BILL ANALYSIS                                                                                                                                                                                                    



                                                                  AB 995
                                                                  Page  1

          Date of Hearing:   May 20, 2009 

                        ASSEMBLY COMMITTEE ON APPROPRIATIONS
                                Kevin De Leon, Chair

                     AB 995 (Block) - As Amended:  May 11, 2009  

          Policy Committee:                              Health Vote:18-0

          Urgency:     No                   State Mandated Local Program:  
          Yes    Reimbursable:              No

           SUMMARY  

          This bill modifies requirements for the California Department of  
          Public Health (DPH) established by SB 1135 (Polanco), Chapter  
          929, Statutes of 2002 and shifts responsibilities to licensed  
          tissue banks. Specifically, this bill: 

          1)Eliminates a requirement for DPH to promulgate regulations  
            governing licensed tissue banks.

          2)Prohibits the collection, processing, storage, or distribution  
            of human tissue unless in accordance with standards published  
            by the American Association of Tissue Banks (AATB) in effect  
            on May 1, 2008. Requires DPH to provide subsequent guidance on  
            updated standards via the DPH website. Establishes related  
            public hearing requirements. 

          3)Establishes a civil penalty of $100 per day per violation not  
            to exceed $3,000 total. 

           FISCAL EFFECT  

          Minor absorbable workload to DPH to continue oversight of tissue  
          banks in California. 

           COMMENTS  

           1)Rationale  . This bill is sponsored by DPH to shift  
            responsibility from the department to licensed tissue banks  
            that comply with national standards published by AATB. Tissue  
            banks harvest and store human cadaver tissue for medical  
            research, education, and treatment. Most tissue banks get  
            their supply of body tissue through donation programs and  








                                                                  AB 995
                                                                  Page  2

            charge medical companies for the services associated with the  
            transportation, storage, and harvesting of tissue. Paying for  
            the tissue directly is illegal. Many academic medical centers  
            also offer training on cadaver specimens. Most of these  
            tissues are obtained through whole body donations.  

           2)Background  . There are 2,000 tissue banks nationally and about  
            500 in California. Tissue banks in California are licensed by  
            DPH and are charged an annual $975 licensing fee. This bill  
            increases the specificity and uniformity of compliance with  
            national standards. According to DPH the AATB oversight will  
            provide greater consistency and will reduce health risks  
            associated with non-standard handling of tissue bank  
            materials. 
           
           
          Analysis Prepared by  :    Mary Ader / APPR. / (916) 319-2081