BILL ANALYSIS                                                                                                                                                                                                    Ó



          SENATE COMMITTEE ON AGRICULTURE
                          Senator Cathleen Galgiani, Chair
                                2015 - 2016  Regular 

          Bill No:    SB 27                   Hearing Date:    4/21/15
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          |Author:    |Hill                                                 |
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          |Version:   |12/1/14                                              |
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          |Urgency:   |No                     |Fiscal:    |Yes              |
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          |Consultant:|Anne Megaro                                          |
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                      Subject:  Livestock:  use of antibiotics

           SUMMARY  :
          This bill would restrict the use of medically important  
          antimicrobial drugs in livestock for specified purposes and  
          require a veterinarian's prescription; require the California  
          Department of Food and Agriculture (CDFA) to develop a program  
          to track antimicrobial use in livestock and the emergence of  
          antibiotic-resistant bacteria; and require CDFA to adopt  
          judicious use regulations and antibiotic stewardship guidelines.  
           This bill would also create a new crime.  Violations of the  
          provisions would be a misdemeanor punishable by a $1,000 fine  
          and/or six months imprisonment in a county jail.

           BACKGROUND AND EXISTING  
          LAW  :
          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 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. 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,  







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          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.

          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.   
          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% of medically important  
          antimicrobial drugs are sold over-the-counter and not through a  
          veterinarian's prescription or feed directive.  The FDA  
          guidances will address this issue and others, as described in  
          further detail below.  

          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  








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          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, described later  
          in this analysis.

          The United States Department of Agriculture (USDA) currently  
          operates national laboratory systems that survey national animal  
          health and monitor antimicrobial resistance: the National Animal  
          Health Monitoring System (NAHMS) and the National Antimicrobial  
          Resistance Monitoring System (NARMS).  NAHMS was created in 1983  
          to collect and analyze data on animal health, management, and  
          productivity and to conduct national studies on livestock  
          populations. NAHMS is recognized as a statistical unit under the  
          Confidential Information Protection and Statistical Efficiency  
          Act (CIPSEA), which allows producers or livestock owners to  
          voluntarily provide sensitive and confidential information such  
          as on-farm management practices and animal health issues.  USDA  
          states that this is vital to encourage voluntary participation  
          and to maintain high response rates.

          NARMS was established in 1996 by the FDA in conjunction with the  
          CDC and USDA to monitor trends in antimicrobial resistance from  
          human, retail meat, and food animal samples. The goals and  
          objectives of NARMS' monitoring program are to monitor trends in  
          antimicrobial resistance among foodborne bacteria, conduct  
          research to better understand the emergence and spread of  
          resistant bacteria, and to assist the FDA in decision making for  
          the approval of antimicrobial drugs for animals.

          The California Animal Health and Food Safety (CAHFS) Laboratory  
          System, created as a partnership between CDFA and the UC Davis  
          School of Veterinary Medicine, is the state entity responsible  
          for providing rapid diagnostic testing for animal health  
          diseases, and those diseases that affect humans.  Most recently,  
          CAHFS has been involved in detecting avian influenza in both  








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          commercial and backyard poultry but also conducts testing on any  
          animal brought to the lab with other concerns such as poisoning  
          (melamine), salmonella or other bacterial infections, rabies,  
          and other serious health issues for both livestock and pets.   
          CAHFS is part of the National Animal Health Laboratory Network,  
          which has been included as a component of national surveillance  
          efforts in President Obama's Action Plan for combating  
          antimicrobial resistance.
           
          Existing federal law:  
          The Food and Drug Administration is responsible for protecting  
          public health by assuring the safety, effectiveness, quality,  
          and security of human and veterinary drugs.  Within FDA, the  
          Center for Veterinary Medicine regulates the manufacture and  
          distribution of drugs that will be administered to animals and  
          regulates medicated feed.

          The Animal Drug Availability Act enacted in 1996 created a new  
          regulatory category for certain animal drugs used in animal  
          feed.  Previously, drugs were only available through two means:  
          over-the-counter (OTC) and by prescription.  As new drugs  
          (antimicrobials) were developed, FDA recognized the need for  
          these drugs to be administered through feed.  However, FDA  
          wanted to establish greater control and safety measures than  
          were currently available under OTC status since some of these  
          drugs could contribute to drug toxicity and antimicrobial  
          resistance or have other unintended outcomes. Therefore, the  
          Veterinary Feed Directive (VFD) was created to allow more  
          flexibility for new animal drugs to be administered through  
          medicated feed but done so under the supervision of a licensed  
          veterinarian (78 Federal Register 75517, December 12, 2013).

