BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 1442
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          Date of Hearing:   March 20, 2012

           ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS
                                Bob Wieckowski, Chair
                 AB 1442 (Wieckowski) - As Amended:  February 6, 2012
           
          SUBJECT  :   Pharmaceutical waste.

           SUMMARY  :  Authorizes the transportation of pharmaceutical waste, 
          as defined, by a common carrier.  Specifically,  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.

          2)Defines "pharmaceutical waste" as any pharmaceutical that for 
            any reason may no longer be sold or dispensed for use as a 
            drug.  Excludes from this definition those pharmaceuticals 
            that still have potential value to the generator because they 
            are being returned to a reverse distributor for possible 
            manufacturer credit.

          3)Authorizes a medical waste generator or parent organization 
            that employs health care professionals who generate 
            pharmaceutical waste to apply to the enforcement agency for a 
            pharmaceutical waste hauling exemption if the generator, 
            health care professional, or parent organization meets all of 
            the following requirements:

             a)   The generator or parent organization has on file one of 
               the following:

               i)     If the generator or parent organization is a small 
                 quantity generator required to register with the 
                 enforcement agency, the required medical waste management 







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                 plan, as defined in statute.

               ii)    If the generator or parent organization is a small 
                 quantity generator not required to register, the 
                 information document, as defined in statute.

               iii)   If the generator or parent organization is a large 
                 quantity generator, a medical waste management plan, as 
                 defined in statute.

             b)   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)   The generator maintains a tracking document, as defined 
               in statute.

             d)   The health care professional who generates and returns 
               the pharmaceutical waste to the parent organization is 
               authorized to substitute a single-page form or multiple 
               entry log for the tracking document if the form or log 
               contains specified information.

          4)Clarifies that this bill does not prohibit the use of a single 
            document to verify the return of more than one container to a 
            parent organization or another health care facility for the 
            purpose of consolidation before treatment and disposal over a 
            period of time, if the form or log is maintained in the files 
            of the parent organization or another health care facility 
            that receives the waste once the form or log is completed.

          5)Makes other conforming changes.

           EXISTING LAW  :

          1)Requires, under the federal Controlled Substances Act, strict 
            protocols for the collection of controlled substances to 
            prevent their illegal diversion and abuse.








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          2)Regulates, under the federal Resource Conservation and 
            Recovery Act (RCRA) of 1976, the management of solid and 
            hazardous wastes.

          3)Authorizes, under the California Hazardous Substances Act, the 
            Department of Toxic Substances Control (DTSC) to regulate 
            hazardous materials and wastes to ensure that the state is 
            delegated authority in accordance with RCRA.

          4)Establishes the Sherman Food, Drug, and Cosmetic Law, 
            administered by the Department of Public Health (DPH), to 
            regulate drugs and medical devices.

          5)Provides for, under the Business and Professions Code, the 
            licensure and regulation of pharmacies, pharmacists, and 
            wholesalers of dangerous drugs or devices by the Board of 
            Pharmacy (BOP) within the Department of Consumer Affairs.

          6)Defines "dangerous drug" or "dangerous device" as any 
            prescription drug or device unsafe for self-use in humans or 
            animals, as specified (Business and Professions Code (BPC) 
            §4022).

          7)Defines "reverse distributor" as every person who acts as an 
            agent for pharmacies, drug wholesalers, manufacturers, and 
            other entities by receiving, inventorying, and managing the 
            disposition of outdated or nonsalable dangerous drugs (BPC 
            §4040.5).

          8)Establishes the Medical Waste Management Act (MWMA) in Health 
            and Safety Code (HSC) Sections 117600 - 118360.  Under the 
            MWMA,:

             a)   Requires the DPH to adopt regulations that will 
               establish and ensure statewide standards for uniformity in 
               the implementation and administration of the MWMA and that 
               will promote waste minimization and source reduction (HSC 
               §117610).

             b)   Includes in the definition of "medical waste" 
               biohazardous waste (HSC §117690).  Includes in the 
               definition of "biohazardous waste" waste that is hazardous 
               only because it is comprised of pharmaceuticals (HSC 
               §117635).








