BILL ANALYSIS                                                                                                                                                                                                    

                             Senator Ricardo Lara, Chair
                            2015 - 2016  Regular  Session

          AB 649 (Patterson) - Medical waste:  law enforcement drug  
          takeback programs
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          |Version: June 24, 2015          |Policy Vote: E.Q. 6 - 0         |
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          |Urgency: No                     |Mandate: No                     |
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          |Hearing Date: August 17, 2015   |Consultant: Marie Liu           |
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          This bill meets the criteria for referral to the Suspense File. 

          Summary:  AB 649 would require Department of Public Health (DPH)  
          to evaluate and approve an alternative medical waste treatment  
          method that is designed to treat pharmaceutical waste by June 1,  
          2017 and would limit the use of such a technology by a law  
          enforcement agency.

           Potential unknown one-time costs, ranging from the thousands  
            to hundreds of thousands, to the Medical Waste Management Fund  
            (special fund) if the first alternative medical waste  
            treatment technology evaluation needs to be expedited to  
            comply with the June 1, 2017 deadline. 
           Unknown costs, potentially in the hundreds of thousands, to  
            the Medical Waste Management Fund (special fund) for DPH to  
            consult with other agencies on compliance with applicable  
            environmental quality laws.


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          Background:  Pursuant to the Medical Waste Management Act, DPH regulates  
          the management and handling of medical waste and authorizes  
          off-site medical waste treatment facilities, oversees transfer  
          stations, approves alternative treatment technologies, and acts  
          as the local law enforcement agency in 25 jurisdictions where  
          local agencies have elected not to conduct their own  
          Approval of alternative medical waste treatment methods is  
          subject to the criteria specified in subdivision (a) of 118215  
          of the Health and Safety Code.

          Proposed Law:  
            This bill would require DPH to evaluate and approve any  
          alternative medical waste treatment solely designed to treat  
          pharmaceutical waste, including a pharmaceutical incinerator.  
          DPH would be required to complete its first evaluation by June  
          1, 2017. DPH would also be required to consult with the State  
          Water Resources Control Board (SWRCB), the Department of Toxic  
          Substances Control (DTSC), the State Air Resources Board (ARB),  
          and local air quality management districts to ensure compliance  
          with all other environmental laws prior to approval of the  
          alternative treatment.
          This bill would also prohibit a law enforcement agency that  
          operates a prescription drug takeback program from utilizing a  
          pharmaceutical incinerator more than four times a year.

          Comments:  DPH has existing authority to approve alternative  
          medical waste treatments. This bill does not alter this  
          authority other than establish a deadline for the first  
          evaluation of a technology that is solely designed to treat  
          pharmaceuticals. The deadline of June 1, 2017 is irrespective of  
          when, and if, an application for such a technology may be  
          received. The time necessary to evaluate a technology can vary  
          widely depending on the type of technology as well as the  
          quality of the data submitted with the application. Should the  


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          first application be received with insufficient time before the  
          deadline to evaluate the technology under the existing process,  
          this bill would require DPH to expedite the evaluation at an  
          unknown cost. 
          Staff notes that under the existing evaluation process in which  
          there are no time limitations, DPH can have evaluation costs  
          that are not offset by the application fee. These costs can  
          exceed the application fee by thousands to hundreds of thousands  
          of dollars. These costs are not attributable to this bill as the  
          bill does not change what must be evaluated, only the timeline  
          in which it must be done. 

          This bill would require DPH to consult with the SWRCB, DTSC, and  
          ARB prior to approval of an alternative medical waste treatment  
          technology. Under the existing approval process, it is the  
          responsibility of the applicant to provide DPH with proof that  
          they have received the appropriate approvals from other agencies  
          that may have regulatory jurisdiction. This bill appears to  
          shift the onus onto DPH. As such, this bill may increase the  
          costs to evaluate a technology to include coordination with  
          other agencies regarding their approval.

          This bill would allow a law enforcement agency operating a  
          prescription drug takeback program to utilize a pharmaceutical  
          incinerator that has been approved by DPH up to four times a  
          year. Under existing law, to use a pharmaceutical incinerator,  
          the law enforcement agency would be required to obtain a permit  
          from DPH. This bill does not alter this requirement; however,  
          the issued permit would have to have a special condition to  
          limit the use of the incinerator. To issue a permit with such a  
          condition can be done without changing DPH's administrative  
          costs. However, staff notes that it is unclear how DPH would  
          enforce such a use limitation or why such a limitation is  
          necessary if law enforcement agency is using an approved  

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