Document elcerrito_gov_doc_3ea6a97837

AGENDA BILL Agenda Item No. 5(G) Date: April 1, 2014 To: El Cerrito City Council From: Garth Schultz, Operations + Environmental Services Manager Yvetteh Ortiz, Interim Public Works Director / City Engineer Subject: Support for Senate Bill 1014 (Jackson) Safe and Convenient Medication Disposal ACTION REQUESTED Authorize Mayor Abelson to sign and send letters to the authors and other appropriate legislators and legislative bodies in support of Senate Bill 1014 (SB1014) requiring producers of pharmaceuticals to create, finance, and manage a collection system for California consumers to safely and conveniently take-back unwanted pharmaceuticals. DISCUSSION Research has shown that prescription drug abuse has skyrocketed in recent years, as have hospitalizations for drug overdoses. One of the four top recommendations of the National Strategy on Preventing Prescription Drug Abuse is to have a safe and convenient method of disposal for over the counter drugs, prescriptions, and veterinary medications that we have in our homes. In response to the growing problems of prescription drug abuse, accidental poisonings, and the detection of pharmaceutical products in California waters, local governments throughout the state have struggled to establish safe and convenient medication take-back programs. The public demand and need for such programs has been tremendous - even limited programs have collected hundreds of pounds of drugs. Law enforcement, federal agencies, public health, and environmental professionals agree that take-back programs are the safest way to dispose of unused pharmaceuticals. Establishing these disposal programs on a city-by-city (or county) basis is haphazard, inefficient, and expensive for local ratepayers. It also means that not all consumers have access to take-back locations, perpetuating a lack of harmonized messaging to the public about safe drug disposal. In addition, the lack of safe and convenient disposal options ensures that consumers choose less than desirable options including home storage of medications, flushing medications down the toilet or throwing them in the garbage. To address these issues, Alameda County was the first jurisdiction in the country to pass an ordinance requiring drug manufacturers to develop, implement, and finance a convenient drug take-back program for residents. Despite operating similar programs in Canada and other countries, three pharmaceutical associations responded by suing Alameda County. The County prevailed at the trial court level, however the case is now being considered by the Ninth Circuit ---PAGE BREAK--- Agenda Item No. S(G) Court of Appeals. King County in Washington adopted a similar ordinance in July 2013 and was then sued by the same associations. Fortunately, El Cerrito residents already have daily access to safe disposal of unwanted medications at the City Recycling + Environmental Resource Center, thanks to a partnership with the East Bay Municipal Utility District. This collection program collects over 300 lbs. of medications each month from thousands of community members every year, with participation continually increasing. SB1014 would ensure the sustainability of El Cerrito's collection program well into the future. STRATEGIC PLAN CONSIDERATIONS If SB 1014 were to be passed and implemented in its current form, the resulting policies could help the City meet the intent of the City ofEl Cerrito's Strategic Plan's Goal B: "Achieve long- term financial sustainability." Specifically, the resulting policies could contribute to achieving the following strategies: • Track and promote state and federal legislation that would create new funding opportunities: Though not strictly a funding opportunity, successful implementation of SB 1014 would potentially reduce City expenses, freeing up existing funds to be used for other purposes. ENVIRONMENTAL CONSIDERATIONS There is no direct environmental impact associated with supporting SB1014. If SB1014 were to be passed and implemented in its current form, the resulting programs could help El Cerrito keep future costs of pharmaceutical collections negligible, and would improve statewide environmental quality by expanding collection programs throughout the state. FINANCIAL CONSIDERATIONS There is no financial obligation associated with the requested action. . Scott Hanin, City Manager Attachments: 1. SB 1014 Support Letter 2. Legislative information for SB 1014 ---PAGE BREAK--- OFFICE OF THE MAYOR Janet Abelson CITY HALL 10890 San Pablo Avenue, El Cerrito, CA 94530 Telephone (510) 215-4305 Fax (510) 215-4319 http://www.el-cerrito.org April 1, 2014 Senator Hannah-Beth Jackson State Capitol, Room 5080 Sacramento, CA 95814 RE: Senate Bill 1014 (Jackson) Safe and Convenient Medication Disposal Dear Senator Jackson, The City Council of the City of El Cerrito strongly supports Senate Bill 1014 (SB 1014), which asks producers of pharmaceuticals to create, finance, and manage a collection system for California consumers to safely and conveniently dispose of expired and unwanted pharmaceuticals – a system structured after the existing program in Canada which the industry has efficiently operated for 15 years. Many communities lack opportunities for safe and convenient disposal of their unwanted pharmaceuticals, which can result in risky home storage, flushing medications down the commode, or depositing them in landfills. Fortunately, El Cerrito residents already have daily access to safe disposal of unwanted medications at our City Recycling + Environmental Resource Center, thanks to a partnership with the East Bay Municipal Utility District. This pharmaceutical program collects over 300 lbs. of medications each month from thousands of community members every year, with participation continually increasing. El Cerrito’s experience demonstrates why SB 1014 is necessary in California. Collection programs of any sort are most successful when there are multiple convenient opportunities for individuals to participate in, and when participation is free. SB 1014 springboards off of the good work already being done by pharmaceutical companies in Canada and Europe. SB 1014 is a free-market approach that allows manufacturers to design the program in whatever way is most cost effective – with minimal oversight from state regulators. We