BILL ANALYSIS                                                                                                                                                                                                    

                                                                  AB 1709
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          Date of Hearing:   April 14, 2010

                           ASSEMBLY COMMITTEE ON AGRICULTURE
                                Cathleen Galgiani, Chair
                      AB 1709 (Conway) - As Amended:  April 5, 2010
          SUBJECT  :  Biologics: animal blood and blood component products:  
          commercial blood banks for animals.

           SUMMARY  :  Deletes the existing state biologics licensure law,  
          recasting it to cover animal blood and blood components and  
          products; makes biologics production and biologics products subject  
          to federal authority and permitting, in lieu of the state.   
          Specifically,  this bill  :  

          1)Recasts the definition of "Biologics" to mean all viruses serum,  
            antibody, toxins (except for antibiotics) or analogous products  
            at any stage of production through sale which are intended for  
            use in the treatment of animals and act through direct  
            stimulation, supplementation, enhancement, or modulation of the  
            immune system or immune response.

          2)Adds the definition of "Blood and blood components products" to  
            mean whole blood collected directly from a donor animal for  
            transfusion or blood components for transfusion including packed  
            red blood cells, platelet-rich plasma, platelet concentrates,  
            fresh plasma, fresh frozen plasma, frozen plasma, cryoprecipitate  
            and cryosupernatant.  Antibody products are considered  
            "biologics" and are excluded from this definition.

          3)Changes the definition of "Production", strikes references to  
            "biologics" and replaces it with "blood and blood component  
            products produced for the purpose of transfusion."

          4)Deletes the definition of "Serial."

          5)Adds the definition for "Commercial blood bank for animals" to  
            mean establishments that produce animal blood or blood component  
            products to market and sell for use in the care, mitigation,  
            treatment, or prevention of disease in animals.

          6)Renames the Article from "Biologics Production" to "Animal Blood  
            and Blood Component Products Production and Biologics  


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          7)Requires all engaged in the production of animal blood and blood  
            component products for retail sale and distribution, except in a  
            commercial blood bank for animals, to be licensed by the  
            California Department of Food and Agriculture (CDFA).

          8)Requires all engaged in the production of biologics to be in  
            accordance with federal law and deletes the exemption for their  
            production and use by an owner or operator of a facility of  
            animals owned by him or her, or licensed by CDFA.

          9)Creates the license for commercial blood banks for animals while  
            deleting the license for biologic facilities meeting the  
            following conditions:

             a)   Operate under conditions that ensure animal blood and blood  
               components, rather than biologics, will not be contaminated,  
               dangerous, or harmful;

             b)   Produce animal blood and blood components rather than  
               biologics under direct supervision of a person qualified in  
               the field; and,

             c)   Maintain onsite records of the animal histories of draws.

          10)Makes conforming changes replacing "biologics" with "animal  
            blood and blood components," and striking redundant language.

          11)Restricts the sale or use of biologics unless they are  
            manufactured pursuant to a valid permit issued by the United  
            States Department of Agriculture (USDA) and animal blood and  
            blood components must be produced in a facility licensed by CDFA.

          12)Deletes the requirement to register biologic production that was  
            exempt form licensure.

           EXISTING LAW  provided definitions, licensure and prohibitions on  
          the production and use of biologics used in the prevention or  
          treatment of, disease in animals, other than man.  (Food and  
          Agricultural Code, Chapter 1.5 (commencing with Section 9201) of  
          Part 1, Division 5.)

          Amendments to the federal Virus-Serum-Toxic Act of 1985 authorized  
          USDA to regulate intrastate and interstate movement of biologics  
          products.  The Code of Federal Regulations (9CFR 107.2) authorized  
          an exemption from federal licensure for products produced under  


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          approved state programs for exclusive use within the respective  
          state.  (California holds this exemption.)

           FISCAL EFFECT  :  This bill is keyed "fiscal" by Legislative Counsel.  

           COMMENTS  :  CDFA has sponsored AB 1709, which proposes to eliminate  
          the statutes for biologics that allow a state exemption from USDA  
          authority for the use and production of animal disease prevention  
          and treatment products within California.  California is the only  
          state that continues to have this federal exemption for these  
          products.  According to CDFA, there are currently three firms  
          licensed by CDFA and producing biologic products in California and  
          they also hold federal licenses for the production of these  

          A recent USDA audit of CDFA's current program found that funding  
          shortfalls have jeopardized their ability to perform the needed  
          specialty training, laboratory testing, and regulatory enforcement  
          activities, to ensure the consumers that these products meet the  
          requirements of being pure, safe, potent and efficacious.  Further,  
          it is stated by CDFA that USDA has agreed to provide a transition  
          period to all companies and assist with the transition of those  
          products currently registered with CDFA over to USDA, and these  
          products will remain available during the transition according to  

          This program was created in 1974 as a result of the 1971-72 Exotic  
          Newcastle Disease outbreak in southern California and modeled after  
          USDA's Center for Veterinary Biologics program.  If CDFA were to  
          continue this program, they estimate needing an additional $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, in  
          order to maintain a federally compliant 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.  This would require the State  
          Veterinarian to make a recommendation to USDA for the need of these  
          regional products.  Biologic products are medications that activate  
          an animal's immune system response to fight off a disease.


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          The committee may wish to ask the sponsor if such a recommendation  
          would be coming from the State Veterinarian, in order to ensure the  
          continuation of these products.  Another issue of concern is the  
          fact that many of these products have been approved for many years  
          and the information used for their approval may not be available  
          for resubmission to USDA, causing the need to do new testing and  
          research in order to meet the requirements for licensure.  With  
          many of these products, while they are critical to the industry,  
          are not produced in large enough quantities to make it financially  
          feasible to pay for the cost of retesting and research for their  
          approval, causing some manufacturers to drop those products.  The  
          committee may wish to ask the sponsor if this could occur, and if  
          so, what alternatives does the industry have to provide disease  
          control in their animals?
          Further, these companies are licensed to produce "autogenous  
          vaccines" which deal specifically with a particular flock or herd  
          of animals.  Once they are approved for these autogenous vaccines  
          they may continue to produce them.  Autogenous vaccines are not  
          industrially mass-produced vaccines but autogenous vaccines are  
          individual, specific, so to say tailor-made vaccines for specific  
          areas or regions.  Autogenous vaccines are:  flock or herd  
          specific; pathogen specific; and, assistance for the immune system.  
           These pathogens are obtained from an infected flock or herd by  
          swab are carefully inactivated and finally administered to the  
          flock or herd again.  By this procedure, the animals' immunity is  
          influenced in such a way  that the infection gets healed or at  
          least alleviated.  The success of a therapy with autogenous  
          vaccines thus depends on the capture of the "right" pathogen and  
          has a limited life expectancy before the right pathogen has to  
          recaptured and the autogenous vaccine redeveloped.

          Currently, there are two state licensed blood banks that produce 11  
          blood products.  A blood product treats medical conditions dealing  
          with the blood supply of an animal.  Blood products that are live  
          vaccines must be treated as such for licensing purposes.  The  
          committee may wish to clarify if these types of products would be  
          licensed by CDFA or USDA, and if by USDA, would there be a cost,  
          and what would that be, to have them licensed?



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          California Department of Food and Agriculture (Sponsor)

          None on file.

           Analysis Prepared by  :    Jim Collin / AGRI. / (916) 319-2084