          As concerns over antimicrobial resistance grew, the FDA created  
          guidelines for industry regarding the judicious use of medically  
          important antimicrobial drugs.  In December 2013, the FDA  
          released the final draft of the Guidance for Industry #213 (GFI  
          #213), which contains nonbinding recommendations regarding the  
          use of medically important antimicrobial drugs in the feed and  
          drinking water of food-producing animals. These recommendations  
          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)  
          veterinary oversight of these drugs when used in the feed or  
          water of food-producing animals.









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          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  
          believed to be critically important and are scheduled to be  
          completed before the three-year implementation timeline for GFI  
          #213.  
           
          Existing state law:
           CDFA, through the Livestock Drug Program, is also responsible  
          for regulating 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 (Food and Agricultural Code §14200 et  
          seq.).

          The California State Board of Pharmacy is responsible for  
          licensing, regulating and enforcing laws and regulations  
          regarding prescription drugs and drugs used exclusively by  
          veterinarians (Business and Professions Code § 4000 et seq.). 

           PROPOSED  
          LAW  :

           This bill:  
             1.   Provides definitions for both "medically important  
               antimicrobial drug" and "livestock."

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

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

             4.   Requires 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.  

             5.   Requires the new tracking program to report the  








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               following:
                  a.        Type of drug used.
                  b.        Number of livestock on which the drug was  
                    used.
                  c.        Livestock species.
                  d.        Duration of administration of the drug.
                  e.        Purpose for which the drug was administered. 

             6.   Requires CDFA, until March 1, 2020, to submit an annual  
               report to the legislature that summarizes the data from the  
               tracking program.

             7.   Requires 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.

             8.   Defines "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.

             9.   Creates 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.

           ARGUMENTS IN SUPPORT:  
          According to the author, "The overuse and misuse of antibiotics,  
          especially antibiotics important in human medicine, contributes  
          to antibiotic resistance as a growing public health threat.  
          Inappropriate antibiotic use and overuse in humans drives the  
          development of antibiotic resistance, but there is also a  
          concern about antibiotic use in livestock and poultry. Based on  
          the best information available from the federal Food and Drug  
          Administration (FDA), it's estimated that at least 70 percent of  
          all medically important antibiotics are sold for use in  
          livestock and poultry. [?]  The data available on antibiotic use  
          in livestock and poultry is in itself a problem; in large part,  
          many consider the data to be insufficient since the only data  
          collected is sales data. More, and better data, needs to be  
          collected to properly address this issue.  While there may be  
          data gaps about antibiotic use in livestock and poultry, we do  








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          know that under current law the majority of medically important  
          antibiotics may be sold for use in livestock and poultry without  
          veterinary oversight. [?] Antibiotic stewardship programs are a  
          commitment to always use antibiotics only when they are  
          necessary, to choose the right antibiotics and to administer  
          them in the right way in every case. Antibiotic stewardship  
          programs have been effective in reducing inappropriate  
          antibiotic use in humans, as well in reducing antibiotic  
          resistance. [?] However, there is no similar requirement that  
          veterinarians and livestock and poultry producers follow  
          antibiotic stewardship guidelines."

           ARGUMENTS IN OPPOSITION:  
          All of the organizations listed on this analysis with the  
          position of "oppose unless amended" have the same concern:  
          namely, that this bill does not go far enough to restrict the  
          use of antimicrobial drugs for preventative or routine uses in  
          livestock.  These organizations state that,  
          "Antibiotic-resistant infections can result in longer illnesses,  
          more hospitalizations, antibiotics with greater side-effects,  
          and even death when treatments fail.   Resistant infections are  
          estimated to cost the U.S. up to $61 billion annually in  
          additional health care costs and lost productivity.  Growing  
          resistance also puts complicated medical procedures such as  
          heart surgery, organ transplants, and chemotherapy in jeopardy"  
          due to reliance on effective antibiotics.  Furthermore, about  
          70% of all medically important antibiotics sold in the US are  
          used in livestock, where much of the use is to accelerate animal  
          growth and to offset risks created by the crowded and stressful  
          conditions at many livestock and poultry facilities.  "Medical,  
          veterinary, and scientific groups have called for an end to the  
          misuse and overuse of antibiotics in livestock to help combat  
          the rise of antibiotic resistance."

