Plan may also accept other Collectors willing to serve as a drop-off site for Unwanted Covered Drugs and able to meet the requirements of this Division I; and
(5) Make mail-back services available, free of charge, to disabled and home-bound residents upon request through the Stewardship Plan's toll-free telephone number and web site, and through distribution of prepaid, pre-addressed mailers to Persons providing services to such residents. The toll-free telephone number and web site required by this subsection (b)(5) shall be in English, Spanish, Chinese, Russian, and Tagalog.
(c) In addition to the collection system described in subsection (b)(1), all stewardship plans shall jointly operate a drop-off site within each City-owned pharmacy.
(d) Drop-off sites shall accept all Covered Drugs from City residents during all hours that the Retail Pharmacy, law enforcement agency, or other Collector is normally open for business with the public. Drop-off sites not operated by a law enforcement agency shall utilize secure collection bins in compliance with all applicable requirements, including but not limited to those of the United States Drug Enforcement Administration and the State of California Board of Pharmacy. In the event that more than one Stewardship Plan operates a drop-off site at a particular location, each drop-off site must accept all Covered Drugs.
(a) All Stewardship Plans shall coordinate with each other and develop a single system of promotion that shall:
(1) Promote the Stewardship Plans so that collection options for Covered Drugs are widely understood by residents, pharmacists, retailers of Covered Drugs and health care practitioners including doctors and other prescribers, veterinarians and veterinary hospitals, and promote the safe storage of Covered Drugs by City residents;
(2) Work with Collectors participating in Stewardship Plans to develop clear, standardized instructions for City residents on the use of collection bins and a readily-recognizable, consistent design of collection bins;
(3) Establish a single toll-free telephone number and single web site where collection options and current locations of drop-off sites will be publicized, and prepare educational and outreach materials promoting safe storage of medicines and describing where and how to return Unwanted Covered Drugs to the Stewardship Plan. These materials must be provided to Pharmacies, health care facilities, veterinary facilities, and other interested parties for dissemination to City residents. Plain language and explanatory images should be used to make use of medicine collection services readily understandable by all residents, including individuals with limited English proficiency;
(4) Conduct a biennial survey of City residents and a survey of pharmacists, veterinarians, and health professionals in the City who interact with patients on use of medicines after the first full year of operation of the plans. Survey questions shall measure percent awareness of the Stewardship Plans, assess to what extent drop-off sites and other collection methods are convenient and easy to use, and assess knowledge and attitudes about risks of abuse, poisonings and overdoses from prescription and nonprescription medicines used in the home. Draft survey questions shall be submitted to the Director tor review and comment at least 30 days prior to initiation of the survey. Results of the survey shall be reported to the Director and made available to the public on the website required in this Section 2206 within 90 days of the end of the survey period. The privacy of all survey respondents shall be maintained.
(b) All surveys, outreach, education, promotion, web sites, and toll-free phone numbers required by this Section 2206 shall be in English. Spanish. Chinese, Russian, and Tagalog.
(c) The Director shall provide guidance on the development of a single system of promotion.
Covered Drugs collected under a Stewardship Plan must be disposed of at a permitted waste disposal facility operating in compliance with all local, state, and Federal requirements applicable to that waste disposal facility. For purposes of this Section, the Director shall determine that a waste disposal facility is in compliance with all local, state, and federal requirements applicable to that waste disposal facility if no local, state, or federal agency with jurisdiction over that facility has issued a notice finding a violation by the facility in the preceding 12-month period.
(a) A Producer or group of Producers participating in a Stewardship Plan shall pay all administrative and operational costs related to their Stewardship Plan, except as provided under this Section 2208. Administrative and operational costs related to the Stewardship Plan include but are not limited to the following:
(1) Collection and transportation supplies for each drop-off site;
(2) Acquisition of all secure collection bins for drop-off sites;
(3) Ongoing maintenance or replacement of secure collection bins, as requested by Collectors;
(4) Prepaid, pre-addressed mailers provided to disabled and/or home-bound residents;
(5) Operation of periodic collection events, including costs of law enforcement staff time if necessary;
(6) Transportation of all collected Covered Drugs to final disposal, including costs of law enforcement escort if necessary;
(7) Environmentally sound disposal of all collected Covered Drugs under Section 2207 of this Division I;
(8) Program promotion under Section 2206 of this Division I; and
(9) Costs related to any review of a Product Stewardship Plan for purposes of obtaining compliance with the California Environmental Quality Act (Cal. Pub. Res. Code §§ 21000 et seq.).
(b) No Person or Producer may charge a point-of-sale fee to consumers to recoup the costs of their Stewardship Plan, nor may they charge a specific point-of-collection fee at the time the Covered Drugs are collected.
(c) Producers are not required to pay for costs of staff time at drop-off sites provided by Collectors volunteering to participate in a Stewardship Plan.
(a) Within six months after the end of the first 12-month period of operation, and annually thereafter, the plan operator of a Stewardship Plan shall submit a report to the Director on behalf of participating Producers describing their plan’s activities during the previous reporting period. The report must include:
(1) A list of Producers participating in the Stewardship Plan;
(2) The amount, by weight, of Covered Drugs collected, including the amount by weight from each collection method and disposal facility used;
(3) A list of drop-off sites;
(4) The number of mailers provided for disabled and/or home-bound residents;
(5) The locations where mailers were provided, if applicable;
(6) The dates and locations of collection events held, if applicable;
(7) The transporters used and the disposal facility or facilities used for all Covered drugs and the compliance status of each disposal facility used;
(8) Whether any safety or security problems occurred during collection, transportation, or disposal of Unwanted Covered Drugs during the reporting period and, if so, what changes have been or will be made to policies, procedures, or tracking mechanisms to alleviate the problem and to improve safety and security in the future;
(9) A description of the public education, outreach, and evaluation activities implemented during the reporting period;
(10) A description of how collected packaging was recycled to the extent feasible, including the recycling facility or facilities used;
(11) A summary of the Stewardship Plan’s goals, the degree of success in meeting those goals in the past year, and, if any goals have not been met, what effort will be made to achieve the goals in the next year; and
(12) The total expenditures of the Stewardship Plan during the reporting period.
(b) The Director shall make reports submitted under this Section 2209 available to the public.
(c) For the purposes of this Section 2209, “reporting period” means the period from January 1 through December 31 of the same calendar year, unless otherwise specified to the plan operator by the Director.
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.
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