BILL ANALYSIS Ó ----------------------------------------------------------------------- |Hearing Date:April 21, 2014 |Bill No:SB | | |1014 | ----------------------------------------------------------------------- SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Ted W. Lieu, Chair Bill No: SB 1014Author:Jackson As Amended:April 21, 2014 Fiscal: Yes SUBJECT: Pharmaceutical waste: home-generated. SUMMARY: Establishes the Home-Generated Pharmaceutical Waste Collection and Disposal Act to be administered by the Department of Recycling and Recovery (CalRecycle) according to certain guidelines. Authorizes a pharmacy to accept the return of home-generated pharmaceutical waste (HGPW) from a consumer. Provides that HGPW under a collection and disposal program is not medical waste. NOTE: This bill was heard by the Senate Committee on Environmental Quality on March 26, 2014 and passed 5-1. The bill has been substantially amended since that hearing but still deals with the same general subject matter of disposal of prescription drugs. Existing law, the Business and Professions Code (BPC): 1) Establishes the Pharmacy Law which provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of dangerous drugs or devices by the Board of Pharmacy (Board) within the DCA. 2) Defines reverse distributor as every person who acts as an agent for pharmacies, drug wholesalers, manufacturers and other entities by receiving, inventorying and managing the disposition of outdated or nonsalable dangerous drugs. (BPC § 4040.5) 3) Establishes a licensure category under the authority of the Board for a "surplus medication collection and distribution intermediary" operating for the purpose of facilitating the donation of medications to, or transfer of, medications between participating entities under a county's unused medication repository and SB 1014 Page 2 distribution program. (BPC § 4046) 4) Authorizes a pharmacy to accept the return of needles and syringes from the public if contained in a sharps container (BPC § 4146) Existing law, the Health and Safety Code (HSC): 1) Establishes the California Uniform Controlled Substances Act which regulates controlled substances. (HSC § 11000 et seq.) 2) Defines drug as: (HSC § 11014) a) Substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them. b) Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals. c) Substances (other than food) intended to affect the structure or any function of the body of man or animals. 3) Establishes the Medical Waste Management Act (MWMA) which regulates the generation, handling, storage, transport, treatment, and disposal of medical waste, as defined, overseen by the Department of Public Health (DPH) and designated local agencies. (HSC §117600 et seq.) 4) Defines "household waste" as any material, including garbage, trash, and sanitary wastes in septic tanks and medical waste that is derived from households, farms, or ranches and does not include trauma scene waste. (HSC § 117670) 5) Defines "home-generated sharps waste" as hypodermic needles, pen needles, intravenous needles, lancets, and other devices that are used to penetrate the skin for the delivery of medications derived from a household, including a multifamily residence or household. (HSC § 117671) 6) Defines "pharmaceuticals" as a prescription or over-the-counter human or veterinary drug including, but not limited to, a drug as defined in the Sherman Food, Drug and Cosmetic Law or the Federal Food, Drug, and Cosmetic Act. "Pharmaceutical" does not include any pharmaceutical that is regulated pursuant to the federal SB 1014 Page 3 Resource Conservation and Recovery Act (RCRA) of 1976 (which governs the management of solid and hazardous wastes) or the Radiation Control Law. (HSC § 117747) 7) Defines "pharmaceutical waste" as any pharmaceutical that for any reason may no longer be sold or dispensed for use as a drug and excludes from this definition those pharmaceuticals that still have potential value to the generator because they are being returned to a reverse distributor for possible manufacturer credit. (HSC § 117748) 8) Specifies that waste comprised only of pharmaceuticals is biohazardous, and is considered "medical waste." (HSC § 117635) 9) Requires all medical waste be transported to an offsite medical waste treatment facility to be transported by a registered hazardous waste transporter. (HSC §118000) 10)Establishes a voluntary drug repository and distribution program (Program) for the purpose of distributing surplus medications to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. (HSC § 150200 et seq.) Existing Law, the Public Resources Code (PRC): 1) Establishes the California Integrated Waste Management Act. (PRC § 40000 et seq.) 2) Requires pharmaceutical manufacturers that sell or distribute a medication in California that is self-injected at home through the use of a hypodermic needle, pen needle, intravenous needle, or any other similar device to submit to CalRecycle a plan that describes what actions, if any, the manufacturer supports for the safe management of sharps waste. (PRC § 47115) This bill: 1) Establishes the Home-Generated Pharmaceutical Waste Collection and Disposal Act. 2) Authorizes a pharmacy to accept the return of home-generated pharmaceutical waste from a consumer. 