          The Consumers Union has similar concerns regarding the  
          preventative use of antimicrobial drugs, as well as the concern  
          that "the data reporting part of the bill does not require  
          reporting of total quantity of antibiotics used."

           COMMENTS  :

           Governor's Veto:   Governor Brown vetoed a previous version of  
          this bill in 2014 (SB 835, Hill).  In his veto message, Governor  
          Brown stated that "more needs to be done to understand and  
          reduce our reliance on antibiotics.  To that end, I am directing  








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          the Department of Food and Agriculture to work with the  
          Legislature to find new and effective ways to reduce the  
          unnecessary antibiotics used for livestock and poultry."  

           Work-in-progress:   The author and many of the stakeholder groups  
          are aware that this bill is a working draft and does not  
          represent the final language or all of the issues involved with  
          limiting antimicrobial use in livestock.  It is the committee's  
          understanding that, although conversations and negotiations have  
          been taking place since January, this bill is awaiting direction  
          from the governor's office before amendments will be adopted.   
          These stakeholder groups have expressed interest in continuing  
          to work with the author, and although many have chosen not to  
          provide position letters, the committee has received a letter  
          stating this intent from the California Veterinary Medical  
          Association. 

           Definitions:
           Antimicrobial vs. antibiotic: These terms tend to be used  
          interchangeably, however, they are not synonyms. Antibiotics are  
          drugs that are designed to attack bacteria; whereas,  
          antimicrobials (which include antibiotics) encompass a larger  
          class of drugs that affect not just bacteria but other  
          disease-causing microorganisms such as fungi, protozoa, viruses,  
          and parasites.  The scope of this bill and that of federal  
          actions are aimed toward reducing antimicrobial resistance, not  
          just antibiotic resistance.  These inconsistences are most  
          noticeable between the documents published by FDA  
          (antimicrobial) and the President's office (antibiotics). 

          Veterinarian-client-patient relationship: The California Code of  
          Regulations (16 CCR § 2032.1) requires a veterinarian to  
          establish a veterinarian-client-patient relationship before  
          administering, prescribing, dispensing, or furnishing a drug or  
          medicine.  This relationship is established when the  
          veterinarian has sufficient knowledge of the animal through an  
          examination or by medically appropriate and timely visits to the  
          premises where the animal is housed.  Additionally, a  
          veterinarian shall not prescribe a drug for longer than one-year  
          duration.  

           Outstanding issues:   The following is a brief summary of the  
          many outstanding issues that have yet to be resolved regarding  
          antimicrobial use in livestock.  This list may not be  
          comprehensive; however, it does represent the major issues of  








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          concern.

          Preventative and routine use: There is argument as to whether  
          antimicrobial drugs are being used judiciously when administered  
          to animals for the purpose of disease prevention.  The concern  
          relates to the use of antimicrobial drugs when a disease is not  
          clinically present and which could provide the opportunity for  
          the continual, prolonged, or routine use of antimicrobial drugs  
          in food animals.  According to those opposed to this bill unless  
          amended, SB 27 maintains a loophole that will allow the routine  
          use of antibiotics in animals that aren't sick and where the use  
          is not medically necessary.  For instance, this bill would not  
          prevent the routine use of antibiotics in animals where the  
          disease risk is elevated due to poor animal husbandry practices.  
           The Natural Resources Defense Council has been working on  
          amendments that would go farther than this bill and President  
          Obama's national Action Plan to prevent the use of antibiotics  
          for routine or preventative purposes.

          Conversely, the California Veterinary Medical Association is  
          concerned that if antimicrobial use is restricted then  
          veterinarians would be prevented from "making the best medical  
          decisions for the health and welfare of their patients.  There  
          are many instances where it is important to administer  
          antibiotics prophylactically, such as to prevent the active  
          spread of 'silent killer' diseases such as Chlamydophila abortus  
          in sheep, particularly when there is no test available to  
          determine which sheep are the carriers of the disease.   
          Veterinarians must have the flexibility to provide scientific  
          and medically appropriate treatment for animals under their  
          care."