know that this program will work due to public surveys conducted in Canada that have demonstrated public awareness and use of the program, the volume of medications collected, and the fact that 96% of Canadian pharmacies host collection bins. SB 1014 is the right solution to this pressing problem because it creates a privately managed and financed system to allow consumers to properly and conveniently dispose of their unwanted pharmaceuticals. For these reasons, the El Cerrito City Council supports SB 1014. Sincerely, Janet Abelson, Mayor City of El Cerrito cc: Senator Kevin de Leon, via fax: (916) 651-4922 Senator Jerry Hill, via fax (916) 651-4913 Agenda Item No. 5(G) Attachment 1 ---PAGE BREAK--- Bill Summary In an effort to manage the clear societal and environmental end-of-life impacts of medications, SB 1014 would require producers of pharmaceuticals, as defined, to create, finance and manage a collection system for California consumers to safely and conveniently take-back unwanted pharmaceuticals - a system structured after an existing program in Canada which the industry has efficiently operated for 15 years. Background In response to the growing problems of prescription drug abuse, accidental poisonings, and the detection of pharmaceutical products in California waters, local governments throughout the state have struggled to establish safe and convenient medication take-back programs. The public demand and need for such programs has been tremendous - even limited programs have collected hundreds of pounds of drugs. Law enforcement, federal agencies, public health and environmental professionals agree that take-back programs are the safest way to dispose of unused medicines. Establishing these disposal programs on a city by city (or county) basis is haphazard, inefficient and expensive for local ratepayers. It also means that not all consumers have access to take-back locations, perpetuating a lack of harmonized messaging to the public about safe drug disposal. To address these issues, Alameda County was the first jurisdiction in the country to pass an ordinance requiring drug manufacturers to develop, implement, and finance a convenient drug take-back program for residents. Despite operating similar programs in Canada and other countries, three pharmaceutical associations responded by suing Alameda County. The County prevailed at the trial court level and the case is now being considered by the Ninth Circuit Court of Appeals. King County Washington adopted a similar ordinance in July 2013 and was then sued by the same associations. The Problem(s) The simple truth is that drugs – both prescription and over the counter – present significant problems at the end of their useful life. Consumers do indeed have leftover drugs in their homes which tend to be stockpiled, flushed, or thrown in the garbage. Unfortunately, the lack of an end-of-life management plan results in significant problems for California: Prescription Drug Abuse – Prescription drug abuse has skyrocketed in recent years,1 as have hospitalizations and deaths from overdoses.2 In fact, opioid pain relievers were involved in more drug poisoning deaths than other drugs, including heroin and cocaine3. One of the four top recommendations of the National Strategy on Preventing Prescription Drug Abuse is to have a safe and convenient method of disposal for prescription drugs, over the counter drugs, and veterinary medicines that we have in our homes. The lack of take-back locations forces consumers to choose less than desirable options according to the EPA’s letter dated 9/26/20124, including home storage, flushing medications down the toilet or throwing them in the garbage. Environmental Impacts – Pharmaceutical products enter our waters by excretion, consumer disposal of unused medications down the toilet or drain, or wastewater siphoned by landfills and discharged into the environment. Numerous studies in California have found detectible levels of pharmaceuticals, including 1 California State Task Force on Prescription Drug Misuse. (2009, March 30). Summary Report and Recommendations on Prescription Drugs: Misuse, Abuse and Dependency. Retrieved from State of California Alcohol and Drug Programs: www.adp.ca.gov/director/pdf/Prescription_Drug_Task_Force.pdf 2 O'Callaghan, T. (2010, April More people hospitalized for prescription drug overdose. Retrieved from Time: http://healthland.time.com/2010/04/06/more-people-hospitalized-for-prescription-drug-overdose/#ixzz2fkIm3CMT 3 Centers for Disease Control and Prevention Fact Sheet on Drug Poisoning Deaths: http://www.cdc.gov/nchs/data/factsheets/factsheet_drug_poisoning.htm 4 EPA Letter dated 9/26/2012 outlining disposal options and best practices: http://www.epa.gov/osw/hazard/generation/pharmaceuticals/pharms- take-back-disposal.pdf Senate Bill 1014 Safe and Convenient Medication Disposal Senator Hannah-Beth Jackson Agenda Item No. 5(G) Attachment 2 ---PAGE BREAK--- birth control, antibiotics, mood stabilizers, and analgesics in San Francisco Bay, as well as both surface and groundwater drinking water sources.5 The environmental impacts on aquatic species are very real even at trace levels, including reproductive failure, behavioral changes that impair their ability to survive, and bioaccumulation and interference with the food chain.6 While the potential impacts on humans exposed through drinking water or by eating contaminated fish are not well studied, scientists are concerned with unknowns such as low dose exposures over long periods of time, effects on vulnerable populations such as infants, and cumulative impacts of drug mixtures. Since wastewater treatment cannot remove these chemicals completely and is cost prohibitive, stopping their entry into our water at the source is one important step in protecting our precious water resources. Cost to Local Governments – For too long, municipal governments have cobbled together local collection options that fail to meet public demand for safe take-back, draw resources from other vital government functions, create a patchwork of regulations, and fail to realize the efficiency that would come from a statewide program. Some counties don’t offer drug take-back sites because they lack the budget - and even those that do have programs are limited. Alameda County, for example, has 28 drop-off