3) Defines "Home-generated pharmaceutical waste" (HGPW) for the purposes of the MWMA as a prescription or over-the-counter human or SB 1014 Page 4 veterinary home-generated pharmaceutical, including, but not limited to, a home-generated pharmaceutical as defined under federal law that is waste derived from a household, including, but not limited to, a multifamily residence or household. 4) Provides that medical waste does not include HGPW, including but not limited to, consolidated HGPW, that is handled by a collection and disposal program operating in accordance with regulations adopted by the Department of Recycling and Recovery (CalRecycle). 5) Makes the following definitions in the Public Resources Code related to HGPW collection and disposal: a) "Consumer" is an individual purchaser or owner of a pharmaceutical and does not include a business, corporation, limited partnership or entity involved in a wholesale transaction between a distributor and a retailer. b) "Entity" is a state or local public agency, pharmacy veterinarian clinic or other office or facility that provides medical services. c) "HGPW" means the same as above and includes all of the following: i) Articles recognized in the official United States Pharmacopoeia, the official National Formulary, the official Homeopathic Pharmacopeia of the United States or any supplement of the formulary or those pharmacopoeias. ii) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals. iii) Articles, excluding food, intended to affect the structure or function of the body of humans or other animals. iv) Articles intended for use as a component of an article specified above. a) "Participant" is an entity that CalRecycle deems appropriate for implementing and evaluating a program in accordance with regulations and that chooses to participate. b) "Sale" is, but is not limited to, transactions conducted SB 1014 Page 5 through sales outlets, catalogs or the Internet, or any other similar electronic means, but does not include a sale that is a wholesale transaction with a distributor or retailer. 6)Requires CalRecycle to adopt regulations authorizing a Participant to establish a program to collect and properly dispose of HGPW. Specifies that the regulations be based upon the model guidelines already developed by CalRecycle and require a Participant to do all of the following: a) Provide, at no additional cost to the consumer, for the safe take back and proper disposal of the type or brand of pharmaceuticals that the participant sells or previously sold. b) Ensure the protection of the public health and safety, the environment and the health and safety of consumers and employees. c) Report to CalRecycle, for the purposes of evaluation, the safety, efficiency, effectiveness and funding sustainability of the implemented program. d) Protect against the potential for the diversion of pharmaceutical waste for unlawful use or sale. e) Provide notices and materials to consumers that provide information about the potential impacts of improper disposal of HGPW and return opportunities for the proper disposal of HGPW that include Internet Web site links, telephone numbers on an invoice, information about opportunities and locations for no-cost HGPW disposal, prominently displayed and easily visible signage, written material provided to consumers at the time of purchase or delivery, reference to the HPW take back 7)Requires the regulations to also do the following and authorizes CalRecycle to revise the regulations if changes will ensure public health and safety: a) Specify the types of Participants authorized to maintain permanent collection locations. b) Establish requirements for obtaining local or state permits or approvals. c) Require Participants to enter into arrangements with medical or hazardous waste haulers to ensure that all HGPW is appropriately picked up and transported by registered waste SB 1014 Page 6 haulers. d) Specify which HGPW may be included in a program, including the requirements for the collection of a controlled substance. e) Specify methods for handling wastes commingled in containers with other household or hazardous waste. f) Provide methods for collecting and storing HGPW, including the use of secured containers and ensure that collected HGPW is not resold, reused, sold, donated or provided to anyone other than a registered medical or hazardous waste hauler. g) Provide that a facility that collects HGPW becomes the generator of the waste and is responsible for ensuring that the storage, removal and transportation of containers and the waste are in compliance with state laws and regulations. h) Require the collection and retention of detailed information and invoices for each collection site. i) Impose requirements for one-time or periodic collection events. j) Impose requirements for mail-back collection and disposal programs. aa) Include provisions for the appropriate management of HGPW to ensure public health and safety. 