BILL ANALYSIS                                                                                                                                                                                                    






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          |SENATE RULES COMMITTEE            |                        SB 770|
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          |(916) 651-1520    Fax: (916)      |                              |
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                                   THIRD READING 


          Bill No:  SB 770
          Author:   Mendoza (D)
          Introduced:2/27/15  
          Vote:     21  

          SENATE AGRICULTURE COMMITTEE:  5-0, 4/7/15
          AYES:  Galgiani, Cannella, Berryhill, Pan, Wolk

           SUBJECT:   Department of Food and Agriculture:  medicated feed


          SOURCE:    California Grain and Feed Association
          
          DIGEST:  This bill requires the California Department of Food  
          and Agriculture to continue to be the primary regulatory agency  
          responsible for regulating medicated feed.

          ANALYSIS:   Existing federal law authorizes the Food and Drug  
          Administration (FDA) to protect public health by assuring the  
          safety, effectiveness, quality, and security of human and  
          veterinary drugs.  Within FDA, the Center for Veterinary  
          Medicine regulates the manufacture and distribution of drugs  
          that will be administered to animals, as well as medicated feed.

          Existing state law:

          1)Requires the California Department of Food and Agriculture  
            (CDFA), through the Feed Inspection Program, to regulate the  
            manufacture of commercial feed through the establishment of  
            good manufacturing practices, hazard analysis, and preventive  
            control measures.  This includes medicated feed premixes and  
            medicated feeds, where regulations shall be based upon federal  
            food and drug laws and regulations (Food and Agricultural Code  








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             14901 et seq.). 

          2)Requires CDFA, through the Livestock Drug Program, to regulate  
            the manufacture, sale, registration, and use of livestock  
            drugs, except when the livestock drug is sold by prescription  
            only, used exclusively by a veterinarian, or used only under a  
            veterinarian's direction. CDFA is required to register  
            over-the-counter livestock drugs and regulate their use for  
            safety and efficacy (Food and Agricultural Code 14200 et  
            seq.).

          3)Authorizes the California State Board of Pharmacy to license,  
            regulate and enforce laws and regulations regarding  
            prescription drugs and drugs used exclusively by veterinarians  
            (Business and Professions Code  4000 et seq.). 

          This bill:

          1)States findings and declarations regarding medicated feed,  
            consolidating governance expertise, and coordination with the  
            federal government on the implementation of feed safety laws  
            such as the federal Food Safety Modernization Act.

          2)Requires CDFA, notwithstanding any other law, to be the  
            primary state agency responsible for regulating medicated  
            feed, including medicated feed quality assurance and safety,  
            and enforcing any handling and inspecting requirements imposed  
            on medicated feed suppliers.

          3)Requires CDFA, notwithstanding any other law, to be the  
            primary state agency responsible for overseeing medicated feed  
            ingredients and the sale of medicated feed that is subject to  
            veterinarian oversight.

          Background

          Antimicrobial resistance:  In December 2013, the FDA released  
          the final draft of the Guidance for Industry #213 (GFI #213),  
          which contains nonbinding recommendations regarding the use of  
          medically important antimicrobial drugs in the feed and drinking  
          water of food-producing animals. These recommendations include:  
          1) phasing out the use of medically important antimicrobial  
          drugs in food-producing animals for production purposes (growth  
          promotion and feed efficiency) and 2) veterinary oversight of  







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          these drugs when used in the feed or water of food-producing  
          animals.
           
           Drug accessibility:  Currently, antimicrobial drugs may be  
          obtained one of three ways: over-the-counter (OTC), through a  
          veterinarian's prescription, or through a veterinary feed  
          directive (VFD) which does not require a prescription but does  
          require veterinary oversight of a food-animal drug that is  
          administered through feed or drinking water.  The FDA's GFI #213  
          would change the status of antimicrobial drugs administered in  
          feed from OTC to VFD.  Due to this change, the FDA recognizes  
          that current VFD regulations must be revised and streamlined to  
          minimize the impact on veterinarians, the animal feed industry,  
          and producers.  These revisions are believed to be critically  
          important and are scheduled to be completed before the  
          three-year implementation timeline for GFI #213.  

          Comments

          Feed authority:  CDFA currently serves as the regulatory and  
          enforcement authority on livestock feed and has the expertise  
          required to inspect, test, and verify that feed is safe and  
          meets all quality assurance and handling and inspection  
          requirements.  However, there are concerns that future state or  
          federal laws could change the status of certain drugs (i.e.  
          antimicrobials) from OTC to VFD or prescription, which could  
          transfer the jurisdiction of medicated feed to the California  
          State Board of Pharmacy, which does not have experience  
          regulating feed manufacturers.  This issue was discussed but not  
          fully addressed in SB 835 (Hill, 2014), which was vetoed, and it  
          remains a concern for both the feed and livestock industries.

          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:NoLocal:    No


          SUPPORT:   (Verified4/7/15)


          California Grain and Feed Association (source)
          Agricultural Council of California
          Animal Health Institute
          Association of California Egg Farmers
          California Cattlemen's Association







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          California Farm Bureau Federation
          California Pork Producers Association
          California Poultry Federation
          Pacific Egg and Poultry Association


          OPPOSITION:   (Verified4/7/15)




          None received




          ARGUMENTS IN SUPPORT:     According to the author, "Federal and  
          state legislation is currently being proposed that will transfer  
          the responsibility of defining the usage of drugs or food  
          additives added to commercial feed to the California State Board  
          of Pharmacy (CBOP). Should this occur, this transfer will create  
          a situation wherein feed manufacturers could be subject to  
          inspections by two different agencies - CDFA and CBOP.  SB 770  
          ensures that the California Department of Food and Agriculture  
          (CDFA) will continue to oversee the manufacture and use of  
          medicated feed in California, regardless of which agency  
          regulates the medication being fed." [sic]

          According to the sponsor, "Because there is an existing  
          Commercial feed program with licensed and trained inspectors,  
          retaining the oversight of the inspection and regulation of the  
          feed mills within CDFA will increase efficiency and cost  
          effectiveness of the program and provide well trained staff.   
          Feed mills are complex manufacturing facilities and in order to  
          have effective regulations, we need inspectors that understand  
          the feed manufacturing process."



          Prepared by:Anne Megaro / AGRI. / (916) 651-1508
          4/8/15 15:13:12


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