BILL ANALYSIS                                                                                                                                                                                                    Ó







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        |Hearing Date:April 21, 2014        |Bill No:SB                         |
        |                                   |1014                               |
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                      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           by receiving, inventorying and managing the disposition of outdated  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  





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           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  





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           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  





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           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  





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             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  





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             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  





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           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  





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           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  





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           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  





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               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)  





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           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  





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          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,  





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                  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  





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           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.  
          





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           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.    





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            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





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        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 





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        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
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        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