8)Requires an Entity that participates in a HGPW program to comply with the regulations, and provides that a Participant operating a program in accordance with the regulations is in compliance with all state laws and regulations related to the handling, management and disposal of HGPW. FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative Counsel. COMMENTS: 1. Purpose. This bill is co-sponsored by Alameda County , City and County of San Francisco , California Alliance of Retired Americans , California Product Stewardship Council and Clean Water Action . According to the Author, in response to the growing problem of prescription drug abuse, accidental poisonings, and the detection SB 1014 Page 7 of pharmaceutical products in California waters, local governments throughout the state have struggled to establish safe and convenient medication take-back programs. The Author states that 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. The Author notes that establishing these disposal programs on a city by city basis is haphazard, inefficient and expensive for local ratepayers. The Author states that this approach means that not all consumers have access to take-back locations, perpetuating a lack of harmonized messaging to the public about safe drug disposal. 2. Pharmaceutical Waste Management and the Need for Take-Back. Laws regulating the collection and disposal of pharmaceuticals are present at the federal, state, and local levels. As reported by CalRecycle in its 2010 report to the Legislature Recommendations for Home-Generated Pharmaceutical Collection Programs in California, there is no single federal or state agency that has sole or ultimate authority for home-generated pharmaceutical waste collection, consolidation, management, and disposal. Instead, the federal Drug Enforcement Administration (DEA) and several California state agencies (Department of Public Health (DPH), Board of Pharmacy, and Department of Toxic Substances Control (DTSC)) all have responsibility, sometimes overlapping, making it challenging for local jurisdictions to develop and maintain effective collection and management programs they know conform to legal requirements. Two federal laws currently control the regulation of pharmaceuticals and their waste. Under the federal Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) is authorized to oversee the safety of food, drugs, and cosmetics. Additionally, under the Resource Conservation and Recovery Act (RCRA) of 1976, the management of solid and hazardous wastes is regulated. This results in strict protocols for the collection of controlled substances to prevent their illegal diversion and abuse such that only law enforcement officials can handle certain pharmaceutical wastes. The federal Secure and Responsible Drug Act of 2010 outlined take-back disposal options for pharmaceutical waste, including a requirement for DEA to promulgate regulations related to the take-back of controlled substances. The draft regulations would allow pharmacies to accept controlled substances for disposal in particular circumstances and under particular conditions. In early 2013, the DEA released these proposed regulation requirements SB 1014 Page 8 for the take-back and destruction of controlled substances with comments due by the end of February 2013; however, the DEA has not yet released final regulation requirements. There are growing concerns about the impact of drugs and pharmaceutical waste based on improper disposal, which in turn leads to contamination of water systems and inappropriate access by potential abusers. The U.S. Geological Survey conducted a study in 2002, sampling 139 streams across 30 states and found that 80 percent had measurable concentrations of prescription and nonprescription drugs, steroids, and reproductive hormones. Exposure, even to low levels of pharmaceuticals, has been shown to have negative effects on fish and other aquatic species and may have negative effects on human health. Proper disposal is believed to decrease the threat of these substances to the environment and waterways. Proper disposal is also believed to decrease the availability of expired and unused prescription drugs to abusers. The guidelines for proper disposal of prescription drugs can be confusing, lack uniformity throughout the state and nation, and are cumbersome to the consumer. A February 2007 statement from the Office of National Drug Control Policy states that unused, unneeded or expired prescription drugs should be taken out of their original containers and thrown in the trash or brought to take-back programs that allow the public to bring unused drugs to a central location for proper