BILL ANALYSIS                                                                                                                                                                                                    



                                                                       



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          |SENATE RULES COMMITTEE            |                   SB 966|
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                                 THIRD READING


          Bill No:  SB 966
          Author:   Simitian (D)
          Amended:  4/30/07
          Vote:     21

           
           SENATE ENV. QUALITY COMMITTEE  :  4-2, 3/26/07
          AYES:  Simitian, Kuehl, Lowenthal, Steinberg
          NOES:  Runner, Aanestad
          NO VOTE RECORDED:  Florez

           SENATE BUS., PROF. & ECON. DEVEL. COMMITTEE  :  5-3, 4/23/07
          AYES:  Ridley-Thomas, Corbett, Florez, Simitian, Yee
          NOES:  Aanestad, Denham, Harman


           SUBJECT :    Pharmaceutical drug disposal

           SOURCE  :     Author


           DIGEST  :    This bill requires every retailer of a drug to  
          have in place, on and after July 1, 2008, a system for the  
          acceptance and collection of drugs for proper disposal, as  
          specified.

           ANALYSIS  :    

           Existing Law
           
          1.Under the United States Federal Food, Drug, and Cosmetic  
            Act the Food and Drug Administration (FDA) is authorized  
            to oversee the safety of food, drugs, and cosmetics. 
                                                           CONTINUED





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          2.Under the Resource Conservation and Recovery Act (RCRA)  
            of 1976, the management of solid and hazardous waste is  
            regulated.

          3.Under the California Hazardous Substances Act, the  
            Department of Toxic Substances Control is authorized to  
            regulate hazardous materials and wastes to ensure that  
            the state is delegated authority in accordance with RCRA.

          4.Under the California Integrated Waste Management Act, the  
            California Integrated Waste Management Board implements a  
            statewide household hazardous substance information and  
            collection program.

          5.Under the Medical Waste Management Act the State  
            Department of Health Services regulates the management  
            and handling of medical waste.  Certain items, such as  
            household waste, are specifically excluded from the  
            definition of medical waste.

          6.Provides for the regulation of prescription drugs and  
            medical devices dispensed by pharmacies by the California  
            State Board of Pharmacy within the Department of Consumer  
            Affairs.

          This bill:

          1. Makes Legislative findings and declarations regarding  
             the harmful effects of improper drug disposal, and the  
             intention to reduce the likelihood of improper disposal  
             of drugs, by establishing a program through which the  
             public may return and ensure the safe and  
             environmentally sound disposal of drugs and may do so in  
             a way that is convenient for consumers and cost  
             effective for retailers.

          2. Defines specified terms and definitions for purposes of  
             the bill.

          3. Requires every retailer of a drug, on and after July 1,  
             2008, to have in place a system for the acceptance and  
             collection of drugs for proper disposal.








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          4. Specifies that a system for the acceptance and  
             collection of drugs for proper disposal shall, at a  
             minimum, include:

             A.    The take-back, at no cost to the consumer, of a  
                drug, the type or brand of which the retailer sold  
                or previously sold.

             B.    A notice to consumers that shall include  
                informational materials, including, but not limited  
                to, Internet Website links or a telephone number,  
                placed on the invoice or purchase order, or  
                packaged with the drug, that provide consumers  
                access to obtain more information about the  
                opportunities and locations for no-cost drug  
                disposal.

             C.    Information made available to consumers about  
                drug return opportunities provided by the retailer  
                and encouraging consumers to utilize those  
                opportunities.  This information may include, but  
                is not limited to, one or more of the following:

               (1)     Signage that is prominently displayed and  
                  easily visible to the consumer.

               (2)     Written materials provided to the consumer  
                  at the time of purchase or delivery, or both.

               (3)     Reference to the drug take-back opportunity  
                  in retailer advertising or other promotional  
                  materials, or both.

               (4)     Direct communications with the consumer at  
                  the time of purchase.

               5.      States the provisions of the bill do not  
                  apply to a controlled substance, as defined.

           Comments
           
          The author's office states that under existing law,  
          hazardous waste and medical waste are regulated under state  
          law to prevent unsafe disposal that may pose a risk to  







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          human health and the environment.  However, because the law  
          considers drugs a household hazardous waste, there is no  
          prohibition against throwing unused drugs in the trash or  
          flushing them down the toilet.

          The author's office states that the United States  
          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.