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             c)   Defines "pharmaceutical" as a prescription or 
               over-the-counter human or veterinary drug including, but 
               not limited to, a drug as defined the Sherman Food, Drug 
               and Cosmetic Laws or the Federal Food, Drug, and Cosmetic 
               Act.  "Pharmaceutical" does not include any pharmaceutical 
               that is regulated pursuant to either RCRA or the Radiation 
               Control Law (HSC §117747).

             d)   Establishes a system to register and oversee small and 
               large quantity medical waste generators.  Requires 
               generators to maintain on file or file with the enforcement 
               agency specified documents relating to the maintenance, 
               treatment and transport of medical waste (HSC §117915 et 
               seq.).

             e)   Prohibits a person from hauling medical waste unless the 
               person is either a registered hazardous waste hauler or has 
               an approved limited-quantity exemption (HSC §117900).

             f)   Establishes a system to register and oversee medical 
               waste haulers (HSC §118000 et seq.).

               i)     Requires all medical waste transported to an offsite 
                 medical waste treatment facility to be transported by a 
                 registered hazardous waste transporter (HSC §118000).

               ii)    Authorizes a medical waste generator or parent 
                 organization that employs health care professionals who 
                 generate medical waste to apply to the enforcement agency 
                 for a limited-quantity hauling exemption, if the 
                 generator or health care professional meets specified 
                 requirements (HSC §118030).

             g)   Establishes a system to permit and oversee medical waste 
               treatment facilities (HSC §118130 et seq.).
           
          FISCAL EFFECT  :   Unknown.

           COMMENTS  :

           Need for the bill  :  According to the author, "Under existing 
          law, pharmaceutical drugs can be sent to health care facilities 
          through standard 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 







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          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.  It is my 
          understanding that administrative agencies cannot make this 
          change without legislation."
           
          Pharmaceutical waste in California  :  According to CalRecycle, 
          waste pharmaceuticals are expired (outdated), damaged, 
          contaminated, or otherwise unwanted medicines which are to be 
          discarded.  They usually consist of prescription or 
          over-the-counter human or veterinary drugs that are no longer 
          needed or useable for their originally intended purpose.

          According to DPH and DTSC, pharmaceutical waste is classified 
          either as hazardous waste, medical waste, or nonhazardous 
          (solid) waste.  Which category a discarded pharmaceutical falls 
          into depends on its chemical, physical, and toxicological 
          properties.  Proper classification is necessary for generators 
          to be in compliance with the laws regulating each waste type.  
          The California Code of Regulations dictates that the generator 
          of the waste is ultimately responsible for proper classification 
          of waste streams, and then, once it is classified, for managing 
          and disposing the waste according to the rule governing the 
          particular waste classification.

          According DTSC, a discarded pharmaceutical may be identified as 
          a hazardous waste in California if it appears on a regulatory 
          list of hazardous wastes or exhibits ignitability, corrosively, 
          reactivity or toxicity.  DTSC is authorized to regulate 
          pharmaceutical wastes to the extent they are regulated as 
          hazardous waste under RCRA.  Hazardous waste must be managed and 
          disposed of in accordance with 40 Code of Federal Regulations 
          (CFR) 261 and Division 4.5, 22 California Code of Regulations 
          (CCR).

          Some wastes that are not regulated under RCRA are nevertheless 
          identified as hazardous waste in California.  Besides the 
          properties mentioned above, a number of additional factors can 
          cause a waste to exhibit the characteristic of toxicity under 
          California standards and thus be considered a hazardous waste in 
          California, including containing a substance listed in 
          California Code of Regulations Section 66261.2, being toxic when 
          inhaled, or being fatal to certain types of fish in laboratory 







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          tests.  Pharmaceutical wastes that meet California's definition 
          of hazardous waste but not RCRA's definition, as well as 
          pharmaceutical wastes generated by people who are not regulated 
          under RCRA, are subject to the MWMA.

          Non-RCRA, non-California hazardous waste is handled as solid 
          waste and may be disposed of in compliance with the disposal 
          requirements of the local treatment works and waste acceptance 
          criteria of the waste disposal facility.
           
