BILL ANALYSIS                                                                                                                                                                                                    Ó



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          SENATE THIRD READING


          SB  
          27 (Hill)


          As Amended  August 31, 2015


          Majority vote


          SENATE VOTE:  25-10


           ------------------------------------------------------------------ 
          |Committee       |Votes|Ayes                  |Noes                |
          |                |     |                      |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |
          |----------------+-----+----------------------+--------------------|
          |Agriculture     |7-1  |Perea, Gallagher,     |Grove               |
          |                |     |Cooper, Dodd, Eggman, |                    |
          |                |     |Irwin, Salas          |                    |
          |                |     |                      |                    |
          |----------------+-----+----------------------+--------------------|
          |Appropriations  |15-0 |Gomez, Bloom, Bonta,  |                    |
          |                |     |Calderon, Chang,      |                    |
          |                |     |Nazarian, Eggman,     |                    |
          |                |     |Gallagher,            |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |
          |                |     |Eduardo Garcia,       |                    |
          |                |     |Holden, Jones,        |                    |
          |                |     |Rendon, Wagner,       |                    |
          |                |     |Weber, Wood           |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |








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          SUMMARY:  Prohibits, beginning January 1, 2018, the use of  
          medically important anti-microbial drugs (MIAMs) for the  
          treatment of livestock animals, except pursuant to a  
          prescription or feed directive from a licensed veterinarian and  
          when, in the professional judgment of a licensed veterinarian,  
          the MIAMs are necessary:  1) to treat a disease or infection; 2)  
          to control the spread of disease or infection; 3) in relation to  
          surgery or a medical procedure; or 4) as prophylaxis to prevent  
          the transmission of disease or infection in specific situations.  
           This bill forbids the use of MIAMs for growth promotion and  
          feed efficiency.


          In order to implement and monitor compliance with the MIAM  
          rules, this bill requires the California Department of Food and  
          Agriculture (CDFA) to:


          1)Coordinate with the federal Food and Drug Administration (FDA)  
            to develop a program to track antimicrobial drug sales, use,  
            resistance, and management practices;


          2)Develop antimicrobial stewardship guidelines on good  
            management practices in consultation with the Veterinary  
            Medical Board (VMB), the Department of Public Health (DPH),  
            universities, and Cooperative Extensions; and, 


          3)Conduct outreach and training, and report to the Legislature  
            by January 1, 2019, the results of outreach and monitoring  
            activities.


          FISCAL EFFECT:  According to the Assembly Appropriations  
          Committee:








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          1)Estimated General Fund (GF) and Special Fund (SF) costs of  
            approximately $864,000 in 2015-16 and $4.8 million in 2016-17  
            to develop programs, stewardship guidelines, monitoring  
            systems and procedures, and regulations, as well as begin  
            training, inspections, and MIAMs use tracking.  Annual GF and  
            SF costs of approximately $4.3 million thereafter to continue  
            training, inspections, and tracking.  Some of these costs may  
            be funded from federal and local sources, and potentially  
            offset in part with civil fine revenue.


          2)Potentially significant costs to VMB and DPH to help develop  
            stewardship guidelines and training materials.


          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.


          The Centers for Disease Control and Prevention (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.  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.  Antibiotics are also  
          used in food-producing animals for the purpose of promoting  
          growth, which CDC recommends phasing out. 


          The FDA has issued several industry recommendations regarding  








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          the use of MIAMs in the feed and drinking water of  
          food-producing animals.  The recommendations contained in  
          Guidance for Industry #152, #213, and #219 establish lists of  
          antibiotics important to human health, promote judicious use of  
          those drugs in food production, and encourage veterinary  
          oversight to ensure compliance with industry best practices.


          In March 2015, President Obama issued a national action plan on  
          combating antibiotic-resistant bacteria.  The five-year action  
          plan articulated goals of slowing the emergence of resistant  
          bacteria, strengthening surveillance efforts, advancing the  
          development and use of rapid diagnostics to identify resistant  
          bacteria, accelerate development of new antibiotics, treatments,  
          and vaccines, and improve collaboration among stakeholders.  For  
          antimicrobial use in food animals, the plan seeks to implement  
          FDA guidance.


          According to the author, overuse and misuse of antibiotics in  
          livestock animals, especially antibiotics important in human  
          medicine, contributes to antibiotic resistance.  To address the  
          overuse and misuse, this bill is intended to ensure veterinary  
          oversight; encourage judicious use of MIAMS and prohibit use for  
          growth promotion and other nontherapeutic purposes; and, monitor  
          MAIM sales, usage, management practices, and resistance.  


          According to the supporters many antimicrobials used in food  
          production are currently available at feed stores and online,  
          without any veterinary prescription or oversight and this bill  
          will stop this practice along with making all use of MIAMs  
          require a prescription.  Furthermore, supporters argue the  
          prophylactic use exception has been carefully crafted for  
          judicious use of MIAMs, and the bill explicitly forbids MIAM use  
          for growth promotion and feed efficiency.  


          Opponents argue this explicitly authorizes the routine use of  








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          antibiotics on animals that are not sick through the exception  
          for prophylactic use to prevent disease transmission or  
          infection.  Opponents fear prophylactic use will allow back door  
          use for nontherapeutic purposes, and is precisely the low-dose  
          use that contributes most to resistant bacteria.  Furthermore,  
          opponents assert that the expanded surveillance of MIAM relies  
          on voluntary cooperation from participants to gather samples and  
          is insufficient to provide statistically significant or accurate  
          data on actual MIAM use and resistance.




          Analysis Prepared by:                                             
                          Victor Francovich / AGRI. / (916) 319-2084  FN:  
          0001679