BILL ANALYSIS                                                                                                                                                                                                    Ó



          SENATE COMMITTEE ON APPROPRIATIONS
                             Senator Ricardo Lara, Chair
                            2015 - 2016  Regular  Session

          SB 27 (Hill) - Livestock:  use of antibiotics
          
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          |Version: December 1, 2014       |Policy Vote: AGRI. 3 - 0        |
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          |Urgency: No                     |Mandate: Yes                    |
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          |Hearing Date: May 4, 2015       |Consultant: Robert Ingenito     |
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          This bill meets the criteria for referral to the Suspense File.




          


          Bill  
          Summary: This bill would (1) restrict the use of antimicrobial  
          drugs in livestock for specified purposes and require a  
          veterinarian's prescription, (2) require the California  
          Department of Food and Agriculture (CDFA) to develop a program  
          to track both antimicrobial use in livestock and the emergence  
          of antibiotic-resistant bacteria, and (3) require CDFA to adopt  
          judicious use regulations and antibiotic stewardship guidelines.  
          Additionally, the bill would create a new crime, such that  
          violations of its provisions would be a misdemeanor punishable  
          by a fine and/or imprisonment in a county jail, as specified. 


          Fiscal  
          Impact: The precise fiscal impact of the bill's provisions to  







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          CDFA is unclear at this time. However, because of the bill's  
          requirements that CDFA (1) track specified data, (2) adopt  
          regulations, and (3) provide a specified report to the  
          Legislature, this bill would likely result in annual new costs  
          to CDFA in the hundreds of thousands of dollars minimally  
          (special fund).  


          Background: Antimicrobial drugs were first developed in 1928 and became  
          widely used in human medicine in the 1940s. These new drugs  
          quickly proved to have significant health benefits in both human  
          and animal medicine and to this day are extremely important and  
          valuable tools used to treat and prevent illness and infection.   
          However, incidences of antimicrobial resistance have been  
          recorded over time and, if not addressed, pose a serious threat  
          to public health.
          Antimicrobial resistance may develop for several reasons, and  
          one of the most widely accepted contributors to antimicrobial  
          resistance is the misuse of antimicrobial drugs.  When bacteria  
          are exposed to an antimicrobial drug, it provides the  
          opportunity for 'survival of the fittest' where only the  
          strongest, most immune bacteria survive.  These surviving  
          antimicrobial-resistant bacteria then multiply to form new  
          colonies of resistant bacteria that may spread and infect other  
          individuals.  For this reason, it is important to use  
          antimicrobial drugs judiciously in both human and animal  
          medicine as one method to mitigate resistance.


          In 2013, the Centers for Disease Control and Prevention (CDC)  
          issued a report titled Antibiotic Resistance Threats in the  
          United States. CDC estimates that, nationwide, more than two  
          million people are sickened every year with antibiotic-resistant  
          infections, 23,000 of which result in death. In its report, 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.  


          CDC notes that the use of antibiotics is the single most  
          important factor leading to antibiotic resistance around the  








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          world. Up to 50 percent of all antibiotics prescribed for people  
          are either not needed or not optimally effective as prescribed.   
          Antibiotics are also used in food-producing animals for the  
          purpose of promoting growth, which the CDC recommends phasing  
          out.  The US Food and Drug Administration (FDA) has developed  
          guidances to promote judicious use of antimicrobials that would  
          prohibit their use for improved feed efficiency or increased  
          weight gain. According to the FDA's annual report on  
          antimicrobial sales for animal use, 97 percent of medically  
          important antimicrobial drugs are sold over-the-counter and not  
          through a veterinarian's prescription or feed directive.  


