BILL ANALYSIS                                                                                                                                                                                                    



          SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
                              Senator Wieckowski, Chair
                                2015 - 2016  Regular 
           
          Bill No:            AB 649
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          |Author:    |Patterson                                            |
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          |Version:   |6/2/2015               |Hearing      |6/17/2015       |
          |           |                       |Date:        |                |
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          |Urgency:   |No                     |Fiscal:      |Yes             |
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          |Consultant:|Rachel Machi Wagoner                                 |
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          SUBJECT:  Medical waste: law enforcement drug takeback programs.


            ANALYSIS:
          
          Existing law: 
          
             1)   Exempts household pharmaceutical waste from hazardous  
               waste classifications (40 CFR 261.4(b)) and as medical  
               waste. (Health and Safety Code 117700)

             2)   Pursuant to the Medical Waste Management Act (MWMA),  
               requires the California Department of Public Health (DPH) to  
               regulate 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 enforcement agency in 25  
               jurisdictions where local agencies have elected not to  
               conduct their own enforcement. 

             3)   Defines "medical waste" to include, among other things,  
               pharmaceutical waste, which includes a prescription or  
               over-the-counter human or veterinary drug, including, but  
               not limited to, a drug as defined in the Federal Food, Drug,  
               and Cosmetic Act. 

             4)   Requires a person that generates or treats medical waste  
               to ensure that the medical waste is treated by one of the  
               following methods rendering it solid waste: 
                  a)        Incineration at a permitted medical waste  







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                    treatment facility in a controlled-air, multichamber  
                    incinerator, or other method of incineration approved  
                    by DPH which provides complete combustion of the waste  
                    into carbonized or mineralized ash;
                  b)        Treatment with an alternative technology  
                    approved by DPH that treats the waste with temperatures  
                    in excess of 1300 degrees Fahrenheit;
                  c)        Steam sterilization at a permitted medical  
                    waste treatment facility or by other sterilization, in  
                    accordance with specified operating procedures for  
                    steam sterilizers or other sterilization; or,
                  d)        Other alternative medical waste treatment  
                    methods which are approved by DPH and result in the  
                    destruction of pathogenic micro-organisms. 

             5)   Requires any alternative medical waste treatment method  
               to be evaluated by DPH and either approved or rejected  
               pursuant to specified statutory criteria. 

             6)   Prohibits a person from hauling medical waste unless the  
               person is a registered hazardous waste hauler; a mail-back  
               system approved by the United States Postal Service; a  
               common carrier allowed to haul pharmaceutical waste; a  
               small- or large-quantity generator transporting limited  
               quantities of medical waste with an exemption; or a  
               registered trauma scene waste practitioner. 

             7)   Requires pharmaceutical takeback programs to be in  
               compliance with the Controlled Substances Act and its  
               implementing regulations. 

             8)   Regulates air emissions from stationary and mobile  
               sources pursuant to the Federal Clean Air Act.  

             9)   Establishes the California Air Resources Control Board to  
               enforce the Federal Clean Air Act. 

          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:  

          1)Amends the MWMA to require any alternative medical waste  








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            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.


            Background
          
          1) What is medical waste?:  Medical waste is waste materials  
             generated at health care facilities, such as hospitals,  
             clinics, physician's offices, dental practices, blood banks,  
             and veterinary hospitals/clinics, as well as medical research  
             facilities and laboratories.  Medical waste includes  
             pharmaceutical waste, including prescription or  
             over-the-counter human or veterinary drugs. Pharmaceuticals  
             were added as covered wastes under the MWMA to transfer  
             management of this waste from the California Department of  
             Toxic Substances Control to the Department of Healthcare  
             Services (now CDPH) in 1996 (SB 1966, Statutes of 1996,  
             Chapter 536).  

          2) Pharmaceutical takeback programs: According to the U.S.  
             Centers for Medicare & Medicaid Services, approximately $275.9  
             billion in prescription drugs were predicted to be prescribed  
             in the U.S. in 2014. By 2020, that number is projected to  
             reach $379.9 billion. An estimated 10 to 33% of prescribed  
             medicines are not consumed.  With a lack of safe, secure and  
             convenient disposal options, consumers traditionally turn to  
             trashing, flushing or storing these medicines at home.

