BILL ANALYSIS                                                                                                                                                                                                    



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          Date of Hearing:  July 1, 2015 


                          ASSEMBLY COMMITTEE ON AGRICULTURE


                                 Henry Perea, Chair


          SB  
          770 (Mendoza) - As Amended April 29, 2015


          SENATE VOTE:  36-0


          SUBJECT:  Department of Food and Agriculture: medicated feed.


          SUMMARY:  This bill requires the California Department of Food  
          and Agriculture (CDFA) to continue to be the primary regulatory  
          agency responsible for regulating medicated feed.  Specifically,  
          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,  
            including the federal Food and Drug Administration's (FDA)  
            guidance for industry (GIF) on the judicious use of  
            antimicrobial drugs in livestock.



          2)Requires CDFA 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.









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


          EXISTING LAW:    





          Federal law:





          1)Authorizes FDA to protect public health by ensuring the  
            safety, effectiveness, quality, and security of human and  
            veterinary drugs.  



          2)Authorizes the Center for Veterinary Medicine, within FDA, to  
            regulate the manufacture and distribution of drugs that will  
            be administered to animals, as well as medicated feed.

          State law:

          1)Requires 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.









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          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.



          3)Authorizes the California State Board of Pharmacy (CBOP) to  
            license, regulate and enforce laws and regulations regarding  
            prescription drugs and drugs used exclusively by  
            veterinarians. 


          FISCAL EFFECT:  Unknown.  This bill has been keyed fiscal by  
          Legislative Counsel.  


          COMMENTS:  Antimicrobial drugs have been widely used in human  
          medicine since the 1940s.  Antimicrobial drugs have significant  
          health benefits in both human and animal medicine, and are  
          important and valuable tools used to treat and prevent illness  
          and infection.  Incidences of antimicrobial resistance have been  
          recorded over time and, if left unchecked, pose a threat to  
          public health.





          CDC notes that the use of antimicrobial is the single most  
          important factor leading to antimicrobial resistance around the  
          world.  Up to 50% of all antibiotics prescribed for people are  
          either not needed or not optimally effective as prescribed.   
          Antimicrobials are also used in food-producing animals for the  
          purpose of promoting growth, which CDC recommends phasing out.  









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          In the past decade, FDA has worked on creating GFIs regarding  
          the judicious use of antimicrobial drugs in food producing  
          animals.  In December 2013, FDA released the final draft of GFI  
          #213.  GFI #213 contains nonbinding recommendations to industry  
          regarding the use of antimicrobial drugs in the feed and  
          drinking water of food-producing animals.  The FDA intends to  
          work with drug companies to help them voluntarily implement the  
          recommendations, which include:  1) phasing out the use of  
          antimicrobial drugs in food-producing animals for production  
          purposes (growth promotion and feed efficiency); and, 2) include  
          veterinary oversight of these drugs when used in the feed or  
          water of food-producing animals.





          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 scheduled to be completed before  
          the three-year implementation timeline for GFI #213.  





          CDFA currently serves as the regulatory and enforcement  








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          authority on livestock feed and has the expertise required to  
          verify that feed is safe and meets all quality assurance and  
          handling and inspection requirements.  There are concerns that  
          future state or federal laws could change the status of  
          antimicrobials from OTC to VFD or prescription, which could  
          transfer the jurisdiction of medicated feed to CBOP, which does  
          not have experience regulating feed manufacturers.  





          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 CBOP.  This transfer will create a situation  
          wherein feed manufacturers could be subject to inspections by  
          two different agencies - CDFA and CBOP.  Furthermore, supporters  
          state the existing commercial feed program 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. Supporters state  
          that feed mills are complex manufacturing facilities and in  
          order to have effective regulations and need inspectors that  
          understand the feed manufacturing process. This bill ensures  
          that CDFA will continue to oversee the manufacture and use of  
          medicated feed in California, regardless of which agency  
          regulates the medication being fed.


          REGISTERED SUPPORT / OPPOSITION:




          Support


          California Grain and Feed Association (Sponsor) 








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          California Farm Bureau Federation 


          Agricultural Council of California 


          Association of California Egg Farmers 


          California Cattlemen's Association 


          California Farm Bureau Federation 


          California Pork Producers Association 


          California Poultry Federation 


          Pacific Egg and Poultry Association




          Opposition


          None on file.




          Analysis Prepared by:Victor Francovich / AGRI. / (916)  
          319-2084









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