BILL ANALYSIS                                                                                                                                                                                                    



                                                                     AB 649


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          Date of Hearing:  April 14, 2015


           ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS


                                    Alejo, Chair


          AB  
                   649 (Patterson) - As Introduced  February 24, 2015


          SUBJECT:  Medical waste:  law enforcement drug takeback programs


          SUMMARY:  Authorizes law enforcement agencies to use  
          prescription drug incinerators not in compliance with various  
          state laws up to four times.  Specifically, this bill:  


          Amends the Medical Waste Management Act (MWMA) to allow a law  
          enforcement agency that operates a prescription drug takeback  
          program to utilize up to four times per year a prescription drug  
          incinerator that does not comply with the requirements of the  
          MWMA or other state laws if the incinerator was purchased prior  
          to January 1, 2018.


          EXISTING LAW:  


             1)   Exempts household pharmaceutical waste from hazardous  
               waste classifications (40 CFR 261.4(b)) and as medical  
               waste. (Health and Safety Code (H&S)  117700)

             2)   Pursuant to the MWMA, requires the California Department  
               of Public Health (CDPH) 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  








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               local agencies have elected not to conduct their own  
               enforcement. (H&S  117600, et seq.)

             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. (H&S  117690 and  117747)

             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  
                    treatment facility in a controlled-air, multichamber  
                    incinerator, or other method of incineration approved  
                    by CDPH which provides complete combustion of the  
                    waste into carbonized or mineralized ash;
                  b.        Treatment with an alternative technology  
                    approved by CDPH 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 CDPH and result in the  
                    destruction of pathogenic micro-organisms. (H&S   
                    118215(a))

             5)   Requires any alternative medical waste treatment method  
               to be evaluated by CDPH and either approved or rejected  
               pursuant to specified statutory criteria. (H&S  118215  
               (a)(1)(B)) 

             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. (H&S  117900)









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             7)   Requires pharmaceutical takeback programs to be in  
               compliance with the Controlled Substances Act and its  
               implementing regulations. (21 U.S.C.  801-971 and 21 CFR  
               1300-1321)



             8)   Regulates air emissions from stationary and mobile  
               sources pursuant to the Federal Clean Air Act.  (42 U.S.C.  
               7401 et seq.)



             9)   Establishes the California Air Resources Control Board  
               to enforce the Federal Clean Air Act. (H&S 39500  et seq.)

          FISCAL EFFECT:  Unknown. 


          COMMENTS:  


          Purpose for reform:  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  
          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."


          What is medical waste?:  Medical waste is waste materials  
          generated at health care facilities, such as hospitals, clinics,  








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          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)).  



          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 percent 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  
          2011-2012; 1,918 pounds in Fiscal Year 2012-2013; and 2,457  
          pounds in Fiscal Year 2013-2014. 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  
          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. 


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










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           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.


          What does this bill authorize, exactly?: The bill would allow a  
          law enforcement agency that operates a prescription drug  
          takeback program to use a prescription drug incinerator that  
          does not comply with the requirements of the MWMA or other state  
          laws if the incinerator was purchased prior to January 1, 2018. 

          The United States Environmental Protection Agency (US EPA), in a  
          September 2012 guidance letter on the disposal of household  
          pharmaceuticals collected by takeback programs, recommended that  
          pharmaceutical waste be sent to a permitted hazardous waste  
          combustor, and, when that is not feasible, be sent to a large or  
          small municipal combustor. The US EPA specifically states,  
          "after pharmaceuticals are collected from ultimate users in a  
          takeback event, they must be disposed of in accordance with  








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          federal, state and/or local environmental regulations." 

          The US EPA also acknowledges that it does "not want  
          [incineration] costs to discourage takeback events", and  
          subsequently recommended incineration facilities that meet the  
          US EPA's Large Municipal Waste Combustor (LMWC) Standards and  
          Small Municipal Waste Combustor (SMWC) Standards (40 CFR parts  
          62 and 60) when hazardous waste combustion is not feasible. 


          According to the author, law enforcement personnel  
          administrating takeback programs are currently hauling or  
          shipping their wastes to one of three federally compliant LMWC  
          or SMWC, of which there are three in California:


                 Commerce Refuse-to-Energy Facility (Commerce)
                 Southeast Resource Recovery Facility (Long Beach)


                 Stanislaus County Resource Recovery Facility (Crow's  
               Landing)


          None of these facilities, however, are permitted under the MWMA  
          to treat pharmaceutical waste. 

          Therefore, this bill would authorize a broader scope of options  
          for pharmaceutical incineration. The bill does not contain a  
          definition for "prescription drug incinerator," so the bill  
          could potentially apply to any incinerator that is or could be  
          permitted to take prescription drugs. 

          One cited example of a noncompliant incinerator this bill could  
          authorize is the "Drug Terminator", which is described as a wood  
          or charcoal fired incinerator that uses two high velocity  
          electric blowers that create a cyclone of intense heat, and  
          render the volume of material as solid waste.   


