BILL ANALYSIS                                                                                                                                                                                                    



                                                                            



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                                    THIRD READING


          Bill No:  SB 835
          Author:   Hill (D)
          Amended:  3/26/14
          Vote:     21

           
           SENATE AGRICULTURE COMMITTEE  :  5-0, 4/1/14
          AYES:  Galgiani, Cannella, Berryhill, Lieu, Wolk

           SENATE APPROPRIATIONS COMMITTEE  :  Senate Rule 28.8


           SUBJECT  :    Food animals:  medically important antimicrobial  
          drugs

           SOURCE  :     Author


           DIGEST  :    This bill codifies the Food and Drug Administrations  
          (FDA) Guidance for Industry #213 dated December 2013 by  
          requiring the Secretary of the Department of Food and  
          Agriculture (DFA) to refuse to register a livestock drug  
          administered in the feed or drinking water of food animals if  
          such drug is a medically important antimicrobial drug.  Requires  
          a veterinarian-client-patient relationship, as described, to  
          exist prior to the use of a medically important antimicrobial  
          drug.

           ANALYSIS  :     Existing federal law:

          1.States the FDA is responsible for protecting public health by  
            assuring the safety, effectiveness, quality, and security of  
            human and veterinary drugs.
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          2.Establishes, within FDA, the Center for Veterinary Medicine  
            which regulates the manufacture and distribution of drugs that  
            will be administered to animals.

          Existing state law:

          1.Requires the Secretary of DFA to register over-the-counter  
            livestock drugs and regulate their use for safety and  
            efficacy.

          2.Requires a license for retail sales of restricted livestock  
            drugs.

          3.Requires each licensee shall keep a record of each sale of a  
            restricted drug, including the kind and quantity of the drug;  
            sale date; purchaser's name, address and signature; and any  
            other information deemed necessary by the Secretary.

          This bill:

          1.Codifies the FDA Guidance for Industry #213 dated December  
            2013. 

          2.Defines "medically important antimicrobial drug" to mean a  
            drug listed in the FDA Guidance for Industry #152 which  
            categorizes these drugs as critically important, highly  
            important, or important antimicrobial drugs.

          3.Requires the Secretary of DFA to refuse to register a  
            medically important antimicrobial drug administered to food  
            animals through feed or drinking water unless the drug  
            complies with the specified requirements below:

             A.   Requires drug manufacturers to remove from the label of  
               said drugs the approved use for growth promotion or feed  
               efficiency.

             B.   Requires drug manufacturers to change the  
               over-the-counter availability of said drugs to 1) requiring  
               a veterinary feed directive (VFD) if the drug is  
               administered in animal feed or 2) requiring a veterinary  
               prescription if the drug is administered in drinking water.


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             C.   Requires that medically important antimicrobial drugs  
               administered through feed or water may only be used under  
               the supervision of a veterinarian to treat, prevent, or  
               control disease.

          1.Requires a veterinarian-client-patient relationship to ensure  
            that medically important antimicrobial drugs are used  
            according to professionally accepted best practices.

          2.Requires drug manufacturers to comply with these provisions by  
            January 1, 2017, and reregister medically important  
            antimicrobial drugs with the Secretary of DFA.

          3.Authorizes the Secretary to continue registering a drug during  
            FDA's GFI #213 review period should the review be delayed  
            beyond January 1, 2017.

          4.Authorizes the Secretary to extend the implementation date if  
            revisions to the VFD cause FDA to delay implementation of GFI  
            #213.

          5.Authorizes the Secretary to promulgate regulations to ensure  
            that California regulations are consistent with GFI #213  
            should revisions to the VFD cause the FDA to revise GFI #213.