disposal. For example, the federal FDA highlights certain drugs that should be flushed down a toilet, but the organization also recommends a lengthy process for proper disposal of the majority of prescriptions drugs, including mixing whole tablets or capsules with an unpalatable substance such as kitty litter or used coffee grounds then placing that mixture in a sealed container before throwing it in household trash. The Board's recommended process for disposal is similarly extensive and requires even additional steps. Controlled substances can currently only be returned to law enforcement agencies. Take-back programs for medication disposal have risen in popularity due to problems surrounding safe, accessible, easy disposal options. These programs are seen as a good way to remove expired, unwanted, or unused medicines from the home and reduce the chance that others may accidentally take the medicine or it ends up being flushed. In California, though, the MWMA currently requires home-generated pharmaceutical waste to be managed as "medical waste" which includes such material as infectious and biohazardous waste and other types of waste that pose a potential harm to public health and safety and the environment if not managed properly. The SB 1014 Page 9 MWMA establishes rigorous management and tracking requirements for medical waste; including requiring the use of hazardous or medical waste haulers and strict manifesting requirements. Many pharmacies and other retail establishments have expressed an interest in providing collection opportunities for their customers and while they are willing and able to provide safe and appropriate collection, they do not want to become licensed medical waste collectors. Concerns have been raised regarding the issue of theft of HPW at collection points, including pharmacies. As pharmacies have the responsibility of keeping the drug supply safe, it is important that assurances are in place for drugs taken back at a pharmacy to remain secure and not diverted to unauthorized users. Similarly, expired or unused medications that have been dispensed to a consumer must not re-enter the drug supply, to ensure quality of products. 3. California's Model Guidelines for Take-Back. In 2007, the Legislature passed SB 966 (Simitian, Chapter 542, Statutes of 2007) which required CalRecycle's predecessor, the California Integrated Waste Management Board (CIWMB), to develop, in consultation with appropriate state, local, and federal agencies, model programs for the collection and proper disposal of pharmaceutical drug waste. Those guidelines were developed in consultation with a pharmaceutical working group which included CIWMB staff, Board staff and representatives from the Department of Public Health, Department of Toxic Substances Control and State Water Resources Board. The model programs include parameters for both permanent and occasional take-back event collection sites and also include a mail back component as an alternative to onsite collection. The guidelines, "Criteria and Procedures for Model Home-Generated Pharmaceutical Waste Collection and Disposal Programs" were adopted by CIWMB in 2009 to provide consumers the ability to dispose of unwanted prescription and over-the-counter drugs without flushing them down the toilet or throwing them in the garbage (the guidelines did not include controlled substances which must be returned only to law enforcement). These guidelines are only guidelines and not currently enforceable as standards. According to the Board, any pharmacy that participates in a voluntary take-back program is expected to use the guidelines when offering the public the opportunity to return drugs. The Board believes that the following should be particularly observed: Drugs should not be reviewed personally by staff at a collection site before being deposited into a secure collection SB 1014 Page 10 bin and the patient or their agent should personally deposit drugs into the bin as a means of preventing staff from knowing what is being returned. Drugs that are collected should be separated from their containers by patients or their agents before being placed in the collection bin, reducing the disposal costs because the containers will not be part of the pharmaceutical waste weight. There should be two separate locks on the secured collection bins: one key should be in the possession of the pharmacy and the other in the possession of the licensed waste hauler who will pick up the waste. This permits each to serve as a control for the other to help establish no one has entered the collection container to retrieve drugs. 