          The MWMA requires incineration to be done at a "permitted  
          medical waste treatment facility in a controlled-air,  








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          multi-chamber incinerator, or other method of incineration  
          approved by the Department." It's not yet determined if the  
          "Drug Terminator" would qualify as an acceptable treatment  
          method in California, but under current law, it is eligible to  
          be considered as an alternative medical waste treatment method.  
          (H&S  118215 (a)(3)(A))


          Managing pharmaceutical waste: Pharmaceutical waste is  
          segregated into three different categories for proper treatment:  
          controlled, hazardous, and non-hazardous. 


          Drugs and other substances that are considered controlled  
          substances under the federal Controlled Substances Act (CSA) are  
          categorized based on whether they have a currently accepted  
          medical use in treatment in the United States, their relative  
          abuse potential, and likelihood of causing dependence when  
          abused.  These pharmaceuticals are managed differently than  
          hazardous and non-hazardous pharmaceuticals; controlled  
          substances must be disposed of in a manner that renders them  
          non-retrievable in accordance with federal regulations, unlike  
          the other categories of pharmaceutical waste. 


          The Drug Enforcement Administration (DEA) hosts National  
          Prescription Drug Takeback Days to provide opportunity for  
          disposing controlled substances. To date, the DEA has held 9  
          takeback days, with the most recent event held in September  
          2014. The DEA initiated these takeback days four years ago  
          because at that time the CSA made no legal provision for people  
          to dispose of unwanted controlled substance prescription drugs  
          except to give them to law enforcement, and the CSA banned  
          pharmacies and hospitals from accepting them.  


          Since the DEA's first Takeback Day, the DEA has developed  
          regulations that outline methods the public can use to transfer  
          pharmaceutical controlled substances and other prescription  
          drugs to authorized collectors for the purpose of disposal.  










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          The DEA has announced it plans to cease holding its takeback  
          days because the new disposal regulations are registered and in  
          effect for disposing controlled substances.   According to the  
          DEA, law enforcement continues to have autonomy with respect to  
          how they collect controlled substance prescription drugs,  
          including holding takeback events.  Any person or entity-DEA  
          registrant or non-registrant-may partner with law enforcement to  
          conduct takeback events.  


          Alternatives for managing pharmaceutical waste over the status  
          quo: There are registered medical waste haulers in California  
          that pick up medical waste and transport to permitted medical  
          waste treatment facilities. There are currently 125 medical  
          waste transporters registered under the MWMA. In addition, there  
          are numerous transfer stations in California that are part of  
          the medical waste disposal chain.  These transfer stations serve  
          as the collection and consolidation points for all types of  
          medical waste.  The waste is further segregated at this point  
          and shipped to the proper treatment facilities (either in or out  
          of state). 


          Registered haulers can pick up and transport hazardous and  
          non-hazardous pharamcetuicals wastes. According to one  
          registered medical waste hauler, average costs to provide  
          pharmaceutical waste pick-up services to a law enforcement  
          agency would range from $60-$110/hour for a pharmaceutical  
          technician to sort through the collected pharmaceuticals and  
          segregate categorically for disposal, and then $1-$3/pound for  
          disposal. 


          Depending on law enforcement agencies' current costs, they could  
          consider the costs to hire a registered medical waste hauler to  
          periodically pick up the agency's collected pharmaceuticals  
          versus shipping or transporting their collected pharmaceutical  
          wastes themselves. While potentially more expensive, this  
          alternative to managing pharmaceutical waste may be more  
          advantageous from a public health perspective than changing  
          state law to allow noncompliant incinerators. 









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          Proposed amendments: As written, the bill may be overly broad in  
          allowing incinerators that don't comply with various  
          environmental protection and medical waste management laws. To  
          maintain the author's intent to authorize more in-state options  
          for treating pharmaceutical waste, and to ensure pharmaceutical  
          wastes are appropriately destroyed, the committee may wish to  
          consider the following amendments:


             1.   Striking lines 1-2 on page 2 in reference to  
               noncompliant incinerators, and replacing with language  
               authorizing CDPH to approve and permit under the MWMA  
               prescription drug incinerators designed to treat  
               pharmaceutical waste as an alternative medical waste  
               treatment method; and  

             2.   Amending the MWMA to authorize CDPH to permit  
               prescription drug incinerators that are specifically  
               designed to solely treat pharmaceutical wastes and that  
               meet any necessary requirements for safely treating those  
               wastes.  


          Related legislation:  


           AB 45 (Mullin), pending before the Assembly Local Government  
          Committee, would establish household hazardous waste collection  
          programs and would include collection of household generated  
          pharmaceutical waste. 

          REGISTERED SUPPORT / OPPOSITION:


          Support


          California Health Collaborative


          California State Sheriff's Association









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          Fresno County Department of Behavioral Health 




          Opposition


          None on file. 


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