BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                      SB 27


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          (Without Reference to File)





          SENATE THIRD READING


          SB  
          27 (Hill)


          As Amended  September 10, 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,        |                    |








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          |                |     |Wagner, Weber, Wood   |                    |
          |                |     |                      |                    |
          |----------------+-----+----------------------+--------------------|
          |Agriculture     |7-0  |Perea, Gallagher,     |                    |
          |                |     |Dodd, Irwin,          |                    |
          |                |     |Jones-Sawyer, Mathis, |                    |
          |                |     |Quirk                 |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |
           ------------------------------------------------------------------ 


          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; or 3) in relation  
          to surgery or a medical procedure. This bill allows for  
          prophylaxis to prevent the elevated risk of disease transmission  
          or infection and forbids the use of MIAMs for growth promotion  
          and feed efficiency. Specifically, this bill:  


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


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


             b)   Develop antimicrobial stewardship guidelines on good  
               management practices in consultation with the Veterinary  
               Medical Board (VMB), the California Department of Public  
               Health (DPH), universities, and cooperative extensions;  








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               and, 


             c)   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, this bill has:


          1)Estimated General (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  








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          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  
          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  
          MIAM sales, usage, management practices, and resistance.  


          According to supporters, many antimicrobials used in food  
          production are currently available at feed stores and online,  
          without any veterinary prescription or oversight and this bill  








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          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.  


          While recent amendments removed much of the opposition, those  
          still opposed argue this bill explicitly authorizes the routine  
          use of 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 surveillance of MIAM use in  
          food animal production needs to be mandatory.




          Analysis Prepared by:                                             
                          Victor Francovich / AGRI. / (916) 319-2084  FN:  
          0002319