BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                            



           ----------------------------------------------------------------- 
          |SENATE RULES COMMITTEE            |                        AB 333|
          |Office of Senate Floor Analyses   |                              |
          |1020 N Street, Suite 524          |                              |
          |(916) 651-1520         Fax: (916) |                              |
          |327-4478                          |                              |
           ----------------------------------------------------------------- 
           
                                           
                                    THIRD READING


          Bill No:  AB 333
          Author:   Wieckowski (D)
          Amended:  8/20/14 in Senate
          Vote:     21


           SENATE ENVIRONMENTAL QUALITY COMMITTEE  :  7-0, 6/18/14
          AYES:  Hill, Gaines, Fuller, Hancock, Jackson, Leno, Pavley

           SENATE APPROPRIATIONS COMMITTEE  :  5-0, 8/14/14
          AYES:  De León, Hill, Lara, Padilla, Steinberg
          NO VOTE RECORDED:  Walters, Gaines

           ASSEMBLY FLOOR  :  67-6, 5/23/13 - See last page for vote


           SUBJECT  :    Medical waste

           SOURCE  :     Stericycle Inc.


           DIGEST  :    This bill makes numerous changes to the Medical Waste  
          Management Act (MWMA) including, among other things, codifying  
          existing federal preemptions and requirements, modifying  
          definitions, creating procedures for the generation of medical  
          waste from a temporary event, modifying contracts with medical  
          waste transporters for the collection of fees, and preempting  
          local programs regarding infectious waste.

           ANALYSIS  :    

          Existing federal law:

                                                                CONTINUED





                                                                     AB 333
                                                                     Page  
          2

          1.Authorizes the United States Department of Transportation  
            (DOT) to enforce rules on the transportation of medical waste  
            on public roads and highways.

          2.Authorizes the United States Postal Service (USPS) to regulate  
            medical waste and sharps waste containers that are transported  
            through the mail.

          Existing state law:

          1.Requires, under the MWMA, the Department of Public Health  
            (DPH) to regulate the management and handling of medical  
            waste.  The program authorizes off-site medical waste  
            treatment facilities, oversees transfer stations, approves  
            alternative treatment technologies, and acts as the local  
            enforcement agency in 26 jurisdictions (including Los Angeles  
            County) where local agencies have elected not to conduct their  
            own enforcement.

          This bill:

          1.Codifies the federal preemptions and requirements under DOT  
            and USPS for the transportation and tracking of medical waste.

          2.Expands the definition of "treatment" to specify the purpose  
            of treatment for each subset of medical waste and authorizes  
            the color coding of biohazard bags as follows: yellow bags are  
            used to further segregate trace chemotherapy waste and white  
            bags are used to further segregate pathology waste.

          3.Increases the fees for medical waste to 7.5% and removes the  
            provision allowing providers of mail-back systems to collect  
            fees.

          4.Specifies that when medical waste is transported out of state,  
            if there is no permitted medical waste treatment facility in  
            the receiving state or if the waste crosses an international  
            border, then the waste must be treated as specified in the  
            MWMA prior to leaving the state.

          5.Requires a medical waste generator to maintain for a minimum  
            of three years individual treatment operating records, and if  
            applicable, shipping documents for all untreated medical waste  
            shipped offsite for treatment, and shall report or submit to  

                                                                CONTINUED





                                                                     AB 333
                                                                     Page  
          3

            the enforcement agency, upon request, all of the following:

             A.   Treatment operating records. Operating records shall be  
               maintained in written or electronic form.

             B.   An emergency action plan complying with regulations  
               adopted by the DOT.
             C.   Shipping documents or electronically archived shipping  
               documents maintained by the facility and medical waste  
               hauler of all untreated medical waste shipped offsite for  
               treatment.

          1.Makes various changes to the provisions relating to medical  
            waste haulers, including removing provisions that conflict  
            with the DOT regulation of those entities, authorizing a  
            registered trauma scene waste practitioner, as specified, to  
            haul medical waste, and making changes to the information  
            medical waste haulers are required to provide to the DOT. 

          2.Makes various changes to the provisions relating to medical  
            waste treatment facilities, including specifying the  
            decontamination methods for a closure plan, lowering the time  
            period for which records are maintained from three to two  
            years, and authorizing the use of electronic information for  
            operating records and shipping documents.

          3.Revises the registration procedures and the record  
            requirements for large quantity and small quantity generators  
            and requires large and small quantity generators that operate  
            treatment equipment to receive annual training to operate the  
            equipment. 