             Over the past several years, Fresno County's takeback program  
             has seen an exponential increase in drug drops offs: the  
             County collected 755 pounds of prescription drugs in Fiscal  
             Year 2011-12; 1,918 pounds in Fiscal Year 2012-13; and 2,457  
             pounds in Fiscal Year 2013-14.  This evidences a growing  
             demand for maintaining a convenient drug takeback program.  


             Law enforcement-operated takeback systems offer a safe and  
             convenient way for residents to appropriately dispose their  








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             expired and unused pharmaceuticals in lieu of flushing or  
             throwing those drugs in the trash can, which is known to cause  
             deleterious impacts to water quality and public health. 


          3) Pharmaceutical waste treatment: Under current law,  
             pharmaceutical waste can be treated in one of several ways,  
             including:

             Incineration at a permitted medical waste treatment facility;

             Alternative treatment methods that treat the waste with  
             temperatures in excess of 1300 degrees Fahrenheit;


             Steam sterilization at a permitted medical waste treatment  
             facility; or


             Other alternative medical waste treatment methods which are  
             approved by CDPH.

             Under the MWMA, pharmaceutical waste must be incinerated and,  
             according to CDPH, there are no permitted incinerators in  
             California for the treatment of that type of medical waste.   
             (The last medical waste incinerator that was in operation in  
             the state (Integrated Environmental Systems in Oakland) was  
             closed in 2001.)

             At this time, all pharmaceutical waste generated from  
             hospitals, pharmacies, retailers, or other generators is  
             shipped by a registered medical waste hauler out of state for  
             treatment.  Permitted in-state facilities treat biohazardous  
             and sharps waste through steam sterilization (autoclaving) or  
             by an approved alternative treatment technology.
            
          Comments
          
          1) Purpose of Bill.  According to the author, no permitted  
             medical waste incinerators exist in California, and states,  
             "[w]ith limited options for disposal of these collected  
             pharmaceuticals, law enforcement agencies that operate these  
             takeback programs often resort to expensive methods such as  
             shipping the materials out of state or taking police officers  








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             off the street to drive long distances to one of the three  
             California locations where this incineration is permitted. 

            "AB 649 would permit law enforcement agencies that operate a  
            prescription drug takeback program to use a noncompliant  
            prescription drug incinerator to dispose of the pharmaceuticals  
            they collect from the community."

          2)Amendment needed.  
                  a.        Required approval.  Amendments added in the  
                    June 2, 2015 version of AB 649 state, "By June 1, 2017,  
                    the department shall complete the first evaluation and  
                    approval of these alternative medical waste treatments,  
                    including a pharmaceutical incinerator."  By requiring  
                    approval, this language assumes that this technology  
                    will meet DPH requirements for public health and  
                    environmental safety.  An amendment is needed to strike  
                    "approval" from this language.

                  b.        Compliance with air quality regulation.  While  
                    nothing in this legislation provides an exemption from  
                    local air quality law or other environmental statute,  
                    because this bill amends MWMA, an amendment should be  
                    added to clarify that any alternative medical waste  
                    treatment evaluated pursuant to this chapter must still  
                    meet requirements pursuant to other environmental  
                    protection laws.

            Related/Prior Legislation

          SB 727 (Jackson, 2014) would have: 1) required a producer of a  
          pharmaceutical sold in the state to, individually or through a  
          stewardship organization, to submit a plan, on or before January  
          1, 2015, to the Department of Resources Recycling and Recovery  
          and 2) required the plan to provide for the development of a  
          program to collect, transport, and process home-generated  
          pharmaceutical drugs and to include specified aspects, including  
          the minimum amount of collection sites, including by January 1,  
          2016, at least one collection service within 10 miles per person  
          in the state.  SB 727 was held by the author in the Senate  
          Business and Professions Committee.

            SOURCE:                    Author  









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           SUPPORT:               

          California Health Collaborative
          California Police Chiefs Association
          California State Sheriff's Association
          City of Fresno Police Department
          City of Reedley, Police Department
          City of Sanger, Police Department
          Fresno County Department of Behavioral Health 
          Valley Children's Healthcare

            OPPOSITION:    

          None received  


           
                                           
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