locations, but estimates it needs at least 60 locations to meet public demand. Solution SB 1014 springboards off of the good work already being done by pharmaceutical companies in Canada and Europe. It is a free market approach that allows manufacturers to design the program in whatever way is most cost effective, with minimal oversight from state regulators. The success of this stewardship model is evidenced by public surveys in Canada demonstrating the strong public awareness and participation in the program7, the volumes of collected medications, and the fact that 96% of the pharmacies voluntarily host collection bins. This bill would require pharmaceutical manufacturers to submit a stewardship plan to CalRecycle for approval on how they will design and operate the take-back program to meet the standards in the legislation. Manufacturers would then implement the program and report to CalRecycle annually on progress. The stewardship plan would be updated every three years. Co-Sponsors Alameda County City and County of San Francisco California Alliance of Retired Americans (CARA) California Product Stewardship Council (CPSC) Clean Water Action (CWA) Contacts Linda Barr, Office of Jason Schmelzer Nicole Wordelman Senator Hannah-Beth Jackson Shaw/Yoder/Antwih, Inc. Platinum Advisors [PHONE REDACTED] [PHONE REDACTED] [PHONE REDACTED] [EMAIL REDACTED] [EMAIL REDACTED] [EMAIL REDACTED] 5 Kolpin, Dana et al. (2002) Pharmaceuticals, hormones and other organic wastewater contaminants in U.S. Streams, 99-2000: A National Reconnaissance, Environmental Science and Technology v. 36:1202-1211. Donn, Je, Martha Mendoza/Justin Pritchard, AP Investigation: Pharmaceuticals Found in Drinking Water. http://hosted.ap.org/specials/interactives/pharmawater_site/day1_04.html, Fram, Miranda S. and Kenneth Belitz (2011) Occurrence and concentrations of pharmaceutical compounds in groundwater used for public drinking-water supply in California, Science of the Total Environment v. 409: 3409-3417. Guo, Y.Carrie et al. (2010) Source, Fate, and Transport of Endocrine Disruptors, Pharmaceuticals, and Personal Care Products in Drinking Water Sources in California, The National Water Research Institute. Harrold, K.H. et al. (2009). Pharmaceutical Concentrations in Wastewater Treatment Plant Influent and Effluent and Surface Waters of Lower South San Francisco Bay. SFEI Contribution 549. San Francisco Estuary Institute, Oakland, CA. 6 Klosterhaus, S.L. et al. (2013) Method validation and reconnaissance of pharmaceuticals, personal care products, and in surface waters, sediments, and mussels in an urban estuary, Environment International v. 54: 92-99. Barber, Larry B. et al. (2011) E_ects of biologically- active chemical mixtures on fish in a wastewater-impacted urban stream. Science of the Total Environment v. 409: 4720-4728. Brodin T. (2013), Dilute Concentrations of a drug alter behavior of fish from natural populations. Science v. 339: 814-15. 7 British Columbia med program public survey results from 2010: ---PAGE BREAK--- SENATE BILL No. 1014 Introduced by Senator Jackson February 13, 2014 An act to add Section 4068.1 to the Business and Professions Code, to amend Section 117700 of, and to add Section 117670.1 to, the Health and Safety Code, and to add Article 3.4 (commencing with Section 47120) to Chapter 1 of Part 7 of Division 30 of the Public Resources Code, relating to pharmaceutical waste. legislative counsel’s digest SB 1014, as introduced, Jackson. Pharmaceutical waste: home-generated. The Department of Resources Recycling and Recovery was required, pursuant to provisions repealed on January 1, 2013, to develop, in consultation with appropriate state, local, and federal agencies, model programs for the collection and proper disposal of drug waste. This bill would enact the Home-Generated Pharmaceutical Waste Collection Disposal Act and would define terms for purposes of the act. The bill would require a producer of covered pharmaceuticals to submit to the Department of Resources Recycling and Recovery, by July 1, 2015, except as specified, a product stewardship plan and would authorize one or more producers to submit a plan or designate a stewardship organization to act as an agent on behalf of the producers to submit a plan. The bill would require the stewardship plan to contain specified elements with regard to the collection and disposal of home-generated pharmaceutical waste, including provisions for the payment of all administrative and operational fees associated with the product stewardship program. The bill would specify procedures for the approval of the plan by the department and would require a producer, group of producers, or 99 ---PAGE BREAK--- stewardship organization operating a stewardship program to take specified actions with regard to the disposal of home-generated pharmaceutical waste and promoting product stewardship programs to consumers, pharmacists, retailers of covered pharmaceuticals, and health care practitioners. The bill would require a producer, group of producers, or stewardship organization operating a product stewardship program to prepare and submit to the department an annual written report describing the program’s activities during the previous calendar year by July 1, 2016, or at a later date as approved by the department, and on or before July 1 annually thereafter. The bill would authorize the department to adopt regulations to implement the act and would require the department to adopt regulations to provide for the appropriate management of consolidated home-generated pharmaceutical waste, to establish a schedule of fees to be charged to cover the department’s costs of administering and enforcing the act, and to adopt a schedule setting the amounts of administrative civil penalties that the department would be authorized to impose. The bill would require a producer, group of producers, or a stewardship organization submitting a plan to the department to pay the fees set by the department and would require the department to deposit the fees into the Home-Generated Pharmaceutical Waste Program Account, which the bill would create in the Integrated Waste Management Fund. The department would be authorized to expend the fees, upon appropriation by the Legislature, to administer and enforce the act. The bill would authorize the department to issue an administrative order to, or impose a civil penalty upon, a producer who is in violation of the act or a regulation adopted pursuant to the act. The bill would require the department to deposit the penalties into the Home-Generated Pharmaceutical Waste Penalty Account, which the bill would create in the Integrated Waste Management Fund, and would authorize the department to expend the moneys in that account, upon appropriation by the Legislature, to enforce the act. The Medical Waste Management Act, administered by the State Department of Public Health, regulates the management and handling of medical waste, including pharmaceutical waste, as defined. Existing law defines the term medical waste and excludes certain types of waste from that definition. 