          4.Authorizes a registered large quantity or small quantity  
            medical waste generator to generate medical waste at a  
            temporary event, including vaccination clinics, and requires  
            the large quantity or small quantity generator to notify the  
            enforcement agency of its participation at such an event at  
            least 72 hours before the event, unless the sponsor of the  
            temporary event previously notified the local enforcement  
            agency of the event.

          5.Exempts from regulation as a hazardous waste hauler a small  
            quantity generator or large quantity generator that meets  
            specified requirements, including retaining specified  

                                                                CONTINUED





                                                                     AB 333
                                                                     Page  
          4

            documentation and complying with certain federal requirements  
            relating to materials of trade exception.

          6.Exempts persons, who unknowingly transports medical waste to a  
            solid waste facility from the MWMA, and requires the solid  
            waste transporter to contact the originating generator of the  
            medical waste to respond to the facility to provide ultimate  
            proper disposal of the medical waste.

          7.Requires the carcasses of animals that have died of infectious  
            diseases or that have been euthanized because of suspected  
            exposure to infectious disease to be treated with a treatment  
            technology approved by the DOT if, in the opinion of the  
            attending veterinarian or local health officer, the carcass  
            presents a danger of infection to humans. 

          8.Requires the DOT to charge an application fee for a permit for  
            a transfer station equal to $100 for each hour which the DOT  
            spends on processing the application, but not more than  
            $10,000, or as provided in the regulations adopted by the DOT,  
            not to exceed the reasonable regulatory costs of the DOT.  In  
            addition, the annual permit fee for a transfer station is  
            $2,000, or as provided in the regulations adopted by the DOT,  
            not to exceed the reasonable regulatory costs of the DOT.

          9.Consolidates all of the subcategories of medical waste into  
            one definition.  The definition of "medical waste" also  
            includes animal specimens infected with pathogens known to be  
            infectious to humans.  Finally, the definition limits "sharps  
            waste" to devices contaminated with bio-hazardous waste.

           Background
           
           Genesis of the MWMA  .  In the fall of 1989, there were 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.  In response to these  
          incidents, both the Legislature and the executive branch  
          considered new approaches to handling medical waste.

          At the time, California statute only defined "infectious waste"  
          as wastes that contain infectious organisms that cause human  
          disease.  This waste was treated as hazardous waste; however,  
          this definition severely limited the types of wastes that could  

                                                                CONTINUED





                                                                     AB 333
                                                                     Page  
          5

          be regulated.

          In 1989 and 1990, bills were introduced by Assembly Member  
          Hayden (AB 109) and Assembly Member Mojonnier (AB 1641).  The  
          goal of the bills was to respond to general concerns over the  
          lax management of medical and infectious wastes and address  
          specific issues identified in California and at the national  
          level.

          Ultimately, the two bills were combined to form the MWMA and  
          according to the original legislative intent, "comprise a  
          single, integrated, and complementary approach to the storage,  
          treatment, transportation, and disposal of medical waste"  
          (Chapters 1613 and 1614, Statutes of 1990).  The MWMA was placed  
          under the Department of Health Services.

          During this same period, Congress enacted the Medical Waste  
          Tracking Act (MWTA, 1988) to create a two year medical waste  
          demonstration project.  This project was designed to define  
          medical waste and those wastes to be regulated, establish  
          cradle-to-grave tracking procedures, and require regulations for  
          standard practices regarding medical waste.  However, the  
          regulations developed under MWTA expired in 1999, leaving this  
          matter under state jurisdiction.

           Timeline of additions to the MWMA since 1990  .  The current bill  
          is one of many attempts to further change or update the MWMA  
          since its introduction.

          In 1995, SB 372 (Wright, Chapter 877) made various changes to  
          the MWMA, including revisions to the definition of large  
          quantity generator, medical waste exclusions, and storage.  The  
          bill also incorporated additional classes into the definition of  
          medical waste and authorized the use of high temperatures to  
          treat medical waste prior to disposal.

          Also in 1995, the MWMA was moved to the Department of Public  
          Health (DPH) during Governor Wilson's reorganization of the  
          Department of Health Services to DPH and the California  
          Environmental Protection Agency (SB 1360, Committee on Health  
          and Human Services, Chapter 415, Statutes of 1995).

          SB 1966 (Wright, Chapter 536, Statutes of 1996) moved the  
          management and handling of waste pharmaceuticals under DPH and  

                                                                CONTINUED





                                                                     AB 333
                                                                     Page  
          6

          the MWMA and reestablished fee authorities for DPH for small  
          quantity medical waste generators.

          In 1997, SB 1034 (Maddy, Chapter 732) added trauma scene waste  
          management to the MWMA.  This addition required the registration  
          of commercial firms who clean up trauma scenes in order to  
          ensure appropriate training and disposal of waste.