1. Take-Back in California. Absent a statewide program, many consumers utilize dedicated, one-day take-back opportunities to safely dispose of medications. These one-time events allow individuals to dispose of prescription or non-prescription medications which are taken to a safe disposal site after collection. The DEA's seventh National Take-Back Day in October 2013 collected 324 tons of expired and unwanted medications across all 50 states. Since the inception of the National Take-Back Day in 2010, the DEA has collected over 3.4 million pounds of medicine from circulation. Between 2009 and 2010, CalRecycle identified 177 continuous collection programs at pharmacies and law enforcement offices in California. In that time, these programs collected more than 200,000 pounds of pharmaceuticals. San Francisco established a Safe Medicine Disposal Pilot Program in 2012, allowing residents to return pharmaceuticals (not including controlled substance) to 13 pharmacies via secured collection bins or any pharmaceuticals to San Francisco police stations during business hours. As of October 2013, over 25,800 pounds of pharmaceuticals had been collected, 93% of which was at the pharmacy locations. The Los Angeles County Sheriff's Department launched their Safe Drug Drop-Off program in September 2009 where drug disposal boxes are available 24 hours a day, 365 days a year outside of sheriff's stations. A total of 21 drop-off locations have collected over 53,000 pounds of prescription medication as of September 2013. Santa Clara County currently has two county agencies that collect and safely dispose of pharmaceuticals - the county Household Hazardous Waste Program, which spends roughly $21,600 annually on the collection and disposal of 7.2 tons of medication a year (1,200 pounds a month) SB 1014 Page 11 and a program run by the county sheriff's office at 10 locations. Annually, the program costs the county $41,600 for 10.8 tons of collected and disposed medication. Alameda County passed a Safe Drug Disposal Ordinance in 2012 that requires producers of covered drugs (including both brand name and generic drugs) to operate take-back programs after submitting a plan to the county's Department of Environmental Health. Programs include the creation, administration, promotion, and payment of the program (including the payment of Alameda County's costs to administer and enforce the Ordinance). CalRecycle reports that the average cost of current take-back programs in California vary from $3-$7 a pound 2. Barriers to Broader Implementation of Take-Back. In implementing take-back programs on a more broad scale throughout the state, concerns still remain and there are only a small number of pharmacies currently accepting drugs back from consumers. Drugs are very heavily regulated throughout each step of the supply chain and there are even a limited number of options (all of which are also tightly regulated) for pharmacies to remove drugs that have not been dispensed. For example, a pharmacy can return unwanted drugs to the wholesaler the pharmacy bought the drugs from provided the drug has not expired or been recalled; wholesalers are Board licensees. Pharmacies can also return outdated, nonsalable drugs that have not been dispensed to a reverse distributor, also a Board licensee, for possible manufacturer credit and destruction. Or pharmacies can provide outdated, nonsalable drugs to licensed hazardous waste haulers. With regards to mandatory take-back collection sites within pharmacies, issues have been raised about the potential for pharmacies to become recycling centers when they are a location where health care is being provided. Pharmacies have also expressed concerns over the past number of years that there may not be the appropriate space needed for proper collection and cite the costs associated with the appropriate handling of drug waste. The 2010 CalRecycle Report found that only about one-third of existing programs in California meet the model guidelines and highlighted a number of barriers. According to CalRecycle, law enforcement programs can readily meet requirements for collecting controlled substances, but the public may not be willing to bring pharmaceutical wastes to police stations. Further, law enforcement agencies themselves have higher resource allocation priorities. Pharmacies are widespread and accessible, but they typically do not meet all of the safety protocols (e.g., regarding collection bins and security) delineated in guidelines. Household Hazardous Waste SB 1014 Page 12 facilities also face similar issues as pharmacies, particularly relative to safety, and are dependent on local government funding support. Periodic collection events are somewhat easier to implement for local governments and can accommodate large amounts of materials in a short time, but are not as cost-effective as continuous collection programs, often do not have safety protocols, and are subject to local government budgetary constraints. Mail-back programs can be convenient and safety is not a major concern, but there are only three such programs in the state and a high return rate is necessary for the method to be cost-effective. Cal Recycle also noted the following as factors which make the model guidelines difficult to meet: The federal Controlled Substances Act