BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                AB 333
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        ( Without Reference to File  )

        CONCURRENCE IN SENATE AMENDMENTS
        AB 333 (Wieckowski)
        As Amended  August 22, 2014
        Majority vote
         
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        |ASSEMBLY: |67-6 |(May 23, 2013)  |SENATE: |33-0 |(August 27, 2014)    |
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        |COMMITTEE VOTE:  |6-0  |(August 29, 2014)   |RECOMMENDATION: |concur    |
        |(E.S. & T.M.)    |     |                    |                |          |
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        Original Committee Reference:   E.S. & T.M.
          
        SUMMARY  :  Makes numerous changes to the Medical Waste Management  
        Act (MWMA) including, among other things, codifying federal  
        requirements, modifying definitions, creating procedures for the  
        generation of medical waste from a temporary event, and modifying  
        contracts with medical waste transporters for the collection of  
        fees.
         
        The Senate amendments  : 

        1)Recognize that the MWMA governs medical waste management at the  
          facility where the waste is generated, transfer stations and  
          treatment facilities, and governs tracking medical waste beyond  
          federal transportation documentation requirements. 

        2)Recognize that the United States Department of Transportation (US  
          DOT) imposes standards for transporting medical waste on public  
          roads and highways while in transit, and the United States Postal  
          Service (USPS) imposes standards for the transportation of  
          medical waste through the mail. 

        3)Require the California Department of Public Health (CDPH) to  
          submit to the Legislature, by January 1, 2016, a report  
          describing the interaction of federal and state law for the  
          transport of regulated medical waste, and require CDPH to convene  
          a stakeholder group, including small and large quantity  
          generators, haulers, transfer station and treatment facility  








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          operators, local enforcement agencies (LEA), and retailers in its  
          effort to develop the report. 

        4)Authorize CDPH to update standards related to the transportation  
          of medical waste through a guidance document provided to MWMA  
          stakeholders and posted on CDPH's Web site, and exempt CDPH from  
          the Administrative Procedures Act if those standards are  
          consistent with the US DOT requirements. 

        5)Authorize CDPH to temporarily waive the state transportation  
          requirements in the event that a person, including CDPH, seeks a  
          preemption determination under federal law, and determine that  
          the federal requirements are the law of this state for  
          transporting medical waste during the temporary waiver and/or if  
          preemption is found. 

        6)Reference US DOT and USPS regulations in various provisions  
          related to the transport of medical waste. 

        7)    Revise and consolidate definitions for "biohazardous waste,"  
          "pharmaceutical waste," "sharps waste," "trace chemotherapeutic  
          waste," and "trauma scene waste," under a single revised  
          definition for "medical waste." 

        8)   Revise additional various definitions used throughout the  
          MWMA, including: 

           a)   The definition of "biohazard bag" and specify color coding  
             requirements for the purpose of segregating waste;

           b)   The definition of "highly communicable diseases" to update  
             categorization to reference the appropriate Centers for  
             Disease Control and Prevention risk group;

           c)   The definition of "medical waste treatment facility" to  
             specify over which land the facility has control; 

           d)   The definition of "pharmaceutical" to reference the  
             Department of Toxic Substances Control's authority over  
             hazardous waste;

           e)   The definition of "sharps container" to specify that trace  
             chemotherapeutic wastes are not required to be lined with a  
             plastic liner; and, 









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           f)   The definition of "transfer station" to clarify defined  
             locations are permitted by CDPH. 

        9)Clarify the reference to existing law for treating medical waste  
          as permitted by an LEA.

        10)Require small quantity generators (SQG) to include additional  
          information in the medical waste management plan ("plan"),  
          including:

           a)   Steps taken to categorize generated pharmaceutical waste  
             and how those wastes are disposed; and, 

           b)   A closure plan for the termination of the treatment  
             facility. 

        11)Require registered medical waste generators to additionally  
          provide to LEA shipping documents of all untreated medical waste  
          shipped offsite. 

        12)Delete requirements for medical waste generators to apply for a  
          limited quantity hauling exemption, and authorize SQGs and large  
          quantity generators (LQG) to transport limited quantities of  
          medical waste up to 35.2 pounds to the central location of  
          accumulation as long as specific conditions are met, including  
          that the transport is in accordance with the requirements of the  
          US DOT Material of Trade Exception, and the person transporting  
          medical waste provides a log to the receiving facility with  
          specified information. 

        13)Reference the applicable transportation requirements for  
          transporting medical waste from adjacent properties.

        14)Require LQGs to include additional information in the plan,  
          including:

           a)   Steps taken to categorize generated pharmaceutical waste  
             and how those wastes are disposed; and, 

           b)   A closure plan for the termination of the treatment  
             facility. 