99 — 2 — SB 1014 ---PAGE BREAK--- This bill would define the term “home-generated pharmaceutical waste” for purposes of that act. The bill would exclude, from the definition of medical waste, home-generated pharmaceutical waste that is handled by a collection and disposal program operating in accordance with the act specified above. This exclusion would not become operative until the Secretary of State posts a notice regarding the effective date of the regulations that the department is required to adopt pursuant to that act. The Pharmacy Law provides for the licensure and regulation of pharmacists and pharmacy establishments by the California State Board of Pharmacy, and makes a knowing violation of that law a misdemeanor. The bill would also authorize a pharmacy to accept the return of home-generated pharmaceutical waste from a consumer, consistent with specified federal laws. Because a knowing violation of this provision would be a crime, the bill would impose a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes. The people of the State of California do enact as follows: line 1 SECTION 1. Section 4068.1 is added to the Business and line 2 Professions Code, to read: line 3 4068.1. A pharmacy may accept the return of home-generated line 4 pharmaceutical waste, as defined in Section 117670.1 of the Health line 5 and Safety Code, from a consumer, consistent with the Federal line 6 Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) and line 7 the Controlled Substances Act (21 U.S.C. Sec. 801 et seq.). line 8 SEC. 2. Section 117670.1 is added to the Health and Safety line 9 Code, to read: line 10 117670.1. “Home-generated pharmaceutical waste” means a line 11 prescription or over-the-counter human or veterinary line 12 home-generated pharmaceutical, including, but not limited to, a line 13 drug, as defined in Section 109925 or in Section 321(g)(1) of Title line 14 21 of the United States Code, that is a waste, as defined in Section 99 SB 1014 — 3 — ---PAGE BREAK--- line 1 25124, derived from a household, including, but not limited to, a line 2 multifamily residence or household. line 3 SEC. 3. Section 117700 of the Health and Safety Code is line 4 amended to read: line 5 117700. Medical waste does not include any of the following: line 6 Waste generated in food processing or biotechnology that line 7 does not contain an infectious agent as defined in Section 117675. line 8 Waste generated in biotechnology that does not contain line 9 human blood or blood products or animal blood or blood products line 10 suspected of being contaminated with infectious agents known to line 11 be communicable to humans. line 12 Urine, feces, saliva, sputum, nasal secretions, sweat, tears, line 13 or vomitus, unless it contains fluid blood, as provided in line 14 subdivision of Section 117635. line 15 Waste which is not biohazardous, such as paper towels, line 16 paper products, articles containing nonfluid blood, and other line 17 medical solid waste products commonly found in the facilities of line 18 medical waste generators. line 19 Hazardous waste, radioactive waste, or household waste, line 20 including, but not limited to, home-generated sharps waste, as line 21 defined in Section 117671. line 22 Waste generated from normal and legal veterinarian, line 23 agricultural, and animal livestock management practices on a farm line 24 or ranch. line 25 (1)Home-generated pharmaceutical waste, including, but line 26 not limited to, consolidated home-generated pharmaceutical waste, line 27 that is handled by a collection and disposal program operating in line 28 accordance with Article 3.4 (commencing with Section 47120) of line 29 Chapter 1 of Part 7 of Division 30 of the Public Resources Code. line 30 The Department of Resources Recycling and Recovery shall line 31 notify the Secretary of State of the effective date of the regulations line 32 adopted pursuant to subdivision of Section 47129 of the Public line 33 Resources Code. The Secretary of State shall post this notification line 34 on its Internet Web site within 15 days after receiving that notice. line 35 Paragraph shall not become operative until the Secretary line 36 of State posts the notice described in paragraph on its Internet line 37 Web site. line 38 SEC. 4. Article 3.4 (commencing with Section 47120) is added line 39 to Chapter 1 of Part 7 of Division 30 of the Public Resources Code, line 40 to read: 99 — 4 — SB 1014 ---PAGE BREAK--- line 1 Article 3.4. Home-Generated Pharmaceutical Waste Collection line 2 and Disposal line 3 line 4 47120. The Legislature hereby finds and declares all of the line 5 following: line 6 Prescription and nonprescription drugs successfully allow line 7 us to live longer, healthier, and more productive lives. line 8 The public, particularly children and the elderly, are at line 9 significant and unnecessary risk of poisoning due to improper or line 10 careless disposal of drugs and the illegal resale of drugs. line 11 Our source water for drinking water is being contaminated line 12 by unwanted, leftover, or expired drugs passing through our line 13 wastewater and treatment centers. line 14 There is no mandatory statewide drug stewardship program line 15 for unwanted drugs in California. line 16 It is the intent of the Legislature that all members of the line 17 supply chain work together to implement an effective program to line 18 maximize the collection and disposal of unused drugs in California. line 19 47121. This article shall be known, and may be cited, as the line 20 “Home-Generated Pharmaceutical Waste Collection and