          SB 407 (Alpert, Chapter 139, Statutes of 1999) authorized the  
          use of chemical disinfection as a treatment method for certain  
          types of laboratory-generated medical waste if specified  
          requirements were met.

          AB 2335 (Saldana, Chapter 166, Statutes of 2006) made various  
          clarifying changes to the MWMA with the aim of reducing medical  
          waste management costs and clarifying the complex regulatory  
          framework.

          AB 1442 (Wieckowski, Chapter 689, Statutes of 2012) defined  
          pharmaceutical waste, exempted the waste generator from certain  
          hauling requirements, and allowed the waste to be transported by  
          a common carrier in order to reduce costs for handling expired  
          pharmaceutical wastes.  
           
           Related Legislation  

          AB 467 (Stone, Chapter 10, Statutes of 2014) created a licensure  
          category for a surplus medication collection and distribution  
          intermediary.

          AB 1893 (Stone and Eggman, 2014) would have made various changes  
          to the handling of home-generated sharps.  This bill failed on  
          the Assembly Floor.

          SB 1014 (Jackson, of 2014) deals with changes to the disposal of  
          home-generated pharmaceutical waste and defines home-generated  
          pharmaceutical waste as not medical waste.

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

          According to the Senate Appropriations Committee:

           Initial costs of $156,000 annually from the Medical Waste  

                                                                CONTINUED





                                                                     AB 333
                                                                     Page  
          7

            Management Fund (special) for FY 2015-16 and FY 2016-17 to  
            assist with compliance with the changes to the MWMA.

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

           SUPPORT  :   (Verified  8/20/14)

          Stericycle Inc. (source)
          California Hospital Association
          Kaiser Permanente

           OPPOSITION  :    (Verified  8/20/14)

          California Department of Public Health
          Department of Finance

           ARGUMENTS IN SUPPORT  :    Kaiser Permanente writes, "The Medical  
          Waste Management Act was created 23 years ago and is in need of  
          modernizing to be more reflective of the changes in federal law  
          that govern transport of these waste products.  AB 333 deletes  
          some out-of-date provisions to the MWMA; provides definitions  
          for new processes and terminology; re-drafts the law to  
          reorganize sections of the act to make it more user-friendly and  
          easier to follow, and it better coordinates state transportation  
          requirements with the federal transportation requirements,  
          providing for more consistency in the requirements of each  
          jurisdiction.

          "There has been extensive effort to develop a consensus bill  
          within the stakeholder community, and I laud you and your staff  
          for your leadership in this complicated policy area."

           ARGUMENTS IN OPPOSITION  :    The Department of Finance is opposed  
          to this bill because it eliminates Public Health's authority to  
          adjust application and permit fees for medical waste transfer  
          stations and onsite treatment facilities through the regulations  
          process.  If current fees are not adequate to cover future  
          program costs, the Medical Waste Management Program could be  
          negatively impacted and Public Health would be forced to  
          increase fees by amending statute, which may not allow Public  
          Health to adjust fees in a timely manner.  Furthermore, this  

                                                                CONTINUED





                                                                     AB 333
                                                                     Page  
          8

          bill imposes additional costs and workload on Public Health.

           ASSEMBLY FLOOR  :  67-6, 5/23/13
          AYES:  Achadjian, Alejo, Allen, Ammiano, Atkins, Bloom,  
            Blumenfield, Bocanegra, Bonilla, Bonta, Bradford, Brown,  
            Buchanan, Ian Calderon, Campos, Chau, Chesbro, Cooley, Dahle,  
            Daly, Dickinson, Eggman, Fong, Fox, Frazier, Beth Gaines,  
            Garcia, Gatto, Gomez, Gordon, Gorell, Gray, Hall, Harkey,  
            Roger Hernández, Jones-Sawyer, Levine, Linder, Logue,  
            Lowenthal, Maienschein, Medina, Melendez, Mitchell, Morrell,  
            Mullin, Muratsuchi, Nazarian, Nestande, Olsen, Pan, Patterson,  
            Perea, V. Manuel Pérez, Quirk, Quirk-Silva, Rendon, Salas,  
            Skinner, Stone, Ting, Wagner, Weber, Wieckowski, Williams,  
            Yamada, John A. Pérez
          NOES:  Bigelow, Chávez, Conway, Donnelly, Hagman, Wilk
          NO VOTE RECORDED:  Grove, Holden, Jones, Mansoor, Waldron,  
            Vacancy, Vacancy


          RM:e  8/20/14   Senate Floor Analyses 

                           SUPPORT/OPPOSITION:  SEE ABOVE

                                   ****  END  ****





















                                                                CONTINUED