        15)Require medical waste generators to update their plan within 30  
          days from when any relevant information in the plan changes, and  
          require the plan be maintained on file for review.      








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        16)Clarify further that "medical waste" does not include waste  
          generated in biotechnology that does not contain a highly  
          communicable disease.     

        17)Authorize registered LQGs to generate medical waste at temporary  
          events, and require LQGs to notify LEA within 72 hours of an  
          event, unless the sponsor of the temporary event previously  
          notified the LEA of the event.

        18)Authorize SQGs to generate medical waste at temporary events,  
          and require SQGs to notify LEA within 72 hours of event, unless  
          the sponsor of the temporary event previously notified the LEA of  
          the event.

        19)Increase the percentage of administrative fee medical waste  
          transporters may retain from 5% to 7.5% to cover administrative  
          costs.

        20)Limit administrative fees paid by medical waste generators to be  
          paid no more than once per year. 

        21)Require operators of onsite sterilization equipment used at SQGs  
          to receive annual training that complies with federal  
          Occupational Safety and Health Administration (OSHA) standards  
          and records of training to be maintained for two years. 

        22)Require LQGs to annually train operators of onsite sterilization  
          equipment consistent with federal OSHA standards, and records of  
          training to be maintained for two years.

        23)Require medical waste transported out of state to be consigned  
          to a permitted medical waste treatment facility out of state and  
          refer to state law for treating medical waste crossing an  
          international border. 

        24)Authorize solid waste facility operators to arrange for proper  
          treatment and disposal of erroneously disposed medical waste at a  
          solid waste facility. 

        25)Require a person applying for a permit for an offsite medical  
          waste treatment facility to additionally include information  
          regarding a plan for closure describing decontamination methods. 

        26)Clarify that heat sensitive tape or another acceptable method  








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          only need to be placed on liner bags when biohazard bags or  
          sharps containers are contained in a larger lined bag for  
          autoclave treatment. 

        27)Require human anatomical parts, excluding teeth, to be disposed  
          of by interment, incineration, or appropriate alternative  
          treatment technologies. 

        28)Specify that the containerization and storage requirements  
          currently in the MWMA only apply at the point of generation and  
          when the waste is collected in the room.  

        29)Specify additional labeling and containerization requirements.

        30)Revise the usage of biohazardous bags in certain health care  
          settings, establish weight limits for medical waste placed in  
          biohazardous bags at three pounds or one gallon, and change the  
          biohazardous waste storage requirements at transfer stations.

        31)Delete outdated implementation and sunset dates. 

        32)Delete confusing statutory cross-references.

         AS PASSED BY THE ASSEMBLY  , this bill made technical and conforming  
        changes to the MWMA.  Specifically, this bill:

          1)  Deleted the existing definition of "biohazard bag," and  
            instead replaced it with the definition in the Code of Federal  
            Regulations.

          2)  Amended the definition of "medical waste management plan" to  
            specify that the document that is completed by generators of  
            medical waste describes how the medical waste generated at  
            their facility shall be segregated, handled, stored, packaged,  
            treated, or shipped for treatment, as applicable.  Specified  
            that the medical waste management plan is to be completed on  
            forms prepared by the enforcement agency, only if those forms  
            are provided by the enforcement agency.

          3)  Required a solid waste transporter who discovers that he or  
            she has (unknowingly) hauled untreated medical waste to a  
            landfill or materials recovery facility to contact the  
            originating generator of the medical waste to respond to the  
            landfill or recovery facility to provide ultimate proper  
            disposal of the medical waste.








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          4)  Clarified that the statutory requirements for treatment of  
            carcasses of animals that die of infectious diseases includes  
            those that are euthanized because they are suspected of having  
            been exposed to infectious disease.
         
        FISCAL EFFECT  :  According to the Senate Appropriations Committee: 

        1)Initial costs of $156,000 annually from the Medical Waste  
          Management Fund for fiscal year (FY) 2015-16 and FY 2016-17 to  
          assist with compliance with the changes to the MWMA.

        2)Minor revenue losses to the Medical Waste Management Fund by  
          allowing medical waste transporters to keep an additional 2.5% of  
          the small generator annual fee for administrative costs.

         COMMENTS  :

        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 can contain pathogens, blood, low  
        levels of radioactivity, discarded needles, syringes, scalpels,  
        expired drugs and vaccines, which can pose a hidden risk of  
        infection, radioactivity exposure, and needle-stick injuries.