          Regulation of pharmaceutical waste under the MWMA  :  
          Pharmaceutical wastes that must be managed according to the MWMA 
          are those that are classified as "California only hazardous 
          waste" by Chapter 11, Title 22, California Code of Regulations.  
          On January 1, 1997, the authority for regulating pharmaceutical 
          waste that is not RCRA hazardous waste but is California 
          hazardous waste was transferred from the DTSC to the Department 
          of Health Services (now DPH) under the MWMA.

          If a pharmaceutical waste meets the criteria of a California 
          hazardous waste, it must be segregated in an appropriate 
          container, properly labeled, stored, manifested, transported and 
          incinerated at a regulated medical waste incinerator or 
          destroyed through another method approved by the DPH.  The MWMA 
          prohibits a person from hauling medical waste unless the person 
          is either a registered hazardous waste hauler or has an approved 
          limited-quantity exemption.

           Reverse distribution and transporting pharmaceutical waste:   It 
          is common practice for pharmacies and other health care 
          facilities to return unused pharmaceuticals to the manufacturer 
          for credit or disposal.  Health care facilities have the option 
          of hiring reverse distributors to manage their unused and/or 
          expired medication that could be returned to the manufacturer or 
          wholesaler for credit.  The reverse distributor determines which 
          medications may be returned to the manufacturer or wholesaler 
          for credit and arranges for disposal of unused medications that 
          are waste.  Once the unused pharmaceutical is determined to be 
          ineligible for credit, it becomes waste and must be managed as 
          such.

          In California, reverse distributors are regulated by both the 
          BOP and the DPH.  The BOP regulates activities involving 
          "dangerous drugs," as defined in BPC § 4022, which includes 
          prescription medications.  Reverse distributors that intend to 







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          receive "outdated or nonsalable dangerous drugs," which could 
          include potentially creditable drugs, must register with the BOP 
          as "drug wholesalers" (BPC §4040.5, 4043 and 4160).  However, 
          once a pharmaceutical is designated as "medical waste" pursuant 
          to the MWMA, it is regulated by the DPH (HSC §117690).  For 
          purposes of the MWMA, the term "pharmaceutical" isn't restricted 
          to "dangerous drugs" as set forth in the BPC, but rather is 
          intended to cover all pharmaceuticals, including both 
          prescription and over-the-counter drugs (HSC §117747).

          The MWMA requires that medical waste pharmaceuticals be sent to 
          reverse distributors via a licensed hazardous waste hauler (HSC 
          §118000).  However, according to DPH's Self-Assessment Manual 
          for Proper Management of Medical Waste, pharmaceuticals that 
          have "intrinsic value" (such as outdated or otherwise unsalable 
          pharmaceuticals that are returned for credit) are not considered 
          "waste" and, thus, may be shipped to a reverse distributor via a 
          common carrier.  Therefore, under current law, whether or not a 
          pharmaceutical is creditable determines whether it must be 
          transported via a registered waste hauler or is authorized to be 
          transported via common carrier.  As is authorized under current 
          law for outdated or otherwise unsalable creditable 
          pharmaceuticals, this bill authorizes the transportation of 
          outdated or otherwise unsalable non-creditable pharmaceuticals, 
          which are designated as medical waste, via a common carrier.

           Proposed amendment  :  This bill currently requires generators of 
          pharmaceutical waste to maintain specified tracking documents.  
          In order to ensure that waste pharmaceuticals reach their 
          intended destination, the Committee may wish to consider 
          requiring that a recipient of pharmaceutical waste also maintain 
          a copy of the required tracking documents.  


















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           REGISTERED SUPPORT / OPPOSITION  :

           Support
           
          EXP Pharmaceutical Services Corp. (sponsor)
          American Federation of State, County, and Municipal Employees 
          (AFSME) 
          Bay Area Clean Water Agencies (BACWA)
          California Product Stewardship Council
          Californians Against Waste
          City of Palo Alto
          Clean Water Action
          Fremont Chamber of Commerce
          Los Angeles County Integrated Waste Management Task Force
          Sierra Club California
          Solid Waste Association of North America

           Opposition
           
          None received.
           

          Analysis Prepared by  :    Shannon McKinney / E.S. & T.M. / (916) 
          319-3965