BILL ANALYSIS                                                                                                                                                                                                    



                                                                       



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          |SENATE RULES COMMITTEE            |                  AB 1709|
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                                    CONSENT


          Bill No:  AB 1709
          Author:   Conway (R)
          Amended:  5/5/10 in Assembly
          Vote:     21

           
           SENATE FOOD AND AGRICULTURE COMMITTEE  :  5-0, 6/15/10
          AYES:  Florez, Emmerson, Hancock, Hollingsworth, Wolk

           SENATE APPROPRIATIONS COMMITTEE  :  Senate Rule 28.8

           ASSEMBLY FLOOR  :  72-0, 5/20/10 (Consent) - See last page  
            for vote


           SUBJECT  :    Biologics: animal blood and blood component  
          products: 
                      commercial blood banks for animals 

           SOURCE  :     Department of Food and Agriculture


           DIGEST  :    This bill deletes the current veterinary  
          biologics licensing law and replaces it with licensing  
          requirements for animal blood banks.

           ANALYSIS  :    The California Department of Food and  
          Agriculture (CDFA) Veterinary Biologics Program (biologics  
          program) was established in 1974 as a result of the 1971-72  
          Exotic Newcastle Disease outbreak in Southern California.   
          The program was modeled after the United States Department  
          of Agriculture's (USDA) Center for Veterinary Biologics  
          Program.  The program licensed biologics products used in  
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          California and ensured that all available veterinary  
          biologics were safe, pure, potent, and efficacious.  CDFA  
          has one veterinarian and $120,000 of General Fund dedicated  
          primarily to the biologics program.  Biologic products are  
          medications that activate an animal's immune system  
          response to fight off a disease.

          Current law defines biologics as: "the following products  
          which are used for the diagnosis and detection of and for  
          the prevention or treatment of, disease in animals other  
          than man:  serum, blood, vaccines, live vaccines, killed  
          vaccine, tissue vaccine, autogenous vaccine, live virus,  
          killed virus, live bacterial culture, killed bacterial  
          culture, bacterin, hormone, tissue extract, gland extract,  
          gland preparation, insulin, and similar products made from  
          human or animal tissues or microorganisms.  

          In 1985, the federal government amended the  
          Virus-Serum-Toxin Act authorizing USDA to regulate  
          intrastate, as well as interstate, movement of biological  
          products and broadened their authority to issue  
          regulations.  Regulations were implemented for an exemption  
          from the federal licensure for products produced under an  
          approved state program for exclusive use in the state.   
          California obtained USDA approval for this exemption and is  
          the only state currently holding this exemption for a state  
          biologics program.  

          Currently, there are three licensed biologic companies in  
          California that are also licensed under USDA's Center for  
          Veterinary Biologics Program.  There are 10 biologic  
          products that are licensed for use in California and could  
          be approved for use by USDA under conditional restricted  
          use in order for their continued use within California.  

          SB 1342 (Kuehl), Chapter 822, Statutes of 2002, establishes  
          additional protocols for commercial blood banks for animals  
          that are licensed by the CDFA.

          This bill:

          1. Prohibits a person from engaging in the production of  
             biologics unless they have a valid permit or license  
             from the USDA.

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          2. Requires the CDFA to submit to the Legislature by June  
             1, 2011, a report on the status of the transition of  
             biologics licenses to the federal government.  In  
             addition, requires CDFA to report annually on the  
             transition until all state licensed biologics businesses  
             have transitioned to the federal license. 

          3. States that this act will not become operative until all  
             California registered biologics businesses as of  
             December 31, 2010, obtain a conditional United States  
             Veterinary Biological Product License from USDA. 

           Comments
           
          CDFA is sponsoring this bill to eliminate the current state  
          biologics program without impacting the program for  
          commercial blood banks for animals and transition  
          California to the federal biologics program to address  
          funding shortfalls in the current state program.  Based on  
          a recent USDA audit of the California biologics program, it  
          is estimated that the cost to maintain a federally  
          compliant program would be approximately $428,000 and three  
          personnel years, further training or special recruitment at  
          higher salaries than are currently allowable, and  
          contracting with a private laboratory for regulatory  
          testing of products.  Without sufficient funding of this  
          bill, CDFA is unable to maintain sufficient oversight which  
          could result in a potentially disruptive action by USDA to  
          disallow the California exemption to the federal biologics  
          program.

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

           SUPPORT  :   (Verified  6/28/10)

          California Department of Food and Agriculture (source)
          Animal Blood Bank
          California Veterinary Medical Association

           
          ASSEMBLY FLOOR  : 
          AYES:  Adams, Ammiano, Anderson, Arambula, Bass, Beall,  

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                                                               AB 1709
                                                                Page  
          4

            Bill Berryhill, Tom Berryhill, Blakeslee, Block,  
            Blumenfield, Bradford, Brownley, Buchanan, Caballero,  
            Charles Calderon, Carter, Chesbro, Conway, Cook, Coto,  
            Davis, De Leon, DeVore, Emmerson, Eng, Feuer, Fong,  
            Fuentes, Fuller, Furutani, Gaines, Galgiani, Garrick,  
            Gilmore, Hagman, Hall, Hayashi, Hernandez, Hill, Huber,  
            Huffman, Jeffries, Jones, Knight, Lieu, Logue, Bonnie  
            Lowenthal, Ma, Mendoza, Miller, Monning, Nestande,  
            Niello, Nielsen, Norby, V. Manuel Perez, Portantino,  
            Ruskin, Salas, Saldana, Silva, Skinner, Smyth, Solorio,  
            Audra Strickland, Swanson, Torlakson, Torres, Torrico,  
            Tran, Yamada
          NO VOTE RECORDED:  De La Torre, Evans, Fletcher, Harkey,  
            Nava, Villines, John A. Perez, Vacancy


          TSM:do  6/29/10   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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