BILL ANALYSIS                                                                                                                                                                                                    



                                                                     AB 649


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          Date of Hearing:  April 29, 2015


                        ASSEMBLY COMMITTEE ON APPROPRIATIONS


                                 Jimmy Gomez, Chair


          AB  
          649 (Patterson) - As Amended April 16, 2015


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          Urgency:  No  State Mandated Local Program:  NoReimbursable:   


          SUMMARY:


          This bill allows law enforcement agencies to use approved  
          prescription drug incinerators up to four times per year to  
          treat and dispose of medical waste as specified.  Specifically,  
          this bill:  








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          1)Amends the Medical Waste Management Act (MWMA) to require any  
            alternative medical waste treatment designed to treat  
            pharmaceutical waste, including a pharmaceutical incinerator,  
            to be evaluated and approved by the Department of Public  
            Health (DPH).


          2)Allows a law enforcement agency that operates a prescription  
            drug takeback program to use an approved pharmaceutical  
            incinerator up to four times per year.


          FISCAL EFFECT:


          Minor increased costs to DPH (special fund), likely of less than  
          $100,000, to approve alternative medical waste treatments.


          COMMENTS:


          1)Rationale.  Under the MWMA, pharmaceutical waste must be  
            incinerated.  According to DPH, there are no incinerators in  
            California permitted for the treatments of this kind of waste.  
             Permitted in-state facilities treat biohazardous and medical  
            sharps waste through steam sterilization (autoclaving) or by  
            an approved alternative treatment technology.
            According to the author, law enforcement personnel  
            administrating takeback programs are currently hauling or  
            shipping their wastes to one of three federally compliant  
            Large Municipal Waste Combustor (LMWC) or Standards and Small  
            Municipal Waste Combustor (SMWC) of which there are three in  
            California: 1) Commerce Refuse-to-Energy Facility (Commerce);  
            2) Southeast Resource Recovery Facility (Long Beach); and 3)  
            Stanislaus County Resource Recovery Facility (Crow's Landing).  
             However, none of these facilities are permitted under the  








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            MWMA to treat pharmaceutical waste. 


            This bill allows a law enforcement agency that operates a  
            prescription drug takeback program to use an alternative  
            medical waste treatment, including a pharmaceutical  
            incinerator, up to four times per year to treat and dispose of  
            medical waste.

           

          2)Background.  The United States Environmental Protection Agency  
            (US EPA) issued a guidance letter on September 2012 on the  
            disposal of household pharmaceuticals collected by takeback  
            programs.  The letter recommended pharmaceutical waste be sent  
            to a permitted hazardous waste combustor, and, when that is  
            not feasible, be sent to a large or small municipal combustor.  
              The US EPA also acknowledges that it does not want  
            [incineration] costs to discourage takeback events and  
            subsequently recommended incineration facilities that meet the  
            US EPA's Large Municipal Waste Combustor (LMWC) Standards and  
            Small Municipal Waste Combustor (SMWC) Standards when  
            hazardous waste combustion is not feasible.

          3)Pharmaceutical Waste. Pharmaceutical waste is segregated into  
            three different categories for proper treatment: controlled,  
            hazardous, and non-hazardous. 


            Drugs and other substances that are considered controlled  
            substances under the federal Controlled Substances Act (CSA)  
            are categorized based on whether they have a currently  
            accepted medical use in treatment in the United States, their  
            relative abuse potential, and likelihood of causing dependence  
            when abused.  These pharmaceuticals are managed differently  
            than hazardous and non-hazardous pharmaceuticals; controlled  
            substances must be disposed of in a manner that renders them  
            non-retrievable in accordance with federal regulations, unlike  
            the other categories of pharmaceutical waste. 








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          4)Federal Programs.  The Drug Enforcement Administration (DEA)  
            hosts National Prescription Drug Takeback Days to provide  
            opportunities for disposing controlled substances. To date,  
            the DEA has held 9 takeback days, with the most recent event  
            held in September 2014. The DEA initiated these takeback days  
            four years ago because at that time the CSA made no legal  
            provision for people to dispose of unwanted controlled  
            substance prescription drugs except to give them to law  
            enforcement, and the CSA banned pharmacies and hospitals from  
            accepting them.  
            Since the DEA's first Takeback Day, the DEA has developed  
            regulations that outline methods the public can use to  
            transfer pharmaceutical controlled substances and other  
            prescription drugs to authorized collectors for the purpose of  
            disposal.  


            The DEA has announced it plans to cease holding its takeback  
            days because the new disposal regulations are registered and  
            in effect for disposing controlled substances.   According to  
            the DEA, law enforcement continues to have autonomy with  
            respect to how they collect controlled substance prescription  
            drugs, including holding takeback events.  Any person or  
            entity-DEA registrant or non-registrant-may partner with law  
            enforcement to conduct takeback events.  





             



          Analysis Prepared by:Jennifer Galehouse / APPR. / (916)  
          319-2081









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