          Without a safe and effective method for disposal,  
          prescription drugs may be left indefinitely in medicine  
          cabinets where they pose a threat of potential prescription  
          drug misuse or abuse.  The author's office believes that  
          this bill provides a safe and environmentally sound method  
          for the disposal of unused prescription drugs.  Currently,  
          when an individual needs to dispose of expired or left over  
          medications, the only safe way to do so is to take it to a  
          household hazardous waste collection site.  Most often  
          drugs are either flushed down the toilet or thrown in the  
          garbage where they can pose a threat to the environment and  
          contaminate our waterways.

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  No    
          Local:  No

           SUPPORT  :   (Verified  5/2/07)

          American Federation of State, County and Municipal  
          Employees
          Breast Cancer Fund
          California Alliance for Consumer Protection
          California Association of Sanitation Agencies
          California Product Stewardship Council
          California Veterinary Medical Association
          Californians Against Waste
          Central Contra Costa Sanitary District
          City and County of San Francisco
          City of Benicia
          City of Livermore Water Resources Division







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          City of Millbrae
          City of Palo Alto
          City of Rohnert Park
          Clean Water Action
          East Bay Municipal Utility District
          EXP Pharmaceutical Services Corp.
          Laguna de Santa Rosa Foundation
          League of California Cities
          Maine Benzodiazepine Study Group
          Maine Unused Drug Disposal Group
          Mt. View Sanitary District
          Orange County Sanitation District
          Planning and Conservation League
          Regional Council of Rural Counties
          San Francisco Public Utilities Commission
          Santa Clara Valley Water District
          Sierra Club California
          Solid Waste Association of North America

           OPPOSITION  :    (Verified  5/2/07)

          California Grocers Association
          California Retailers Association
          Rite Aid

           ARGUMENTS IN SUPPORT  :    Californians Against Waste  
          contends that currently there are few safe and convenient  
          ways for consumers to dispose of unused prescription drugs.  
           A 2006 study showed that only five percent of pharmacies  
          had a consistent message to patients on the safe disposal  
          of pharmaceuticals.  Nearly all unused pharmaceuticals  
          enter either our solid waste system or our sewage system.   
          Neither disposal methods are environmentally sound.   
          Pharmaceuticals flushed down the toilet pass through our  
          sewage treatment plants, which are generally not designed  
          to screen for these chemicals.  Pharmaceuticals discarded  
          in landfills can seep into the surrounding water table.   
          Existing law already requires many pharmacies to provide  
          consumers with a take-back and recycling obligation for  
          other problem products, including plastic bags,  
          rechargeable batteries and cell phones.  Extending this  
          take-back responsibility to pharmaceuticals is a logical  
          step.








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          Sierra Club California states that this bill provides a  
          safe and environmentally sound method for the disposal of  
          unused prescription drugs and agrees that pharmacies  
          provide a convenient location for consumers to return  
          unused drugs.  Without a safe and effective method for  
          disposal, prescription drugs maybe left indefinitely in  
          medicine cabinets where they pose a threat of potential  
          prescription drug misuse.

           ARGUMENTS IN OPPOSITION  :    The California Retailers  
          Association states that although its members agree with the  
          goal of appropriate and safe disposal of prescription  
          drugs, there remain substantial concerns regarding the  
          burdens that would be imposed on pharmacies by such an  
          unfunded mandate.  Its members fear that they would be  
          unable to support the administrative, personnel, time and  
          cost demands that would be imposed by this bill.

          Rite Aid opposes the requirement that every retail pharmacy  
          have a system for the acceptance and collection of unused  
          pharmaceutical drugs for proper disposal.  Pharmacies would  
          be prohibited from collecting a fee to cover the cost of  
          implementing this mandated program.  Pharmacies will incur  
          substantial costs by participating in a mandated drug  
          disposal program.  In addition to the obvious labor cost  
          associated with such a program, there will also be costs  
          associated with establishing the notification and outreach  
          mandates outlined in the bill.

          Other states that have established drug disposal programs  
          have made them voluntary and have allowed pharmacies to  
          charge a nominal fee to cover the cost associated with the  
          program.  In addition, some states have established  
          voluntary take-back days in which pharmacies collect unused  
          drugs on certain days.  State agencies then collect the  
          returned drugs from each store and properly dispose of  
          them.  Rite Aid believes that other programs represent well  
          thought-out approaches to establishing a drug take-back  
          program.  
           
          TSM:do  5/2/07   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE








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