BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                      



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          |SENATE RULES COMMITTEE            |                  AB 1442|
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                                 THIRD READING


          Bill No:  AB 1442
          Author:   Wieckowski (D), et al.
          Amended:  8/21/12 in Senate
          Vote:     21

           
           SENATE ENVIRONMENTAL QUALITY COMMITTEE  :  7-0, 7/2/12
          AYES:  Simitian, Strickland, Blakeslee, Hancock, Kehoe, 
            Lowenthal, Pavley

           SENATE APPROPRIATIONS COMMITTEE  :  7-0, 8/16/12
          AYES:  Kehoe, Walters, Alquist, Dutton, Lieu, Price, 
            Steinberg

           ASSEMBLY FLOOR  :  78-0, 5/30/12 - See last page for vote


           SUBJECT  :    Pharmaceutical waste

           SOURCE  :     Author


           DIGEST  :    This bill defines pharmaceutical waste for 
          purposes of the Medical Waste Management Act, and exempts a 
          pharmaceutical waste generator or parent organization that 
          employs health care professionals who generate 
          pharmaceutical waste from specified medical waste hauling 
          requirements if the generator, health care professional, or 
          parent organization retains specified documentation and 
          meets specified requirements and if the facility receiving 
          the medical waste retains specified documentation and meets 
          specified requirements.  This bill also authorizes 
          pharmaceutical waste to be transported by the generator or 
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          health care professional who generated the pharmaceutical 
          waste, a staff member of the generator or health care 
          professional, or common carrier, as defined, pursuant to 
          these provisions.

           ANALYSIS  :    The existing Medical Waste Management Act, 
          administered by the State Department of Public Health, 
          regulates the management and handling of medical waste, as 
          defined.  Existing law requires that all medical waste be 
          hauled by either a registered hazardous waste hauler or by 
          a person with an approved limited-quantity exemption 
          granted pursuant to specified provisions of law.  Violation 
          of these provisions of law is a crime.

          This bill:

          1.Defines "common carrier" as either of the following:

             A.   A person or company that has a United States 
               Department of Transportation number issued by the 
               Federal Motor Carrier Safety Administration and is 
               registered with the Federal Motor Carrier Safety 
               Administration as a for-hire property carrier.

             B.   A person or company that has a motor carrier of 
               property permit issued by the Department of Motor 
               Vehicles pursuant to the Motor Carriers of Property 
               Permit Act and, if applicable, a carrier 
               identification number issued by the Department of the 
               California Highway Patrol.

          1.Defines "pharmaceutical waste" as any pharmaceutical that 
            for any reason may no longer be sold or dispensed for use 
            as a drug.  Pharmaceutical does not include any 
            pharmaceutical that meets either of the following 
            criteria:

             A.   The pharmaceutical is being sent out of the State 
               of California to a reverse distributor, as defined, 
               that is licensed as a wholesaler of dangerous drugs by 
               the California State Board of Pharmacy.

             B.   The pharmaceutical is being sent by a reverse 
               distributor, as defined, offsite for treatment and 







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               disposal in accordance with applicable laws, or to a 
               reverse distributor that is licensed as a wholesaler 
               of dangerous drugs by the California State Board of 
               Pharmacy as is permitted transfer stations if the 
               reverse distributor is located within the State of 
               California. 

          1.Specifies that medical generators keep the name of the 
            common carrier used by the generator to transport 
            pharmaceutical waste offsite for treatment and disposal, 
            on file, or file that information with the enforcement 
            agency, along with other required information relating to 
            the maintenance, treatment and transport of medical 
            waste.

          2.Exempts a pharmaceutical waste generator or parent 
            organization that employs health care professionals who 
            generate pharmaceutical waste from the hazardous waste 
            hauling requirement if the generator, health care 
            professional, or parent organization meets certain 
            specified requirements, including:

             A.   Maintaining on file, or filing with the enforcement 
               agency, specified documents relating to the 
               maintenance, treatment and transport of medical waste. 


             B.   The requirement that the generator or health care 
               professional who generated the pharmaceutical waste 
               transports the pharmaceutical waste himself or 
               herself, or directs a member of his or her staff to 
               transport the pharmaceutical waste to a parent 
               organization or another health care facility for the 
               purpose of consolidation before treatment and 
               disposal, or contracts with a common carrier to 
               transport the pharmaceutical waste to a permitted 
               medical waste treatment facility or transfer station.

             C.   Maintaining and providing a tracking document, as 
               specified, to the intended destination facility, 
               requiring the destination facility to notify the 
               generator of any discrepancies between the items 
               received and the tracking document, and requiring the 
               generator to notify the enforcement agency of any 







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               discrepancies, unless the health care professional who 
               generates pharmaceutical waste returns the 
               pharmaceutical waste to the parent organization, and 
               under that case, is authorized to substitute a 
               single-page form or multiple entry log for the 
               tracking document if the form or log contains 
               specified information.

          1.Requires that medical waste treatment facilities maintain 
            copies of tracking documents from common carriers.

           Background
           
          Some pharmaceutical wastes are classified as hazardous 
          wastes.  Others are medical waste, and still others are 
          nonhazardous wastes.  Which category a discarded 
          pharmaceutical falls into depends on its chemical, 
          physical, and toxicological properties and who generates 
          the waste.  The California Code of Regulations dictates 
          that the generator of the waste is ultimately responsible 
          for proper classification of waste streams and subsequently 
          managing and disposing of the waste according to the 
          appropriate rule governing each waste classification. 