Disposal line 21 Act.” line 22 47122. For the purposes of this article, the following terms line 23 have the following meanings: line 24 “Consumer” means an individual purchaser or owner of a line 25 covered pharmaceutical. “Consumer” does not include a business, line 26 corporation, limited partnership, or an entity involved in a line 27 wholesale transaction between a distributor and retailer. line 28 “Controlled substance” means a substance listed in Chapter line 29 1 (commencing with Section 11053) of Division 10 of the Health line 30 and Safety Code, or in Section 812 of Title 21 of the United States line 31 Code or subject to Section 813 of Title 21 of the United States line 32 Code. line 33 “Cosmetic” means anything defined as a cosmetic in Section line 34 109900 of the Health and Safety Code. line 35 “Covered pharmaceutical” means a prescription drug line 36 or an over-the-counter human or veterinary drug. line 37 “Covered pharmaceutical” does not include any of the line 38 following: line 39 A drug that is regulated pursuant to either of the following: 99 SB 1014 — 5 — ---PAGE BREAK--- line 1 The federal Resource Conservation and Recovery Act of line 2 1976, as amended (42 U.S.C. Sec. 6901 et seq.). line 3 (ii) The Radiation Control Law (Chapter 8 (commencing with line 4 Section 114960) of Part 9) of Division 104 of the Health and Safety line 5 Code. line 6 A Vitamin or supplement. line 7 A herbal-based remedy or a homeopathic drug, product, or line 8 remedy. line 9 Cosmetics, soap, with or without germicidal agents, laundry line 10 detergent, bleach, household cleaning products, shampoos, line 11 sunscreens, toothpaste, lip balm, antiperspirants, or other personal line 12 care products that are regulated cosmetics under the Federal Food, line 13 Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq). line 14 A drug for which a producer provides a take-back program line 15 as part of a Federal Food and Drug Administration managed risk line 16 evaluation and mitigation strategy (21 U.S.C. Sec. 355-1). line 17 A drug that is a biological product, as defined in subsection line 18 of Section 600.3 of Title 21 of the Code of Federal Regulations, line 19 as it read on January 1, 2015, if the producer provides a take-back line 20 program. line 21 A pet pesticide product contained in a pet collar, powder, line 22 shampoo, topical application, or other delivery system. line 23 “Drug” means anything defined as a drug in Section 109925 line 24 of the Health and Safety Code or in Section 321 of Title 21 line 25 of the United States Code. line 26 “Home-generated pharmaceutical waste” means a covered line 27 pharmaceutical that is a waste, as defined in Section 25124 of the line 28 Health and Safety Code, derived from a household, including, but line 29 not limited to, a multifamily residence or household. line 30 “Mail-back program” means a system whereby a generator line 31 of home-generated pharmaceutical waste may obtain a prepaid line 32 and preaddressed mailing envelope in which to place line 33 home-generated pharmaceutical waste for shipment to an entity line 34 that will dispose of it safely and legally. line 35 “Over-the-counter drug” means a drug that may be lawfully line 36 sold without a prescription. line 37 “Pharmaceutical wholesaler” means a person that sells or line 38 distributes covered pharmaceuticals for resale to an entity other line 39 than a consumer. 99 — 6 — SB 1014 ---PAGE BREAK--- line 1 “Plan” or “product stewardship plan” means a product line 2 stewardship plan to implement a program to collect and dispose line 3 of home-generated pharmaceutical waste. line 4 “Prescription drug” means a drug required by federal or state line 5 law to be dispensed lawfully only on prescription. line 6 “Producer” shall be determined with regard to a covered line 7 pharmaceutical that is sold, offered for sale, or distributed in the line 8 state as meaning one of the following: line 9 The person that manufactures a covered pharmaceutical line 10 and that sells, offers for sale, or distributes that covered line 11 pharmaceutical in the state under that person’s own name or brand. line 12 If there is no person who meets the condition specified in line 13 subparagraph the producer of the covered pharmaceutical is line 14 the owner or licensee of a trademark or brand under which the line 15 covered pharmaceutical is sold or distributed in California, whether line 16 or not the trademark is registered. line 17 If there is no person who meets the conditions specified in line 18 subparagraph or the producer of that covered line 19 pharmaceutical is the person who brings the pharmaceutical into line 20 the state for sale or distribution. line 21 “Producer” does not include either of the following: line 22 A retailer that puts its store label on a covered line 23 pharmaceutical. line 24 A pharmacist who dispenses prescription drugs to, or line 25 compounds a prescribed individual drug product for, a consumer. line 26 “Product stewardship program” or “program” means a line 27 program financed and operated by one or more producers to collect, line 28 transport, and dispose of home-generated pharmaceutical waste. line 29 “Stewardship organization” means an organization line 30 designated by a group of producers to act as an agent on behalf of line 31 each producer to operate a product stewardship program. line 32 47124. On or before July 1, 2015, or on a later date that line 33 may be specified by the department, a producer shall submit to the line 34 department a product stewardship plan that complies with the line 35 requirements of subdivision One or more producers may submit line 36 a plan or designate a stewardship organization to act as an agent line 37 on behalf of the producers to submit a plan. A producer that line 38 designates a stewardship organization shall enter into an agreement line 39 with that stewardship organization to operate, on the producer’s line 40 behalf, a product stewardship program and the stewardship 99 SB 1014 — 7 — ---PAGE BREAK--- line 1 organization shall submit a plan pursuant to this section on or line 2 before July 1, 2015, or on a later date that may be specified by the line 3 department. line 4 A product stewardship plan shall contain all of the following line 5 elements: line 6 A certification that the product stewardship