           Background
           
          The Centers for Disease Control and Prevention (CDC) recently  
          issued a report titled Antibiotic Resistance Threats in the  
          United States, 2013.  The CDC estimates that in the United  
          States more than two million people are sickened every year with  
          antibiotic-resistant infections with at least 23,000 infections  
          resulting in death.  In its report, the CDC lists four core  
          actions that fight the spread of antibiotic resistance:  1)  
          preventing infections from occurring and preventing resistant  
          bacteria from spreading, 2) tracking resistant bacteria, 3)  
          improving the use of antibiotics, and 4) promoting the  
          development of new antibiotics and new diagnostic tests for  
          resistant bacteria.  

          The CDC notes that the use of antibiotics is the single most  
          important factor leading to antibiotic resistance around the  
          world.  Up to 50% of all antibiotics prescribed for people are  
          either not needed or not optimally effective as prescribed.   

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          Antibiotics are also used in food-producing animals for the  
          purpose of promoting growth, which the CDC recommends phasing  
          out.  The FDA is currently developing guidance to promote  
          judicious use of antimicrobials, as described below.
           
          Over the last few years, the FDA has worked on creating  
          Guidelines for Industry (GFI) regarding the judicious use of  
          medically important antimicrobial drugs.  In a series of three  
          guidances, the FDA has compiled a list of medically important  
          antimicrobial drugs categorized by their importance to human  
          health (GFI #152), developed principals that determine the  
          appropriate or judicious use of such drugs by limiting use to  
          only when necessary to maintain animal health and with  
          veterinary oversight or consultation (GFI #219), and provided  
          recommendations as to the implementation of these guidelines  
          (GFI #213).  The FDA concludes that using medically important  
          antimicrobial drugs for animal growth promotion or feed  
          efficiency is not a judicious use and that veterinary oversight  
          or consultation is necessary when using these drugs.

          In December 2013, the FDA released the final draft of GFI #213.   
          This document contains nonbinding recommendations to industry  
          regarding the use of medically important 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 medically important 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.

           Prior Legislation
           
          SB 416 (Florez, 2009) would have authorized a school district to  
          make every effort to purchase poultry and meat products that  
          have not been treated with nontherapeutic antibiotics. SB 416  
          failed passage in the Senate.

          SB 1058 (Alquist, Chapter 296, Statutes of 2008) establishes the  
          Medical Facility Infection Control and Prevention Act, which  
          requires specified hospitals to implement procedures for  
          screening, prevention, and reporting of hospital-related  
          infections, including MRSA, an antimicrobial-resistant  

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          bacterium.

          SB 739 (Speier, Chapter 526, Statutes of 2006) establishes the  
          Hospital Infectious Disease Control Program, which requires the  
          Department of Public Health and specified hospitals to implement  
          a disease surveillance and hospital associated infection  
          prevention program.

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

           SUPPORT  :   (Verified  4/28/14)

          California Cattlemen's Association
          California State Grange
          California Veterinary Medical Association
          The Pew Charitable Trusts
          Infectious Disease Association of California
          Health Officers Association of California
          Health Care Without Harm

           OPPOSITION  :    (Verified  4/28/14)

          Consumers Union 

           ARGUMENTS IN SUPPORT  :    The California Veterinary Medical  
          Association writes in support of this bill stating that it  
          "?ensures that this important relationship between veterinarians  
          and food producers will continue to remain strong, in accordance  
          with the law."

          Health Care Without Harm states, "This bill helps protect public  
          health by ending the misuse of antibiotics for the purposes of  
          growth promotion in animal agriculture.  Moreover, it increases  
          medical oversight over our valuable drugs by requiring  
          prescriptions by veterinarians when antibiotics are administered  
          to animals through food and water."

           ARGUMENTS IN OPPOSITION  :    Consumers Union states in opposition  
          that under this bill, agribusiness would be able to continue the  
          regular feeding of antibiotics to animals, potentially every day  
          of their lives, for disease prevention.  To combat antibiotic  
          resistance, the daily feeding of antibiotics to animals must be  
          ended and that antibiotics should be used in animals in the way  

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          they are used in humans - only for treatment of a specific  
          illness, for a limited period of time.


          JL:nl  4/29/14   Senate Floor Analyses 

                           SUPPORT/OPPOSITION:  SEE ABOVE

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