          The Department of Toxic Substances Control regulates 
          pharmaceutical wastes that are considered hazardous under 
          the federal Resource Conservation and Recovery Act.  Some 
          pharmaceutical waste that is not identified under the Act 
          may be deemed hazardous under California standards, and 
          subsequently classified as medical waste and therefore 
          subject to the Medical Waste Management Act (MWMA).  The 
          Department of Public Health (DPH) oversees the MWMA and 
          regulates medical waste.  

          The MWMA specifies that medical waste, including 
          pharmaceutical waste comprised of nonsalable and outdated 
          prescription and over-the-counter drugs must be transported 
          by a licensed hazardous waste hauler.  If they meet certain 
          requirements, medical waste generators can apply for a 
          limited-quantity waste hauling exemption, and the generator 
          of the medical waste may transfer the waste themselves to a 
          medical waste treatment facility.  These exemptions last 
          one year, and do not allow the medical waste transporter to 
          contract with a common carrier. 







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          Current law is not clear regarding what constitutes 
          "pharmaceutical waste," but according to DPH's 
          Self-Assessment Manual for Proper Management of Medical 
          Waste, pharmaceuticals that have "intrinsic value," or are 
          creditable, are not considered waste and can be returned by 
          a common carrier to a reverse distributer, which is 
          licensed by the Board of Pharmacy to handle outdated or 
          nonsalable prescription drugs and regulated by DPH to 
          handle pharmaceuticals registered as medical waste.  AB 
          1442 would define "pharmaceutical waste," as a subset of 
          medical waste currently included in the DPH MWMA manual and 
          allow pharmaceutical wastes to be transported by a common 
          carrier as is authorized in most other states. 

          Environmental concerns.  A 2002 study by the US Geological 
          Survey revealed widespread contamination in US waterways of 
          prescription drugs, natural and synthetic hormones, 
          detergent metabolites, plasticizers, insecticides, and fire 
          retardants at low concentrations downstream from areas of 
          intense urbanization and animal production.  The results 
          found that one or more of these chemicals were found in 80 
          percent of the streams sampled.  Prescription drugs are of 
          particular concern because of the low concentration 
          necessary for activity in the body.  According to the U.S. 
          EPA, further research suggests that certain drugs may cause 
          ecological harm and that more research is needed to 
          determine the extent of harm and any role they may have in 
          potential human health effects.

          California health facilities that generate large amounts of 
          pharmaceutical waste must currently follow strict and 
          costly handling and transporting protocols for medical 
          waste.  Allowing these facilities to transport 
          pharmaceutical waste via common carrier may lessen the 
          financial burden, and improve compliance with proper 
          disposal procedures for pharmaceutical waste by health 
          facilities, and potentially reduce pharmaceutical 
          contamination in California wastewater.

           Comments
           
          According to the author, "Under existing law, 
          pharmaceutical drugs can be sent to healthcare facilities 







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          through common carriers, or standard shipping means.  
          Unused drugs can sometimes be returned to the manufacturer 
          for credit, via a common carrier.  Expired and 
          non-dispensable drugs must be shipped as "Medical Waste", 
          requiring expensive hazardous waste shipping, instead of 
          common carrier.  This is unnecessarily expensive for 
          pharmacies, hospitals, and other health care facilities, 
          who are simply returning the exact same drug that was 
          shipped to them by common carrier." 

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

          According to the Senate Appropriations Committee, $280,000 
          from the Medical Waste Management Fund in 2013-14 and 
          2014-15 for two full time and one limited term Department 
          of Public Health staff to coordinate with stakeholders 
          statewide, oversee rulemaking process and develop 
          regulations and $160,000 annually thereafter to review 
          exemption requests and ensure compliance with documentation 
          requirements.

           SUPPORT  :   (Verified  8/20/12)

          American Federation of State, County and Municipal 
          Employees
          Bay Area Clean Water Agencies
          California Product Stewardship Council
          Californians Against Waste
          Central Contra Costa Solid Waste Authority
          City of Palo Alto
          City of San Jose
          City of Sunnyvale
          Clean Water Action
          East Bay Municipal Utility District
          EXP Pharmaceutical Services Corp.
          Fremont Chamber of Commerce
          Los Angeles County Solid Waste Management Committee IWM 
          Task Force
          San Francisco Water Power Sewer
          Santa Clara Valley Water District
          Sierra Club California
          Solid Waste Association of North America








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           ASSEMBLY FLOOR  :  78-0, 5/30/12
          AYES:  Achadjian, Alejo, Allen, Ammiano, Atkins, Beall, 
            Bill Berryhill, Block, Blumenfield, Bonilla, Bradford, 
            Brownley, Buchanan, Butler, Charles Calderon, Campos, 
            Carter, Cedillo, Chesbro, Conway, Cook, Davis, Dickinson, 
            Donnelly, Eng, Feuer, Fong, Fuentes, Furutani, Beth 
            Gaines, Galgiani, Garrick, Gatto, Gordon, Gorell, Grove, 
            Hagman, Halderman, Hall, Harkey, Hayashi, Roger 
            Hernández, Hill, Huber, Hueso, Huffman, Jeffries, Jones, 
            Knight, Lara, Logue, Bonnie Lowenthal, Ma, Mansoor, 
            Mendoza, Miller, Mitchell, Monning, Morrell, Nestande, 
            Nielsen, Norby, Olsen, Pan, Perea, V. Manuel Pérez, 
            Portantino, Silva, Skinner, Smyth, Solorio, Swanson, 
            Torres, Wagner, Wieckowski, Williams, Yamada, John A. 
            Pérez
          NO VOTE RECORDED:  Fletcher, Valadao


          DLW:n  8/21/12   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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