program will line 7 accept all home-generated pharmaceutical waste that results from line 8 a covered pharmaceutical sold by the producer, or by the producers line 9 that enter into agreement with the stewardship organization, from line 10 all households, including multifamily households, unless excused line 11 from this requirement by the department as part of the approval line 12 of the plan. line 13 Contact information for the producer submitting the plan or line 14 for each of the producers participating in the product stewardship line 15 program submitting the plan. line 16 A description of the methods by which home-generated line 17 pharmaceutical waste will be collected and an explanation of how line 18 the collection system will conveniently and adequately serve the line 19 residents of the state. line 20 A description of how the product stewardship plan will line 21 provide collection services for home-generated pharmaceutical line 22 waste in all areas of that state that are convenient to the public and line 23 adequate to meet the needs of the population in the area being line 24 served. line 25 The location of each collection site and locations where line 26 envelopes for a mail-back program are available, if applicable. line 27 A list containing the name, location, permit status, and record line 28 of any penalties, violations, or regulatory orders received in the line 29 previous five years by each person that will be involved in line 30 transporting home-generated pharmaceutical waste and each line 31 medical waste disposal facility proposed to participate in the line 32 product stewardship program. line 33 A description of how the home-generated pharmaceutical line 34 waste will be safely and securely tracked and handled from line 35 collection through final disposal and the policies and procedures line 36 to be followed to ensure security. line 37 A description of how the public education and outreach line 38 activities required by subdivision of Section 47126 will be line 39 implemented and how the effectiveness of those activities will be line 40 evaluated. 99 — 8 — SB 1014 ---PAGE BREAK--- line 1 A description of how the scope and extent of the product line 2 stewardship program are reasonably related to the amount of line 3 covered pharmaceuticals that are sold in the state by the producer line 4 or group of producers. line 5 (10) A starting date when the collection of home-generated line 6 pharmaceutical waste will begin. line 7 (11) A description of how support will be provided to any law line 8 enforcement agencies within the state that have, or later agree to line 9 have, a collection program for controlled substances, including all line 10 of the following: line 11 The provision of a collection kiosk with appropriate line 12 accessories and signage. line 13 An ability to accept controlled substances and other line 14 home-generated covered pharmaceutical waste. line 15 Technical support, including an appropriate person to line 16 provide onsite assistance with the sorting and separation of line 17 controlled substances at no cost to a participating law enforcement line 18 agency. line 19 (12) A description of how collection sites for home-generated line 20 pharmaceutical waste may be placed at appropriate retail stores in line 21 the state, including a description of the involvement of the retail line 22 stores. line 23 (13) If more than one producer will be involved in a proposed line 24 product stewardship program, the product stewardship plan for line 25 that program shall include a fair and reasonable manner for line 26 allocating the costs of the program among the participants in that line 27 program, so that the portion of costs paid by each producer is line 28 reasonably related to the amount of covered pharmaceutical sold line 29 by the producer in the state. line 30 (14) Provisions for the payment of all administrative and line 31 operational fees associated with the product stewardship program, line 32 including the cost of collecting, transporting, and disposing of line 33 home-generated pharmaceutical waste and the recycling or line 34 disposal, or both, of packaging collected with the home-generated line 35 pharmaceutical waste. line 36 The plan shall not allow a person or producer to charge a line 37 specific point-of-sale fee to consumers to recoup the costs of their line 38 product stewardship program, or charge a specific line 39 point-of-collection fee at the time the home-generated line 40 pharmaceutical waste is collected or delivered for disposal. 99 SB 1014 — 9 — ---PAGE BREAK--- line 1 47125. A producer, group of producers, or stewardship line 2 organization shall not collect home-generated pharmaceutical line 3 waste until it has received written approval of its product line 4 stewardship plan from the department. line 5 Within 180 days after receipt and review of a product line 6 stewardship plan, the department shall conduct a noticed public line 7 hearing and determine whether the plan complies with the line 8 requirements of this article and any regulations adopted pursuant line 9 to this article. As part of its approval, the department may set line 10 reasonable performance goals for the program proposed to be line 11 implemented by the plan. line 12 The department shall notify the applicant in writing of the line 13 approval of the plan. line 14 If the department rejects a plan, it shall notify the applicant line 15 in writing of its reasons for rejecting the plan. The department may line 16 reject a plan without conducting a public hearing, other than the line 17 hearing required by subdivision line 18 An applicant whose plan has been rejected by the department line 19 shall submit a revised plan to the department within 60 days after line 20 receiving notice of the rejection. The department may require the line 21 submission of a further revised plan or may develop, approve, and line 22 impose its own product stewardship plan or an approved plan line 23 submitted by other producers pursuant to this article. The line 24 department shall present the imposed plan at a public hearing. The line 25 department is not required, and nothing in this article shall be line 26 interpreted as requiring the department, to create or impose a line 27 product stewardship plan. line 28 If the department rejects a revised product stewardship plan line 29 or any other subsequently revised plan, a producer that is subject line 30 to the plan shall be considered to be out of compliance with this line 31 article and subject to the enforcement provisions contained in this line 32 article. If the department imposes its own plan, the producer shall line 33 not be considered out of compliance with this article if the producer line 34 complies with that plan. line 35 At least every three years, a producer, group of producers, line 36 or stewardship organization operating a product stewardship line 37 program shall update the product stewardship plan and submit the line 38 updated plan to the department for review and approval. 