          Tracking: The creation of an antimicrobial use and resistance  
          tracking program has expressed support from the Natural  
          Resources Defense Council, which believes that more data should  
          be collected and available given the amount of antimicrobials  
          used in feed and water.  Conversely, a tracking program is an  
          expressed concern of many of the agricultural stakeholders as  
          well as the California Veterinary Medical Association given that  
          the implementation of such a program is believed to be difficult  
          and expensive, and that many details and responsibilities not  
          specified in the current bill.  For instance, it is unclear  
          which entity would be required to report antimicrobial use: the  
          producer, veterinarian, slaughterhouse, feed mill, or other  
          entity.  Another great concern of these groups is  








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          confidentiality of this information, as previously described  
          with the NAHMS laboratory.  Furthermore, the federal government  
          is currently proposing an expanded nationwide antimicrobial use  
          and resistance surveillance program, as outlined in the United  
          States Department of Agriculture (USDA) Antimicrobial Resistance  
          Plan published in June 2014 and in President Obama's Action  
                    Plan.

          Over-the-counter accessibility: This bill would require that all  
          medically important antimicrobial drugs administered to  
          livestock be available through a veterinarian's prescription  
          only. (It is the author's intent that this 'prescription'  
          includes VFD as well, which will be clarified in the next  
          version of this bill).  However, there are concerns from the  
          cattle industry that this change will limit their ability to  
          obtain necessary medication for their livestock.  In some cases,  
          the ranch is located in a remote area where a veterinarian is  
          not readily available.  Furthermore, if the antimicrobial is no  
          longer available OTC at the local farm store and given that not  
          all pharmacies carry livestock drugs, there is concern that the  
          antimicrobial will not be available for purchase in a timely  
          manner.  However, the California Veterinary Medical Association  
          believes that "there should be veterinary supervision of  
          antimicrobial drugs in animals, since their improper use has  
          serious implications."

          Continuing education: The California Veterinary Medical  
          Association has proposed amendments that would make a course on  
          the judicious use of antimicrobial drugs a required component of  
          continuing education courses for veterinary license renewal.   
          Currently, veterinarians must complete 36 hours of continuing  
          education credits every two years as a requirement of license  
          renewal.  These classes allow veterinarians to stay current on  
          new therapies, studies, treatments, illnesses, technologies, and  
          other related issues; therefore if this amendment were adopted,  
          veterinarians would be required to attend an approved course on  
          the judicious use of antimicrobial drugs at least once every two  
          years (Business and Professions Code § 4846.5).

          Misdemeanor charges: Existing provisions within the Veterinary  
          Medicine Practice Act authorize the Veterinary Medical Board to  
          revoke or suspend a veterinarian's license and to assess a fine  
          up to $5,000 for unprofessional conduct including, but not  
          limited to, fraud, negligence, incompetence, animal cruelty, or  
          conviction of a crime in regards to dangerous drugs or  








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          controlled substances (Business and Professions Code § 4875 et  
          seq.). According to the California Veterinary Medical  
          Association, the creation of a misdemeanor crime for failure to  
          comply with this chapter would be unduly punitive given the  
          existing authority of the Veterinary Medical Board as previously  
          described.

          However, this misdemeanor charge would apply to all Californians  
          in violation of this chapter, not just veterinarians.  According  
          to the Business and Professions Code § 4831, any person who  
          violates any provisions of the Veterinary Medicine Practice Act  
          is guilty of a misdemeanor that is punishable by a fine of $500  
          to $2,000 and/or 30 days imprisonment in a county jail.

           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 the secretary of the California  
          Department of Food and Agriculture 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.  Vetoed.                                              

          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  








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          of medically important antimicrobial drugs.  Hearing canceled at  
          the request of the author; died in the Assembly Committee on  
          Agriculture.


           SUPPORT  :
          
          None received

           OPPOSE UNLESS AMENDED:
           
          CALPIRG
          California League of Conservation Voters
          California Public Health Association - North
          Center for Food Safety
          Dignity Health
          Environmental Working Group
          Food & Water Watch
          Food Chain Workers Alliance
          Health Care Without Harm
          Humane Society Veterinary Medical Association
          Natural Resources Defense Council
          Physicians for Social Responsibility, San Francisco Bay Area  
          Chapter
          Prevention Institute
          Roots of Change

           OPPOSITION  :
          
          Consumers Union

                                      -- END --