requires strict protocols for the collection of controlled substances to prevent their illegal diversion and abuse and although controlled substances represent only about 10 percent of HGPW, the requirements for their safe management (e.g., requiring only law enforcement officials to handle them) means most collection programs are costly. The pending DEA regulations appear to address this barrier highlighted by CalRecycle, as they would allow controlled substances to be handled differently and not only by law enforcement which is an integral component to the successful development of drug take-back programs. There is no clear statutory definition of HGPW, nor is there an identified agency or department that has sole or ultimate authority for HGPW collection, consolidation, management, and disposal. This bill appears to begin to address this barrier highlighted by CalRecycle by defining HGPW and clarifying that it is not medical waste. There is a lack of funding, as local governments currently fund more than 80 percent of collection programs and pharmacies fund another 15 percent. A number of different funding models have been proposed through legislation and also imposed by other jurisdictions to address the lack of funding for take-back programs. In Alameda County, producers of drugs are required to operate take-back programs, including the creation, administration, SB 1014 Page 13 promotion, and payment for the program. In British Columbia, manufacturers are required to pay for the cost of a take-back program, not including agency oversight. Kings County, Washington established an industry-funded product stewardship model in 2013 to collect and safely dispose of unwanted household medicines from residents of the county. While there is no agreement on any single best practice for funding continuous drug take-back programs, there appears to be a continuously echoed sentiment that any successful program should include a role for all players in the drug supply chain who have a part in providing prescription drugs to consumers. Assessing whether the specific role for specific players is related to monetary contributions through a regulatory fee or other forms of participation shapes the core of current debates on this particular aspect of implementing take-back programs. 1. Extended Producer Responsibility and Product Stewardship. According to CalRecycle, Extended Producer Responsibility (EPR), also known as Product Stewardship, is a strategy to place a shared responsibility for end-of-life product management on the producers, and all entities involved in the product chain, instead of the general public, while encouraging product design changes that minimize a negative impact on human health and the environment at every stage of the product's lifecycle. CalRecycle states that this allows the costs of treatment and disposal to be incorporated into the total cost of a product and places primary responsibility on the producer, or brand owner, who makes design and marketing decisions. According to CalRecycle, EPR also creates a setting for markets to emerge that truly reflect the environmental impacts of a product, and to which producers and consumers respond. Cal Recycle states that EPR is a waste reduction strategy and that by shifting costs and responsibilities of product discards to producers and others who directly benefit, EPR provides an incentive to eliminate waste and pollution through product design changes. Products in California that are currently subject to an EPR-like framework include mercury thermostats, paint, carpet and mattresses. There have also been proposals related to batteries, fluorescent lights, home-generated medical sharps and other consumer products. When introduced, this bill would have required a producer of a pharmaceutical sold in this state, individually or through a stewardship organization, to submit a stewardship plan to CalRecycle by July 1, 2015, to provide for the development of a SB 1014 Page 14 program to collect, transport, and dispose of home-generated pharmaceutical waste that includes information on tracking, education, placement in retail stores, and cost allocation. As amended, the bill no longer requires the creation of a stewardship plan and instead codifies the model guidelines adopted by CalRecycle with input from various other entities. 