BILL ANALYSIS                                                                                                                                                                                                    �



                                                                  SB 419
                                                                  Page 1

          Date of Hearing:   June 28, 2011

           ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS
                                Bob Wieckowski, Chair
                SB 419 (Simitian) - As Introduced:  February 16, 2011

           SENATE VOTE  :   32-8
           
          SUBJECT  :   Medical waste: home-generated sharps.

           SUMMARY  :   This bill requires pharmaceutical manufacturers to 
          provide their existing safe management plans to the Department 
          of Resource Recovery and Recycling (DRRR) electronically and the 
          manufacture shall make them readily accessible on their 
          websites.

           EXISTING LAW  :

          1)Defines "home-generated sharps waste" to mean hypodermic 
            needles, pen needles, intravenous needles, lancets, and other 
            devices that are used to penetrate the skin for the delivery 
            of medications derived from a household, including a 
            multifamily residence or household.

          2)Prohibits the disposal of home-generated sharps waste in solid 
            waste or recycling streams. 

          3)Requires pharmaceutical manufacturers that sell or distribute 
            a medication in California that is self-injected at home 
            through the use of a hypodermic needle, pen needle, 
            intravenous needle, or any other similar device to submit to 
            DRRR a plan that describes what actions, if any, the 
            manufacturer supports for the safe management of sharps waste.

          4)Requires that the safe management plan be submitted annually 
            after the initial date of July 1, 2010, and be posted on 
            DRRR's website as well as the manufacturer's website. 

           FISCAL EFFECT  :   Not Known

           COMMENTS  :

           Need for the bill  :  According to the author, "although it is 
          illegal to throw sharps into the trash, many people are unaware 
          and continue to illegally dispose of their sharps.  In 








                                                                  SB 419
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          California, approximately 1 in 12 households have someone who 
          must self-inject to treat diabetes, cancer, hepatitis B & C, 
          arthritis, multiple sclerosis, hemophilia, infertility, serious 
          allergies or other medical conditions generating approximately 
          389 million sharps annually.   Improper disposal poses a 
          significant risk of injury and/or infection to children, hotel 
          workers, janitors and solid waste employees as well as making 
          almost one million Californians in violation of current law."

           Medical Sharps  :  An estimated one million Californians inject 
          medications outside traditional health care facilities, which 
          generate approximately 389 million sharps each year.  The 
          numbers of patients using injectable medications will continue 
          to grow because it is an effective delivery method.  The most 
          common home use of sharps is to manage diabetes.  Other reasons 
          to home-inject include multiple sclerosis, infertility, 
          migraines, allergies, hemophilia and medications for pets.

          California was one of the first states to address the problems 
          of sharps with the passage of SB 1305 (Figueroa, Chapter 64, 
          Statutes of 2006) to prohibit the disposal of medical sharps in 
          California's landfills.  Although illegal, most of these used 
          needles still end up in household trash and pose a significant 
          risk of injury and/or infection to children, custodial workers 
          and solid waste employees.

          This bill expands on SB 486 (Simitian, Chapter 591, Statutes of 
          2009).  SB 486 requires pharmaceutical manufacturers who sell 
          medications that are routinely injected at home to submit annual 
          plans to DRRR describing how they support and provide safe 
          sharps collection and disposal programs.

          This bill addresses implementation challenges learned after the 
          submission of the first round of plans required pursuant to SB 
          486.  Many plans were submitted in hard-copy form that required 
          time for DRRR staff to scan and post them.  Also, some 
          stakeholders found it challenging to find the manufacturer's 
          report on their websites.  
           
          Ensuring that these reports are readily available to sharps 
          users was a key goal of the initial legislation.  Patients who 
          self-inject can use the information to identify and evaluate 
          what pharmaceutical companies are doing to assist them in 
          managing their sharps waste.  
           








                                                                  SB 419
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           Status of SB 486 reports:   In 2010 DRRR has received sharps 
          collection and disposal plans from approximately 30 
          pharmaceutical companies.  DRRR is following up with additional 
          pharmaceutical manufacturers that it believes are subject to the 
          reporting requirement but have yet to submit a plan.

          A review of the plans by a group of public health, local 
          governments and environmental organizations released in 2011 
          found that manufactures of injectable drugs that treat chronic 
          illnesses are failing to provide patients safe, convenient, cost 
          effective methods of needle disposal.  According to the Home 
          Sharps Evaluation Team, "75% percent of California's injectable 
          drug makers failed because they either did not in any way meet 
          customer expectations or did not submit reports at all and are 
          currently not in compliance with the law.  The failing 
          companies' literature is almost completely silent on disposal 
          methods.  Some actually give patients the impression that they 
          can put used sharps in non-approved containers and dispose of 
          them in the regular trash.  This is utterly false and against 
          the law."

           REGISTERED SUPPORT / OPPOSITION  :
           
          Support:
           Alameda County Board of Supervisors
          California Sharps Coalition
          Clean Water Action
          National Multiple Sclerosis Society
          Waste Management, Inc.

           Opposition  :
          None on file.

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