99 — 10 — SB 1014 ---PAGE BREAK--- line 1 Any proposed changes to a product stewardship plan shall line 2 be submitted in writing to the department and approved by the line 3 department in writing prior to implementation of any change. line 4 On and after July 1, 2015, a producer who commences to line 5 sell a covered pharmaceutical in the state shall submit a product line 6 stewardship plan to the department or provide evidence of having line 7 joined an existing approved product stewardship program no later line 8 than 180 days after the date the producer commences to sell that line 9 covered pharmaceutical, following the producer’s initial sale of line 10 the offer for sale of a covered pharmaceutical. line 11 47126. A producer, group of producers, or stewardship line 12 organization operating a stewardship program shall comply with line 13 all local, state, and federal laws and regulations applicable to its line 14 operations, including laws and regulations governing the disposal line 15 of medical waste and controlled substances, and shall additionally line 16 take all of the following actions when operating the program: line 17 Dispose of all home-generated pharmaceutical waste, line 18 in accordance with paragraph of subdivision of Section line 19 118215 of the Health and Safety Code. line 20 A producer or stewardship organization operating a line 21 stewardship program may petition the department for approval to line 22 use a final disposal technology, if lawful, that provides superior line 23 environmental and human health protection than provided by line 24 current medical waste disposal technology for covered line 25 pharmaceuticals, if and when the technology is proven and line 26 available. The department may approve that technology, if it line 27 provides equivalent protection in each, and superior protection in line 28 one or more, of the following areas: line 29 Monitoring of any emissions or waste. line 30 Worker health and safety. line 31 Air, water, or land emissions contributing to persistent, line 32 bioaccumulative, or toxic pollution. line 33 Overall impact on the environment and human health. line 34 Encourage the separation of home-generated pharmaceutical line 35 waste from its original containers, when appropriate, prior to line 36 collection or disposal. line 37 Promote the product stewardship program to consumers, line 38 pharmacists, retailers of covered pharmaceuticals, and health care line 39 practitioners as to the proper and safe method to dispose of 99 SB 1014 — 11 — ---PAGE BREAK--- line 1 home-generated pharmaceutical waste, in accordance with the line 2 following: line 3 Develop and update as necessary, educational and other line 4 outreach materials aimed at retailers of covered pharmaceuticals. line 5 These materials may include, but are not limited to, one or more line 6 of the following: line 7 Signage that is prominently displayed and easily visible to line 8 the consumer. line 9 Written materials and templates of materials for reproduction line 10 by retailers to be provided to the consumer at the time of purchase line 11 or delivery, or both. line 12 Advertising or other promotional materials related to the line 13 product stewardship program. line 14 Prepare education and outreach materials that publicize the line 15 location and operation of collection locations in the state and line 16 disseminate the materials to health care facilities, pharmacies, and line 17 other interested parties. line 18 Establish an Internet Web site publicizing collection line 19 locations and program operations and a toll-free telephone number line 20 that residential generators can call to find nearby collection line 21 locations and understand how the program works. line 22 47127. On or before July 1, 2016, or at a later date as approved line 23 in writing by the department, and on or before July 1 annually line 24 thereafter, a producer, group of producers, or stewardship line 25 organization operating a product stewardship program shall prepare line 26 and submit to the department an annual written report describing line 27 the program’s activities during the previous calendar year. The line 28 report shall include all of the following information: line 29 A list of producers participating in the product stewardship line 30 program. line 31 The amount, by weight, of home-generated pharmaceutical line 32 waste collected at each drop-off site and in the entire state and, if line 33 applicable, the total amount by weight collected by a mail-back line 34 program. line 35 A description of the collection system, including the location line 36 of each collection site and if applicable, locations where envelopes line 37 for a mail-back program are provided. line 38 The name and location of disposal facilities at which line 39 home-generated pharmaceutical waste were disposed of and the 99 — 12 — SB 1014 ---PAGE BREAK--- line 1 weight of home-generated pharmaceutical waste collected from line 2 residential generators disposed of at each facility. line 3 Whether policies and procedures for collecting, transporting, line 4 and disposing of home-generated pharmaceutical waste, as line 5 established in the plan, were followed during the previous calendar line 6 year and a description of any noncompliance. line 7 Whether any safety or security problems occurred during line 8 collection, transportation, or disposal of home-generated line 9 pharmaceutical waste during the previous calendar year and, if so, line 10 what changes have been or will be made to policies, procedures, line 11 or tracking mechanisms to alleviate the problem and to