2. Related Legislation This Session. SB 727 (Jackson) of 2013 would have created the Drug Abuse Prevention and Safe Disposal Program stewardship program and required a producer of a pharmaceutical sold in this state, individually or through a stewardship organization, to submit a plan to CalRecycle by January 1, 2015, to provide for the development of a program to collect, transport, and process home-generated pharmaceutical drugs. ( Status: The bill was not heard in a policy committee.) AB 333 (Wieckowski) of 2013 would make various changes to the MWMA. ( Status: The bill is currently pending in the Senate Environmental Quality Committee.) AB 403 (Stone) of 2013 would have required businesses that sell medical sharps to establish a product stewardship plan for the end of life management of home-generated medial sharps. ( Status: The bill was held under submission by the Assembly Committee on Appropriations.) AB 467 (Stone, Chapter 10, Statutes of 2014) created a licensure category for a surplus medication collection and distribution intermediary. AB 1727 (Rodriguez) of 2014 would restrict certain pharmaceuticals from county operated prescription drug collection and redistribution programs. ( Status: This bill is currently pending in the Assembly Committee on Health.) AB 1893 (Stone and Eggman) of 2014 would require all sharps sold to the general public in California to be sold with a sharps waste container approved by DPH. ( Status: This bill is currently pending in the Assembly Committee on Health.) 3. Prior Related Legislation. AB 1442 (Wieckowski, Chapter 689, Statutes of 2012) defined pharmaceutical waste as any pharmaceutical that may no longer be sold or dispensed, excluding pharmaceuticals that could be returned to a reverse distributor for possible manufacturer credit. SB 1014 Page 15 SB 419 (Simitian) of 2011 required pharmaceutical manufacturers to provide their annual reports on disposal of sharps waste to CalRecycle electronically and make them readily available on their websites. ( Status: The bill was vetoed by the Governor.) SB 26 (Simitian) of 2009 would have defined HGPW and exempt it from existing regulatory requirements for the handling of medical waste and would have authorized pharmacies and other facilities to collect HGPW, under specified conditions. ( Status: The bill was amended to deal with a different topic and was not heard in a policy committee.) SB 486 (Simitian, Chapter 591, Statutes of 2009) required a pharmaceutical manufacturer that sells or distributes a medication that is self-injected at home through the use of a hypodermic needle, pen needle, intravenous needle, or any other similar devices to submit to the CIWMB, or its successor agency, a plan that describes how the manufacturer supports the safe collection and destruction of home-generated sharps waste. SB 966 (Simitian, Chapter 542, Statutes of 2007) required CIWMB to develop, in consultation with appropriate state, local, and federal agencies, model programs for the collection and proper disposal of pharmaceutical drug waste. AB 501 (Swanson and Hancock) of 2007 would have required a pharmaceutical manufacturer whose product is administered through a syringe to provide a postage prepaid mail-back sharps container for safe disposal of the used device, or storage and transport to a sharps consolidation location. ( Status: The bill was vetoed by the Governor.) SB 1305 (Figueroa, Chapter 64, Statutes of 2006) prohibited a person from knowingly placing home-generated sharps waste in commercial and residential solid waste collection containers after September 1, 2008. 4. Arguments in Support. According to the California Alliance for Retired Americans (CARA), many seniors fear that highly potent and addictive drugs around the house could get into the wrong hands and cite the lack of safe and convenient disposal options for consumers that lead to less than desirable options like home storage, flushing medications down the toilet or throwing them in the garbage. CARA supports this bill along with a statewide, long-term solution to providing a safe, convenient and secure method of disposal for unwanted drugs in medicine cabinets. SB 1014 Page 16 Californians for a Healthy and Green Economy and the Center for Environmental Health note that the safe disposal of pharmaceutical chemicals is crucial to protect the health of all Californians. The California Product Stewardship Council (CPSC) believes that by establishing standards on how to safely manage medication collection in pharmacies through the model guidelines, we are ensuring the safety of the return to system for medications at pharmacies to prevent the illegal diversion of drugs and providing protection for entities operating under these standards. CPSC believes that with no consistent or convenient take-back option for unwanted pharmaceuticals, the household medicine cabinet continues to be a source that fuels the nation's prescription drug abuse epidemic. Clean Water Action and the Alameda County Board of Supervisors support this bill, noting that model guidelines were developed through a series of meetings with state agencies and stakeholders and will help ensure that those who decide to conduct a voluntary take-back program has good standards to follow to ensure the protection of public health, safety and the environment while also protecting against the potential for diversion of pharmaceutical waste for unlawful use or sale. SUPPORT AND OPPOSITION: Support: Alameda County Board of Supervisors California Alliance for Retired Americans California Product Stewardship Council Californians