        Medical Waste Management Act:  The MWMA was created in response to  
        several incidents of medical waste washing up on San Diego County  
        beaches, as well as several reports of medical waste being disposed  
        of in dumpsters and trash bins.  AB 109 (Hayden), Chapter 1613,  
        Statutes of 1990, and AB 1641 (Mojonnier), Chapter 1614, Statutes  
        of 1990, were ultimately combined to form the MWMA to, according to  
        the original Legislative intent, "comprise a single, integrated,  
        and complementary approach to the storage, treatment,  
        transportation, and disposal of medical waste."



        The MWMA allows any local ordinance regulating infectious waste  
        that was in existence before 1990 and regulated both large and  
        small quantity generators to continue.










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        Enforcement, by the numbers:  The MWMA allows local governments to  
        elect to be the enforcement agency of the MWMA and to assess  
        appropriate fees for their enforcement activities.  Currently, CDPH  
        is the enforcement authority for 25 counties, and as part of those  
        duties issues permits to generators in those counties.  CDPH also  
        issues permits to transfer stations.  Under CDPH's jurisdiction,  
        there are:


        1)118 transfer stations in California.

        2)Roughly 6,500 SQGs registered with CDPH (defined as generating  
          less than 200 pounds per month of medical waste).  These can be  
          doctor's offices, veterinary offices, dental offices,  
          laboratories, research labs, and pharmacies.

        3)Approximately 800 LQGs registered with CDPH.  These are typically  
          hospitals, skilled nursing facilities, psychiatric facilities,  
          veterinary hospitals, or any of the examples above.

        Data is not maintained for the number of small and large quantity  
        generators in the counties that serve as their own enforcement  
        agencies and issue permits for the generators in their counties.  

        Purpose for reform:  According to the author, "[t]he Medical Waste  
        Management Act was signed in to law in 1990 by Governor George  
        Deukmejian.  The MWMA made California one of the leading states in  
        the nation in governing this waste stream.  Many changes during the  
        intervening 23 years in medical waste treatment, transportation  
        oversight, and new requirements by landfill and waste water  
        treatment operators regarding acceptance of portions of this waste  
        stream necessitate an update of the Act.


        "Since enactment of the Medical Waste Management Act (MWMA), the  
        federal Department of Transportation (DOT) has increased its  
        regulatory oversight of transportation of medical waste which  
        preempts state law.  Similarly, the United States Postal Service  
        (USPS) requirements for the mail back of medical waste also preempt  
        state law.  When the Act was initially implemented it was common  
        practice to dispose of pharmaceutical wastes into landfills or  
        through sewer systems.  Heightened regulation of receiving waters  
        of waste water treatment plants and the potential of runoff from  
        landfills has resulted in these facilities tightening requirements  








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        for acceptance of pharmaceutical wastes for disposal.

        "The current Medical Waste Management Act (Sections 117600-118360  
        Health & Safety Code) was implemented in 1991 and federal agencies  
        (Department of Transportation and US Postal Service) now regulate  
        transportation of medical waste and pre-empt the state  
        requirements.  This creates conflict for California healthcare  
        facilities and places them at risk of non-compliance with federal  
        statutes.  Administrative solutions cannot fix the problem as there  
        is a conflict in the statutes governing medical waste treatment and  
        transportation."

        Clarifying the role of federal requirements:  Since this bill was  
        amended to recognize the US DOT and USPS's requirements for  
        transporting medical waste, confusion between stakeholders and CDPH  
        has lingered over where federal law preempts state law, and where  
        state law is permitted to be enforced over federal law.  
         
        Supporters contend that clarification in the MWMA over which laws  
        govern the transportation of medical waste - federal or state -  
        will remove confusion from the industry over compliance  
        requirements, and reduce risk for non-compliance with federal  
        requirements. 

        As reflected in the current version of this bill, negotiations have  
        achieved consensus between stakeholders and CDPH on addressing the  
        blurred lines between state and federal laws.  This bill requires  
        CDPH, in coordination with MWMA stakeholders, to develop a report  
        regarding the implementation and interaction of federal and state  
        law for the transport of regulated medical waste, and to provide  
        that report to the legislature by January 1, 2016. 

        While differences of opinion may remain on state versus federal  
        authority for transporting regulated medical waste, this bill gives  
        MWMA stakeholders clearer guidance on which rules to follow and  
        which documentation forms to submit and maintain, and gives CDPH  
        time to identify precise state jurisdiction and federal preemption  
        where ambiguities from a regulator's perspective may remain. 

        Substantial amendments in the Senate:  While the subject matter of  
        this bill is the same as was passed by the Assembly, the bill was  
        substantially amended in the Senate to update and revise the MWMA. 
         

        Analysis prepared by  :    Paige Brokaw / E.S. & T.M. / (916)  








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