          September 18, 2014, President Obama issued Executive Order  
          13676: Combating Antibiotic-Resistant Bacteria, which states  
          that this is an issue of national security and that "the Federal  
          Government will work domestically and internationally to detect,  
          prevent, and control illness and death related to  
          antibiotic-resistant infections by implementing measures that  
          reduce the emergence and spread of antibiotic-resistant bacteria  
          and help ensure the continued availability of effective  
          therapeutics for the treatment of bacterial infections."  Later  
          that same month, the White House issued the National Strategy  
          for Combating Antibiotic-Resistant Bacteria, and in March 2015,  
          the White House issued the National Action Plan for Combating  
          Antibiotic-Resistant Bacteria (Action Plan). The Action Plan  
          lays out a five-year plan with five distinct goals: 1) slow the  
          emergence of resistant bacteria, 2) strengthen One-Health  
          surveillance efforts, 3) advance the development and use of  
          rapid diagnostic tests to identify resistant bacteria, 4)  
          accelerate the development of new antibiotics, other treatments,  
          and vaccines, and 5) improve international collaboration to  
          achieve these goals.  For antimicrobial use in food animals  
          (livestock), the Action Plan seeks to implement FDA's guidances  
          for industry.




          Proposed Law:  
          This bill would, among other things, do the following:
                 Provide definitions for both "medically important  
               antimicrobial drug" and "livestock."









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                 Prohibit the administration of a medically important  
               antimicrobial drug unless prescribed by a veterinarian that  
               has established a veterinarian-client-patient relationship.


                 Prohibit the use of a medically important antimicrobial  
               drug for the sole purpose of increasing weight gain or  
               improving feed efficiency.


                 Require CDFA to develop a program to track the use of  
               medically important antimicrobial drugs in livestock as  
               well as antibiotic-resistant bacteria and patterns of  
               emerging resistance, and report specified information.


                 Require CDFA, until March 1, 2020, to submit an annual  
               report to the Legislature that summarizes the data from the  
               tracking program.


                 Require CDFA to adopt regulations to promote the  
               judicious use of medically important antimicrobial drugs in  
               livestock.  Regulations shall include antibiotic  
               stewardship guidelines that include rules on the proper use  
               of medically important antimicrobial drugs for disease  
               prevention.


                 Define "antibiotic stewardship" as a commitment to: a)  
               use medically important antimicrobial drugs only when  
               necessary to treat and, in some cases, prevent disease and  
               b) to choose and administer the appropriate medically  
               important antimicrobial drug correctly each time.


                 Create a new crime by making a violation of this chapter  
               a misdemeanor punishable by up to six months in county jail  
               and/or a fine not exceeding $1,000.












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          Related  
          Legislation:
                 SB 770 (Mendoza) of 2015. This bill would require the  
               California Department of Food and Agriculture to continue  
               to be the primary regulatory agency responsible for  
               regulating medicated feed.  This bill is currently on Third  
               Reading on the Senate Floor.


                 AB 49 (Mullin) of 2015. This bill would make findings  
               and declarations regarding antibiotic use in food-producing  
               animals and would state the intent of the legislature to  
               enact legislation that would address the overuse of  
               antibiotics in livestock production.  This bill has not yet  
               been assigned to a committee.


                 SB 835 (Hill) of 2014. This bill would have codified the  
               Food and Drug Administration's Guidance for Industry #213,  
               dated December 2013, by requiring CDFA 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. The bill was vetoed by the  
               Governor.


                 AB 1437 (Mullin) of 2014. This bill would have  
               prohibited the sale of poultry or livestock in California  
               if a medically important antimicrobial drug had been  
               administered to the animal for nontherapeutic use such as  
               growth promotion, feed efficiency, weight gain, or disease  
               prevention.  This bill would have required producers to  
               maintain records and slaughter facilities to report  
               specified information in regards to the use of medically  
               important antimicrobial drugs.  Hearing canceled at the  
               request of the author; died in the Assembly Committee on  
               Agriculture.




          Staff  
          Comments:  As noted above, the Governor vetoed a previous  
          version of this bill in 2014 (SB 835, Hill).  In his veto  








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          message, Governor Brown stated that "more needs to be done to  
          understand and reduce our reliance on antibiotics.  To that end,  
          I am directing CDFA to work with the Legislature to find new and  
          effective ways to reduce the unnecessary antibiotics used for  
          livestock and poultry."  As was discussed when the bill had its  
          hearing before the Senate Agriculture Committee, the current  
          version of the bill is generally considered to be a working  
          draft, and is currently awaiting input from the Administration.


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