for a Healthy and Green Economy Center for Environmental Health Clean Water Action Support: (Received for prior version of the bill) 7th Generation Advisors Alameda County Health Care Services Alameda County Sheriff's Office Ashland Cherryland Together Association of Bay Area Governments Breast Cancer Action Butte County Office Of The Sheriff Californians Against Waste SB 1014 Page 17 California Alliance for Retired Americans California Association of Environmental Health Administrators California Association of Sanitation Agencies California Nurses Association California Police Chiefs Association Inc. California Product Stewardship Council California Resource Recovery Association California Rural Legal Assistance Foundation California School Employees Association California State Association of Counties California State Sheriff's Association California Teamsters Public Affairs Council California Water Environment Association Center for Biological Diversity Central California Alliance For Health Central Contra Costa Sanitary District Central Contra Costa Solid Waste Authority City of Chula Vista Police Department City of Chula Vista Office of the Mayor City of Cotati City of Covina City of El Cerrito City of Fortuna City of Livermore City of Los Altos City of Menlo Park City of Palo Alto The City of Pleasanton City of Porterville City of Roseville City of Sacramento City of San Diego Environmental Services Department City and County of San Francisco City and County of San Francisco Police Department City of San Jose City of San Rafael City of San Mateo City of Millbrae City of Santa Monica City of Santa Rosa City of Sunnyvale City of Torrance City of Ukiah Clean Water Action Clover Flat Coalition for Safe Medication Disposal of Tompkins County, NY SB 1014 Page 18 CommPre Community Prevention Partners of Santa Cruz County Community Water Center Consumer Federation of California Contra Costa County Board of Supervisors County of Alameda County of Los Angeles Public Health County of Los Angeles County of Marin Board of Supervisors County of San Mateo Board of Supervisors County of Santa Barbara County of Santa Clara County of Santa Cruz Defenders of Wildlife Delta Diablo District Attorney Alameda County Ecology Action Ecology Center East Bay Municipal Utility District Eastern Municipal Water District El Dorado Irrigation District Environment California Environmental Working Group Goleta Sanitary District Goleta West Sanitary District Gray Panthers of San Francisco Green Science Policy Institute Heal the Bay Health Officers Association of California The Hope2gether Foundation Hospice of Santa Cruz County Las Gallinas Valley Sanitary District Las Virgenes Municipal Water District League of California Cities League of Women Voters of California Leucadia Wastewater District Mammoth Community Water District Marin County Hazardous and Solid Waste Management Joint Powers Authority Marin Sanitary Services Mendocino Solid Waste Management Authority The Metropolitan Water District of Southern California Midway City Sanitary District Mt. View Sanitary District Monterey Regional Waste Management District The National Association of Clean Water Agencies SB 1014 Page 19 The North American Hazardous Materials Management Association The National Coalition Against Prescription Drug Abuse Napa County Board of Supervisors National Resources Defense Council Napa Sanitation District Older Women's League Pajaro Valley Community Health Trust Pajaro Valley Water Management Agency Palo Alto Medical Foundation Pharmacists Planning Service, Inc. Prescription Drug Abuse Prevention Coalition Product Stewardship Institute Physicians for Social Responsibility Rural County Representatives of California Regionalsan Russian River Watershed Association Sacramento State Student Health Services Pharmacy Santa Cruz Desal Alternatives San Francisco Water Power Sewer Scotts Valley Police Department Sierra Club of California Sierra Club Foundation Silicon Valley Clean Water Shasta County Sheriff Solid Waste Association Sonoma County Waste Management Agency Sonoma County Water Agency Stege Sanitary District Stopwaste Tehama County Teleosis Foundation Town of Fairfax Town of Windsor United Long Term Care Workers Upper Valley UPSTREAM Union Sanitary District Vallejo Sanitation and Flood Victor Valley Wastewater Reclamation Authority Watsonville Pharmacy West County Wastewater District Western Placer Waste Management Authority Women's Recovery Services Multiple individuals Opposition: (Received for prior version of the bill) SB 1014 Page 20 BayBio BIOCOM California Chamber of Commerce California Healthcare Institute California Manufacturers and Technology Association California Medical Association Civil Justice Association of California Consumer Healthcare Products Association Generic Pharmaceutical Association Healthcare Distribution Management Association Pharmaceutical Researchers and Manufacturers of America TechNet Consultant:Sarah Mason