improve line 12 safety and security. line 13 A description of public education and outreach activities line 14 implemented during the reporting period, including the line 15 methodology used to evaluate the outreach and program activities. line 16 How the product stewardship program complied with all line 17 other elements in the product stewardship plan approved by the line 18 department, including its degree of success in meeting any line 19 performance goals set by the department as part of the approval line 20 of the plan. line 21 Any other information that the department may reasonably line 22 require. line 23 47128. The department shall provide on its Internet Web site line 24 a list of all producers participating in product stewardship programs line 25 approved by the department and a list of all producers the line 26 department has identified as noncompliant with this article or the line 27 regulations adopted pursuant to this article. line 28 47129. The department may adopt regulations to implement line 29 this article. line 30 The department shall adopt regulations to do all of the line 31 following: line 32 Provide for the appropriate management of consolidated line 33 home-generated pharmaceutical waste to ensure public and line 34 environmental safety, including, but not limited to, handling, line 35 storage, containment, tracking, transportation, and disposal. line 36 Establish a schedule of fees to be charged to the producers line 37 to cover the department’s costs of administering and enforcing line 38 this article. In setting the fee schedule, the department shall only line 39 recover its actual costs of administration and enforcement under 99 SB 1014 — 13 — ---PAGE BREAK--- line 1 this article and shall not charge any amounts under this article in line 2 excess of its actual administrative and enforcement costs. line 3 Adopt a schedule setting the amounts of administrative civil line 4 penalties that the department may impose pursuant to Section line 5 47130, based on the nature, extent, and severity of the violation line 6 and any other relevant factors. line 7 A producer, group of producers, or a stewardship line 8 organization submitting a plan to the department shall pay the fees line 9 set by the department pursuant to subdivision line 10 The department shall deposit all fees collected pursuant to line 11 this section into the Home-Generated Pharmaceutical Waste line 12 Program Account, which is hereby created in the Integrated Waste line 13 Management Fund. Upon appropriation by the Legislature, moneys line 14 deposited into the account may be expended by the department to line 15 administer and enforce this article. line 16 47130. The department may issue an administrative order line 17 to, or impose an administrative civil penalty upon, a producer who line 18 is in violation of this article or a regulation adopted pursuant to line 19 this article, to require compliance with this article or the regulation. line 20 The department shall deposit all penalties collected pursuant line 21 to this article into the Home-Generated Pharmaceutical Waste line 22 Penalty Account, which is hereby created in the Integrated Waste line 23 Management Fund. Upon appropriation by the Legislature, moneys line 24 deposited into the account may be expended by the department to line 25 enforce this article. line 26 47134. This article does not require a retailer to host a line 27 collection site and nothing in this article shall be interpreted as line 28 requiring this participation. line 29 47135. A producer or stewardship organization that creates line 30 and operates a plan that is approved by the department is not in line 31 violation of the Cartwright Act (Chapter 2 (commencing with line 32 Section 16700) of Part 2 of Division 7 of the Business and line 33 Professions Code), the Unfair Practices Act (Chapter 4 line 34 (commencing with Section 17000) of Part 2 of Division 7 of the line 35 Business and Professions Code), or the Unfair Competition Law line 36 (Chapter 5 (commencing with Section 17200) of Part 2 of Division line 37 7 of the Business and Professions Code), with regard to actions line 38 that are taken in accordance with the plan or this article. line 39 SEC. 5. No reimbursement is required by this act pursuant to line 40 Section 6 of Article XIIIB of the California Constitution because 99 — 14 — SB 1014 ---PAGE BREAK--- line 1 the only costs that may be incurred by a local agency or school line 2 district will be incurred because this act creates a new crime or line 3 infraction, eliminates a crime or infraction, or changes the penalty line 4 for a crime or infraction, within the meaning of Section 17556 of line 5 the Government Code, or changes the definition of a crime within line 6 the meaning of Section 6 of Article XIII B of the California line 7 Constitution. O 99 SB 1014 — 15 — ---PAGE BREAK--- file:///CI/Users/gas/Dropbox/Work/Policy/SB1014%20April%201%202014/SB%201014%20-%20History.txt[3/13/2014 5:00:58 PM] SB 1014 Senate Bill - History COMPLETE BILL HISTORY BILL NUMBER : S.B. No. 1014 AUTHOR : Jackson TOPIC : Pharmaceutical waste: home-generated. TYPE OF BILL : Active Non-Urgency Non-Appropriations Majority Vote Required State-Mandated Local Program Fiscal Non-Tax Levy BILL HISTORY 2014 Feb. 27 Referred to Coms. on E.Q. and P. & E.D. Feb. 14 From printer. May be acted upon on or after March 16. Feb. 13 Introduced. Read first time. To Com. on RLS. for assignment. To print. ---PAGE BREAK--- file:///CI/Users/gas/Dropbox/Work/Policy/SB1014%20April%201%202014/SB%201014%20-%20Status.txt[3/13/2014 5:00:58 PM] SB 1014 Assembly Bill - Status CURRENT BILL STATUS MEASURE : S.B. No. 1014 AUTHOR(S) : Jackson. TOPIC : Pharmaceutical waste: home-generated. HOUSE LOCATION : SEN TYPE OF BILL : Active Non-Urgency Non-Appropriations Majority Vote Required State-Mandated Local Program Fiscal Non-Tax Levy LAST HIST. ACT. DATE: 02/27/2014 LAST HIST. ACTION : Referred to Coms. on E.Q. and P. & E.D. COMM. LOCATION : SEN ENVIRONMENTAL QUALITY TITLE : An act to add Section 4068.1 to the Business and Professions Code, to amend Section 117700 of, and to add Section 117670.1 to, the Health and Safety Code, and to add Article 3.4 (commencing with Section 47120) to Chapter 1 of Part 7 of Division 30 of the Public Resources Code, relating to pharmaceutical waste.